TRAINING

MODULES (1-4)
FOR
PROGRAMME MANAGERS &
MEDICAL OFFICERS

National TB Elimination Programme

Central TB Division
Ministry of Health & Family Welfare,
Government of India, New Delhi
TRAINING
MODULES (1-4)
FOR
PROGRAMME MANAGERS &
MEDICAL OFFICERS
TRAINING MODULES (1-4) FOR PROGRAMME MANAGERS AND MEDICAL OFFICERS
© Central TB Division, Ministry of Health and Family Welfare (MoHFW), Government of India 2020

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Contents
Abbreviations I

MODULE 1
Learning Objective 1
Introduction 2
Pathogenesis of TB 3
Magnitude of TB 4
Annual Risk of Tuberculosis Infection (ARTI) 4
HIV co-infection among TB patients 5
Drug-resistant tuberculosis (DR-TB) 5
Findings of National Drug Resistance Survey (NDRS) India - 2014-16 6
Socio-economic impact of TB 7
Evolution of Revised National Tuberculosis Control Programme 7
Standards for TB Care in India 10
END TB STRATEGY- A holistic approach to end TB 12
Pillars and Components 13
National Strategic Plan 2017-25 14
Vision, Goals and Targets of NSP 14
Results Framework (impact and outcome indicators and targets) 15
Health System structure & functions for delivery of TB care 16
NTEP Organogram 17
- National Level 17
- State Level 17
- Organization structure 18
- District Level 18
- Sub-District Level (Tuberculosis Unit Level) `18
-Peripheral Health Institutions (PHIs) 19
TB Laboratory Services 19
Model of Care 21
Work exercises 21

MODULE 2
Learning Objectives 22
Section A: Overview of Diagnostics 22
Section B: External Quality Assurance of Diagnostic services 22
Introduction 23
Denitions 23
Importance of properly identifying Presumptive TB cases 24
Screening of vulnerable population 24
Screening of Presumptive Pulmonary TB patients 25
Referral for sputum examination 26
Diagnostic tools 27
Other diagnostic tools 28
Sputum Smear Microscopy 29
Rapid diagnostic tools include 29
Line Probe Assay (LPA) 29
Process of diagnosis of pulmonary TB 29
Case Denitions 30
Classication based on anatomical site of disease 30
Classication based on history of previous TB treatment 30
Diagnostic Algorithm for Drug Sensitive TB 31
Diagnosis of TB among children 33
Diagnostic algorithm for Pediatric Pulmonary Tuberculosis 34
Extra-pulmonary TB 36
Diagnosis of Extra-Pulmonary TB 37
Diagnostic Algorithm for Extra Pulmonary TB 37
Diagnosis of Drug Resistance TB (DR-TB) 38
Integrated drug-resistant TB algorithm 39
Classication based on drug resistance 40
Collection of sputum from Presumptive Tuberculosis cases 40
Guidelines for collecting sputum 40
- Tasks performed before sputum collection 41
- Tasks performed during sputum collection 44
- Tasks performed After sputum collection 47
Transportation of all specimens 47
Tasks Performed After Samples are Received in Laboratory 49
Laboratory procedures 51
- Ziehl–Neelsen staining 51
Importance of Grading of smears 53
Fluorescent staining Procedures 53
Grading scales for ZN/ FM 54
Monthly Abstract 58
Points to be Remembered 63
Section A: Quality Assured Laboratory Services 64
Structure of NTEP laboratory network 64
 Levels of laboratories under NTEP 64
Section B: Quality Assurance (QA) for smear microscopy 65
- Internal Quality Control (IQC) 65
- External quality assessment for sputum smear microscopy 66
- Panel Testing 67
- Random Blinded Re-Checking of Routine Slides (RBRC) 68
- Structure & Functions of EQA 71
- Quality improvement (QI) 71
Calculation of consumables required for examination of 3000 smears 73
Supervisory visits to designated microscopy centres 75
- Preparation for visits to designated microscopy centre 75
Checklist for laboratory supervision 76
Quality assurance for CBNAAT 81
- Internal Quality Control 81
- External Quality Assurance (Prociency Testing) for CBNAAT: 81
Infection Control 82
Disposal of sputum container with specimen and wooden sticks 84
Disposal of stained slides 84
Points to remember 85

MODULE 3
Learning objectives 86
Introduction 87
Goal and Objectives of treatment 87
Scientic basis of treatment of TB 87
Basis of chemotherapy 87
Pharmacological basis of treatment 89
Daily Regimen 89
Directly observed treatment (DOT) 90
Case denitions 90
- Classication by anatomical site of disease 90
- Classication by H/O previous TB treatment 90
Classication based on drug resistance 91
Treatment regimen 91
- Regimen for Drug-Sensitive TB (DSTB) cases 91
Fixed Dose Combinations (FDCs) 92
Drug dosages for rst line anti- TB drugs 93
Daily Dose Schedule for Adults (as per weight bands) 93
Treatment of Paediatric TB 93
Drug Dosage for Paediatric TB 94
Operational guidelines for treatment initiation 94
Treatment support program 96
Contact investigations 99
TB Preventive Therapy (IPT) 100
IPT in children 100
Response to treatment in children 101
Patient Provider Interaction 102
Treatment related information 103
Standardized Records 104
Filling up of the treatment card 108
Other comorbidities 111
Contact Investigation 111
Determination of date of treatment outcome 117
Management of patients with treatment interruptions 117
Summary of Denitions 118
Death audit 120
Prevention and management of Adverse Drug Reactions to Anti-TB drugs 120
Adverse effects of Anti-TB drugs 120
Side effects of rst line anti-TB drugs 120
Management of ADRs 121
Symptom-based approach to evaluation of possible side effects of anti-
TB drugs 121
Pharmacovigilance in TB control Programme 125
Need for Pharmacovigilance 125
Management of Hospitalized patients 127
Management of Extrapulmonary TB patients 128
Follow up 128
Management of TB patients in special situations 129
- TB in Pregnant and Lactating women 129
- TB and Contraceptive pills usage 129
- Management of TB in patients with liver disorders 129
- TB patient with renal failure and severe renal insufciency 130
- TB in patients with seizure disorders 132
Latent Tuberculosis Infection (LTBI) 132
- Differentiating Between Latent TB Infection and TB Disease 132
TB Comorbidities 133
TB AND HIV 133
HIV Testing for TB Patients / Presumptive TB Cases 133
TB Screening among HIV patients 134
Intensied TB Case Finding (ICF) 135
ICF at ICTC 136
ICF at ART Centres 136
ICF at Link ART Centres (LAC) 137
ICF among HIV high risk groups (HRG) 138
Care and support centres 138
- Treatment of HIV-infected TB 138
- Anti-TB Treatment of HIV infected TB patients 138
- Anti-retroviral therapy and co-trimoxazole prophylactic therapy in
- HIV infected TB patients 139
Initiation of rst-line ART in relation to anti-TB therapy 140
Rifabutin Drug Interactions 140
Provision of Co-trimoxazole Prophylaxis Therapy (CPT) to HIV-Infected
TB patients 142
Isoniazid Preventive Therapy (IPT) For PLHIVs 142
TB and Diabetes 144
Screening Intervention and Diagnosis of Diabetes among TB patients 145
WHO criteria for diagnosing Diabetes will be as follows 146
Linkage of TB patients with DM for Diabetes care and management 146
Screening and referral of Diabetic patients for TB 146
Linkage of Diabetic patients with TB for TB case management 147
TB & Nutrition 147
TB and Tobacco 148
Involvement of NTCP in tuberculosis control 149
TB & Silicosis 150
Drug-Resistant TB 151
Integrated drug-resistant TB algorithm 152
Integrated DR TB Diagnostic Algorithm 152
Management of DR-TB 153
Pre-treatment evaluation for DR TB patients 153
Providing health education/ counselling to patient and family members 154
Classes of anti -TB drugs recommended for treatment of
DR TB patients (WHO) 155
Grouping of anti-TB drugs for longer MDR regimen 155
Newer anti-TB drugs 157
Criteria for patients to receive standard DR TB regimen 159
Regimen for DR TB treatment 161
Treatment initiation 162
Replacement drugs in sequence of preference 163
Drug dosage and administration 164
Dosage of DR TB drugs for adults 166
Counselling for DR TB patients 167
 Extension of treatment in various DR TB regimens 167
- All oral H mono-poly DR TB regimen 167
- Shorter MDR TB regimen 167
- All oral longer MDR TB regimen 168
- Patient ow for DR TB patients 168
Treatment Interruptions & DRTB 169
- Management of DR TB patients with treatment interruptions and
lost to follow-up 169
- Follow-up evaluations during treatment 170
- Treatment outcomes 172
- Final outcomes 172
Outcomes for all oral H mono/ poly DR TB patients 173
Outcomes for shorter MDR TB regimen 173
Outcomes for all oral longer regimen for
MDR/RR TB (except shorter MDR TB regimen) and/or XDR TB patients 173
Non-Tuberculous Mycobacteria (NTM) 175
Improving Interpersonal Communication Skills in NTEP Training:
Key Concepts and Sample Role Plays 178
Principles of Patient-provider Interaction 179
Types of Communication 179
Role Plays for Doctors 185
Interpersonal Communication 186
Sample key messages 187
- Listening and understanding 187
Demonstrating caring 188
Role Play Scenarios 192

MODULE 4
Program management in Peripheral Health Institutions for TB Elimination 194
Learning objectives 194
Introduction 194
Peripheral Health Institution 195
Role of PHIs in Program Management for TB Elimination 196
Infection control at PHI 201
Notication at Diagnosis 208
- Basics of process of notication 208
- Scenarios of Notication process 208
Supportive systems for real time notication. 210
Concept of an episode of TB 210
NTEP TB Notication register 210
Notication of Patients Seeking Care in Private Sector 214
Abbreviations
aDSM Active Drug Safety Monitoring and Management

ACH Air Change per Hour

ADR Adverse Drug Reaction

AE Adverse Event

AFB Acid Fast Bacilli

AIC Airborne Infection Control

AIDS Acquired Immune Deciency Syndrome

ALT Alanine Aminotransferase

Am Amikacin

AMC Adr Monitoring Center

Amx/Clv Amoxicillin/clavulanate

ART Anti-retroviral Therapy

ARV Anti-retroviral

AST Aspartate Aminotransferase

ATS American Thoracic Society

Bdq Bedaquiline

BPL Below Poverty Line

BTS British Thoracic Society

CAP Conditional Access Programme

CBNAAT Cartridge Based Nucleic Acid Amplication Test

Cfz Clofazimine

Clr Clarithromycin

Cm Capreomycin

CMO Chief Medical Ofcer

CP Continuation Phase

CPT Co-trimoxazole Preventive Therapy

Cs Cycloserine

CTD Central Tb Division

CUP Compassionate Use Programme

I
C-DAC Centre For Development of Advanced Computing

C-DST Culture and Drug Susceptibility Test

CL-HIV Children Living With HIV

DAIDS Division of Aids

DBT Direct Beneciary Transfer

DCGI Drugs Controller General of India

DDG Deputy Director General

DDS District Drug Store

DDR TBC District Dr Tb Centre

DG Director General

DGHS Directorate General of Health Services

Dlm Delamanid

DMC Designated Microscopy Centre

DOT Directly Observed Treatment

DOTS Core Approach Underpinning the Stop TB Strategy for TB Control

DRT Drug Resistance Testing

DR TB Drug-resistant Tuberculosis

DR TBC Drug-resistant Tuberculosis Centre

DSMC Drug Safety Monitoring Committee

DST Drug Susceptibility Testing

DTO District TB Ofcer

DVDMS Drug Vaccine Distribution Management System

E Ethambutol

ECG Electrocardiogram

ECHO Extension of Community Health Care Outcomes

EP-TB Extra-pulmonary Tuberculosis

EQA External Quality Assurance

Eto Ethionamide

EU European Union

FDA Food and Drug Administration

FEFO First Expiry First Out

III
FL LPA First Line-line Probe Assay

FQ Fluoroquinolone

GLC Green Light Committee

GFATM Global Fund for Aids, Tuberculosis & Malaria

Gfx Gatioxacin

GMSD General Medical Stores Depot

GoI Government of India

H Isoniazid

Hh High Dose Isoniazid

HRCT High Resolution Ct Scan

ICH International Conference on Harmonization

ICT Information Communication Technology

ICMR Indian Council for Medical Research

IP Intensive Phase

Ipm Imipenem

IPAQT Initiative For Promoting Affordable & Quality TB Test

IQC Internal Quality Control

IRL Intermediate Reference Laboratory

ISO International Standard Organization

Km Kanamycin

LC Liquid Culture

LFT Liver Function Test

Lfx Levooxacin

LJ Lowenstein Jensen

LPA Line Probe Assay

LT Laboratory Technician

LTFU Lost To Follow Up

Lzd Linezolid

MAC Mycobacterium Avium Complex

MDR TB Multi-drug Resistant TB

Mfx Moxioxacin

IV
Mfxh High Dose Moxioxacin

MGIT Mycobacteria Growth Indicator Tube

MIC Minimum Inhibitory Concentration

MIS Management Information System

MO Medical Ofcer

MoHFW Ministry of Health and Family Welfare

MO-DMC Medical ofcer-designated Microscopy Centre

MO-PHI Medical ofcer- Peripheral Health Institute

MO-TC Medical ofcer TB Control

MOTT Mycobacterium other Than Tubercle Bacilli

MoU Memorandum of Understanding

Mpm Meropenem

MR Mono Resistance

MSS Monthly Stock Statement

NAAT Nucleic Acid Amplication Test

NABL National Accreditation Board for Laboratories

NTEP National TB Elimination Programme

NDRS National Drug Resistance Survey

NDR TBC Nodal Dr TB Centre

NGO Non-government Organization

NGS Next-generation Sequencing

NHPS National Health Protection Scheme

NHM National Health Mission

NIRT National Institute for Research in Tuberculosis

NITRD National Institute For Tuberculosis and Respiratory Diseases

NRL National Reference Laboratory

NSP National Strategic Plan

NTI National TB Institute

NTM Non-tuberculous Mycobacterium

Ofx Ooxacin

OPD Out Patient Department

V
PAS P-aminosalicylic Acid

Pdx Pyridoxine

PDR Poly Drug Resistance

PHI Peripheral Health Institute

PK/PD Pharmacokinetic/pharmacodynamics

PL-HIV People Living with HIV

PMDT Programmatic Management of Drug-resistant Tuberculosis

PP Private Provider

PQC Product Quality Compliance

PSM Procurement and Supply Management

PT Previously Treated

PTE Pre-treatment Evaluation

Pto Protionamide

PvPI Pharmaco-vigilance Programme of India

QA Quality Assurance

QSE Quality System Elements

R Rifampicin

RNTCP Revised National Tuberculosis Control Programme

RR TB Rifampicin Resistant Tuberculosis

R&R Recording & Reporting

RT-MERM Real Time Medication Event Reminder Monitor Device

S Streptomycin

SA Statistical Assistant

SAE Serious Adverse Event

SCM Supply Chain Management

SDG Sustainable Development Goals

SDS State Drug Store

SLD Second Line Anti-TB Drugs

SLDST Second Line Drug Susceptibility Testing

SLI Second Line Injectable

SL-LPA Second Line-line Probe Assay

VI
SME Supervision, Monitoring & Evaluation

SoP Standard Operating Procedures

SPC Specimen Processing Control

STLS Senior TB Laboratory Supervisor

STO State TB Ofcer

STR Standardized Treatment Regimen

STS Senior Treatment Supervisor

TALFU Treatment After Lost To Follow Up

TAT Turn-around Time

TB Tuberculosis

TBHV Tb Health Visitor

Thz Thioacetazone

ToR Terms Of Reference

Trd Terizidone

TU TB Unit

UDST Universal Drug Susceptibility Testing

ULN Upper Limit of Normal

UPT Urine Pregnancy Test

USAID United States Agency For International Development

USFDA United States Food & Drug Administration

WCO India World Health Organization Country Ofce for India

WHO World Health Organization

XDR TB Extensively-drug Resistant TB

Z Pyrazinamide

VII
 MODULE 1
OVERVIEW OF
TB CONTROL
IN INDIA

Learning Objectives
In this module we will learn about:

• Pathogenesis of Tuberculosis (TB)

• Burden of TB and its impact (Extent of TB problem in the National and Global context

• Evolution of the National Tuberculosis Control Programme

• Sustainable Development Goals

• End TB strategy

• National Strategic Plan (2017-25)

• Health System structure & functions for delivery of TB care

- Delivery of TB care in public and private sectors
- Patient Centric Model of Care

1
Introduction
The National Tuberculosis Control Programme (NTP) of India was initiated in 1962. A
comprehensive review of the NTP in 1992 found that the NTP had not achieved its aims or
targets. Based on the recommendations of the 1992 review, the Revised National Tuberculosis
Control Programme (RNTCP), incorporating the components of the internationally
recommended Directly Observed Treatment Short-course (DOTS) strategy for the control of TB,
was developed. RNTCP has now been implemented in the country for more than two decades,
and has been expanded geographically to achieve nation-wide coverage in March 2006. The
spread of human immuno-deciency virus (HIV) during the last two decades, emergence of
various forms of drug resistant TB and unorganised and unregulated vast private sector pose
additional challenges in effective TB control.

Over a period of time, there are several landmark achievements including policy and system
preparedness for Universal access to TB care including mandatory notication of TB cases,
development of Standard for TB Care in India, Comprehensive Real time TB Information
Management System – NIKSHAY, use of rapid molecular diagnostics, successful innovations in
Private Sector engagement for TB care- Universal Access To TB Care (UATBC). A considerable
progress in addressing Drug Resistant TB with focus on Drug Susceptibility Testing (DST) guided
treatment including introduction of newer drugs (like bedaquiline, delamanid), TB and co-
morbidities, paediatric TB, nutritional support through Nikshay Poshan Yojana by DBT, active
case nding, intensied case nding and urban TB control models has also been made and a
major progress has been achieved in advocacy and communication areas.

The programme gives priority in detecting and treating Microbiologically conrmed PTB, thereby
aiming to cut the chain of transmission of infection. However, it needs to be remembered that
under NTEP all types of TB cases are diagnosed and treated.

2
Pathogenesis of TB
Source of infection and exposure
Tuberculosis (TB) is an airborne infectious disease caused predominantly by Mycobacterium
tuberculosis species of pathogenic bacteria, rst discovered in 1882 by Robert Koch. TB is caused
by one of several mycobacterial species that belong to the Mycobacterium tuberculosis complex.

Mycobacterium tuberculosis is a fairly large, non-motile & rod-shaped bacterium that are 2-4
micrometer in length and 0.2-0.5 in width. It is an obligate aerobe, so in the classic case of
tuberculosis, MTB complexes are always found in the well-aerated upper lobes of the lungs. The
bacterium is a facultative intracellular parasite, usually of macrophages, and has a slow
generation time, 15-20 hours, a physiological characteristic that may contribute to its virulence.

M. tuberculosis has a waxy coating on its cell surface primarily due to the presence of mycolic
acid. This coating makes the cells impervious to Gram staining. Hence, Acid-fast stains such as
Ziehl-Neelsen or uorescent stains such as Auramine O are used to identify M. tuberculosis with
a microscope.

Patients suffering from Microbiologically conrmed pulmonary TB (PTB) constitutes the most
important source of infection. The infection occurs most commonly through droplet nuclei
generated by coughing, sneezing etc., inhaled via the respiratory route. The chances of getting
infected depend upon the duration, the frequency of exposure, load and virulence of TB bacilli
and the immune status of an individual.

Primary Infection
Entry and establishment of bacilli in human body constitutes infection. It usually takes 6-8 weeks
for the establishment and manifestation of infection. Infection is indicated by detection of
release of interferon gamma by a positive reaction to a tuberculin skin test (Mantoux test) or
Direct IGRA. Primary infection is an infection occurring for the rst time in susceptible individuals
who are exposed to tubercle bacilli. Droplet nuclei that are inhaled into the lungs, are so small (<
5µm) that they evade the muco-ciliary defences of the bronchi and lodge in the terminal
bronchiole or alveoli of the lungs. Subsequently, the bacilli multiply and invade the hilar lymph
nodes through the lymphatics. The subpleural lung lesion, lymphangitis and hilar adenopathy
together constitute a “primary complex”. In most cases, the host’s immune defences overcome
the primary infection, which generally passes unnoticed.

Secondary bacillary multiplication that occurs at the regional lymph nodes causes bacillaemia
resulting in the implantation of seedlings of bacilli in different parts of the body, such as the
apical & sub-apical areas of the lungs, the meninges & cerebral cortex, intervertebral discs, renal
parenchyma and the epiphysial ends of long bones. In such environments, the bacilli continue to
multiply as these environments favour their continued growth and multiplication. In a few cases,
the infection may develop into progressive primary forms of TB disease such as meningitis and
miliary TB. However, in majority of the cases, the multiplication of the bacilli is contained by the
host defence mechanism.

Post-primary TB
Post-primary TB disease occurs after a latent period of many months or even years after the
primary infection. Disease may occur either due to endogenous reactivation of dormant tubercle
bacilli acquired from a primary infection or by exogenous re-infection. Post-primary TB disease
usually affects the lungs, but can involve any part of the body except nails and hair.

3
Risk of infection
A smear positive pulmonary TB case in the general population may infect 10-15 other persons in
a year and remain infectious for 2 to 3 years if left untreated.

Risk of developing disease

Tuberculosis is most commonly transmitted by inhalation of infected droplet nuclei which are
discharged in the air when a patient with untreated TB coughs or sneezes. TB disease usually
affects the lungs, but can involve any part of the body. Pulmonary TB which affects lungs is an
infectious form of disease. Extra-pulmonary TB can affect the lymph nodes, pleura, bones and
joints, the Genito-urinary tract, the nervous system (meningitis, tuberculoma), abdominal TB
(intestines, mesentery, solid organs), skin, etc. All those who get infected do not necessarily
develop TB disease. The life time risk of breaking down to disease among those infected with TB
is 10–15%, which gets increased to 10% per year amongst those co-infected with HIV. Other
determinants such as diabetes mellitus, smoking tobacco products, alcohol abuse and
malnutrition also increase the risk of progression from infection to TB disease.

Magnitude of TB
India accounts for more than one fourth of the global TB burden i.e. 27 Lakh out of 1 crore new
cases annually. In India, more than 40% of population is infected (prevalence of infection) with
Mycobacterium tuberculosis. The table below shows the estimated gures for TB burden globally
and for India provided by WHO for the year 2018.

Estimates of TB
Global (Million) India % of Global
Burden (2018)
Incidence TB cases 10 2.69 Million 27%

Mortality of TB 1.2 440,000 31%

Incidence HIV TB 0.86 92,000 9%

Mortality of HIV-TB 0.25 9,700 4%

MDR-TB 0.5 130,000 24%

Children with TB 1.12 342,000 31%

Annual Risk of Tuberculosis Infection (ARTI)

It is dened as the proportion of individuals getting infected or re-infected with Mycobacterium
tuberculosis over a period of one year. This depends upon the burden of infectious cases in the
community, the duration and frequency of exposure to the source of infection (smear positive PTB
cases), nutritional status, co-morbidities etc. The ARTI in effect reects the overall infectious pool
in the community. Currently, ARTI is not being used under the programme.

4
HIV co-infection among TB patients
As per the recently released, India HIV Estimates 2017 report, National adult (15–49 years) HIV
prevalence in India is estimated at 0.22% (0.16% – 0.30%) in 2017 translating into 21.4 lakhs
people living with HIV/AIDS.

In India it is estimated that 92,000 TB patients are living with HIV infection in 2018, which
accounts to approximately 9% of the Global burden. Based on available country data, it is
estimated that 3% of incident TB patients in India were HIV positive in 2017.

Tuberculosis is the most common opportunistic infection amongst HIV-infected individuals. It is a

major cause of mortality among patients with HIV and poses a risk throughout the course of HIV
disease, even after successful initiation of antiretroviral therapy (ART). In India 55-60% of AIDS
cases reported had TB at any time in their life time, and TB is one of the leading causes of death in
'People living with HIV/AIDS' (PLHIV).

Impact of HIV on TB
The primary impact of HIV on TB is that the risk of developing TB becomes higher in patients with
HIV. An HIV-infected person newly infected with TB has a 16-27 times higher chances of
developing the disease than among patients infected with TB only. Amongst TB infected PLHIV,
3–10% of persons develop TB per year. Furthermore, HIV-infected TB patients suffer much higher
mortality than HIV negative TB patients. Even if TB is successfully treated, recurrence of TB and
long-term post-TB mortality among PLHIV is extremely high.

Impact of TB on HIV
In a TB patient infected with HIV, inammatory response to TB bacilli increases HIV replication. As
a result of the increase in number of viruses in the body, there is rapid progression of HIV
infection. The viral load can increase by 6-7 folds. As a result, there is a rapid decline in CD4
count and patient starts developing symptoms of various opportunistic infections. Thus, the
health of the patient who has dual infection deteriorates much more rapidly than with a single
infection. Amongst the AIDS cases, TB is the most common opportunistic infection. The mortality
due to TB in AIDS cases is also high.

Paediatric TB
Children in the rst ve years of their life are likely to suffer from serious and fatal forms of TB,
more so, if not vaccinated with BCG. Globally, it is estimated that about 10 lakh children become
ill with TB every year, 52% under 5 years of age and 2,33,000 deaths occur annually due to TB
among children. It is estimated that 67 million children are infected with TB and therefore at risk
of developing disease in the future. Moreover, 25,000 children develop multi-drug resistant TB
every year globally. Estimated 2.2 lakh children are affected with TB in India each year. Reliable
data on the incidence and prevalence of the disease is not available due to the difculties in
diagnosis of pediatric TB under eld conditions.

Drug-resistant tuberculosis (DR-TB)

Drug resistant TB is dened as TB disease where the bacilli is resistance to one or more anti TB
drugs. Inadequate or poorly administered treatment regimen (mono-therapy, irregular
consumption, frequent interruptions or trial therapy) in taking treatment for TB is the most
common cause of acquiring drug resistance.

5
Multi Drug Resistance (MDR-TB) is dened as tuberculosis disease where the bacilli are resistant
at-least to isoniazid (H) and rifampicin (R), with or without resistance to other rst line drugs.

As per the recently concluded drug resistance survey data in India, MDR-TB amongst new cases
are estimated at 2.84% and amongst re-treatment cases at 11.6%. Extensively Drug Resistant TB
(XDR–TB) is a subset of MDR-TB where the bacilli, in addition to being resistant to R and H, are
also resistant to uoroquinolones and any one of the second-line injectable drugs (namely
Kanamycin, Capreomycin or Amikacin).

Findings of National Drug Resistance Survey (NDRS) India - 2014-16

DST Pattern NEW TB case Previously TB cases ALL TB cases

Total DST results

3065 1893 4958
available

2374(77.46 %) 1196(63.18 %) 3570(72.01 %)

Susceptible to
all drugs (75.93 – 78.92 %) (60.96 – 65.36 %) (70.73 -73.25 %)

691(22.54 %) 697(36.82 %) 1388(28.00 %)

Any drugresistance
(21.10 - 24.1 %) (34.64 – 39.04 %) (26.77 – 29.29 %)

87(2.84%) 220(11.62 %) 307(6.19%)

MDR
(2.28 – 3.50 %) (10.21 – 13.15 %) (5.54 – 6.90 %)

Ÿ Any drug resistance among new patients is 22.54%, among previously treated (PT)
patients is 36.82% and among all patients 28.02%;
Ÿ Any H resistance (16% in all with 11.6% in new and 25.09% in previously treated patients)
being the driver for R resistance;
Ÿ Almost all RR-TB patients are resistant to H with/without other rst or second-line drugs;
Ÿ MDR-TB is 6.19% in all patients (2.84% among new and 11.6% among previously treated
patients);
Ÿ Among MDR-TB patients, additional resistance to other rst-line drugs is high at 74.3%.
The drug specic resistance in combination with MDR-TB includes:
- any Streptomycin resistance – 70% in new and 59.09% in PT;
- any E resistance - 45.98% in new and 46.36% in PT; and
- any Z resistance – 31.03% in new and 20.45% in PT.
Ÿ State level and cluster-wise variations clearly indicate that although the national DR TB
situation is well within the range of previous state level surveys, there exist focal
epidemics of DR TB in some states.
Ÿ Programmatically, MDR-TB (at-least to H & R), Rifampicin resistance (RR-TB) and XDR-TB
(at least H, R, second-line injectable [SLI] and uoroquinolones [FQ]) received priority. As
facilities for detecting other varieties of resistance became increasingly available, making
available regimens for their treatment also became a programmatic priority.

6
While prevention of development of drug resistance is of paramount importance for ending TB,
early detection and immediate initiation of appropriate regimen and completion of treatment
are keys to interrupt on-going transmission, to prevent death and reduce chances of sequelae
post-treatment. The programme has so far been able to successfully treat 46% of the cohorts of
patients initiated on treatment 30-33 months ago. However, treatment outcomes vary from
state-to-state. While few states were able to achieve more than 70% treatment success rate
among the diagnosed MDR/RR-TB patients, others could achieve less than 40%, suggesting the
variability of the health system to deliver treatment, care and cure. Main reasons attributed for
the attrition were death and lost to follow-up (LTFU) during treatment. In India, the great concern
is the potential threat of drug resistant TB (DR-TB) with the existing unregulated availability and
injudicious use of rst and second-line anti-TB drugs in the country.

Socio-economic impact of TB
The estimated loss in economic well-being from TB in India amounted to US$ 23.7 billion in
2006. Mortality accounts for the majority of this burden reecting the greater number of life-
years lost due to premature deaths. The economic burden of TB has fallen by US$ 2.0 billion, or
7.8%, in absolute terms since 1990. On a per capita basis, the economic burden of TB has fallen
by 31.1% from US$ 29.9 in 1990 to US$ 20.6 in 2006.

Most of the improvement since the mid-1990s has come through reduced mortality, due to the
implementation of RNTCP. Morbidity has also recorded a large improvement reecting the
decrease in prevalence. However, TB remains a signicant cause of loss of health, life and
economic well-being of India's population.

TB primarily affects people in their productive age group; with important socio-economic
consequences for the household. Almost 70% of TB patients are aged between 15 and 54 years.
The disease is more common amongst the poorest and the marginalized sections of the
community. Whilst two-thirds of cases are male, TB takes a disproportionately larger toll among
young females, with more than 50% of cases occurring amongst females less than 34 years of
age. In addition, there is a devastating social cost with an estimate of more than 300,000
children forced to leave school because their parents have TB, and more than 100,000 women
with TB rejected by their families. Previous studies suggest that on an average, 3-4 months of
work-time is lost as a result of TB, resulting in an average potential loss of 20-30% of the annual
household income. This leads to increased debt burden, particularly for the poor and
marginalized sections (tribal, migrant and urban slums) of the population.

Evolution of Revised National Tuberculosis Control Programme

The National TB Institute (NTI), Bengaluru, was established in 1959 to devise strategies for TB
control in India. A scientically logical and economically feasible national tuberculosis control
programme was formulated during 1959 to 1962 at NTI, Bengaluru. The National Tuberculosis
Control Programme of India was initiated in 1962 and was originally designed for domiciliary
treatment using self-administered standard drug regimens.

The NTP had created an extensive infrastructure for TB control with a network of more than 446
district TB centres, 330 TB clinics and more than 47,600 TB beds. The NTP had also raised the
awareness of TB and TB treatment facilities and had succeeded in placing more than 1.3 million
patients on treatment annually. Despite the NTP being in existence since 1962, no appreciable
change in epidemiological situation of TB in the country had been observed. The HIV-AIDS
epidemic and the spread of drug resistant TB were threatening to further worsen the situation.

7
In view of this, in 1992, GOI, with WHO and SIDA (Swedish International Development
Cooperation Agency) reviewed the TB situation and the performance of the NTP. The
observations revealed that the NTP, though technically sound, suffered from managerial
weakness, inadequate funding, an over reliance on X-ray for diagnosis had frequent interrupted
supplies of drugs, and low rates of treatment completion. The Government decided to give a new
thrust to TB control activities by revitalising the NTP, with assistance from International agencies.

In 1993, The Revised National TB Control Programme was piloted in a population of 24 Lakh in
ve states (Delhi, Gujarat, Maharashtra, West Bengal and Kerala). This was later expanded to
cover 13 million people by 1995 and 2 crores by 1996.

In 1997, the RNTCP was launched as a national programme with a plan to scale up in a phased
manner. The RNTCP thus formulated, adopted the internationally recommend Directly Observed
Treatment Short-course (DOTS) strategy as the most systematic and cost-effective approach to
revitalise the TB control programme in India.

RNTCP had adopted the internationally recommended Directly Observed Treatment Short-
course (DOTS) strategy as the most systematic and cost-effective approach to revitalise the TB
control programme in India.

Directly Observed Treatment Short course (DOTS) strategy

DOTS is a systematic strategy to control TB disease. This has the following 5 components:
Ÿ Political and administrative commitment
Ÿ Good quality diagnosis, primarily by sputum smear microscopy and other
microbiological tools
Ÿ Uninterrupted supply of quality drugs
Ÿ Directly observed treatment (DOT)
Ÿ Systematic monitoring and accountability

Political and administrative commitment: The government's commitment is measured in

terms of continued nancial assistance, human resources and administrative support. This
priority must be reected at the National, State, District and local levels.

Quality assured diagnosis through sputum microscopy and other microbiological tools:
Under RNTCP, sputum microscopy and other microbiological tools are the tools for detection of
infectious TB cases, facilitating categorization of treatment and an objective method for
monitoring the response to treatment. Quality assured laboratories are established for this
purpose.

Uninterrupted supply of quality drugs: The policy of procurement and distribution of drugs
ensures sufcient quality assured anti-TB drugs available at all levels. The unique feature of
RNTCP is the use of strips of xed dose combination of anti TB drugs, as per weight bands, for the
entire course of treatment.

Directly observed treatment (DOT): DOT is one of the key elements of the DOTS strategy. In
DOT, an observer (health worker or trained community volunteer, or trained family member for
selected patients) watches and supports the patient intaking their drugs. Direct observation
ensures treatment adherence with the right drugs, in right doses for the right duration.

8
Systematic monitoring and accountability: A standardized recording and reporting structure
which allows for rigorous monitoring and evaluation of the outcome of every patient diagnosed
put under treatment is essential. In RNTCP, the key indicators like TB Notication rate and
treatment success rates are monitored regularly at every level of the health system. The
uniqueness of the programme is that it shifts the responsibility and accountability of cure from
the patient to the health system.

Previously the objectives of the RNTCP were to achieve at least 85 percent cure rate among the
new smear positive cases initiated on treatment, and thereafter a case detection rate of at least
70 percent of such cases. The RNTCP was built on the infrastructure and systems built through
NTP. Major additions to the RNTCP, over and above the structures established under the NTP was
the establishment of a sub-district supervisory unit, known as TB unit, with dedicated RNTCP
supervisors (STS, STLS) posted, and decentralization of both diagnostic and treatment services,
with treatment given under the support of DOT providers. The entire country was covered by
March 2006. The programme has made rapid strides ever since its implementation and
consistently been achieving global benchmarks of case detection and treatment success rates
since 2007.

The widespread implementation of the DOTS strategy has proved to be an effective tool in
controlling TB on a mass scale and practised in over 200 countries. The prime task for the next
decade was to achieve the Millennium Development Goals (MDGS) and related STOP TB
Partnership targets for TB control. The target under MDG for tuberculosis is to halt and begin
reversal of incidence of tuberculosis, malaria and other major diseases by 2015.The indicators
were to reduce the prevalence and death rates by 50% between 1990 and 2015.

Meeting these targets required a coherent control strategy. The WHO released STOP TB Strategy
in 2006 with six principal components to realize the global TB related MDGs by 2015.These were
pursuing high quality DOTS expansion and enhancements; Addressing TB, HIV, MDR-TB and
other challenges; Contributing to health system strengthening; Engaging all care providers;
Empowering patients and communities; and Enabling promoting research.

India adopted the components of STOP TB strategy and strived to achieve targets under it.
National AIDS Control Programme (NACP) and RNTCP have developed “National framework of
joint TB/HIV collaborative activities” in 2007 which were revised in February 2008 to redene
the scope of TB/HIV collaborative activities being implemented in the country. Programmatic
management of drug resistant (DR)TB services began in 2007 and national coverage has been
achieved in March 2013. Scope of engagement of all care providers was expanded with
revisions in schemes for involvement of private providers and NGOs in 2008 and Global Fund
supported engagement of professional associations like Indian Medical Association (IMA) and
Catholic Bishop Conference of India (CBCI). Task force mechanisms were established to engage
medical colleges to support patient care, training and research.

Emboldened by its achievements, the programme in 12th ve-year plan (2012-17) had
articulated National Strategic Plan with a vision of TB free India. The goal of the NSP is to achieve
universal access to quality TB diagnosis and treatment for all TB patients in the community.

The objectives of the National Strategic Plan are

1. To achieve 90% notication rate for all cases
2. To achieve 90% success rate for all new and 85% for retreatment cases
3. To signicantly improve the successful outcomes of treatment of DR -TB cases

9
4. To achieve decreased morbidity and mortality of HIV associated TB
5. To improve outcomes of TB care in the private sector

To achieve these objectives, RNTCP further strengthened and improved through quality of basic
DOTS services aligning sub-district level management unit with health system under National
Health Mission (NHM), deploying improved rapid diagnostic tools in the eld level, increasing
efforts to engage all health care providers, strengthening urban TB control, expanding diagnosis
and treatment of DR-TB, improving communication, outreach and social mobilization and
promoting research for development and implementation of improved tools and strategies.

A Government order issued by GOI on 7th May 2012 mandates all healthcare providers to notify
every TB case diagnosed and/or treated, to local authorities.

To support TB notication and strengthen TB surveillance in general, a case base web-based TB

notication system-NIKSHAY was established to provide platform for notication from both
public and private sector, decrease lead time of data transmission and increase use of
information for programme management for betterment of care of delivery of services at local
level. Amendment in this Government order was made on 21st July 2015 for including public
health action. Ministry of Health and Family Welfare further notied this in the Gazette of India
on 19th March 2018.

Ministry of Health and Family Welfare has notied in the Gazette of India, for prohibiting the
import of sero-diagnostic kits for TB and the manufacture, sale, distribution and use of such kits
for TB on 7th June 2012.

RNTCP, World Health Organization and other stakeholders jointly prepared standards for TB
care in India (STCI) in 2014, which lays down uniform standards for TB care.

National TB Elimination Programme (NTEP)

Government of India has committed to end TB by 2025, ve years ahead of the global target
under Sustainable Development Goals. The Ministry of Health & Family Welfare is implementing
the National Strategic Plan (NSP) for Tuberculosis Elimination (2017-2025) with commensurate
resources to rapidly decline TB incidence and mortality in India. The NSP aims to seek the
attention of all stakeholders to the most important interventions or activities that will bring about
signicant changes in the incidence, prevalence and mortality of TB. Key activities include active
TB case nding, use of newer and shorter regimen, private sector engagement,
nancial/nutritional support to TB patients; IT enabled surveillance, preventive and awareness
measures. In view of End TB targets, the programme has been renamed from 'Revised National
Tuberculosis Control Program (RNTCP) to 'National Tuberculosis Elimination Program (NTEP)

Standards for TB Care in India

The vision of NTEP is that the people suffering from TB receive the highest standards of care and
support from all healthcare providers of their choice. It spelt out in the National Strategic Plan
(2012-17) to extend the umbrella of quality TB care and control to include those provide by
private sector.

The private sector holds a factual predominance of health care service delivery in India. There is
very little information about TB patients from the private sector available to the programme and
little is known about their quality of treatment, including treatment outcomes. The need for
quality and standards for TB care is made particularly acute where a large unorganized private
sector accounts for almost half of the TB care delivered in India.

10
Thus, it was felt essential to develop and disseminate the standards for TB care that is
particularly relevant in India context, acceptable to the medical fraternity in both the public and
private sector in India. Also, the availability of new diagnostic tools and strategies for early TB
diagnosis, emerging evidences on existing regimens and newer regimens and the need for
better patient support strategies including addressing social inclusiveness necessitated the
development of Standards for TB care in India.

The standards in STCI differ from existing guidelines in that the standards present what should
be done whereas guidelines describe how the action is to be accomplished. These standards
represent the rst what is expected from the Indian healthcare system. It is expected that the
standards laid down in STCI are clear and will be accessible to all providers as an easy reference.

Twenty-six standards developed after a National Workshop with support from various public
health administrators, programme managers, representative from various professional
association (IMA, API, College of Physicians Association of India, IAP, FOGCI, etc) academicians
and specialists from public and private sectors (pulmonologists, physicians, surgeons,
paediatricians, gynaecologists, orthopaedic surgeons, microbiologists, public health specialists
etc.) donors, technical and implementation partners and pharmaceutical companies and
pharmacists. There are six standards for diagnosis (standard 1 to 6), ve for treatment (standard
7 to 11), nine for public health (standard 12 to 20) and six for social inclusion (standard 21 to 26).

11
END TB STRATEGY- A holistic approach to end TB
Ending the TB epidemic is a SDG target that requires implementing a mix of biomedical, public
health and socioeconomic interventions along with research and innovation.

The End TB Strategy encompasses a package of interventions that can be fully adapted at country
level. It has ten components organized under three pillars and four underlying principles.

Implementing the pillars and components of the End TB Strategy while adhering to its underlying
principles requires intensied action from and beyond the ministries of health, in close
collaboration with all stakeholders including other ministries, communities, civil society and the
private sector.

END TB STRATEGY

VISION A WORLD FREE OF TB

Zero deaths, disease and suffering due to TB

GOAL END THE GLOBAL TB EPIDEMIC

Milestones Targets
INDICATORS
2020 2025 SDG 2030 End TB 2035

Reduction innumber 35% 75% 90% 95%

of TB deaths compared
with 2015 (%)

Reduction in TB 20% 50% 80% 90%

incidence rate compared
with 2015 (%)

TB-affected 0 0 0 0
family facing
catastrophic costs
due to TB(%)

PRINCIPLES
A. Government stewardship and accountability, with monitoring and evaluation
B. Strong coalition with civil society organizations and communities
C. Protection and promotion of human rights, ethics and equity
D. Adaptation of strategy and targets at country level, with global collaboration

12
PILLARS AND COMPONENTS
Integrated, patient-centred care and prevention
A. Early diagnosis of tuberculosis including universal drug-susceptibility testing, and
systematic screening of contacts and high-risk groups
B. Treatment of all people with tuberculosis including drug-resistant tuberculosis, and patient
support
C. Collaborative tuberculosis/HIV activities, and management of co-morbidities
D. Preventive treatment of persons at high risk, and vaccination against tuberculosis

Bold policies and supportive systems

A. Political commitment with adequate resources for tuberculosis care and prevention
B. Engagement of communities, civil society organizations, and public and private care
providers
C. Universal health coverage policy, and regulatory frameworks for case notication, vital
registration, quality and rational use of medicines, and infection control
D. Social protection, poverty alleviation and actions on other determinants of tuberculosis

Intensied research and innovation

A. Discovery, development and rapid uptake of new tools, interventions and strategies
B. Research to optimize implementation and impact, and promote innovations

THE SUSTAINABLE DEVELOPMENT GOAL

The Sustainable Development Goals (SDGs), are a universal call to action to end poverty, protect
the planet and ensure that all people enjoy peace and prosperity. The consolidated goal for
health is SDG 3, 2015 which is dened as “Ensure healthy lives and promote well-being for all at
all ages”. Thirteen targets have been set for this goal, and one of these targets is 'End TB
strategy'.

Ÿ Target 3.3, explicitly mentions TB

“By 2030, end the epidemics of AIDS, tuberculosis, malaria and neglected tropical
diseases and combat hepatitis, water-borne diseases and other communicable
diseases”. Ending epidemics is also now a prominent element of global health strategies
developed by WHO and the Joint United Nations Programme on HIV/AIDS (UNAIDS) for
the post- 2015 era, including the End TB Strategy.

National Strategic Plan 2017-25

The National Strategic Plan (NSP) sets out the strategic direction and key initiatives that the
Ministry of Health and Family Welfare will undertake from 2017 to 2025 for working towards
achieving the goals of eliminating TB by 2025. We have seen excellent commitment and the
progress achieved through the previous NSP period (2012-17), yet much more is required to be
done to accelerate the march towards a TB free India.

India's achievements in TB control over the past decade are remarkable. More than 90 million
people have been tested, more than 19 million TB patients detected and treated, and millions of
lives saved by the RNTCP's efforts.. The country achieved complete geographic coverage for
management of drug resistant TB and more than 100,000 MDR TB cases were diagnosed and
treated.

13
In the NSP 2017-2025 we are moving towards rapidly ending the epidemic of TB in India. This
necessitates a paradigm shift in approach and strategy. This NSP addresses requirements for
achieving the SDG and End TB targets for India and is driven by the 'DETECT-TREAT-PREVENT-
BUILD' approach. The focus is on early diagnosis of all the TB patients, prompt treatment with the
right drugs and regimens along with suitable patient support systems including nancial and
nutritional support. This is supplemented by prevention strategies including active case nding,
contact tracing and LTBI management in high risk population, and airborne infection control.
There is an urgent need for management and nancial system upgradation for the TB control
programme at all the levels and these issues have been addressed in the said NSP.

This NSP is a framework to provide guidance for the activities of 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. The NSP 2017-2025 is a three-year costed plan and an eight-
year strategy document. It provides goals and strategies for the country's response to the disease
during the period 2017-2025 and aims to direct the attention of all stakeholders to the most
important interventions or activities that the programme believes will bring about signicant
changes in the incidence, prevalence and mortality of TB. These strategies and interventions are
in addition to the processes and activities already ongoing in the country.

Vision, Goals and Targets of NSP

The NSP proposes bold strategies with commensurate resources to rapidly decline TB incidence
and mortality in India by 2025, ve years ahead of the global End TB targets and Sustainable
Development Goals to attain the vision of a TB-free India.

VISION: TB-Free India with zero deaths, disease and poverty due to TB

GOAL: To achieve a rapid decline in burden of TB, morbidity and mortality while working
towards elimination of TB in India by 2025.

14
Results Framework (impact and outcome indicators and targets)

Baseline Target
IMPACT INDICATORS
2015 2020 2023 2025

To reduce estimated TB Incidence 217 142 77 44

rate (per 100,000 population) (112-355) (76-255) (49-185) (36-158)

To reduce estimated TB prevalence 320 170 90 65

(per100,000 population) (280-380) (159-217) (81-125) (56-93)

To reduce estimated mortality 32 15 6 3

due to TB (per 100,000 population) (29-35) (13-16) (5-7) (3-4)

To ensure no family should 35% 0% 0% 0%

suffer catastrophic cost due to TB

OUTCOME INDICATORS
Total TB patient notication 3.6
1.74 2.7 2
(in millions)

Total patient private providers

0.19 2 1.5 1.2
notication (in millions)

MDR/RR TB patients notied 28,096 92,000 69,000 55,000

Proportion of notied TB
25% 80% 98% 100%
patients offered DST

Proportion of notied patients 95%

90% 95% 95%
initiated on treatment

Treatment success rate among

75% 90% 92% 92%
notied DSTB

Treatment success rate among

46% 65% 73% 75%
notied DRTB

Proportion of identied targeted

key affected population 0% 100% 100% 100%
undergoing active case nding

Proportion of notied TB patients

receiving nancial support through 80%
0% 90% 90%
Direct Benet Transfers (DBT)

Proportion of identied/eligible
individuals for preventive therapy / 10% 60% 90% 95%
LTBIs - initiated on treatment

15
Health System structure & functions for delivery of TB care
For a patient centred delivery of TB care, a systematic approach is required involving both public
and private sectors.

Delivery of TB care in the public sector

The organisation at the national level consists of the Union Ministry of Health and Family welfare
(MoHFW). In each State, the organisation is under the State Department of Health and Family
Welfare that is headed by a State Minister and with a Secretariat under the charge of the
Secretary/ Commissioner (Health and Family Welfare).

a) In 2005, National Rural Health Mission (NRHM) was launched to provide accessible,
affordable, accountable, effective and reliable primary health care facilities, to the rural
population, especially vulnerable groups. In addition, the National Urban Health Mission
(NUHM) was also launched to further strengthen urban health structure and both NUHM
and NRHM have been clubbed together under National Health Mission (NHM) from 2013.
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 inter-
sectoral convergent action to address the wider social determinants of health”.

b) NHM further aims to provide support to the existing national programmes of health and
family welfare including RCH-II, malaria, blindness control, iodine deciency, lariasis,
kala- azar, tuberculosis, and leprosy and for integrated disease surveillance

c) NTEP is one of the components under the National Health Mission which is a agship
scheme under Govt. of India. The MoHFW follows equity-based approach to allocate funds
under programme to various States. The overall allocation is made on the basis of
population of the states, disease burden and socio-economic status. The nancial
management procedures for RNTCP are well established and administered by the Finance
Cell of the Central Tuberculosis Division (CTD). These procedures are documented in
manuals and guidelines available on the program's website (www.tbcindia.gov.in ).
i. Institutional arrangements: Overall responsibility for nancial management of the
program is with the, Ministry of Health & Family Welfare (DGHS) a part of the National
Health Mission of the MoHFW. At state level these are through state TB cell and at
district level through district TB cell.
ii. Budget and release of funds: Program expenditures are budgeted in the Demand
for Grants of the MoHFW under the Disease exi-pool funding arrangement under two
separate budget lines for Externally Aided Component (EAC) and General Component
(GC).
iii. Funds ow: Funds ow for the program will remain within the existing nancial
management systems of MoHFW, which operates through the centralized Pay and
Accounts Ofce. Funds are being released to state in 2-3 instalments. All the states are
required to submit the annual audit report to CTD by 30th September.

16
NTEP Organogram
NTEP structure comprises of ve levels: National, State, district, sub-district and peripheral
health institution level.

National Level
Central TB Division (CTD) manages the National TB Control Programme for the entire country at
the central level under AS&DG (RNTCP & NACO) through a National Programme manager,
Deputy Director General TB (DDG TB). The nancial and administrative control of the
programme is managed by the Joint Secretary from the administrative arm of the MoHFW.

The CTD is supported by a National TB Institute (NTI) Bengaluru, six National Reference
Laboratories (NRL) including NTI, National Institute for Research in Tuberculosis (NIRT),
Chennai, National Institute of Tuberculosis and Respiratory Diseases (NITRD), Delhi, National
Japanese Leprosy Mission for Asia (JALMA) Institute for Leprosy and other mycobacterial
diseases, Agra, Regional Medical Research Centre, Bhubaneshwar and -Bhopal Memorial
Hospital & Research Centre – (BMHRC) , Bhopal. The CTD is also supported by National Task
Force for collaboration of Medical Colleges activities in country through ZTF/STF.

Various committees of experts to guide the programme at different levels on technical & policy
matters are there supporting Central TB Division.

State Level
The States have total ownership and accountability for the TB control in their state. State Health
Society or its equivalent under National Health Mission of the state manages the TB Control
Programme. A full-time State Tuberculosis Ofcer (STO), trained at national level and based at
the State TB Cell (STC), is responsible for planning, training, supervising and monitoring the
programme in all the districts of their respective states. STO is administratively accountable to
the State Government, technically follows the instructions of the CTD, and coordinates with CTD
and the districts and is assisted by other technical & secretarial staff.

State TB cell is being supported by State TB Training and Demonstration Centre (STDC) in many
states through its three units – a training unit, Supervision and monitoring unit and an
Intermediate Reference Laboratory (IRL) supporting an effective Quality Assurance system of the
Sputum smear microscopy network and laboratory services for PMDT (molecular DR testing and
C&DST) in the State. Operational Research is also a component of STDC.

Each state also has one fully operational State Drug Store (SDS) for each 5 crore of
population. It is responsible for effective management of medicines and other logistics and
ensuring uninterrupted supply of good quality 1st & 2nd line anti-TB medicines for adults and
paediatric population.

17
Organization structure
Supporting Facilities Ministry of Health & Family Welfare

· National Institutes (3) Central TB Division

· National Reference Laboratories (6)

Central
StateTB
TBDivision
Cell
· Intermediate Reference Laboratories (29)
37 states / UTs
· State TB Training and Demonstration Centre (26)
· Culture and DST Laboratories (42) Central
District TB Division
Centre
767 Districts
· Nodal DR-TB Centre (154)
· CBNAAT Laboratories (1180)
Central
TBTB
Unit
Division
One per 1.5 – 2.5 lakh
population

Designated
Central
Microscopy
TB DivisionCentre

50,000 to 1 Lakh population

Peripheral Health
Institute

District Level
The key level for the management of primary health care services is the district. The Chief District
Health Ofcer (CDHO) / Chief District Medical Ofcer (CDMO) / Civil Surgeon or an equivalent
functionary in the district is responsible for all medical and public health activities including
control of TB. The District Tuberculosis Centre (DTC) is the nodal point for TB control activities in
the district. A full-time District Tuberculosis Ofcer (DTO), trained at national level & based at the
DTC, is responsible for planning, training, supervising and monitoring the programme in the
district. DTO is assisted by other technical & secretarial staff. The primary role of the DTC is a
managerial one.

Sub-District Level (Tuberculosis Unit Level)

Integrating the TB control programme with the health system increases effectiveness and
efciency of TB care and control. India's TB control programme has been mainstreamed
efciently with National Health Mission (NHM).

A major organizational change in NTEP is the creation of a sub-district level (Tuberculosis Unit -
TU). The TU is the nodal point for TB control activities in the sub-district. TUs are based mainly in
NHM health blocks with the overall aim to align with NHM Block Programme Management Unit
(BPMU) for optimum resource utilization and appropriate monitoring. In urban areas 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 population and 1 per 1,00,000 (0.75 – 1.25 lakh) population in hilly/tribal/difcult areas.
The Tuberculosis unit (TU) consists of a designated Medical Ofcer-Tuberculosis Control (MO-TC),
as well as one full-time supervisory staff - Senior Treatment Supervisor (STS). However, One
Senior TB Laboratory Supervisor (STLS) will continue to be in 5 lakh population (one per 2.5 lakh
population for tribal/hilly/difcult areas). There is a provision of additional STS if more than 300
TB cases are registered in public sector annually in a TU; additional STS if more than 50 private

18
health establishments are registered in NIKSHAY in a TU and more than 200 TB patients are
notied from these private health establishments annually in a TU.

The Block Medical Ofcer also functions as a Medical Ofcer TB Control (MO-TC). For the urban
TB Units, a medical ofcer from the health facility where TU is located should be designated, in
coordination with CM&HO/DHO to function as a MO-TC. All MO-TCs should be trained in NTEP
at a state level institution. MO-TC has the overall responsibility of management of TB Control
Programme at the TU and is expected to undertake supervisory visits for seven days in a month.
The team of STS and STLS are under the administrative supervision of the MO-TC and the DTO.
The TU will have one Microscopy Centre for every 100,000 population (50,000 in tribal, desert,
remote and hilly regions) referred to as the Designated Microscopy Centre (DMC However, for
complete geographic coverage National programme envisages to expand sputum smear
microscopy services at PHC level. ). Microscopy Centres may also be established beyond
population norms in Medical Colleges, Corporate hospitals, ESIC, Railways, NGOs, private
hospitals, etc.

Peripheral Health Institutions (PHIs)

For the purpose of NTEP, a PHI is a health facility which is manned by at least a medical ofcer. At
this level, there are dispensaries, PHCs, CHCs, referral hospitals, major hospitals, specialty clinics
or hospitals (including other health facilities), TB hospitals, ART Centres and Medical colleges
within the respective district. All health facilities in the private and NGO sectors participating in
NTEP are also considered as PHIs by the programme. Some of these PHIs also function as DMCs.
Peripheral health institutions undertake tuberculosis case-nding and treatment activities as a
part of the general health services. In situations where more than one MO is posted in any of the
peripheral health centres, one of them may be identied and entrusted with the responsibilities of
the NTEP. There is 1 TB Health Visitor (TBHV) per one lakh urban population to support the urban
TB control activities.

TB Laboratory Services
The services of the laboratory are utilized for diagnosing TB & DR-TB cases and for monitoring of
treatment of these patients. The Laboratory network under NTEP is a 3-tier system for provision of
diagnostic services and maintaining its quality.

A. The peripheral laboratories are situated in the public sector like the dispensaries, PHCs,
CHCs, referral hospitals, major hospitals, specialty clinics / other sector hospitals / TB
hospitals / Medical colleges and in the private/NGO sectors. For establishment of
microscopy centre in a lab, it must have adequate physical infrastructure, Binocular
microscope and a trained LT. These laboratories are covered under quality assurance
mechanisms
I. Some of the labs not having facility for sputum microscopy, function as a sputum
collection centres, and such facilities are also established in areas such as the tribal, hilly,
desert and difcult to reach areas of the country for improving the access to diagnostic
services.
ii. In addition, large hospitals and medical colleges have facilities of digital X-Ray, rapid
molecular test (Cartridge based nucleic acid amplication test -CBNAAT & Line Probe
Assay - LPA), Fine Needle Aspiration Cytology (FNAC), histopathology, and culture & DST
for diagnostic services of TB.

B. At the state level a nodal laboratory is designated as Intermediate reference laboratory

(IRL) which is usually situated in the State TB Training and Demonstration Centre (STDC) /

19
 medical college/ public health laboratory. The main functions of IRLs are monitoring of
laboratory services across the state and maintenance of its quality through external quality
assurance. There are 27 IRLs with facilities for culture & DST using Phenotypic (Solid – LJ &
Liquid Culture – MGIT) and Genotypic technology (LPA & CBNAAT).

CBNAAT sites
In addition to the culture DST laboratories, CBNAAT centres are also established to diagnose
Rifampicin resistance among all TB patients (Universal DST). Usually these are established in
DTCs, TB units and Medical Colleges. The country is in the process of expanding CBNAAT site
network. They also serve to diagnose TB among presumptive TB cases from key population.

DRTB Centres
DRTB Centres are specialised centres for clinical management of drug resistant TB. At
state/regional/division level, there are Nodal DRTB Centres (NDRTBC), to manage seriously ill
DRTB cases, DRTB with extensive resistance and DRTB cases to be treated with regimes
containing new drugs (Bedaquiline and Delamanid).

At the district level, there are district DRTB Centres (DDRTBC), to manage DRTB cases with
MDRTB, and H mono/poly resistance. These centres will function under the guidance of
NDRTBCs.

C. At the central level there are six designated National Reference Laboratories (NRLs)
namely National Tuberculosis Institute, Bengaluru, National Institute for Research in
Tuberculosis (NIRT), Chennai, National Institute of Tuberculosis and Respiratory Diseases
(NITRD), Delhi, National JALMA Institute, Agra, Regional Medical Research Centre,
Bhubaneshwar and Bhopal Memorial Hospital & Research Centre (BMHRC), Bhopal. NIRT
Chennai is also a Supra National Reference Lab (SNRL) for World Health Organization
(WHO) for the South East Asia Region. NTI is a WHO Collaborating Centre for Training,
while NITRD is WHO centre of excellence in TB laboratory services. The NRLs are mainly
responsible for External Quality Assurance of Lab network, drug resistance surveillance,
training and research.

Delivery of TB care services in the private sector

The private sector referred to in this section is everything outside the ambit of the government run
public health initiatives. The private sector in India varies widely in its size, nature of service
delivery and the socio-economic groups served. It consists of a wide range of providers from
individual medical practitioners of many different systems of medicine, including allopathic as
well as Indian Systems of Medicine and Homeopathy, paramedics and even traditional healers
who possess no formal training, private hospitals and nursing homes, NGO run hospitals, and
corporate sector health care institutions.

The private sector holds a factual predominance of health care service delivery in India. As per
National Sample Survey Organization report of 71st round of survey, more than 70% of patients
seek care in private clinics or hospitals. Delays in diagnosis, over-diagnosis of TB due to an over-
dependence on X-rays, the use of multiple non-standard regimens for inappropriate durations,
the lack of a mechanism to ensure the full course of treatment and to record treatment outcomes
are some issues of concern in the private sector. Similar problems in varying degrees are
encountered in other health sectors as well.

The strategic vision of NTEP is to lay down guidelines and norms for TB care in country. The
underlying principle is for NTEP to extend public services to privately-managed patients.

20
Standards for TB care in India, mandatory TB notication, NIKSHAY, ban on Serodiagnostics and
amendments in H1 schedule etc, are among the tools to improve TB care services in private
sector. Regulatory tools, however, are limited, and partnership is preferred. Programme staff
should understand that NTEP needs private providers more than private providers need the NTEP
to achieve TB elimination by providing a patient centric care.

Other approaches include an expanded acceptance by NTEP of internationally approved

diagnostic and treatment protocols, reliance on market forces rather than normative
exhortation, increased use of accreditation and contracting. Further outreach to private
laboratories, increased control of TB drugs, and innovative use of information and
communication technologies for TB notication and treatment adherence monitoring. It is
important to recognize that partnerships come in a wide variety of shapes and sizes, and operate
at all levels, from local to global.

Model of care envisioned for delivery of services in continuum of care of TB patients from being a
presumptive TB to the diagnosis, treatment and nal treatment outcome in public and private
sector is depicted below. It also shows what systems are in place for ensuring the various aspects
of patient care in the public sector in the upper half and the other sectors in the lower half. All
these systems ensure quality of services being provided to the patients irrespective of the place
where the patient seeks care.

Model of Care

Work exercises
Q1. District X has a population of 20 Lakh, with 5 lakhs population residing in hilly tribal areas.
Q2. What is the number of TUs and DMCs that the district is expected to have in place?
Q3. What are the key pillars of END TB Strategy?
Q4. Discuss the organogram of NTEP

21
 MODULE 2
DIAGNOSIS OF
TB AND QUALITY
ASSURANCE

Learning Objectives
In this chapter the participants will learn about the following:

Section A: Overview of Diagnostics

a. Symptoms of tuberculosis
b. Presumptive TB Patient
c. Screening for TB symptoms
d. Active Case nding from key population
e. Process of Diagnosis
f. Collection of Biological specimens
I. Tasks to be performed before, during & after collection of sputum
ii. Use of appropriate form
g. Transportation of Biological specimen
I. For smear microscopy from collection centres
ii. For Culture and DST from DMC/DTC/ CBNAAT sites
h. Diagnostic Tools
I. Sputum smear examination (ZN/ FM staining procedure) Rapid Molecular techniques:
NAAT (CBNAAT)/ TruNAAT), LPA
j. Universal Drug Susceptibility Testing
k. Documentation related to diagnostic services
I. Referral slip
ii. NTEP Request form for examination of biological specimen for TB
iii. TB Laboratory register
iv. TB Notication register
v. NTEP Laboratory register for culture, CBNAAT and drug susceptibility testing

Section B: External Quality Assurance of Diagnostic services

22
Introduction
Pulmonary tuberculosis, microbiologically conrmed by Sputum Smear Microscopy, WHO
endorsed rapid molecular tests (WRD) or culture, is the most common and infectious form of
tuberculosis and forms the major source of infection in the community. Every sputum smear
positive patient has the potential to spread infection to 10 – 15 persons annually, if untreated.
From the public health point of view, it is of utmost importance to detect and treat all forms of TB
as early as possible, to cut the chain of transmission of disease in the community.

Diagnostic services for all forms of tuberculosis such as Extra-Pulmonary tuberculosis, Paediatric
TB, HIV-TB and Drug Resistant TB are available under programme.

Sputum Smear microscopy is the primary tool which is reliable, inexpensive, easily accessible
and rapid method of diagnosing PTB, where in the bacilli are demonstrated in the sputum
specimen of a patient suffering from PTB. Chest X-ray is both a screening and a supportive tool for
the diagnosis of smear negative PTB. Solid (LJ) and Liquid Culture (MGIT) methodologies and
molecular based diagnostic technologies including Nucleic Acid Amplication Test (CBNAAT/
Truenat), Line Probe Assay etc., are available under the programme.

Denitions:
Presumptive Pulmonary TB refers to a person with any of the symptoms and signs suggestive of
TB, including: cough for 2 weeks or more, fever for 2 weeks or more, signicant weight loss,
haemoptysis, any abnormality in chest radiograph.

Note: In addition, contacts of microbiologically-conrmed TB Patients, PLHIV, diabetics,

malnourished, cancer patients, patients on immune-suppressants or steroid should be regularly
screened for sign and symptoms of TB

The following are also to be investigated as presumptive PTB

a. Contacts of Microbiologically conrmed TB patients having cough of any duration
b. Presumptive /conrmed extra-pulmonary TB having cough of any duration
c. HIV positive patient having cough of any duration

Presumptive Extra Pulmonary TB refers to the presence of organ-specic symptoms and signs
like swelling of lymph node, pain and swelling in joints, neck stiffness, disorientation, etc.,
and/or constitutional symptoms like signicant weight loss, persistent fever for 2 weeks or
more, night sweats.

Presumptive Paediatric TB refers to children with persistent fever and/ or cough for 2 weeks or
more, loss of weight*/ no weight gain and/ or history of contact with infectious TB cases**.

• History of unexplained weight loss or no weight gain in past 3 months; loss of weight is
dened as loss of more than 5% body weight as compared to highest weight recorded in
last 3 months.

** In a symptomatic child, contact with a person with any form of active TB within last 2 years may
be signicant

23
Presumptive DR TB refers to the patient who is eligible for Rifampicin resistant screening at the
time of diagnosis or/and during the course of treatment for DS TB or H mono/poly. This includes
following patients:

- All Notied TB patients (Public and private) - Follow-up positive on microscopy

including treatment failures on standard rst line treatment and all oral H mono/poly
regimen; - Any clinical non-responder including paediatric (if specimen available)

To diagnose TB, appropriate diagnostic test may be used

Importance of properly identifying Presumptive TB cases

Identication of Presumptive TB patient
Most patients with TB attend health facilities for seeking relief of symptoms. It is important to
suspect tuberculosis among these chests symptomatic and subject them for sputum
examination. These TB patients if not diagnosed will continue to spread the infection. If left
untreated it is likely that more than half of them die by three years. Hence, every case of
presumptive pulmonary TB should be referred for sputum examination and presumptive EPTB
cases for appropriate investigations on time.

NTEP referral slip (Annexure-1)

The referral slips are used by peripheral health workers like ASHA, AWW, Link Workers etc. to
refer patients to health facilities for examination or specimen collection. This referral slip has
contact details and symptoms of presumptive TB case. At the referred health facilities, Request
form for examination of biological specimen for TB is lled up by Medical Ofcer.

Passive Case Finding: When the Patient Voluntarily reports symptoms to the Medical Ofcer.

Intensied Case Findings: When the Medical Ofcer searches for TB symptoms among the
individual seeking care in the health facility e.g., ART Centre, Diabetic Clinics, NCD Clinics.

Active Case Finding: When the Community health workers seeks for TB symptoms among the
vulnerable key population. The Programme encourages Active Case nding as an intervention
for Ending TB

All health workers and community volunteers should be encouraged to

identify and refer presumptive TB patients to DMCs for early diagnosis and
treatment to prevent further spread of the infection

Screening of vulnerable population

Vulnerable population is a group of people in whom the prevalence or incidence of TB is
signicantly higher than in the general population. The recommended vulnerable groups to be
considered for intensied case nding may be classied as follows:

24
 Clinical Social Geographical
Clients attending HIV
Prisoners Urban Slums
Care Settings

Occupations with risk of

developing TB (mines, coal
industry, sand blasting
Substance abuse industries, weaving & glass Hard to reach
including smokers industries, stone crushers, areas
cotton mill workers, tea
garden workers, rice mill
workers etc.,)
Co-morbidities like Diabetes
Mellitus, Malignancies, patients
on dialysis and on long term
immunosuppressant therapy

Health Care Workers People in Congregate

settings – e.g., night Indigenous and tribal
Household & Workplace
shelters, De-addiction populations
Contacts
centres, Old age homes
Patients with Past History
of TB

Malnourished

Antenatal mothers attending

antenatal clinics/MCH clinics

Adopting a well thought ACSM strategy and integrating it with the planning process for ICF will
result in a multiplier effect in case nding efforts.

Utilizing Mobile Medical Units for screening presumptive TB patients in identied and hard to
reach areas, using Information & Communication Technology (ICT) tools to enhance case nding
are some examples of innovation in ICF which can be adopted.

Screening of Presumptive Pulmonary TB patients:

Patients attending health institutions - government/private need to be systematically screened
for cough of two weeks or more. Persons with cough for more than 2 weeks, with or without other
symptoms suggestive of TB, should be promptly identied as presumptive pulmonary TB
patients. They are to be referred to designated microscopy centre (DMC) for sputum examination
using the Request form for examination of biological specimen. Patients belonging to the key
population EPTB, HIV and Paediatrics (after X-ray screening in case of children) can be directly
referred for CBNAAT.

25
In a peripheral health institution (PHI), it is expected that at least 2-3% of new adult out patients
are chest symptomatic (Presumptive PTB Cases). However, this will vary widely in different
settings e.g., chest clinics, Medical Colleges and TB hospitals. A good number of TB patients may
be left undetected, if a health facility is identifying and subjecting less than 2 - 3% of new adult
outpatient for sputum examination. Further, it is expected that on an average 5-15% of the chest
symptomatic subjected for sputum examination are found to be sputum smear positive following
standard operating procedures of smear microscopy. This percentage varies depending on the
clinical/epidemiological settings.

The number of Presumptive TB patients examined can be expressed as numbers / lakh

population. There should be an increasing trend year on year commensurate with
more efforts required to detect additional patients.

Sustained efforts have to be taken to examine as many Presumptive TB

patients as possible to maximize case detection under the program.

Referral for sputum examination

Specimen from Presumptive Pulmonary TB patients are subjected to sputum smear microscopy
at Designated Microscopy Centres (DMC). Presumptive PTB patients attending peripheral health
institutions other than DMC are either referred to nearest DMC for sputum examination or their
sputum specimens are collected and transported to the DMC as per guidelines. For diagnosis,
two sputum specimen have to be examined by Microscopy.

To provide better access for diagnosis of TB all peripheral health institutions including the PHC
wherever, laboratory technicians and Binocular microscope are available can be upgraded to
designated microscopy centre, irrespective of the population norms or OPD attendance. In
addition, DMCs can be established in other public sector undertakings, (e.g., ESI, Railways)
private hospitals and NGO health facilities. All DMCs should comply with the Quality Assurance
mechanisms as per the External Quality Assurance (EQA) Guidelines.

Tools for diagnosis Pulmonary TB in adults

Anatomical Site of TB Type of TB Type of TB Geographical

Pulmonary / Extra- Drug Sensitive 1. Sputum smear microscopy

NAAT
Pulmonary TB (Zeihl-Neelson Staining
/Fluorescence staining)

2. Solid and liquid culture

Drug Resistant 1. Liquid culture & DST 1. NAAT

TB
2. Solid culture & DST 2. LPA

• Sputum smear microscopy

• Nucleic Acid Amplication Test (NAAT)
• Sputum culture and DST for diagnosis of Drug Resistant TB
• Line Probe Assay for diagnosis of MDR/XDR TB

26
Supportive tools for the clinical diagnosis of TB
• Chest X-ray and other radiological tests
• Tuberculin Skin Test (TST), Interferon Gamma Release Assay (IGRA) and other blood
tests, Histopathology and other tissue-based tests.

Diagnostic Tools
Tools for microbiological conrmation of TB
Under the programme acceptable methods for microbiological diagnosis of TB are:

A. Sputum Smear Microscopy (for AFB):

• Zeihl-Neelsen Staining
• Fluorescence staining

B. Culture:
• Solid (Lowenstein Jensen) media
• Automated Liquid culture systems e.g. BACTEC MGIT 960, BacT Alert or Versatrek etc.

C. Drug Sensitivity Testing:

• Modied Proportionate Sensitivity Testing (PST) for MGIT 960 system
• Economic variant of Proportion sensitivity testing (1%) using LJ medium

D. Rapid molecular diagnostic tests:

• Line Probe Assay (LPA) for MTB complex and detection of RIF & INH resistance (FL LPA)
and FQ and SLI resistance (SL LPA)
• Nucleic Acid Amplication Test (NAAT) (CBNAAT/Truenat)

Smear microscopy being the most commonly used method for microbiological diagnosis of TB
for the last several decades, has had enormous value in TB diagnosis but with limited sensitivity,
more so in children and PLHIV. Under the programme, two methods of microscopy are currently
being used- ZN stain-based microscopy using conventional microscope and Light Emitting

Diode based Fluorescent Microscopy (LED FM).

Culture though highly sensitive and specic method for TB diagnosis, requires 2-8 weeks to yield
results and hence does not help in early diagnosis. However, culture will be used for follow up of
patients on drug resistant TB treatment to detect early recurrence. In addition, it is also used for
long term follow up for DS TB patients as per programme guidelines, to ensure relapse free cure.

Liquid culture system– Mycobacteria Growth Indicator Tube system (MGIT-B is an automated
culture system that detects the growth of mycobacteria. The culture results are usually available
up to 42 days. DST results are available 14-26 days after the cultures turn positive.

Molecular Assays– Polymerase Chain Reaction (PCR) based technologies using various
modications are used for detecting the presence of putative resistance genes (rpoB for
rifampicin, katG and inhA for Isoniazid etc.,).

The most widely evaluated and used assays are Line Probe Assays (LPA) which are based on in-
situ hybridization on nitrocellulose strips of specic genetic targets for resistance genes. These
are now available for RIF and INH resistance (MDR-TB) and also for XDR-TB (gyrA and gyrB for
Fluoroquinolones, rrs(second line injectable) and eis(low level kanamycin resistance)for second
line injectable).

27
Nucleic Acid Amplication Test (NAAT) provides accurate and rapid diagnosis of TB by detecting
Mycobacterium tuberculosis (M. tuberculosis) and Rifampicin (Rif) resistance conferring
mutations, in sputum specimen as well as specimen from extra-pulmonary sites. under the
programme, its use is recommended for diagnosis of DR-TB in presumptive DR-TB patients and
TB preferentially in key population such as children, PLHIV, Extra-pulmonary TB and in smear
negative TB as per the diagnostic algorithm.

Diagnosis of TB by any microbiological tools and treatment for

TB are available FREE of cost at all health facilities under RNTCP

Other diagnostic tools

Radiography
Chest X-Ray is to be used as a screening tool to increase sensitivity of the diagnostic algorithm.
Any abnormality in chest radiograph should further be evaluated for TB including
microbiological conrmation.

For the diagnosis in the absence of microbiological conrmation, X-ray can be used as a tool for
supportive evidence. Though the inter and intra observer variability is high in X ray and no X ray
shadow is specic for TB and 10-15% culture positive cases may remain undiagnosed (under
reading) when x-ray alone is used as a diagnostic tool, careful clinical assessment and
supportive X-ray ndings can be used to diagnose TB and such cases will be considered as
clinically diagnosed TB. It is also useful for diagnosing extra pulmonary TB like pleural effusion,
pericardial effusion, mediastinal adenopathy and miliary TB.

Tuberculin Skin Test (TST) and Interferon Gamma Release Assay (IGRA) Are not to be used for
diagnoseis of TB in adults as well as children. However, for LTBI these tests have a role which will
be discussed latter.

Serological tests
The Government of India issued Gazette notication vide 433E 7th June 2012 has banned the
manufacture, importation, distribution and use of currently available commercial serological
tests for diagnosing TB. These tests are not recommended for diagnosis of TB (Annexure 3).

• Lateral ow urine lipoarabinomannan (LF-LAM) assay can only be used

for diagnosis of TB in HIV positive patients with signs and symptoms of TB
(pulmonary and/or extra-pulmonary) who have a CD4 cell count less than
or equal to 100 cells/μL.

• C-Tb is the next-generation skin test for detection of Tuberculosis. It has

high specicity and contains the same antigens used in IGRA i.e., ESTA 6
and CFP 10. It is unaffected by BCG vaccination status and hence can be
used as a tool for latent TB diagnosis

28
Sputum Smear Microscopy
Sputum smear microscopy is the most widely used and acceptable testing tool for diagnosing
smear positive pulmonary TB. Ziehl-Neelsen / Fluorescent staining technique is used under the
programme. Sputum smear microscopy has the following advantages: -
A. Simple, inexpensive, requires minimum training
B. High specicity
C. High reliability with low inter-reader variation
D. Can be used for diagnosis, monitoring and dening cure
E. Results are available quickly
F. Feasible at peripheral health institutions
G. Correlates with infectivity in pulmonary TB

Therefore, this is the key diagnostic tool used for case detection under the programme..

Microscopy is more specic and has less inter and

intra-reader variability than X-ray

The MO / health worker / laboratory technician (LT) should instruct the patient about proper
sputum collection. If sputum collected is not of good quality and the patient has smear- positive
pulmonary tuberculosis, the diagnosis may be missed, and the patient may continue to spread
the infection to others. The LT should label the sputum container properly by writing the patient's
laboratory serial number on the side of the sputum container and not on the lid.

Rapid diagnostic tools include:

The CB-NAAT system detects DNA sequences, specic for Mycobacterium tuberculosis complex and
rifampicin resistance by polymerase chain reaction. It concentrates Mycobacterium tuberculosis
bacilli from sputum samples, isolates genomic material from the captured bacteria by sonication
and subsequently amplies the genomic DNA by PCR. The process identies clinically relevant,
rifampicin resistance inducing mutations in the RNA polymerase beta (rpoB) gene in the
Mycobacterium tuberculosis genome in a real time format using uorescent probes called
molecular beacons. Results are obtained from unprocessed sputum samples in 90 minutes.

Line Probe Assay (LPA)

Line Probe Assays detect DNA sequences specic for Mycobacterium tuberculosis complex as
well as mutations conferring resistance. Sputum samples are decontaminated and the
concentrated deposit subjected to smear microscopy. DNA is extracted from all smear positive
samples and subjected to PCR; while all smear negative samples are inoculated in liquid culture
and LPA performed using the culture isolate obtained upon growth of Mycobacteria. The PCR
amplied products are reverse hybridized on nitrocellulose strips containing probes specic for
detection of M.tb and mutations associated with drug resistance. First Line LPA detects resistance
to Rifampicin (rpoB) and Isoniazid (katG , inhA), while Second Line LPA detects Fluoroquinolone
class resistance (gyrA,gyrB) and Second line injectable class resistance (rrs ,eis)

Process of diagnosis of pulmonary TB

Medical Ofcers of the health care facilities (government medical college and non-government)
should identify all presumptive pulmonary TB and refer for sputum examination using the
Request form for examination of biological specimen for TB or by enrolling the patient in Nikshay
and requesting the test on-line. Where the facilities are available, X-ray may be done
simultaneously.

29
Add details of Enrolment details and screenshot
Patient may be given sputum containers for collecting early morning sputum and visit the
laboratory if the health facility is a non-DMC. Patient should be educated about how to collect
the sputum by the Health Worker or Medical Ofcer. If it is a DMC, LT will be educating, and
giving sputum containers for collecting spot specimen and early morning sputum specimen on
the next day. If, the health facility is transporting the sputum specimen, it should reach DMC as
soon as possible. Two sputum samples are collected within a day or on two consecutive days.

Case Denitions:
Microbiologically conrmed TB refers to apresumptive TB case
Microbiologicallyc from whom a biologicalspecimen is positive for acid fast bacilli,
onrmed TB or positive forMycobacterium tuberculosis on culture, or positive
fortuberculosis through Rapid Diagnostic molecular test

A clinically diagnosed TB refers to apresumptive TB case who is not

microbiologicallyconrmed, but has been diagnosed with active TB
Clinically Diagnosed TB bya clinician on the basis of X-ray abnormalities, histopathology or
clinical signs with a decision totreat the patient with a full course of
Anti-TBtreatment.

Classication based on anatomical site of disease

a) Pulmonary tuberculosis (PTB) refers to any microbiologically conrmed or clinically
diagnosed TB involving the lung parenchyma or the tracheo-bronchial tree.
b) Extra Pulmonary tuberculosis (EPTB) refers to any microbiologically conrmed 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.
Miliary TB is classied 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.

Classication based on history of previous TB treatment

a) New TB patient - 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 TB patient.
b) Previously treated TB – A patient who has received one month or more of anti-TB drugs from
any source in the past.
I. Recurrent TB patient - A TB Patient previously declared as successfully treated
(cured/treatment completed) and is subsequently found to be microbiologically
conrmed TB is a recurrent TB patient.
II. 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.
III. Treatment after lost to follow-up A TB patient previously treated for TB for one month or
more and was declared lost to follow-up (LFU) in their most recent course of treatment
and subsequently found to be microbiologically conrmed TB
IV. Other previously treated patients are those who have previously been treated, who
cannot be classied into any of the above.

c) Transfer in A TB patient who has been received for treatment in a Tuberculosis Unit, after
starting treatment in another TB unit where s/he has been registered is considered as
transferred in.

30
 Diagnostic Algorithm for Drug Sensitive TB
31
 *All TB patients have to be referred for UDST

The diagnostic algorithm given above should be strictly followed. If not followed, patients may
either be treated unnecessarily based only upon X-ray results or left untreated.

In any clinical settings presumptive PTB patients can be identied by screening for chest
symptoms. Some of the patients may walk in with a chest X-ray, if there are some abnormality in
chest X-ray those patients also will be identied as presumptive PTB.

A. These presumptive PTB patients should be subjected for sputum smear microscopy (ZN/FS).
Two specimens will be collected (spot-early morning or two supervised spot specimen
collected at least one hour apart and smears made from both the samples. If one or both of
the smear is positive*, the patient is diagnosed as a microbiologically conrmed Pulmonary
TB.

B. If both of the smears are negative, and the patient is already having a recent chest X-ray
suggestive of TB; S/he should be referred for testing to the nearest CBNAAT laboratory.

C. If both smears are negative and the patient is not having a chest X-ray, s/he should be
referred for chest X-Ray. If chest X-ray suggestive of TB, the patient should be referred for
CBNAAT. If the rst smear is negative and X-Ray is offered in parallel, the second specimen is
sent to CBNAAT laboratory (if the X-ray is abnormal).

D. If both smears are negative and chest X-ray is NOT suggestive of TB and there is strong
clinical suspicion of TB, then also the patient needs to be referred for CBNAAT testing.

Two sputum specimens are to be collected from the patient and sent to the CBNAAT site.. One
specimen is tested using CBNAAT and if TB was detected, the other sample is used for further
cascade testing
a. If CBNAAT result is MTB detected, the second sample need to be transported to C&DST
Lab immediately
b. If CBNAAT result suggest rifampicin sensitive, second sample is sent for FL-LPA to look
for H-mono/ poly resistance.
i. If FL-LPA suggests H sensitive, then DSTB treatment is continued.
ii. If FL-LPA suggests H resistance, then patient is managed as per Integrated diagnostic
algorithm for DRTB (Fig on Page 31)
iii. If MTB is not detected by CBNAAT, CXR is suggestive of TB or otherwise but the
clinician considers TB as a probable clinical diagnosis requiring anti-TB treatment
after ruling out other alternative diagnosis,the patient is labelled as Clinically
diagnosed TB . In such cases alternative diagnosis should be actively ruled out.
E. If MTB is not detected by CBNAAT / CBNAAT result is not available and clinician does not
consider TB as a probable diagnosis at this stage, the patient is not a TB case and needs to
evaluated for other respiratory diseases.
F. All key population (PLHIV, Children, EPTB etc.) will be preferentially offered upfront CBNAAT.

G. The algorithm does not mandatorily decide the “order to DO” the tests / investigations. If
multiple tests are available at a site, they may be offered to the patient to avoid diagnostic
delay with a focus on microbiology conrmation.

32
H. If the clinician considers coexisting clinical conditions, along with TB, appropriate
investigations must be done to diagnose those conditions.

Diagnosis of TB among children

The extent of TB in children is a reection of the pool of infectious adult pulmonary tuberculosis
cases in the community and their ability to transmit infection. All adolescents up to 18 years of
age are to be treated using paediatric weight bands and those weighing more than 39 kg with
adult weight bands.

Diagnosis
Early and prompt diagnosis of TB in children is often difcult. A battery of tests is required to
arrive at accurate diagnosis of TB in children. Generally, diagnosis should be made by a Medical
Ofcer and the existing NTEP case denitions are to be used for all cases diagnosed.

High index of suspicion of TB in a child is the rst step in the diagnosis. Tuberculosis should be
suspected among children presenting symptoms of prolonged / unexplained fever and / or
cough for more than 2 weeks, with no weight gain or history of failure to thrive. It is to be
remembered that cough may not be the predominant and constant symptom unlike in an adult.
Children presenting neurological symptoms like irritability, refusal of feeds/failure to thrive,
headache, vomiting or altered sensorium and convulsions, may be suspected to have TB
meningitis.

History of contact with a Presumptive TB patient or a diagnosed patient of PTB within the last 2
years reinforces the suspicion of tuberculosis. Special efforts should be made to elicit the history
of contact with tuberculosis patient.

Establishment of malnutrition on an objective basis is also helpful in reinforcing the diagnosis.

(refer to CTD published guidelines on nutrition)

The diagnosis is further based on sputum examination wherever possible, Chest X-ray
examination and Mantoux test (tuberculin skin test) using standard tuberculin.

Sputum examination, if feasible, is a very helpful tool in the diagnosis. It is pertinent to

remember that pulmonary TB among children is most often pauci- bacillary and there are
practical difculties in obtaining good quality sputum. All attempts to be made to collect a good
quality specimen. After X- Ray screening and sputum/gastric aspirate/gastric lavage, induced
sputum etc., can be used for testing in CBNAAT.

Tuberculin skin test using standard tuberculin is an adjunct tool in the diagnosis of TB among
children. While administering Tuberculin skin test it is to be ensured that a standard product -
PPD RT23 with tween 80 is used and a dose of not more than two tuberculin units is given to elicit
specic reaction to M.tb. Induration of 10mm and above read after 48-72 hours of properly
administered tuberculin indicates that the child is infected. It may be noted that currently there is
no standard PPD available in the country. A new skin test called C-Tb (which is equivalent to
IGRA) is likely to be become available by mid- 2020.

Chest X-ray, also aids in the diagnosis of TB among children. Features in chest X-ray include hilar
adenopathy inltrations, pleural effusion etc., See paediatric pulmonary diagnostic algorithm
given below.

33
 Diagnostic algorithm for Paediatric Pulmonary Tuberculosis

Persistent Fever> 2wk, without a known cause and/or

Unremitting Cough for >2w and/or
Wt loss of 5% in 3m or no wt gain in past 3 months h/o contact

Chest X Ray

CXR NS shadows /NA CXR Normal CXR Normal

CXR highly suggestive
Skin test +ve/NA Skin test +ve Skin test - ve
34

Expectorated sputum/ Give course of

Microbiological GA/IS for CBNAAT Antibiotics
conrmed TB Case
Evaluate for EPTB
Refer to expert
CBNAAT CBNAAT -ve CBNAAT - ve Persistent shadow
+ve Skin test +ve Skin test - ve and symptoms
Look for
alternate cause
Look for Expectorated sputum/
alternate cause GA/IS for CBNAAT

No other likely alternative diagnosis CBNAAT - ve & Refer to expert for

Clinically Diagnosed TB case Skin test +ve work up of
persistent
CBNAAT CBNAAT - ve &
+ve Skin test - ve pneumonia
The following foot notes to be included:
1. This algorithm is for children who are likely to have drug sensitive disease i.e., have not
received ATT previously ever and are not presumptive drug resistant TB cases (lost to follow
up, relapse, treatment failure, HIV).

2. Proper characterization of symptoms is a very important starting point. Weight loss or not
gaining weight should always be documented with appropriate weighing.

3. Rapid molecular test (CBNAAT)

a. Whenever Rif Resistant result is reported on Rapid molecular test (CBNAAT) further
management should be carried out as per the guidelines on Drug Resistant TB.

b. Rapid molecular test to be offered in non-specic symptoms with high index of

suspicion. Rapid molecular test to be repeated for special situations including HIV,
malnourished population. Where Rapid molecular test is not doable, smear
examination may be done.

c. A RIF indeterminate/Invalid/Error/No result will get an additional CBNAAT to get a valid

result and in case of indeterminate on second occasion, an additional specimen will be
collected and sent to the nearest Intermediate Reference Laboratory (IRL) or Culture &
Drug Susceptibility Testing (C&DST) centre for LPA or Liquid Culture & DST as
appropriate.

d. If a specimen is positive by Rapid molecular test / Culture / smear examination, the

disease is labelled as Microbiologically conrmed TB.

e. Whenever indicated, alternative specimens (Gastric lavage/ Induced sputum/ broncho-

alveolar lavage) should be collected by a skilled health care provider, depending upon
available infrastructure and sample should be subjected to Rapid molecular test.

f. A good sputum sample consists of recently discharged material from the bronchial tree
with minimum amount of oral or nasopharyngeal material, presence of mucoid or
mucopurulent material and should be 2-5 ml in volume. It should be collected in a
sterile container after rinsing of the oral cavity with clean water.

The collected specimens should be transported to the laboratory as soon as possible after
collection. If delay is unavoidable, the specimens should be refrigerated (maximum up to one
week) to inhibit the growth of unwanted micro-organisms.

g. Samples for culture should never be collected in formalin

h. No preservative should be used for any extra-pulmonary specimen for culture.

Necessary instructions are to be given to the concerned staff for sending the biopsy
specimen in normal saline for culture and not in 'FORMALIN'' as it kills bacilli.

35
4. Chest X Ray
a. Chest X ray if available within 7 days, may be used.

b. Highly suggestive Chest X-ray refers to skiagrams showing either Miliary or

lymphadenopathy (hilar or mediastinal) or chronic bro-cavitatory shadows. If the
radiological picture is highly suggestive of TB, then proceed to do further investigations
irrespective of the TST result as the sensitivity of the test is not 100%.

c. Non-Specic Chest X-ray: Refer to patterns other than highly suggestive like
consolidations, inhomogeneous shadows or bronchopneumonia, etc.

5. For Antibiotic trial, 7-10 days of broad-spectrum antibiotic - amoxicillin and Amoxyclav may
be given. Antibiotics like linezolid or any quinolone should not be used as they have anti-TB
action.

6. Skin test:

a. Current recommendation is to use 2TU PPD RT23 for all diagnostic purposes

b. Mantoux test or PPD skin test is considered positive if the induration is 10 mm or more, In
HIV co-infected cases, 5mm may be taken as the cut off.

c. Cut offs for higher strengths are not established. Higher strengths increase false positive
reactions. The standard cut off of 10 mm can actually not be justied for any higher
strength of PPD used

7. No role for inaccurate / inconsistent diagnostics like serology (IgM, IgG, IgA antibodies
against MTB antigens), various in-house or non-validated commercial PCR tests and BCG
test

8. Currently there is no role of IGRAs in clinical practice for the diagnosis of TB.

9. Children with persistent symptoms, non-specic shadows and negative smears and
negative other samples (GA/IS) by Rapid molecular test should be referred to experts for
further work up of persistent pneumonia.

10. All TB cases diagnosed must be offered testing for HIV.

There is no role for inaccurate / inconsistent diagnostics like

serology (IgM, IgG, IgA antibodies against MTB antigens- these
serological tests are banned in India), various in-house or non-
validated commercial PCR tests and BCG test.

Currently there is no role of IGRAs

in clinical practice for the diagnosis of TB.

Extra-pulmonary TB
15%-20% of the total TB cases comprise of Extra-pulmonary TB . Tuberculosis of organs other
than the lungs such as pleura, lymph nodes, intestine, genito-urinary tract, joint and bones,
meninges of the brain etc., is called as extra-pulmonary TB. Pleural tuberculosis is classied as
extra-pulmonary. Tubercular lymphadenitis and pleural effusion are most common among
extra-pulmonary TB.

36
Diagnosis of Extra-Pulmonary TB
Demonstration of AFB in a smear from extra-pulmonary site is often difcult because of low
bacillary load. The clinical features pertaining to the system affected should be considered in the
diagnosis of extra-pulmonary tuberculosis.

CBNAAT and Liquid Culture are the preferred diagnostic technologies for microbiological
conrmation of Extra Pulmonary Tuberculosis.

However, the following are some of the special investigations which are helpful in diagnosing
extra pulmonary tuberculosis. These may be radiological, cytological / pathological,
biochemical and immunological.

(a) Fine Needle Aspiration Cytology (FNAC) and direct smear examination

(b) Excision / Biopsy of specimen for histopathological examination

(c) Fluid for cytology, biochemical analysis and smear examination

(d) X-ray of the involved region

(e) Ultra-Sonography for Abdominal Tuberculosis

Precise diagnosis of some forms of extra pulmonary tuberculosis is a challenge to the physicians
as they present symptom complex with extraordinary diversity. Delay in the diagnosis can be fatal
or result in life threatening sequelae as in the case of meningeal TB.

Patients with symptoms suggestive of extra pulmonary tuberculosis should be referred to the
respective speciality for further investigations.

Diagnostic Algorithm for Extra Pulmonary TB

37
1. CBNAAT in specimen from extra-pulmonary sites provides the following results:

a. M. tuberculosis detected, Rifampicin sensitive: Diagnosis of microbiologically conrmed

EPTB is made.

b. M. tuberculosis detected, Rifampicin indeterminate: a repeat CBNAAT test is performed on

the 2nd specimen. If found to be indeterminate on the repeat test, an additional specimen
should be collected and sent to the nearest NTEP certied lab for culture and DST.

c. M. tuberculosis detected, Rifampicin resistance: patient should be treated as per PMDT

guidelines;

d. M. tuberculosis not detected: The patient should be evaluated for TB based on clinical,
radiological ndings and other investigations like histo-pathological examination,
ultrasonogram etc.,. In the event of a decision to treat with anti TB drugs, of the patient
will be classied as clinically diagnosed TB. Otherwise, an alternate diagnosis should be
sought.

e. Invalid test: a repeat CBNAAT test is performed on the 2nd specimen, if available.

f. Error/No result: a repeat CBNAAT test is performed on the same sample/2nd specimen, if
available.

Note: Second sample may not be available for most patients with extra-
pulmonary TB.
1. In case CBNAAT is not available, liquid culture needs to be performed. If culture is positive,
then diagnosis of microbiologically conrmed EPTB is made. Further work up may be done to
evaluate Rifampicin and INH resistance.

2. If investigations like CBNAAT/smear microscopy/culture turn out to be negative or if

appropriate specimen is not available for these investigations, consultation with a specialist
followed by other tests such as histopathology, radiology, cytology, biochemical
examinations, etc., may be undertaken. In the event of a decision to treat with a full course of
anti-TB drugs, diagnosis of clinically diagnosed EPTB is made.

3. Depending on the site of EPTB accessibility of the sampling procedure and the amount of
sample available, decision may be taken to do CBNAAT, Culture or both and the sample will
be collected as per SOP. Sample should not be split in eld conditions. Formalin should not be
used for collecting the specimen.

Diagnosis of Drug Resistance TB (DR-TB):

Patients can have drug resistance tuberculosis through transmission from a drug resistant index
case (Primary transmission) or develop resistance while on treatment (Acquired Resistance).

Emergence of Drug resistance is due to genetic mutation that makes a drug ineffective against
the mutant bacilli. In clinical settings an inadequate or poorly administered treatment regimen
allows drug-resistant mutants to become the dominant strain in a patient infected with TB.

Preventing emergence of drug resistance is of paramount importance. To prevent drug

resistance, the Medical Ofcer has to ensure that the programme is implemented as per

38
Guidelines. All TB patients in his/her jurisdiction have to be diagnosed early, initiated promptly
on treatment followed up correctly and supported well to complete the treatment successfully.
MO should also help the Private health providers in his/her jurisdiction to diagnose ,manage,
and notify TB as per National guidelines. When resistance has already occurred, it is important to
diagnose it early prevent further transmission by following the Air borne infection control
measure as well as to treat and cure the patient at the earliest.

The rst step for detection of DR-TB cases is to identify presumptive DR-TB cases at the earliest.

Presumptive DR-TB: It refers to the following patients in order of their risk:

TB patients found positive on any follow-up sputum smear examination during treatment with
rst line drugs including treatment failures;

Ÿ paediatric TB non-responders;

Ÿ TB patients who are contacts of DR-TB;

Ÿ previously treated TB patients;

Ÿ new TB patients with HIV co-infection;

Ÿ all notied new TB patients*.

* Under the Programme, all notied New Patients are offered CBNAAT to know if they are
resistance to Rifampicin. This is termed as universal DST for Rifampicin. Efforts are to be made to
collect specimen from all TB patients for CBNAAT at baseline.

Integrated drug-resistant TB algorithm

The integrated DR TB algorithm clearly indicates the management strategies to be followed right
from the day the result of NAAT test is available. The programme must strive to offer DST to all
notied TB patients at diagnosis of TB or a maximum within 15 days of rst line treatment
initiation. The algorithm further offers FL LPA for the patients found R resistance not detected on
NAAT. States must ensure availability of laboratory capacity to perform LPA (both SL and FL LPA)
as per the estimated requirement including the patient notied from the private sector. Within
the rst 2 months of treatment initiation, patients would receive their LC DST results, their nal
classication will be arrived at and they will be treated with appropriate regimen. .

As per the algorithm, the TB patients with R resistance not detected will be initiated on rst line
treatment regimen while awaiting the results of FL LPA and continued on rst line treatment if H
resistance is not detected. These patients will be monitored closely and in patients with signs of
non-response to treatment during follow up, another NAAT test will be offered. All follow up
positive, failures and clinical non-responders of DS-TB treatment are also eligible for repeat
NAAT irrespective of NAAT offered at the time of initiation of DS TB treatment.

If resistance to H is detected, the patient will be initiated on all oral H mono-poly DR TB regimen
at the PHI level while awaiting the results of SL LPA and the regimen would be appropriately
modied at the N/DDR TBC if Lfx/Mfx(h) resistance is detected on SL LPA. The patients with RR TB
will be considered for shorter MDR TB regimen at N/DDR TBC after ruling out the exclusion
criteria for shorter MDR TB regimen. Decision to start shorter MDR TB regimen will be based on

39
non-DST and DST based exclusion criteria(refer PMDT guidelines 2019 for details). The patients
excluded from shorter MDR TB regimen would be initiated on all oral longer MDR TB regimen at
N/DDR TBC. In case of additional resistance on LC DST, the all oral longer MDR TB regimen
would be appropriately modied.

A patient is conrmed to have drug resistant TB, only when the results are from a NTEP quality-
assured Culture & DST Laboratory and by a NTEP-endorsed testing method. Such patients are
classied according to the following denition.

Classication based on drug resistance

a. Mono-resistance (MR): A TB patient, whose biological specimen is resistant to one rst-line
anti-TB drug only.

b. Poly-Drug Resistance (PDR): A TB patient, whose biological specimen is resistant to more than
one rst-line anti-TB drug, other than both isoniazid (INH) and Rifampicin (R).

c. Multi Drug Resistance (MDR): A TB patient, whose biological specimen is resistant to both
isoniazid and rifampicin, with or without resistance to other rst line drugs, based on the
results from a quality assured laboratory.

d. Rifampicin Resistance (RR): resistance to rifampicin detected using phenotypic or genotypic

methods, with or without resistance to other anti-TB drugs excluding INH. Patients, who have
any Rifampicin resistance, should also be managed as if they are an MDR TB case.

e. Extensive Drug Resistance (XDR): A MDR TB case whose biological specimen is additionally
resistant to a uoroquinolone (ooxacin, levooxacin, or moxioxacin) and a second-line
injectable anti TB drug (kanamycin, amikacin, or capreomycin) from a quality assured
laboratory.

So far, we have discussed on proper and early identication of Presumptive TB and Presumptive
DR TB cases. Now we will shall discuss the process of diagnosis.

Collection of sputum from Presumptive Tuberculosis cases.

Presumptive Tuberculosis attending the DMC will be referred for sputum examination at the
same facility. There are two options for patients attending PHI which is not a DMC.

Ÿ Either the patient may be referred to the nearest DMC for sputum examination or

Ÿ Sputum sample may be collected from such patients and transported to the DMC.

The above options may be left to the convenience of the patient in order to minimize the possible
delay in diagnosis and initiation of treatment or avoid repeated visits by the patient. If sputum
microscopy is not possible on the day the patient visits the PHI due to any unavoidable reason,
his/her sputum sample should be collected on the same day and sputum microscopy may be
done on the following day.

Guidelines for collecting sputum

The patients are given the sputum container with laboratory serial number written on its side.
The person collecting the sputum demonstrates how to open and close the container, takes the
patient to an open space away from other people and demonstrates how to bring out sputum
from the depth of chest. The patient is instructed to inhale deeply 2–3 times with mouth open,
cough out deeply from the chest, open the container and spit out the sputum into it, and close the

40
container. This is the spot specimen labelled as 'a'.

Ÿ Further, patient is given a labelled container with instructions to cough out sputum into the
container early in the morning after rinsing the mouth with water. This is the early morning
specimen. This is labelled as specimen 'b'.

Ÿ If the health facility is not a DMC, then the patient is given a sputum container with
instructions to collect an early morning specimen and go with the sputum specimen to the
DMC where the spot specimen can be collected. In case the patient is not able to travel to the
DMC, then the spot specimen could be collected at the nearest health facility or sputum
collection centre and transported to the DMC.

Ÿ These two samples should be collected within a day or two consecutive days.

Ÿ Two supervised spot samples may be collected one hour apart if patient is too sick, coming
from a long distance or likelihood of not giving a second sample is signicant.

Ÿ To obtain good quality sputum specimens and to prevent contamination, the staff must
perform certain tasks:

Ÿ Before sputum collection

Ÿ During sputum collection and

Ÿ After sputum collection.

The following are the details of the task to be performed:

1. Tasks performed before sputum collection

Before collecting the sputum specimen, the health worker should briey explain to the patient
the reasons for sputum collection. The NTEP request form for examination of biological
specimens should be lled up completely, by the MO. This form is sent to the DMC along with the
sputum specimens. Only one form needs to be lled for two sputum specimens collected from a
patient. The form accompanies the patient's sputum specimens when they are transported from
the peripheral health facility to the DMC for examination.

Request form for examination of biological specimens: (Annexure-2)

The request form is kept at all the PHIs. It is lled generally by the MO of the referring health
facility. This form is used for microscopy or CBNAAT or culture DST or Chest X-Ray or TST. Only
one form is lled for each patient. Patient will report to the diagnostic health facility along with
the request form. In case PHI is a sputum collection centre, sputum samples are sent to the
diagnostic facility along with the request form. It is essential to record patient details, reason for
testing and type of test requested. The same form is sent back to the treating unit with the results.
When this format is used for C&DST, a copy of this form will be sent electronically to lab and DTC.
In turn, the laboratory will send the result in electronic copy back to district with copy to DR-TB
centre.

Request form for examination of biological specimen has eleven parts to include all the possible
relevant investigations in a single format. The same form is used to request test to diagnose TB,
Drug susceptibility testing and follow up.

41
The rst part contains details on general information like name of the referring health facility,
name of the patient, complete address, age & gender of the patient and date of referral. The
type of presumptive TB, the key population to which the patient belongs to, site of disease in
terms of pulmonary and extra-pulmonary or disease in terms of pulmonary and extra-
pulmonary has to be indicated. The upper half of this form is completed by the MO/ health care
worker who requests a sputum examination.

Second part contains details of referring facilities and NIKSHAY ID for previously notied patient,
the names of State, district and TB units.

The third and fourth portions contain reasons for testing. The third portion is for the diagnosis
and follow up of TB and the fourth portion is for the diagnosis and follow up of Drug resistant TB.

The fth portion is to indicate the required tests with the details of the person requesting the test.

Parts six to eleven are used for reporting test results.

Detailed description of completing the form is as follows:

Name of Referring Health Facility

Date
The date (day/month/year) on which the patient is examined and the form is lled up, is written
in the space provided.

Patient Name
The patient's full name (also nickname, if any) is written in the space provided.

Age (in yrs.)

The age of the patient is written in the space provided.

Gender
The letter 'M' is ticked if the patient is a male, 'F' if female and 'TG' if Transgender.

Patient Mobile No. or other contact no.

More than one Mobile number available try to capture all. This will help to provide the
information and communication technology (ICT) based treatment adherence support after
diagnosis.

Specimen date of collection: To be given in a DD/MM/YY format

Tick the box for sputum or others according to the specimen: If the specimen is not sputum,
specify that.

Patient address with Landmark:

Complete address of the patient with landmarks is written in the space provided. It is very
important to write the complete address of the patients, so that they can be easily traced when
they do not return to the laboratory or the outpatient department of the hospital for their results.
The contact telephone number (landline or mobile) has to be obtained and recorded in the form.

42
HIV Status: Tick the status as 'Reactive' or 'Non-Reactive' if known and 'unknown' otherwise.

Key Population: Patients who belong to the key population are eligible for a direct CBNAAT
test, for concurrent diagnosis of Rifampicin resistance if present. Appropriate boxes (more than
one if required) to be ticked.

Name of reference health facility: The name of the referring facility (any health sector)
from where the patient is being referred for sputum examination is written in the space provided.

Health establishment ID: Most of the health facilities might have been registered in Nikshay
and hence having a health establishment ID, (if not available, the facility has to be registered in
Nikshay).

Patient ID allotted by Nikshay:

When the patient is enrolled in Nikshay as a presumptive TB case, this ID (Nikshay ID/ Patient ID)
will be generated.

If this ID is available write in the provided space.

Write the name of State, District and TB Unit to which the health facility referring the patient for
test belongs to.

Reason for testing:

Diagnosis and follow up of TB:

Left portion of this segment is for 'diagnosis of TB' and the right portion is for the 'follow up of TB'.

Under the diagnosis section

Tick the appropriate box for H/o of treatment for more than one month. And tick the reason for
requesting test as Presumptive TB, Repeat Examination, Private Referral and Presumptive NTM.

In case of any discordance, Error, Invalid results and indeterminate results and reconrmation a
repeat CBNAAT test will be done.

Predominant symptom of the patient and its duration are to be noted in the space provided
Example Cough 35 days, fever, 15 days etc.

Under the Follow Up section: Follow up by microscopy will be required for all drug sensitive
TB cases and TB cases with unknown sensitivity status. Follow up with microscopy and culture will
be required for all drug resistant TB cases on treatment with H mono poly regime and shorter
MDR regimen,

PMDT TB No: When a patient is registered in District DR TB centre or Nodal DR TB centre a

PMDT No. is given. Write this number in the space provided for when the patient is referred for
follow up.

The duration to which the patient has taken the treatment need to be mentioned as month and
week.

43
Test Requested:
The appropriate test requested for diagnosis or follow up has to be marked by ticking the
appropriate box.

All the columns have to be lled meticulously legibly, correctly and completely and signed with
date by the medical ofcer.

The remaining portion is for the laboratory personnel to report the result of the test. The details
of the Laboratory test and its procedures are given below.

Specimen Identication Number

If specimens are being transported to a DMC and CBNAAT site from another health facility, a
Specimen Identication Number is given at the referring facility, because the Laboratory Serial
Number can only be assigned at the DMC. Sputum specimens are assigned specic numbers to
keep track of each patient's sputum results. After the request form for examination of biological
specimens is lled up, this number is written on the side of the patient's sputum container (If a
sputum specimen is separated from its request form for examination of biological specimens, a
LT can nd out whose specimen it is by using the Specimen IdenticationNumber on the sputum
container. The laboratory technician can then locate the form by using the date and the
identication number.) Each separate specimen will generally have its own unique Specimen
Identication Number. If sputum is collected and transported to the DMC and CBNAAT site, the
list of patients whose sputum is being sent should accompany the samples and laboratory forms
for sputum examination. An example of such a list is given below

List of Patients whose sputum are sent to DMC

Health Facility: PHI 101 DMC: PHI 237 For DMC use
Sent on: 4/9/18
Received on:
6/9/18
Examined
Health Worker who collected
on:________
specimen: Raju
Result sent back
on:
Specimen Name Age Sex Address Date of collection
Identication No. of sputum
C1, C2 Lakshmi Kumari 46 F 223 Gandhi Dham 3/9/18,4/9/18
D1, D2 Lakshmi Pati Rao 50 M 223 Gandhi Dham 3/9/18,4/9/18
E1, E2 Girija Devi 32 F 225 Gandhi Dham 3/9/18,4/9/18
F1, F2 Kailash Nath 35 M 225 Gandhi Dham 3/9/18,4/9/18

2. Tasks performed during sputum collection

Person collecting the sputum specimen should follow the guidelines specied below:

Ÿ A specimen collected under supervision is likely to be of good quality and yield better results.
The person guiding the patient for specimen collection should stand behind and encourage

44
 him to cough from the depth of the chest and produce a quality specimen.

Ÿ Sputum should be collected in an open well ventilated space away from other crowded
places in a health facility.

Ÿ The patient should be given a sputum container with the Laboratory Serial Number written on
its side. If the sputum is being collected at a location other than the DMC, then the Specimen
Identication Number (or patient's name with age) is written on the side of the container.

Ÿ For the diagnosis of tuberculosis, the two specimens of a patient i.e., one
“SPOT-and the other an early MORNING ” sample are collected. The spot sample is
designated as 'A' and the early morning sample as 'B' adjacent to laboratory serial number.
For follow-up sputum examination of patients, one specimen of sputum is collected. The
specimen collected in the early morning is marked as 'B' and spot sample collected
subsequently is marked as 'A'.

Ÿ The person collecting the specimen demonstrates how to open and close the container. The
patient is instructed to inhale deeply (2–3 times), cough out sputum from the chest, spit into
the container and close it.

Ÿ The person collecting the specimen should make sure that no one stands in front of the
patient who is trying to collect sputum. Sputum should not be collected in closed rooms,
toilets or ill-ventilated rooms.

Ÿ When a patient has only coughed up saliva or has not coughed up at least 2 l of sputum, the
patient should be encouraged to give good specimen

Ÿ In case the container is soiled outside, it should be wiped dry using cotton swab and the same
is disinfected in a bin containing 5% phenol solution.

45
 Triple packaging system for sputum transportation

46
3. Tasks performed after sputum collection
The person collecting the sputum specimens should follow the guidelines specied below:

Ÿ If the sputum specimens are to be sent immediately to the laboratory, the person should put
the container into a special box meant for transport.

Ÿ If the sputum specimens are not being sent immediately to the laboratory, these should be
refrigerated in the referring health facility.

Ÿ The person should wash hands thoroughly with soap and water whenever infectious material
is handled.

Ÿ Patients should be instructed to collect the results of sputum examination. Alternatively,

sputum results may be sent to the referring health facility by hand.

Transport of sputum specimens

Sputum collected in referring health facilities should be transported to the nearest DMC within 2
days. Once examined, the microscopy results should be reported on the same day.
Arrangements should be made locally for transporting the specimens to the DMC and for
sending the results to the referring health centres. The specimens should be packed carefully

Sputum specimens should be examined by microscopy on the same day and not later than 2
days after collection. The containers along with the sample MUST be disinfected with 5% phenol
solution and disposed as per guidelines after the sputum smears results are recorded in the
laboratory register.

Transportation of all specimens

Fresh sputum samples will need to be transported from the DMC to the CBNAAT laboratory in
cool chain within 72 hours. Ideally an agency (courier/speed post) with a pan district presence
should be identied by the DTO of every district for prompt transport of the specimen.

All States and districts should ensure that sample is always transported in cool chain The
packaged box should be sent on the same day from the DMC to the courier / speed post ofce in
the locality for onward transport to the CBNAAT/ Culture & DST laboratory assigned.

Ÿ The falcon tubes and the 3 layer packing materials like thermocol box, ice gel pack (pre-
frozen at-20oC for 48 hours), request for C-DST forms, polythene bags, tissue paper roll for
absorbent packing, paralm tapes, brown tape for packing the thermocol box, permanent
marker pen, labels, bio-hazard sticker, scissors, spirit swab etc. Should be supplied to the
DMCs for collection of sputum through the DTO.

Ÿ The Lab technicians at DMCs should be trained to carefully pack the sputum samples in the
cool box avoiding spillage of the samples.

Ÿ The LT of DMC issuing the falcon tubes, should also give clear instructions to the patients on
correct technique of collection of the sputum. Also, the date of issue of the falcon tubes to the
patient should be recorded.

Ÿ Two sputum samples are collected from each patient in a sterile 50ml falcon tube.

47
Ÿ At this point the lab number is written on the cap of the tube.

Ÿ The lab technician will perform surface disinfection of both the falcon tubes by placing the
tubes in 5% Phenol for 20mins.

Ÿ After which the tubes will be wiped with tissue paper and left to air dry before packaging.

Ÿ After the tubes are completely dry, a label is afxed on the side of the tube indicating the date
of collection of the samples and the patient's details like name, date of sample collection,
name of DMC/DTC, Lab No., specimen A or B.

Ÿ Following this the cap tube interface is sealed using a small strip of paralm.

Ÿ The tubes are then wrapped with absorbent cotton individually and is held in place with the
help of a rubber band.

Ÿ Each tube is then placed inside a self-sealing cover/ ziplock pouch and wrapped around itself
with a rubber band.

Ÿ The lled Annexure 15A should be folded and kept inside another self-sealing cover/ zip lock
pouch.

Ÿ Both the falcon tubes along with the Annexure 15A is placed inside the thermacol box
containing two frozen gel packs.

Ÿ The thermacol box is sealed using brown tape.

Ÿ “To” address and “from” address are afxed on the box. A biohazard symbol is also afxed
on the box and is dispatched to the concerned lab for further testing.

Ÿ The LT of the DMC should promptly inform the sample transport agency like a courier/

Ÿ Speed post service, or a human carrier to collect and transport the samples.

Ÿ As per the national guidelines for BiomFedical waste management the containers used for
transporting sputum samples to the NTEP-certied laboratory should be labelled with a “BIO-
HAZARD” sticker.

EXERCISE 1 (Refer to annexure 2 – )

For this exercise assume that all patients are attending same health facility as the designated
microscopy centre, called PHI 237. Complete annexure 15A NTEP request form for examination
of biological specimen for TB and enrol in NIKSHAY for those where indicated. Date is 3rd
September 2018. Referral is not indicated in all the patients. For patients in whom examination
is necessary, specimen will be collected on 3rd September and 4th September. For ease of
reference, each patient is given an alphabetic reference, which should be used for the specimen
Identication Number wherever required.

1. Arun Kumar (Patient A) is 24-year-old male, labourer from 7 Institutional slum Area, Lodhi
Road, 110006, weighing 40 kg with pain in the chest and cough for two weeks.

2. Raman Lamba (Patient B) of No. 18, Shalimar Bhagh, near sabji Mandi is a 24-year-old male
labourer with pain in the chest for one week which increases on movement and cough/
sneeze.

48
3. Pooja Gupta (Patient C) is 13-year-old female student from 1064, Paranthe Wali Gali,
Chandni Chowk – 110008, weighing 36 kgs with non-tender swelling of the lymph nodes in
the interior and posterior areas of the left side of the neck for the last one month. She is also
complaining of four days of cough.

4. Lakshmi Kumari (Patient D) is 46-year-old woman from 223 Gandhi Dham, Bapu Nagar -
110013 weighing 45 kg who has had cough for two months with fever, sweats at night, and
occasional coughing up of blood.

5. Sita Devi (patient E) of 2586 Gali No. 3, Govind Puri, Near Gurudwara, is an eighty-year-old
woman who complains that she feels tired. She does not have cough or any other symptoms.
She has heard that people who are weak receive treatment at this centre and get better.

6. Narendra Kumar (Patient F) is 50-years known diabetic and alcoholic male from 223 Gandhi
Dham, Bapu Nagar – 110013 weighing 40 kgs. He has had cough for a month. He gives no
history of taking ATT in the past.

7. Ravindra Mehrothra (Patient G) of No. 70, Masjid ke pas, Sulthan Bazar, is a forty year old
woman who complains of rash on her scalp and trouble sleeping at night.

8. Girija Devi (Patient H) is 50-year old female from 225 Gandhi Dham, Bapu Nagar- 110013
weighing 45 kgs. She has cough for a month. When asked about previous history of taking TB
treatment, she remembers receiving multiple tablets taken for a few months once which
made her urine turn orange. She recalls that these medicines helped her feel much better.
She is a known HIV positive patient on ART and CPT.

9. Ashok kumar (patient I) of No. 55, Raja Garden, Near post ofce, is a 31 year old vendor who
complains of cough and high fever for the past ten days. He is otherwise been healthy, but
now feels very ill and short of breath when he walks. He remembers fever came suddenly.

10.Kailash Nath (Patient J) is 35-year-old, from 2586 Gali No. 3, Gobind Puri, Near Gurudwara
110036, weighing 60 kg. He is coughing and spitting blood. When asked, he reports that he
has been coughing for several years. He has not taken any treatment before. He has two
children aged 5 and 8 years at home who are asymptomatic.

TASKS PERFORMED AFTER SAMPLES ARE RECEIVED IN LABORATORY

The Tuberculosis Laboratory Register is a document maintained in a DMC for recording the
details of the specimen smear examinations. The Laboratory Technician is responsible for
maintaining and updating the laboratory register.

The TB Lab register (Annexure 3) captures all information of the patient who are being referred
from referring health facility like PHI, ICTC, PHC CHC, ART centre, Medical college or even
private health facilities

a. The left-hand portion of the TB lab register capture details of patient sample, his complete
address, information on key population, the reasons for examination.

b. The right portion of the Lab register capture details of type of specimen, visual appearance
results along with dates HIV and diabetics status, details of DST testing, Nikshay ID /
Notication, Treatment initiation details and column for signature and remarks. of related top
rapid DST results (Applicable for Dist. eg. CBNAAT), Culture results, DST results and reporting
of the results.

49
 1. Lab Serial no: A Laboratory Serial Number is assigned to each patient who has been
referred for sputum examination.

2. Date of collection of rst specimen: The date on which the rst sample has been collected
in the container.

Name
The patient's full name (also nickname, if any) is written in the space provided.

Age (in yrs)

The age of the patient is written in the space provided.

Gender
The letter 'M' is written for Male, 'F' for female and 'TG' for Transgender.

Complete Address (for diagnosis of patients)

Complete address with landmark. If more than one Mobile number available, try to capture all.
This will help to provide the ICT based treatment adherence support after diagnosis.

Key Population: The numeric code for key populations given as foot note on the left side of the
Lab register. The appropriate code for key population given in the request form need to be
identied and recoded in this column.

Name and type of referring health facility: The name of referring health facility is as
given in appropriately mentioned on Request form for examination of Biological specimen.

Reason for Examination:

In the rst column under reason for examination, write whether patient is referred as
presumptive TB, Repeat examination or Private. Presumptive NTM will be handled in the Culture
& DST laboratory only.

Predominant symptoms and duration: Predominant symptom of the patient and its
duration are to be noted in the space provided. Example, C 35 days, F 15 days etc. The coding is
mentioned in the foot note in the Lab register.

Under Follow Up section: Follow up by microscopy will be required for all drug sensitive TB
patients and TB patients with unknown sensitivity status. Follow up with microscopy and culture
will be required for all drug resistant TB patients on treatment with H- mono/poly regimen and
shorter MDR regimen,

History of 1 month of anti-TB treatment (ATT): Write Yes / No according to the history of
treatment more than one month.

Follow up: for Follow Up patient Nikshay ID (Patient ID) will already available. Write that in the
column for in the Nikshay ID.

Regimen: under the column regimen mention whether it is 1st tline ATT(Regimen for drug
sensitive TB), or H-mono/poly or shorter MDR.

Month: Duration of treatment in completed month:

50
Post Treatment follow up month: After completion of treatment, the patients should be
followed up at the end of 6, 12, 18 & 24 months. 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.

At the right side of the TB Lab register

Type of Specimen: Here mention whether the specimen is Sputum /Extra-pulmonary

(CSF/Pleural Fluid, etc).

Visual Appearance: M- Mucopurulent, B- Blood Stained, S- Saliva.

A- For Supervised Spot,
B- Early Morning

Results: For sputum smear microscopy if the sputum is positive, write the exact grading in RED
Ink, and for the Scanty mention the exact number of bacilli seene.g., Sc-5.

Date of Result: It is date on which the result is reported.

HIV Status (Reactive/ Non-Reactive/ Unknown): Mention whether Reactive or Non-

Reactive or Unknown

Diabetic Status (Diabetic/ Non-Diabetic/ Unknown): Mention whether Diabetic/

Non-Diabetic/ Unknown

Sample for DST sent (Y/N) with date: Write Yes if the sample has been sent for CBNAAT or
Culture Lab for Further diagnosis and No if not sent. All TB patients are expected to undergo DST
for Rifampicin (Universal DST).

DST result (write the drugs to which resistance is demonstrated): Write the DST
result obtained from CBNAAT or DST lab.

Patient ID (NIKSHAY ID): It is a Patient ID generated during enrolment in NIKSHAY.

Treatment Initiation Details: Name of PHI and TU in which the patient has been initiated on
treatment or transferred to.

Signature: The Lab technician has to put his signature here.

Remarks: this is for additional comments if any e.g., Date of starting treatment, treatment
regimen, referral details with date, remarks on unblinded rechecking

Laboratory procedures:
Ziehl–Neelsen staining:
1. A new unscratched slide is selected and Laboratory Serial Number is labelled on the slide
using diamond marking pencil. New slide is selected in order to avoid deposition of carbol
fuchsin which may result in false positive results.

51
2. Mucopurulent portion of the sputum is picked with a piece of clean broom stick and an oval
shaped smear measuring 2 x 3 cm in size is prepared. The smear should neither be too thick
nor too thin.

3. The optimum thickness smear of the smear can be assessed by placing the slide on printed
matter .The print should be just readable through the smear.

4. Smears should be prepared near a ame as it sterilizes an area of six inches around the ame
and disinfects the aerosols generated.

5. The slide is allowed to air dry for 15–30 minutes to clear air bubbles which would spurt while
heating to x the smear.

6. The smear is xed by passing the slide over a ame 3–5 times for 3–4 seconds each time.
Coagulation of the proteinaceous material in the sputum will facilitate xing of the smear.

7. Carol fuchsin (1%, ltered) is poured to cover the entire slide and the slide is gently heated till
vapour rises. The slide should not be heated to the extent of boiling. The carol fuchsin is kept
on the slide for 5 minutes. Heating helps penetration of dye through the lipid wall of the
bacilli.

8. The slide is gently washed using running water till free carol fuchsin stain is washed away. At
this point, the smear on the slide looks red in colour.

9. 25% sulphuric acid is poured and allowed to stand for 2- 4 minutes. This will facilitate
decolourisation of background except that of the bacilli.

10. The slide is gently rinsed under tap water and kept tilted to drain off the water.

11. A properly decolorized smear will appear light pink in colour. If the smear is still red, it is to be
decolorized again using sulphuric acid for 1–3minutes. Slide is gently washed with tap water
and the under surface of the slide is wiped clean with a swab dipped in sulphuric acid.

12. The smear is counterstained using methylene blue (0.1%) for 30 seconds. This renders the
background blue and bacilli stained pink by ocarbon fuchsin, stand out in contrast. The slide
is again rinsed gently with tap water and allowed to dry.

13. The slide is examined under the microscope using 40x lens to select the suitable area and
then examined using 100x lens under of oil immersion ( heavy liquid parafn).

14. The results are recorded in the Laboratory Form and the Laboratory Register.

15. After the smear is read, the slide is inverted on a tissue paper till the immersion oil is
completely absorbed. Xylene should not be used for cleaning the slides, as it may give false
results upon repeat examination after storage.

16. All positive and negative slides are stored serially in the same slide-box until further
instructions by the supervisor.

17. All contaminated material should be disinfected before discarding as per Bio-Medical Waste
(management and handling) Rules 2016, using 5% phenol solution.

52
Importance of Grading of smears
Ÿ Grading of smears is a tool indicating the bacterial load in the patient. It is also used as a
monitoring and supervisory tool under the program.

Ÿ This is meant to enhance the attention of the technician while reading the smears and
facilitates supervision by STLS also.

The table below depicts information on grading and the number of elds to be examined in
different situations:

Grading depends upon the number of Acid-Fast Bacilli (AFB) seen while examining the slides.
Generally, laboratory technicians should have no difculty in reading and grading the smear
except in situations where the smears are scanty positive. The results should be reported to the
treating physician after the examination of the specimen.

No. of elds
If the slide has: to be Grading Result
examined

No AFB in 100 oil immersion elds 100 0 Negative

1-9 AFB per 100 oil immersion elds 100 Scanty* Positive

10-99 AFB per 100 oil immersion elds 100 1+ Positive

1-10 AFB per oil immersion eld 50 2+ Positive

More than 10 AFB per oil 20 3+ Positive

immersion eld

Fluorescent staining Procedures:

1. A new unscratched slide is selected and Laboratory Serial Number is labelled on the slide
using diamond marking pencil. New slide is selected in order to avoid deposition of
Auramine-O which may result in false positive results.

2. Mucopurulent portion of the sputum is picked with a piece of broom stick and an oval shaped
smear measuring 2 x 3 cm in size is prepared. The smear should neither be too thick nor too
thin.

3. The optimum thickness of the smear can be assessed by placing the smear on printed matter.
The print should be just readable through the smear.

4. Smears should be prepared near a ame as it sterilizes an area of six inches around the ame
and disinfects the aerosols generated.

5. The slide is allowed to air dry for 15–30 minutes to clear air bubbles which would spurt while
heating to x the smear.

6. The smear is xed by passing the slide over a ame 3–5 times for 3–4 seconds each time.
Coagulation of the proteinaceous material in the sputum will facilitate xing of the smear.

53
7. Arrange slides in serial order on staining bridge, with smear side up, at a distance of at least
one cm between every slide.

8. Flood the slide with ltered 0.1% Auramine solution. Do not heat

9. Keep the staining reagent for at least 20 minutes, make sure that the smear area is
continuously covered with Auramine by adding more, if needed. Rinse with water and drain.

10. Apply decolourising solution, 0.5% acid alcohol for 3 minutes.

11. Gently rinse with water until the macroscopically visible stain has been washed away and
drained

12. Flood smear with 0.5% potassium permanganate solution for 1 minute. Time is critical
because counter staining for longer time may quench the acid-fast bacilli uorescence.
Gently rinse with water and drain.

13. Air dry on a slide rack away from sunlight. If they are not read immediately place them in
slide box.

Grading scales for ZN/ FM

Tubercle bacilli are quite variable in shape, from very short fragments to elongated types. They
may be uniformly stained or with one or many gaps, or even granular. They occur singly or in
small groups, are rarely in large lumps. The typical appearance is of bacilli that are rather long
and slender slightly curved rods, with good staining (always check rst a freshly stained positive
control), there may still be uorescing (sometimes green) artefacts which do not have a typical
shape. Also, non-uorescing bacillary shapes must be considered as artefacts.

Reasons for false-negative smear results

Ÿ Improper/Inadequate sputum collection

54
Ÿ Improper storage of sputum specimens

Ÿ Using saliva for smears

Ÿ Too thin or thick smears

Ÿ Over-heating / Insufcient heating of the slide while xing

Ÿ Boiling carol fuchsin in ZN staining

Ÿ Over decolourization with sulphuric acid/ acid alcohol

Ÿ Improper storage of stained slides

Ÿ Inadequate examination

Ÿ Reading and reporting errors

Consequences

Ÿ Patients suffering TB may be missed and he/she may continue to spread the disease in the
community.

Ÿ Wrong categorization

Ÿ Inadequate duration of treatment.

Ÿ Errors in declaring treatment outcome.

Ÿ Patients and the community may lose condence in the programme

Ÿ Unnecessary repetition of investigations

Reasons for False-positive smear results

Ÿ Faulty sputum collection (presence of food particles)

Ÿ Using old scratched slides / already used slide

Ÿ Using unltered carbol fuschin in ZN staining

Ÿ Inadequate decolourization with sulphuric acid/ / inadequate exposure of acid alcohol

resulting in inadequate decolourisation.

Ÿ Contamination due to transfer of bacilli from one smear to another

Ÿ Not wiping the oil immersion lens after examination of a positive slide

Ÿ Reading and reporting errors

Consequences

Ÿ Patients without TB may be put on anti-TB treatment unnecessarily

Ÿ Treatment may continue beyond the recommended duration

Ÿ Medicines are wasted

Ÿ Patients and the community may lose condence in the programme

55
Preservation of slides:
Fluorescence fades with exposure to light and passage of time, thus it is important to store all the
slides in slide storage box, immediately after smear microscopy.

Store all slides in slide boxes in the order they were recorded in the laboratory register. This will
allow easy sampling of slides for external quality assessment using random blinded slide
rechecking (RBRC)

Exercise 2:
Request form for examination of biological specimen for TB
Complete the Laboratory Form: Results Section

Start with Laboratory Serial Number 501. The appearance of the specimen is given in brackets.
Specimens are examined on 4 September 2018. Sign your own name.

Using the Tuberculosis Laboratory Register

Ÿ Every week the MO in Charge (or his designate) of the DMC should review the Tuberculosis
Laboratory Register to ensure that correct numbers of sputum smear examinations (i.e., 2 per
presumptive TB case) are being performed for diagnosis.

Ÿ Results recorded in the laboratory register, treatment cards and the TB Notication register
are veried and ensured that they are consistent.

Ÿ It is the responsibility of the MO to ensure that all smear-positive patients diagnosed are
started on treatment or are referred for treatment.

Ÿ If any smear-positive patients are not entered in the Tuberculosis Notication Register and
are on treatment, they should be notied.

Ÿ For patients who have not been put on treatment it should be ensured that they are traced,
put on treatment immediately and notied.

56
Accuracy of the Tuberculosis Laboratory Register
Ÿ The accuracy of recordings in the TB laboratory register should be checked by the laboratory
technician (LT).

Ÿ All results of sputum smear examinations done in a Designated Microscopy Centre should be
written only in Tuberculosis Laboratory Register, and not in any other register.

Ÿ Duplicate registers should not be maintained.

Ÿ LTs should ensure that correct laboratory serial number is recorded.

Ÿ Laboratory serial number is given to the patient and not to the sample.

Ÿ A new number should be assigned to every presumptive TB case whose sputum is to be

examined.

Ÿ The Laboratory Serial Number should begin with a new serial (number 1) every calendar
year.

Ÿ The Laboratory Serial Number is also written in the Tuberculosis Notication Register as well
as the TB Treatment Card.

Ÿ It can be used as a cross-reference when the MO of the DMC cross-checks the results of the
sputum examination in the Tuberculosis Register with that of Tuberculosis Laboratory Register
and the TB Treatment Card.

Ÿ By using the name of the patient and his Laboratory Serial Number from the Tuberculosis
Register, the MO of the DMC can easily locate the results of sputum examinations in the
Tuberculosis Laboratory Register.

Ÿ Without this Laboratory Serial Number, it would be tedious to go through many pages of the
Tuberculosis Laboratory Register for sputum results.

Ÿ The MO of DMC should check the Tuberculosis Laboratory Register and make sure all the
columns have been completed. For example, it may be found that a patient's address or name
of referring health facility is missing or incomplete in the Tuberculosis Laboratory Register.

The MO should emphasize on laboratory technicians, the importance of recording the complete
addresses of patients examined for diagnosis. This facilitates tracing and initiation of treatment.

If the sputum smear examination is intended for diagnosis, the name of the health facility
referring the patient should be written in the column meant for name of referring health facility
(e.g. Dr CU Shah, Private Practitioner, or XYZ Hospital). If the presumptive TB case has attended
the OPD of the DMC on his own, the name of the DMC should be mentioned in this column. If the
patient has been referred from ICTC or ART centre, the same should be mentioned in this
column. If the sputum smear examination is for follow-up examination, the name of the health
facility where the patient is undergoing the treatment should be written in the Name of Referring
Health Facility column.

The patient ID generated by Nikshay for all presumptive TB patients and the treatment initiation
status of all diagnosed TB patients should be recorded in the columns meant for it. For patients
whose sputum is examined for follow-up, patient ID, treatment regimen and month of follow-up
should also be mentioned in the designated columns.

57
Recording of results of sputum smear examinations
Ÿ LTs should understand the importance of accurate recording of results of sputum smear
examinations on the Request Form for examination of biological specimen for Sputum
Examination.

Ÿ The Lab Technician should be informed that patients are put on appropriate regimen based
on the results of the sputum examinations and further management of patients also depends
upon the results of the follow-up sputum examination and at the end of the treatment.

Limiting administrative errors

Ÿ If the patient's sputum specimens are not labelled properly at the health facility or if the
Request Form for examination of biological specimen gets separated from the specimens, the
laboratory technician may not know whose sputum specimens are in the containers when
they reach the laboratory.

Ÿ The LTs should ensure that the Laboratory Serial Number on the Request Form for
examination of biological specimen matches with what is written on the side of the sputum
container and on the slide used for smear preparation. Other health facilities which collect
specimens and transport them to the DMC should assign Specimen Identication Numbers
and write it on the side of the containers.

Results: The lower portion of the request form for examination of biological specimen of TB is to
record the result of sputum smear microscopy. The Lab technician has to report the lab serial
number, visual appearance and results of sample A and sample B correctly in this portion. The
date tested, the date reported and the Laboratory name also have to be mentioned with the
name and signature of the lab technician.

The visual appearance of the sputum specimen is to be entered in the relevant column. Results
declared are to be entered in the column as either positive or negative and if positive, the
appropriate grading is to be entered. This portion of the form should be duly signed by the
laboratory technician of the DMC with date before dispatching the same to the Medical ofcer.

After receiving the sputum results

When the referring health facility receives the sputum results from the DMC, MO reviews the
patients and based on the results of sputum smear examination, classies the patient
accordingly (as shown in the “diagnostic algorithm” earlier).

Monthly Abstract
The laboratory technician should summarize the information on sputum smear examinations
done during that month. This information should be summarized in the prescribed format,
printed in the Laboratory Register, at the end of each month . The STLS should write the monthly
supervisory abstract after the last entry of the month. A new page is used every month for
recording the sputum examination undertaken.

If only one sputum specimen was examined for diagnosis, patient should be traced and second
sample should be examined. MOs are responsible for ensuring that the patient is traced. A
smear- positive patient may be missed if the second sputum is not collected and examined. To
minimize the proportion of 'false' smear-negative patients, at least 2 smear-negative sputum
specimens should be available.

58
Accuracy of the results of follow-up sputum smear examinations recorded in the Tuberculosis
Register, should be ensured by comparing with those in the TB Lab Register. Such comparisons
especially for patients who were smear-positive at the beginning of treatment should be made.

59
60
Exercise 3:
Complete the pages of the Laboratory Register using the laboratory form you
have completed in Exercise 1 & 2
Processing of Sputum specimens using CBNAAT Preparation directly from sample:
Ÿ For each of the sample: unscrew the lid of sputum collection container.

Ÿ Add directly in the collection container, 2 volumes of sample reagent to 1 volume of

sample
Ÿ Replace the lid, and shake vigorously 10-20 times. (Note: one back and forth movement
is a single shake.)
Ÿ Incubate at room temperature. After 10 min. of incubation, shake (or vortex) the
specimen vigorously 10-20 times.
Ÿ Specimen should now stand for 5 minutes
Ÿ Sample should be perfectly uid before being processed, with no visible clumps of
sputum.

Prepare your cartridge

Ÿ Label the cartridge with the sample ID by writing on the left or right side of the cartridge or
afx ID label.

Ÿ Transfer 2 ml of processed sample to cartridge.

Ÿ Begin test by loading the cartridge into the Gene X-pert Machine.

Note: do not put the label on the lid of the cartridge or obstruct the existing 2D barcode on the
Cartridge. Do not touch 2D barcode on the cartridge.

Ÿ CBNAAT results are available within two hours from the time of loading the cartridge into
the machine. The different type of results available are;
a. MTB Detected High; RIF Resistance Detected
b. MTB Detected Medium; RIF Resistance Detected
c. MTB Detected Low; RIF Resistance Detected
d. MTB Detected Very Low; RIF Resistance Detected
e. MTB Detected High; RIF Resistance Not Detected
f. MTB Detected Medium; RIF Resistance Not Detected
g. MTB Detected Low; RIF Resistance Not Detected
h. MTB Detected Very Low; RIF Resistance Not Detected
i. MTB Not Detected
j. MTB Detected Very Low; RIF Resistance Indeterminate
k. Error
l. Invalid

61
62
Points to be remembered
Ÿ Undiagnosed and untreated pulmonary sputum smear-positive TB patients are the source of
infection in the community and have the potential to transmit infection to others.

Ÿ The most common symptom of pulmonary TB is a persistent cough for 2 weeks or more.

Ÿ Under the programme, sputum smear microscopy, x-ray and molecular diagnostic tests are
the main tools for the diagnosis of TB patients.

Ÿ Two sputum smears should be examined (Spot—Early morning) for diagnosis.

Ÿ Sputum should be examined within 2 days of collection and the results should be reported on
the same day.

Ÿ It is important to elicit past history of anti-TB treatment from the patient.

Ÿ Extra-pulmonary TB patients, contacts of all smear-positive cases and PLHIV with cough
should be subjected for sputum examination irrespective of the duration of cough.

Ÿ On an average, about 2–3% of new adult out-patients in a general clinic (in rural PHC
settings) will be presumptive TB cases and should be referred for sputum examination.

Ÿ On an average, 10% of the presumptive TB cases, subjected for sputum examination (SOP)
are found to be smear positive pulmonary tuberculosis.

Ÿ Grading of smears is helpful as a quality assurance tool

Universal drug susceptibility testing

The programme is committed to providing Universal Drug Susceptibility Testing (UDST) for all
notied TB patients (bacteriologically conrmed and clinically diagnosed). All TB patients are
offered DST to at least the Rifampicin through rapid molecular test. Cascading DST for
Fluoroquinolones and second line injectable are offered through LPA.

63
Section B: Quality Assured Laboratory Services
Introduction:
An effective quality assurance (QA) system of sputum smear microscopy network is crucial for
reliability of data generated under NTEP. QA is a system consisting of internal quality control
(QC), external quality assessment (EQA), and continuous efforts for quality improvement (QI) of
laboratory services. The system also provides credibility of laboratory results and motivation of
staff for further improvement of their efciency.

A nation-wide network of designated microscopy laboratories provide appropriate, accessible

and quality assured laboratory services.

NTEP has established a three tier Quality Assurance system to monitor laboratory activities
based on international guidelines which includes NRLs at the national level, STDCs / IRLs at the
State level & DTC / TU at the District level.

In this section of the module the participants will learn about

Ÿ Structure of NTEP laboratory network
Ÿ Quality assurance for smear microscopy
Ÿ Maintenance of adequate supply of quality laboratory consumables
Ÿ Supervisory visit to DMC
Ÿ Infection control: Safe disposal of contaminated materials
Ÿ Annexures, Checklist and IQC documents

Structure of NTEP laboratory network

A wide national network of Designated Microscopy Centres (DMCs) with competency in smear
microscopy has been established, to provide diagnostic services with an “easy access for the
entire population” under the programme. The network of DMCs is supported by larger State TB
Training and Demonstration Centres (STDCs), also referred to as Intermediate Reference
Laboratories (IRLs), and overseen by six National Reference Laboratories (NRLs), viz., National
Tuberculosis Institute (NTI), Bangalore, National Institute of Research in Tuberculosis (NIRT)
Chennai, (SNRL), National Institute of Tuberculosis and Respiratory Diseases (NITRD) New Delhi,
National JALMA Institute for Leprosy and Other Mycobacterial Diseases Agra, Bhopal Memorial
Research Centre (BMRC) Bhopal and Regional Medical Research Centre (RMRC), Bhubaneswar.

The Central TB division is advised on all technical issues by the National Reference Laboratory
Coordination Committee which includes members from all the six NRLs and representatives
from WHO & CTD.

Levels of laboratories under NTEP

National Reference Laboratory: Each NRL will supervise sputum microscopy EQA of states
designated to them. The NRL will ensure prociency of NTEP staff for carrying out good quality
diagnosis by providing technical training to the STOs, STDC Directors, Microbiologists and Lab
Technicians of States.

Intermediate Reference Laboratory: The states will designate one Intermediate Reference
Laboratories in the STDC or Medical College or in any Public Health Laboratory of the state. The
IRL should be a facility deemed t for certication by the respective NRL supervising the State.
The designated IRL will conduct sputum microscopy EQA for the state and occasionally for a

64
neighbouring state or union territory. The IRL will provide technical training to district and sub-
district technicians and STLS.

Designated Microscopy Centre: Sputum microscopy diagnostic services under NTEP are
provided by Designated Microscopy centres (DMC) established for every laboratory where
Binocular microscope and trained Lab Technician is available. LED Fluorescent microscopes are
provided to DMCs of medical colleges and other DMCs with high work load.

Section B: Quality Assurance (QA) for smear microscopy

Quality assurance system includes
A. Internal Quality Control (IQC)
B. External Quality Assessment (EQA)
C. Quality Improvement (QI)

A. Internal Quality Control (IQC)

Ÿ It's a systematic internal monitoring of working practices.
Ÿ It includes technical procedures, checking instruments, quality of new batches of
staining solution, smear preparation, grading, equipment infection control measures,
waste management etc.
a. Staining reagents:

Preparation of 1% carbol Fuchsin:

Ÿ Ensure dye content is mentioned on the bottle while procurement
Ÿ Potency to be corrected before preparing the stain
Ÿ Stain should be ltered (Whatmann Filter No 1) before use

Preparation of 25% Sulphuric Acid

Ÿ Concentrated acid to be stored separately (away from other chemicals) to avoid
accidental spillage.
Ÿ The required quantity of acid may be transferred into a small glass container (Borosil
Glass). The accurately measured quantity of acid (using a measuring cylinder) is slowly
transferred along the walls of the container into a round bottom ask containing the
required quantity of distilled water. The reaction is exothermic (generates heat) and
hence the ask (Borosil) should be kept in a cold-water bath/ice bath during preparation.
Ÿ Utmost care to be taken while transportation

Preparation of 0.1 % Methylene Blue

1. Ensure dye content is mentioned on the bottle while procurement
2. Potency to be corrected before preparing the stain
b. Manufacturing QCP and QCN by STLS:
Ÿ QCP & QCN slides to be prepared by the STLS only.
Ÿ QCP slides may be prepared by pooling 3+ grade sputum samples.
Ÿ QCN slides may be prepared by pooling Negative sputum samples with adequate
number of pus cells (approximately 20 cells /eld).
Ÿ One set of QCP & QCN to be used by the STLS while preparing each new batch of
Staining reagent and entry made in the batch register (IQC document).

65
 Ÿ One set of QCP & QCN to be supplied to the DMC LT by the STLS along with each batch of
reagent. The DMC LT to stain and examine the QCP & QCN slides and enter the results in
the IQC document.
Ÿ All Quality control slides should be stored for a maximum period of three months.
c. General maintenance of Binocular Microscope
Ÿ Oil to be removed from the objective lens using a soft lens cleaning tissue paper after
examining each slide.
Ÿ The microscope to be stored inside a microscope box at the end of the day.
Ÿ The Microscope box should contain Silica Gel and an Electric Bulb of 10-15 Watt for
desiccation to prevent fungal growth on the lens.
Ÿ The Silica Gel should be dehydrated periodically under direct sunlight and may be
reused (Dehydrated gel looks blue in color).

All Microscopes should be under AMC with routine preventive maintenance.

External quality assessment for sputum smear microscopy

1. The activities of NRL:
a. On-site evaluation of STDC/ IRL Labs
b Manufacture of Panel testing slides and panel testing of STDC/ IRL Lab staff
c. Training of STDC supervisory staff in:
I. On site evaluation of STLS
ii. Manufacture of panel slides
iii. Assessment of blinded re-checking of DMC slides at DTC
iv. Facilitating the training of STLS for External Quality Assessment (EQA)
d. Re-training of STDC/ IRL supervisory staff, if required.
e. Prompt reporting of the results of activities and feedback to STO/DDG TB.
2. The activities of STDC/ IRL:
a. Training of EQA for STLS, DTO, MO-TC
b. On-site evaluation of DTC Labs and a sample DMCs
c. Manufacture of Panel testing slides and panel testing of DTC Lab supervisors including
all STLS of the district
d. Assessment of blinded re-checking of DMC slides at DTC
e. Re-training of DTC LT/ STLS, if required.
f. Prompt reporting the results of activities by Director STDC/ IRL to STO, CTD & NRL.
3. The activities of DTC/ TU:
a. On-site evaluation of DMC Labs
b. Unblinded re-checking of DMC slides at DMC
c. Random Blinded re-checking (RBRC) of DMC slides at DTC
d. Prompt reporting of the results of activities to LT and MO of DMC as well as STDC/ IRL.
e. Panel testing and re-training of DMC LTs, if required.
a. On-Site Evaluation (OSE)

66
A visit to STDCs/IRLs and DTC/DMCs is an essential component of a meaningful QA
programme. As part of an ongoing EQA process, depending on the performance of the
laboratory being visited, the frequency of on-site evaluation is decided. On-site evaluation is
conducted at least once a month by STLS to the DMC, once a year by STDC/ IRL laboratory
supervisors to District TB Centres (DTCs) and TB Units (TUs) and once a year by laboratory
supervisors of NRLs to STDCs/ IRLs. This provides an opportunity for immediate problem solving,
taking corrective action and on-site retraining.

When poor performance is identied through any of the above-mentioned activities, additional
visits by trained laboratory personnel from the higher level laboratory (the STDC/ IRL or NRL
laboratory Supervisors) are mandatory for evaluation of all laboratory procedures.

The visit includes a comprehensive assessment of laboratory safety procedure, conditions of

equipment, adequacy of supplies as well as the technical components of AFB smear microscopy,
which includes preparation, staining and reading of smears. Sufcient time must be allotted for
the visit to include observation of all the work associated with AFB smear microscopy.

On-site evaluation at DMCs should also include examining ve positive and ve negative
smears to observe the quality of smear and staining as well as condition of the microscope. At the
DMC, the LT arranges all the slides in the slide box serially as per laboratory register and
preserves all the slides after examination (LT has to preserve all the slides till RBRC process is
complete and feed-back is given). The supervisor (STLS) re-checks monthly in an unblinded
manner, on his onsite evaluation visits, 5 positive and 5 negative slides selected from the lab
register by systematic random sampling procedure. STLS marks in the Laboratory register with a
small 'x' sign and makes entries in his OSE-checklist and “remarks” column of the lab register.
STLS should discuss discrepant slides with the LT, identify the cause of error, if any and provide
specic corrective measures.

Checklists used during OSE (Annexure 5)

Checklists are developed to assist both laboratory and non-laboratory supervisors during the
eld visit and to allow for the collection and analysis of standard data for subsequent remedial
action. Checklists may be rened to focus on problems that are frequently identied or most
likely to occur, such as preparation of stains or errors in grading. Copies of the checklist should
be left behind in the unit being evaluated. This will provide written documentation of the visit and
ndings and will also assist subsequent evaluations to monitor improvements. When poor
performance is identied through any of the above-mentioned activities, additional visits are
mandatory for evaluation of all laboratory procedures.

Comprehensive checklist for on-site evaluation of DMCs is provided in the annexure A. The
checklist contains open, non-leading questions and recommended observations along with
objective criteria for acceptable practices. Use of a simple standardized checklist even by well-
trained district supervisors (e.g. DTO), can reduce the time necessary to evaluate a laboratory
effectively.

Panel Testing
Panel testing is a method of EQA that is used to determine whether a laboratory technician can
adequately perform AFB smear microscopy. This method evaluates individual performance in
staining and reading, and not all the laboratory activities. Utilization of panel testing for EQA is
considered to be less effective than random blinded re-checking of routine slides because it does
not monitor routine performance.

67
Panel testing is a useful supplement to the system of re-checking of slides. It provides
information on the capabilities of the peripheral laboratories prior to implementing a re-
checking programme. It can also be used to assess the level of performance or to quickly detect
problems associated with very poor performance. The prociency of laboratory technicians after
training can be evaluated.

Panel testing is used for supervisory lab staff of STDCs/ IRLs and DTCs, and will be conducted
under the supervision of the visiting lab team during their annual on- site evaluation visit. A
panel will consist of 5 unstained smears per laboratory personnel. Panel testing is not performed
as a routine in the DMCs, as they will have regular on-site evaluation and blinded re-checking.

Random Blinded Re-Checking of Routine Slides (RBRC)

Blinded rechecking is a process of rereading a statistically valid sample of slides from a
laboratory to assess whether that laboratory has an acceptable level of performance. This
activity is performed once a month for every DMC.

Random blinded re-checking must ensure that:

Ÿ The sample contains a sufcient number of randomly selected slides to be representative
of all slides of the DMC,
Ÿ The supervisor (STLS) of the laboratory (rst controller), must not be aware of the original
result of peripheral laboratory technician to prevent bias, i.e. results are “blinded”,
Ÿ Minor false errors are included with major errors for the purpose of obtaining a smaller
sample size. The smaller sample size facilitates implementation and sustainability of
rechecking
Ÿ Discrepant results are resolved by a second controller (umpire).
Ÿ There must be a system to provide timely periodic feedback and improvements to the
laboratories that are supervised.
Random blinded re-checking of routine slides from the DMCs is implemented throughout the
laboratory network. A system utilizing Lot Quality Assurance Sampling (LQAS) method is used to
calculate the sample size (LQAS Table)

68
 Ÿ The STLS selects from lab register RBRC sample slides for random blinded rechecking
(RBRC) on the advice of the DTO
Ÿ These slides are selected using a systematic random blinded sampling procedure and the
results of the slides selected are circled in the Lab register by STLS.
Ÿ The LT will enter the slide numbers that are selected by STLS in 'Annexure B' along
with results;
Ÿ Encloses the annexure B in a sealed envelope;
Ÿ Arranges the slides in a separate box supplied by DTO and marks on the top of box as
well as envelope with the title: RBRC slides, Name of DMC, TU and the month & year.
Ÿ STLS picks up the box and sealed envelope and hands them over to DTO.
Ÿ DTO conducts RBRC and gives feedback and corrective actions to LT through MO- DMC.

The activities to be performed by DTO at DTC are briey given below.

Every calendar month, DTO instructs all STLS to collect appropriate number of slides from LTs of
DMC as per LQAS method.

1. DTO receives sealed envelopes with Annexure B and slide boxes from the respective STLS.

2. DTO will code the boxes ensuring that the DMC does not get same code every month. Coding
of boxes is an important activity of DTO and blinding of slides must be ensured by DTO.

3. DTO should maintain a register where he would enlist the codes given to each DMC for each
of their RBRC months. The register should also show how DTO has allotted the codes to the
STLSs. STLSs should be allotted the coded DMC boxes taking care that DMC allocation is not
repeated to the same STLS who is supervisor of that DMC. Rotation of DMCs amongst
different STLSs should also be ensured over consecutive RBRC monthly cycles.

4. DTO retains sealed Annexure B in his possession. (Annexure 6)

5. DTO will make a roster from 11th of the calender month onwards giving one or two or three
days (based on no. of samples to be re-checked) for each STLS to come to DTC for the re-
checking. No two STLS should come for re-checking at the same time. All STLSs are informed
of the month's Blinded re-checking roster. STLS to read and record results for slides as per
Annexure C - one slide box at a time.

6. After getting results from STLS, DTO transfers the results of LT from Annexure-B to Annexure-
C (for each DMC).

7. DTO identies the discordant slides for re-checking by second controller (called Umpire
reader). Discordance is any slide with 'positive' smear result of LT (of any grade) being read as
'negative' by STLS and vice- versa and for 'positive' slides having a difference of more than one
grade between LT and rst controller.

DTO takes out the discordant slides in a separate box and gives it to an Umpire reader who could
be any STLS.

Umpire has to de-stain and re-stain the slides before reading. De-staining is performed by
dipping the slides in absolute alcohol for 5 mins. These are re-stained by ZN staining method.
The format for giving these results to Umpire reading is as follows, which is maintained in a
separate note book with DTO. Results 1 and 2 should not indicate the identity of the either LT or
STLS and are interchanged frequently to maintain the condentiality of the original readers.

69
10. STLS/DTO/MO-TC to evaluate results and give feedback to each DMC (MO and LT) as per
annexure D, with information to the CMO/Civil Surgeon.

11. DTO receives a copy of the monthly on-site supervision report from STLS through MO- TC
and decides on the next course of action in consultation with MO-TCs.

12. DTO sends a copy of the monthly report on random blinded rechecking to STDC/ IRL/STO
every month (as per annexure E), Monthly lab abstract of district, DMC-wise (Annex M for
district) and a copy of OSE summary report of EQA (Annex F) to STDC/ IRL every quarter and
percentage of DMCs with high false error in the district, in district PMR report to STO/Central
TB Division every quarter.

13. The pattern of errors that are likely to occur, possible causes for these errors and suggested
investigation steps to be taken by the Lab supervisors including DTOs/ MO-TCs/ STLS are
given in Annexure K.

14. DTOs and MO-TCs should familiarize themselves with these in order to effectively supervise
the DMCs under their area.

15. The DTOs and MO-TCs have to report the EQA activities in their respective Quarterly report
on Programme Management.

70
Structure & Functions of EQA

Quality improvement (QI):

Ÿ A process by which all components of smear microscopy diagnostic services are carefully
analyzed with the aim of looking for ways to permanently remove obstacles to success.

Ÿ Appropriate data collection, data analysis, correct interpretation of the results and creative
problem solving are the key components of this process.

Ÿ Involves continued monitoring, identifying defects, followed by remedial action including

retraining when needed, to prevent recurrence of problems.

Ÿ Relies on effective on-site evaluation

Maintenance of adequate supply of quality consumables

The MO of DMC is responsible for determining the amount of reagents and other materials the
DMC needs every month. The STLS will make sure these supplies are distributed in a timely
manner, usually on a monthly basis or as and when required.

It is made sure that there is an adequate stock of reagents and other materials in the at all levels.

It is very important for the laboratory to maintain an adequate stock of reagents and other
laboratory materials. If the laboratory has less stock of any items, it is ensured that supplies are
provided to the laboratory from the district or sub-district stock. LTs are reminded to exhaust the
old supplies before starting to use the new supplies. Old reagents should not be mixed with the
new supplies. They should be kept in separate containers.

It is ensured that the reagents are of good quality. It should be freshly prepared at the DTC and
supplied to the DMCs on monthly basis. In case the TU has adequate infrastructure and

71
equipment (Weighing balance, water bath, round bottom asks etc.,), the reagents may be
prepared at TU level as well. The LT himself should stain and examine the Quality Control slides
supplied to him by STLS after receiving the fresh batch of reagents.

Reagents should not be used beyond 3 months from the date of its preparation. Commercially
available 'readymade' laboratory reagents should not be used. It is ensured that the binocular
microscope is in good working condition. Regular arrangements have to be made by the DTO for
maintenance of the microscope through Annual Maintenance Contract. In case the microscope
is under warranty, the supplier may be contacted for undertaking its repair. The following
laboratory materials should always be available in the laboratory.

Chemical & Reagents Consumables

• Carbol fuchsin (1%) • Glass slides for microscopy, and slide-boxes
• Sulphuric acid (25%) for storing slides
• Methylene blue (0.1%) • Diamond markers (for marking the slides) and
• Auramine O (0.1%) marking pens or grease pencils (for making
• Acid Alcohol (0.5%) the sputum containers)
• Potassium Permanganate (0.5%) • Broom sticks (thick enough to make good
• Synthetic immersion oil smears)
• Methylated spirit

• 5% phenol / 40% phenolic compound • Transparent glass bottles (1000 ml) for
(proprietary Phenyl) diluted to 5% storage of reagents (with self-adhesive labels
• Absolute alcohol to be available at the stating date of preparation of reagents) and
DTC only for de-staining discrepant dropper bottles (100 ml)
slides during umpire reading • Plastic tumblers / mugs
• Silica gel (hygroscopic agent) to • Glass (or metal) rods (or holding slides during
maintain the microscope in moisture the staining process)
free environment (to be placed in the • Staining racks (for drying the slides)
cabinet for Binocular Microscope) • Sputum containers
• Spirit lamp or Bunsen burner
• Foot- operated bin (for disposal of
contaminated materials)
• Time (stop-watch)
• Fine Silk and Lint cloth
• Lens paper (for wiping the oil immersion lens
after examination of each slide)
• Whatmann lter paper No. 1
• Filter paper (to drain the oil from the slides)
Consumables Stationery
• Request form for examination of
biological specimen for sputum
examination
• TB Laboratory Register
• Referral / Transfer form for treatment
• Stock register - laboratory

* These items are reusable

** If cut discs are not available, roll sheets can be procured

72
Calculation of consumables required for examination of
3000 smears

Reagents/ Equipment for staining Quantity

Binocular microscope with 10x, 40x and oil
At least 1 per
immersion objective (100x) eyepieces (10x) and spare
DMC
bulbs and fuses

Plastic disposable sputum containers 3,300

Slides for microscope, 25*75 mm, 1.1 mm-1.3 mm

3,300
Thick

Broom stick 10 cms length 3,300

Diamond marker pencil 3 number

Timer, 30 or 60 minutes 1 number

Forceps, Chitel forceps stainless steel for slides 15 cm 1 number

Scissors, 25 cm stainless steel 1 number

Slide rack, Staining slide rod of metal or plastic or

2 numbers
glass for 12 slides

33 boxes + 2 per
Slide boxes, For 100 slides
DMC for RBRC

Tissue rolls 4 numbers

Marker pen 12

Absorbent cotton, 500 gms/ roll 4 numbers (2 k.g)

Pressure cooker, For disposal by autoclaving Optional

Phenol with concentration mentioned on the bottle 80 litres

Methylated spirit 3 litres

Cotton, full sleeves Aprons 2

Disposable gloves, 6 and 8 inches (box of 25 pairs) 12 boxes

Spirit lamp with wicks 1 number

Metal wire, For swab for heating of Carbol fuchsin 1 number

Sputum specimen transport box, Insulated box, made

of plastic 10” x 10” x 10”, thickness 1” with lid,
handle and nylon belt 1” width 2.5 feet length, nylon 2 numbers
strap of 1” width 2 feet length with Velcro to strap the
lid of the box from side to side.

73
For preparation of reagents at DTC/TU

Reagents/ Equipment for staining Quantity

Reagents for ZN staining
Basic fuchsin, Pararosaniline hydrochloride, C19 H18 N3
Cl, molecular wt: 323.8, Colour: Metallic green, Dye
content: Should be available on the container. 250 gms
Approximately 85%-88%

Carbolic acid (Phenol), C6H5OH, and molecular wt:

94.11, Melting point: 400C, Solidication point: 40.50C, 850 gms
Purity: 99.5%

Sulphuric acid: H2SO4, molecular wt: 98.08, Purity: 95-

97%, Colour: Clear (potency correction should not be 6 ltrs
made)

Methylene blue, (Methylthioninechloride),

C16H18CIN3S, molecular Wt: 319.9 Dye content: Should 25 gms
be available on the container. Approximately 82%

Alcohol (absolute) 2.5 ltrs

Distilled water (instead of distillation apparatus) 50 ltrs

Reagents for FM
AuramineO Dye powder 20 gm

Carbolic acid (Phenol), C6H5OH, and molecular wt:

94.11, Melting point: 400C, Solidication point: 40.50C, 400 gm
Purity: 99.5%

Alcohol (absolute) 20 ltrs

Concentrated Hydrochloric acid (HCl) 200 ml
Potassium Permanganate KMnO4 100 gm
Distilled water (instead of distillation apparatus) 35 ltrs
Equipment required
Funnel, 7” dia 7” height and 5” stem height 4 nos.
Funnel, 3” dia 4” height and 5” stem height 4 nos.
Drop bottles, Glass/ plastic 100 ml capacity 8 nos.

Bottles for storage of stock solutions, Brown bottles 2 litre capacity 2 nos.

Bottles for storage of stock solutions, 2 litre capacity 10nos

Flat bottom round ask, Capacity 5 litres of borosil

5 nos.
Glass
Wash bottle, Plastic 500 ml 6 nos.
Drop plastic bottle for immersion oil, 10 ml capacity 2 nos.
Disposable bucket, Plastic foot operated 12 litres 2 nos.
Measuring cylinder, 1000 ml capacity plastic or glass 6 nos.
Measuring cylinder, 100 ml capacity plastic or glass 4 nos.

74
 Water tanks, Plastic with tap, 100 litres where there is
1 no
no running water facility.

Filter paper, Whatman no. 1 packs of 100 2” * 2 3 box

Adhesive labels for sputum containers 6 rolls

As per
Soap, soap box, towel and clean rags as needed
requirement

Aluminium vessel, for the purpose of carbol fuchsin

1 no.
solution preparation 16” diameter 9” height

Water bath, for the preparation of carbol fuchsin (to t

1
5 lit round bottom ask)
5 lit round bottom ask)
Beaker, 250 ml with spout 1 no.
Display board 1 no.
Stove wick type/ Bunsen burner with butane gas
1
cylinder/ burner with gas cylinder

Supervisory visits to designated microscopy centres

Designated microscopy centres are supervised by STLS from the sub-district. The DTO/MO-
TC/MO will coordinate with the STLS to ensure that tuberculosis-related laboratory services are
properly performed and recorded by the laboratory technician. Prior to the visit to the designated
microscopy centre, one has to plan thoroughly.

In this section, DTO/MO-TC/MO will learn how to prepare for visits to designated microscopy
centre, review the items to be checked during the visit to a laboratory and will develop a checklist
to use the same during supervision visit.

Preparation for visits to designated microscopy centre

1. The DTO/MO-TC has to decide when to visit each designated microscopy centre in the
TU/district. The visit is planned in advance so that a DTO can visit all DMCs in his/her district
at least every quarter and a MO-TC can visit all DMCs in his TU at least every month.

2. Decide what to check. Some important items to check are listed under point 4 (below). Review
the recommendations made during previous visits and the actions taken.

3. Decide when to check each item. Some items, such as the Tuberculosis Laboratory Register,
should be checked during each visit. Other items including stocks of sputum containers,
slides and reagents may be checked periodically.

4. Decide how to check each item. Depending on the time available for the visit, decide the best
ways to collect information:

(I) Review the Tuberculosis Laboratory Register. Check the Tuberculosis Laboratory Register
to make sure it is lled completely and accurately. Make sure that all smear-positive
patients in the Tuberculosis Laboratory Register have undergone Universal DST. Look for
the name of the PHI/TU/District in the remarks column if the patient is referred for
treatment. Verify that patients who were examined for diagnosis had correct number of

75
 sputum specimens examined. Also verify that the details of follow up examination (Patient
ID., regimen and month) have been entered in the reasons for examination column. Make
sure that LT is writing the monthly summary correctly. Lastly verify whether in the remarks
column there are any entries mentioning about DR TB suspects and sample sent for C &
DST.

(ii) Talk with the laboratory technicians. Make sure that they understand the importance of
examining the correct number of sputum specimens. Also, make sure that they
understand the importance of limiting administrative errors and accurately recording the
results of sputum smear examinations on the Laboratory Form for Sputum Examination. In
addition, make sure that the laboratory technicians keep the examined sputum smear
slides of all patients until the EQA procedure is completed. Reiterate that LT should
immediately inform the treating physician regarding every follow up positive patient., .

(iii) Examine supplies. Check to see if there are adequate numbers of sputum containers,
slides, reagents, forms and other laboratory supplies.

5. Develop a checklist. Once it is decided what to look for when one goes to the designated
microscopy centre and how to check each item, it will be helpful to organize the information
into a 'checklist'. In general, the checklist should be just long enough to remind the supervisor
about the important items/activities that needs to be checked. It should be easy to use.
Include important general information, such as the name of the centre and supervisor, and
date of the visit. A more comprehensive checklist is given below. Review it now. This checklist
is longer than the one that should be used during supervisory visits, but is provided for
reference. You should develop your own checklist based on this.

Conduct the visit- Information should be given to the Medical Ofcer/ BMO/ In-charge and STS
and STLS in advance about the visit to the designated microscopy centre. In the DMC, the
checklist that you have prepared should be used.

Checklist for laboratory supervision

Review of resources

Please write Yes/No in the column “Observation”

No Check-points Observations
1 Is at least one trained Medical Ofcer available in the health facility? Yes No.
2 Is a full-time trained Laboratory Technician (LT) available for sputum
microscopy?
3 Have provisions been made for sputum collection when LT is absent?

4 Is a functional binocular microscope available?

5 Has the binocular microscope undergone any servicing during last12

months?
6 Are all essential lab consumables available adequately, enough to last
at least for one month?

76
 7 Is running water available for sputum microscopy?

8 Is electricity available for the binocular microscope?

9 Have civil works been done in the Lab as per NTEP guidelines?

10 Are printed reference materials on standard operating procedures

available?

11 Are all the samples collected at collection centre and transported to

the DMC are documented and examined?
12 Are all SOPs displayed at the place where LT prepares the slides
(staining charts, grading charts, BMW material etc.,)

Review of forms, registers, records and reports

1 Are the request forms for examination of biological specimens Forms for
Sputum Exams lled correctly, completely and legibly?

2 Is the TB Laboratory Register lled correctly, completely and legibly?

3 st
Is the Lab Serial Number entered correctly, starting with 1 on 1 January
of the year and continuing until 31 December?
4 Are results correctly recorded?
5 Are there 2 sputum smears for diagnosis?
6
7 Are positive results written as scanty, 1+, 2+ or 3+in red and
negative in black/blue?

8 Are results up-to-date?

9 Does the Lab register have the summary abstract completed at the end
of each month?
10 Is there a duplicate Lab Register?
11 Are copies of supervisory reports of Senior TB Lab Supervisor available
with LT?
12 Is there evidence of supervision by STLS on lab register?

13 Is monthly PHI-level report on sputum microscopy and logistics being

submitted by the health facility?

14 Is there a TB notication register available in DMC? Are the names of all

the smear positive patients recorded in the notication register with all
relevant details?
15 Are all smear positive patients notied in NIKSHAY? Log on to NIKSHAY
and verify.

77
 16 Is the Lab register consistent with the treatment cards and TB notication
register? (Check information for at least 4-6 randomly selected new
smear -positive patients.)

17 Review the OSE reports and Annexure D kept at the laboratory

18 Review whether all patients smear positive on follow up were identied

as presumptive DR TB patients.(Remark column)

19 Review whether the sputum sample collection was done from all
identied DR-TB suspects?

20 Review whether the QC usage register is being maintained?

Observe the Lab Technician during the sputum-collection procedure

1 Did the LT check to ensure that the Lab Form was complete and
correct?

2 Is the sputum container clearly labelled on the side and not on the lid?

3 Are each set of sputum samples from a single patient given a single
Lab Serial Number?

4 Is the Patient ID written in the space provided for all patients whose
reason for examination is “follow-up” of treatment?

5 Does the LT demonstrate to patients how to bring up sputum?

6 Does the LT supervise patients when they provide spot sputum

specimens?

7 Does the LT visually examine the sputum provided to determine if it is

sputum or saliva only?

Observe the Lab Technician preparing smears for examination

1 Does the LT use only new slides?
2 Does the LT engrave the Lab Serial Number on each slide with a
diamond marker?

3 Does the LT use a different broom stick for each sputum smear?

78
 4 Are the sputum smears made on the slide of the correct size(2cmX3cm)
and thickness?

5 Does the LT wait for the slide to dry before heating the slide to x it?

6 When the Lab technician xes the slide by heating, does s/he do it for
the proper duration of time?

7 Is only “freshly prepared” carbol fuchsin being used, instead of

ready-made commercially-available solutions?

8 Is the carbol fuchsin free of particles and properly ltered before use?

9 When the LT heats the carbol fuchsin, does s/he do it properly, avoiding
boiling and allowing the slides to stand for 5 minutes after heating?

10 Does the LT tilt the slides after rinsing with water to remove excess
water?

11 Is the sulphuric acid allowed to stand on the slide for the appropriate
time period (2–4minutes)?

12 Is the methylene blue allowed to stand on the slide for the appropriate
time period (30 seconds)?

Observe the Lab Technician examining slides under the microscope

1 While placing immersion oil on the slide, does the LT take care to avoid
touching the slide with the applicator?

2 While examining the slide with the X100 lens, does the LT take care to make
sure that the lens does not touch the slide?
3 Does the LT examine negative sputum smear slides for at least 5 minutes?

4 Does the LT have correct knowledge about grading?

5 Does the LT see 100 elds before declaring the smear as negative?

6 Does the LT correctly complete the Lab Form for Sputum Examination and Lab
Register?

7 Does the LT clean the X100 lens with lens paper/ne silk after completing the
examination?

8 Are slides correctly cleaned and maintained serially in slide boxes for review
by the supervisor?

9 Are all smear-positive results recorded in red ink in the Lab Register?

79
 10 After examining the slides, does the LT put the sputum containers and lids
(with lids removed) along with the broom sticks, into a foot-operated bucket
containing 5% phenol?

11 Does the LT break all the remaining slides of the previous month after The
EQA procedure is completed?

12 Does the LT ensure that smear-positive as well as smear-negative slides are

not being re-used for AFB microscopy?

Exit-interviews of atleast 2 patients undergoing sputum microscopy

1 Do the patients know how to cough out good quality sputum properly?

2 Do the patients know when they should return for the next sputum exams?

3 Do the patients nd the timings and location of the Lab convenient?

4 Do the patients face any difculties for undergoing sputum microscopy?

80
Quality assurance for CBNAAT
Internal Quality Control:
Each CBNAAT cartridge contains internal controls, Specimen Processing Control (SPC) and
Probe Check Control.

If the probe check fails, then the test is stopped and an error result is obtained. Troubleshooting is
required based on the error code generated. Error rates higher than 5% should be investigated.

SPC must be positive when the result is MTB not detected. It can be negative/positive when the
result is MTB detected. The test result is considered invalid if the SPC is negative when the test
result is found negative.

External Quality Assurance (Prociency Testing) for CBNAAT:

EQA is a specialized form of assessment focused on assuring accuracy and reliability of
examination methods.

EQA /PT is an effective tool to promote continual improvement which can identify
occurrences/nonconforming events and offers external assessment of process output.

Importance:
Ÿ Gives assurance to users that the CBNAAT instrument is functioning properly at the time of
installation.

Ÿ Checks to verify that users can correctly interpret and report results.

Ÿ Veries that there are no major errors in the process control system and that samples are
identied correctly, tested correctly and reported correctly.

Ÿ Quickly recognizes major problems with an instrument or user at installation.

Dried tube specimens (DTS) PT panels are used for testing the efciency of laboratories. Panel
consists of inactivated non-infectious dried culture of M.tb with RIF sensitive and resistant and
negative / NTM. Procedure are safe and compatible with testing protocol.

PT panel of 5 DTS samples are provided for testing to the laboratories to check pre-analytical,
analytical and post-analytical processes, and the results of all laboratories are analyzed,
compared, and reported to the laboratories.

To enable prompt initiation of corrective actions, feedback regarding PT results is provided in a

timely manner to the testing sites and to supervisory staff. PT will help to identify major non-
conformities, allowing supervisors to target the most poorly performing laboratories for on-site
supervision.

Quality assured CBNAAT test results are essential to ensure

patients are correctly diagnosed early and initiated on an
appropriate treatment regimen.

81
Infection Control
There is the risk of transmission of tuberculosis infection occurring in health care facilities
including the laboratory when patients remain undiagnosed and untreated for tuberculosis. This
may be curtailed by early diagnosis and immediate initiation and adherence to NTEP treatment
regimens. This prompt and timely action will make infectious TB patients rapidly non-infectious.

It is now mandatory that any Infection Control plan of the facility should include infection control
for TB and TB/ HIV. Broadly, infection control needs to be addressed at three different levels:
administrative, environmental and personal.

Administrative control relies on the extent of complete implementation of diagnostic and

treatment guidelines in the health care facility. TB infection control plan includes the following:

Ÿ Giving priority for patients with cough for clinical and laboratory investigations for early
detection of smear-positive pulmonary tuberculosis patients

Ÿ Reducing delay in starting appropriate treatment once diagnosed

Ÿ Avoiding unnecessary admission for inpatient care

Ÿ Assessment of health care workers training needs

Sputum collection should ideally be done outside the facility and away from the people. It should
not be done in closed areas such as toilets and in ill-ventilated rooms. Processing specimens for
smear microscopy (after sputum collection) has not been documented to cause any increased
risk to laboratory personnel. However, TB suspects amongst health care workers should be
subjected to screening procedures.

Second priority is environmental control, which is used to reduce the generation and
concentration of droplet nuclei in the air in high-risk areas. High-risk areas that increase
transmission include exposure in relatively small, enclosed rooms in health facilities, which lack
adequate cross ventilation in the form of open windows and doors to “clean” the environment
through dilution or removal of infectious droplet nuclei. Hence, the TB IC plan should also
include educating the patients regarding cough hygiene (covering the face while coughing and
avoiding indiscriminate spitting), frequent identication of risk areas within the facility and
providing good cross-ventilation to the area.

Wearing of surgical masks made of cotton wool/ gauze/ paper for personal protection does not
protect the person who is wearing the mask from inhaling the droplet aerosols and hence is not
recommended as a means to prevent hospital infection. However, masks are useful in
preventing droplets when worn by the patient.

The key to reducing the risk of tuberculosis transmission at health facilities is early
diagnosis and prompt initiation of treatment regimens. Infectious TB patients
become rapidly non-infectious once they are started on treatment.

All health care workers at the district level should receive onsite training at least once in two-
years regarding M. tuberculosis transmission and airborne infection control. Training should
include Signs and symptoms of TB, increased risk of TB disease in persons who have HIV infection
and other immunosuppressive conditions and prevention of airborne infection with M.
tuberculosis.

82
An Infection control plan for TB-HIV may include precautions to be observed for HIV, in addition
to that observed for TB, especially when streptomycin injections are being provided. The risk of
acquiring HIV following percutaneous exposure (needle stick/ needle prick with inoculation)
from an HIV-positive source is extremely low: 0.25- 0.3%. This is because the concentration of
HIV in peripheral blood is extremely low (104 infectious virions /ml). On the other hand, the risk
of acquiring hepatitis virus (HBV) following similar exposure ranges from 9-30% because the
concentration of HBV in blood is high (>10,000,000 infectious doses /ml). The chance of
acquiring Hepatitis C is approximately 3-10%. Disposable needles and syringes should be used
for injections. Needles and syringes should be disposed as per the Bio Medical waste
management guidelines.

Health care workers can effectively prevent infections

acquired through contaminated blood by the adoption of
“Universal Precautions” or “Bio-safety Precautions”

Bio-Medical Waste Management under NTEP at PHIs:

The Government of India (GoI) under its Environment Protection Act (1986), passed the
Biomedical Waste (Management and Handling) Rules in 1998 and a subsequent amendment
followed in 2000. The rules form the legal framework for the collection, segregation,
transportation, treatment and disposal of biomedical waste throughout the country. The State
Pollution Control Boards (SPCBs) in the states and the Pollution Control Committees (PCCs) in
the Union Territories are monitoring the compliance to the rules in the respective states.

BMW is integrated into the general health system of the states. Waste management is a
component of overall facility management of the respective state health system institutions
where TB centres are located. Accordingly, the waste generated by PHIs, DMCs should not be
viewed in isolation, but is to be integrated in the broad framework of the peripheral institutions'
waste management practices. The peripheral health institutions would be responsible for
disposal of the wastes and reporting to their respective PCBs.

Types of wastes generated by the PHIs

Ÿ Human/biological waste (sputum);

Ÿ Sharp waste (needles, glass slides etc.);

Ÿ Used blister packs, drug packaging material;

Ÿ Plastic waste (waste generated from disposable syringes, cups and glasses); and

Ÿ Laboratory and general waste such as liquid waste, broomsticks, and paper waste; and

Ÿ Construction waste (waste generated from civil work activities).

Waste Management at Phis

Waste generated by TB laboratories will be discarded with the overall waste of the health facility
in which TB services are provided. The staff carrying out TB services like LTs and DOT providers in
PHIs will adopt infection control techniques as detailed in the guidelines and will take action to
integrate waste generated by the TB laboratory into the waste management activities of the

83
concerned PHI. The activities by the PHIs will include organized waste collection, information
dissemination, reporting and monitoring of disposal of the waste.

Disposal of sputum container with specimen and wooden sticks

Step 1: After the smears are examined, remove the lids from all the sputum cups.

Step 2: Put the sputum cups, left over specimen, lids and wooden sticks in foot operated plastic
bucket/bin with 5% phenol or phenolic compound diluted to 5%. The cups and lids
should be fully immersed in the solution. Keep it overnight/ for about 12 hours.

Step 3: Next day/ at the end of the day, drain off the phenol solution in to the drain.

Step 4: Take out the sputum cup/lid/wooden sticks and put into a reusable metal or autoclave-
able plastic container or red bag. The red bag should have a biohazard symbol and
adequate strength so that it can withstand the load of waste and be made of non-PVC
plastic material.

Step 5: Put this container/bag into the autoclave with other autoclavable BMW and the contents
should be autoclaved at 121°C at 15 psi pressure for 15 – 20 minutes. The autoclave
shall comply with the standards stipulated in the rules. Under certain circumstances, if
autoclaving is not possible, boil such waste in a pressure cooker of approximately 7 litre
capacity containing adequate amount of water to submerge the contents and boiled for
at least 20 minutes using any heating source, electrical or non-electrical. However, the
District Hospital/CHC/PHC etc. shall ultimately be expected to make the necessary
arrangements to impart autoclaving treatment on regular basis.

Step 6: After adequate cooling, the material can be safely transported to a common waste
treatment facility for mutilation / shredding / disposal.

lf a common waste treatment facility is not available in the area, the sputum cups/lids/ wooden
sticks after autoclaving, can be buried in a deep burial pit.

LTs and support staff handling biological waste should wear gloves.

Disposal of stained slides

Step 1: The slides should be put into a puncture proof container and red bag. The red bag
should have a biohazard symbol and should be made of non-PVC plastic material. This
bag/sharp container should then be put in to an autoclave or pressure cooker for
autoclaving/boiling.

Step 2 : Dispose off the autoclaved/ pressure boiled slides into a pit for sharps.

Under no circumstances should the slides should be broken.

84
Points to remember
• DTO and MO-TC are responsible for supporting laboratory services.
• STLS is responsible for supervisory activities of all the designated microscopy centres
in the sub-district.
• Only Tuberculosis Laboratory Register should be used to record information about
sputum smear results.
• All smear-positive (including scanty) results should be recorded in red ink in the
Tuberculosis Laboratory Register.
• Slides once used should not be reused.
• Contaminated materials should be disinfected and disposed safely.
• Only one Laboratory Form for Sputum Examination is used for one patient and only
one Laboratory Number is given for 2 sputum examinations for diagnosis.
• Grading of smears increases the accuracy of results and helps in quality control
measures. Grading is resorted to enhance the concentration of the laboratory
technician while reading the smears.
• Follow-up sputum smears done at scheduled time help in monitoring treatment.
• Accurate recording of results of sputum smear examinations on the Laboratory Form
for Sputum Examination ensures correct diagnosis and appropriate treatment.
• Ensuring quality of each and every designated microscopy centre is an essential
feature under the programme.ach and every designated microscopy centre is an
essential feature under the programme.

85
 MODULE 3
TREATMENT SERVICES

Learning objectives
In this module, the participants will learn about the following:
• Goal and objectives of treatment
• Scientic basis of treatment
• Case denitions
• Fixed Dose Combinations (FDC)
• Treatment Regimen and drug dosages
• Operational guidelines for treatment initiation
• Treatment support systems
• Follow-up of treatment
• Contacts
• TB Preventive Therapy
• Flow of patients
• Treatment outcomes
• Prevention and management of Adverse reactions to drugs
• Management of Special situations and comorbid conditions
• Hospitalization
• Extrapulmonary TB
• Drug-Resistant TB
• Nikshay entries- Transfer, Initiation, Prescription, Comorbidity, Rell, follow ups,
adherence, and outcome
• Organization of DOT and ow of patients for treatment

86
Introduction
The previous module has dealt with the provision of quality assured laboratory services. This
module deals with the technical and operational aspects of the treatment services provided by
the programme.

Goal and Objectives of treatment

• Render patient non-infectious, break the chain of transmission and decrease pool of
infection
• Decrease case fatality & morbidity by ensuring relapse free cure
• Minimize & prevent development of drug resistance

Scientic basis of treatment of TB

The strategies adopted in the treatment of TB are based on both scientic and
operational research.

The following four components are discussed in brief

• Domiciliary treatment
• Short course chemotherapy
• Treatment regimen
• Direct observation of treatment

Domiciliary treatment
Domiciliary chemotherapy has been proved to be as effective as sanatoria treatment. Studies in
India have shown that smear positive TB patients treated on a domiciliary basis have achieved
high cure rates as good as those when treated at sanatorium besides having other social
benets of being at home. The patients after the initiation of treatment on domiciliary basis also
did not pose extra risk as a source of infection among contacts at home.

Short course chemotherapy

Short course chemotherapy regimens have made it possible to treat and cure TB patients in as
short a period as six months. Reduction in the duration of treatment regimens was possible
because of the introduction of Rifampicin and Pyrazinamide. Treatment regimens of six months
duration given daily have been found to be effective and achieve high cure rates, prevent
emergence of drug resistance and minimize relapses. The shorter duration has contributed to
improvement in the treatment adherence. Short course chemotherapy regimens of 6 months
are recommended internationally for most forms of extra-pulmonary TB.

Basis of chemotherapy
(a) Bacteriological basis
i. Existence of naturally occurring drug resistant mutants
• In an untreated smear positive pulmonary tuberculosis patient, there are naturally
occurring drug resistant mutants to different drugs at different frequencies. The
larger the bacterial population higher is the probability that resistant mutant strains
are present. The number of bacilli is lower in smear negative and extra pulmonary
lesions. The number of viable bacilli commonly found inside the cavities sized about
2 centimetres in diameter on an average is likely to be in excess of 100 million (108).
As a thumb rule the frequency of occurrence of drug resistant mutants would be
roughly ~1 in 106 to isoniazid (H), ~1 in 106 to streptomycin (S) and ~1 in 108 to

87
 rifampicin (R). Based on these frequencies, the chances of naturally occurring
organisms that is resistant to both H and R would be roughly ~1 in 1014, which is
virtually negligible.

There would be appreciable numbers of mutant resistant to any single drug before the start of
the treatment that are capable of multiplying and will not be affected by a single drug, e.g.
isoniazid. This accounts for frequent failures observed with monotherapy of patients harbouring
large number of bacilli. Thus, if two or more drugs are given concurrently, in the initial Intensive
Phase when the bacterial load is high the chances of survival and selection of drug resistant
organism to any drug would be very small as mutants resistant to one drug are as a rule
susceptible to other and vice versa. This is the basis for the use of multi-drug therapy in the
treatment of tuberculosis.

Role of intensive phase

The objective of combining four drugs in the intensive phase (IP) is to achieve rapid killing of
actively multiplying bacillary population. This phase will eliminate naturally occurring drug
resistant mutants and prevent the further emergence of drug resistant mutants.

Role of continuation phase

Continuation phase (CP) with fewer drugs for a comparatively longer time will ensure
elimination of persisters which are responsible for relapses.

Existence of sub-bacillary population

In a given lesion of TB, there are 4 bacterial sub-populations having different metabolic rates
depending on their surrounding environment. They are acted upon with different intensity by the
different anti-TB drugs. The bacillary population and different drugs acting on them are shown in
the gure below.

88
The bacillary sub populations B and C are referred as semi-dormant or persisters which are
difcult to eliminate and are the source of relapse.

Anti-TB drugs have the following three actions:

a. Early bactericidal activity
b. Sterilizing activity
c. Ability to prevent emergence of drug resistance

Isoniazid (H): Isoniazid is a potent drug exerting early bactericidal activity, prevents emergence
of drug resistant mutants to any companion drug and has low rates of adverse drug reactions.

Rifampicin ®: Rifampicin is a potent bactericidal and sterilizing drug acting on semi- dormant
bacilli which multiply intermittently and causing relapse.

Pyrazinamide (Z): Pyrazinamide is a bactericidal and sterilizing drug effective in eliminating

the semi dormant bacilli multiplying slowly in an acidic environment.

Ethambutol (E): Ethambutol is an effective bacteriostatic drug helpful in preventing

emergence of resistance to other companion drugs.

Streptomycin (S): Streptomycin is a bactericidal drug known to reduce septicaemia and toxicity.

The ranking of the drugs with respect to their type of activity is indicated in the following table.

Prevention of emergence
Drugs Early bactericidal Sterilizing activity
of drug resistance

Isoniazid ++++ ++ ++++

Rifampicin +++ ++++ +++

Streptomycin +++ - ++

Pyrazinamide ++ +++ +

Ethambutol + - ++

Pharmacological basis of treatment

It is established that in the treatment of tuberculosis it is of importance to achieve peak serum
levels of all the drugs simultaneously, so that maximum bactericidal effect is obtained. This is
achieved by administration of all the drugs at the same time. This also renders operational
convenience of advising the patients to consume all the drugs at the same time.

Daily Regimen
The NTEP had adopted thrice weekly regimen for treatment of drug sensitive TB until the year
2016. Various research studies have shown that relapse rates were higher with intermittent
regimen. Hence the programme has now shifted to daily regimen for treatment of all drug
sensitive TB patients. The adverse drug reactions with daily regimen may be higher compared to
intermittent regimen, therefore, it is necessary to clinically monitor the patients on treatment.

89
Directly Observed treatment (DOT):
Studies in India and many other countries have consistently shown that at least one third of
patients do not consume medicines regularly. DOT is a supportive mechanism that ensures the
best possible results in treatment of TB. Here a treatment supporter helps the patient in taking
the treatment, thereby ensuring adherence. Many patients who do not receive directly observed
treatment stop taking drugs once they feel better. It is neither possible to predict who these
patients will be nor to prevent non-adherence through health education. Studies have shown
that there will be poor treatment outcome and high death rates in the absence of DOT, even
when regular supply of drugs is ensured. Hence, by providing DOT, NTEP ensures that patients
receive the right drugs, in the right doses, at the right intervals and for the right duration.

CASE DEFINITIONS
• Microbiologically conrmed TB:
– presumptive TB patient with biological specimen positive for AFB, or positive for MTB on
culture, or positive for TB through Quality Assured Rapid Diagnostic molecular test.
• Clinically diagnosed TB case:
– A presumptive TB patient who is not microbiologically conrmed, but diagnosed
with active TB by a clinician on the basis of X-ray, histopathology or clinical signs with
a decision to treat the patient with a full course of Anti-TB treatment.
– In children, this is based on the presence of abnormalities consistent with TB on
radiography, history of exposure to an infectious case, evidence of TB infection
(positive TST) & clinical ndings suggestive of TB in the event of negative or
unavailable microbiological results

TB cases are also classied according to:

– anatomical site of disease
– history of previous treatment
– drug resistance

Classication by anatomical site of disease

• Pulmonary tuberculosis (PTB): any microbiologically conrmed or clinically
diagnosed case of TB involving lung parenchyma or tracheo-bronchial tree.
• Extra Pulmonary tuberculosis (EPTB): any microbiologically conrmed or clinically
diagnosed case of TB involving organs other than lungs e.g. pleura, lymph nodes,
intestine, genitourinary tract, joint and bones, meninges of the brain etc.
Miliary TB classied 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 PTB.

Classication by H/O previous TB treatment

• New case - A TB patient who has never had treatment for TB or has taken anti-TB drugs
for less than one month.
• Previously treated patients have received 1 month or more of anti-TB drugs from
any source in the past.
– Recurrent TB case - A TB Patient previously declared as successfully treated
(cured/treatment completed) and is subsequently found to be microbiologically
conrmed TB case.

90
 – Treatment After failure- those patients who have previously been treated for TB and
whose treatment failed at the end of their most recent course of treatment.
– Treatment after lost 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 conrmed TB case.
– Other previously treated patients are those who have previously been treated for TB but
who cannot be classied into any of the above classication.

Classication based on drug resistance

• Mono-resistant (MR): A TB patient, whose biological specimen is resistant to one rst-
line anti-TB drug only.
• Poly-Drug Resistant (PDR): A TB patient, whose biological specimen is resistant to
more than one rst-line anti-TB drug, other than both INH and Rifampicin.
• Multi Drug Resistant (MDR): A TB patient, whose biological specimen is resistant to
both isoniazid and rifampicin with or without resistance to other rst line drugs, based
on the results from a quality assured laboratory.
• Rifampicin Resistant (RR): resistance to rifampicin detected using phenotypic or
genotypic methods, with or without resistance to other anti-TB drugs excluding INH.
Patients, who have any Rifampicin resistance, should also be managed as if they are an
MDR TB case.
• Extensively Drug Resistant (XDR): A MDR TB case whose biological specimen is
additionally resistant to a uoroquinolone (ooxacin, levooxacin, or moxioxacin) and
a second-line injectable anti TB drug (kanamycin, amikacin, or capreomycin) from a
quality assured laboratory.

Treatment regimen
For all TB patients whether being treated in public or private sector, clinicians should follow
Standards for TB care in India (STCI) guidelines. In NTEP, the principle of treatment for
tuberculosis (other than conrmed Drug Resistant forms of TB) is to administer daily xed dose
combinations of rst – line anti-tuberculosis drugs in appropriate weight bands. For patients
being treated in private sector, FDCs may be provided by NTEP whenever requested.

Regimen for Drug-Sensitive TB (DSTB) cases: 2HRZE/4HRE

This regimen is for H & R sensitive TB cases and cases with unknown sensitivity pattern.

Treatment is given in two phases:

• Intensive phase (IP) consists of 8 weeks (56 doses) of isoniazid (H), rifampicin (R),
pyrazinamide (Z) and ethambutol (E) given under direct observation in daily dosages as
per weight band categories.
• Continuation phase (CP), consists of 16 weeks (112 doses) of isoniazid, rifampicin and
ethambutol in daily dosages. Only pyrazinamide will be stopped in the continuation
phase. The CP may be extended by 12-24 weeks in certain forms of TB like CNS TB,
Skeletal TB, Disseminated TB etc. based on clinical decision of the treating physician on
case to case basis. Extension beyond 12 weeks should only be on recommendation of
specialists.

91
 Regimen for IP* CP

Doses Doses

Drug Sensitive TB 56 112

Loose Drugs could be used as substitutions in case of adverse drug reaction or with comorbid
conditions.

Steroids as an adjunctive therapy is useful in patients with TB pericarditis and meningeal TB, with
an initial high dose tapered downwards gradually over 6 - 8 weeks.

Type of TB case Treatment Regimen in IP Treatment regimen in CP

New and previously treated cases 2 HRZE 4 HRE

(H and R Sensitive / unknown)

Prex to the drugs stands for number of months

Fixed Dose Combinations (FDCs)

Fixed Dose Combinations (FDCs) refer to products containing two or more active ingredients in
xed doses, used for a particular indication(s).
IN NTEP, for Adults - 4-FDC (given in IP) consists of HRZE and 3-FDC (given in CP) consists of HRE
For paediatric patients -Dispersible 3 FDC consists of HRZ and Dispersible 2 FDC consists of HR.

Advantages of FDCs
• Simplicity of treatment
• Increased patient acceptance
– Fewer tablets to swallow
– Prevents 'concealed' irregularity
• Increased health worker compliance
– Fewer tablets to handle, hence quicker supervision of DOT
• Easier drug management
• Reduced use of monotherapy
– Lower risk of misuse of single drugs
• Lower risk of emergence of drug resistance
• Easier to adjust dosages by body weight

92
Drug dosages for rst line anti- TB drugs

*Streptomycin is administered only in certain situations, likeTB meningitis or if any rst line drug
need to be replaced due to ADR as per weight of the patient
** Ethambutol is given separately for children to monitor ophthalmic ADR.

Daily Dose Schedule for Adults (as per weight bands)

Weight category Number of tablets (FDCs)

Intensive phase Continuation phase

HRZE HRE

75/150/400/275 75/150/275

25-34 kg 2 2

35-49 kg 3 3

50-64 kg 4 4

65-75 kg 5 5

>75 kg 6 6

During treatment if the weight of the patient increases by more than 5 kg and crosses the next
weight band category then patient should be given the next higher weight band FDC drugs.

Treatment of Paediatric TB
Paediatric cases are to be treated under NTEP in daily dosages as per 6 weight band categories.
All adolescents up to 18 years of age and weighing less than 39 kg, are to be treated using
paediatric weight bands and children weighing more than 39 kg with adult weight bands.

93
Key Product Information (for Paediatric)
1. Dispersible FDC, avoured
Rifampicin 75 mg + Isoniazid 50 mg + Pyrazinamide 150 mg
Rifampicin 75 mg + Isoniazid 50 mg

2. Dispersible Loose drugs

Ethambutol 100 mg
Isoniazid 100 mg

Drug Dosage for Paediatric TB

A=Adult FDC (HRZE = 75/150/400/275; HRE = 75/150/275). It is added in higher weight

band categories i.e. > 25 kg as these children may be able to swallow tablets.

• Change in weight bands to be effective upon crossing of weight bands irrespective of

the quantum of weight gain/loss
• Pyridoxine may be given at a dosage of 10 mg per day to all children receiving INH
containing therapy irrespective of age group

Operational Guidelines for treatment initiation

After receipt of the diagnostic test results, the MO of the Peripheral Health Institution (PHI)
should take the following measures:

1. Initiation of appropriate regimen- Establishment of diagnosis of tuberculosis and

decision on type of patient and treatment regimen (based on drug sensitivity pattern, i.e., DSTB
or H-mono/ poly resistance, history of ADR to ATT). Initiation of appropriate regimen and
ensures completion of treatment. All diagnosed patient should be initiated on treatment at the
diagnosing PHI

Counselling: MO-PHI should counsel all TB patients before initiating treatment. It is advisable
to involve close family members during the counselling. Counselling should include education
of patient and family members about type, and mode of spread of disease and dosage schedule,

94
duration, common side-effects of treatment & methods to prevent them. Counselling regarding
importance of need for regular treatment and consequences of irregular treatment or
premature cessation of treatment should be given. Treatment adherence monitoring methods
as in DOT manually, other ICT methods should be explained.

Cough etiquette Patient should also be explained about cough etiquette and proper disposal of
sputum for prevention of transmission of disease and encourage him to get all his close contacts
(especially household contacts) screened at the earliest.

Assure the patients that h/she will be supported during the entire course of treatment by the MO
and peripheral health workers.

2. Clinical evaluation:
• Record weight of the patient and also height to assess Body Mass Index (BMI), which
would provide a good indicator for prognosis of disease and also for initiating treatment
regimen based on weight bands.
• Assess nutritional status of patient and link the patient for extra nutritional support.
• Assess general condition to identify patients who may need hospitalization.
• Assess for comorbidities like HIV, diabetes, liver or renal diseases, neurological
disorders etc so that appropriate management measures can be taken.
• Assess for substance abuse especially tobacco (in any form) & alcohol and link him/her
to respective TCC (Tobacco Cessation Clinic)/ de-addiction centre.

3. HIV Testing
All presumptive TB patients should be offered HIV testing. For all diagnosed TB patients, MO
should make efforts to get HIV testing done. All HIV positive TB patients must be referred to ART
centre for initiation of ART and CPT.

4. Assess the socioeconomic status of the patient and link him/her with appropriate
treatment support schemes.

5. Open a treatment card (in duplicate when required) (Annexure 5) for each patient at the
time of initiation of treatment. Each patient must be given TB Identity Card. (Annexure 6)

6. Plan appropriate treatment adherence and monitoring mechanisms at the time of

treatment initiation in consultation with the patient, his/her family members and the peripheral
health worker who is responsible for monitoring treatment adherence

7. Drugs should be made available at the treatment centre along with the TB treatment card
and arrange for sputum containers for collection of early morning samples for follow-up
examinations.

8. Arrange for follow up during treatment and long term follow up of TB cases.

9. MO should maintain TB Notication register (Annexure 7) for patients diagnosed in PHI and
transferred in PHI and also ensures updating of notication register and NIKSHAY.

10. Arrange for Public Health Action for all notied TB patients including those notied
from private sector.

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11. Clinical examination of all TB cases should be done by MO and clinically follow up the
patient once in a month to early identify any adverse drug reaction and also to assess clinical
improvement. Follow up should be supported by laboratory investigations whenever necessary.

Nikshay entry- Once the treatment regimen is nalized, all patients will be initiated on
treatment after opening of the treatment card and entries are done in Nikshay. MO-PHI should
ensure that the treatment details are entered in Nikshay immediately, by the PHI staff
designated by him. Nikshay entry should not be a separate activity, all events starting from
notication to treatment outcome are from Nikshay only and its integrated part of
documentation

Patient ow in Nikshay

a. Nikshay 1- Initiating the patient on appropriate treatment regimen
b. Nikshay 2- Transfer / referral ow after initiation of treatment
c. Nikshay 3- Nikshay Aushadhi

Treatment support program

Adherence to regular and complete treatment is the key to relapse free cure from TB. To assess
and foster adherence, a patient-centred approach to administration of drug treatment, based
on the patient’s needs and mutual respect between the patient and the provider, should be
developed for all patients.

The treatment support plan should include initial and frequent follow-up counselling of the
patient and family members, supervision of treatment by a trained treatment supporter (a health
worker, family member or community volunteer), locally managed additional nutritional
support, retrieval of treatment interrupters, screening for adverse reactions, psycho-social
support, co-morbidity management and follow up laboratory investigations. Considering
patient as a VIP, the treatment support plan need to be tailored as per patient’s need.

Direct observation of treatment (DOT) is one of the best practices to promote adherence. It
ensures patient consumes every dose of the treatment before a trained treatment supporter and
provides additional opportunity to support treatment. Government health staff (Eg. Pharmacist,
ANM, MPW, Staff nurse, nursing assistants etc.), health volunteers from the community (ASHA,
AWW, NGO volunteer, shop keeper, TB survivors etc.) can act as a treatment supporter and
provide directly observed treatment (DOT). The treatment supporter should be accessible and
acceptable to the patient and accountable to health system. All efforts must be put in to nd a
treatment supporter close to the patient’s residence.
• It must be ensured that each and every dose taken by the patient should be supervised
in IP and at-least twice in a week in CP by a trained treatment provider.
• The record of the supervision during IP & CP need to be maintained.
• Only in exceptional circumstances, like sick and bedridden patients & children, a trained
family member can be assigned with the responsibility of observing treatment and the
decisions in such situations, will be taken by the DTO/MO.
• These patient’s adherence need to be supervised by the programme staff and
documented.
• Such exceptions should be restricted to less than 5% of all TB patients in the district
including private sector.
• Each patient and his/her treatment supporter should be supervised by a health worker.

96
 o It may be a peripheral health worker in the public health system.
o For patient initiated on treatment by a private health care provider, public health
support needs to be provided to the patients on treatment.
o It is the responsibility of MO to sensitize nearby private practitioners about the
services provided under public health action (PHA).

• Digital Adherence Technology (DAT) like intelligent deployment of information

communication technology (ICT) like frequent calls, SMS reminders, IVRS, etc also may
be deployed to further enhance adherence to treatment

For the purpose of identifying an ideal treatment supporter and an appropriate DOT Centre, a
DOT Directory should be maintained at PHI level. This directory should contain a locality- wise
list of DOT Centres / treatment supporter in the area. It should be updated regularly. It is the
responsibility of the Government eld staff (PHWs / MPWs / TBHV) in coordination with treating
physician (private/public) to organize and ensure DOT for the patient. They would also monitor
and supervise the community treatment supporter in their respective sub centres.

If the patient is to be given DOT by treatment supporter, a duplicate treatment card will be
prepared and given. The MO of the PHI will ensure uninterrupted supply of drugs. MO PHI
should monitor monthly replenishment of stock to treatment supporter if drugs are not already
given and update in drug stock register maintained at the PHI and in NIKSHAY Aushadhi.

The PHW visits the house of the patient within a week of diagnosis. During this visit, he/she
should give counselling to patient and family members regarding disease, treatment and its
adherence and ensures treatment support to the patient. Patient should be started on treatment
as early as possible after diagnosis. Emphasis is given to the points similar to the ones mentioned
above for the MO-PHI. This opportunity should also be used for screening of contacts.
Residential address is also veried so that in case of interruption, retrieval action can be taken.
The initial home visit should be recorded in treatment card in the space provided. A convenient
location for drug administration and a suitable treatment supporter is decided mutually by the
PHW and the patient.

Tasks performed by the health worker on home visit:

1) Address verication
2) Screening of all contacts (close and household contacts, reverse contact tracing in case of
children)
3) Facilitating diagnostic testing of all symptomatics irrespective of duration of symptoms
4) TB Preventive Therapy(TPT) to all eligible
5) Collection of the address and phone number of the contact person outside the household
6) Collection of Bank account number of the patient/ or one of the households and the phone
number. Facilitate getting the bank account opened if not having one.
7) Health education and Counselling of patient and family members

A community treatment supporter is a person who has volunteered to administer DOT as per the
programme guidelines and is:
• from the community where patient resides/works,
• other than Government salaried staff

97
For example, a shopkeeper, NGO volunteer, priest, ASHA could be the treatment supporter.

In case, the DOT is organized through a community treatment supporter, then duplicate TB
treatment card, TB identity card and anti TB medicines are handed over to the patient by the
PHW. Sputum container for collection of morning samples for follow-up sputum examinations is
also provided. The name of the DOT centre and name and designation of the treatment
supporter should be entered in treatment card in the space provided. Before starting treatment,
Onsite training is to be provided for the community treatment supporter, by the PHW, focussing
on directly observed treatment, adherence, contact tracing, identication of adverse reactions,
follow-up sputum examination and recording of drug intake. The treatment supporter should
also be trained to impart health education to the patient. The PHW is responsible for supervising
and ensuring DOT and updating of the original treatment card at the PHI on a fortnightly basis.
In case the patient interrupts treatment, PHW will help the community DOT worker in retrieving
the patients. The MO of the PHI (where treatment card was opened) and the STS should also
supervise DOT on a regular basis. DTO and MO-TC should support them in their efforts through
eld- visits.

During TB treatment, each and every dose is taken under direct observation of the treatment
supporter. DOT is administered at a place which is convenient to both patient and treatment
supporter. This place is designated as DOT centre. However, in situations where patient is
bedridden, children, long day workers etc. DOT should be administered under supervision at the
patient’s home by the family member who will be treatment supporter.

Only under exceptional circumstances, unsupervised drug administration can be allowed for a
limited number of doses. For instance, if a patient is being discharged from hospital after
initiation of treatment, s/he will have to be provided with one week doses of treatment so that
the treatment is not interrupted during transfer to a nearby PHI. A home visit should also be
made for these patients by health worker of the receiving unit preferably within a week of
receiving the patient.

The treatment supporter indicates the drug administration by a tick mark against the days in the
appropriate box on the tuberculosis treatment card. Patient is also asked about adverse drug
reactions and, if necessary, referred to the MO. Patient is referred to the Designated Microscopy
Centre (DMC) for follow-up sputum examinations. When patient reports to the DMC along with
an early morning sputum sample on the scheduled day.

Patient should be referred for follow-up sputum examinations at the prescribed intervals at the
end of IP, end of CP and long term follow up from outcome/last dose of the treatment up to 2
years (at 6 months, 12, 18, 24 months).

Other modalities for treatment adherence, Digital Adherence Technology (DAT) While observing
treatment is one of the best modalities of promoting treatment, other modalities like intelligent
deployment of information communication technology (ICT) like frequent calls, SMS reminders,
IVRS, etc also may be deployed to further enhance adherence to treatment for patient who is
unable to undergo supervised treatment for e.g. frequent on job travellers, truck drivers, sailor
etc. This decision is taken by the MO/ DTO after exploring the possibility of making a co-worker,
for example, Cleaner for the truck driver etc., We should remember that this option when opted,
there is always a possibility of the patient stopping the treatment before completion thereby
increasing the possibility of development of drug resistance. Hence, good quality of programme

98
will have no patient on self-administered treatment and reects on the efciency of the program
manager in convincing the patient for direct observation, along with other modalities of
monitoring adherence of treatment as only adjunctive to DOT.

Patient support systems:

1. Mobility support for patients in situations like patients visit to ART centre, DRTB centre, DMC
for collection of sputum for follow up visits for DRTB patients.

2. Counselling may be required to quit substance abuse.

3. Nutritional assessment & support

a. Nutritional support to TB patients (NIKSHAY Poshan Yojana): Under this scheme all
notied TB patients are provided incentive of Rs 500 per month during anti-TB treatment
for Nutritional support in cash or in-kind support through Direct benet transfer (DBT).
b. All individuals with active TB should receive assessment of nutritional status,
appropriate counselling based on nutritional status at diagnosis and throughout their
treatment. If malnutrition is identied, it should be managed according to ‘Guidance
Document- Nutritional care and support for TB patients in India’.
c. Linkages for extra nutritional support for TB patients or of his/her contacts on IPT may be
explored with existing Govt. schemes like public distribution system (PDS) or Food
security act.

4. Ancillary drugs for management of ADR, comorbidities etc.

5. Comorbidity management

To avail above, synergy between social welfare support systems like RSBY, TB pension
schemes, national rural employment guarantee scheme, corporate social responsibility
(CSR) initiatives, counselling centres etc. to mitigate out of pocket expenses such as transport
and wage loss incurred by TB patients should be established.

6. Under the programme, compensation is provided for transport costs incurred by DR TB

patient for sending specimen for follow up or for travel to DR-TB centre. TB patients in tribal
and difcult areas get Rs. 750.

Contact investigations
‘Close contacts’ are those individuals who share a common air space with the patient.
All close contacts, especially household contacts should be screened for TB. In case of paediatric
TB patients, reverse contact tracing for search of any active TB case in the household of the child
must be undertaken. All close contacts of DR-TB cases should be identied through contact
tracing and evaluated for active TB disease as per NTEP guidelines. This information has to be
entered in Nikshay by the PHI staff
Insert Nikshay screen shot / ow

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TB Preventive Therapy (TPT)
TPT is given to prevent breakdown of TB infection to TB disease.
Isoniazid Preventive Therapy (IPT)
INH is the drug currently used for TPT to prevent breakdown of TB infection to TB disease.
Currently IPT should be given after ruling out active TB disease in contacts of drug sensitive TB
patients who are aged 5 years or less and PLHIV (IPT in PLHIV is dealt in detail in TB and HIV
section of this module).

IPT in children:
Children are more susceptible to TB infection, more likely to develop active TB disease soon after
infection and are more likely to develop severe forms of disseminated TB. Children <6 years of
age, who are close contacts of a TB patient, should be evaluated for active TB by a medical
ofcer/ paediatrician. After excluding active TB, he/she should be given INH preventive therapy
irrespective of their BCG or nutritional status.

The dose of INH for preventive therapy is 10 mg/kg body weight administered daily for a
minimum period of six months. The INH tablets should be collected on monthly basis. During the
monthly collections, child should be closely monitored for TB symptoms to rule out active TB and
also assess for any INH related adverse effects.

INH preventive therapy should also be considered in following situations: -

• For all HIV infected children who either had a known exposure to an infectious TB case
or are Tuberculin skin test (TST) positive (>=5mm induration) but have no active TB
disease
• All TST positive children who are receiving immunosuppressive therapy (e.g. Children
with nephrotic syndrome, acute leukaemia, etc.).
• A child born to mother who was diagnosed to have TB in pregnancy should receive
prophylaxis for 6 months, provided congenital TB has been ruled out. BCG vaccination
can be given at birth even if INH preventive therapy is planned.

Asymptomatic Close contacts of DR-TB patients should be closely monitored for signs and
symptoms of active TB as isoniazid may not be prophylactic in them. Alternative prophylaxis
treatments have been suggested but there is no consensus regarding the choice of the drug(s)
and the duration of treatment. Prompt treatment of DR-TB in index case is the most effective way
of preventing the spread of infection to others.

Follow up of treatment
Patient should be closely monitored for treatment progress and disease response. There are two
components of follow up: Clinical follow up and Laboratory follow up

Clinical follow up
MO should clinically follow up for every patient at least monthly (patient visits the clinical facility
or the MO reviews during home visit). Improvement on clinical symptoms, increase in weight etc.
may indicate good prognosis. Control of comorbid conditions like HIV and diabetes by
appropriate treatment is essential for getting a better prognosis to TB treatment. Symptoms and
signs of adverse reactions to drugs should be specically asked for. Detailed description of
symptoms and signs of adverse reactions to anti-TB drug should be recorded in TB treatment
card.

100
Laboratory investigations for:
• assessing the prognosis of disease, monitoring the treatment and
• managing comorbidities or adverse reaction whenever needed.

In case of pulmonary tuberculosis, sputum smear microscopy should be done at the end of IP
(56th dose) and end of treatment (preferably when collecting the 108th dose of the CP, Patient is
given the sputum container for collecting the early morning sputum of the next day for the end of
treatment follow up sputum test or i.e., four doses before the last dose). CP will be initiated and
continued till completion. A negative sputum smear microscopy result at the end of IP may
indicate good prognosis. If Sputum result is positive at the end of IP, then CP will be initiated and
continued till the DST results are available and modied if warranted after the results of DST.

At completion of treatment, a sputum smear and/or culture should be done for every patient.
The follow-up sputum smear examination at the end of treatment is very important for
evaluating the results of treatment. However, in the presence of clinical deterioration, the
medical ofcer may consider repeating sputum smear microscopy even during CP. This will
provide the patient an additional opportunity to undergo drug susceptibility testing if s/he is
found to be sputum smear positive.

One sputum sample is to be collected, preferably early morning. If not available, supervised spot
sample can be collected. It must be ensured that the patients undergo the follow-up sputum
smear examination as scheduled and the last follow-up sputum examination is done before the
completion of the last dose of treatment.

The results of follow up sputum collected not later than two weeks of completion of treatment,
should be available as early as possible so that appropriate outcome for the patient can be given
in the TB Treatment Card.

Chest X-ray may be a good tool to assess the progress of clinically diagnosed TB case and it is to
be offered whenever required and available. For drug resistant TB, it may be carried out at end
of IP, end of treatment, and whenever required.

Response to treatment in extra-pulmonary TB may be best assessed clinically. Help of

radiological and other relevant investigations may be taken.

CBNAAT should not be done as a follow-up sputum examination

Discuss Nikshay ow

Response to treatment in children:

In children in their early ages are unable to produce sputum, the response to treatment among
them may be assessed clinically. Improvement should be judged by absence of fever or cough,
weight gain, etc. Clinical or symptomatic improvement is to be assessed at the end of the
intensive phase and at the end of treatment. The help of radiological and other relevant
investigations may be taken. Radiological changes may persist and may not correlate with
clinical improvement and hence should not cause concern.

For the monitoring of treatment in children who can produce sputum, follow-up sputum
examinations are to be performed with the same frequency as in adults. CBNAAT is not
appropriate follow up tool for monitoring the progress of the disease. Hence it should not be
used as a follow up test.

101
Long term follow-up:
After completion of treatment, the patients should be followed up clinically at the end of 6, 12,
18 & 24 months. In the presence of any clinical symptom, (e.g., cough) sputum microscopy
and/or culture of the biological specimen should be considered. This is important in detecting
recurrence of TB at the earliest.

Patient Provider Interaction

The following information regarding the disease and treatment should be provided to the
patient: -

• Diagnosis
• Cause and spread of disease
• Treatment related information
- Reassuring that TB is curable
- Importance of regular and complete treatment
- Importance of treatment being given under DOT.
- Duration of treatment, Intensive phase & Continuation Phase
- Adherence to follow-up schedules
- Early disappearance of symptoms is not a sign of cure, treatment to be stopped only
when advised by the treating physician.
- Treatment is available free of cost.

Other important issues:

• Diet/ DBT
• Cough hygiene and sputum disposal
• Provision of transfer facility during treatment
• Referral for HIV counselling and testing
• Smoking / alcohol abuse
• Comorbid conditions for example diabetes, renal failure, patient on
immunosuppressive drugs
• Sensitization on adverse reactions
• Importance of screening of close contacts and children aged5 years or less and
chemoprophylaxis

Information is to be provided at the treatment initiation and periodically during the treatment.
Patients are reassured that they are being provided effective, high-quality curative care. Patients
are encouraged to continue their treatment by drawing their attention to the gain in weight and
relief of symptoms. In NTEP, the patient is the VIP and should be treated accordingly.

Divulgence of TB diagnosis: Diagnosis should be revealed in such a way that patient neither
gets unduly perturbed nor takes it very casually. Patient should be reassured that TB is
completely curable provided the drugs are taken regularly as prescribed for the entire duration.
Patients will be informed that they continue to spread TB if they do not take treatment as
prescribed. Reassure them frequently that TB is curable.

Cause and spread of disease: Efforts should be made to clear the taboos associated with the
disease. It should be explained to the patient that TB is caused by Mycobacterium tuberculosis

102
through droplet infection from patient suffering from pulmonary tuberculosis. The disease
neither runs in the family (hereditary) nor is a curse.

Treatment related information:

DOT and its necessity: It is important for the patient to take the drugs under observation. The real
purpose of direct observation is to develop a human bond with the patient and not to
mechanically watch the patient swallow the drugs. Patients if given self-administered treatment
are likely to take it irregularly or discontinue the treatment upon relief of symptoms. DOT is not
because of suspicion about the patient but it is an expression of compassion and care for the
patient so that s/he completes the treatment, comes out of their own suffering and will not be
source of infection to the community. Early Disappearance of symptoms is not a sign of cure. It is
very important for the patient to know the duration of treatment and understand the necessity of
taking all prescribed drugs regularly.

Patient is also explained about the importance of sputum smear conversion at the end of two
months and at the completion of treatment and also about long-term follow up. Patient should
be made aware that treatment services are provided free of cost.

Diet: Health staff should advise patient on balanced diet and they can be told to take the food
they can afford and also about nutritional support systems available for the eligible patients.

Role of isolation and rest: Patient and family members are made to understand that once the
treatment is started, patient ceases to spread the infection and there is no need to isolate him in
terms of accommodation, use of utensils and clothes. However, patient should be advised to use
appropriate air-borne infection control measures and rest is required only if constrained by
physical weakness. Patient should be impressed that it is the treatment alone which cures.

Cough hygiene and sputum disposal: Patient should be educated in exercising the cough
hygiene- not resorting to indiscriminate coughing and spitting, and covering nose and mouth
while coughing or sneezing.

Provision of transfer facility during treatment: In case the patient wishes to shift or migrate
to other TU / district / state after the initiation of the treatment, patient should be informed that
there is a provision of transfer facility for treatment. Any such event should be duly informed to
the treating medical ofcer for completing the formalities for transfer and necessary
arrangement for further treatment.

Referral for HIV counselling and testing: All the patients diagnosed as TB cases should be
encouraged and referred to the nearest ICTC for HIV testing.

Comorbid conditions for example diabetes, renal failure, patient on immunosuppressive

drugs: History regarding the conditions mentioned above and any treatment for the same has to
be elicited as these conditions and treatment for the same may adversely interfere with the TB
Treatment. Patients are to be referred to the respective speciality and managed appropriately
depending upon the co-morbid conditions.

Adherence to follow-up schedules: The patients should be impressed upon the necessity of
complying with periodic follow-up sputum examination schedule as advised. This will help in
objective assessment of response to the treatment. Conversion to smear negativity is a
forerunner of successful treatment.

103
Sensitization on Adverse reactions: In case patients experience any unusual symptoms
after initiation / during treatment, they should be instructed to approach the medical ofcer
and report the same. On their own they should not take a decision either to stop or to
continue the drugs.

Smoking: It should be impressed upon the patient that smoking of tobacco will adversely affect
the treatment outcome. The patients should be protected from passive smoking. The
environment of the patient has to be smoke free at home / ofce and at clinic. Smoking status of
the TB patient should be checked at every interaction. The Medical Ofcer has to help the patient
with simple tips to quit smoking. However, if this does not yield any positive result, he should be
referred to the Tobacco cessation Clinic (TCC).

Alcohol abuse: History of addiction to alcohol should be elicited. If found alcoholic, the patient
should be advised to strictly refrain from alcohol as it would increase the chances of patient
developing hepatitis (Jaundice), irregularity in drug intake and adverse treatment outcome. The
patients should be encouraged to give up alcohol with the help of frequent motivation, family
and social support.

Importance of screening close contacts: Patients should be encouraged to bring

symptomatic adult contacts and all children aged ve years and below for screening at health
facility. This will facilitate early detection of cases among them and appropriate treatment.
Eligible children will be administered chemoprophylaxis.

Use the following documents as per the ow of the patients:

Maintenance of accurate records and registers of patients and programme activities; and
reporting data to the state/central unit, is essential for proper monitoring and management of
Revised National Tuberculosis Control Programme (NTEP). NTEP records and reports are
standardized and provide the required information for managing the programme effectively

Standardized Records
The following standardized records are used in the NTEP:

Forms Registers
• Referral Slip • Tuberculosis Laboratory Register
• NTEP Request form for examination of • NTEP Laboratory Register for
biological specimen for TB Examination CBNAAT and CDST
• Tuberculosis Treatment Card • Tuberculosis Notication Register
• NTEP PMDT Treatment Card • NTEP PMDT notication register
• NTEP TB Identity Card • Stock Register
• NTEP PMDT Treatment Book • Reconstitution Register
• NTEP Referral/ Transfer form
• NTEP PMDT Referral for treatment form
• aDSM treatment initiation form
• aDSM treatment review form
• TB Preventive Treatment Card

104
1. Referral slip This is used b peripheral health workers to refer patients to health facilities
where specimen is collected either for examination or transportation

2. NTEP Request form for examination of biological specimen for TB

The request form is kept at all the PHIs. It is lled generally by the MO of the referring health
facility. This form is used for microscopy or CBNAAT or culture DST or Chest X-Ray or TST. Only
one form is lled for each patient. Patient will report to the diagnostic health facility along
with the request form. In case PHI is a sputum collection centre, sputum samples are sent to
the diagnostic facility along with the request form. It is essential to record patient details,
reason for testing and type of test requested. The same form is sent back to the treating unit
with the results. When this format is used for C&DST, a copy of this form will be sent
electronically to lab and DTC. In turn, the laboratory will send the result in electronic copy
back to district with copy to DR-TB centre.

3. Tuberculosis Treatment card

Treatment card is lled at the PHI when patient is initiated on treatment. This card contains
important information about a patient, such as: Name, age, sex and address of the patient;
Type of disease; history of anti-TB treatment; Regimen prescribed; Duration of treatment;
Amount of drugs to be given; Results of investigation before and during treatment; Drugs
administered during the intensive and continuation phases of treatment; Treatment outcome
of the patient; Retrieval actions for missing doses; Adverse event, Preventive treatment for
children; details of X-ray or other tests for diagnosis of EP TB; information on TB comorbidity
and Remarks. It also has information on the treatment supporter, person conducting the
initial home visit and the signature of the MO. An additional treatment card should be kept, if
treatment supporter is not at health facility. In such cases, treatment supporter should be
trained on recording treatment card.

4. NTEP TB Identity Card

Identity card is completed for each patient who has a Tuberculosis Treatment Card. It is kept
with the patient. Information from the Tuberculosis Treatment Card is used to complete the
identity card. The front part of the ID card has patient information, name and address of the
TU/ district and treatment details of patient including disease classication, type of patient,
weight bands, smear results and information on the date of starting treatment. The back
portion of the ID card has the results of follow-up smear examination, appointment dates for
visits for drug administration and treatment outcome. This information will help to continue
treatment in case the patient is transferred, or admitted to any other health facility anytime
during the treatment period

5. NTEP PMDT notication Register

This register is maintained at each Nodal and District DR TB Centres level. Additionally, DTC is
expected to maintain an aggregate register only in those districts where more than one nodal or
district DR TBCs are functional. At each DR TB site working as District DR TB centre, all diagnosed
DR TB patients (H mono/poly, MDR/RR or XDR TB) from both public and private sector for which
the specimen was collected within the district should be entered in the list irrespective of location
of diagnosing facility (within or outside the district). Each episode based on diagnosis of
additional resistance requires a change in the regimen is entered in separate row against a new
episode ID with patient ID in remarks column. Senior DR TB and TB HIV supervisor of the
respective district is expected to coordinate with all NAAT sites, CDST labs and compile all the DR

105
TB patients diagnosed to enter it in PMDT notication register maintained at district level.
Information about DR TB patients notied from private sector can be extracted from Nikshay.
NDR TBC are also expected to update this register for the patients initiated on treatment at the
centre. As far as possible, patients should be entered consecutively by their date of diagnosis.
The following is recorded in the PMDT notication register

6. TB Notication register
A TB notication register is maintained at each peripheral health facility. This register contains
records of all patients diagnosed with TB and eligible for TB treatment, regardless of initiation of
treatment. It will also incorporate those cases initiated on rst line treatment and offered drug
susceptibility testing and results are awaited. The registration data is based on the date on which
a TB patient is diagnosed.

If patient is put on treatment in area of facility where s/he is diagnosed then information on
treatment and follow up is recorded in the same TB notication register. If patient is treated in
area other than where h/she is diagnosed then information on treatment and follow up is
recorded in TB notication register of health facility where patients is residing.

In each health facility, TB notication register is maintained by its staff. STS of the respective TB
units will support updation and coordination for completing the information.

For every patient, status of treatment should be recorded. The status of treatment for any patient
would be one of the following:
1. Initiated on First line treatment in the same Health Facility
2. Initiated on treatment outside Health Facility
3. Initiated on second line treatment in the same Health Facility
4. Treatment initiated outside NTEP
5. Incomplete/ incorrect address
6. Died
7. Migrated & untraceable
8. Refusal of treatment
9. Repeat diagnosis
10. Patient already on treatment/ Follow up patient
11. Wrong diagnosis
12. Referred for treatment with pending feedback
13. Other

7. Transfer form for treatment

It is to be used while transferring notied patients for treatment from one PHI to another. If a
patient is “transferred out”, this form needs to be lled and given to patient. If patient is already
on treatment, a copy of TB treatment card also is given.

The rst part of the form contains information about the patient, her/his disease, treatment
details and address of the transferring unit and his/her NIKSHAY ID. This information should be
used to complete a new TB treatment card for the patient.

When the patient has reported to the receiving unit, the bottom part of the form is completed by
the receiving unit and returned to the transferring unit. Patients follow up examination results at

106
the end of intensive phase and treatment outcome should be communicated to the
transferring unit.

8. IPT Card
IPT is given for a period of 6 months after ruling out TB.
IPT card need to be lled up in a manner the TB treatment card is lled up.

It has 5 sections, viz., demographic details of the patient and his treatment provider, treatment
section, details on drug adverse reaction including follow up and clinical details and ndings on
CXR and remarks section.

IPT Card can be utilised both for children and adults who receive IPT for any indication. Mark
ticke (0) similar to the way we tick for adult treatment and Zero (0) mark for the day the IPT is
missed. If the there is a missed dose/doses, missing doses should be made up at the end and the
total doses of IPT should be completed. Every time when there is a irregular intake and when
restart of IPT is planned and whenever clinically indicated the child/ patient should be
reassessed for active TB before restarting the IPT.

For every eligible patient for IPT, two cards will be opened by the treatment provider.
One card will be with the treatment provider and the other will be with the person
identied in the family (preferably, mother or father in case of child). The drugs for IPT
will be provided on monthly basis. The card at the centre will be updated by the
treatment provider on a monthly basis

107
Filling up of the treatment card
Treatment Card
Each patient who begins treatment for TB must have a tuberculosis treatment card. Original TB
treatment card should be kept at PHI and duplicate treatment card is to be given to the treatment
supporter for documentation of daily events. Information in the original TB treatment card is to
be updated fortnightly.

The information on the patient’s treatment card should be accurate, reliable, relevant, up to
date and legible as this would be the source of information for updating the TB notication
register and NIKSHAY. This card contains TB Notication No., Nikshay ID and name of State,
city/district/TB Unit where he/she belongs to.

This card contains other important information about patient, including the following details:

General information Data related to Treatment related

about patient treatment support information

• Name, Age, • TB unit with code • Disease classication and site

sex of the
• Name of the PHI • Type of patient
patient
• Basis of diagnosis
• Complete • Name, designation,
contact no. of • Details of Investigations for
address and
treatment supporter diagnosis and follow up
phone number
(ZN/FM/CBNAAT/Culture)
of the patient • DOT centre
with important • other investigations for diagnosis if
landmark • Initial home visit by any
whom (Name and
• Occupation & • Source of treatment
Designation) with
Socioeconomic date • Contact investigations
status
• Type of treatment • HIV, Diabetes and other
c Name, address adherence comorbidities related data
and phone • Addiction related information
number of the
contact person • Chemoprophylaxis for less than years
children Treatment regimen
• Drug intake in intensive and
continuation phase
• Retrieval actions for missed doses
• Adverse drug reactions
• Post treatment follow up
• Details of X Ray
• Nutritional support
• Treatment outcome with date
• Remarks

108
The Tuberculosis Treatment Card is maintained at health facility where the patient is initiated on
treatment. For patients receiving treatment in a DOT centre other than the place of treatment
initiation, a duplicate treatment card is prepared and maintained at the DOT centre by the DOT
provider. The original treatment card at the PHI is to be updated at least once in a fortnight.

General information of patient

Name: Full name of the patient with father/husband name is recorded (Id card/relevant
document may be referred to where available for correct spelling of the name)

Age and Gender: Age and sex of the patient is recorded. Estimated age is recorded if actual
age is not known.

Complete address and phone number of the patient: Complete address with land marks is
recorded which will facilitate in locating patient’s residence in case of interruption of treatment.
The same has to be veried at the time of initial home visit by the health worker. The telephone
numbers both landline and mobile of the patient, if available, are also to be recorded along with
the address.

Occupation of the patient: Occupation may be specied. If unemployed, the same may be
stated. Nature of occupation will help in arranging suitable DOT facility. For example, a truck
driver who needs to travel out for a long time, one of his colleagues can be made treatment
supporter.

Name, address and phone number of the contact person: Name and address of a person,
identied by the patient through whom patient can be contacted. A relative not from the same
household, community/tribal leader, village doctor, community volunteer, employer could be
contact persons. This person can be contacted in case the patient is not traceable following
interruption of treatment. Relationship of the contact person to the patient may be specied.

Data related to Treatment support

TB unit with code: Name of the TB unit and code allotted are recorded

TB Notication number: TB notication number generated in NIKSHAY at the time of

notication needs to be lled in treatment card.

Name of the PHI: Name of the PHI where the treatment is initiated is recorded.

Name, designation and contact number of treatment supporter: Designation of the

treatment supporter namely Anganwadi worker /staff nurse/ ANM/ Health Inspector / ASHA /
NGO /Health Visitor/ Laboratory technician/ Pharmacist / is indicated.

DOT centre: A place which is mutually convenient for the patient and treatment supporter
where Directly Observed Treatment can be administered is identied and the same is recorded.
For example, a PHI, sub-centre, shop, etc.

Initial home visit: Name and designation of the person undertaking the initial home visit. This
will ensure accountability and authenticity. Initial home visit will ascertain the reliability,
completeness of address and changes if any. It is necessary to conrm the residential status of
the patient from the neighbourhood. The details regarding the work place will also benet in
retrieving patient in case of interruption of treatment. During initial home visit, patient and
family members should be counselled and contact investigation should be carried out after
diagnosis and not later than a week of initiation of the treatment.

109
Type of treatment adherence – DOT / Family DOT with or without ICT: Treatment adherence
to regular and complete treatment is important for successful treatment outcome and relapse
free cure from TB. DOT is one of the best practices to promote adherence. For patients who are
unable to undergo supervised treatment, other ICT modalities can be utilized in that district.
Family members can be assigned role of treatment supporter can be instituted in case of
children, sick and bedridden patients etc.

Treatment related information

Disease classication: Box provided for pulmonary or extrapulmonary TB is ticked as the case
may be. If extra pulmonary, the site is specied. In patients having both pulmonary and
extrapulmonary TB, the box for the pulmonary is ticked and site of extrapulmonary is specied.

Type of patient- Box provided for new, Treatment after lost to follow up (LTFU), recurrent,
treatment after failure, others, previously treated, is ticked as the case may be.

Basis of diagnosis - Microbiologically conrmed or clinical TB may be ticked as appropriate.

Recording
Results of Investigation before and during treatment (ZN/FM/CBNAAT/culture): Date of
examination, DMC/lab conducting the bacteriological examination, Laboratory serial number
allotted, test results are recorded in the rows meant for pre-treatment, end of IP and at the end of
the treatment. Date of sample sent to culture & DST lab and DST results are to be entered in
appropriate row. Other investigations if any to be entered with date in the box provided.

This information is to be transferred from NTEP request form for examination of biological
specimen for TB to the treatment card.

History of previous anti TB treatment: Previously treated patients may require close
monitoring compared to new patients due to high risk for resistance. However, this information
is not used to decide the treatment regimen. Patients should be assured that revealing of facts
about previous history of treatment for TB is in their best interest. The medical ofcers should
impress upon the patients the importance of providing the complete facts, without any
apprehension of discrimination with regard to subsequent treatment. While eliciting the history,
emphasis should be given for ascertaining the following:

Previous history from patients Review of available record / documents

• Cough with expectoration • Sputum examination/Bacteriological
examination reports
• Blood in the sputum
• Chest X-ray reports / any other relevant
• Sputum examination/chest X-ray
reports /
examination
• Drug prescriptions
• Consuming drugs which turned urine
red/taken injections for >1 month • Empty blister packs/strips of anti TB
drugs
• Injections taken for a long duration
e.g. two months.

Source of treatment: Public or private box may be ticked as appropriate.

The previous regimen should also be mentioned.

110
HIV related data
This box is meant for recording information regarding the HIV status of the patient, and if
positive, details of CPT and ART being administered to be given.

Information on HIV status, CPT delivery and ART referral and initiation of the TB patient is to be
documented only in the original TB treatment card and must be kept condential within health
system. This should not be disclosed to the community treatment supporter.

1. HIV Status:
i. HIV testing is a voluntary procedure and not mandatory. Patients not willing for HIV
testing or sharing their HIV test result should not be forced to undergo testing or disclose
their HIV status.
ii. If HIV status of the patient is known, tick the appropriate box ('Reactive or 'Non-Reactive
{NR}) and record the date of test along with PID Number. If the HIV status is not known,
don't tick any box initially.
iii. Patients already on HIV care should not be required to show proof of HIV test result
iv. If the HIV status is ascertained during the course of TB treatment, the latest information
should be updated on the card.
v. If HIV status of the patient remains unknown at the end of the treatment, tick the
appropriate box ('unknown'), at the time of declaring treatment outcome for the patient.

2. CPT (Cotrimoxazole Prophylactic therapy) delivery

i. All known HIV-infected TB patients are to be provided access to CPT.
ii. Record dates of each monthly CPT delivery in the space provided.
iii. In case the TB patient is already on CPT before the initiation of TB treatment, record most
recent date of CPT pickup.

3. Referral and initiation on ART

1. All known HIV-infected TB patients are to be referred for ART to the nearest ART Centre.
2. If patient initiated on ART, tick the “yes” box, and the date of initiation of ART and ART
Registration Number should be recorded on the treatment card.
3. In case the TB patient is already on ART before the initiation of TB treatment, tick yes,
and record approximate date of initiation.

Diabetes related information

This box is meant for recording information regarding the Diabetes status of the patient
(unknown/Diabetic/Non-Diabetic). RBS and FBS value to be given. If patient initiated on Anti-
diabetic treatment (ADT), tick the “yes” box, and the date of initiation of ADT and ADT Number
should be recorded.

Other comorbidities if any should be mentioned.

Contact Investigation-
Record the number of household contacts less than 6 years age. Among these recorded
contacts, document the number of contacts screened, contacts with symptoms, contacts
evaluated, contacts diagnosed, and contacts put on treatment.

111
Chemoprophylaxis
Preventive chemotherapy with isoniazid (H) is administered to all the children aged 5 years and
below who are in contact with all forms of Drug sensitive TB case. The number of such children
residing in the household should be enquired during the initial home visit. The parents are
advised to bring children to the Health Centre for screening for the evidence of TB. They are
examined and investigated to rule out active TB disease. If found to be suffering from disease,
they should be treated appropriately. Children found eligible for chemoprophylaxis after ruling
out the TB are to be administered preventive chemotherapy with INH 10 mg/kg body weight
daily for 6 months.

The number of children aged5 years or less put on chemoprophylaxis should be mentioned.
Name, weight of the child and dose of INH should be recorded with tick mark in the appropriate
column for monthly delivery of INH.

Addiction related information

Details regarding tobacco and alcohol intake are recorded here. If current tobacco user,
mention whether smoking or smokeless and also link him/her to district tobacco control centre.

At the end of treatment, status of tobacco use should be documented.

If patient has history of chronic alcohol intake, whether linked to de-addiction centre.

Treatment Regimen
The MO of the PHI will initiate all patients who are sensitive to H & R and all patients whose H & R
status is not known on rst line anti-TB treatment. Date of initiation of IP and CP should be
recorded. Dosage frequency, drug formulations and drug packaging should be tick marked
appropriately. Relevant weight bands are to be tick marked in the boxes provided. Number of
FDC tablets to be taken per day needs to be mentioned. If patient is on loose drugs, the dosages
and pills against each drug needs to be mentioned in the box provided.

Administration and monitoring of treatment

Recording of drug administration and monitoring

The month and the year during which the patient is undergoing treatment are written under the
month and year column in the table. Last column is for recording weight of the patient each
month.

A tick mark '(√)' is recorded in the appropriate box (according to the dates of the month 1 – 31 as
the case may be) to indicate the day the drugs were consumed under direct observation.

Missed dose, is denoted by a circle (0) in the appropriate box.The entry for unsupervised doses
should be recorded by encircling the tick mark on the TB Treatment Card

Each row is for recording whether dosages taken under observation or not, and also the
interrupted doses against each month.

The continuation phase should always start from fresh row.

Intensive phase
Month and year

112
Month and year of initiating the intensive phase is recorded.
Date of initiation of treatment- The date of initiation of IP of treatment regimen prescribed is
ticked () on the appropriate box under the date against the month. Then with every daily dose
consumed a tick mark is placed in the against that date.

The date/day (for example on 10thApril) on which patient fails to attend for DOT, and interrupts
the dose, is denoted by a circle (0) in the appropriate box and effort should be made to retrieve
the patient. In case, the patient visits the health facility the next day (for example on 11th April),
the drugs interrupted are administered on that day and continues the treatment as scheduled,
however, it should be ensured that patient completes 56 doses of IP before transiting into CP.

Month 1 2 3 4 5 6 7 8 9 1 1 1 1 1 1
/ 0 1 2 3 4 5
year
April
ü ü ü ü ü ü ü ü ü 0 ü ü ü ü ü
17

On Sunday, treatment will be unsupervised and marked as tick with in the circle
Only under exceptional circumstances unsupervised drug administration can be allowed for a
limited number of doses. For instance, if a patient is being discharged from hospital after
initiation of treatment, s/he will have to be provided with maximum 7 doses of treatment so that
her/his treatment does not get interrupted during her/his transfer to a nearby PHI. In such
circumstances, the entry for unsupervised doses should be recorded by encircling the tick mark
on the TB Treatment Card and the reason for the same should be stated in the Remarks column
of the treatment card.
Month 1 1 1 1 1 2 2 2 2 2 2 2 2 2 2 3 3
/ 5 6 7 8 9 0 1 2 3 4 5 6 7 8 9 0 1
year

April ü
ü ü ü ü ü ü ü ü ü ü ü ü ü ü ü
10

Continuation phase
Month and year
Month and year of initiating the continuation phase is recorded.
The date of initiation of CP of treatment regimen prescribed is ticked (√) on the appropriate box under
the date against the month in the fresh row of the box provided in treatment card, as given below.

Month 1 2 3 4 5 6 7 8 9 1 1 1 1 1 1
/ 0 1 2 3 4 5
year

April
ü ü ü ü ü ü ü
17
April
17 ü ü ü ü ü ü ü ü

113
During the continuation phase of treatment, patient is administered the drugs on daily basis
under direct observation.

The recording of doses taken is similar to as in IP. The total of 112 doses of CP should be
completed before declaring treatment outcome. In some circumstances where CP is
extended by 12 to 24 weeks, the treatment outcome should be declared after completion of
all the prescribed doses.

Monitoring of drug administration can be done by comparing the stock of drugs available in the
strips with the dosages given and marked in the Tuberculosis Treatment Card. Any observed
variation should be looked into and remedial measures taken.

Retrieval actions in interruptions of treatment

In case of interruption of treatment, health staff should visit the patient at his home. Reason for
interruptions should be reviewed carefully and efforts made to bring the patient back for
treatment. This should be done by the treatment supporter not later than the day after the
patient was due to come for treatment irrespective of whether the patient is in IP or CP. It is very
important to take prompt action after knowing that the patient has missed the dose. Delays in
retrieval actions can lead to irretrievable loss of the patient for treatment.

If a patient does not take medication as scheduled in IP or CP, s/he should be traced and given
the medication as per regular schedule and complete total of 56 doses of IP/112 doses of CP.

If the treatment supporter is not successful in retrieving such patients, it should be reported to
next higher level of supervisors (e.g. MPW, STS, etc.) and take all efforts to retrieve the patient. If
the patient interrupts treatment on two occasions, MO-PHI should visit the patient’s home. The
MO-PHI can review the reasons for the same, give intensive counselling to the patient and may
provide additional support to continue the treatment without interruption.

Despite all efforts, if the patient does not return for treatment after interrupting the treatment for
continuous 1 month or more, the outcome of treatment should be recorded as “Lost to follow up”
and the reason should be mentioned in the “remarks” column of the treatment card and the
drugs should be returned to the PHI.

Recording of Retrieval actions

Action taken to retrieve patients interrupting treatment has to be recorded in the space provided
on the reverse of the treatment card with details of date, name of the health staff taking retrieval
action, person contacted, reasons for interruption and the outcome of such efforts.

The number of doses to be administered must be strictly adhered to.

In DOT centres with large numbers of patients, Tuberculosis Treatment Cards should be
organized according to the day of scheduled drug administration and the phase of treatment.
After the patient consumes the medication under direct observation, the Tuberculosis Treatment
Card should be updated and placed behind the divider for the next observation. In this manner,
the Tuberculosis Treatment Cards of patients who do not present for treatment will be apparent
on the same day, facilitating appropriate retrieval action of patients.

Recording of Adverse events

Adverse events must be recorded in the space provided on the reverse of the treatment card with
details of date of event, symptoms of event, action taken, duration of management of adverse
event and outcome of adverse event.

114
Post-treatment Follow-up for clinical & sputum examination
Clinical, sputum examination and chest X ray ndings with impression should be recorded
against each scheduled follow up at 6, 12, 18- and 24-months post treatment.

Details of Chest X-ray:

This space is provided on the bottom of reverse side of the treatment card for recording chest x-
ray ndings.

Nutritional support
Details of nutritional support given to the patient needs to be recorded in the space provided.

Bank Details
Information regarding bank details entered in Nikshay should be mentioned as ‘Yes’ or ‘No’

Remarks
The following information has to be recorded in the remarks box on the bottom of reverse side of
treatment card:
• Reasons for unsupervised dose(s)
• Reason for interruption (e.g. Migrated, patient transferred to another district, etc.)
• Details of hospitalization if any during the treatment
• Information on dispatch of sputum for culture & drug sensitivity test
• Any other relevant information about the patient such as pregnancy status, cause of
death in case the outcome is “died” etc.

Determination of treatment outcome with date

There are seven possible treatment outcomes –viz., Cured, treatment Completed, Lost to follow-
up, Failure, Died, Not evaluated and Treatment regimen changed. Determination of treatment
outcome depends upon:
- Type of patient
- Recording of drug administration
- Follow up sputum smear results
- DST Reports
- Recording in remarks column

The relevant outcome along with the date is recorded in the line provided for this on the reverse
of the treatment card. A patient will have only one outcome at a time.

For determination of ‘Cure’ and ‘Treatment completed’, the date of outcome is the date on
which the last dose was taken in the CP.

For the determination of date of outcome in cases of Failure, the date on which the sputum was
found to be positive at the end of treatment is taken as date of outcome.

For ‘Lost to follow-up, ‘the date of interrupting treatment is taken as a date of outcome. For
‘Died’ on which the event occurred is taken as a date of outcome.

If patient on treatment cannot be given any of these outcomes, he is considered as ‘Not

Evaluated’.

115
The treatment outcome has to be recorded on the Treatment Card, NIKSHAY and in the TB
Notication register within one month of the event. Declaration of the treatment outcome has to
be decided upon and signed with date by the MO.

Treatment outcomes for drug susceptible TB Patients

1. Cured: Microbiologically conrmed TB patients at the beginning of treatment who was
smear or culture negative at the end of the complete treatment

2. Treatment completed: A TB patient who has completed treatment without evidence of

failure or clinical deterioration BUT with no record to show that the smear or culture results of
biological specimen in the last month of treatment was negative, either because test was not
done or because result is unavailable.

E.g. A microbiologically conrmed patient who has completed treatment with positive smear at
the end of IP but no resistance to H and R detected or with negative smears at end of the intensive
phase, but none at the end of treatment, the outcome is declared as treatment completed.

or

A clinically diagnosed patient, pulmonary or EP, who has received full course of treatment with
no positive smear or culture at the end of treatment.

3. Failure: A TB patient whose biological specimen is positive by smear or culture at end of

treatment.

Failure to Respond: A case of paediatric TB who fails to have microbiological conversion to

negative status or fails to respond clinically / or deteriorates after 12 weeks of compliant
treatment shall be deemed to have failed response provided alternative diagnosis/ reasons for
nonresponse have been ruled out.

4. Lost to follow up: A TB patient whose treatment was interrupted continuously for ONE
month or more.

5. Not Evaluated - A TB Patient for whom no treatment outcome is assigned. This includes
former “transfer-out”

6. Treatment Regimen Changed - A TB patient who is on rst line regimen and has been
diagnosed as having DRTB and switched to drug resistant TB regimen prior to being declared as failed.

7. Died: A patient who has died during the course of anti-TB treatment.

Treatment Success: TB patients either cured or treatment completed are accounted in

treatment success. It is an indicator and not an outcome.

116
Determination of date of treatment outcome

A patient will have only one outcome. The outcome which occurs rst is considered and recorded
in treatment card and subsequently in the TB notication register and NIKSHAY. Outcome
should be declared within one month of the event.

Management of patients with treatment interruptions

The factors to be considered for the management of interruptions are
i. Type of case – Whether new, relapse or failure etc case
ii. Duration of treatment taken: Less than one month / more than one month.
This helps in assessing the risk of presence of drug resistance.
iii. Duration of Interruption: Less than one month / more than a month.
If it is more than one month, patient is to be declared the outcome as ‘lost to follow up’. If patient
returns the health facility after interrupting treatment for more than one month, patient sample
needs to be subjected for DST to determine resistance/sensitive status to anti TB drugs.
In case interruption is for less than one month, continue same treatment regimen to complete all
doses.

117
118
119
Death audit:
The medical ofcer should conduct an in-depth audit of all the deaths occurring amongst the TB
patients irrespective of initiation of treatment. Similarly, DTO should conduct death review of all
MDR-TB patients died. This would be benecial in understanding the causes leading to the
deaths and guide the programme in taking appropriate action to prevent them.

Prevention and management of Adverse Drug Reactions to Anti-TB drugs

Most TB patients on rst line drugs complete their treatment without any signicant adverse
drug effects. However, a few patients do experience adverse effects and some of the drugs
induced side effects can be prevented. Moreover, many second line drugs are associated with
more side effects during long duration of treatment. It is therefore important that patients be
clinically monitored during treatment so that adverse effects can be detected promptly and
managed properly.

Treatment supporter should be aware of the commonly occurring adverse reactions so that they
can identify it promptly and refer the patient to the medical ofcer for further management. Any
adverse reactions reported during treatment is recorded in the space provided for ADR in the
treatment card. Orange / red discoloration of the body uids especially urine which is commonly
encountered is not an adverse reaction and patient should be made aware of this.

All health personnel should monitor patients about adverse drug effects and inform patients to
report to health system in case of any side effects. Health care workers need to be informed and
trained about the methodology and channels for reporting ADRs

Adverse effects of Anti-TB drugs

Anti-TB treatment with rst-line drugs is generally safe and well tolerated. Side effects to anti-TB
drugs are common. Trivial side effects may lead to reduced compliance with treatment. These
adverse effects must be recognized early, to reduce associated morbidity and mortality.

Side effects of rst line anti-TB drugs:

Drug Main effects Rare effects

Isoniazid Peripheral neuropathy Convulsions
Skin rash Psychosis
Hepatitis Arthralgia
Sleepiness and lethargy Anaemia

Rifampicin Gastrointestinal: abdominal pain, Osteomalacia

nausea, vomiting Pseudomemberanous colitis
Hepatitis Pseudoadrenal crisis
Generalised cutaneous reactions Acute renal failure
Thrombocytopenic purpura Haemolytic anaemia
Pyrazinamide Arthralgia Cutaneous reactions
Hepatitis Sideroblastic anaemia
Gastrointestinal
Ethambutol Retrobulbar neuritis Generalised cutaneous reactions
Arthralgia
Peripheral neuropathy
Hepatitis (very rare)

120
 Streptomycin • Allergy –severe fever
• Burning or tingling sensation
• Vertigo
• Nausea and vomiting
• Difcult or painful urination
• Blurred or double vision
• Hearing impairment - SEVERE
• Fast/irregular heart beat

Management of ADRs:
What to do if symptoms of adverse effects occur? If symptoms of ADRs occur, the following
should be done: -
• The dose of drugs should be checked
• All other causes of symptoms should be excluded
• The seriousness of the adverse effects should be estimated
• The adverse effects should be registered
• The drugs may need to be stopped and should eventually be reintroduced gradually
when symptoms disappear
• Development of drug resistance should be avoided

A symptom-based approach to the management of the most common adverse effects is

adopted. These side effects are classied as major or minor. In general, a patient who develops
minor adverse effects should continue TB treatment and be given symptomatic treatment. If a
patient develops a major side effect, the responsible drug or the entire regimen may need to be
stopped and the patient should be urgently referred to a clinician or health care facility for
further assessment and treatment. Patients with major adverse reactions should be Managed in
a hospital with sufcient infection control measures and expertise. In DR TB patients, the DR TB
committee needs to be involved in the management and modication of the regimen if required.

Symptom-based approach to evaluation of possible side effects of anti-TB drugs

Symptom Drug (abbreviation) Action to be taken Action to be taken

by HW by MO
Gastrointestinal Any oral medication Reassure patient. Maintain hydration
(vomiting or Give drugs with less
epigastric water and over a Consider treatment
discomfort) longer period of time with anti-emetics (e.g.
(e.g. 20 minutes). Do domperidone) and
not give drugs on an proton pump
empty stomach inhibitors (e.g.
Omeprazole)
If the above fails,
refer to MO

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Itching/Rashes Isoniazid (and other Reassure patient Itching without rash
drugs also) or a mild rash
If severe, stop all
drugs and refer • Continue treatment
patient to MO and give
antihistamines

Itching with moderate

to severe rash

• Stop all drugs till

symptoms subside

• Treat with
antihistamines

• Patients with
mucosal
involvement, fever
and hypotension
will require
treatment with
corticosteroids

• When the reaction

subsides
reintroduce drugs
one by one in this
order

INH. Rifampicin
Pyrazinamide
Ethambutol

• Re-introduce each
drug in a small
dose and gradually
increase over 3
days before
introducing the
next drug.

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Tingling/burning Isoniazid Refer to MO • Give pyridoxine
/numbness in the 100 mg/day orally or
hands and feet parenterally until
symptoms subside.

Patients not
responding to
pyridoxine will require
treatment with
amitryptiline

Joint pains Pyrazinamide Reassure that it is a • Give NSAIDs like

self-limiting condition. paracetamol,
Aspirin or
Encourage patients to ibuprofen and in
increase intake of severe cases
liquids. Indomethacin for a
If severe, refer patient week to 10 days
to MO for evaluation • In severe cases
estimate serum uric
acid levels

- If uric acid levels

are signicantly
raised treat with
NSAIDs and
colchicine.
Allopurinol is not
effective

In severe cases with

normal or slightly
elevated uric acid
consider reduction of
the dose of
Pyrazinamide.

Impaired vision Ethambutol STOP • Refer to

ophthalmologist for
Ethambutol, refer evaluation
patient for evaluation
• Impaired vision
may, within a few
weeks, or may not
return to normal
after stopping
ethambutol. Don’t
restart ethambutol.

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Ringing in the Streptomycin STOP • Refer to oto-rhino-
ears Loss of Streptomycin, refer laryngologist for
hearing patient for evaluation opinion
Dizziness and • As hearing loss is
loss of balance usually not
reversible do not
restart Streptomycin

Hepatitis: Isoniazid, Rifampicin STOP all anti TB drugs, • Rule out other
Anorexia / or Pyrazinamide Refer patient for causes of hepatitis
Nausea / evaluation • Do not restart
vomiting / treatment till
Jaundice symptoms resolve
and liver enzymes
return to baseline
levels
• If liver enzymes
cannot be
performed wait for
2 weeks after
jaundice has
disappeared to
restart treatment
• Restart treatment
with one drug at a
time starting with
Rifampicin INH
Pyrazinamide.
• In patients with
severe disease in
whom treatment
cannot be stopped
use a non-
hepatotoxic
regimen consisting
of Streptomycin
and Ethambutol

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Pharmacovigilance in TB control Programme
Pharmacovigilance is dened by the 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 activity to inform the management of patient safety measures in health care.

Pharmacovigilance is a public health surveillance activity. There are 3 methods for reporting on
Pharmacovigilance activities: -
1. Spontaneous reporting
2. Targeted reporting
3. Active surveillance

• Spontaneous reporting: -Spontaneous (or Voluntary) reporting means that no active

measures are taken to look for adverse effects other than encouragement of the health
professionals and others to report safety concerns. Reporting is entirely dependent on
the initiative and motivation of the potential reporters. This is the most common form of
pharmacovigilance, sometimes termed passive reporting.

• Targeted reporting: -It focuses on capturing ADRs in a well-dened group of patients

on treatment. Health professionals in charge of the patients are sensitized to report
specic safety concerns.

• Active surveillance: - It is a pro-active effort made to elicit adverse events. Events

detected by asking patients directly, screening patient record as, laboratory and clinical
tests. It is best done prospectively.

Need for Pharmacovigilance

NTEP has a strong monitoring mechanism but information on ADRs is lacking (Indian database).
There is minimal information from private sector. The mortality, morbidity and reduced quality of
life associated with ADRs are poorly documented. Anti-TB drugs used for drug-resistant TB are
commonly associated with ADRs. In TB-HIV patients, use of anti-retroviral drugs along with anti-
TB drugs is associated with ADRs. Pharmacovigilance will help in understanding and detecting
ADRs associated with newer drugs to treat TB (Bedaquiline, Delamanid). To strengthen patient
safety, safeguard patient’s interest and ensure adherence to prescribed drug regimens.
Antimicrobial resistance

For details “A practical handbook on the pharmacovigilance of medicines used in the treatment
of Tuberculosis” by WHO in 2012 may be referred. Under the Pharmacovigilance Programme of
India (PvPI) set up by the Ministry of Health and Family Welfare, Govt. of India in July 2010
routine reporting and monitoring of ADRs will be continued.

Priority is given to establishing pharmacovigilance at DR-TB centres for drug resistant cases. The
DR-TB centres would be linked with ADR monitoring centres established under PvPI in medical
colleges to initiate reporting of ADR in systematic manner. With introduction of daily anti-TB
treatment regimen priority will be given to establish Pharmacovigilance at ART centres for TB-
HIV patients. The standardized suspected ADR reporting form (Annexure-11) and needs to be
lled by the treating doctor.

125
126
Management of Hospitalized patients:
The usual mode of TB treatment is domiciliary, but patients require hospitalization in the
following conditions:
• pneumothorax or
• large accumulations of pleural uid leading to breathlessness
• massive hemoptysis etc. the patients might need hospitalization.
• In case of severe adverse reactions
• Severe malnutrition

These patients can be managed in general hospitals preferably in wards where adequate air
borne infection control measures are taken to prevent the spread.

All indoor patients who are found to be suffering from TB are to be treated with same NTEP
regimen. The DOTS Centre of the respective hospital/Medical College must be informed of the
patient’s admission at the earliest, to enable transfer out of the patient to their respective DOTS
Centre on discharge.

If the hospitalized patient is newly diagnosed, he/she should be notied. Once these patients go
back, the peripheral health workers and NTEP staff should conduct home visits within a week. If
transferred for treatment, the follow up results and treatment outcome should be sent back to
the referring PHI/TU and updated in Nikshay. On discharge, patients may be given a maximum
of 1-week drug supply to cover the transit period prior to their resumption of treatment at their
respective DOT Centre, ensuring uninterrupted treatment.

127
Management of Extrapulmonary TB patients
The burden of EPTB ranges from 15-20% of all TB cases in HIV-negative patients while among
PLHIV, it accounts for 40-50% of new TB cases. Every attempt should be made to establish
microbiological conrmation of EPTB wherever specimen is available. All EPTB patients should
be offered CBNAAT upfront for diagnosis which will also help in detection of a greater number of
drug-resistant EPTB cases in the country. All EPTB patients should be screened for HIV. All
patients suspected of EPTB should have clinical assessment for active Pulmonary TB also.

The treatment regimen and schedule for EP TB cases will remain the same as for pulmonary TB.
However, the duration of continuation phase in EPTB may be extended by 3 to 6 months in
special situations like TB meningitis, Bone & Joint TB, Spinal TB with neurological involvement
and neuro- tuberculosis. Unless drug resistance is suspected, adjuvant corticosteroid treatment
is recommended for TB meningitis and pericarditis.

Although sometimes required for diagnosis, surgery plays little role in the treatment of
extrapulmonary TB. It is reserved for management of late complications of disease such as
hydrocephalus, obstructive uropathy, constrictive pericarditis and neurological involvement
from Pott’s disease (spinal TB). For large, uctuant lymph nodes that appear to be about to drain
spontaneously, aspiration or incision and drainage appear benecial.

Same outcome denitions would be used as for drug sensitive /drug resistant Pulmonary TB
patients, treatment outcome of treatment completed will be considered. Treatment outcome will
depend on availability of culture reports of specimens, treatment completion and clinical
improvement of the patient.

For further details on management of EPTB, refer to Index-TB guidelines on management of

EPTB. There are 10 key principles for managing EPTB patients as described in Index-TB guidelines
on management of EPTB.

Follow up
a. Clinical Follow up: it is the most important criteria for the follow up of patients with
Extra-pulmonary TB. The follow up is mainly based on following clinical parameters. -
• Weight Gain
• Decrease or increase in symptoms (e.g. healing of ulcer/scrofuloderma)
• Increase or Regression in size of nodes {possibility of Immune Reconstitution
Inammatory Syndrome (IRIS) should be considered and differentiated from disease
progression}
• Appearance of new nodes
• If chest symptomatic, monthly sputum for AFB and chest X-ray (to rule out pulmonary
involvement)
• Other Extra-pulmonary sites should be monitored (USG abdomen if necessary)
• Serum Creatinine – monthly for the rst three months of treatment and then quarterly
till the patient receives Kanamycin and further when clinically indicated
• Liver function test – as clinically indicated
• USG-abdomen – if necessary
• Monitoring for drug adverse reactions

128
b. Bacteriological Follow up: it should be done as per schedule, whenever specimen is
available.

Management of TB patients in special situations

TB in Pregnant and Lactating women
Before initiating treatment for tuberculosis, women of childbearing age should be asked about
current or planned pregnancy and counselled appropriately. A successful treatment of TB is
important for successful outcome of pregnancy. Except for streptomycin, the rst line anti-TB
drugs are safe for use in pregnancy. Streptomycin is ototoxic to the fetus and should not be used
during pregnancy.

A breastfeeding woman should receive a full course of TB treatment. Correct chemotherapy is

the best way to prevent transmission of TB to baby. Breast feeding must be continued. After
ruling out active TB, the baby should be given 6 months of isoniazid preventive therapy, Breast
feeding should not be discouraged. The mother should be advised about cough hygiene
measures such as covering the nose and mouth while coughing, sneezing or any act which can
produce sputum droplets.

Mothers receiving INH and their breastfed infants should be supplemented with vitamin B6
(pyridoxine), recommended dose of Pyridoxine in infants is 5 mg/day and for mother is
10mg/day

TB and Contraceptive pills usage

As Rifampicin is a potent inducer of hepatic enzymes, the protective efcacy of oral contraceptive
pills may be decreased. Oral contraceptives might have decreased efcacy due to vomiting and
drug interactions with second line anti-TB drugs. Hence, women suffering from TB and using
contraceptive pills should be advised to use alternative contraception method.

Patients with mono- and poly-resistant TB who are susceptible to rifampicin, rifampicin interacts
with the contraceptive drugs resulting in decreased efcacy of protection against pregnancy. A
woman on oral contraception while receiving rifampicin treatment may choose between two
options following consultation with the treating physician:
• Use of an oral contraceptive pill containing a higher dose of estrogen (50 /g)
• Use of another form of contraception.

Methods that can be used for contraception, based on individual preference and eligibility
• Barrier methods (Condoms/ diaphragms)
• IUDs (CuT)
• Depot medroxy-progesterone (Depo-provera)

Management of TB in patients with liver disorders

• Patients with hepatitis virus carriage, a past history of acute hepatitis, current excessive
alcohol consumption can receive the usual TB regimens provided that there is no clinical
evidence of chronic liver disease.
• Hepatotoxic reactions to anti-TB drugs may be more common
• In patients with unstable or advanced liver disease, liver function tests should be done at
the start of treatment.
• If the liver disorder is severe, lesser hepatotoxic drugs have to be used.
– Expert consultation is advisable in treating patients with advanced or unstable
liver disease.

129
 • Clinical monitoring (and liver function tests, if possible) of all patients with pre-existing
liver disease should be performed during treatment.
• If the serum alanine aminotransferase level is more than 3 times normal before the
initiation of treatment, the following regimens should be considered:
– Containing two hepatotoxic drugs:

• 9 months of isoniazid and rifampicin, plus ethambutol (until or unless isoniazid

susceptibility is documented)- 9HRE
• 2 months of isoniazid, rifampicin, streptomycin and ethambutol, followed by 7 months
of isoniazid and rifampicin-2SHR/ 7HR
• 6–9 months of rifampicin, pyrazinamide and ethambutol-(6-9 RZE)
– Containing one hepatotoxic drug:

• 2 months of isoniazid, ethambutol and streptomycin, followed by 10 months of

isoniazid and ethambutol (2SHE/10 HE)
– Containing no hepatotoxic drugs:

• 18–24 months of streptomycin, ethambutol and a uoroquinolone. (18-24 SLE)

TB patient with renal failure and severe renal insufciency

• Patients suffering from Chronic Kidney diseases (CKD) are at an increased risk of
developing Tuberculosis.
• Active TB should be excluded in patients with CKD by appropriate investigations in
patients who have an abnormal chest x-ray or a history of prior pulmonary or EPTB that
has been either inadequately or not previously treated.
• TB should be considered in all patients with unexplained systemic or system-specic
symptoms as EPTB is common, particularly in patients on dialysis, with peritoneal TB
being common in patients on chronic ambulatory peritoneal dialysis.
• Any patient with active TB, either pulmonary or extrapulmonary, should receive
standard chemotherapy agents, albeit with dose interval modications where
appropriate.
• Isoniazid and rifampicin are eliminated by biliary excretion, so no change in dosing is
necessary.

There is signicant renal excretion of ethambutol and metabolites of pyrazinamide, and doses
should therefore be adjusted
• For patients with stages 4 and 5 Chronic renal disease and on haemodialysis, dosing
intervals should be increased to three times weekly for ethambutol, pyrazinamide and
the aminoglycosides.
• Treatment can be given immediately after haemodialysis to avoid premature drug
removal. With this strategy there is a possible risk of raised drug levels of ethambutol
and pyrazinamide between dialysis sessions.

Alternatively, treatment can be given 4 to 6 hours before dialysis, increasing the possibility of
premature drug removal but reducing possible ethambutol or pyrazinamide toxicity. Three
times per week administration of these two drugs at the following doses is recommended:
pyrazinamide (25 mg/kg), and ethambutol (15 mg/kg). These doses are the ones used in
daily regimens.

130
Estimated creatinine clearance calculations
• Men:
– Ideal Body Weight (kg) X (140 – age) / 72 X serum creatinine (mg/dl)

• Women:
– 0 85 X Ideal Body Weight (kg) X (140 – age) / 72 X serum creatinine (mg/dl))

Dose adjustment of anti-TB drugs in presence of renal impairment

*Companion Handbook to the WHO guidelines for the programmatic management of drug-
resistant tuberculosis 2014. (30)
Estimated creatine calculations:
Men: Ideal body weight (kg) x 140-age) / 72 x serum creatinine (mg/dl)
Women: 0.85 x ideal Body Weight (kg) x (140-age) / 72 x serum creatine (mg/dl)

131
TB in patients with seizure disorders
• The use of isoniazid and rifampicin may interfere with many of the antiseizure
medications.
• High dose isoniazid also carries a high risk of seizure and should be avoided in patients
with active seizure disorders.
• The prophylactic use of oral pyridoxine (vitamin B6) can be used in patients with seizure
disorders to protect against the neurological adverse effects of isoniazid or cycloserine.
• Suggested prophylactic dose
– for at-risk patients on isoniazid is 10 to 25 mg/day
– for patients on cycloserine is 25 mg of pyridoxine for every 250 mg of cycloserine daily.
• The optimal prophylactic dose of pyridoxine for children has not been established,
– 1–2 mg/kg/day has been recommended with a usual range of 10–50 mg/day for
paediatric patients at risk for neurological sequel.

Latent Tuberculosis Infection (LTBI)

• Latent tuberculosis infection (LTBI) is the presence of Mycobacterium tuberculosis in the
body without signs and symptoms, or radiographic or bacteriologic evidence of
tuberculosis (TB) disease. Studies have demonstrated that Isoniazid (INH) taken for at
least 6 months in persons with LTBI reduced subsequent TB incidence by 25 to 92 per
cent, the differences in effectiveness largely explained by differences in treatment
completion. Refer to the recently updated WHO guidelines for management of LTBI in
the year 2018. (Latent TB infection: updated and consolidated guidelines for
programmatic management).

• India, with one-fourth of the global burden of TB, has 40 per cent of the population
infected with M.TB. Treating 40 per cent of the population for LTBI based on Tuberculin
Skin Test (TST) positivity or Interferon Gamma Release Assay is neither rational nor
practicable, thus emphasizing the need for a focussed approach. In clinical situations,
the most obvious group for LTBI treatment would include high-risk patients such as those
receiving long term corticosteroids, immunosuppressants, HIV-infected and juvenile
contacts of sputum-positive index cases.

Differentiating Between Latent TB Infection and TB Disease

LTBI TB Disease
• No symptoms or physical ndings • Symptoms may include one or more of the
suggestive of TB disease. following: fever, cough, chest pain, weight loss,
• TST or IGRA result usually night sweats, haemoptysis, fatigue, and decreased
positive. appetite.
• Chest radiograph is typically • TST or IGRA result usually positive.
normal. • Chest radiograph is usually abnormal. However,
• If done, respiratory specimens are may be normal in persons with advanced
smear and culture negative. immunosuppression or extrapulmonary disease.
• Cannot spread TB bacteria to • Respiratory specimens are usually smear or culture
others. positive. However, may be negative in persons with
• Should consider treatment for extrapulmonary disease or minimal or early
LTBI to prevent TB disease. pulmonary disease.
• May spread TB bacteria to others.
• Needs treatment for TB disease.

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TB Comorbidities
Several medical conditions are risk factors for TB and poor TB outcomes. Similarly, TB can
complicate course of some diseases. It is therefore important to identify these comorbidities in
people diagnosed with TB and manage both the conditions in order to ensure early diagnosis
and improved outcome.

TB and HIV
The primary impact of HIV on TB is that the risk of developing TB becomes higher in patients with
HIV. Overall, HIV-infected persons have approximately an 8-times greater risk of TB than
persons without HIV infection. The risk of TB in HIV-infected persons continues to increase as HIV
disease progresses and CD4 cell count decreases. While anti-retroviral treatment can
substantially decrease the risk of TB, this risk always remains higher than that in HIV negative
individuals. Furthermore, among cured TB survivors with HIV infection, the risk of recurrent TB is
also quite high.

Similarly, Tuberculosis is the most common opportunistic infection amongst HIV-infected

individuals. It is a major cause of mortality among patients with HIV and poses a risk throughout
the course of HIV disease.

The presentation of TB in the HIV-infected patient may vary with degree of immune suppression.
The diagnosis of TB in PLHIV can be more difcult and may be confused with other pulmonary or
systemic infections. As the HIV disease progresses and the individual become more immune-
compromised, the clinical presentation is proportionately more likely to be extra-pulmonary or
smear-negative than in HIV-uninfected TB patients. This can result in misdiagnosis or delays in
diagnosis, and in turn, higher morbidity and mortality.

It is estimated that there are 2.14 million people living with HIV in India with an estimated (2017
report)Adult, 15-49 years, HIV prevalence in India of 0.22% (0.16% – 0.30%).TB accounts for
25% of deaths among People Living with HIV and AIDS (PLHIV) in India. Although only 5% of
incident TB patients are HIV-infected, in absolute terms it means more than 100,000 cases
annually, ranks second in the world and accounts for about 10% of the global burden of HIV-
associated TB. HIV positivity among PLHIV varies from states /districts in the country, the
proportion of HIV positive among TB patients over 10% in high HIV burden states to up to 40% in
some high burden districts.

HIV Testing for TB Patients / Presumptive TB Cases

1. National HIV counselling testing services guidelines (HCTS), 2016 and WHO consolidated
guidelines on HIV, 2015 recommend offering routine HIV testing to all presumptive and
diagnosed TB cases, partners of known HIV positive TB patients, decentralization of HIV testing
facilities, task sharing & multitasking of HIV testing responsibilities in order to reduce coverage
gaps and improve access to HIV prevention, treatment, care and support.

2. Presumptive / Diagnosed TB patients coming to the health facilities will be referred to

Stand Alone-Integrated Counselling & Testing Centre (SA-ICTC) by health care workers,
called provider-initiated testing & counselling (PITC), where they will be offered counselling &
testing as per the norms and standard operating procedures of the National AIDS Control
Programme (NACP).

133
3. In PITC, health care worker or counsellor provides basic information on HIV, the testing
process, clinical and prevention benets of testing and potential risk of discrimination. The
clients are also informed about their “right to refuse” the offer of HIV testing and that declining
the test will not affect their access to other services.

4. At many health facilities where infrastructure of ICTC is not available, Facility Integrated
Counselling & Testing Centres (F-ICTC) have been established by State AIDS Control
Societies (SACS) under NACP. At F-ICTCs, Presumptive / Diagnosed TB patients are screened
for HIV by whole blood nger prick test (WBFPT) kits. It is easy to perform and provides results
within 30 minutes.

5. If the test result on the initial screening test is negative then the LT will hand over report of
HIV screening test to presumptive TB patient/ diagnosed TB case provided with the serial number
of tests in counselling register & date and signature of a Medical ofcer.

6. If test result is found ‘Reactive’ for HIV at screening, no report is given to the presumptive TB
patient/ diagnosed TB case. They are further referred to nearest SA-ICTC for conrmation of the
HIV diagnosis

7. NACP also recommends the establishment of provider-initiated HIV screening at all DMCs
under the NTEP.

8. HIV screening at all F-ICTCs will be implemented through their existing staff with due
sensitization, orientation, guidance, monitoring and supervision by the linked SA-ICTC. The WBFPT
kits need to be stored between 2°C and 8 °C in the refrigerator available at the health facility.

9. For patients with HIV positive results at conrmatory site (SA-ICTC), the counsellor will link
the patient to the nearest ART centre available in the district/state. This will be done by giving a
referral form and explaining the patient on how to access the centre. The patient will be given
the contact details of the district programme managers for any assistance needed.

10. The counsellor will document the HIV status, date of HIV testing and Patient ID number in the
‘NTEP Request form for examination of biological specimen for TB’ as a feedback to LT of DMC.
The counsellor will also assist the DMC LT to update the laboratory register with information on
HIV status (Reactive /Non-reactive).

TB Screening among HIV patients

Intensied TB case nding (ICF) at ICTCs, ART and Community Support Centres (CSCs)
Intensied TB case nding at HIV care settings is an important strategy for early diagnosis of TB
among PLHIV.

Three “I” s to reduce burden of TB among PLHIV

• ICF: Intensied (TB) case nding (ICF) at ICTC, ART centres and Link ART Centres (LAC)
• IC-AIC: Air-borne infection control measures for prevention of TB transmission at HIV
care settings
• IPT: Implementation of Isoniazid preventive treatment (IPT) for all PLHIV (On ART +
Pre-ART)
• Provision of ART for HIV infected TB patients

134
Intensied TB Case Finding (ICF)
• Actively looking for signs and symptoms of TB disease
– Symptom screening and then follow-up evaluation as indicated
– Can be in settings (clinic, prison, etc.) or community-based

• Goals of ICF for PLHIV

– Earlier diagnosis and treatment of TB to reduce mortality
– Prevent ongoing transmission
– Initial step in ICF-IPT cascade for excluding disease to provide TB preventive therapy

• Steps for ICF

– Screening for TB using 4 symptom complex
– Fast tracking
– Early diagnosis

4. symptom complex for TB screening among PLHIV

Adult Children

• Current cough • Current cough

• Fever • Fever

• Weight loss • Poor weight gain

• Night Sweats • Contact with TB case

135
ICF at ICTC
All ICTC clients should be screened by ICTC counsellors for presence of TB symptoms at every
encounter (pre, post or follow-up counselling). Clients who have symptoms or signs, irrespective
of their HIV status, should be referred to NTEP diagnostic and treatment facility located in same
institution. Therefore, NACP and NTEP promote establishing co-located facilities, for better
coordination between the two programmes. Hence, as network of HIV testing facilities is being
expanded, consideration should be given to establish them at sites, which already have NTEP,
designated microscopy centres (DMC).

The referrals of presumptive TB cases from ICTCs to TB diagnosis facility should be recorded on a
line list to facilitate exchange of information with NTEP and track the client through the process
of TB diagnosis and initiation of TB treatment. To streamline this process further NTEP
programme staff should stay in touch with ICTC counsellors to complete the exchange of
information in time. In addition, ICTC counsellors and NTEP programme staff participate in
monthly HIV/TB coordination meeting at district level to validate line-lists and Monthly HIV/TB
reports and resolve operational issues if any.

ICF at ART Centres

HIV-infected persons attending ART centres for pre-ART registration have a high prevalence of
TB disease (6 to 8%). The incidence of TB among ART clients is also very high, even when on ART.
Although ART reduces risk of incident TB, it remains many times higher compared to general
population. In addition, HIV-infected clients having undiagnosed or untreated TB may seek care
at ART centres and thus exposing other HIV-infected persons to the risk of acquiring TB.
Therefore, active efforts for intensied TB case nding (ICF) at ART centres is critical for early
suspicion and detection of TB, linkage to treatment and thus for prevention of transmission of
infection to other clients. The national ART guidelines clearly state that all patients coming to ART
centres should be actively screened for opportunistic infections, particularly tuberculosis. All

136
people living with HIV should be regularly screened for four symptoms viz., current cough of any
duration, fever of any duration, signicant weight loss or drenching night sweats, during every
visit to a health facility and every contact with a health-care provider. Those with history of
coughing blood and sputum and with any pulmonary abnormality in chest X-ray should also be
evaluated for TB. Similarly, children living with HIV who have one or more of the following
symptoms – failure to thrive, fever or cough of any duration or history of contact with a TB patient
should be evaluated for TB.

Screening for TB is important regardless of whether the PLHIV is receiving IPT or ART. The
presumptive TB cases identied at ART centres or Link ART centres should be prioritized and
“fast-tracked” for evaluation by SMO/MO to minimize opportunities for airborne transmission
of infection to other PLHIV.

PLHIVs suspected to have TB by MO, should be subjected to testing of sputum / appropriate

specimen from a relevant extra-pulmonary site by CBNAAT at the nearest facility. CBNAAT is the
frontline test for diagnosis of TB among PLHIV. If CBNAAT is not available, arrangements have to
be made for collection and transportation of sputum specimen to the nearest CBNAAT site. If
CBNAAT linkage is not available, then the patient should be evaluated with microscopy and
Chest-X ray on the same day.

Smear negative TB and extra pulmonary TB is more common among people living with HIV and
therefore a high level of suspicion is required. In the event of suspicion of Extra Pulmonary TB,
the diagnostic algorithm as for HIV negative presumptive EPTB patients may be followed.
Similarly, refer to diagnostic algorithm for paediatric pulmonary TB.

Preferably, PLHIVs should be offered TB and HIV diagnostic facility at the same premises as a
“one-stop service” in order to reduce diagnostic delay and to link those not having any of the
four symptom complex to IPT services.
In addition, the referrals presumptive TB cases should be recorded on an ART centre TB-HIV line
list to facilitate coordination with NTEP programme staff and to track the patient closely through
the process of TB diagnosis and TB treatment initiation. It is also crucial that ART Centre staff
members attend monthly HIV/TB coordination meeting. The HIV/TB monthly reporting format to
be generated at ART centres is incorporated into the ART centre monthly report (CMIS).

Information of all HIV infected TB patients in HIV care should be recorded in the ART centre
HIV/TB register. These include TB patients detected by ART centre staff as well as those TB
patients found HIV infected while on TB treatment and referred to ART centre by the NTEP. TB-HIV
register is an important monitoring tool to track timeliness of initiation of CPT and ART the TB
treatment outcome to modify ARV regimens as per guidelines. It is also important that ART
centre staff carry this register when they attend monthly HIV/TB coordination meeting to update
information on TB treatment outcome from NTEP staff and share information pertaining to CPT
and ART with them for recording into NTEP TB Notication registers.

PLHIV diagnosed to be suffering from TB are presumptive MDR cases and need to follow the
algorithm for diagnosis of drug resistant TB.

ICF at Link ART Centres (LAC)

The ICF activity is also implemented at all Link ART plus and Link ART centres in the country. As in
ART centres LAC-Plus and LAC should 1) implement ICF using symptom screening on every
encounter 2) promptly refer presumptive TB case to NTEP diagnostic facilities, and 3) refer the

137
patient to ART centre promptly if TB is detected for initiation of ART or modify current ARV
regimen. Similar to ART centre, the LAC staff nurse /counsellor should maintain line-list,
exchange with local NTEP staff to seek information on TB diagnosis and treatment and complete
the line-list.

The LAC Plus use same line-list format as the ART centre while at LAC the ICTC line-list format is
used (since ICTC counsellor runs the LAC). The completed line-list from LAC-plus is merged with
ART centre line-list whereas that from LAC is merged into ICTC line-list for the same period and
monthly report is generated accordingly.

These mechanisms are designed considering operational feasibility but key point is if TB is
detected among patients at LAC plus of LAC, they must be promptly referred to ART centre for
further management.

ICF among HIV high risk groups (HRG)

Operational research conducted in high HIV prevalent states have shown that HRG’s like female
sex workers (FSW), men having sex with men (MSM), injection drug users (IDU) etc. are more
likely to have tuberculosis compared to general population. In addition, it is known that HIV
prevalence among the HRG is several times higher than general population. While NACP
provides HIV prevention interventions for the HRG through its targeted interventions, the ICF
provides an opportunity to provide additional services to this population. This intervention is
likely to help in detection HIV/TB cases early and link to care support and treatment. Among the
HRG’s, IDU have highest HIV prevalence therefore the programmes aim to provide ICF services
and prompt linkage to care support and treatment to IDU as a priority.

Care and support centres:

TB symptom screening based on 4 symptom complex should also be done by counsellors and
outreach workers at Care and support centre in collaboration with SACS.

Treatment of HIV-infected TB
Early diagnosis and effective treatment of TB among HIV-infected patients are critical for
controlling the disease and minimizing the adverse impact of TB on the course of HIV. Hence,
initiation of treatment is very important soon after the diagnosis of TB. Among HIV-infected
persons, treatment of TB is same as that in the HIV-negative TB patients.

Anti-TB Treatment of HIV infected TB patients:

• Based on the clinical history and investigation reports ART MO will categorize patients as
Rifampicin sensitive/ rifampicin sensitivity status not known/ clinically diagnosed TB cases,
prior history of taking Anti-TB drugs (Cat I /Cat II) accordingly and initiate daily anti TB
treatment in Fixed Dosage Combination as per NTEP guidelines at ART Centre itself.
• All HIV-infected TB patients if not tested already should be tested for drug susceptibility
before initiation of treatment. Staff nurse will refer the patient to the nearest drug
resistant TB centre in coordination with to NTEP and record the same in the line list as
DRTB /Rif resistant patient. PLHIV with drug resistant TB should be managed by DR-TB
center in consultation with ART centre.
• The STS of TU where ART Centre / CBNAAT site is located (nodal TU) will link the patient
to the concerned TU based on the residence of the patient for TB treatment provision
and follow up as per NTEP guidelines. STS (nodal TU) will also be responsible to get the
registration details from the concerned TU. Overall responsibility of this linkage and
coordination lies with District HIV –TB and PMDT coordinator.

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 • TB patients living with HIV infection should receive the same duration of TB treatment
with daily regimen as HIV-negative TB patients.
• If drug sensitive TB patient and on second line ART, Rifampicin should be replaced with
Rifabutin 300 mg three times a week or 150 mg daily.
• TB Treatment card for these patients will be prepared by staff nurse in duplicate and will
be duly signed by medical ofcer. One copy of the TB treatment card is to be handed
over to the patient. Patient will be registered in Nikshay by data manager of ART Centre
and patient ID will be created. Under this ID, treatment details of the patient will be
entered by the data manager.
• Pharmacist will maintain the inventory of stocks of Anti-TB drugs at ART centre.
District HIV- TB and PMDT coordinator should ensure availability of adequate stock of
Anti-TB drug and logistics in coordination with ART centre, District TB Ofcer, District
Drug store pharmacist
• NTEP will identify local treatment supporter for all HIV –TB co-infected patients. Anti TB
treatment will be supervised by the local treatment supporter and any adverse drug
reactions should be informed immediately to local medical ofcer at PHI and ART
medical ofcer.
• Regular follow up of the patients, testing for sputum as per NTEP Guidelines and
adherence to ATT & ART treatment is to be ensured by the treatment supporter, STS,
STLS, ART MO. ART Counsellor should ensure proper counselling in all the HIV-TB co-
infected patients regarding adherence and possible side effects to ART and ATT.
• A mechanism of ensuring and checking adherence has been instituted by sending a
missed call by patient to pre-printed phone numbers hidden behind selected pills
after taking dose. As the sequence of hidden numbers cannot be predicted by
patients, but are known by the system for each month of medication prescribed, the
system offers high condence that patients who respond correctly have indeed taken
their medication.
• PLHIV with drug resistant TB should be managed by DR-TB centre in consultation with
ART centre. The treatment of HIV positive individual with MDR-TB is the same as for HIV
negative patients. However, treatment is more difcult and adverse events more
common. Due to the increased frequency of adverse drug events, rigorous monitoring in
this particular group of patients is required in order to ensure adherence to treatment,
early identication and treatment of adverse events and reduce lost to follow up.

Anti-retroviral therapy and co-trimoxazole prophylactic therapy in HIV infected TB

patients:
In addition to TB treatment, all HIV-infected TB patients must be provided access to care and
support for HIV disease, including co-trimoxazole preventive therapy and antiretroviral therapy.
ART reduces TB case fatality rates and the risk of recurrent TB. Co-trimoxazole preventative
therapy has been shown to reduce mortality among PLHIV by preventing opportunistic
infections.
• Anti-retroviral therapy must be offered to all patients with HIV and TB as well as drug-
resistant TB, irrespective of CD4 cell-count, as early as possible (after 2 weeks)
following initiation of anti-TB treatment. Appropriate arrangements for access to
anti-retroviral drugs should be made for patients. However, initiation of treatment
for TB should not be delayed.

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Initiation of rst-line ART in relation to anti-TB therapy

Clinical staging Cd4 cell count Timing of ART in ART

(cells/mm3) relation to Recommendations
initiation of TB
treatment
Start ART Cd4 count of any • Start ATT rst Start ART Regimen
irrespective of value TLE for patients not
• Start ART as soon
any clinical stage on ART.
as TB treatment is
For patients already
tolerated (between
on 1st line ART, ZLN,
2 weeks and 2
shift to ZLE &
months)
continue ZLE even
after ATT is stopped.

Rationale for ART recommendation during TB treatment:

In the absence of ART, TB therapy alone does not signicantly increase the CD4 cell count.
Nor does it signicantly decrease the HIV viral load. Thus, CD4 counts measured during
active TB are likely to reect the actual level of immune suppression
The use of HAART in patients with TB can lead to a sustained reduction in the HIV viral load. It
can also facilitate immunological reconstitution, and decrease AIDS-dening illness and
mortality. This benet is seen across different ranges of CD4 counts

• The use of the standard 600mg/day dose of EFV is recommended for patients receiving EFV and Rifampicin.
• *In women of child-bearing age, the use of contraceptives should be ascertained because of drug reaction, as
and when NNRTIs and Rifampicin are being used
• *Special Attention to be paid for monitoring hepatotoxicity

Rifabutin Drug Interactions

Rifabutin is an anti-mycobacterial agent similar to Rifampicin however Rifabutin has signicantly
less effect on drugs metabolised by cytochrome P 450 3a enzymes; this may reduce the
magnitude of drug- drug interactions. Drugs that induce or inhibit CYP3A metabolizing enzymes
can inuence Rifabutin concentrations leading to the need for Rifabutin dose adjustment, which
adds to the complexity of co-treatment. If a patient whose Rifabutin dose was decreased to avoid
drug interactions related to co-treatment with antiretroviral therapy, subsequently stops taking
the interacting antiretroviral drug (e.g., ritonavir), the resulting Rifabutin concentrations can
become sub-therapeutic, putting the patient at risk of tuberculosis treatment failure or
emergence of “Rifamycin” resistance.

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Management of HIV –TB co-infection Specic Situations

Immune reconstitution inammatory syndrome (IRIS) may occur in up to one-third of patients

who have been diagnosed with TB and who have started ART. It typically presents within three
months of the initiation of ART but can occur as early as ve days. Patients with TB-associated
IRIS most commonly present with fever and worsening of pre-existing lymphadenopathy or
respiratory disease. The symptoms are similar to the paradoxical reactions seen in immuno-
competent patients on ATT, but occur more frequently. Most cases resolve without any
intervention and ART can be safely continued. Serious reactions, such as tracheal compression
caused by massive adenopathy or respiratory difculty, may occur. Therapy may require the use
of corticosteroids.

First Line ART for HIV-TB

TENOFOVIR 300mg + LAMIVUDINE 300 mg + EFAVIRENZ 600 mg (FDC)

Regimen Tenofovir + All new co-infected patients should be initiated on FDC of TLE
Lamivudine + single pill based regimen irrespective of HB level/ CD4 count.
Efavirenz Those patients who are already on ART on ZLN regimen at the
time of TB diagnosis need to be changed to regimen ZL+E at the
initiation of ATT due to interaction of ATT & NVP. Such patients will
not be changed from EVF to NVP after ATT is completed and will
continue on ZLE regimen. There is no change of regimen for
patients who are already on ZLE at the time of TB diagnosis &
treatment

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Second Line ART for HIV-TB:
The following regimens are available under the National Programme currently for second line ART:

Tenofovir + Lamivudine + PI (Atazanavir/ritonavir or Lopinavir/Ritonavir)

Zidovudine + Lamivudine+ PI (Atazanavir/ritonavir or Lopinavir/Ritonavir)
Stavudine+ Lamivudine + PI (Atazanavir/ritonavir or Lopinavir/Ritonavir)
Abacavir+ Lamivudine+ PI (Atazanavir/ritonavir or Lopinavir/Ritonavir)

Rifampicin alters the metabolism of Protease Inhibitors, including Atazanavir and Ritonavir and
reduces their effectiveness in standard doses

Provision of Co-trimoxazole Prophylaxis Therapy (CPT) to HIV-Infected TB patients:

• Co-trimoxazole is a xed dose combination of sulfamethoxazole and trimethoprim; it is
a broad spectrum antibiotic that targets a range of gram-positive and gram-negative
organisms, fungi, and protozoa. Co-trimoxazole is given routinely for the prevention of
opportunistic infections in HIV-infected persons; this strategy is called Cotrimoxazole
prophylaxis therapy. CPT reduces morbidity and mortality of HIV-infected patients in
general and HIV-infected TB patients in particular. Additional points to remember
include:
• Dose for prophylaxis for adults (> 14 years old) and > 30 kg body weight): 960 mg (800
mg sulfamethoxazole + 160 mg trimethoprim) daily.
• For children and very low-weight adults (<30 kg), CPT for these patients is managed by
ART centres as per separate protocol.
• CPT is provided to patients in monthly pouches.
• CPT is self-administered by the patient on a daily basis, and not under direct
observation.
• CPT can be taken alongside anti-tuberculosis treatment (ATT) and ART. Many patients
who are eligible for ART would also have CPT continued at ART center.
• Pregnant patients are also eligible, regardless of foetus gestational age.
• Patients should have no history of a serious drug allergy to sulpha drugs or glucose-6
phosphate dehydrogenase (G6PD) deciency.

Isoniazid Preventive Therapy (IPT) For PLHIVs

IPT is one of the 3 I’s globally recommended for prevention of incident TB among HIV infected
individuals. Isoniazid is the most effective bactericidal, anti-TB drug available at currently. While
it protects against progression of latent TB infection to active disease i.e. reactivation, it also
prevents TB reinfection post the exposure to an open case of TB. In 2011 the World Health
Organization (WHO) issued specic recommendations regarding the use of IPT in its guidelines
on “Intensied TB case nding and isoniazid preventive therapy for people living with HIV in
resource constrained settings”. The key recommendations included the following:
a) Adults and adolescents living with HIV should be screened for TB with a clinical
algorithm and those who do not report any one of the symptoms of current cough, fever,
weight loss or night sweats are unlikely to have active TB and should be offered IPT. The
guideline group strongly recommend use of Isoniazid 300 mg once daily for 6 months,
in adult and adolescents,

b) Children living with HIV who do not have poor weight gain, fever or current cough are
unlikely to have active TB

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 c) Children living with HIV who have any one of above symptoms may have TB and should
be evaluated for TB and other conditions. If evaluation shows no TB, such children
should be offered
IPT regardless of their age.
d) Children living with HIV who are more than 12 months of age and who are unlikely to
have active TB on symptom-based screening, and have no contact with a TB case should
receive six months of IPT (10 mg/kg/ day) as part of a comprehensive package of HIV
prevention and care services

e) All children living with HIV who have successfully completed treatment for TB disease
should receive INH for an additional six month

f) Although IPT is more effective among Tuberculin Skin Test positive individuals (TST), it is
not a requirement for initiating IPT intervention among the PLHIV considering difculty
in logistics and administration of the TST

g) Providing IPT to people living with HIV does not increase risk of developing isoniazid
(INH) resistant TB later. Therefore, concerns regarding development of INH resistance
should not be a barrier to providing IPT
Steps in Provision of Isoniazid Preventive Therapy (IPT): The IPT provision involves
following steps:
a) TB symptom screening at ART centre /Link ART-Plus and Link ART centres
b) Investigations for diagnosis of TB, if found symptomatic
c) If found Asymptomatic, assessment for the eligibility of Isoniazid Preventive therapy
d) If found eligible, initiation of IPT and Registration in IPT register maintained at the Nodal
ART centre
e) Monthly collection of Isoniazid
f) Systematic recording and reporting e.g., Use of IPT Card
g) Continued TB symptom screening on each follow-up visits and reconsideration of IPT if
symptoms develop
Monthly collection of Isoniazid: All eligible patients are to be initiated on IPT. The
regimen prescribed are as below:
a) Adult and Adolescent: Isoniazid 300mg +Pyridoxine 50mg (Vitamin B6) per day for 6
months
b) Children above 12 months: Isoniazid 10mg/kg +Pyridoxine25 mg (Vitamin B6) per
day for 6 months

The strategy for monthly collection of Isoniazid + Pyridoxine is as follows:

a) Patients on ART monthly collection from the ART centre, LAC-Plus or LAC along with
monthly collection of the ART
b) Patients in pre-ART care visit the ART centre only once in six months. These patients may
collect the monthly Isoniazid/Pyridoxine packet from the designated stand-alone ICTC.
Systematic recording and reporting:
All events in the cascade of IPT implementation including symptom screening at all contacts, IPT
eligibility assessment, investigations, and the compliance with regimen are to be systematically
recorded and reported.

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Recording & reporting
1. Information on HIV status and treatment details are captured in treatment card and
notication register

The following documents of NACP & NTEP are used for recording & reporting
• Line-List of Persons Referred from ICTC to NTEP
• ICTC TB-HIV monthly report
• HIV-TB Line List
• HIV/TB -Intensied TB Case Finding Report
• HIV TB Register
TB and Diabetes
As a consequence of urbanization as well as social and economic development, there has been
a rapidly growing epidemic of Diabetes Mellitus (DM). India has second largest number of
diabetic people in the world. As per recent estimates, there are around 66 million DM cases,
with a further 77 million people having impaired glucose tolerance.
People with a weak immune system, as a result of chronic diseases such as diabetes, are at a
higher risk of progressing from latent to active TB. Hence, people with diabetes have a 2-3 times
higher risk of TB compared to people without diabetes.
- About 10% of TB cases globally are associated with diabetes.
- A large proportion of people with diabetes as well as TB is not diagnosed, or is
diagnosed too late. Early detection can help improve care and control of both diseases.
- DM can lengthen the time to sputum culture conversion and theoretically this could lead
to the development of drug resistance if a 4-drug regimen in the intensive phase of
therapy is changed after 2 months to a 2-drug regimen in the presence of culture-
positive TB.
- People with diabetes who are diagnosed with TB have a higher risk of death during TB
treatment and a higher risk of TB relapse after completing treatment.
- DM is complicated by the presence of infectious diseases, including TB.

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 - It has been argued that good glycaemic control in TB patients can improve treatment
outcomes
- The precise biological mechanisms that result in this interaction between Diabetes
and TB are still not clear. Epidemiological models have shown that DM accounts for
20% of smear-positive pulmonary TB and recent analyses have indicated that the
increase in DM prevalence in India has been an important obstacle to reducing TB
incidence in the country
Screening Intervention and Diagnosis of Diabetes among TB patients
• All TB patients who have been diagnosed and registered under NTEP will be referred for
screening for Diabetes. Referral of TB patients for screening for DM and its recording &
reporting is responsibility of the Peripheral Health Institutions (PHI) where TB treatment
is initiated.
• The screening for DM will follow the guidelines stipulated by NPCDCS in India. Those
guidelines stipulate that fasting blood glucose (FBG) be carried out using a nger prick and
glucometer with cut-off thresholds in line with those recommended by the NPCDCS.

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Screening TB patients for DM should be conducted as early as possible after diagnosis of TB; but
can be done at any time during the course of TB treatment. Because of the difculties in getting
TB patients to rst come to the clinic in a fasting state, TB patients will be initially screened with a
random blood glucose (RBG) using a glucometer. If the RBG is less than 140 mg/dl, this is a
normal result and no further tests need be carried out. If the RBG is at or greater than 140 mg/dl,
this might indicate an abnormal glucose state and there is a possibility of DM. The patient will be
asked to return in a fasting state, and a fasting blood glucose (FBG) will be carried out. FBG value
at or greater than 126 mg/dl indicates DM.

WHO criteria for diagnosing Diabetes will be as follows.

Diagnosis Fasting Glucose (mg/dl) 2-hour Post-Glucose Load (mg/dl)

Diabetes Mellitus ≥126 ≥200

Impaired Glucose Tolerance ≥110 to <126 >140 to <200

• Criteria for suspected Diabetes case is reading of 140 mg/dl for Random Blood Glucose
by glucostrip. The suspected case needs to undergo Fasting Blood Glucose test and Post
Prandial tests to conrm diabetes

• The blood glucose testing will be done by a person designated and trained for the
purpose at every peripheral health institution (PHI). Though, this would vary from site to
site the following general principles would apply. Wherever, NPCDCS is being
implemented, the ANM (Auxiliary Nurse Midwife) has been trained to use glucometer
and screen people for DM. In case this mechanism is not available, the laboratory
technician working in the PHI will be trained to do the test. If a PHI does not have a
laboratory technician, then either the staff Nurse or any other staff designated by the
MO-PHI will be trained to do the test.

Linkage of TB patients with DM for Diabetes care and management –

All Diabetic TB patients should be linked for diabetic care. In the districts where NPCDCS is being
implemented, TB patients with DM or with a FBG at or higher than 126 mg/dl will be referred to
diabetes care using a referral form for denite diagnosis and management. A referral and
feedback mechanism will be developed to enable timely exchange of information. Good
cooperation and collaboration will need to be developed between the two sets of staff working
in the different service areas.
• At districts where NPCDCS is not implemented, TB patients should be referred to the
nearest healthcare facility for further diagnosis and management of TB-DM
comorbidity.
• TB patients diagnosed with Diabetes should receive the same duration of TB treatment
with daily regimen as non- Diabetic TB patients.

Screening and referral of Diabetic patients for TB

• Four-symptom complex screening for active TB in Diabetes patients is to be done.
Screening is expected to be carried out every time the patient visits the DM clinic.
Patients will be asked whether they are on TB treatment, and if not, they would be
screened for four-symptom complex, i.e. Cough of any duration, Fever, Weight loss,
Night sweat.
• The Screening results for Diabetes are to be recorded in the patient NPCDCS register
• NCD clinic will implement basic infection measures as stipulated in NTEP guidelines

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Linkage of Diabetic patients with TB for TB case management
On screening, patients with one or more symptoms will be referred to nearest diagnostic facility
for diagnosis of TB. A referral and feedback mechanism will be developed to enable timely
exchange of information. The patients diagnosed for TB would be initiated on TB treatment as
per management guidelines stipulated in NTEP.

TB & NUTRITION
Undernutrition is considered as one of the risk factors in the development of TB, since
undernutrition is known to adversely affect the immune system. Still, there remains a question as
to whether malnutrition predisposes to tuberculosis, or whether it is a consequence of the
disease. There is as yet little evidence showing that additional nutrition support improves TB-
specic outcomes, but low body mass index as well as lack of adequate weight gain during TB
treatment are associated with an increased risk of TB relapse and death.

The basic recommendations to address nutritional needs of TB patients are discussed below-
1. Conducting an initial nutrition assessment of TB patients with further monitoring;
2. Providing ongoing counselling for patients on their nutritional status; Diet for TB
patients starting treatment should include: cereals (maize, rice, sorghum, millets, etc.);
pulses (peas, beans, lentils, etc.); oil; sugar, salt; animal products (canned sh, beef and
cheese, dried sh); and dried skimmed milk.
3. Management of severe acute malnutrition should be treated according to national
guidelines and WHO recommendations;
4. Management of moderate under nutrition for TB patients who fail to regain normal
Body Mass Index (BMI) after two months of TB treatment or appear to lose weight during
TB treatment should be evaluated for a proper treatment adherence and other
comorbidities. If indicated, these patients should be provided with locally available
nutrient- rich or fortied supplementary foods. Special categories of TB patients such as
• Children who are less than 5 years of age should be managed as any other children
with moderate under nutrition.
• Pregnant women with active TB, patients with MDR TB should be provided with
locally available nutrient- rich or fortied supplementary foods.
5. Micronutrient supplementation for all pregnant women as well as lactating women with
active TB. These women should be provided with iron and folic acid and other vitamin and
minerals to complement their maternal micronutrient needs. In situations when calcium
intake is low, calcium supplementation is recommended as part of antenatal care.

For this the guidelines for nutrition for the TB patients are available. A mobile application [N-TB]
is available for decision making on nutritional support to TB patients.

Undernutrition and underlying food insecurity are among the most important determinants of
TB. Improving nutritional status at population level is important for TB prevention. This should be
part of broader actions on social determinants. All efforts should be made to link TB patients for
the nutritional support. It can be through the existing public distribution system, local self-
government or NGO or donor agencies or through corporate sector under Corporate Social
Responsibility (CSR).

Management of severe acute malnutrition: Children below 5 years, School-age children and
adolescents (5 to 19 years), and adults, including pregnant and lactating women, with active TB
and severe acute malnutrition should be managed for severe acute malnutrition.

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TB & Tobacco
India is the second largest consumer and the third largest producer of tobacco in the world (FAO,
2005). Nearly one million Indians die from tobacco use every year, which is much more than
combined mortality resulting from HIV/AIDS, TB and Malaria. As per Global Adult Tobacco
Survey, (GATS 2010, a household survey of persons 15 years of age and above) there are 275
million adult tobacco users in India. It is estimated that more than one- third (35%) of adults in
India use tobacco in some form or the other. The prevalence of smokeless tobacco use (26%) is
almost twice that of the prevalence of smoking tobacco (14%).

Tobacco smoke contains toxic chemicals which cause disturbances in the bronchial surface of the
lung. It also weakens the immunity of the patient to ght with the TB bacteria.

The following evidence emerges from several studies conducted to look at the association of TB
and tobacco in India:
• Almost 38% of TB deaths are associated with the use of tobacco.
• Prevalence of TB is 3 times as high among ever-smokers as compared to that of among
never-smokers.
• Mortality from TB is 3 to 4 times as high among ever-smokers as compared to that
among never-smokers.
• Smoking contributes to half the male deaths in 25-69 age groups from TB in India.

Exposure to tobacco smoke has also been found to affect TB in the following ways:
• Increase the risk of tuberculous infection and the risk of developing TB
• Affect clinical manifestations and increase risk of relapse among TB patients
• Affect microbiological conversion (sputum smear or culture) and outcome of treatment
in TB patients
• Increase tuberculosis mortality and drug resistance to anti–tubercular drugs

Integrating Brief Advice for Tobacco Cessation

• When a patient gets registered as a tuberculosis case, the status of tobacco use is enquired.
• The information will be recorded in the TB treatment card in front portion using stamp
• If the TB patient is a smoker or tobacco user, he/she is offered ‘Brief Advice’ to quit
tobacco used based on 5As and 5 Rs model
• The patient is assessed at every visit for follow up for TB and the status of tobacco use
or quitting. At the end of treatment, his/her status of tobacco use is recorded in
treatment card.
• If the patient has not quit tobacco use, he/she will be referred to the nearest Tobacco
Cessation Clinic (TCC) or Quit line or m- cessation initiative.
• The information recorded in treatment card will be sent through the existing HMIS
under NTEP

Brief advice for quitting tobacco use consists of 5 ‘A’s

1. Ask the patient if he/she is a tobacco user, during the course of every visit.
2. Briey Advise against continuing tobacco use and link the current condition/ailment to
continued tobacco use, where possible. Eg, “Quitting smoking/tobacco use would
improve your health and will aid in early recovery from illness.”
3. Then Assess readiness to quit by asking the patient whether he or she is ready to quit
tobacco use at this time. Eg, “How recently have you thought about quitting tobacco?” If
the patient appears ready to change (quit), next steps are:

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 4. Assist the tobacco user in making a quit plan.
5. Arrange for follow-up by setting the next contact date.

If the tobacco user is not yet thinking about quitting tobacco use, the doctor/counsellor/
treatment supporter will promote greater awareness of the Relevance to the patient of the
advice to quit, the Risks of tobacco use and the Rewards (benets) of quitting. Many tobacco
users are largely unaware of the potential harm that continued tobacco use can do to them. If
the patient is not ready to quit, the doctor/ counsellor/treatment supporter must not push the
patient. People usually need time to change the mindset. If the patient is at least thinking about
quitting, the doctor/ counsellor/treatment supporter can nd out the patients’ Roadblocks to
quitting and help the patient see ways to overcome these. This process will assist the patient to
get ready for quitting the tobacco use, without being pushy.

The 5 R’s are for non-willing tobacco users:

• Relevance of quitting
• Risks of continuing
• Rewards of quitting
• Roadblocks to quitting
• Repeat at each visit

Awareness and IEC

• All the DOTS centre /Clinics will be made tobacco free
• IEC material will be displayed at TUs, DMCs and Tobacco Cessation Clinics.
• DMCs and TUs will display IEC material about the hazards of tobacco use, along with
the brief advice.
• Tobacco Cessation Clinics will display hygiene and TB awareness related materials.
• Awareness building efforts will be done at both units for patients and staff.
• Sensitisation of all stakeholders (partners, policy-makers and administrators) will be
done on regularly basis.
• Every effort will be made by both the programme divisions to sensitise the community
about the ill effects of TB and tobacco use

Recording & reporting- Information on tobacco usage and its status is captured in treatment card.

Involvement of NTCP in tuberculosis control

For enhancing active screening of TB patients through NTCP, the following process is indicated:
• Screening of four symptoms of active TB among tobacco users registered at the District
TCC clinic and NCD Clinic at CHC- cough, fever, night sweat and weight loss
• Quit line established for tobacco cessation advice to conduct follow up of comorbid
patients (TB patients with tobacco use) registered as TB cured, to identify TB relapse cases

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 • m-cessation initiatives to include TB-screening symptoms in cessation modules to
identify active TB cases in people registered for tobacco cessation
• Ensure implementation of infection control guidelines in TCC Clinics
• Tobacco training modules prepared for teachers to include TB symptoms for increasing
awareness among children and young adults

TB & SILICOSIS
Occupational high-risk group: Although reliable statistics are not available in India, it is known
that thousands of workers and local residents are exposed to hazardous silica levels during
stone crushing operations. Studies have shown increased morbidity and mortality rates among
stone crushing mill workers from silicosis, lung cancer, and other lung diseases. Several other
occupations also increase risk for tuberculosis including coal and other mining, tobacco (bidi
rolling) and carpet weaving. Vulnerable and socially marginalised groups including tribal
communities, children and migrant population are often used in these industries and do not
have access to routine health services.

The NTEP is in process of engaging with the Ministry of Labour and Mining to identify high
priority districts with stone crushing units / mining industry. The specic guidelines will be
developed to support persons with an occupational risk for TB and provide access, diagnosis and
treatment services from the programme.

Exercise 4

COMPLETION OF TUBERCULOSIS TREATMENT CARDS

Use a calendar for 2018-19 and exercise 3. Treatment begins in 2018. Neither diagnosis nor
treatment (DOT) is initiated on Sundays. Use your own state, district and sub-district names on
the Tuberculosis Treatment Card. Be sure to indicate outcome and date on back side of the
Tuberculosis Treatment Card.

Remember that you must make up for missed doses. For this exercise, names and addresses of
contact persons and treatment supporter are not given. In practice, the names and addresses of
contact persons and treatment supporter must be lled up to aid in retrieving patients who have
interrupted treatment. Use the NTEP request form for examination of biological specimens for TB
that you completed in previous Exercise to record the results of investigations in front side of
Tuberculosis Treatment Cards.

1. Arun Kumar (Patient A) is 24-year-old male, labourer from 7 Institutional slum Area, Lodhi
Road, 110006, weighing 40 kg with pain in the chest and cough for two weeks. His sputum was
sent for smear examination and was found to be positive for AFB. There was no history of ATT in
the past. He was initiated on treatment on 10thSeptember 2018. He took all the doses of
treatment regularly under direct observation. His follow-up sputum was done at end of IP and
found to be negative. His end CP result was negative. What is the advice?

2. Pooja Gupta (Patient C) is 13-year-old female student from 1064, Paranthe Wali Gali,
Chandni Chowk – 110008, weighing 36 kgs with non-tender swelling of the lymph nodes in the
interior and posterior areas of the left side of the neck noticed for the last ten days. She was
diagnosed as having TB by CBNAAT. She has never been treated for TB before. She was initiated
on treatment on 13thSeptember 2018. She responded to treatment well. She had taken all
doses of IP under direct observation except 10th and 11th dose which she had missed and
continued the rest of treatment from 12th day. She had taken all doses of CP as prescribed.

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3. Lakshmi Kumari (Patient D) is 46-year-old woman from 223 Gandhi Dham, Bapu Nagar -
110013 weighing 45 kg who has had cough for two months with fever, sweats at night, and
occasional coughing up of blood. Her sputum examination was found to be positive. She was
initiated on treatment on 13th September 2018. She took 20 doses under direct observation.
After 20 doses she requested to continue her treatment at her place of residence near PHI 101.
She was given 5 doses for unsupervised consumption during her transit. From 26th dose, she
continued her treatment at PHI 101. Her End CP sputum follow up was found to be positive.

4. Narendra Kumar (Patient F) is 50-years known diabetic and alcoholic male from 223
Gandhi Dham, Bapu Nagar – 110013 weighing 40 kgs. He has had cough for a month. He gives
no history of taking ATT in the past. His sputum was found to be positive and was diagnosed as
Pulmonary TB. He was started on TB treatment on 10th September 2018. He took all the doses of
IP regularly under direct observation. At the end of IP, his weight was 43 kg and smear was
negative. In CP, he discontinued the treatment after taking 76th dose.

5. Girija Devi (Patient H) is 50-year old female from 225 Gandhi Dham, Bapu Nagar- 110013
weighing 45 kgs. She has cough for a month. When asked about previous history of taking TB
treatment, she remembers receiving multiple tablets taken for a few months once which made
her urine turn orange. She recalls that these medicines helped her feel much better. Her
CBNAAT was now done and found to be M. TB positive and Rifampicin sensitive. She is a known
HIV positive. Patient on ART and CPT. She was initiated on TB treatment at ART centre on
10thSeptember 2018. Her sputum was found to be positive at the end of IP. What next is
expected of you for her further management? She was started on CP and completed treatment.

6. Kailash Nath (Patient J) is 35-year-old, from 2586 Gali No. 3, Gobind Puri, Near
Gurudwara 110036, weighing 60 kg. He is coughing and spitting blood. When asked, he
reports that he has been coughing for several years. He has not taken any treatment before. His
sputum examination was found to be positive. He has two children aged 5 and 8 years at home
who are asymptomatic. He was initiated on treatment on 11th September 2018. He experienced
vomiting after 10th dose due to which drugs were withheld for one week and reintroduced
afterwards. The rest of the doses were under direct supervision and end of IP and end CP sputum
was negative.

Drug-Resistant TB
The management of DR-TB is very complex, and hence preventing it’s development by the
effective implementation of the DOTS strategy under NTEP is crucial. Selection of appropriate
treatment regimen for patients by medical ofcer, after eliciting history of previous treatment, is
very important. The diagnosed patients should be explained why it is essential to reveal previous
TB treatment and to take drugs under direct observation. Similarly, treatment supporter should
be educated and convinced about the importance of Directly Observed Treatment (DOT). DOTS
has been documented to not only prevent the emergence of drug resistant TB, but also to
decrease its prevalence in the community.

Prevention of spread of DR-TB infection:

While prevention of development of drug resistance is of paramount importance for ending TB,
early detection and immediate enrolment as well as completion of an effective treatment
regimen are keys to interrupt on-going transmission, to prevent death and reduce chances of
sequelae post-treatment.

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Besides, counselling patient and family members on infection control measures like cough
etiquette and sputum disposal is important to cut the chain of transmission in community.
Screening of contacts for early detection of DR-TB cases is also needed.

Integrated drug-resistant TB algorithm

The integrated DR TB algorithm clearly indicates the management strategies to be followed right
from the day the result of NAAT test is available. The programme must strive to offer DST to all
notied TB patients at diagnosis of TB or a maximum within 15 days of rst line treatment
initiation. The algorithm further offers FL LPA for the patients found R resistance not detected on
NAAT. The states must ensure availability of LPA lab capacity in consultation with central TB
division, for both SL and FL LPA as per the estimated requirement including patient notied from
the private sector. Within the rst 2 months, patients would receive the LC DST results, reach
their nal classication and treated with the appropriate regimen.
• any other reason as per treating physician’s advice.

Integrated DR TB Diagnostic Algorithm

The left path of the algorithm starts with persons presumed to have TB. From this group those
belonging to the PLHIV, EP group or with a smear negative chest X-ray suggestive of TB (including
children), vulnerable group as dened by TOG – 2016 and contact of DR TB patient will be
offered NAAT test. By virtue of using NAAT as the TB diagnostic test, the R status is also available
simultaneously along with TB detection.

The middle and right path begins with offer of NAAT to all notied TB patients &non respondent
at different time place. Based on the result obtained on the NAAT, the patient would be classied

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as R resistant detected (RR TB) or R resistance not detected to guide decision of the appropriate
treatment. As soon as the NAAT results are available, the reports must be immediately updated
in Nikshay by the NAAT lab and communicated to the concerned district, DDR TBC, DTO, MO PHI
and the patient.

For patients with NAAT result as M.tb detected (irrespective of R status), the second specimen will
be reexly transported in cool chain from the NAAT lab to the C-DST lab. In rare circumstances
when the second specimen is used at NAAT lab itself to repeat the test, a fresh specimen is to be
collected from the patient and transported in cool chain to the concerned C-DST lab.

However, this may not be always possible for EP specimen. Reconrmation of RR among the
new TB patients will be carried out at C-DST lab by FL LPA with the second specimen sent from
NAAT site.

Management of DR-TB
Guidelines for Programmatic Management of Drug resistant TB was released under NTEP in the
year 2019. This document gives detailed guidelines about structures of DR-TB centres,
integrated diagnostic algorithm for DR-TB and treatment regimen for various types of DR-TB
patients. In this section of the module, only brief overview of pre-treatment evaluation and
treatment regimens are discussed. For detailed guidelines on DR-TB management, PMDT 2019
document may be referred to.

DR-TB management has to be preferably undertaken only at district DR-TB or

nodal DR-TB centres where expertise and facilities are available for pre- treatment evaluation,
initiation and monitoring of treatment are available.

Pre-treatment evaluation for DR TB patients

Pretreatment evaluation for any TB patient including DR TB patients should include, a thorough
clinical evaluation by a physician including
• history and physical examination,
• height/weight,
• random blood sugar (RBS),
• urine pregnancy test (in women of reproductive age group),
• chest X-ray and
• HIV testing

No additional investigations are required for H mono/poly DR TB patients unless

clinically indicated.
In majority of DR TB patients, pretreatment evaluation can be done on an outpatient basis. The DTO
can arrange pretreatment evaluation at N/DDR TBC or at sub-district level health facility, wherever
possible. The patient should be fast-tracked for pretreatment evaluation and for infection control
purposes and a separate space for specimen and blood collection should be identied.

Patients will be referred to the N/DDR TBC with pretreatment evaluation results for initiation of
treatment. The physician may decide for admission to N/DDR TBC for initiation of treatment or
get it done on an outpatient basis. A specialist consultation along with reports of pre-treatment
evaluation tests can be arranged, if required. Since the drugs used for the treatment of DR TB
have signicant adverse effects, a pretreatment evaluation is essential to identify patients at
increased risk of developing such adverse effects. In addition to the above pre-treatment
evaluation, the evaluation of MDR/RR TB patients will also include:

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Complete Blood Count (Hb, TLC, DLC, Platelet count) 2. B. Urea & S. Creatinine 3. Audiometry
4. Liver Function Tests 5. Thyroid Stimulating Hormone levels to assess the thyroid function (TSH
levels alone are usually sufcient to assess the thyroid function of the patient) 6. Urine
examination – Routine and Microscopic 7. Psychiatric evaluation if required 8. Serum
electrolytes (Na, K, Mg, Ca) only for new drugs 9. S. protein (Albumin, Globulin and total
proteins) (only if on Dlm) 10. ECG (if on Mfx, Bdq, Cfz or Dlm) 11. urine pregnancy test (in women
of reproductive age group) 12. Ophthalmologist opinion – rule out chorioretinitis/uveitis (only if
on Linezolid) 13. Surgical evaluation if required Each of the DR TBCs (N/DDR TBC) must ensure
that capacity to carry out pre-treatment investigations and consultancy services of various
specialists are available, either in-house supported under institutional/state government
mechanism or through outsourced mechanisms including tie up under Free Diagnostic
Initiative. Tie up with private facility under Partnership Guidelines should be undertaken for
investigations that are not available.

The concerned DR TBC committee provides counselling, initiates activities related to active drug
safety monitoring (aDSM) like, assessing the baseline history of known adverse/serious adverse
events (AE/SAE), biochemical investigations, ECG, Audiometry etc., and initiates the patient on
an appropriate treatment regimen. Care must be taken to correct any electrolyte imbalance
before treatment initiation.

DRTB patients can be initiated on an appropriate standard treatment regimen at N/DDR TBC. If
required, the DDR TBC may refer the patients to NDR TBC for management of patients with
additional drug resistance, drug intolerance, contraindication, failing regimen, return after
treatment interruption of >1 month, emergence of exclusion criteria for standard regimen, for
expert opinion, management of any complications warranting regimen change.
Active drug safety management and monitoring (aDSM) treatment initiation form needs to be
completed and uploaded on Nikshay for all DR TB patients at the time of initiation of each new
episode of treatment.

Providing health education/ counselling to patient and family members

Providing counselling and health education to the DRTB patient and family members about the
disease, the mechanism of transmission and necessity of taking regular and adequate
treatment, is of utmost importance. Health education and counselling is provided to all patients
and family members at different levels of health care, from the periphery to the DDR TBC facility.
It is started at the initial point of contact and continued during all visits by the patient to a health
facility. Condentiality and informed decision-making process according to sound ethics
standards is paramount when performing education and counselling to patients and their family
members.

N/DDR TBC counsellors to provide counselling for all DR TB patients on the following:
• nature and duration of treatment;
• possible change in the regimen based on the additional investigations carried out;
• importance of adherence to treatment and need for complete and regular treatment;
• possible side effects of drugs;
• mechanism of transmission;
• Cough etiquette; and
• consequences of irregular treatment or premature cessation of treatment.

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It is advisable to involve close family members during the counselling, since family support is an
essential component in the management. Patients should be advised to report any side effects
immediately. Female patients should receive special counselling on family planning. The
treatment must be presented as an option and include information on any uncertainty about the
adverse effects of drugs as detailed in the patient treatment booklet.

The counsellors would be trained exclusively with a counsellors training module on an e-

learning platform by NTEP. This covers the various approaches, steps involved in counselling,
tools, activities to be undertaken as well as the records and reports to be maintained by the
counsellors. A counselling register must be maintained for all patients for recording information
about patients’ situation and counselling services provided from the time of diagnosis till post-
treatment follow-up period.

Pretreatment counselling must serve as an informed decision-making process that enables

patients to make a duly informed decision regarding the use of all anti-TB drugs including newer
drugs like Bdq/Dlm. No separate written consent is needed for any treatment regimen under the
programme.

Classes of anti -TB drugs recommended for treatment of DR TB patients (WHO)

The anti-TB drugs recommended for treatment of MDR/RR TB patients are grouped based on
efcacy, experience of use and drug class and aligned with revised classication as per WHO
consolidated guidelines for treatment of drug resistant TB (2019). WHO guideline development
group assessed the individual contribution to patient outcomes of drugs used in longer MDR TB
regimens using primarily the estimates of effect from the 2018 individual patient data – meta
analysis (IPD-MA) and Trial 213 (Delamanid) and summarized of evidence for each drug as well
as the evidence-to-decision framework. Following a thorough assessment of the relative
benets and harms, recommendations were made for each drug and they were classied into
three groups. The same is explained in the table below.

Grouping of anti-TB drugs for longer MDR regimen (Table XXX)

GROUPS & STEPS DRUG

Levooxacin OR Lfx
Group A Moxioxacin Mfx
Bedaquiline Bdq
Linezolid Lzd
Clofazimine Cfz
Group B Cycloserine OR Cs
Terizidone Trd
Ethambutol E
Delamanid Dlm
Pyrazinamide Z
Imipenem-cilastatin OR Ipm-Cln
Meropenem Mpm
Group C
Amikacin Am
(OR Streptomycin) (S)
Ethionamide OR Eto
Prothionamide Pto
p-aminosalicylic acid PAS

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Other drugs that are not included in Groups A–C are:
• Kanamycin and Capreomycin, which were associated with poorer outcomes when used
and are therefore no longer recommended for use in MDR TB regimens;
• Gatioxacin and high-dose Isoniazid were used in very few patients and thioacetazone
was not used at all. Quality-assured preparations of Gatioxacin are not currently
available following its withdrawal from the market due to concerns about
dysglycaemias. Thioacetazone is unlikely to have a role in contemporary longer
regimens and is not currently available in a quality-assured formulation.
• Clavulanic acid should be included in MDR/RR TB regimens only as a companion agent to
the carbapenems (Imp-Cln and Mpm). When used in this way, it should be given with every
dose of carbapenem and should not be counted as an additional effective TB agent.

The risk–benet considerations for the use of Bdq in patients aged 6–17 years and Dlm in
patients aged 3-5 years are similar to those considered for adults. On the basis of ndings in
adults and on the pharmacological and safety data reviewed, extrapolations on efcacy and
safety should be restricted to children aged 3–5 years but not to children younger than 3 years.

The prioritized order of the drugs in the groups has been derived from the evidences on efcacy
(Table - 2) and safety of the second line anti-TB drugs (Table - 3).

Relative risk for (i) treatment failure or relapse and (ii) death (versus treatment success), 2018 IPD-
MA for longer MDR TB regimens and delamanid Trial213 (intent-to-treat population) Table-2:

156
Table -3: Serious adverse events (SAEs) in patients on longer MDR TB regimens*

Newer anti-TB drugs

After almost ve decades of discovery of Rifampicin, the two new drugs named Bedaquiline and
Delamanid with anti-TB effect were approved for treatment of multidrug resistant TB by The
Central Drugs Standard Control Organization (CDSCO).

Bedaquiline is a new class of drug, diarylquinoline that specically targets mycobacterial ATP
synthase, an enzyme essential for the supply of energy to Mycobacterium TB. Strong bactericidal
and sterilizing activities against M.tb have been shown in pre-clinical, laboratory and animal
experiments. The drug has a high volume of distribution, with extensive tissue distribution,
highly bound to plasma proteins and is hepatically metabolized. The drug has an extended half-
life, which means that it is still present in the plasma up to 5.5 months post stopping BDQ. The
dosing schedule has been established after extensive pharmacokinetic/ pharmacodynamic
(PK/PD) studies in animals and humans and hence need to be administered as per the
manufacturer’s advice. BDQ has shown signicant benets in improving the time to culture
conversion in MDR TB patients. Bedaquiline is now well incorporated within the programme as a
part of standard all oral longer regimen for eligible patients.

Delamanid is the rst approved drug in the class of nitro-dihydro-imidazo-oxazoles for the
treatment of MDR TB. It is bactericidal drug with 36 hrs of Half-life and act with two different
mechanism of action. It blocks the synthesis of mycolic acids (i.e., stopping the bacteria from
creating building blocks important for their cell walls) as well as poison the bacilli with nitric
oxide, which the drugs release when metabolized.

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158
As per the algorithm, the patients with R resistance not detected TB will be initiated on rst line
treatment regimen while awaiting the results of FL LPA and continued on rst line treatment if H
resistance is not detected. These patients will be monitored closely and in patients with signs of
non-response to treatment during follow up, another NAAT test will be offered. All follow up
positive, failures and clinical non-responders of DS-TB treatment are also eligible for NAAT
irrespective of NAAT being offered at the initiation of DS TB treatment.

If H is found to resistant, the patient will be initiated on all oral H mono-poly DR TB regimen at
the PHI level while awaiting the results of SL LPA and the regimen would be appropriately
modied at the N/DDR TBC if Lfx/Mfx(h) resistance is detected on SL LPA. The patients with RR TB
will be considered for shorter MDR TB regimen at N/DDR TBC after ruling out the exclusion
criteria for shorter MDR TB regimen. Decision to start shorter MDR TB regimen will be based on
non-DST and DST based exclusion criteria mentioned in the table below. The patients excluded
from shorter MDR TB regimen would be initiated on all oral longer MDR TB regimen at N/DDR
TBC. In case of additional resistance on LC DST, the all oral longer MDR TB regimen would be
appropriately modied.

Criteria for patients to receive standard DR TB regimen

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In presence of any non-DST based exclusion criteria for shorter MDR TB regimen like pregnancy,
any extrapulmonary disease in PLHIV and disseminated, meningeal or central nervous system
TB, the patient will be initiated on all oral longer MDR TB regimen. If SL LPA result or DST for Lfx,
Mfx, Km, Am, Cm is not available at the time of treatment initiation, the patient will be initiated
on shorter MDR TB regimen only if there is no history of use of any drug like Mfx, Km, Eto, Cfz, Z,
or E for > 1 monthor intolerance to any drugs in the shorter MDR TB regimen. Rest of the
patients will be initiated on the all oral longer MDR TB regimen.

In case of additional resistance, failing regimen, drug intolerance, return after interruption
(>1m) or emergence of any exclusion criteria, the patients already on any MDR/RR TB regimen
would be switched to all oral longer MDR TB regimen at the N/DDR TBC and evaluated further
for presence of additional resistance. MDR/RR Patient with additional resistance to any second
line drugs would also be considered for all oral longer regimen with modication in standard
regimen as described later in this chapter.

Inclusion criteria for newer drugs (Bdq/Dlm)

• Patient aged > 6 years having MDR/RR TB. (Bdq/Dlm can be provided to the patient ≥ 18
yrs, for children & adolescents between 6 to 17 years, Dlm can be provided. Use of Bdq
for 6 to 17 yrs and Dlm for 3 to 6 yrs may be considered only after approval of DCGI.
• non-pregnant females or females not on hormonal birth control methods are eligible.
They should be willing to continue practicing birth control methods throughout the
treatment period or have been post-menopausal for past 2 years; and
• patients with controlled stable arrhythmia can be considered after obtaining cardiac
consultation.

Exclusion criteria for newer drugs (Bdq/Dlm)

• Pregnancy & lactating mother
• currently having uncontrolled cardiac arrhythmia that requires medication;
• having any of the following QTcF interval (Annexure 8) characteristics at screening:
• QTcF ≥ 500 at baseline & normal electrolytes, ECG to be repeated after 6 hours and If
both ECGs show QTcF>500 then the patient should not be challenged with cardiotoxic
drugs.
• history of additional risk factors for Torsade de Pointes, e.g. heart failure, hypokalaemia,
family history of long QT syndrome;

If results of the serum chemistry panel, haematology or urinalysis are outside the normal
reference range (including above listed parametres), the patient may still be considered if the
physician judges that the abnormalities or deviations from normal to be not clinically signicant
or to be appropriate and reasonable. Hypokalaemia, hypomagnesaemia and hypocalcaemia
should be corrected prior to a patient receiving any QTc prolonging drugs.

Caution must be exercised that Bdq/Dlm is not added to a failing regimen in any MDR RR TB
patient already on DR TB treatment.

Caution to be exercised in choosing other group A and B drugs:

• Lzd may cause anaemia, thrombocytopenia, peripheral neuritis and optic neuritis.
Adequate precaution may be taken accordingly.
• Cs should be used carefully in pre-existing seizure disorders not adequately control with
medication. Neurologist consultation should be taken prior to initiation of Cs in such

160
 patients, also psychiatrist opinion should be taken in severe depression as Cs can cause
depression and suicidal tendency.
• Cfz causes dark brown discoloration of the skin. Accordingly, the patient should be
counselled prior to initiation of treatment with Cfz

Regimen for DR TB treatment

Principles of designing a WHO recommended all oral longer MDR TB regimen
In MDR/RR TB patients on longer regimens, all three Group A agents (Lfx/Mfx, Bdq&Lzd) and one
Group B agent (Cfz&Cs) should be included to ensure that treatment starts with at least four TB
agents likely to be effective, and that at least three agents are included for the rest of the
treatment after Bdq is stopped. If only one or two Group A agents are used, both Group B agents
are to be included. If the regimen cannot be composed with agents from Groups A and B alone,
Group C agents are added to complete it.

As the likelihood of stopping Lzd due to toxicity is greater, the all oral longer MDR TB regimen for
India would include the fth drug Cs upfront to prevent the need for replacing Lzd, if dropped.

Under NTEP, the following are the standard DR TB regimens:

1. All oral H mono/poly DR TB regimen
2. Shorter MDR TB regimen
3. All oral longer MDR TB regimen

Standard regimen for initiating treatment of MDR/RR TB or H mono-poly DR TB

*If the intensive phase is prolonged, the injectable agent is only given three times a week in the extended intensive phase.
# Reduce Lzd to 300 mg/day after 6 to 8 months.
@ Pyridoxin to be given to all DR TB patients as per weight band.

• All oral H mono/poly DR TB regimen is of 6 months with no separate IP/CP.

• Shorter MDR TB regimen is of 9-11 months with 4-6 months of IP containing injectables
and 5 months of CP.
o If the IP is prolonged, the injectable is only given three times a week in the extended
intensive phase.
• All oral longer MDR TB regimen is of 18-20 months with no separate IP/CP.
• Newer drugs like Bdq and Dlm would be given for 6 months duration while the dose of
Lzd will be tapered to 300 mg after the initial 6-8 months of treatment.
o This regimen will also be used for treatment of XDR TB patients with 20 months duration.

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Treatment initiation
At Peripheral Health Institutions:
If LPA reveals H mono-poly DR TB, the patient will be initiated on the all oral H mono/poly
regimen even at the PHI level. In case of any additional resistance, the patient may be sent to the
N/DDR TB Center for modication in the regimen.

At N/DDR TB Centres
If the DRTs reveal MDR/RR TB, the patient must be counselled by the PHI staff to visit the N/DDR
TBC with a family member for management without further delay. The rst-line treatment will be
stopped and the appropriate standard DR TB regimen (shorter or longer) will be initiated at the
N/DDR TBC.

In patients put on shorter MDR TB regimen, if any exclusion criteria like detection of additional
resistance, intolerability of shorter MDR TB regimen emerges, the patient is counselled by the
PHI staff and referred to the N/DDR TBC immediately. The pretreatment evaluations and
baseline a DSM assessment done at the N/DDR TBC would be considered valid, only if
additional resistance is reported on the basis of direct SL LPA. However, the pretreatment
evaluation would be need not to be repeated within one month, unless clinically indicated the
additional resistance is reported on the basis of LC-DST, the standard shorter MDR TB regimen
shall be stopped and the N/DDR TBC committee would consider initiating all oral longer MDR TB
regimen with or without modications as appropriate. As the patient would still be in early IP, the
patient would be re-classied and re-registered for a new episode of treatment and updated on
Nikshay on the same ID. For monitoring the treatment outcome, the patient would be accounted
for the most recent episode of treatment. However, patients who need regimen change in CP will
be declared with outcome as “Treatment failed” and re-registered for the next episode of an
appropriate treatment.

The N/DDR TBC Committee can decide on a case-to-case basis, the need for admission of DR TB
patients for initiation of treatment. The patient is initiated on standard regimen (shorter or
longer) at N/DDR TBC on indoor or outpatient basis.

All oral longer MDR TB regimen can be initiated on outpatient basis if the patient is satisfying all
following risk assessment criteria:
• QTcF< 450 ms in males and <470 ms in females at baseline.
• Normal serum K, Mg, Ca at baseline.
• No history of structural cardiac abnormalities (LVH or RVH secondary to hypertension
can also cause ECG changes, however mere presence of LVH need not be an exclusion
criteria) or ECG abnormalities.

Patients with QTcF between >450 to 500 ms in male and > 470 to 500 ms in female upto 500ms
require daily monitoring of ECG for 3 days along with evaluation and correction of any
electrolyte abnormalities. A cardiologist opinion may need to be taken.

The rst dose is given under supervision at the treatment initiating facility for ambulatory
patients. In patients who are admitted, the duration of indoor management would be decided by
N/DDR TBC committee as clinically indicated. On discharge, the patient will be provided with a
maximum seven days of drug supply for the transit.

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Once initiated on treatment, MO-PHI to identify and prepare the treatment supporter and
provide drugs and records to the treatment supporter DTO to coordinate for advance
information to concerned PHI. The results of FL/SL LPA are expected to be available within a
week of specimen submission. The results of LC DST are expected to be available after 6-8 weeks
of specimen submission. Based on results, if no additional resistance is detected, the patient will
be continued on the same regimen. The nodal ofcer of the N/DDR TB center must make all
efforts to get the reports of SL LPA and SL LC DST from the C-DST lab at the earliest.

Patients need to be offered counselling with details of the nature and duration of treatment
including information on the second line drugs; need for regular treatment; possible side-effects
of these drugs; other drugs to be avoided and the consequences of irregular treatment or
premature termination of treatment. Female patients will receive special counselling on family
planning. Whenever standardized, WHO endorsed DST methods for Z, Cfz, Bdq, Dlm etc., are
available and included as programme policy, patients found to be resistant to any of the above
drugs would be managed with the all oral longer regimen with the modication in standard oral
longer MDR TB regimen if required.

Replacement drugs in sequence of preference

Drugs of the component regimens will require to be replaced in case of an adverse drug
reaction, poor tolerance, contraindication or non-availability of the component drugs of the
combination regimen or resistance detected on baseline LC DST.

In case of the need for replacement of any of the component(s) in the all oral longer MDR TB
regimen, the following broad principles apply:
1. The drugs are replaced according to their efcacy, no demonstrable resistance, prior use,
side-effects prole and background resistance to the replacement drug in the country as
per the NDRS report.
2. The regimen should preferably be fully oral. However, in certain circumstances, an
Injectable may have to be used for the need of efcacy and side-effect prole.
3. Five drugs are to be used in IP and at least 4 drugs in CP. However, in case of individual
need for replacement of one of either Lzd, Cs or Cfz without replacement of Bdq or FQ,
there is no need to add another drug as there will still be minimum 4 effective drugs in IP
and 3 drugs in CP as per the WHO principles. For replacement of Bdq or FQ, the
scenarios have been given in the table below.
4. Dlm and Am will not be used in CP.
5. Though Imp-Cln is 4th in the sequence of drugs of group C, it will only be used as the
last resort for designing the regimens, operational issues of a Peripherally Inserted
Central Catheter (PICC) placement for the entire duration of its use, need for
admission to a NDR TBC.

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The following sections deal with the replacement of drugs in the various DR TB regimens:
Sequence of using replacement drugs to modify the regimen

Drug dosage and administration

The dosage of drugs would vary as per weight of the patients. Adult patients (≥ 18 years) would
be classied in weight bands of <16 kg, 16-29 kg, 30-45 kg, 46-70 kg and >70kg. All drugs in
the regimen are to be given on a daily basis under observation. Injectable will be administered
for six days/week (excluding Sundays). All morning doses are to be supervised by the treatment
supporter. After taking the morning doses on Saturday, next day’s oral drugs would be given to
the patient to be taken at home on Sunday. Empty blisters of drugs taken unsupervised in the
evening and on Sundays are to be collected by treatment supporter. In cases of drug intolerance
– Eto, Cs and Na-PAS can be given in divided doses (twice a day).

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The dosage for drugs used in various DR TB regimens by weight bands for adults are enumerated
in Table 6.7. These are in accordance to the WHO recommended doses of anti-TB drugs for
adults and paediatric patients.

Bedaquiline: All patients eligible for Bdq will receive Tab. Bdq400 mg once daily for the rst 2
weeks and 200 mg 3 times a week (with at least 48 hours between doses) for the following 22
weeks, in combination with the regimen. The regimen will be continued beyond 24 weeks of Bdq
administration for the NTEP recommended duration of treatment.
Week 0–2: Bdq 400 mg (4 tablets of 100 mg) daily (7 days per week) + other drugs;
Week 3–24: Bdq 200 mg (2 tablets of 100 mg) 3 times per week (with at least 48 hours between
doses) for a total dose of 600 mg per week + other drugs; and

Week 25 (start of month 7) to end of treatment: Continue other second-line anti-TB drugs only as
per NTEP recommendations.

If taking a light meal with Bdq and other anti-TB drugs, patients should not consume milk-
containing products at the same time, as the calcium in these can decrease the absorption of
FQs. Also, large fatty meals should be avoided, as these can impair absorption of some of the
other anti-TB drugs (Cs, H, etc.,).

The following medications are disallowed during the 24-week administration of Bdq and up to
one month after the last dose of Bdq because of potential drug–drug interactions:
• systemic use of moderate and strong CYP3A4 inhibitors, e.g. azole antifungals:
ketoconazole, voriconazole, itraconazole, uconazole; ketolides such as telithromycin
and macrolide antibiotics other than azithromycin for more than 2 consecutive weeks;
• systemic use of strong CYP3A4 inducers, e.g. phenytoin, carbamazepine, phenobarbital,
St. John’s wort and rifamycins (rifampin, rifabutin, rifapentine); and
• cholesterol lowering medications of the “statin” class. (Add Annexure on Drugs to avoid
with BDQ and Dlm)

165
Dosage of DR TB drugs for adults

1
For H mono/poly resistant TB;
2
For adult more than 60 yrs of age, dose of SLI should be reduced to 10mg/kg (max up to 750 mg)
3
In patient of PAS with 80% weight/volume the dose will be changed to 7.5gm (16-29Kg); 10 gm (30-45 Kg); 12
gm (46-70 Kg) and 16 gm (>70 Kg)
4
Drugs can be given in divided doses in a day in the event of intolerance

Bdq should be used with caution in PLHIV infection treated with ARVs that exhibit drug-drug
interactions with Bdq (efavirenz) or prolong the QT interval (lopinavir/ritonavir) as well as in
patients with comorbidities (such as diabetes) or persons with drug or alcohol use, due to limited
or no information. Bdq has been used in large cohorts of patients. While experience is growing
and drug monitoring is still required, concern is less, due to cohort data reviewed from South
Africa. However, frequent clinical and cardiac evaluation is required in these patients.

Bdq will be provided through NTEP. The dosage of BDQ would apply to all weight bands while the
dosage of other drugs in the regimen would be as per weight bands in accordance to guidelines.

Delamanid: All patients >12 yrs of age will receive Tab. Delamanid 100 mg (two tablets of 50
mg) orally twice a day for 24 weeks in combination with other drugs in the regimen while
patients belonging to 6 to 11 yrs of age group will receive Tab. Delamanid 50 mg (one tablets of

166
50 mg) twice a day for 24 weeks. Remaining drugs in regimen will be continued beyond the 24
weeks of Dlm administration for the NTEP recommended duration of treatment. It is important
that Dlm be taken daily preferably after a standard meal to improve bioavailability.

Patients should not consume milk-containing products at the same time, as calcium can
decrease the absorption of FQs. Also, large fatty meals should be avoided as these can impair
absorption of some of the other anti-TB drugs (Cs, H, etc).

Counselling for DR TB patients

Counselling offers an opportunity to explore and heal past and present difculties faced by
patients in a condential and supportive environment, especially while dealing with life issues.
The role of counselling in the management of DR TB is signicant. A competent counsellor can
sensitize patients in several key aspects of TB with particular emphasis on DR TB care and
control. It is important to understand the mode of disease transmission and its prevention.

A counsellor can help the patient to better understand importance of regular treatment as well
as consequences of deviation from the treatment. His/her role is to empower patients with
disease related information and enable him to take informed decision related to treatment
adherence. Treatment duration of any DR TB regimen is long enough for the patient which needs
multiple sessions of counselling, preferably more frequently in the initial phase of treatment.

Documentation is an essential part of counselling. It helps the counsellor in being aware about
the progress of the sessions and targets achieved in the process. It informs about the efforts
made by the patients to make desired changes. It also gives space for the counsellor to record
his/her observations. In case of any legal issue cropping up, the documentation stands as proof
of the work done with the client. The DR TB counselling register that is available with the
counsellor serves the purpose of documentation. NTEP provides a counsellor at every NDR TB
centre for this purpose.

Extension of treatment in various DR TB regimens

All oral H mono-poly DR TB regimen
Total duration of H mono-poly DR TB regimen is 6 months can be extended to 9 months in
certain conditions. In patients with extensive disease; uncontrolled comorbidity; extra-
pulmonary TB; if smear at the end of 4th month is found positive and three conditions mentioned
in table 6.6 sequence of replacement drugs where in regimen is modied, the treatment may be
extended to 9 months. In CNS, skeletal and milliary TB, treatment may be given up to a year. In
patients who remain sputum smear positive at the end of 5-month or later of treatment, the
outcome will be declared as treatment failure.

Shorter MDR TB regimen

Total duration of shorter MDR TB regimen is for 9-11 months, depending on IP duration. IP
should be given for at least four months. After fourth month of treatment, if the result of sputum
microscopy is negative then CP should be initiated. If sputum smear microscopy does not
become negative by the fourth month of treatment, subject the patient to FL LPA and SL LPA and
culture DST. If no additional resistance is detected, the IP should be prolonged until sputum
smear converts. If the intensive phase is prolonged, the injectable agent is only given three times
a week. IP should be extended to 5th or 6th month based on smear results at the end of 4th and
5th month of treatment. This will be done for a maximum of 2 months (i.e., total duration of IP is
not more than 6 months). Duration of CP is xed for 5 months. If the patient remains smear

167
positive at the end of 6th month of treatment, the patient will be declared as “Treatment
Failure”, re-evaluated as per integrated DR TB algorithm and initiated on an appropriate
modied regimen based on the extended DST.

All oral longer MDR TB regimen

Total duration of all oral longer MDR TB regimen is 18-20 months. At the end of 6th month of
treatment, the patient must be reviewed based on the 5th month culture result. If 5th month
culture result is not available at the end of 6th month, decision to tapper the dose of Lzd to half
(300/150 mg) will be based on 4th month culture result. If the 5th or 4th month culture result
(whichever applicable) remains positive, the dose of Lzd (600/300 mg) and the regimen is
extended by 1 more month. However, the duration of new drugs (Bdq or Dlm) is limited to 24
weeks only. Decision for continuation of extended IP with Lzd (600/300 mg) beyond 7th month,
is decided based on the culture results of 6th/5th month and the clinical/radiographic response.
Extension of IP beyond 8th month is not permitted and patient should be switched to CP. (i.e.,
total duration of treatment is not more than 20 months).

If the patient continues to remain culture positive or reverts back to culture positive after 8
months of treatment, the patient is declared as “Treatment failed”, re-evaluated as per
integrated DR TB algorithm and initiated on an appropriate modied regimen based on the
extended DST. For XDR TB patients the duration of all oral longer MDR TB regimen would be for
20 months.

Patient ow for DR TB patients

• N/DDR TBC and the PHI concerned should be involved actively in management of all DR
TB patients;
• DDR TBC will be the reporting unit for the respective district and will register all MDR/RR
TB and H mono/poly DR TB patients initiated on any regimen at N/DDR TBC. The patient
will be registered in the PMDT notication register with issue of unique PMDT number.
Patient details will also be entered and regularly updated on Nikshay;
• Similarly, NDR TBC will be the reporting unit for catering districts. All DR TB patients
initiated on treatment from respective districts will be registered in PMDT notication
register. Patient details would be entered and regularly updated on Nikshay. Overall
accountability of all such patients will be shared by the concerned DDR TBC and DTO;
• PMDT treatment card of DR TB patients managed at the concerned DR TBC for
pretreatment evaluation will be opened by responsible staff (SA at NDR TBC/ DR TB & TB
HIV coordinator at DDR TBC) of N/DDR TBC;
• After pretreatment evaluation and initiation of treatment, the patient should be referred
back to the PHI with up to a maximum of one week’s supply of drugs, arrangements for
injections in transit and a copy of the PMDT treatment book and referral form under
intimation of the DTO. The respective DTO/ MO-PHI should be informed by the
concerned DR TBC on referral of patients for ambulatory care in advance, by means of
the NTEP PMDT referral for treatment form via Nikshay, email or mobile phone;
• Drugs provided to the patients to cover for transit period may be counted as
unsupervised doses. However, as much as possible, efforts should be made by the
district staff to restrict these transit doses;
• DTO arranges for availability of the monthly drug box to the treatment supporter (via the
TU staff like STS/TBHV) and the patient records at the identied treatment support
centre with timely information to the respective MO-PHI;

168
 • MO-PHI is responsible for supplying patient records and drugs to the designated
treatment supporter. The MO-PHI will need to make suitable arrangements during
intensive phase of the treatment for daily injections, including free sterile needles and
syringes; and
• Patient’s information as per PMDT treatment book and aDSM treatment review form as
detailed later must be regularly updated on Nikshay (at least weekly) by the concerned
eld staff responsible.

Overall responsibility of monitoring the patient’s progress on treatment, including follow-up is

with the MO-PHI where patient is being treated with support of the respective TU team.

Treatment Interruptions & DRTB

Management of DR TB patients with treatment interruptions and lost to follow-up
All efforts must be made to ensure that DR TB patients do not interrupt treatment or are lost to
follow-up. Action should be taken to promptly retrieve patients who fail to come for their daily
dose by the treatment supporter as discussed later. The following strategies are applicable for
patients who interrupt treatment:

Patients who miss doses: In shorter MDR TB regimen, all missed doses during IP must be
completed prior to switching the patient to CP. Similarly, all missed doses during CP must be
administered prior to ending treatment. In longer MDR TB regimen, all missed doses during
treatment must be administered prior to ending treatment.

Patients who interrupt treatment for less than one month: When the patient returns to resume
treatment, the treatment will be continued. However, the duration of treatment will be extended
to complete the regimen. The follow-up cultures will be done as per the schedule.

Patients who are “lost to follow-up” (interrupt treatment continuously for one month or more)
and return back for treatment: Such patients will be given an outcome of “lost to follow-up”. The
patient would be subjected to repeat NAAT & FL /SL LPA and LC DST as per the diagnostic
algorithm to restart with appropriate treatment. If there are signs of impending treatment failure
for any MDR RR TB patient with or without additional resistant to second line drugs, the patient
should be switched to an all oral longer DR TB regimen and evaluated further to modify
appropriately based on DST results if required. If a patient has received the shorter MDR TB
regimen for more than one month and returns for treatment after an interruption of one month
or more, the patient is not restarted on a shorter MDR TB regimen.

MDR/RR TB patients on Bdq/Dlm containing regimen who interrupt treatment or are “lost to
follow-up” or recurrent DR TB

Patients who interrupt Bedaquiline treatment during the rst two weeks of Bdq course and
returns to resume the treatment:
• if interruption is up to 7 days, Bdq containing regimen will be continued to complete the
doses and the duration of treatment will be extended to complete IP. Follow-up cultures
will be done as per the revised schedule; and
• if interruption is more than 7 consecutive days, Bdq course will be reloaded (started
afresh) and a fresh specimen collected for culture. The culture isolate must be stored for
Bdq DST in future.

169
Patients who interrupt Bedaquiline treatment during 3-24 weeks of Bdq course and return to
resume treatment:
• if interruption is up to one month, Bdq containing regimen will be continued to complete
the doses and duration of treatment will be extended to complete full course of Bdq .
Follow-up cultures will be done as per revised schedule; and
• if interruption is more than one month, Bdq will be permanently discontinued. Such
patients will be given an outcome of “Lost to follow-up” (LTFU), registered afresh and
initiate all oral longer MDR TB regimen with appropriate modication. A sputum specimen
will be collected for culture. The culture isolate must be stored for Bdq DST in future.

Delamanid:If the patient misses one or more doses of Dlm during treatment up to a maximum of
one month, one should continue the treatment and complete the Dlm for rest of the period
which may prolong the Dlm containing phase beyond 24 weeks from initiation of treatment to
make the adjustment of missed dosage.

Patients who initiated on Bdq/Dlm containing regimen and return after treatment interruption of
one month or more will be declared as “loss to follow up”. Such patients would not be considered
eligible for administration of same drug (Bdq/Dlm) anymore.

Where further treatment is concerned, if the patient has any indication of a treatment failure or
recurrence, the NDR TBC Committee will be contacted to discuss whether s/he should be
retreated. The decision will be made on a case-to-case basis, using all available bacteriological
and clinical data.

Follow-up evaluations during treatment

The follow-up evaluation schedule during treatment for DR TB patients managed with various
regimen classes are summarized in the table below:

170
Follow up evaluation schedule of DR TB patient during treatment by regimen

171
The most important evidence of response to DR TB treatment is conversion of sputum smear and
culture to negative. Good quality sputum specimen is therefore essential to get reliable results
that form the basis of monitoring bacteriological response to treatment.
Smear examination would be used on a monthly basis from 3rd month onwards to guide the
decision on moving from IP to CP in shorter MDR TB regimen and extension of treatment to 9
months for all oral H mono/poly regimen.

For H mono/poly regimen, follow up culture would be done at 3rd, 6th and 9th month (if
applicable)

For shorter MDR TB regimen, smear microscopy would be continued on monthly basis from 3rd
month onwards if IP needs to be extended if the previous month smear is positive up to a
maximum of six months while follow-up culture will be done at the end of IP, end of extended IP
and end of treatment. If smear/culture remains positive at the end of IP and/or extended IP, a
fresh specimen/culture isolate of that time will be subjected to FL/SL-LPA to check for
amplication of resistance to FQ/ SLI or InhA mutation. If the patient is found to be susceptible to
both FQ and SLI at fourth month of treatment, the intensive phase will be extended on monthly
basis up to a maximum of six months. At end of extended IP or later, if any resistance is detected
by SL-LPA OR InhA mutation detected on FL-LPA OR if found to be culture positive, the patient
will be declared as treatment failure. The patient is then re-evaluated for all oral longer MDR TB
regimen with appropriate modication if required.
DST to Mfx (1.0), Lzd, Z*, Cfz*, Bdq* and Dlm* (*whenever available) will be set up on liquid
culture on the LPA deposits only for all MDR/RR TB patients if patient remains smear/culture
positive at beyond end of IP in shorter MDR TB regimen and beyond 6th month treatment for any
longer MDR RR TB regimen. Long term follow-up will be done with six monthly cultures among
symptomatic patients till two years after completion of any DR TB regimen.

Smear conversion is less reliable than culture conversion, which reects viability of tubercle
bacilli even in very low bacilli per ml of sputum and is a more accurate reection of response to
treatment. Hence, for all patients put on all oral longer regimen, culture will be done as per table
7.1 to decide on extension of treatment regimen. Patients will be considered smear converted
after having two consecutive negative smears taken at least one month apart. Patients will be
considered culture converted after having two consecutive negative cultures taken at least one
month apart.

Time-to-culture conversion is calculated as the interval between the date of DR TB treatment

initiation and date of the rst of these two negative consecutive cultures (date of sputum
specimens collected for culture should be used).

Follow-up sputum culture should be done on liquid culture. In case of extension of treatment,
the follow-up culture months will shift by every month of extension of treatment till maximum
limit specied for all regimen classes. However, it must be noted that the nal treatment
outcome of all DR TB patients will be declared on the basis of follow-up culture results only.

Treatment outcomes
The progress of the patient on treatment would be monitored using interim as well as nal
treatment outcomes for various DR TB regimens.

Interim outcomes
Culture conversion: Patient is considered to have culture converted when two consecutive

172
cultures, taken at least 1 month apart, are found to be negative. In such a case, the specimen
collection date of the rst negative culture is used as the date of conversion.

Culture reversion: Patient is considered to have culture reverted when, after an initial culture
conversion, two consecutive cultures, taken at least 1 month apart, are found to be positive. For
the purpose of dening Treatment failed, reversion is considered only when it occurs in the
continuation phase.

The term microbiological conversion/reversion can also be used either for smear or culture
based follow ups.

Final outcomes
The nal treatment outcome denitions would vary with type of regimen & the duration of
treatment.

Outcomes for all oral H mono/ poly DR TB patients

The denitions to use when assigning outcomes are the same ones as for drug-susceptible TB.
No new outcome denitions (or registration categories) are warranted.

Cured: Microbiologically conrmed H mono/poly DR TB patients at the beginning of treatment

who was culture negative at the end of the complete treatment (To be discussed)
Treatment completed: A H mono/poly DR TB patient who completed treatment without
evidence of failure or clinical deterioration BUT with no record to show that the smear or culture
results of biological specimen in the last month of treatment was negative, either because test
was not done or because result is unavailable.

Failure: A H mono/poly DR TB patient whose biological specimen is positive by smear or culture

at 5 months or later (check if the denition of failure given under “Outcome for all oral longer
regimen” will apply here also).
Lost to follow up: A H mono/poly DR TB patient who interrupted treatment for consecutive 1
month or more

Not Evaluated: A H mono/poly DR TB Patient for whom no treatment outcome is assigned. This
includes former “transfer-out” & “still on treatment”

Regimen Changed: A need for permanent discontinuation of existing regimen and initiation of
new regimen with change of at least one or more anti-TB drugs prior to being declared as failed.
(To be discussed- same as above)

Died: A patient who has died during the course of anti-TB treatment

Outcomes for shorter MDR TB regimen

Cure: Microbiologically conrmed MDR/RR TB patient at the time of beginning of the treatment,
completed the treatment and culture was negative at end of treatment and on at least one
previous occasion.

Treatment completed: A patient who has completed treatment according to guidelines but
does not meet the denition for cure or treatment failure due to lack of microbiological results.

Failure: Treatment terminated or need for permanent regimen change in CP because of lack of
microbiological conversion by end of extended intensive phase or microbiological reversion in
the continuation phase after conversion to negative or evidence of additional acquired
resistance to drugs in the regimen or adverse drug reactions (ADR).

173
Died: A patient who dies for any reason during the course of treatment.
Lost to follow-up: A patient whose treatment was interrupted for one month or more for any
reasons prior to being declared as failed.

Not evaluated: A DR TB patient for whom no treatment outcome is assigned, this includes
former “transfer-out”.

Regimen changed: A need for permanent discontinuation of existing regimen and initiation of
new regimen with change of at least one or more anti-TB drugs prior to being declared as failed.

Outcomes for all oral longer regimen for MDR/RR TB (except shorter MDR TB regimen)
and/or XDR TB patients

Cure: Microbiologically conrmed MDR/RR TB patient at the time of beginning of the treatment
completed the treatment and three or more consecutive cultures taken at least 1 month apart
from 6-8 months onwards are negative including culture at the end of treatment.

Treatment completed: Treatment completed as recommended by the national policy without

evidence of failure but no record to declare it as cured.
Treatment failed: Treatment terminated or need for permanent regimen change of at least two
or more anti-TB drugs from 8th months onwards because of
• lack of microbiological conversion by the end of the 8th month of treatment or
• microbiological reversion in the 8th month or later after conversion to negative or
• evidence of additional acquired resistance for drugs in regimen or
• adverse drug reactions (ADR).

Died: A patient who dies for any reason during the course of treatment.
Lost to follow-up: A patient whose treatment was interrupted for one month or more for any
reasons prior to being declared as failed.

Not evaluated: A patient for whom no treatment outcome is assigned, this includes former
‘transfer- out’.

Regimen changed: A need for permanent discontinuation of existing regimen and initiation of
new regimen with change of at least one or more anti-TB drugs prior to being declared as failed.
(To be discussed – will this also apply to regimen changes because of baseline resistance report
that comes 1 month later / Will this apply to drug change due to toxicity / Will this apply to
regimen change due subsequent development of resistance)

Treatment outcome is dened by reviewing patient PMDT treatment card. The treatment
outcome and date the patient stopped treatment is written in the appropriate column in the TB
treatment card. Transferred out patient should be tracked vigorously before declaring them as
not evaluated or lost to follow up. The date on which the patient stopped treatment is the date of
the last dose of drugs taken. Details of treatment outcome should be updated in Nikshay. The
MO of the PHI should record the treatment outcome in the treatment card and sign it. The
treatment card of the patients whose outcome has been declared should be handed over to the
STS during his routine monthly visits. Every patient started on treatment must be given one and
only one treatment outcome for each episode of treatment regimen.

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Non-Tuberculous Mycobacteria (NTM)
A large number of Mycobacteria other than Mycobacterium tuberculosis are being increasingly
recognized as a cause of human disease. Commonly referred to as non-TB Mycobacteria (NTM),
they are also known as atypical mycobacteria, anonymous mycobacteria or mycobacteria other
than tubercle bacilli (MOTT). NTM are ubiquitously distributed in the environment and hence
also known as environmental mycobacteria. They are distinct from M.tb in their characteristics
that they can survive outside the human or animal host. They are generally nonpathogenic or
opportunistic pathogens and most commonly causes disease when there is immunosuppression
or injury, except for few species which infect immune-competent humans.

Often these bacteria inhabit the respiratory passages in the form of commensal organisms.
Pulmonary infection from NTM though rare, can cause disease similar to TB. They more
commonly infect the skin, soft tissue, lymph nodes, implant devices, wounds, bones and joints.
Disseminated NTM disease is mostly seen in patients who are immunosuppressed or who have
Acquired Immunodeciency Syndrome (AIDS).

Though NTM are widely distributed in the environment, the clinical infection is rare. They may be
falsely recovered from clinical specimens due to laboratory contamination or contamination of
medical instruments. Chronic pulmonary infection due to M. avium complex and M. Kansasii
generally occurs in elderly persons especially males who are smokers or who have preexisting
lung lesions. Cervical lymphadenopathy occurs in children due to M. Scrofulaceum, while skin
and soft tissue infections may develop from M. Fortuitum, M. Chelonei, M. Xenopi and M.
Ulcerans. Exposure of humans to NTM may occur while bathing, swimming and drinking and the
organism can also gain entry through cuts and abrasions. However, the risk of infection is
generally less. Disseminated lesions are found in immunocompromised patients due to
infection from M. Avium complex. Sometimes, M. Chelonei may cause very indolent pulmonary
infection.

Diagnosis of NTM
Because of their omnipresence in our environment, isolation of NTM from non-sterile body sites
does not imply true infection or disease, per se. Repetitive isolation, signs of clinical disease,
radiological abnormalities, the exact species isolated and predisposing conditions of the patient
involved, are all helpful in determining whether the isolated mycobacteria are to be considered
causative agents of the patient’s disease. In normally sterile sites, isolation of NTM, preferably
backed up by histological evidence of granulomatous inammation, sufces for the diagnosis of
NTM disease.

Table : Most frequently isolated Non-TB Mycobacteria and their sites of infection

175
The minimum evaluation of a patient presenting with features suggestive of non-TB
Mycobacterial (NTM) lung disease should include the following:
• chest radiograph or chest high-resolution computed tomography (HRCT) scan. HRCT
may be done in settings where access to this technology is available. However, it is not
mandatory for evaluation and decision to treat the patient;
• three or more sputum specimens for acid-fast bacilli (AFB) analysis;
• exclusion of other disorders, such as TB;
• expert consultation should be obtained when NTM are recovered that are either
infrequently encountered or that usually represent environmental contamination.
Patients suspected of having NTM lung disease but who do not meet the diagnostic
criteria should be followed until the diagnosis is rmly established or excluded; and
• making the diagnosis of NTM lung disease does not, per se, necessitate the institution of
therapy, which is a decision based on potential risks and benets of therapy for
individual patients.

Clinical, radiological and microbiological criteria are equally important and all must be met to
make a diagnosis of NTM lung disease. The following criteria apply to symptomatic patients with
radiographic opacities, nodular or cavitary or an HRCT scan that shows multifocal bronchiectasis
with multiple small nodules. These criteria best t with Mycobacterium avium complex (MAC), M.
Kansasii and M. Abscessus.

Clinical
• pullusion of any other etiologies.

Radiological
• radiological ndings pertain to nodular or cavitary opacities on chest radiograph; and/or
• HRCT scan that shows multifocal bronchiectasis with multiple small nodules.

Microbiological
Table: Microbiologic criteria for diagnosis of NTM lung disease

The diagnostic processes for NTM to be followed at C-DST laboratories are detailed in Annexure
7. The laboratory staff would be separately trained in these standard operating procedures for
laboratory conrmation of NTM. For more information on NTM including extra-pulmonary
NTM, microbiologists are encouraged to refer to the latest American Thoracic Society (ATS)
guideline.

Treatment of NTM:
NTM are uncommonly encountered clinical pathogens; some species, in fact, are much more
likely to be isolated as a result of specimen contamination than as a result of disease. It can also
be isolated from patients with lower respiratory infections especially from patients who live in
areas of higher density of environmental NTM presence. This is a transient carriage and usually
does not meet the criteria for NTM disease. However, even these species can, under some
circumstances, cause clinical disease. The clinician, therefore, must always know the context in
which an NTM isolate was obtained to assess accurately the clinical signicance of that isolate.
Given these complexities, the treatment of NTM will be the prerogative of the NDR-TBCs. When
questions about the clinical signicance of an NTM isolate arise, expert consultation is strongly
encouraged. In this context, important points to note would be:

176
 • treatment recommendations for infrequently encountered NTM are made on the basis
of only a few reported patients. With that limitation in mind, unless otherwise stated, the
duration of therapy for most pulmonary NTM pathogens is based on treatment
recommendations for more frequently encountered species such as MAC and M.
kansasii (e.g., continue therapy for at least 12 months after the last negative sputum
culture). For disseminated disease, treatment duration for most NTM pathogens is the
same as for disseminated MAC infection;
• treatment of NTM disease is generally not directly analogous to the treatment of TB. In
vitro susceptibilities for many NTM do not correlate well with clinical response to
antimycobacterial drugs. Recommendations for routine in vitro susceptibility testing of
NTM isolates are limited. The clinician should use in vitro susceptibility data with an
appreciation for its limitations;
• empiric therapy for suspected NTM lung disease is not recommended; and
• there are not widely accepted criteria for choosing patients with NTM lung disease for
resectional surgery. In general, the more difcult an NTM pathogen is to treat medically,
the more likely surgery should be considered from a risk/ benet perspective. Expert
consultation is strongly encouraged at NDR-TBC.
Suggested treatment regimen covering maximum NTMs mainly MAC
• Rifampicin 450-600 mg OD;
• Ethambutol 800 – 1200 mg OD;
• Clarithromycin 1gm OD (split into two doses); and.
• Add injection Amikacin 750mg-1gm thrice weekly for the rst 2-3 months.

Intensive phase is for 3 months and can be extended to a maximum of 6 months with all four
drugs. Continuation phase of treatment will be with the same drugs except injectable. This
should be continued for 12 months after sputum culture conversion. Drugs will be given as per
the standard weight bands. If the patient does not culture covert by end of 3 months, then
species identication and DST is required for further management by the NDR-TBC committee
based on expert consultations.

Note:- As the proportion of the patients estimated is very low, drugs will not be available
through NTEP but will have to be made available through the general health system.

Points to note for treatment of NTM

• recommended initial regimen for most patients with nodular/bronchiectatic MAC lung
disease is a thrice-weekly regimen including Clarithromycin 1000 mg or Azithromycin
500 mg, E 25 mg/kg, and R 600 mg administered three times per week;
• recommended initial regimen for bro-cavitary or severe nodular/bronchiectatic MAC
lung disease includes clarithromycin 500–1000 mg/day or azithromycin 250 mg/ day,
E15 mg/kg/day, and R 10 mg/kg/day (maximum, 600 mg). An initial 2 months of E at 25
mg/kg/day is no longer recommended;
• intermittent drug therapy is not recommended for patients who have cavitary disease, or
patients who have been previously treated or patients who have moderate or severe
disease;
• primary microbiologic goal of therapy is 12 months of negative sputum cultures while on
therapy; therefore, sputum must be collected from patients for AFB examination
throughout treatment on monthly basis in IP and quarterly basis in CP after culture
conversion is achieved;

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 • macrolides should not be used as monotherapy for MAC because of the risk for
developing macrolide-resistant MAC isolates;
• macrolide with a single companion drug, E, may be adequate for nodular/
bronchiectatic MAC disease but should not be used in patients with bro-cavitary
disease because of the risk of emergence of macrolide resistance;
• patients respond best to MAC treatment regimens the rst time they are administered;
therefore, it is very important that patients receive recommended multidrug therapy the
rst time they are treated for MAC lung disease; and
• expert consultation should be sought for patients who have difculty tolerating MAC
treatment regimens or who do not respond to therapy.

For further details on management of individual NTMs including EP NTMs, the physicians of
NDR-TBC are encouraged to refer to the latest ATS guidelines.

IMPROVING INTERPERSONAL COMMUNICATION SKILLS IN NTEP TRAINING:

KEY CONCEPTS AND SAMPLE ROLE PLAYS
The principles of the NTEP are:
a. Political and administrative commitment
b. Good quality diagnosis, primarily by sputum microscopy (using microscopy to examine
sputum smears among patients in health facilities)
c. Uninterrupted supply of Good quality drugs (short-course chemotherapy, patient-wise
boxes)
d. Direct Observation of treatment (The right treatment, given the right way)
e. Systematic monitoring and accountability (outcome of each and every case initiated on
treatment).

Successful application of each of these principles depends, in part, upon developing and
maintaining positive relationships among the individuals who work in the Programme, as well as
with the community and patients who are served by the Programme. While technical and clinical
aspects of the Programme must be adequately addressed, social and communication
dimensions are equally necessary to make this information acceptable, and to encourage
Programme participation. Interpersonal communication (IPC) skills are invaluable at all levels of
the NTEP, and are powerful tools to help cure patients, and thereby, to control TB.

For example, quite often patients discontinue treatment as soon as they start feeling better. They
may not understand about drug-resistant TB and that it can be very difcult to cure. This sort of
information needs to be conveyed to patients and their families without causing undue alarm.
Service providers should be able to communicate with the patients in a way that makes patients
feel comfortable and ensures that patients develop condence in the service providers and
ultimately in the services received. The best way to make a patient comfortable is to
communicate in a language that is easily understood by the patient. Sympathy and concern
about the patient and his/her disease should invariably emerge during the conversation. Good
IPC encourages patients to complete treatment and also consult the service provider in case of
any questions or concerns (such as adverse effects of the medications). Willingness to contact the
service provider to clarify any apprehensions is an important indicator of good IPC between
patients and providers.

In addition to improving interactions with patients, good IPC skills will help NTEP staff obtain

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participation from ofcials, laboratory personnel, public sector physicians, and treatment
observers.

PRINCIPLES OF PATIENT-PROVIDER INTERACTION

How we learn to change behaviour
People adopt habits and behaviour for a variety of reasons. Changing behaviour is often a
gradual and complex process.

Information: We often become aware of the need to change behaviours by receiving

information. But information alone is rarely enough to bring about the change. We often have
information but are still not motivated to change our behaviour. Some reasons for this are:
• We don’t believe the information
• We don’t believe that we are capable of changing
• We believe that the behaviour is not under our control
• We believe that the change is not warranted.
Motivation: We often actually get started on a change as a result of a personal experience or
crisis that provides us with the motivation to try a difcult change.

Support: To succeed, most of us receive some form of support. Support comes from something
we nd within ourselves and/or from peers, family, health workers and others who are
important to us.

To help people change their behaviour, good IPC, or “counselling” skills will work toward
providing information, motivating, helping people to overcome obstacles, and providing
support to try to change.

Counselling is a process of enabling/helping someone to overcome a problem; meet a need,

make a decision, or accept their situation. Counselling differs from education. Education
involves providing information. Counselling is a process of helping others use information and
relate it to their own lives. Counselling is not giving advice alone. The aim of counselling is not to
solve other people’s problems but to enable people to solve their own problems. Good
counselling is client-cantered, which means counselling must centre on the client’s feelings,
thoughts, concerns and needs. Thus, counselling is a process of empowering clients to make
their own decisions through dening feelings and providing objective information.

Characteristics of effective counselling:

• Condential
• Non-judgmental
• Non-directive
• Empathetic
• Encouraging
• Reinforcing

Types of Communication
There are two types of communication—verbal and non-verbal. Verbal communication is for
correctly providing facts. This is important, but is only one component of communication. The
other component is non-verbal communication.

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Non-verbal communication creates the atmosphere of the interaction. It can create either a
welcoming, caring environment that makes the facts acceptable and easy to understand, or a
formal, confusing, or even hostile environment that makes it difcult for the facts to be
understood or accepted.

Effective communication skills include active listening, praise and encouragement,

paraphrasing (repeating in slightly different words), questioning, reecting, and non-verbal
communication. Communication is a process by which information, ideas and/or feelings are
exchanged between individuals. The ability to communicate effectively can be learnt.

The development of good verbal and non-verbal communication by improving IPC skills is the focus
of this module. It will help trainers and trainees to develop insights into and improve their own
behaviour. Role plays are a good way to practice interacting with others and to improve IPC skills.

The skills involved in good interpersonal communication include:

• Listening and Understanding
• Demonstrating caring, concern and commitment
• Problem solving and Motivating
Listening and understanding involve more than simply being present while someone is
speaking. Active listening means genuinely hearing the other person’s words. Often, we think
we are listening, but we actually do not pay close attention or do not really hear what the other
person is trying to say. Some key points for improving listening and understanding skills include:

DO:
Offer a seat before interacting with the patient
• Allow sufcient time for the interaction
• If time must be limited, give your full attention during the time you have and the same
should be apparent to the patient
• Be prompt so the other person does not have to wait a long time for your attention
• Sit with the other person so you are at their level
• Maintain eye contact
• Move your head to indicate you are paying attention
• Apologize for any unforeseen interruptions
• Ask open-ended questions (questions that cannot be answered with “yes” or “no”) such
as questions that begin with “What”, “Why” or “How”. These questions require more
than just a few words in the answer
• Periodically summarize what the other person has said to ensure that you have
understood; use their own words to repeat the ideas back to them.

DON’T:
• Interrupt while the other person is speaking
• Yell at the other person
• Ask questions that can be answered with just one word (for example, questions that
begin with “Do”)
• Perform other activities during the meeting
• Ask difcult/embarrassing questions

********************

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You can demonstrate that you care by expressing your understanding of the feelings and
concerns of the other person and by letting them know that you want to help them. You can
reect the other person’s emotions back to them with facial expressions that show you are
concerned. You can also provide verbal feedback to them to show acknowledgement and
recognition of their fears and concerns. Some key points are:
DO:
• Greet the patient
• Say, “Hello, please be seated.”
• Address the person by name or appropriate title but always with respect
• Acknowledge and respond to each of their concerns
• Emphasize that your job is to help them
• Ask about family members
• Treat the person with respect
• Smile.
DON’T:
• Minimize or dismiss their concerns
• Put down the other person
• Act superior
• Assume the person knows their way to another person/room/ofce; give them proper
guidance to their next destination
• Argue with the patient.

*******************
After listening, understanding and showing that you care, you can then use your knowledge of
the NTEP to discuss ways you can work together to solve any problem the other person has with
participating in the Programme. Some key points for this include:

DO:
• Listen carefully to their point of view
• Paraphrase and summarize frequently to make sure that you understand the problem
Use non-technical words
• Help them to comply
• Demonstrate that you are concerned about the patient
• Convey that you understand their fears and apprehensions
• Make them comfortable
• Identify obstacles to their participation

DON’T:
• Assume you know all the answers
• Use technical words
• Treat them as your student
• Tell them to comply
• Assume you know their condition
• Expect compliance without explanation.

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Finally, you can use all of the knowledge, understanding and trust you’ve gained during your
interaction to continue to motivate each person to maintain involvement in the Programme.
Here are some of the main points to keep in mind for motivating:

DO:
• Repeat important information in different ways each time you meet
• Emphasize that your job is to help them
• Emphasize that they will be cured
• Use examples from your own experience
• Tell them that this is what you would recommend to your family members
• Compliment the other person on what they have done well
• Recognize their progress
• Emphasize that their welfare is your concern/job
DON’T:
• Use technical words
• Ignore the efforts the other person has made so far
• Overlook their fear and anxiety
• Ignore or minimize practical barriers
• Criticize their omissions/commissions.

******************

How To Use This Section

This section contains role play examples for NTEP trainers. Groups should perform the role plays
in the section that pertains to their dened role in NTEP. This section must be used throughout the
training to ensure that participants receive consistent information. Role plays should be
performed at appropriate time in the course of training.

The section begins with a role play that should be performed by the trainer(s) to exhibit as many
poor IPC skills as possible. The trainer(s) should tell the group to watch this role play looking for
poor IPC behaviours. The trainer(s) will perform the scene using many of the “DON’Ts” listed
earlier and performing as many incorrect IPC skills as possible. Stress these poor behaviours to
the point of comedy. It must be made clear that poor IPC behaviours are NOT acceptable for
good IPC.

After the performance, have the group make a list and discuss the exhibited poor IPC skills.
Then, address each of these behaviours in turn, and discuss ways that good IPC skills could be
substituted for the poorer ones. Finally, the trainers should perform the same role play again,
using only good IPC skills. After this performance, discuss with the participants the differences
between the two scenes. Also have the participants discuss how they think each person in the
scene felt and the differences in their feelings between the rst and second scene.

Once this discussion is nished, you will have the participants form smaller groups of no more
than six people per group. Then, ask the group members to perform relevant scenes listed in this
book using as many effective IPC skills as possible. Participants who play the role of patient or
person being supervised should be told that they should freely add/invent details which are
realistic. Groups do not need to perform ALL of the scenes listed, but continue to have them

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perform scenes until you feel the important points have been covered sufciently and everyone
in the group appears to be able to exhibit good IPC skills. Trainers and participants should invent
more role play scenes that depict their own experiences and use these in addition to or instead of
the role play scenes in this book.

Motivate the participants. If they are reluctant to do role plays because they feel they are not
“actors”, tell them that they do indeed act every day. Everyone does. Each time they interact with
another person, they are acting. Whenever they try to convince someone to do something, they
are acting. If they are tired but must appear energetic toward their boss, they are acting. When
they rst met their wife or husband and wanted to impress them, they put on their best
behaviour. This is normal, natural behaviour and is acting.

Give them these and other examples from your own experience to help them realize they
already have the skills to do the role plays.
During the role plays, observe each group but avoid interrupting them; interrupt only if the
participants are having extreme difculty or are going totally out of context.

It will be your job to answer questions, talk with the participants about the role plays, lead group
discussions and generally give participants any help they need to successfully develop better IPC
skills. To do this, you will need to be very familiar with the material being taught.

Ensure that each participant understands what they are expected to do in the role play exercises.
By participating in the role play scenes, they will be able to:
• observe and practice the desired practical responses to patients and others
• discuss and share ideas with each other about the situations
• use what they have practised when they encounter these situations during the course of
their own work.

Role plays should be used to sharpen IPC skills so that these skills will come naturally during
NTEP work.

Demonstrate good interpersonal skills yourself

Answer questions from the participants
Encourage the participants to ask questions and make comments. This means that you need to
be available when participants are working on the role play. Respond positively to questions (for
example, say, “Yes, I see what you mean.” or “That’s a good question.”). Avoid facial expressions
and comments that convey that the question is trivial. Always spend enough time with each
participant to answer their questions fully so that both you and the participant are satised. If
you cannot answer a question, say so. Get help from others in the group or from a colleague.

Clarify any issues that the participant nds confusing

Role plays allow you to see what participants do and do not understand. Do not always wait for a
participant to ask for help. Instead, as you watch the participants, offer help during pauses or
breaks, without interrupting. Help the participants understand how to solve practical problems
in actual situations. Identify gaps in a participant’s understanding and skills and provide help to
correct them. If a participant has difculty with the language used, make sure they receive the
help needed to understand the concepts. Use language which is familiar to the participants.

Lead group discussions at the end of each role play

Ask questions to spark discussion. Use open-ended questions to get participants to share

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information and experience. Open-ended questions are questions that require more than a yes
or no answer. When you ask a question, pause long enough to give participants a chance to
think about their answer and to respond. Allow silences so participants can have time to think
before responding.

Check to see if participants are having problems, even if they do not ask for help
If you show interest and give each participant undivided attention, they will be more motivated.
Also, if the participant knows that someone is interested in what they are doing, they are more
likely to ask for help when they need it. Be available to the participants at all times; remain in the
room and look approachable.

Answer participants’ questions willingly and encourage them to ask questions when they arise
rather than waiting until a later time. Call the participants by name when you talk with them.
Maintain eye contact with the participants. Present information in the form of a conversation
rather than by just reading it. Move around the room and use natural hand gestures. Speak
clearly. Vary the pace and pitch of your voice. Paraphrase and summarize frequently to keep
participants focused and clear on a particular idea and to keep discussions on track.
Demonstrate enthusiasm for the work that the participants are doing.

Complement each participant for improvements in understanding, approach or progress. Get

everyone in the group to share experiences so they can learn from each other. Encourage
participants to explore how the role plays apply to their activities and how the IPC skills will help
them in improving cure and case detection.

Manage
Make sure participants have access to supplies and materials when they need them (for
example, chalk and board to write) and that there are no major obstacles to learning (such as too
much noise, not enough light or not enough work space). Make the course interesting by giving
examples from real work situations. Think about the skills taught in the role plays and how they
can be applied to the participants’ jobs. Add these to the points to be made when introducing or
summarizing the role play. Discuss the application of new concepts to real problems. Ask
participants whether they can use the skills that were taught, and discuss any potential
difculties in implementation of these skills. Do not summarily reject alternative methods
suggested by the participants; discuss alternative methods thoughtfully and positively.

*******************

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ROLE PLAYS FOR DOCTORS
Example Role Play

INTRODUCTION
You are a doctor talking to a newly diagnosed TB patient. The Patient does not believe he has TB.
He agrees for an X-ray, but not for sputum examination.

Sample Key Messages

Role Play Scenarios
1. Doctor is meeting with a patient diagnosed as having TB by a private doctor on the basis
of an X-ray report. The patient wants free drugs without delay and without further
examination.
2. Doctor is meeting with a newly diagnosed TB patient, a daily wage-earner and who is
reluctant for direct observation because he does not want to miss work
3. Doctor is meeting with a chest symptomatic patient who is reluctant to give two sputum
samples and is ready to bribe the doctor
4. Doctor is meeting with a newly diagnosed schoolboy who does not want to disclose his
illness
5. Doctor is meeting with a newly diagnosed patient who is a truck driver and who says he
will have difculty coming to the local facility for DOTS when he is working
6. Doctor is meeting with a chest symptomatic patient from a tribal area who insists on
hospitalization
7. Doctor is meeting with a newly diagnosed married woman who does not want her
husband or family to know about her illness
8. Doctor is meeting with the father of a woman who is to be married and he does not want
the community to know that his daughter has TB
9. Doctor is meeting with a newly diagnosed TB patient who wants to leave the area
10. Doctor is meeting with a newly diagnosed sputum-positive TB patient who is reluctant to
bring in her family members for examination because she feels guilty about possibly
having infected them

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INTERPERSONAL COMMUNICATION
INTRODUCTION
For developing good interpersonal communication (IPC) skills, you, the trainer, will need to be
aware of the duties that the doctors have to perform. These include explaining to the patient
about TB and the importance of continuing treatment. They also include developing a strong
bond with the patient to help motivate them to continue participation in the treatment. Doctors
also need to be able to gain the trust of the patient’s family and community. In addition, doctors
must provide an example to their staff about how to interact with patients.

In this section, you will help the doctor participants become better at these duties through role
plays. Through the role plays, poor IPC skills and good IPC skills will be demonstrated.
Demonstrating poor IPC skills develops insight into common behaviours that occur in real
situations. Identication of these will help in working towards developing good IPC skills.
Therefore, for the role plays to be effective, two sessions will have to be done for each scene; one
highlighting poor IPC skills and the other showing good IPC skills. In order to help the
participants, understand the importance and potential pitfalls of non-verbal communication,
perform the following exercise: Tell the participants to just observe you without making any
comments. Then, sit down in a chair with your arms and legs crossed, your body turned slightly
away from the participants, and an annoyed expression on your face. Swing your legs and gaze
around the room. After about 30 seconds, ask the participants to describe what they were
feeling when you were sitting in front of them. List their responses on the board or ip chart.

Then discuss:
• Do we communicate without words?
• Describe ways that we communicate without words.

Discuss with them that we need to be aware of what we are communicating non- verbally, for
example, boredom, dislike, superiority, impatience We also need to be aware of what our patients
and others communicate non-verbally, such as fear, embarrassment, discomfort and shame.

After this discussion, you will tell the participants that you are going to enact a role play scene for
them. Tell them to watch for behaviours that depict poor IPC skills.

Next, choose another trainer (if available) or a participant (if no other trainer is available) to play
the part of the patient in the following role play. A trainer should play the part of the Doctor. You
will then enact the following role play scene using as many poor IPC skills as possible (for
example, you will yell at the patient, you will have them stand while you sit, you will tell them
facts using big words that they don’t understand, and so forth).

After you have completed enacting the scene, ask the participants to list the poor IPC skills. Write
these on the chalk board or ip chart. Then, go through each item listed and discuss the ways in
which the poor behaviours could be improved. Spend as much time as needed to thoroughly
discuss the poor behaviours. Be sure to discuss non-verbal communication elements such as eye
contact, posture, nodding, encouraging or discouraging sounds, etc. Also discuss the messages
about the NTEP that were conveyed during the scenario. Discuss the accuracy of the messages
and, for inaccurate messages, discuss how they could be more accurately conveyed.

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Once the discussion is nished, perform the scene again using only good IPC behaviours.
Afterward, ask the participants to discuss the differences in the two role play scenes. Encourage
them to discuss how the two different scenarios made them feel and how they think the patient
and Doctor felt in each scene.

After this discussion, inform the participants that everyone in the group is now going to practice
IPC skills by doing role plays themselves, with the other participants. Tell them that you will be
handing out their roles and that they will perform the scene twice; once using poor IPC skills,
followed by a group discussion on how the behaviours can be improved, and then again using
good IPC skills.

Split the group of participants into smaller groups of no more than six people per group. Make
sure each small group contains an even number of participants. Then, choose scenarios from
the list of “Role Play Scenarios for Doctors” which can be found at the end of this chapter and
write the roles on separate pieces of paper to give to the participants in each small group. You
can also use your own experiences to come up with other role play scenarios and roles. Make
sure that everyone receives a role.

After you have handed out the roles, give the participants a few minutes to think about how they
will act out their role. Then, have the participants play each scenario in front of their small group
using good IPC skills.

During the play by the trainees, circulate to each group to ensure that participants are exhibiting
the appropriate IPC skills, such as smiling, sitting with the patient or other person, looking at the
other person when speaking, pausing after asking questions, asking open- ended questions,
etc. Also, use the following list of “Key Messages” to guide you as you watch the role play. After
each role play by the participants, stop and have the group discuss the good ideas and IPC skills
that were exhibited in the role play scene, and also discuss things that could improve IPC skills
and improve the accuracy of NTEP messages.

Sample key messages

Listening and understanding
“Please sit-down.”
“How are you feeling?”
“How many children do you have?”
“Where do you stay? How long have you been residing in this area?”
“What are their ages?”
“How is your wife/husband?” “Are they doing well?”
“What do you do for a living?”
“Tell me when you rst fell sick. Since becoming ill what you have done to feel better?” “Have
you ever been ill like this before?”
“Have you ever had to take injections for over two weeks?” “Have you ever had to take pills for
many months?”
“Do you have a cough?”
“For how long have you been having a cough?”
“Is the cough dry or associated with expectoration?” “Do you have any fever?”
“What colour is the expectoration? Is it ever blood-stained?”
“Do you get a pain in the chest when you cough?”

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“How is your appetite?”
“Have you noticed any weight loss, lethargy or weakness?” “What other symptoms do you
have?”
“What medicines are you taking?”
“What medicines have you taken in the past?”
“Have you ever taken a medicine that turned your urine orange-red?”
“Has anyone in your family had an illness like this before?”
“Does anyone in your family also have cough?”
“Have you heard of TB?”
“What do you understand TB to be?” “What do you think causes TB?”
“Have you ever seen an X-ray?”
“What do you think X-ray shows?”
“Have you heard of the microscope sputum test to diagnose TB?”
“Have you ever had a blood or sputum test?”
“Do you know that we need to test your sputum two times to conrm whether you have TB?”
“Do you know that TB can be cured?”
“Do you know that TB can spread from one person to another if it is not properly cured?”
“Do you know that other people in your house can contract TB from you?”
“Do you know that till complete investigations are done we cannot assess the degree of damage
that has been caused?”
“The tests to detect TB are simple and will have to be done at regular intervals to monitor
improvement in your condition.”
“You will have to take your medicines as prescribed so that your illness does not get worse.”
“If you do not take medicines as prescribed, you can develop a more dangerous form of TB and
you will spread the same to your family.”
“Covering your mouth when you cough can prevent the spread of TB to others.”

Demonstrating caring
“TB is not a disease which should cause worry as it is curable if drugs are taken regularly.” “We
want to make sure that you are completely cured.”

“By following the treatment schedule, you will also make sure that you do not spread the disease
to your near and dear ones.”

“All treatment is free here, so please don’t even think about money.”

“Anti-TB medicines are strong drugs that must be taken under direct observation. This will ensure
that you not only take the medicines regularly but also in the right dosage. This way I can know
that you are responding well to treatment and if you have any problems.”

“Anti-TB drugs can have side-effects in some people. If you take them under our supervision, we
will make sure you do not have any uncomfortable side-effects and if you do we will be able to
tackle them at the earliest and prevent any problems.”

“At times people develop resistance to certain drugs and show no improvement when taken
irregularly. If you take the medicines under our supervision, we will be able to observe that the
drugs are having the required effect and you will continue to constantly getting better.”

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“If you have any doubts regarding the duration of treatment, the dosages of the drugs or any
side-effects, please feel free to clarify your doubts with me.”

“To make sure that I have explained things well, please show me on this calendar [show the
patient a calendar] how long you must take medicines.”

“I want to make sure that I give you the best medicines. That is why a sputum test is so
important—so we can be sure that you are getting the right medicines.”

“We don’t want to unnecessarily give you a strong medicine, which is why all the tests are
important. The tests will tell us how severe your condition is and we can give you the best
medicines.”

“If you have any doubts about the disease or the medicines, do not hesitate to ask me.” “It is my
responsibility to cure you.”

“I am not only worried about you, but if you have TB and are not treated then your family may get
sick, and obviously I do not want that to happen and I am sure you also don’t want that to
happen.”

Motivating and Problem solving

“An ordinary cough does not last that long. You have been coughing for a month and we must
nd out why. Only when we know the cause can we cure it completely.”

“A sputum test is very important in diagnosing the type of TB. Only then can we be sure that you
are getting the right medicines for the right duration of time.”

“TB is a disease and should not be a cause for worry as it is fully curable now but it should be
diagnosed early so that it doesn’t spread to other parts of the body or to others. Therefore, it is
necessary to have your sputum tested.”

“A chest X-ray will only tell us that you MAY HAVE TB. X-rays are just shadows and, like any
shadow, can be caused by many different things. X-ray is not a ‘pucca’ test for TB.”

“Sputum examinations do not cause any harm or discomfort. You just have to have two sputum
examinations done as all treatment will be based on their results.”

“If you have any doubts regarding sputum examination or want to know how to bring out
sputum, you can either ask me or the laboratory technician. We will be happy to clarify your
doubts and help you.”

“If the sputum test conrms your disease you will get regular attention and treatment.”

“A sputum test is very important for us to know what medicines should be given to you. We will
start treatment as soon as we get the results of sputum examination.”

“If I or my wife/husband had your symptoms, I would certainly have two sputum examinations
done.”

“The reason for conducting two sputum examinations is because one test may not be enough to
detect the TB germs.”

“It is important to understand that the better the diagnosis, the better will be the treatment and
faster the cure. And for a good diagnosis you must go through all the tests as prescribed. The test

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results will help us prescribe the best drugs for you.”

“Yes, as soon as your sputum test results are available, we will also tell you whether you need to
bring your family members for examination.”

“Yes, your symptoms suggest that you MAY HAVE TB, but we cannot be sure till we test your
sputum.”

“Sputum tests are done free here, and of excellent quality. The test here is better than what you
can get even in a private laboratory.”

“The sputum test is much more accurate than an X-ray. We can actually see whether you have TB
germs when we look at your sputum with a microscope.”

“It is not just you but everyone like you who has a cough for two weeks or more has to go through
all the tests, so that we can know exactly what the problem is and treat you accordingly.”

“If it is convenient for you to come for your sputum tests on your off days, we could make
adjustments for you accordingly. However, you must come for your tests on the appointed day
without fail.”

“To check your progress towards cure we shall again examine your sputum after two months.”

“Tuberculosis is fully curable if complete treatment is given under DOTS.”

“It is very important that the disease does not spread to anyone else, especially to your family
members.”

“After only a few days on the medication, you will stop infecting others, but you will have to
continue on your medication for the full duration of 6 to 7 months.”

“We will arrange for medicines to be provided near your home.”

“I can understand that it is difcult for you to come every day. We will nd a treatment observer
near your place of work.” Or “We will arrange for the treatment observer to give you medicines
before you go for work.”

“If I had TB, I would certainly come every day for treatment for six months and hence you will also
be required to come.”

“I understand that you do not want others to know that you have TB. We will be careful about
that. But it is equally important that others do not get TB from you. If you do not take your
medicines as advised, you will spread TB to others at home and work.”

“Although TB is curable, cure can only take place through constant monitoring. This helps us to
assess your response to the drugs. We have to make sure that there is continuous improvement
and no untoward effects of medicines and that is why you are required to come on every day for
six months.”

“TB can be cured completely only if treatment is uninterrupted. And the only way to ensure
regular treatment is to monitor it.”

“Every dose is crucial and the treatment is designed for your complete cure.”

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“It is not in your interest to take medicines home. Medicines can be lost. It is also easy to forget to
take medicines every day.”

“If you forget to take even a few doses of medicine, you may fall ill again, in which case the
dosage and duration of treatment may increase and would be very expensive and your chances
of getting fully cured will be reduced.”

“If you come in everyday, we can make sure you are getting better and we can observe if you are
having any problems with the medicines.”

“Once you are cured you will be able to work much better and earn more. So, it is in your interest
to complete the entire course and come for regular check-ups as prescribed. These are all aimed
at curing you completely.”

“You don’t want your wife and children to get tuberculosis from you. So, for their sake you should
get well and for that you must take the prescribed treatment regularly and completely.”

“If any of them have symptoms of the disease, they also need to be examined and treated.”

“If your children are infected, they will be physically weak and may not be able to help out with
the household chores or in the elds. More money will be spent on medications. So, it is better
that you get yourself fully treated so that the question of their getting infected does not arise and
they enjoy good health.”

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ROLE PLAY SCENARIOS
(These are only some examples. Use your own experiences to come up with other scenarios and roles.)

Scenario 1: Doctor is meeting with a patient diagnosed as having TB by a private doctor on the
basis of an X-ray report. The patient wants free drugs without delay and without further
examination

Write the following instructions on two separate pieces of paper and hand them out to two
participants.

Doctor: You are a doctor who is seeing a patient diagnosed as having TB by a private doctor on
the basis of an X-ray report.

Patient: You are a newly diagnosed TB patient who wants free drugs without further
examination.

******************

Scenario 2: Doctor is meeting with a newly diagnosed TB patient, a daily wage-earner who is
reluctant for direct observation because he does not want to miss work

Doctor: You are a doctor who is seeing a newly diagnosed TB patient in your ofce.

Patient: You are a TB patient who is a daily wage-earner and you do not want to come for direct
observation because you do not want to miss work.

******************

Scenario 3: Doctor is meeting with a chest symptomatic patient who is reluctant to give two
sputum samples and is ready to bribe the doctor

Doctor: You are a doctor who is seeing a new patient in your ofce.

Patient: You are a person who has had a cough for several weeks with blood in your sputum and
you have come to see the doctor. You do not want to give two samples of sputum and you are
ready to bribe the doctor to just give you medicines without the sputum samples.

******************

Scenario 4: Doctor is meeting with a newly diagnosed schoolboy who does not want to disclose
his illness

Doctor: You are a doctor seeing a schoolboy who has been newly diagnosed with TB.

Patient: You are a schoolboy who has been told you have TB and you do not want to disclose
your illness to your family or your friends.

Scenario 5: Doctor is meeting with a newly diagnosed patient who is a truck driver and who says
he will have difculty coming to the local facility for DOTS when he is working

Doctor: You are meeting with a newly diagnosed patient in your ofce.

Patient: You are a truck driver and it is difcult for you to come to the local DOTS facility when
you are working.

******************

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Scenario 6: Doctor is meeting with a chest symptomatic patient from a tribal area who insists on
hospitalization

Doctor: You are meeting with a new patient in your ofce.

Patient: You are a woman who has had symptoms of TB for several weeks and you want to be
hospitalized until you feel better.

******************

Scenario 7: Doctor is meeting with a newly diagnosed married woman who does not want her
husband or family to know about her illness

Doctor: You are a doctor meeting in your ofce with a woman who is a newly diagnosed TB
patient.

Patient: You are a married woman who has been newly diagnosed with TB and you do not want
your husband or family to know about your illness.

******************

Scenario 8: Doctor is meeting with the father of a woman who is to be married and he does not
want the community to know that his daughter has TB

Doctor: You are a doctor meeting with a man who is not one of your patients but wants to talk
with you.

Father of TB Patient: You are the father of a woman who is being treated for TB and you do not
want the community to know that your daughter has TB.

******************

Scenario 9: Doctor is meeting with a newly diagnosed TB patient who wants to leave the area

Doctor: You are a doctor meeting in your ofce with a TB patient.

Patient: You are a newly diagnosed TB patient who wants to leave the area.

******************

Scenario 10: Doctor is meeting with a newly diagnosed sputum-positive TB patient who is
reluctant to bring in her family members for examination because she feels guilty about possibly
having infected them

Doctor: You are a doctor meeting in your ofce with a newly diagnosed sputum-positive TB
patient and you would like her to bring in her family members for examination.

Patient: You are a newly diagnosed sputum-positive TB patient who is reluctant to bring in your
family members for examination because you feel guilty about possibly having infected them.

******************

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 MODULE 4
PROGRAM MANAGEMENT IN
PERIPHERAL HEALTH
INSTITUTIONS FOR
TB ELIMINATION

Learning objectives:
in this section the participants will learn about the following:
• Peripheral Health Institutions
• Role of PHIs in TB Elimination
• Patient care in PHI
• Infection control
• Program management in PHI
• TB Notication
• Ensuring notication of all TB patients
• Incentives
• Public Health Action by MO-PHI

Introduction
Prevention of infection, early diagnosis, universal DST, appropriate & prompt treatment and
long-term follow-up for early detection of recurrence, are the key steps for elimination of
tuberculosis. Management of LTBI & Co-morbidities are important components of NTEP. Patients
suffering from tuberculosis are residing in the community with their close contacts. Hence all the
above activities have to happen as close as possible to the patients’ residences for the highest
impact. Like all other communicable diseases, tuberculosis also has to be managed by the
primary health care network of the country, which is designed for the delivery of public health
services including basic clinical care.

Since the beginning of NTEP, TB units were considered as the basic reporting units. To facilitate
recording and reporting, a Tuberculosis register was placed in all TUs. All patients initiated on
NTEP treatment in any health facility in the jurisdiction of a TU had to be registered in the TB

194
register of concerned TU (Notication of TB cases on treatment in public sector). The
responsibility of registering cases within a month of initiating treatment was vested with the
Senior Treatment Supervisor of the TU.

However, this practice had one serious drawback. We were missing information on patients who
were diagnosed but not initiated on treatment (initial loss to follow up) and patients treated with
non-NTEP regimen. This prevented the high quality NTEP services to be extended to these
patients. It also prevented loss of highly relevant programmatic information essential for
planning and implementing TB elimination activities in the country. To overcome this, all cases of
TB need to be tracked from the time of diagnosis irrespective of health care sector and notied
from that time point.

Government of India has made TB a notiable disease by an executive order of 7th May 2012
followed by a gazette notication on 19th March 2018. Based on the gazette, whenever a case
of TB is diagnosed in the country by any healthcare provider, they must mandatorily notify this to
the relevant public health authority. Failing to notify will attract prosecution under sections 269
and 270 of the Indian Penal Code (IPC), as the case may be (269 – Negligent act likely to spread
infection of disease dangerous to life / 270 – Malignant act likely to spread infection of disease
dangerous to life).

Notication can be directly done on Nikshay (Public and Private) by a registered healthcare
provider/ Facility. Nikshay also allows further case management in terms of referral for
advanced testing and transfer to any public/ private health facility across the country.

In this section, we will learn about the functions of a peripheral health institution in diagnosis,
management and notication of TB cases.

Peripheral Health Institution

Peripheral Health Institution (PHI) is any health facility managed by at least one medical ofcer
where diagnosis and management of TB happens. The range of services provided by various
types of PHIs may vary. For example, a primary health centre (PHC) is a PHI managed by only one
medical ofcer (a few in some cases) and supportive staff. All community based public health
services like immunization, family planning, surveillance of communicable diseases and basic
clinical services like diagnosis and management of uncomplicated diseases happen in PHCs.
Referral centres like Sub-district/Taluka hospitals are PHIs with more medical ofcers including
specialists and more supportive staff for specialized clinical care and minimal public health
services. District Hospitals, General Hospitals and Medical College Hospitals are examples of
PHIs with highly specialized tertiary care and limited public health activities. In all these PHIs, TB
is diagnosed, treated and notied.

Is District TB Centre (DTC) a PHI? A DTC is the central program management unit of the district
where the program manager is the District TB Ofcer (DTO). The post of DTO is a sanctioned and
regular designated post and DTC is a program management unit at District level. DTC is
supported by a Medical Ofcer, District Pharmacist, District Programme Coordinator (DPC),
Public-Private Mix (PPM) Coordinator, DRTB/HIVTB supervisor, Accountant and Nikshay operator
in program management. However, there is a PHI in DTC managed by Medical Ofcer of DTC
(sometimes DTO acts as MO-DTC also), pharmacist, staff nurse, nursing assistant, laboratory
technicians (LTs), clerical staff etc. It is called a DTC PHI and is always a DMC and most of the
times a CBNAAT site also. Hence DTC not a PHI. Similar is the case of TB Unit, where the program
manager is the MOTC (Block Medical Ofcer) supported by the Health Supervisors, STS and

195
STLS, and TU-PHI is managed by medical ofcers, staff nurses, pharmacists, LTs and nursing
assistants.

NTEP has provided additional contractual staff to support general health system staff in program
management at various levels. For example, a DPC, DRTB/HIVTB supervisor, and PPM
coordinator is posted at DTC level, STS and STLS at TU level and a TBHV at PHI level in urban
settings and medical colleges. Designated Microscopy Centre (DMC) and CBNAAT site are
situated at PHIs level.

This description provides an overview of organization of NTEP activities at central and peripheral
levels.

Role of PHIs in Program Management for TB Elimination

All PHIs diagnose and manage cases of TB. PHIs with predominant public health components do
community interventions too. PHIs with predominantly clinical components do diagnosis and
clinical management of TB. Thus, a primary health centre will do ACSM activities, active case
nding, diagnosis and treatment of TB, treatment adherence support, contact investigation,
domestic airborne infection control support, referral for universal DST, diagnosis of co-
morbidities like HIV and diabetes, tobacco cessation, and support for direct benet transfer,
additional nutrition and Comprehensive Real time TB Information Management System–
NIKSHAY. A medical college or district hospital in addition to diagnose and treat TB, will provide
indoor facility for management of those TB patients who are seriously ill, have drug resistant TB,
adverse drug reactions and co-morbid conditions. Medical College also support DTC in capacity
building of health system through trainings and supportive supervision.

Let us now understand the role of a PHI in TB elimination in detail. As we have discussed, a PHC
has the complete responsibility of public health activities including prevention, early detection,
treatment and follow-up of all communicable diseases including TB among the population it
caters to. Thus, the most important responsibility of a PHC/CHC in TB Elimination are as follows.

1. Case Finding Activities

1.1. Intensied case nding among the outdoor and indoor patients in the health facility.
1.1.1. Patients with TB symptoms may often report them to MO and staff (self-
reporting/passive case nding). However, in many occasions, patients may fail to
identify their symptoms. Hence it is always better to ask patients in the OPD and IPD
about symptoms for TB. This activity is termed as intensied case nding from the
health facility. Patients may be encouraged through appropriate audio/visual
messages to report symptoms.

1.1.2. Referral for appropriate laboratory investigations

1.1.3. Current national policy is to have designated microscopy centre in as many or all
PHIs according to requirement and wherever there is availability of a LT and a
binocular microscope to improve access to diagnosis. Medical Ofcer should refer
all identied presumptive pulmonary TB cases for sputum smear microscopy & Chest
X-ray and presumptive EPTB cases for appropriate investigations.

1.1.4. MO of PHI not having a microscopy centre may maintain a ‘presumptive TB register’
for recording the details of presumptive TB cases identied in the OPD and referred
for diagnosis, to track patients who do not report for testing. If the PHI is enrolling all
presumptive TB cases in Nikshay, the register may be extracted from Nikshay

196
 1.1.5. Presumptive TB cases with a negative sputum test result should not be ignored.
Chest X-ray followed by CBNAAT is important to complete the diagnostic algorithm
to ensure no TB case is missed.

1.2. Active case nding

1.2.1. Active case nding (ACF) is identifying population with high risk for TB and screening
them for early detection of disease.

1.2.2. District TB centre, under the guidance of District Chief Medical Ofcer, will identify
the population for active case nding. Each Block Chief Medical Ofcer (BCMO), in
his block, will prepare the block wise micro plan with support from MO PHIs

1.2.3. MO PHI and team should organize eld activities with good microplanning.

1.2.4. Logistics support will be provided by the DTO.

1.2.5. Under supervision of MO of PHIs, Government Health workers (MPW/ANM and

equivalents), with the help of community volunteers, ASHA, Anganwadi workers,
etc., should conduct eld visits to identify presumptive TB cases and refer them to the
MO using a referral slip.

2. Notication of all diagnosed TB cases

2.1.TB cases may be diagnosed amongst the presumptive cases referred for tests by the MO
PHI or diagnosed elsewhere and transferred to the PHI for treatment. All these cases
have to be entered in the ‘PHI TB notication register’. If they are not notied in Nikshay
earlier (process of notication in Nikshay is described below), MO and the PHI staff
should notify them in Nikshay. All diagnosed cases, irrespective of their treatment status
have to be notied.

2.2. After notication at diagnosis, cases that are expected to be initiated on treatment at other
PHIs should be transferred to the respective PHI. This will help the MO and staff of the
receiving PHI to enter the patients details in their notication register as a ‘transferred in’
case and arrange for treatment at a place and time convenient to the patient.

3. Universal DST
3.1. All diagnosed TB patients should be subjected for CBNAAT test for early diagnosis of
resistance to Rifampicin.

3.2. All Rif sensitive TB patients will be subjected to rst-line LPA. If H resistance is detected
then it will be subjected to second line LPA and DST for Z. If there is rifampicin
resistance, then it is subjected to First- and second-line LPA (for details refer to
Integrated algorithm). Where the smear is negative, culture isolate is expected to be
subjected for LPA.

4. Initiation of diagnosed patients on treatment

4.1. All patients residing in the area of the PHI, whether diagnosed in the PHI or transferred
in, have to be initiated on treatment. Process of initiation of treatment has been
discussed in detail in Module 3.

4.2. Patients with known susceptibility to Rifampicin and INH have to be initiated on rst line
regimen [2HREZ / 4HRE].

197
 4.3. Patients with resistance to Rifampicin have to be started on shorter MDRTB regimen.
After the diagnosis, patient should be counselled for pre-treatment evaluation and
reporting to DTC.

4.4. Patients with H mono resistance have to be treated with H-mono/poly resistant regimen

4.5. All other patients (status of Rifampicin and INH unknown) have to be initiated on rst-
line regimen. Treatment regimen may be modied with availability new DST results.

4.6. Initiation of treatment should not be delayed waiting for DST results. Thus, for practical
reasons, appropriate specimen for DST may be collected from all patients and rst-line
regimen may be started and later modied according to DST result. It is important to tell
patients in advance that treatment regimen may change as more DST results become
available.

5. Filling up of original and duplicate treatment cards

5.1.MO should ll the original (it is ‘original’ since it is the document written by the MO)
treatment card with details of regimen according to weight-band and DST pattern.

5.2. Pharmacist / Nursing Staff / MPW / ANM should make a copy (duplicate) of the original
card and send it to the treatment supporter with the drugs.

5.3. Pharmacist / Nursing Staff / MPW / ANM should also ll an identity card for the patient.

6. Providing support for treatment adherence

6.1. MO and staff should identify appropriate treatment supporter for the patient, educate
patient, family members and treatment supporter on direct observation of treatment,
ICT based adherence monitoring, ADR and follow up schedule.

7. Collection and entry of bank account details

7.1. MO and staff should ensure that the bank account details of the patient are collected
and enteredin Nikshay for Direct Benet Transfer of Nikshay Poshan Yojana.

8. Initial home visit

8.1. MPW / ANM should visit the house of the patient within a week of starting treatment

8.2. They will Counsel the patients and their families

8.3. They will screen contacts for symptoms

8.4. They will provide IPT to children under 6 years of age, after ruling out TB

8.5. They will Link the patient with other social support schemes

9. Monitoring adherence to treatment

9.1 Treatment supporter will observe each and every dose that the patient takes and makes
entries in the treatment card.

9.2.Health supervisor / MPW / ANM will visit treatment supporter and patients regularly
during every visit to the village

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 9.3. Health supervisor / MPW / ANM to check daily the ICT based treatment monitoring and
also updates original treatment card at the PHI.

9.4. MO-PHI to review treatment cards and ICT based monitoring once in a week.

9.5. Retrieval of patients interrupting treatment within 24 hours of discontinuation be the

Treatment supporter or ANM/ MPW

10. Monitoring of response to treatment, ADR and co-morbidities

10.1. MO-PHI to clinically review patients at least once in a month and as and when
required

10.2. Follow up sputum examination at the end of IP and at the end of treatment

10.3. Other laboratory investigations to ensure control of co-morbidities, e.g. blood sugar

10.4. Referral to ICTC / F-ICTC for HIV testing

10.5. Referral to higher centres if necessary, to manage ADR and co-morbidities

11. Training and supervision of staff

11.1. MO-PHI and Health supervisors have to train their staff on NTEP, Nikshay and active
case nding with the support of TU and DTC

11.2. They should also supervise the staff in their activities for TB elimination

11.3. They should ensure that all PHI level records of NTEP are maintained by the
respective staff

11.3.1. Presumptive TB register (if any), referral slips

11.3.2. Stock registers of drugs, consumables and other logistics

11.3.3. TB Laboratory register

11.3.4. TB Notication Register

11.3.5. Supervisory register

11.3.6. Original treatment cards

11.3.7. Copies of monthly PHI report

12. Reporting
MO-PHI should submit a monthly report on program management and logistics (monthly PHI
report to MOTC).

12.1 Add time line/ freezing policy

12.2 Add Monthly PHI report

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13. ACSM Activities
13.1. Generation of awareness about TB in the community is important for prevention of
infection and promoting seeking care for TB symptoms at the earliest. Medical ofcer
and staff should plan for awareness activities through community meetings, door to
door campaigns, school-based activities and similar communication strategies.
Appropriate communication materials will be provided by the DTO.

13.2. Advocacy with local self-government ofcials, administrators and private sector
managers for TB elimination will help MO and staff to gather local resources for TB
elimination

13.3. Social mobilization activities by engaging local self-help groups, activists and TB
survivors will generate demand commitment for TB elimination.

13.4. TB Forum-For a community-led response to TB, an institutional mechanism has been

set up to support TB patients through their treatment and recovery

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Infection control at PHI
Administrative control strategies for health-care facilities Administrative control measures
(policies and work practices) have the greatest impact on preventing TB transmission. They serve
as the rst line of defense for preventing the spread of TB in health care settings.
Table 2: Summary of key recommendations on administrative controls

Outpatient Settings
• Screen for respiratory symptoms as early as possible upon patient’s arrival at the tealth
care facility
• Provide patient education on cough hygiene and sputum disposal
• Segregate patients with respiratory symptoms
• Fast-track patients with respiratory symptoms

Inpatient Settings
• Minimize hospitalization of TB patients
• Establish separate rooms, wards, or areas within wards for patients with infectionus
respiratory diseases
• Educate inpatients on cough hygiene and provide abeqate sputum disposal
• Establish safe radiology procedures for patients with infectious respiratory disease,
including smear-positive TB cases or TB suspects

Administrative controls for outpatient areas

The aim of administrative interventions in the outpatient area of any healthcare facility that
manages patients with suspected tuberculosis is two-fold: (a) reduce the total time period that
such a patient stays in the healthcare facility, and (b) reduce airborne transmission to other
patients and healthcare workers in this limited time period. Given the heavy patient load at most
health care institutions, it is but natural that patients of tuberculosis, like any other patient, have
to sometimes wait long periods before they are actually examined by the physician. During this
period, these patients are a constant source for airborne spread of disease to others. Reducing
the overall stay of such patients in the healthcare facility is likely to prove the single-most
effective measure of reducing airborne disease transmission in these areas. This can be
achieved by fast tracking these patients, which itself can be accomplished by several measures
that are not mutually exclusive. Fast-tracking will also depend upon the type of healthcare
facility. At a chest centre/hospital, most patients are chest symptomatics where fast-tracking has
no real application. But the process will be more useful for general hospitals and OPDs. The
implementation of the key administrative interventions (screening, education, segregation, and
fast tracking) would vary from facility to facility.

Screening: Screening for respiratory symptoms should occur as early as possible upon patient’s
arrival at the health care facility. Patients can be effectively screened at the registration counter
itself by asking simple questions related to chronic respiratory symptoms, and those suspected to
have tuberculosis can be given special cards or priority slips. The services of existing staff at the
registration counter can be used for this purpose, or a special screening counter can be
established prior to the registration process. This screening can be performed by physicians,
nurses, paramedical staff and/or volunteers specially deputed for this purpose. If a separate
screening counter is used, patients can be encouraged to rst visit this counter if they have
suggestive symptoms, by appropriate advertisements, posters or announcements in the
registration area. Even if screening at registration is not possible, screening can occur when
patients register at specic clinics or when in waiting areas.

201
Education on cough etiquette and respiratory hygiene: Another physical method that can
prove useful for reducing airborne transmission is the provision patient education on cough
hygiene and sputum disposal. This education can easily be imparted to patients through posters
and other means in the waiting area, as well as by actual discussion by a paramedical staff or
volunteers while the patient is waiting for his turn. Where possible, disposable medical masks
can be provided to patients by health care workers or volunteers. These workers should also
explain to patients how and when to use masks. Cough etiquette should be reinforced by all staff
members when poor cough etiquette is observed. Disposal of sputum at health care settings
need to be considered. Outpatient settings should make available tissue papers, and make bins
with disinfectants accessible to patients for disposal of sputum. Wall posters with instructions on
cough etiquette and sputum disposal should be provided; these handouts should be available at
the NTEP IEC resource centre.

Patient segregation: Segregation of patients with respiratory symptoms can be achieved by

having a separate waiting area for chest symptomatics, within the overall outpatient area. This is
particularly important in larger institutions with heavy OPD loads. If feasible, a separate doctor
can be deputed to assess these patients in the segregated waiting areas, so that these patients
do not mix with other patients waiting in the outpatient area. Another alternative is to implement
a patient ow control mechanism at the entry point of the waiting area, so that chest
symptomatics (who have been screened earlier and are carrying priority slips or other similar
identication) are diverted to this special area rather than the common waiting area. The
outpatient area, more so this segregated area, should be well ventilated to reduce overall risk of
airborne transmission.

Fast tracking of patients with respiratory symptoms: Those identied as patients with
respiratory symptoms can be further fast-tracked in both their clinical and laboratory evaluation.
One option could be to directly send these patients for sputum smear examination before they
see a doctor. The other options are to allow these patients to jump the routine queue and be seen
earlier than other patients, or to have totally segregated physician areas for these patients. The
other important area where these patients can be given priority is while performing chest
radiography. It is acknowledged that limited evidence is available to support the feasibility and
effectiveness of these administrative interventions. In a setting of high patient load, it may prove
difcult to screen and fast-track some patients at the expense of others, although with proper
counselling and explanation, this may still be feasible. Patient misgivings, for instance in visiting
the laboratory before the doctor, also need to be factored in. The site(s) of screening and the
personnel involved need to be identied and/or created, and this may mean more
administrative approvals. With all the ethnic, linguistic, social, economic and educational
diversity existing in Indian patients, it is unlikely that a single measure will work well for all
groups of patients. This eld is an important area of operational research, and pilot projects
need to be undertaken to identify what sets of administrative measures are likely to yield good
results in a particular setting.

Administrative interventions in the inpatient areas

Minimize hospitalization of TB patients: One of the most effective means to reduce the risk of
transmission of airborne pathogens such as M. tuberculosis in hospital settings is to manage
such patients in the outpatient setting whenever possible. Many patients can be managed
entirely as outpatients, thereby avoiding hospitalization and the risk of exposing other patients
and staff. If hospitalized, patients should be re-evaluated frequently for possible discharge with
continuation of therapy as outpatients.

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Establish separate rooms, wards, or areas within wards for patients with infectious respiratory
diseases: When hospitalization is required, patients with infectious respiratory diseases should
be physically separated from other patients so that others are not exposed to the infectious
droplet nuclei that they generate. Policies on patient separation inevitably generate concern
about stigma, but with appropriate measures – such as training and public posting of separation
rules – stigma can be minimized. Administrative procedures should ensure that separation
happens promptly and automatically, similar to the automatic separation of men and women
during inpatient admission. If sputum-smear microscopy or other relevant diagnostic tests are
performed for patients with respiratory symptoms at the time of admission, then those who are
most infectious can be quickly identied for separation from other patients.

Suggested priorities for separation of patients are as follows:

1. Separation of patients with conrmed or suspected diseases of public health concern, such
as epidemic inuenza, from all other patients.
2. Separation of sputum-smear positive TB patients from immune-compromised patients.
3. Separation of patients with known or suspected drug-resistant TB from
immunecompromised patients.
4. Separation of patients with known or suspected TB from all other patients.

The best choice for infectious or potentially-infectious patients is to house and manage them in
airborne precaution rooms. Where such airborne precaution rooms are not feasible, other
options for physical separation include:
• Having a few small ‘airborne precautions rooms’ for patients with infectious respiratory
disease patients.
• Having a separate ward designated for patients with infectious respiratory disease.
• Keep a designated area with better ventilation available for the placement of
potentially-infectious patients.
• Where it is not possible to have a designated airborne precaution room, ward, or area of
a ward, there can at least be an area designated as a “No Immune-Compromised
Patient Area”, where TB inpatients would be preferentially placed. This approach avoids
specically labelling patients as immune-compromised, HIV+, or having infectious TB.
If properly implemented, this approach would keep vulnerable immune-compromised
patients safely away from areas where infectious TB patients (if any) might be housed.

Educate inpatients on cough hygiene and provide adequate sputum disposal: Wards
housing infectious patients should display sign boards in the ward demonstrating cough
hygiene. All patients admitted in the ward/area should be issued surgical masks and counseled
on their proper use. Adequate measures for safe collection and disposal of sputum

Establish safe radiology procedures for patients with infectious respiratory disease,
including smear-positive TB cases or TB suspects: When caring for an infectious TB case /
suspect, the radiology departments should attempt to:
• Schedule inpatient chest radiographs on infectious and suspect TB patients for non-busy
times, such as the end of the afternoon.
• Provide coughing patients with a surgical mask to wear, or tissues or cloth to cover their
mouths.
• Provide priority service to potentially infectious TB patients to minimize the length of time
spent in the department.
• Restrict access to the radiology suite to patients and essential personnel only.
• Use the room with the best ventilation for taking images of potentially infectious TB
patients.

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Environmental controls
Environmental control measures are the second line of defense for preventing the spread of TB
in health care settings. Environmental controls include ventilation (natural and mechanical),
ultraviolet germicidal irradiation, ltration and other methods of air cleaning. It is important to
recognize that if administrative controls (policies and work practices) are inadequate,
environmental controls may not eliminate all the risk. Some environmental control measures
are simple and inexpensive while many others are technically complex and expensive
Environmental controls work on the same basic principle – dilution of infectious particles
through real or ‘effective’ air exchange. In the case of ventilation, that dilution occurs through
the introduction of fresh, uninfected air and the removal of infected air. In the case of UVGI or
ltration, dilution is ‘effective’ through the creation and re-circulation of ‘cleaned’ air, in which
infectious particles have been removed by irradiation or physical extraction. Certain
circumstances may require directional control of airow, so that air containing infectious
particles is not introduced into clean air where staff or other patients are located.

2 World Health Organization. Natural Ventilation for Infection Control in Health Care Settings.
Available at http://www.who.int/water_sanitation_health/publications/natural_ventilation/
en/index.html

Ventilation
Ventilation can reduce the risk of infection through dilution and removal. When clean or fresh air
enters a room, by either natural or mechanical ventilation, it dilutes the concentration of
airborne particles, such as droplet nuclei, in room air. This is similar to opening of windows and
doors to remove foul odours. Dilution reduces the likelihood that a person in the room will
breathe air that may contain infectious droplet nuclei. As room air exchange doubles, the
concentration of airborne particles in the room falls by half. Improved ventilation in health-care
facilities is essential in preventing transmission of airborne infections and is strongly
recommended. Better ventilation lowers the risk of transmission of TB and other airborne
infections.

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Natural ventilation is "controlled" when openings are xed and unrestricted to maintain air ow
at all times. Unrestricted openings (i.e. those that cannot be closed) on opposite sides of a room
provide the most effective natural ventilation (Figure 1. In existing health-care facilities that
have natural ventilation, when possible, effective ventilation should be achieved by proper
operation and maintenance of openings, and by regular checks to see that openings remain free
of obstruction at all times.

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Where ACH is not able to be measured, as is usually the case in rooms with natural ventilation,
the following standards for ventilation should be followed to ensure that air exchange is safely
>12 ACH under all climactic conditions.
• Natural ventilation should be "controlled", with xed, unrestricted openings that are
insensitive to climactic conditions
• Openings should constitute >20% of oor area
• Openings should be on 2 sides, preferably opposite sides. For example, a 100 ft2 room
should have >10 ft2 xed, unrestricted openings on two sites, for a total of 20 ft2

Considerations for hot climates

Climactic extremes may require some adjustments to ensure that minimum ventilation
standards are achieved. In the case of hot climactic conditions, the following design
considerations should be made.
• Air conditioners are to be avoided, or very cautiously used in patient care areas. If air
conditioners are used, it must be acknowledged that the need to maintain adequate
ventilation for airborne infection control may to some degree necessarily compromise
the comfort of room occupants and the efciency of the air conditioner.
• Minimize solar heat gain through proper use of sunshades or external shading.
• Use outdoor shaded waiting areas to the greatest extent possible.
• Where augmentation of ventilation is required, use air supply fans may help improve
thermal comfort, compared to exhaust fans.
• The use of evaporative coolers (“desert coolers”) may be an effective solution to achieve
both comfort and adequate ventilation, as these tend to have powerful fans. Proper
maintenance, however, is essential.

An online tool for estimating the total fan rating for a given room can be found at
http://www.csgnetwork.com/airexchangecalc.html. This reference is provided for convenience,
and is not an endorsement of the site.
• The installation of “whirlybirds” (also known as whirligigs or wind turbines) that do not
use electricity and provide a roof exhaust system can greatly increase both ventilation
and comfort.

Considerations for cold climates In cold climates, high ventilations rates may adversely affect
thermal comfort, and are difcult to achieve as windows may be closed to keep the building
warm. Even if normal heating is introduced, high ventilation rates usually mean energy
efciency will be low. Therefore, ventilation and heating strategies must be planned carefully.

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 • Building design should seek to capture the solar heat and minimize conduction loss
through the wall. Proper insulation of walls and the use of double glazing on windows
are desirable.
• Where augmentation of ventilation is required, use air exhaust fans may help maintain
adequate ventilation, even where windows or doors are closed.
• Targeted radiant or direct near-body heating methods are more effective than common
convective radiators. This includes modern electric coil heaters and heated
blankets/mattresses.

Optimal arrangement of patient and staff should be implemented in all settings. Health care
staff should be mindful of the direction of airow to ensure they are closest to the clean air
source, and that patients are closest to the exhaust. This involves arranging patients and staff so
that contaminated air is not likely to cross directly into staff/patient spaces. The natural direction
of air ow should be between patients and staff, and not across patients and staff (Figure 4). This
is especially important for settings such as DOT centres, OPD exam rooms, and smear
microscopy laboratories.

Directional control of air ow is recommended in specic high-risk settings where infectious
patients with drug-resistant TB or other acute respiratory diseases of potential concern are likely
to be managed – i.e. airborne precaution rooms, MDR-TB wards and clinics, and bronchoscopy
suites. This simply means having in place a system to minimize the chance that airow goes
from. In a room relying on natural ventilation that is situated away from other patient care areas,
no additional changes would be required as there would be no area of concern for
contaminated air to ow. It is important to keep the doors to corridor or other rooms closed, to
prevent escape of infectious aerosols to other parts of the facility. The direction of air movement
can be easily assessed using smoke tubes, strips of ribbon, or simply by observing the
directionality of dense smoke from “Dhoop” or incense. Directional control of airow can be
achieved in mixed mode ventilation by proper attention to adequate exhaust and supply
ventilation (as in Figure 3 above).

Figure 5: Schematic showing seating Figure 6: Schematic diagrams of mechanical

arrangement for patient and health care worker ventilation, with optimal directional control or
(red cross). In (A), natural ventilation would allow airow in the room. In (A), supply is on one side,
potentially infected air to cross health care worker. In exhaust from the other, so aerosols are not
(B), with this seating arrangement the chance of such dispersed to other patients or staff. In (B), supply is
exposure is lessened somewhat. from the top, and again exhaust near the patient’s
head, for optimal directional control.

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UVGI
Priority should be given to achieving adequate air exchange using ventilation (natural or
mechanical). However, in some settings it is not possible to achieve adequate ventilation; for
example, because of climatic changes (e.g. in winter or during the night), or building structure.
In addition, in settings such as MDR-TB wards and ART centres, transmission of TB poses a high
risk of morbidity and mortality. In high-risk settings where adequate ventilation is not possible, a
complementary option is to use upper room or shielded ultraviolet germicidal irradiation
devices.

Notication at Diagnosis
Let us try to understand more about the concept of notication at diagnosis.
A TB patient may be diagnosed in two ways, by any TB care provider. One way is to diagnose with
microbiological evidence (microbiologically conrmed TB case) and the other way is to diagnose
TB clinically in absence of microbiological evidence (clinically diagnosed TB). Health care
providers who diagnose TB in either methods have to notify TB cases in Nikshay as early as
possible, preferably on the same day (real-time entry). This process is termed as notication at
diagnosis.

Basics of process of notication

As we know, the diagnostic process starts with identication of a presumptive TB case. Nikshay
has a provision to enter the details of the presumptive TB case (Enrolment) and request for a
diagnostic test online. This is a direct or prospective enrolment. However, in majority of the
cases, the enrolment may start after diagnosis. In this situation, data entry should begin from the
presumptive TB status. This is a lateral enrolment or retrospective enrolment.

To understand this concept better, let us think about a presumptive TB case identied by the
Medical Ofcer of the PHI. The MO or the supportive staff in PHI can refer the patient for
laboratory diagnosis to any NTEP diagnostic facility (e.g. DMC, CBNAAT site) by requesting a
test. This can be done by lling up a Test request form on paper (NTEP Request Form for
examination of biological specimen for TB) and/or in Nikshay. We have discussed the
information to be collected and lled in during this step in Module 2.

Once all the relevant information pertaining to the presumptive TB case are entered in Nikshay
and saved, a numeric ID is generated in Nikshay. This ID is termed ‘Patient ID’ and will uniquely
identify the person. The patient can go to any NTEP diagnostic facility with this Patient ID for
obtaining a test. After performing the test, to report the test result, a laboratory technician can
log on to Nikshay, search for the patient details with the patient ID and simply enter the test
result. Once the test result is updated in Nikshay, if it is microbiologically positive (AFB
positive/MTB detected), the system identies the patient as a diagnosed TB patient. This is real
time notication.

Scenarios of Notication process

Scenario 1: Consider patient who was referred for laboratory investigation through a paper-
based form. Here, the laboratory technician does not have an opportunity to search the patient
in Nikshay by patient ID. Hence the LT has to enter all information from the request form in
Nikshay (patient demographics and test request information). When the LT does that a patient ID
will be generated. When the result is available, the LT enters the test result in Nikshay. If it is
microbiologically conrmed (AFB positive / MTB detected), the system identies the patient as a
diagnosed TB patient. This process is also real time notication.

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Instead of entering the details of all presumptive TB patients in Nikshay, the LT may enter the
details of only the diagnosed TB cases starting with their presumptive status. Once the positive
test results are entered, Nikshay recognises this patient as TB case. This process also is real time
notication.

Scenario 2: Now let us consider a patient who is referred by a MO PHI through paper-based
request form. The LT also reports a positive test result on the paper form. Since entry has not
been done in Nikshay, it has not recognised this patient as a TB patient, and notication has not
happened. Later the patient returns to the referring PHI, the MO or the supporting staff of the
PHI, has to enter the details of the patient starting with presumptive TB status and the test result
in Nikshay. And when the test result entered is positive, Nikshay recognises this patient as a TB
patient. This process also is real time notication.

Scenario 3: Let us consider another example where a patient is clinically diagnosed as TB. In this
case all his microbiological tests are negative. He is diagnosed by a clinician. Nikshay will recognise
this case as a TB patient only if the status is updated in Nikshay as clinically diagnosed TB.

Scenario 4: Consider a TB patient seeking care in a private health facility. He may either be
referred for diagnosis to a NTEP facility or a non-NTEP one. He is diagnosed to have TB. When
referred to a NTEP facility, there is a high probability of the patient to be notied real time. If not,
the information on diagnosis may reach NTEP late. It leads to a notication, but it will be a
delayed notication done by the health system as proxy for the health practitioner.

Among all scenarios explained above, the most prompt and fastest notication happens through
a prospective enrolment and real time notication. The worst situation would be a retrospective
enrolment with a delayed notication where NTEP misses the opportunity to provide important
public health actions to the TB patient. Hence NTEP encourages prospective enrolment where all
presumptive TB patients are referred for diagnosis through Nikshay.

When all presumptive TB cases are referred for diagnosis through Nikshay, a few may not reach
the laboratory and complete the test (Test pending). After testing, a few may be diagnosed to
have TB microbiologically or clinically (Notied). Among majority of the presumptive TB, the
disease will be ruled out by microbiological and clinical examination (TB not conrmed).

Example: 100 presumptive TB cases are referred for diagnosis from a PHC by enrolling in
Nikshay. 10 were AFB positive in DMC, 4 had M.Tb detected in CBNAAT site. One was clinically
diagnosed to have TB by expert clinician after negative reports from sputum smear microscopy
and CBNAAT. All results including clinical diagnosis are updated in Nikshay. 10 presumptive TB
cases did not reach any diagnostic laboratory. In this example, the number enrolled is 100, test
pending is 10, notied TB is 15 and TB not conrmed is 75.

Nikshay dash board on desk-top, tablet PC or mobile application will show these numbers on
logging-in.

Thus, enrolling all presumptive cases in Nikshay provides an opportunity to trace and test all the
patients with a status of ‘test pending’ and re-evaluate the patients with a status of ‘TB not
conrmed’ in future if necessary. This is crucial to accelerate the efforts to end TB in India by early
and complete diagnosis of all TB cases.

If it is not feasible to refer all presumptive TB cases through Nikshay, the next best option is to
enrol the patient retrospectively but immediately after diagnosis by completely updating the test

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results including the clinical diagnosis. In this scenario, the ‘test pending’ and TB not conrmed
will be always zero in Nikshay.

To achieve prompt enrolment and notication, medical ofcers, practitioners and their
supportive staff of the public and private health facilities are to be sensitised/trained on
enrolment and notication processes. Sensitization or training of these personnel one of the
most important responsibilities of NTEP program managers (STO/ DTO/ MOTC) and key staff
(STS/ STLS/ TBHV/ DEO).

Supportive systems for real time notication

We have understood the concept of real time notication. It is ideal to have all presumptive TB
patients to be referred for appropriate tests by directly enrolling in Nikshay. However, availability
of computer systems and internet connectivity is not uniformly adequate with every public PHI
and private health care provider of the country. Even then immediate priority is to get all
diagnosed TB patients enrolled and notied in Nikshay. Tablet computers have been made
available to all NTEP key staff with this objective. However, states are encouraged to use the
computer systems and internet connectivity in the PHIs and health facilities and the mobile
phone applications for faster and effective notication.

While locally the most appropriate situation is enrolment and notication after diagnosis
(retrospective enrolment and real time notication), the information of all patients diagnosed in
the PHI must be available at one place. Though the treatment card of the TB patients is a good
source of this information, it would be available for only patients initiated on NTEP treatment.
Information on patients initiated on treatment using private ATT and patients in the private
sector would be missed. Hence it is decided that all health facilities (public/private/individual TB
practitioners) need to maintain a paper-based TB notication register which will contain all
important information required for notifying a diagnosed TB patient in Nikshay.

Concept of an episode of TB
A person/ citizen may get affected with TB more than once in his lifetime. There is a chance that
he may get re-infected with TB or there may be a change in the type of TB Disease (New to
relapse or DRTB). So, one person may become a case of TB more than once and each event of
that person getting diagnosed TB is a fresh episode of TB. For example; Mr. Ramu got diagnosed
as a case of TB in January 2015 as a new case and later got cured; later in December 2015 he
got diagnosed with TB again as a case of recurrent TB. The recurrent TB is the second TB episode
of Ramu.

All episodes are required to be notied and each episode will be considered
as a fresh notication. For example, there might be 2456 notications from your district;
however, there might only be 2000 persons affected with TB.

In Nikshay each person is provided with a Patient ID and each episode is uniquely identied with
an ‘Episode ID’.

NTEP TB Notication register

TB notication register is different from erstwhile TB register. TB register was based at the TB unit
and contained information on patients initiated on treatment somewhere in the jurisdiction of
the TU. TB notication register is based at the PHI/health facility and contains information on all
patients diagnosed in the PHI. Some of the patients in the notication register may be initiated
on treatment in a different health facility, area, district or even in a different state. Additionally,

210
there may also be cases transferred in from other PHIs after being notied from there; these
cases also are entered into the TB Notication Register of the PHI.

(If the patient is to be initiated on treatment in a different PHI, the patient has to be transferred to
that facility through Nikshay or a paper-based transfer form as discussed in the previous
module. Transfer for may have also to be used when a patient has to be transferred from one PHI
to another during treatment. The State/District/TU/PHI from where the patient is currently on
treatment is termed as Current State/ District/ TU/ PHI).

Check annexure for TB Notication register

The TB notication register has two portions. The left-hand side is to record information till
initiation of treatment. The right-hand side is for follow up during and after treatment till 24
months after successful completion of treatment. We will now have a detailed understanding
about each information recorded in the TB notication register.

Information on the left-hand side of TB notication register

TB Notication number (Episode ID): This is a seven-digit ID generated in Nikshay after his/her
status has changed to Notied. This ID can be entered in notication register only after enrolling
and updating a TB diagnosis result in Nikshay. The patients in a PHI notication register will not
have serial IDs specic to that PHI. If the rst patient of a PHI has a patient ID 1018192, the
immediate next patient may have a patient ID 1976543 since other PHIs in the country might
have enrolled many patients by the time in Nikshay.

Though enrolling a patient in Nikshay will generate the patient ID, notication process
will not be complete. Notication will be complete only when a positive microbiological test
result or clinical TB status of the patient is updated in Nikshay. Otherwise this patient will be
shown as ‘Test pending’ in Nikshay.

Name in Full:
Age:
Sex:
Complete Address:

PIN code: PIN code of the post ofce of patient’s address

Mobile/Landline number: If more than one number are available, record all
Aadhaar number: Aadhaar number is the Unique Identication Digit of an Indian Citizen. It
will ensure that the correct person is provided TB care services. In addition, it will also ensure that
the benets like Nikshay Poshan Yojana are not denied to the to the right individual. However,
Aadhaar number is not mandatory for TB services. Patient may be encouraged to voluntarily
share the same.

Key population: Some patients are at increased risk for tuberculosis due to the presence of
certain factors. Individuals with these vulnerabilities are included in the key population. These
are contacts of TB patients, Diabetics, Tobacco Users, Prison Inmates, Miners, Migrants,
refugees, Urban Slum Dwellers and Health Care Workers. Apart from the patients belong to key
population, PLHIV, Children and EPTB will be directly tested with CBNAAT.

Type of patient: New, Recurrent, Treatment after Failure, Treatment After Loss to Follow Up,
Transfer-in and Others

Site (P/EP): Pulmonary/Extrapulmonary

Case Denition:

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Microbiological conrmation test result
Date:
Lab name:
Lab No.:

Test: Type of the microbiological test used to conrm diagnosis. If the patient is clinically
diagnosed, mention the microbiological test, if done, and its result (Negative/M. Tb not
detected) in the next column

Result of Test: Result of the test as described above.

Result of other tests: Result of other tests used to clinically diagnose TB (X-ray, FNAC,
Histopathology, Clinical diagnosis etc.)

HIV status: Reactive, Non-reactive or Unknown. ‘Unknown’ will be marked only when the
outcome of treatment is provided and the patient still has not undergone HIV testing

Diabetes status: Diabetic, Non-Diabetic, Unknown. Unknown will be marked only when the
outcome of treatment is provided and the patient still has not undergone test for Diabetes

Date of sample sent for DST: After diagnosis, all new patients are expected to undergo
universal DST with CBNAAT for Rifampicin and all previously treated TB patients with LPA for
Rifampicin and INH. Specimen may not be available for some clinically diagnosed patients.
Collecting second sample may be difcult in a few cases like EPTB, Children etc. Therefore, they
are subjected for an upfront CBNAAT. If the patient is tested with CBNAAT upfront, the date of
sample sent for DST is mentioned as the same date when the sample for CBNAAT is collected.

Result of DST: Rif sensitive, Rif Resistant, H Sensitive, H Resistant

Status of treatment: All patients are expected to be initiated on treatment as soon as possible
after diagnosis. Patients with known resistance to Rif and/or INH will be initiated on respective
regimens. All others will be initiated on a standard rst-line regimen for 6 months. However,
some of the patients might be transferred for treatment after notication to a health facility other
than the diagnosing PHI, some may not be initiated on treatment, and some may be on private
treatment. Another few may be wrongly diagnosed (especially clinical TB) when the diagnosing
clinician revokes his decision. All these statuses are to be mentioned in this column.

Health facility for treatment: Health facility where the patient is initiated on treatment

Date of initiation of treatment: date on which the patient is initiated on treatment.

Information on the right-hand side of the TB notication register

Type of Regimen: The regimen on which the patient is initiated on treatment is recorded here.
First Line regimen, if the patient is on a standard 6-month st-line regime for new and previously
treated patients (2HREZ + 4HRE). Shorter MDR-TB regimen, Conventional MDR-TB regimen, H-
Mono/poly regimen, Regimen for MDR-TB with additional resistance to quinolones, Regimen for
MDR-TB with additional resistance to SLID, XDR-TB regimen, new dug containing regimen and
DST guided regimen are the currently available treatment regimen for DR-TB patients in NTEP.

Weight at the beginning of treatment: Weight has to be accurately measured and recorded
in Kg for starting the patient on appropriate dosage in the correct weight band, to monitor

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response to treatment and to manage malnutrition if present.

Dosage Frequency: Currently only daily regimen is administered under NTEP.

Follow-up Smear Examination

End of IP

Date: Date on which the sputum smear result is collected for follow up.

DMC Name: Name of the DMC where the follow up examination was performed.

Smear result: Grading in red ink if the result is positive and Neg in blue if smear is negative.

Date of sample collected for DST: All patients found to be smear positive on follow up are
identied as presumptive DRTB cases. Fresh paired samples of sputum have to be collected from
them and sent for CBNAAT. The date on which the sample was collected for CBNAAT has to be
mentioned here.

Result of DST: Result of CBNAAT is to be mentioned here.

End of Treatment

Date: Date on which the sputum smear result is collected for follow up.

DMC Name: Name of the DMC where the follow up examination was performed.

Smear result: Grading in red ink if the result is positive and Neg in blue if smear is negative.

Date of sample collected for DST: All patients found to be smear positive at the end of treatment
are “Failure” and identied as presumptive DRTB cases. Fresh paired samples of sputum have to
be collected from them and sent for CBNAAT. The date on which the sample was collected for
CBNAAT has to be mentioned here.

Result of DST: Result of CBNAAT is to be mentioned here.

Treatment Outcome

Outcome with date: Cured, Treatment Completed, Died, Lost to follow up, Failure, Not
evaluated or Treatment change

If HIV reactive

All PLHIV have to be started on Co-trimoxazole Preventive Therapy (CPT) and Antiretroviral
Therapy (ART). These treatments are started from the ART Centre. The information is to be
sought and updated in the notication register with the dates of starting ART and CPT.

Post Treatment follow-up

TB patients are followed up periodically after successful completion of treatment for 24 months.

213
They are to be told at the time of declaration of outcome that in case they develop TB symptoms
later, they should report for testing for TB. Even if they do not report in between, MO-PHI and
supportive staff have to screen all patients for presence of symptoms of TB at the end of 6th,
12th, 18th and 24th month after completion of treatment and do a sputum culture in presence of
symptoms to diagnose recurrent TB.

Notication of patients seeking care in private sector

A signicant proportion of the TB cases seek care in the private sector. Preference of health care
sector is the choice of the patient. NTEP is committed to provide TB care services to all TB patients
irrespective of the sector of choice. A private care provider is doing an important TB elimination
service by diagnosing TB patients and providing correct and complete treatment.

All health care providers including private providers have to notify TB cases at diagnosis. To
enable this process, District TB Ofcers have to ensure that all such providers (Hospitals, clinics,
laboratories, individual practitioners, chemists) are registered in Nikshay. Healthcare providers
can register themselves on Nikshay (and obtain user credentials) or DTO register them in
Nikshay (and convey user credentials to each private provider). This will enable them to log on to
Nikshay and notify TB cases while ensuring the condentiality of their patient data. The patient
data is available only to the public health authorities. This information will help public health
authorities to provide public health action to all TB patients.

For seamless notication, there needs to be facilitatory mechanisms in the premises of private
providers and between the private provider and NTEP authorities. Let us understand this through
a few examples.

Example 1. Let us consider a major private hospital, with a number of specialty departments,
units and indoor and outdoor patients. This health facility has a Nikshay User ID and password.
However, unless the information of all patients diagnosed in the hospital reach the personnel
handling the user ID and password, all the cases will not be notied. Hence all major hospitals
should have a single window system established, which will collect the information of newly
diagnosed TB cases from all departments on a daily basis and notify them in Nikshay.
Alternatively, staff from various units can visit the single window, document the details in the
notication register and the nodal person for notication [PRO, nursing assistant, receptionist,
pharmacist etc.] can notify the same in Nikshay on the next day. It is also to be mentioned here
that, an incentive of Rs.500/- is provided to enable these processes. DTO and key staff are
expected to support the private health facility to establish the single window system and train the
nodal person from the concerned private facility in Nikshay. A PPM coordinator is provided to
assist DTO and support NTEP key staff in coordinating with private providers.

Additionally, the single window will also help the hospitals to track patients by phone calls [and
also by house visits where capacity for outreach activities is there] and to remind them on follow
up schedules and treatment. This will serve as support mechanism for adherence.

Filling up of TB Notication register

Exercise -4
Using workbook E3, complete the TB Notication register using six treatment cards which you
have completed in exercise E2.

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 Arun Kumar (Patient A)

Pooja Gupta (Patient C)

Lakshmi Kumari (Patient D)

Narendra Kumar (Patient F)

Girija Devi (Patient H)

Kailash Nath (Patient J)

Exercise-5
Complete the transfer form for the appropriate patient mentioned in module three.

Exercise -6
1. What information is recorded in the TB notication Register at the time of notication?
2. Who is responsible for notication of TB patients and when should be the patient
notied?
3. What is public health action and who is supposed to do it? list the actions to be taken.

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Notes
ANNEXURES

• NTEP Request Form for examination of biological specimen for TB

• TB Laboratory Register
• Referal slip
• TB identity card
• NTEP PMDT Treatment Card
• NTEP PMDT Treatment Book
• Referral /Transfer form for treatment
• NTEP PMDT Referral for treatment form
• TB Notication Register
• NTEP PMDT Treatment Register
• NTEP Laboratory Register for CBNAAT and CDST
• Annexure EQA formats
NTEP

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 National Tuberculosis Elimination Programme

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 NTEP

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NTEP

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NATIONAL TUBERCULOSIS ELIMINATION PROGRAMME

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 National Tuberculosis Elimination Programme - TB Notification Register

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NTEP EQA Network

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(National Tuberculosis Elimination Programme)

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