RNTCP Training Course For Program Manager Module 1 To 4

MODULE – 1 to 4
Module 1 : 1-14
Introduction to Tuberculosis and Revised National Tuberculosis
Control Program (RNTCP)
Module 2 : 17-98
Laboratory Diagnosis of TB and Quality Assurance
Module 3 : 101-175
Treatment Services
Module 4 : 189-196
Registering Cases and Monitoring Treatment
Course Introduction
About the Training Course
Tuberculosis (TB) remains a major public health problem in India. This course provides
training relevant to managing RNTCP at the state, district and sub-district levels. A set of
nine modules provide uniform training material including management of TB-HIV co-
infection, MDR-TB, pediatric and extra-pulmonary TB, private sector involvement and other
related aspects
Course for Program Managers

The content of this course has been revised keeping in mind the evolving role of Program
Managers at the state and district levels. Since the program is taking on newer directions
like TB-HIV, MDR TB etc it is important that the these changes are reflected in RNTCP
basic modular training to aid effective functioning of program managers.
Learning objectives
• At the end of this course, participants are expected to effectively manage the
programme at their respective levels. The specific learning objectives for each of the
modules are detailed in each module.
Materials and methods:

In addition to reading of modules by the participants the training would be imparted through
lectures, group discussions, field visits, open house sessions, role plays and presentation
by participants. This course is structured in such a way that each participant performs
exercises at his own pace, and is encouraged to discusses with the facilitator, the problems
or questions, if any.
• Facilitators: The training will be organized at the National level. Competent facilitators
are to be drawn from the faculty of the National RNTCP training institutes and State TB
Training and Demonstration Centers. The facilitator-trainee ratio should ideally be
around 1:7.
• Training Schedule: The training duration is 12 working days. The table on the following
page gives a broad outline to be followed in the training schedule.
• Certification: A certificate would be awarded to the trainees upon satisfactory

completion of the course.
Schedule for RNTCP modular training
Days Session Topic and activities

One Fore Noon Pretest
Module 1 Introduction to Tuberculosis and
the Revised National
Tuberculosis Control Programme
After Noon Module 2 Diagnosis of TB
• Module 2
• Presentation on Quality
Assurance on lab services
Two Fore Noon • Module 2 Quality assured Lab services

After Noon • Module 3 Treatment strategy and service
Three Fore Noon • Field visit - Microscopy DMC

activities
After Noon Module 3

Four Fore Noon Module 3 (complete)
After Noon Module 4 Registering cases and monitoring
of treatment
Five Fore Noon Module 5 Monitoring of the programme
After Noon Programme implementation
Six Fore Noon Module 5 (complete)
After Noon Open house session
Seven Fore Noon Field visit – Treatment and TB Unit
programme performance
activities
After Noon Field visit for TB-HIV DMC, ICTC and ART centers
collaborative activities
Eight Fore Noon Module 6 Programme implementation
After Noon
Nine Fore Noon Module 6 (complete)
After Noon Module 7 Logistics management including
preventive maintenance
Ten Fore Noon Module 7 (complete)
After Noon Module 8 and Module 9 Supervision and evaluation
Eleven Fore Noon Open house session / field visit

After Noon • Presentation
• Post test
Twelve Fore Noon • Discussion on post test
• Any other topic
After Noon Concluding session
At the end of this course, the participants will be able to do the following tasks:
 Manage the program in a more effective manner , as the modules answer all
pertinent questions / issues faced by program managers ( STOs /DTOs, STDC staff,
Medical College Professors)
 train MOs and health workers to correctly identify patients who should be
investigated for tuberculosis at nearest Designated Microscopy Centers
 monitor the maintenance of the Tuberculosis Laboratory Register
 monitor documentation related to sputum microscopy examinations
 classify and categorize patients for treatment correctly
 complete TB Treatment Cards of patients
 ensure proper administration of drugs through directly observed treatment (DOT)
 identify, train and supervise others who give directly observed treatment (peripheral
health workers, community volunteers, etc.)
 provide health education to patients and their families and train MOs and health
workers to do the same
 monitor the registration of patients in the Tuberculosis Register
 verify that correct number of sputum specimens have been examined at stipulated
intervals and the results have been recorded in the Tuberculosis Register
 regularly review Tuberculosis Treatment Cards to assess treatment outcomes and to
verify that the treatment outcomes have been recorded correctly in the Tuberculosis
Register
 complete and submit the monthly PHI reports in the standardized format
 complete and submit the quarterly reports on case-finding, sputum conversion,
treatment outcomes and programme management
 ensure maintenance of Binocular Microscope, adequate supply of drugs, printed
materials and laboratory consumables
 conduct regular supervisory visits and provide feedback for corrective actions
 make active efforts to involve other health service providers of the public as well as
the private sector
 evaluate the performance of the tuberculosis programme in the area
 deal with Human Resource and other management issues – team management ,
staff performance , partnerships , communication strategies among others
TB can be controlled only with EFFECTIVE SUPERVISION and

GOOD PROGRAMME MANAGEMENT
Table of Contents
Module 1
Introduction to Tuberculosis (TB) & Revised National Tuberculosis
Control Programme (RNTCP)
Learning Objectives........................................................................................... 1
Introduction ....................................................................................................... 1
Pathogenesis of TB ........................................................................................... 1
Post Primary TB ................................................................................................ 2
Extent of TB problem in India ............................................................................ 2
Annual Risk of Tuberculosis Infection (ARTI) .................................................... 3
HIV co-infection among TB patients .................................................................. 3
Multidrug-resistant tuberculosis (MDR-TB) ....................................................... 4
Pediatric TB....................................................................................................... 4
Socio-economic impact of TB............................................................................ 4
Goal and Objectives of RNTCP ......................................................................... 5
Directly Observed Treatment Short Course (DOTS) Strategy ........................... 5
Stop TB Strategy ............................................................................................... 6
Involvement of Medical Colleges ....................................................................... 6
Public Private Mix .............................................................................................. 7
TB-HIV Collaborative activities .......................................................................... 7
RNTCP and DOTS-Plus services for MDR-TB.................................................. 8
Advocacy, Communication and Social Mobilization (ACSM)............................. 8
National Level ................................................................................................... 8
State Level ........................................................................................................ 10
District Level ...................................................................................................... 10
Sub-District Level ............................................................................................. 11
Peripheral Health Institution (PHIs) ................................................................... 12
Work Sheet ....................................................................................................... 13
Training Course for Program Manager
Module 1
Introduction to Tuberculosis and
Revised National Tuberculosis Control Programme
Learning Objectives
In this module participants will learn about:
Pathogenesis of Tuberculosis (TB),

• Extent of TB problem in the National and Global context,
• Evolution of the Revised National Tuberculosis Control Programme (RNTCP) and its
objectives, the DOTS Strategy and the STOP TB Strategy.
• Organizational structure and functions of RNTCP.
Introduction
India has had a National Tuberculosis Programme (NTP) since 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
DOTS strategy for the control of TB, was developed. RNTCP has now been implemented in
the country for more than a decade, and has been expanded geographically to achieve
nation-wide coverage in March 2006. The spread of human immuno-deficiency virus (HIV)
during the last two decades, emergence of various forms of drug resistant TB and
unregulated vast private sector pose additional challenges in effective TB control.
Pathogenesis of TB
Source of infection and exposure
Tuberculosis is an infectious disease caused predominantly by Mycobacterium
tuberculosis. Patients suffering from smear positive 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 and the immune
status of an individual. The programme gives priority in detecting and treating smear
positive PTB, thereby aiming to cut the chain of transmission of infection. However, it needs
to be remembered that under RNTCP all types of TB cases are treated.
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 a
positive reaction to a tuberculin skin test (Mantoux test). Primary infection is an infection
occurring for the first time in susceptible individuals who are exposed to tubercle bacilli.
Droplet nuclei that are inhaled into the lungs, are so small (< 5µm) that they avoid the
muco-ciliary defenses of the bronchi and lodge in the terminal bronchiole or alveoli of the
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lungs. Subsequently, the bacilli multiply and invade the hilar lymph nodes through the
lymphatics. The sub-pleural lung lesion, lymphangitis and hilar adenopathy together
constitute a “primary complex”. In most cases, the host’s immune defenses 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 defense 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.
Risk of infection
A smear positive pulmonary TB case in the general community may infect 10 – 15 other
persons in a year, and remain infectious for 2 to 3 years if left untreated.
Risk of developing disease

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, malnutrition and alcohol abuse also increase the risk of
progression from infection to TB disease.
Extent of TB problem in India

The extent of the TB problem is generally described in terms of incidence, prevalence and
mortality. Incidence is the number of new events (infection or disease) that occur over a
period of one year in a defined population. Prevalence is total of new and existing events
(infection or disease) at a given point of time in a defined geographical population.India
accounts for one fifth of the global TB burden i.e. 1.98 million out of 9.4 million new cases
annually. In India, more than 40% of population is infected (prevalence of infection) with
Mycobacterium tuberculosis. It is estimated that there are 3.3 million prevalent case of all
forms of TB disease (smear positive PTB, smear negative PTB and Extra-Pulmonary TB).
Approximately 75 new smear positive PTB cases (incident cases) occur per lakh
population per year. It is also estimated that about 2,76,000 people die due to TB annually
(mortality). The table below shows the estimated figures for TB burden globally and for
India provided by WHO for the year 2008.
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Magnitude of TB - Global and Indian scenario*
HIV prevalence
Incidence of Prevalence of
Mortality among incident
disease disease
cases
9.4 million 11.1 million 1.32 million
Global 15%
(139/lakh/year) (165/lakh/year) (19.6/lakh/year)
1.98 million 2.18 million 2.76 lakhs
India 6.7%
(168/lakh/year) (185/lakh/year) (23/lakh/year)
*Source: Global TB Report 2009-Update
Annual Risk of Tuberculosis Infection (ARTI)

It is defined 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 reflects the overall infectious pool in the community. ARTI of 1.0% is presumed to
reflect an incidence of 50 new smear positive pulmonary tuberculosis cases occurring per
lakh population per year. From the earlier ARTI survey (2000-2003) it is estimated that in
India the average ARTI is 1.5%, with variations between regions (North 1.9%, West 1.6%
East 1.3% and South 1.1%). A repeat ARTI survey is being conducted from 2009-11 to
arrive at current estimates.
HIV co-infection among TB patients

In India, it is estimated that 2.31 million individuals are living with HIV infection, which
equates to approximately 0.34% of the adult population of the country. Based on available
country data of 2007, it is estimated that 4.9% of new adult TB patients in India are HIV
positive. Hence, the TB epidemic in India continues to be predominantly driven by the pool
of HIV negative TB infected individuals.
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, and TB is one of the leading causes of death
in ‘People living with HIV/AIDS’ (PLHA).
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 10-30 times higher
chances of developing the disease than among patients infected with TB only. Amongst
PLHA, 3–10% of persons develop TB per year. Furthermore, HIV-infected persons with TB
suffer much higher mortality than non-HIV infected persons. Even if TB is successfully
treated, long term post-TB mortality among PLHA is extremely high.
In a TB/HIV co-infected person, the immune 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
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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.
Multidrug-resistant tuberculosis (MDR-TB)

MDR-TB is defined as tuberculosis disease where the bacilli is resistant to isoniazid (H) and
rifampicin (R), with or without resistance to other drugs. Irregular consumption and frequent
interruption in taking treatment for TB is the most common cause of acquiring multidrug
resistance. In India, MDR-TB amongst new cases are estimated at 2- 3% and amongst re-
treatment cases at 14-17%. 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
fluoroquinolones and any one of the second-line injectable drugs (namely Kanamycin,
Capreomycin or Amikacin). Although XDR-TB has been reported in India, its magnitude
remains undetermined as yet due to the lack of laboratories being capable of conducting
quality assured second line drug susceptibility testing.
In India, the great concern is the potential threat of drug resistant TB (DR-TB) with the
existing unregulated availability and injudicious use of first and second line anti-TB drugs in
the country.
Pediatric TB
Children in the first five 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 1.1 million new
cases are reported and 1,30,000 deaths occur annually due to TB among children. Reliable
data on the incidence and prevalence of the disease is not available due to the difficulties in
diagnosis of pediatric TB under field conditions. However, limited data available reveals that
prevalence of TB among children in the age group 0-14 years is estimated to be 0.3% of
radiological cases and 0.15% of bacteriological cases.
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 reflecting 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. The majority 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 reflecting the
decrease in prevalence. However, TB remains a significant cause of loss in the health 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 of the population.
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Following an external review of the existing National TB Programme in 1992, the Revised
National TB Control Programme (RNTCP) was formulated. The RNTCP addressed the
weaknesses of the NTP noted by the 1992 review, and adapted to the Indian setting the
globally recommended “DOTS Strategy” for TB control. After a pilot phase (1993 – 97),
RNTCP was scaled up in a phased manner to cover the entire country by March 2006.
Goal and Objectives of RNTCP

The goal of RNTCP is to decrease the mortality and morbidity due to tuberculosis and cut
down the chain of transmission of infection until TB ceases to be a public health problem.
The goal is achieved through the following objectives:
To achieve and maintain:

• cure rate of at least 85% among newly detected smear-positive (infectious)
pulmonary tuberculosis cases; and
• case detection of at least 70% of the expected new smear positive PTB cases
in a community.
However, the current focus is on ensuring universal access to quality assured TB diagnosis
and treatment services under the programme.
Directly Observed Treatment Short course (DOTS) strategy

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

measured in terms of continued financial assistance, human resources and
administrative support. This priority must be reflected at the National, State, District and
local levels.
• Quality assured diagnosis through sputum microscopy: Under RNTCP, sputum

microscopy is the primary tool for detection of infectious TB cases, facilitating
categorization of treatment and an objective method for monitoring the response to
treatment. Quality assured smear microscopy laboratories are established for this
purpose.
• Uninterrupted supply of quality drugs: The policy of procurement and distribution of

drugs ensures sufficient quality assured anti-TB drugs available at all levels. The unique
feature of RNTCP is the use of blister combipacks in patient wise drug boxes for
adults and weight band wise drug boxes for pediatric cases which contain drugs for
the entire course of treatment. Patient wise boxes have not only helped to improve
patient care and treatment adherence but also to streamline drug supply and drug stock
management.
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special efforts have been made to involve all medical colleges in RNTCP activities,
beginning from incorporation of the programme policies and guidelines in the medical
curriculum and up to their involvement in the actual activities of the programme. For
effective implementation of RNTCP in the medical colleges (both Government & private),
the programme has established a Task Force mechanism at the National, Zonal and State
levels.
Public Private Mix

The Government is committed to provide quality assured diagnostic and treatment facilities
free of cost to all TB patients in the country, irrespective of the health care sector from
where they receive care or are referred from. RNTCP lays great emphasis on involving both
government and non-governmental agencies, including private practitioners. An advocacy
kit containing material and documents for sensitizing these other sectors has been
developed to support this.
TB-HIV collaborative activities

The National Framework for Joint TB/HIV Collaborative Activities was first developed in
2007, with revisions in February 2008 and October 2009. The National Framework
extended basic TB-HIV activities nationwide. An intensified TB/HIV package of services
was developed to offer additional services in States with the higher burden of HIV-TB to
begin with and planned to cover the entire country by 2012.
Specific TB-HIV collaborative activities undertaken are:
1. Establishment / Strengthening NACP-RNTCP coordination mechanisms at national,

state and district level.
2. Scaling up of Intensified TB/HIV Package of services across the country.
3. Joint Monitoring and Evaluation including standardized reporting shared between the
two programmes.
4. Training of the programme and field staff on TB/HIV
5. TB and HIV service delivery coordination
5.1. Offer of HIV testing to TB patients
5.2. Intensified TB case finding at ICTCs, ART and Community Care Centres
5.3. Linking of HIV-infected TB patients to NACP for HIV care and support ( including
antiretroviral treatment) and to RNTCP for TB treatment
5.4. Provision of Cotrimoxazole Prophylactic Treatment (CPT) for HIV-infected TB
patients
6. Implementation of feasible and effective infection control measures
7. Involvement of NGOs/CBOs and affected communities working with NACP and
RNTCP for all activities on TB/HIV collaboration.
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8. Operational research to improve the implementation and impact of TB/HIV
collaborative activities.
RNTCP and DOTS-Plus services for MDR-TB
RNTCP reaffirms that the prevention of the MDR-TB is the priority task which can be
achieved only through the implementation of a good quality DOTS programme. Available
information suggests that prevalence of MDR-TB is relatively low in India. However, this
translates into a large absolute number of cases, estimated at over 99,000 in 2008. The
country is slowly gearing up to manage tens of thousands of MDR-TB patients annually by
2012-13. Specific measures are being taken by RNTCP for the diagnosis and management
of MDR-TB cases, based on a framework organized around similar five components as
those of the DOTS strategy.
RNTCP reached a landmark achievement with the launching of RNTCP DOTS-Plus

services for the management of MDR-TB patients in the states of Gujarat and Maharashtra
in 2007. Specific guidelines have been formulated for the implementation of DOTS-Plus
activities in a phased manner across the country. RNTCP aims to establish a network of
accredited, quality assured culture and drug susceptibility testing laboratories across the
country by 2012-13.
Advocacy, Communication and Social Mobilization (ACSM)

The intensification of ACSM activities is an important component of RNTCP. An effective
RNTCP ACSM strategy is in place in order to maintain high visibility of TB and RNTCP
amongst the policy makers and other stakeholders, opinion leaders and community. ACSM
activities support the efforts for improving case detection and treatment adherence,
combating stigma and discrimination, empowering people affected by TB, and for mobilizing
political commitment and resources for TB. The activities have clearly laid out objectives,
target groups and media options to reach the respective target group.
Organizational structure and functions

The structure of RNTCP comprises of five levels: National level, State level, District level,
Sub-district level and Peripheral health institution level (refer to flow chart below).
National Level
At the central level, the Revised National TB Control Programme is managed by the Central
TB Division (CTD) of the Directorate General of Health Services, the technical arm of the
Ministry of Health and Family Welfare (MoH&FW). A national programme manager - Deputy
Director General-TB (DDG-TB), is in-charge of RNTCP nation-wide. The respective Joint
Secretary of Health from the administrative arm of the MoH&FW looks after the financial
and administrative aspects of the programme. The CTD is assisted by 4 national level
institutes, namely the National TB Institute in Bangalore, the TB Research Centre in
Chennai, the Lala Ram Sarup Institute of TB and Respiratory Diseases in New Delhi and
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the JALMA Institute of Leprosy and other Mycobacterial Diseases, Agra. The Central TB
Division has five units assigned to managing the various areas of programme activities.
These units are headed by a Chief Medical Officer (CMO), and assisted by other technical
and secretarial staff. The five units are:
1. Supervision, monitoring and epidemiological surveillance unit
2. Human resource development unit
3. Procurement, supply and logistic unit
4. Finance unit and
5. Advocacy, communication and social mobilization unit.
An important area of co-ordination at the national level is with the respective office and staff
dealing with the National Rural Health Mission (NRHM) within the MoH&FW.
Committees at National level

Various committees have been constituted at national level to provide technical guidance
for programme implementation. These are:
National Laboratory Committee

A central Laboratory Committee has been constituted with the representatives of the four
RNTCP National Reference Laboratories, CTD , WHO India and few other partners as its
members. This committee works as a task force to guide and oversee laboratory related
activities of the programme
National Technical Working Group for TB-HIVp

The National technical working group comprises of key officials from NACO and CTD
dealing with TB/HIV Collaborative activities and experts from WHO. The purpose of the
TWG, which meets at least quarterly, is to review, optimize and plan for future TB/HIV
Coordination activities. The function of National TWG also includes supervision of TB/HIV
collaborative activities by officials of both programmes, including joint field visits.
National DOTS- Plus committee

National DOTS Plus Committee formulates policies and develops guidelines for all
categories of staff, including monitoring and evaluation mechanisms. Routinely review
implementation status of DOTS-Plus activities and provide recommendations to CTD for
improvement and/or change.
National Task Force for Medical Colleges

A National task Force has been formed for effective implementation of RNTCP in Medical
Colleges. DDG (TB) is the Member Secretary of the NTF and the members are one each
from CTD, 7 nodal medical colleges, TRC, NTI, LRS and WHO. The main task of NTF will
be to provide leadership and advocacy, coordination, monitoring and policy development on
issues related to effective involvement of medical colleges in RNTCP.
National Standing Committee on Operational Research

The National Standing Committee comprises individuals and institutional members,
including heads of prominent institutes and eminent persons from the centers of excellence
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in the field of medicine and research, Central TB Division and technical agencies. This
committee provides technical guidance to CTD on the RNTCP OR, provides expertise to
identify OR priority areas for commissioned research. They also serve on panels of experts
for the review of commissioned research activities and technically review and approve
proposals submitted by State/Zonal OR Committees to the National Level.
State Level
At the State level, the State Tuberculosis Officer (STO) is responsible for the planning,
training, supervising and monitoring of the programme in their respective states as per the
guidelines of the State Health Society and CTD. The STO, based at the State TB Cell, is
answerable to their respective State Government, whilst implementing the technical policies
and guidelines issued by the CTD. The STO coordinates with the CTD and the respective
districts for execution of their duties mentioned above. It is required that there be a full-time
trained STO for RNTCP in each state.
The State TB Cells have been provided with equipment, infrastructure and RNTCP
contractual staff to carry out its functions. The staff at the STC are the State TB Officer,
Deputy State TB Officer, Assistant Programme officer/Epidemiologist, Medical Officer STC,
State IEC Officer, State Accountant, Secretarial Assistant, Pharmacist and Data Entry
Operator The functions of the State TB Cell and the responsibilities of their staff are listed in
the RNTCP Technical and Operational Guidelines
In most of the larger states, a State TB Training and Demonstration Centre (STDC)
support’s the State TB Cell. The STDC has 3 units: a training unit, supervision and
monitoring unit and an Intermediate Reference Laboratory (IRL). The functions of the STDC
are listed in the RNTCP Technical and Operational Guidelines.
It is essential to have a State Drug Store (SDS) for the effective management of anti-TB
drug logistics. For the long-term sustainability of the programme, decentralization to the
states of many aspects of drug management has been undertaken. One SDS per 50 million
population is established in all larger states.
District Level
The district is the key level for the management of the primary health care services. The
district level (or municipal corporation level) performs functions similar to those of the state
level in its respective area. The Chief District Health Officer (CDHO) / Chief District Medical
Officer (CDMO) or an equivalent functionary in the district, is responsible for all medical and
public health activities, including TB control. The District Tuberculosis Centre (DTC) is the
nodal point for all TB control activities in the district. In RNTCP, the primary role of the DTC
has shifted from clinical to managerial functions. The District TB Officer (DTO) at the DTC
has the overall responsibility of management of RNTCP at the district level as per the
programme guidelines and the guidance of the District Health Society. The DTO is also
responsible for involvement of other sectors in RNTCP and is assisted by a Medical Officer,
Statistical Assistant and other paramedical staff. For each district, there should be a full-
time DTO, who is trained in RNTCP at a central level institution. The functions of the
CDMO/CDHO, District TB Officer and other staff of the DTC are listed in the RNTCP
Technical and Operational Guidelines.
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Sub-District Level (Tuberculosis Unit Level)

The creation of a sub-district level Tuberculosis Unit (TU) is a major organizational change
in RNTCP, and is the nodal point for TB control activities at the sub-district level. The TU
consists of a designated Medical Officer-Tuberculosis Control (MO-TC) who does RNTCP
work in addition to other responsibilities. There are also two full-time RNTCP contractual
supervisory staff exclusively for tuberculosis work - a Senior TB Treatment Supervisor
(STS) and a Senior TB Laboratory Supervisor (STLS). The TU is generally based in a
Community Health Centre (CHC), DTC, Taluk Hospital (TH) or a Block Primary Health
Centre (BPHC). The team of STS and STLS at the TU level are under the administrative
supervision of the DTO and MO-TC. These TUs cover a population of approximately
500,000 (250,000 in tribal, desert, remote and hilly regions).
The TU is responsible for the maintenance of the Tuberculosis Register and the timely
submission of the RNTCP quarterly reports to the district level. The MO-TC at the TU has
the overall responsibility of management of RNTCP at the sub-district level, assisted by the
STS and STLS. The MO-TC is trained in RNTCP at a state level institution and is expected
to undertake supervisory visits in the TU for 7 days in a month. The functions of the TU
team are given in the RNTCP Technical and Operational Guidelines.
There is one RNTCP Designated Microscopy Centre (DMC) for every 100,000 population
under a TU (50,000 in tribal, desert, remote and hilly regions). DMCs are also established in
Medical Colleges, Corporate hospitals, ESI and Railway health facilities, NGOs, private
hospitals etc, depending upon the requirement.
11
Peripheral Health Institutions (PHIs)

For the purpose of RNTCP, a PHI is a health facility which is manned by at least a medical
officer. At this level, there are dispensaries, PHCs, CHCs, referral hospitals, major
hospitals, specialty clinics or hospitals (including other health facilities), TB hospitals, and
Medical colleges within the respective district. All health facilities in the private and NGO
sectors participating in RNTCP are also considered as PHIs by the programme. Some of
these PHIs also function as DMCs.
Peripheral health institutions undertake tuberculosis case-finding and treatment activities as
a part of the general health services. In this regard, they are supervised by the TU
contractual paramedical staff (STS and STLS). In situations where more than one MO is
posted in any of the peripheral health centres, one of them may be identified and entrusted
with the responsibilities of the RNTCP. The categories of staff involved in TB control at PHI
level and their principal responsibilities are given in the RNTCP Technical and Operational
Guidelines.
Organizational structure of RNTCP

Central TB Division, Deputy Director General -TB
DGHS, Mo H& FW Chief Medical Officers
National Lab Committee

National institutes National TWG for TB-HIV
(NTI, TRC, LRS, National DOTS Plus committee
JALMA) NTF for medical colleges, National
OR committee
State TB Training and State TB Cell STO, Deputy STO, MO,

Demonstration centre / Epidemiologist, Secretarial Assistant,
DEO, Accountant, IEC Officer,
SDS / IRL
Nodal centre for TB District TB Centre DTO, MO-DTC, DEO, support

control in the district staff. District TB-HIV & DOTS
Plus Supervisor
One per 5 lakh

population / 1 per 2.5 Tuberculosis Unit MO-TC, STS, STLS
lakh in tribal, hilly and
difficult areas
One per 1 lakh Designated MO, LT

population / 1 per 0.5 Microscopy Centre
lakh in tribal, hilly, desert
and difficult areas
Peripheral Health
MO
Institutions
12
Work exercises
1. District X has a population of 2 million, with 5 lakhs population residing in hilly tribal
areas. What is the number of TUs and DMCs that the district is expected to have in
place?
2. List five major responsibilities of

a. STO
i.________________________________________________________
ii.________________________________________________________
iii._______________________________________________________
iv._______________________________________________________
v.________________________________________________________
b. DTO
i.________________________________________________________
ii.________________________________________________________
iii._______________________________________________________
iv._______________________________________________________
v.________________________________________________________
c. MOTC
i.________________________________________________________
ii.________________________________________________________
iii._______________________________________________________
iv.______________________________________________________
v.________________________________________________________
Q.3 A. What is the impact of HIV on TB control programme?

Q.3 B. What is the impact of TB infection on HIV?
Q.4 Mention important activities under TB-HIV coordination
Q.5 Define MDR-TB
Q.6 Enlist the components of WHO Stop TB Strategy
Q.7 What is prevalence of TB among children?
13
POINTS TO REMEMBER
• TB is the number one killer of adults among all infectious diseases, in India.
• DOTS strategy is the globally accepted standard for diagnosis and treatment of
tuberculosis
• The Objectives of RNTCP are to achieve and maintain a cure rate of at least 85%
among newly detected sputum smear-positive cases and to achieve and maintain
detection of at least 70% of such cases in the population.
• RNTCP shifts the responsibility for TB cure from patient to the health system.
• A well managed TB control programme will save many lives and reduce the economic
burden
• Impact of HIV on TB
Risk of developing TB is higher in HIV infected persons.
Life-time risk of developing TB disease is 60% in persons infected with both HIV and
TB.
The rate of progression to disease is 10-30 times higher in HIV infected persons.
• Impact of TB on HIV
TB increases the risk of developing other Opportunistic infections among PLHA.
TB increases the rate of progression from HIV to AIDS.
TB shortens the life span of patients with HIV infection.
TB is a common cause of death in AIDS patients
14
Table of Contents
Module 2
Laboratory Diagnosis of TB and Quality Assurance
Introduction ....................................................................................................... 17
Symptoms of tuberculosis ................................................................................. 18
Pulmonary TB suspects .................................................................................... 18
Process of diagnosis of Pulmonary TB.............................................................. 22
Diagnostic Algorithm of Pulmonary TB .............................................................. 23
Diagnosis of TB among children ....................................................................... 25
Diagnostic Algorithm for pediatric Pulmonary Tuberculosis .............................. 26
Extra Pulmonary TB .......................................................................................... 27
Diagnosis of Pleural TB ..................................................................................... 29
TB in HIV positive patients ................................................................................ 29
Collection of sputum from tuberculosis suspects .............................................. 30
Transport of sputum specimens ........................................................................ 35
Exercise workbook E1 ....................................................................................... 37
Ziehl-Neelsen staining procedure ...................................................................... 39
Importance of grading of smears....................................................................... 40
Accuracy of the Tuberculosis Laboratory Register ............................................ 43
Recording of results of sputum smear examinations......................................... 44
Limiting administrative errors ............................................................................ 44
Documentation for referral for treatment ........................................................... 44
Monthly Summary ............................................................................................. 45
Section – B ........................................................................................................ 53
• Introduction ............................................................................................. 53
• Quality Assurance (QA) for smear microscopy ...................................... 54
• External quality assessment (for lab quality assurance) ......................... 57
• Maintenance of adequate supply of quality consumables ...................... 64
• Supervisory visits to designated microscopy centres ............................ 65
• Checklist for laboratory supervision ....................................................... 67
• Exercise 5 ............................................................................................... 69
• Section – C ............................................................................................. 71
• Bio-Medical Waste Management under RNTCP by PHIs: ...................... 72
• Annexure A to Q .................................................................................... 74-98
Module - 2
LABORATORY DIAGNOSIS OF TB AND QUALITY ASSURANCE

SECTION- A: Diagnosis of Tuberculosis
Introduction
Smear positive pulmonary tuberculosis (PTB) is the most common and infectious form of
tuberculosis and forms the major source of infection in the community. Every such case of
untreated case has the potential to spread infection to 10 – 15 persons annually. From the
public health point of view, it is of utmost importance to detect and treat such cases as early
as possible to cut the chain of transmission of disease in the community. Diagnostic
services for other forms of tuberculosis such as smear negative pulmonary TB, extra
pulmonary tuberculosis, pediatric TB, TB in HIV and drug resistant TB are also available
under programme.
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 a supportive tool for the diagnosis
of smear negative PTB.
In this section of the module the participants will learn about:
• Symptoms of tuberculosis
• Pulmonary TB suspects
• Screening of TB suspects
• Process of Diagnosis
• Collection of sputum specimens
• Tasks to be performed before, during, and after collection of sputum
• Filling up of Laboratory Forms for sputum examination
• Transportation of sputum
• For smear microscopy from collection centres
• For Culture and DST from DMC/DTC
• Monitoring and documentation related to microscopy services
• Sputum smear examination ( ZN staining procedure)
• Documentation of smear microscopy in TB laboratory register
Symptoms of tuberculosis
Pulmonary tuberculosis
The most common symptom of PTB is a persistent cough of two weeks or more, with or
without expectoration.
It may be accompanied by one or more of the following symptoms:-

• Fever, night sweats, weight loss
• Chest pain, hemoptysis, shortness of breath, tiredness and loss of appetite
17
Such patients should be selected and subjected for sputum examination. This enhances the
chances of detection of the bacilli in the smear microscopy.
Extra pulmonary tuberculosis

A person with extra-pulmonary TB may have symptoms related to the organs affected along
with constitutional symptoms stated above.
• Enlarged cervical lymph nodes with or without discharging sinuses (TB Lymphadenitis)
• Chest pain with or without dyspnoea in pleural TB
• Pain and swelling of the joints in bone tuberculosis (fever, backache, deformity in spinal
TB)
• Signs of raised intra-cranial tension like irritability, headache, vomiting, fever, stiffness of
the neck and mental confusion in TB meningitis
• Painless haematuria or sterile pyuria in renal tuberculosis and infertility in genito-urinary
TB.
Pulmonary TB suspects
Pulmonary smear-positive tuberculosis patients expel tubercle bacilli into the air while
coughing/sneezing. Contacts of undiagnosed/untreated pulmonary smear-positive patients
become infected when they inhale these tubercle bacilli.
A pulmonary TB suspect is defined as:
• An individual having cough of 2 weeks or more.

• Contacts of smear positive TB patients having cough of any duration
• Suspected/confirmed extra-pulmonary TB having cough of any duration
HIV positive patient having cough of any duration
Persons having cough of 2 weeks or more, with or without other

symptoms, are referred to as pulmonary TB suspect. They should have
2 sputum samples examined for AFB.
Importance of properly identifying TB suspects

Most patients with TB attend health facilities promptly for seeking relief of symptoms. It is
important to suspect tuberculosis among these chest symptomatics and subject them for
sputum examination. If TB is not suspected, patients with smear-positive pulmonary
TB will not be identified. These patients will continue to spread the infection and it is likely
that more than half of them die by three years. Hence, every pulmonary TB suspect should
be referred for sputum examination in time.
Therefore, all health workers and community volunteers should be encouraged to

identify and refer TB suspects to DMCs for early diagnosis and treatment to prevent
further spread of the infection
18
Screening of pulmonary TB suspects

Patients attending health institutions - government/private need to be systematically
screened for cough of two weeks or more by the health facilities. Persons with cough of 2
weeks, or more, with or without other symptoms suggestive of TB, should be promptly
identified as pulmonary TB suspects. They are to be referred to the designated microscopy
centre (DMC) for sputum examination using the RNTCP laboratory form for sputum
examination.
Expected number of referrals for sputum examination

In a peripheral health institution (PHI) of rural setting, it is expected that atleast 2% of new
adult out patients are chest symptomatics (pulmonary TB suspects). However this will vary
widely in different settings eg., 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% of new adult outpatient for sputum examination. Further, it is
expected that on an average 5-15% of the chest symptomatics subjected for sputum
examination are found to be sputum smear positive following standard operating
procedures of ZN staining. This percentage varies depending on the clinical/epidemiological
settings.
The number of TB suspects examined can be expressed as numbers / lakh population/

quarter.
Sustained efforts have to be taken to examine as many TB suspects as possible to

maximize case detection under the program.
In a PHI of rural setting atleast 2% of new adult out-patients are estimated to be TB

suspects. However, it can vary greatly in secondary and tertiary level health care settings.
In an average DMC, 5-15% of TB suspects are expected to have sputum smear-positive
pulmonary TB
Referral for sputum examination

Pulmonary TB suspect (PTB suspects) at designated microscopy centers (DMC) are
subjected for two sputum examinations. PTB suspects 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.
Generally, a PHI covering a population of 1 lakh and having a new adult OPD attendance of
atleast 100 per day is selected as a DMC. In difficult areas, more laboratories are required.
Hence, in such areas, a PHI may be allowed to function as a DMC even if it covers a
population of 50,000 and has a new adult OPD attendance of 60-100 per day. In addition,
DMCs can be established in private or NGO or other public sector undertakings (other than
Health Ministry) which fulfills the criteria.
The DMCs should satisfy the following criteria:

1. A Qualified and RNTCP trained Laboratory technician should be present
2. A functional Binocular Microscope should be present in the laboratory
3. Physical infrastructure in Laboratory should meet RNTCP guidelines
19
4. Daily new adult OPD of at least 60-100 and / or workload of at least 3-5 sputum
smears per day for the Laboratory Technician in the laboratory.
5. The laboratory should be under functional RNCTP Quality Assurance Program.
RNTCP laboratory form for sputum examination has to be filled by the Medical Officer/
Health worker of the health facility appropriately and sent along with the patient for sputum
examination.
Tools for diagnosis of Pulmonary TB in adults:

• Sputum smear microscopy
• Chest X-ray
• Sputum culture and DST for diagnosis of Drug Resistant TB
• Newer rapid diagnostic tools for detection of MDR TB
• Newer tools under evaluation for diagnosis of MDR/XDR TB
Sputum Microscopy
Sputum smear microscopy is the most widely used and acceptable testing tool for
diagnosing smear positive pulmonary TB. Ziehl-Neelsen staining technique is used in
RNTCP. Sputum microscopy has the following advantages:-
• Simple, inexpensive, requires minimum training

• High specificity
• High reliability with low inter-reader variation
• Can be used for diagnosis, monitoring and defining cure
• Results are available quickly
• Feasible at peripheral health institutions
• Correlates with infectivity in pulmonary TB cases
Therefore this is the key diagnostic tool used for case detection in RNTCP.
X-ray
Chest x-ray as a diagnostic tool is more sensitive but less specific with higher inter and intra
reader variation. However, it should be used judiciously. It should always be preceded by a
repeat sputum smear examination following treatment with antibiotics (refer to diagnostic
algorithm). It is also useful for diagnosing extra pulmonary TB like pleural effusion,
pericardial effusion, mediastinal adenopathy and miliary TB. The following are the
limitations of the chest x-ray as a diagnostic tool
• High inter and intra-reader variation

• No shadow is characteristic of TB
• 10–15% culture-positive cases remain undiagnosed (under reading)
20
• 40% patients diagnosed as having TB by x-ray alone may not have active TB disease
(over reading).
Sputum smear microscopy is the primary tool for diagnosing TB as it is more

specific and has less inter and intra-reader variability than X-ray.
Diagnosis of Drug Resistant-TB

Culture of mycobacterium tuberculosis bacilli is a very sensitive and specific tool. It is the
gold standard for evaluating other tools of diagnosis. It is mainly used for the diagnosis of
drug resistant TB as it is expensive (liquid culture systems) and time consuming (solid
culture). Drug susceptibility testing using the proportion susceptibility method is the
accepted gold standard.
Diagnostic tools for MDR-TB / XDR TB:

Drug resistant TB (MDR/XDR and other types) is a laboratory based diagnosis either
phenotypically i.e., growing the bacteria (culture) and demonstrating the ability of bacteria to
grow in the presence of the anti-TB drugs (drug sensitivity testing - DST) or genotypically by
demonstrating the presence of resistance genes using molecular methods.
The conventional and newer rapid tools used for diagnosis are:
• Solid culture medium - (Egg-based Lowenstein Jensen) or agar based 7H11/10

medium
• Liquid culture medium – Commercial automated MGIT 960.
Newer rapid diagnostic tools include:

Non-commercial solid culture methods – Nitrate Reductase Assay using the property of
M.Tb to reduce nitrate to nitrite as means of detection of drug resistance.
Non-commercial liquid culture methods include – Microscopic observation of drug

susceptibility assay (MODS) using 7H9 medium in microtitre wells and observing growth
using an inverted microscope for both culture and DST.
Liquid culture system –Mycobacteria growth indicator tube system (MGIT) available in
automated (MGIT-960) and MGIT manual systems. This can detect growth of mycobacteria
as early as 4 days from inoculation and DST will be available in 21-28 days.
Molecular Assays – PCR based technologies using various modifications are used for
detecting the presence of putative resistance genes (rpoβ for rifampicin, katG and inhA for
INH etc). The most widely evaluated and used assays are Line Probe Assays (LPA) which
are based on in-situ hybridization on nitrocellulose strips of specific genetic targets for
resistance genes. These are now available for RIF and INH resistance (MDR-TB) and will
be shortly available for XDR-TB (resistance to aminoglycosides, polypeptides,
fluoroquinolones and ethambutol)
Newer tools under evaluation include, Cepheid GeneXpert – a completely closed

automated system using real-time PCR which has a sensitivity of 70-90% even for smear
negative cases and can also detect the presence of rifampicin resistance
21
Process of diagnosis of Pulmonary TB

Medical Officers of health care facilities (governmental or non governmental) should identify
all pulmonary TB suspects from patients attending health facilities and refer them for
sputum examination using the RNTCP laboratory request form for sputum examination. In
Medical Colleges and other hospitals, indoor-patients suspected of TB should also be
referred by the treating physician using the same RNTCP laboratory forms for sputum
examination.
In the laboratory the patients are given sputum containers with instructions to provide
quality sputum specimen which are then subjected for smear microscopy examination. If
the health facility is transporting the sputum specimen, it should reach the DMC and sputum
examination should be completed as early as possible not later than two days.
Two sputum samples are collected within a day or two consecutive days.
• One sample is collected on the spot under supervision and

• Other is collected early in the morning by the patient at home.
Diagnosis by sputum smear microscopy and treatment for TB are available FREE of
cost at all health facilities under RNTCP
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.
• Two sputum specimens (spot and early morning) should be collected in a day or
within two consecutive days).
• Sputum should be at least 2 ml in quantity and preferably mucopurulent
• Sputum samples should be transported and examined as soon as possible and
not later than two days after collection
• Results of sputum tests should be reported within a day
Definitions:
Smear-positive pulmonary TB
A patient with one or two smears being positive for AFB out of the two sputum specimens
subjected for smear examination by direct microscopy is diagnosed as having smear-
positive pulmonary TB.
Smear-negative pulmonary TB
A patient with symptoms suggestive of TB with two smear examination negative for AFB,
with evidence of pulmonary TB by microbiological methods (culture positive or by other
approved molecular methods) or Chest X-ray is classified as having smear negative
pulmonary tuberculosis
22
Diagnostic Algorithm of Pulmonary TB
COUGH OF 2 WEEKS OR MORE
2 Sputum smears
1 or 2 positives 2 Negatives
Antibiotics 10-14 days
Cough persists
Repeat 2 sputum
Examinations
1 or 2 positives Negative
X-ray
Suggestive of TB Non-TB
Smear positive TB Smear negative TB

(Initiate treatment (Initiate treatment
regimen for TB) regimen for TB)
The diagnostic algorithm given above should be strictly followed. If not followed, patients
may either be treated unnecessarily based upon X-ray results or left untreated.
23
Patients with two or atleast one out of two sputum positive smear results are diagnosed by
the physician as having smear-positive pulmonary TB. They are further classified as a new
or re-treatment case based on their previous treatment history and appropriate regimen is
prescribed.
Patients who are negative for AFB in both the samples, will be prescribed a course of
antibiotics for a duration of 10-14 days. In such cases antibiotics such as fluoroquinolones
(Ciprofloxacin, Ofloxacin, Levofloxacin, Moxifloxacin etc.), clavulunate macrolides,
rifampicin or streptomycin, which are active against tuberculosis, are not to be used.
Antibiotics of choice include Cotrimoxazole, Amoxycillin, & doxycycline. Most patients are
likely to improve with antibiotics if they are not suffering from TB. If the symptoms persist
after a course of broad spectrum antibiotics, repeat sputum smear examination (2 samples)
must be done for such patients.
In repeat sputum examination, patients with two or at least one out of two sputum positive
smear results are diagnosed by the physician as having smear-positive pulmonary TB and
prescribed appropriate treatment regimens after taking proper treatment history.
However, if repeat sputum examination turns to be negative, they are subjected for chest x-
ray examination. If chest x-ray is suggestive of pulmonary TB and they will be diagnosed as
smear negative pulmonary TB and treated accordingly. If chest x-ray is not suggestive of
TB, then they should be evaluated for other respiratory diseases.
For patients infected with HIV, antibiotic trial is not indicated and Chest X-ray needs to be
taken to avoid delay in diagnosis of smear negative TB.
Patients whose sputum smears are negative, but with positive test results by culture or
molecular methods from accredited laboratories are also included under the definition of
smear negative TB.
If good diagnostic practices are followed as indicated above, it is expected that among the
new pulmonary TB cases, at least 50% will be sputum smear-positive cases.
TB cases remain undiagnosed IF:

TB suspects are not identified among outpatients
TB suspects are not sent for sputum examination
Sputum microscopy is of poor quality
24
Diagnosis of TB among children

The extent of TB in children is a reflection of the pool of infectious adult smear-positive
pulmonary tuberculosis cases in the community and their ability to transmit infection.
Diagnosis
Early and prompt diagnosis of TB in children is often difficult. A battery of tests is required
to arrive at accurate diagnosis of TB in children. Generally, diagnosis should be made by a
Medical Officer and the existing RNTCP case definitions are to be used for all cases
diagnosed.
High index of suspicion of TB in a child is the first 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 suspected or diagnosed case 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.
Establishment of malnutrition on an objective basis is also helpful in reinforcing the

diagnosis.
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 found feasible, is a very helpful tool in the diagnosis. It is pertinent
to remember that pulmonary TB among children is most often abacillary and there are
practical difficulties in obtaining good quality sputum. Wherever facilities are available, the
gastric lavage may be resorted to for isolation of AFB.
Tuberculin skin test using standard tuberculin is one of the reliable and relevant 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 specific reaction to M.Tb. Induration of 10mm and
above read after 48-72 hours of properly administered tuberculin indicates that the child is
infected.
Chest X-ray, also aids in the diagnosis of TB among children Features in chest X-ray
include hilar adenopathy infiltrations, pleural effusion etc.,
See flow chart given below for the diagnosis of pediatric TB.
25
Diagnostic algorithm for pediatric pulmonary Tuberculosis
Pulmonary TB Suspect
• Fever and / or cough 2 weeks
• Loss of wt/No wt gain
• History of contact with suspected
Or diagnosed case of active TB
Is expectoration present?
If no, refer to
Pediatrician
If yes, examine 2 sputum smears
1 or 2 Positives 2 Negatives
Antibiotics
10-14 days
Cough Persists
Repeat 2 Sputum
Examinations
Negative 1 or 2 Positives
X-ray + Sputum Positive

Mantoux TB (Anti TB
Treatment)
Sputum-Positive TB
Negative for TB Suggestive of TB
(Anti-TB Treatment)
Sputum-Negative TB
(Anti-TB Treatment)
26
Extra-pulmonary TB
Extra-pulmonary TB comprises 10% - 15% of the total TB cases. 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
classified as extra-pulmonary. Tubercular lymphadenitis and pleural effusion are most
common among extra-pulmonary TB.
Diagnosis of Extra Pulmonary TB

Demonstration of AFB in a smear from extra pulmonary site is often difficult because of low
bacillary load. The clinical features pertaining to the system affected should be considered
in the diagnosis 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
(f) Culture for Mycobacterium tuberculosis (M.Tb)
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.
TB lymphadenitis
This form of TB is more common in children and adults who are less than 30 years of age
and more so among women. Though, lymph nodes in the neck are more frequently
involved, it is not rare to find TB in mediastinal and abdominal lymph nodes. Axilla/groin are
infrequent sites for occurrence of tuberculosis.
TB lymphadenitis usually presents as slowly progressive, painless enlargement of the

lymph nodes in the neck and it is rare to find involvement of more than one group of lymph
nodes. Individual nodes are firm and discrete though matting of nodes may occur and
progress to abscess and sinus formation if left untreated. Tubercular abscess is also called
“cold abscess”.
The commonest form of extra-pulmonary TB is Tubercular Lymphadenitis
In addition, constitutional symptoms like fever, malaise, weight loss, anorexia, etc. may or
may not be present. Diagnosis based on clinical findings alone can lead to over-diagnosis
in a high proportion of cases. Therefore, attempt should always be made to confirm by
cytological or histopathological diagnosis by undertaking fine needle aspiration cytology
(FNAC) or excision biopsy. This procedure can be undertaken wherever facilities are
available. In addition, chest X-ray taken incidentally may reveal mediastinal widening
suggestive of hilar adenitis.
27
Intermittent 6-month SCC regimen has been proven to be very effective in the treatment of
TB lymphadenitis.
During treatment, paradoxical reactions in the form of persistence or enlargement of

existing nodes or appearance of new nodes or abscess formation may occur in about one
third of the cases. Repeat non-dependent aspiration should be undertaken in such
cases.These reactions do not indicate treatment failure and this represents host immune
response to the release of mycobacterial antigens caused by the rapid bactericidal activity
due to treatment. Therefore, extension or modification of treatment is not warranted as they
usually regress spontaneously. Residual lymphadenopathy, after treatment completion has
also been reported in about one third of patients. Studies have shown that re-treatment is
required only if residual lymph node biopsy is bacteriologically confirmed as positive by
culture for Mycobacterium tuberculosis. As culture facilities are not available everywhere,
FNAC may be resorted to. However the granulomatous changes may persist for a long time
even after adequate treatment. Hence, the decision to start re-treatment can not be based
on histo-pathological evidence alone. The relapse rates after SCC are reported to be quite
low.
Diagnostic algorithm for TB lymphadenitis
Lymph node enlargement of > 2 cm in one or more sites, with or

without periadenitis, evidence of TB elsewhere, abscess,
discharging sinus
Prescribe a course of antibiotics for two weeks
If lymph node enlargement persists, suspect TB lymphadenitis
Pus from sinus / Fine Needle Aspiration Cytology (FNAC)

Mantoux test for children < 14 years
Diagnosis confirmed if the pus / aspirate from FNAC shows:

1. ZN smear positive for AFB in pus / aspirate
2. Histopathological changes suggestive of TB
Excision biopsy, if FNAC results are inconclusive Start treatment
28
Diagnosis of Pleural TB
Tubercular plueral effusion is considered as extra pulmonary tuberculosis. Patients may
present with cough and/or chest pain with or without difficulty in breathing. Constitutional
symptoms like fever, loss of appetite may be present but not invariably. In pleural effusion,
chest X-ray features may include obliteration of costophrenic angle and varying degree of
effusion. Biochemical and cytological analysis of the aspirated pleural fluid will help in
confirming the diagnosis. Pleural fluid is generally an exudate with mainly lymphocytes and
few mesothelial cells. Pleural biopsy is confirmatory in a high proportion of patients.
TB in HIV positive patients

Pulmonary TB (PTB) is most common form of TB disease. HIV positive and HIV negative
patients with active pulmonary TB generally manifest similar clinical features, namely
cough, fever, night sweats, haemoptysis and weight loss. The presentation may sometimes
vary with the degree of immune suppression. In patients with mild immune suppression, the
clinical picture often resembles usual adult post-primary pulmonary TB i.e., the sputum
smear is frequently positive for acid-fast bacilli (AFB), and the chest X-ray (CXR) typically
may show unilateral or bilateral upper lobe infiltrates, cavitations, pulmonary fibrotic
changes, and/or volume loss.
In severely immune suppressed patients, the overall risk of TB is even higher, but it is more
difficult to distinguish TB from other serious chest diseases. In persons with advanced HIV
infection, disseminated and extrapulmonary TB (EPTB) are more common than in early HIV
infection and may be as common as pulmonary TB. The most common forms of EPTB seen
are lymphadenitis, pleural effusion, pericarditis, miliary disease and meningitis. In PTB, the
features of the disease are frequently atypical, resembling those of primary TB as
historically seen in children. Smear-negative TB is as common as smear-positive TB. The
chest x-ray pattern in advanced HIV infection may show any pattern. Hilar
lymphadenopathy is frequently observed and interstitial infiltrates tend to be common,
especially in the lower zones; features such as cavitation or fibrosis are less common.
Infiltrates may be unilateral or bilateral, and are seen more often in the lower lobes than in
the upper lobes.
Features of PTB Stage of HIV Infection
Early Late
Clinical Picture Often resembles post- Often resembles primary

primary TB TB
Sputum Smear Result Often Positive Often Negative
Chest X-ray Appearance Often cavities Often infiltrates with no

cavities
The advent of HIV has made the diagnosis of TB more difficult, and false diagnosis of TB
probably occurs frequently among patients affected by other HIV-related illnesses. These
false-positive diagnosis in most cases, however account for a very small proportion of all
forms of TB notified and thus do not negate the huge increases observed in TB notifications
in HIV-endemic areas.
29
Intensified TB case finding at ICTCs, ART and Community Care Centres

(CCCs)
Intensified TB case finding should be established in ICTCs, ART Centre & CCCs.
Intensified Case Finding means screening for symptoms and signs of TB in places where
HIV-infected people are concentrated, followed by diagnosis and prompt treatment,
increases chances of survival, improves quality of life and reduces transmission of TB.
All ICTC clients should be screened by the ICTC counselors for the presence of the
symptoms of TB disease (at pre, post and follow-up counseling). All clients who have
symptoms or signs of TB disease, irrespective of their HIV status, should be referred to the
nearest facility providing RNTCP diagnostic and treatment services. The detail guidelines
for operationalization of Intensified TB case finding at ICTCs is given in the Chapter VI.
Collection of sputum from tuberculosis suspects

TB suspects 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.
• Either the patient may be referred to the nearest DMC for sputum examination or
• 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 repetition of 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 container. This is the spot specimen labeled as ‘a’.
• Further, patient is given a labeled 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 labeled as specimen ‘b’.
• 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.
30
• These two samples should be collected within a day or two consecutive days.
• To obtain good quality sputum specimens and to prevent contamination, the staff must
perform certain tasks:
Before sputum collection,
During sputum collection, and
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 briefly explain to the
patient the reasons for sputum collection. The laboratory form for sputum examination
should be filled up completely, generally by the MO. This form is sent to the DMC along
with the sputum specimens. Only one form needs to be filled 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.
Laboratory form for sputum examination

The laboratory form comprises of three parts. The first 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 suspect or disease in terms of
pulmonary and extra pulmonary has to be indicated. The upper half of this form is generally
completed by the MO/ health care worker who requests a sputum examination
The middle portion has to be filled up by the staff of the centre collecting and transporting
the sputum specimens to DMCs. This also provides information on date of sputum
collection and specimen identification number and signature of the person collecting the
specimens.
The results section, located on the lower half / reverse of the laboratory form, is completed
by the DMC after the sputum examinations. Sputum examination results of both the sputum
samples can be recorded in this form
The detailed description of completing the form is as follows:

Name of Referring 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.
Date
The date (day/month/year) on which the patient is examined and the form is filled up, is
written in the space provided.
Name of patient
The patient’s full name (also nickname, if any) is written in the space provided.
31
Age
The age of the patient is written in the space provided.
Sex
The letter M is ticked if the patient is a male. The letter F is ticked if the patient is a female.
Complete address
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.
Only ONE Laboratory Form for Sputum Examination is filled out for two sputum
specimens collected from an individual patient
Type of suspect / disease

Pulmonary box is ticked 3 if patient is having cough and the specimen is sputum.
Extra-pulmonary (EP) box is ticked 3 if sputum specimen is collected from a EP TB

suspect/patient with cough of any duration.
Reason for examination

The diagnosis box is ticked (3) if the sputum specimen is collected from a tuberculosis
suspect. A patient who had both sputum samples negative for AFB and was given 10-14
days of broad spectrum antibiotics but did not improve again will have to undergo repeat
sputum examination. “Repeat Examination” box is to be ticked (3) in such cases. In follow-
up cases, follow-up of anti-TB treatment box is ticked (3) and TB number of the patient is
also recorded.
Follow up examinations: This is to be filled up by the MO / Health Care Worker while

referring the patient for follow up examination . For new, previously treated cases or MDR-
TB cases, the month of follow up examination may be indicated in the space provided.
Treatment Regimens : Treatment regimen given viz., regimen for new cases, regimen for
previously treated and MDR DOTS Plus treatment being administered to the patient may be
indicated by (3) in appropriate box provided.
Patient’s TB Number.
This is to be filled up only for patients who are undergoing follow-up sputum examination.
This is not available for patients undergoing the process of diagnosis. The TB number for
the patients diagnosed will be available after the process of registration in the TB register is
completed.
32
Name and signature of the referring person/official

The name and signature of the referring person/official who referred the TB suspect or
follow-up patient is recorded in the space provided.
Date of sputum collection

The date/s (day/month/year) on which sputum specimens are collected is written in the
space provided.
Specimen Indentification Number

If specimens are being transported to a DMC from another health facility, a
Specimen Identification Number is given at the referring facility, because the
Laboratory Serial Number can only be assigned at the DMC. Sputum
specimens are assigned specific numbers to keep track of each patient’s
sputum results. After the laboratory form for sputum examination is filled up,
this number is written on the side of the patient’s sputum container (If a
sputum specimen is separated from its laboratory form for sputum
examination, a LT can find out whose specimen it is by using the Specimen
Identification No. on the sputum container. The laboratory technician can then
locate the form by using the date and the identification number.) Each
separate specimen will generally have its own unique Specimen Identification
Number.
Name and signature of the specimen collector

The name and signature of the specimen collector is recorded in the space provided.
The middle portion of the form has the information related to transportation of sputum
samples in cases the sputum is collected and transported to the DMC.
If sputum is collected and transported to the DMC, 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: 8/9/09
Received on: 8/9/09
Examined on:________
Health Worker who collected specimen: Raju Result sent back on:
Specimen Name Age Sex Address Date of collection

Identification No. of sputum
C1, C2 Lakshmi Kumari 46 F 223 Gandhi Dham 6/9/09,7/9/09
D1, D2 Lakshmi Pati Rao 50 M 223 Gandhi Dham 6/9/09,7/9/09
E1, E2 Girija Devi 32 F 225 Gandhi Dham 6/9/09,7/9/09
F1, F2 Kailash Nath 35 M 225 Gandhi Dham 6/9/09,7/9/09
33
Results The lower portion of the form deals with the information regarding
results to be completed by the laboratory technician of the DMC.
The name of the DMC where the sputum examination is done
Laboratory serial number as given in the laboratory register
Date of Examination: The date on which the first sample was examined is to
be entered under this column.
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 officer.
2. Tasks performed during sputum collection

Person collecting the sputum specimen should follow the guidelines specified below:
• 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 him to cough from the depth of the chest and produce a quality specimen.
• Wherever possible, sputum should be collected in an open space / well ventilated room
meant for this purpose away from other crowded places in a health facility.
• 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 Identification Number (or patient’s name) is written on the side of the
container.
• 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, two specimens of sputum are collected. The
specimen collected in the early morning is marked as ‘b’ and spot samples collected
subsequently is marked as ‘a’.
• 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.
• 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 and ill-ventilated rooms.
• When a patient has only coughed up saliva or has not coughed up at least 2 ml of
sputum, the patient should be encouraged to give good specimen
• 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.
34
3. Tasks performed after sputum collection

The person collecting the sputum specimens should follow the guidelines specified below:
• 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
• If the sputum specimens are not being sent immediately to the laboratory, these should
be stored in a cool and dark place in the referring health facility
• The person should wash hands thoroughly with soap and water whenever infectious
material is handled
• 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 in a box to avoid spillage. Before sending the sputum specimens to the DMC, the
person should verify that:
1. The accompanying dispatch list contains the necessary data for all patients and clearly
identifies the referring health facility collecting the sputum.
2. The total number of sputum specimens corresponds to the total number in the
accompanying dispatch list.
3. The Specimen Identification Numbers on the sputum containers correspond to those on
the accompanying dispatch list.
4. One laboratory form for sputum examination is to be enclosed for each patient.
The health worker should then mark the date of dispatch on the dispatch list, put the list in
an envelope and attach it to the box outside.
Sputum specimens should be examined by microscopy not later than 2 days after
collection. The containers along with the sample MUST be disinfected with 5% phenol
solution and disposed off as per guidelines after the sputum smears results are recorded in
the laboratory register.
35
REVISED NATIONAL TUBERCULOSIS CONTROL PROGRAMME

Laboratory Form for Sputum Examination
Name of Referring Health Facility: __________________________ Date: ___________

Name of patient: _____________________________________ Age: ____ Sex: M F
Complete address: _______________________________________________________
________________________________________________________________________
Contact Phone number / Mobile No.: ________________________________________
Type of suspect / disease: Pulmonary
Extra-pulmonary Site: ______________
Reason for examination:
Diagnosis
Repeat Examination for Diagnosis
Follow-up examinations
• For new and previously treated cases - Month of follow-up ………………….
• For MDR-TB cases – Month of follow-up ………………………
Treatment Regimens (tick 9 appropriate box):

New cases previously treated MDR-TB
Patient’s TB No. ____________

(Name and signature of referring person/ official)
If sputum samples are being transported:

Specimen identification No.: ___________ Date of sputum collection: __________
Specimen Collector’s name and signature _________________________________
RESULTS (To be completed in the laboratory of DMC)

Name of DMC: ___________________________________________________
Lab. Serial No.: __________________________________________________
Visual Results Positive (grading)

Date of examination Specimen appearance (Neg or
(M, B, S)* Pos) 3+ 2+ 1+ Scanty**
A
B
* M = Mucopurulent, B = Blood stained, S = Saliva
** Write actual count of AFB seen in 100 oil immersion fields
Signature of Lab. Technician
Date: ______________ ____________________
The completed form (with results) should be sent to the referring PHI within a day of the
examination.
36
MANAGEMENT OF PATIENTS 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, classifies the patient
accordingly (as shown in the “diagnostic algorithm” earlier).
REMEMBER, the health system is responsible to ensure that all diagnosed sputum
smear-positive patients are traced and put on treatment within 7 days of diagnosis.
Have a group discussion about Module 2 before beginning Exercise

Workbook E1.
EXERCISE WORKBOOK E1:

LABORATORY FORM FOR SPUTUM EXAMINATION
Top Section
Please open Exercise Workbook E1 at this time.
The upper portion of the form is to be completed by the Medical Officer.
For this exercise, assume that all patients are attending the same facility as the Designated
Microscopy Centre, called PHI 237, except where noted otherwise. Complete only those
Laboratory Forms for patients in whom sputum examination is indicated. The date is 3
September 2009. Sputum examination is not indicated for all patients. For patients in whom
sputum examination is necessary, sputum will be collected on 3 September and 4
September. For ease of reference, each patient is given a letter as well as a name. This
letter should be used for the Specimen Identification Number wherever required.
1. Raman Lamba (Patient A) of 7 Institutional Area, Lodhi Road, is a 24-year-old male

labourer with pain in the chest for two weeks. There is no cough. Pain is worse with
movements.
2. Parvathi Sinha (Patient B) of 196, Gali Paranthe Wali, Chandni Chowk, is a 16-year-
old female student with non-tender swelling of the lymph nodes in the anterior and
posterior areas of the left side of the neck. She reports that she has occasional
cough for the past 5 days.
3. Lakshmi Kumari (Patient C) of 223 Gandhi Dham, Bapu Nagar, is a 46-year old
woman who has had cough for two months with fever, sweats at night, and
occasional coughing up of blood. The patient is being attended to at a remote health
facility (PHI 101). Sputum will be transported to the Designated Microscopy Centre
(PHI 237).
4. Kailash Nath (Patient F) of 225 Gandhi Dham, Bapu Nagar, is the 35 year old
husband of E. He came to health facility PHI 101 only to meet C, D and his wife E.
He wants to go back home before it gets late. He is coughing and spitting blood.
When asked, he reports that he has been coughing for several years.
37
5. Sita Devi (Patient G) of 2586 Gali No. 3, Gobind Puri, Near Gurudwara, is an 80
year old woman who complains that she feels tired. She does not have cough or
fever. She has heard that people who are weak receive treatment at this centre and
get better.
6. Ashok Kumar (Patient H) of No. 55 Raja Garden, near Post Office, is a 31 year old
vendor who complains of cough and high fever for the past 10 days. He has
otherwise been healthy, but now feels very ill, and is short of breath when he walks.
He remembers that the fever came on suddenly.
7. Ghanshyam Singh (Patient I) of 124 JJ Colony, Rajiv Puram, is a 16 year old boy
who has slight difficulty in walking over the last two years. His right knee is swollen.
He saw a physician in town who took a biopsy which showed caseating granuloma.
He could not afford treatment from the physician, and was referred to the centre for
care. He has no cough.
8. Bhola Ram (Patient J) of Gobi Wali Gali No. 1704, near Mandir, is a 32 year old
farmer. He has had a cough for the past 4 months. He has lost weight.
9. Ravindra Mehrotra (Patient N) of No. 70 Masjid Ke Pas, Sultan Bazar, is a 40-year-
old woman who complains of rash on her scalp and trouble sleeping at night.
10. Kiran Kumar (Patient O) of No.15 Gulmohar Park is a 37 year old man. He has had a
cough for two months. Though he is able to carry on work, occasionally he feels
feverish and has lost weight. He had come to PHI 237 on 28th August and underwent
sputum examination and his 2 smears were found negative for AFB. His cough has
not subsided in spite of 2 weeks of antibiotics.
POINTS TO BE REMEMBERED
• Undiagnosed and untreated pulmonary sputum smear-positive TB cases are the source
of infection in the community and have the potential to transmit infection to others.
• The most common symptom of pulmonary TB is a persistent cough for 2 weeks or more.
• In RNTCP, sputum smear microscopy is the main tool for the diagnosis of TB cases.
• Two sputum smears should be examined (Spot—Early morning) for diagnosis.
• Sputum should be examined within 2 days of collection and the results should be
reported on the same day.
• It is important to elicit past history of anti-TB treatment from the patient.
• Extra-pulmonary cases and contacts of all smear-positive cases with cough should be
subjected for sputum examination irrespective of the duration of cough.
• On an average, about 2–3% of new adult out-patients in a general clinic (in rural PHC
settings) will be TB suspects and should be referred for sputum examination.
• On an average, 10% of the TB suspects, subjected for sputum examination (SOP) are
found to be smear positive pulmonary tuberculosis.
• Grading of smears is helpful as a quality assurance tool
38
Ziehl–Neelsen staining procedure:

1. A new unscratched slide is selected and Laboratory Serial Number is labeled on the
slide using diamond marking pencil. New slide is selected in order to avoid deposition
of carbon fuchsin which may result in false positive results.
2. Yellow purulent portion of the sputum is picked with a piece of clean broom stick
and an oval shaped smear measuring 2 x 3 cms 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 flame as it sterilizes an area of six inches
around the flame 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 fix the smear.
6. The smear is fixed by passing the slide over a flame 3–5 times for 3–4 seconds each
time. Coagulation of the proteineceous material in the sputum will facilitate fixing of the
smear.
7. Carbol fuchsin (1%, filtered) 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
carbol 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 carbol fuchsin stain is washed
away. At this point, the smear on the slide looks red in color.
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 color. If the smear is still red, it
is to be decolorized again using sulphuric acid for 1–3 minutes. 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 Carbol 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.
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 guidelines,
using 5% phenol solution.
39
Importance of Grading of smears

• 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.
• 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 fields 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 difficulty 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.
If the slide has: No. of fields to Grading Result

be examined
No AFB in 100 oil immersion fields 100 0 Neg
1-9 AFB per 100 oil immersion fields 100 Scanty* Pos
10-99 AFB per 100 oil immersion fields 100 1+ Pos
1-10 AFB per oil immersion field 50 2+ Pos
More than 10 AFB per oil immersion

20 3+ Pos
field
*Record actual number of bacilli seen in 100 fields – e.g. “Scanty 4”
Smear-positive results including those of scanty positives are always recorded in red ink in
the Tuberculosis laboratory register.
Reasons for false-negative smear results

• Improper/Inadequate sputum collection
• Improper storage of sputum specimens
• Using saliva for smears
• Too thin or thick smears
• Over-heating/ Insufficient heating of the slide while fixing
• Boiling carbol fuchsin
• Over decolorization with sulphuric acid
• Improper storage of stained slides
• Inadequate examination
• Reading and reporting errors
40
Consequences
• Patients suffering TB may be missed and he may continues to spread the disease in the
community.
• Wrong categorization
• Intensive phase treatment may not be extended for the correct duration, resulting in
inadequate duration of treatment
• Errors in declaring treatment outcome.
• Patients and the community may lose confidence in the programme
• Unnecessary repetition of investigations
Reasons for False-positive smear results

• Faulty sputum collection (presence of food particles or fibers)
• Using old scratched slides / already used slide
• Using unfiltered carbol fuschin
• Inadequate decolorization with sulphuric acid
• Contamination due to transfer of bacilli from one smear to another
• Not wiping the oil immersion lens after examination of a positive slide
• Reading and reporting errors
Consequences
• Patients without TB may be put on anti-TB treatment unnecessarily
• Treatment may continue beyond the recommended duration
• Medicines are wasted
• Patients and the community may lose confidence in the programme
Documentation of smear microscopy

Tuberculosis laboratory register
The Tuberculosis Laboratory Register is a document maintained in a DMC for recording the
details of the sputum smear examinations. The Laboratory Technician is responsible for
maintaining and updating the laboratory register. A Laboratory Serial Number is assigned
to each patient who has been referred for sputum examination. The following information
about the patient is recorded in the register.
• Laboratory serial number

• Date of sputum smear examination,
• Full name, Age & Gender
• Complete address
41
• Phone number (land line and Mobile)

• Name of the health facility (PHC, Medical College, private practitioner, NGO) requesting
the examination.
• Reason for examination {diagnosis, repeat diagnosis and follow-up (mention category
and month of follow-up) of chemotherapy}.
• Results of sputum examinations (results of specimens ‘a’ and ‘b’ can be recorded).
• Signature of Laboratory Technician and
• Remarks
For TB suspect being evaluated, the technician ticks the Diagnosis column under Reason
for Examination. In case patients are undergoing repeat sputum examination for diagnosis,
the laboratory technician should write RE in the column for diagnosis and for patients
undergoing follow-up sputum examination, follow-up column under reason for examination
is ticked. Also mention the month of follow-up sputum examination and category of
treatment.
The column for signature is to be signed by Laboratory Technician.
The remark column can be used for recording the following:
• TB number
• Treatment regimen being given to smear positive patients residing in the same TU
• Action taken, in brief, for patients belonging to other TU/districts, (e.g., “Referred to
Udaipur districtt” In this case, as soon as the TB No. is received from Udaipur district,
the TB No. along with treatment regimen is entered in the remarks column, e.g., 234/04
New case – smear positive).
• Referral details and remarks on un-blinded rechecking of slides during OSE visits by the
STLS, etc.
Assistance of STS/STLS can be sought for recording entries in the remarks column.
Using the Tuberculosis Laboratory Register

• 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 TB suspect) are being performed for diagnosis.
• Results recorded in the laboratory register, treatment cards and the TB register are
verified and ensured that they are consistent.
• It is the responsibility of the MO to ensure that all smear-positive patients diagnosed
are started on treatment or are referred for treatment.
• If any smear-positive patients are not entered in the Tuberculosis Register and are
on treatment, they should be registered.
• For patients who have not been put on treatment it should be ensured that they are
traced, put on treatment immediately and registered.
42
The results of examination of up to TWO sputum specimen can be recorded for each
patient in one line of the Tuberculosis Laboratory Register.
Accuracy of the Tuberculosis Laboratory Register

• The accuracy of recordings in the TB laboratory register should be checked by the
laboratory staff.
• Laboratory register should not be used for recording results of any test / investigation
other than sputum.
• 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.
• Duplicate registers should not be maintained.
• It is to be ensured that Tuberculosis Laboratory Register is filled

completely and correctly.
• The MO PHI to ensure all smear-positive patients are started on treatment.
• LTs should ensure that correct laboratory serial number is recorded.
• A new number should be assigned to every TB suspect whose sputum is to be

examined.
• The Laboratory Serial Number should begin with a new serial (number 1) every
calendar year.
• The Laboratory Serial Number is also written in the Tuberculosis Register as well as
the TB Treatment Card.
• 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.
• 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.
• Without this Laboratory Serial Number, it would be tedious to go through many

pages of the Tuberculosis Laboratory Register for sputum results.
• 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.
43
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 or for repeat examination 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 TB suspect 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 Tuberculosis Number of all TB patients, with their respective category of treatment,
should be recorded in the remarks column, and the Tuberculosis Number of all patients
whose sputum is examined for follow-up must be written in the space provided.
Recording of results of sputum smear examinations

• LTs should understand the importance of accurate recording of results of sputum
smear examinations on the Laboratory Form for Sputum Examination.
• 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.
A LABORATORY SERIAL NUMBER is assigned to a PATIENT,

not to a sputum specimen
Limiting administrative errors

• If the patient’s sputum specimens are not labeled properly at the health facility or if
the Laboratory Form for Sputum Examination gets separated from the specimens,
the laboratory technician may not know whose sputum specimens are in the
containers when they reach the laboratory.
• The LTs should ensure that the Laboratory Serial Number on the Laboratory Form
for Sputum Examination 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
Identification Numbers and write it on the side of the containers.
Documentation for referral for treatment

• Information regarding referral of a patient should be noted in the “Referral for
Treatment” register as well as the remarks column of the Tuberculosis Laboratory
Register.
44
• A “Referral for Treatment” register (dealt in detail in the next module) should be
maintained in DMCs situated in bigger hospitals including that of medical colleges
that are referring large number of patients to other health facilities for treatment.
Monthly summary
The laboratory technician should summarize the information on sputum smear
examinations done during that month. This information should be summarized in the
prescribed format at the end of each month, printed in the Laboratory Register itself. 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.
Ensure that two sputum samples are examined for both diagnosis and follow- up
cases irrespective of the results of the first sample
If only one sputum specimen was examined, 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.
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.
Once a sputum specimen reaches a laboratory the laboratory technician gives a

Laboratory Serial No. The number is subsequently entered
a) In the Laboratory Form for Sputum Examination
b) On the side of the sputum cup
c) On the slide
d) In the TB Laboratory Register
e) In the Treatment Card
f) In the TB Register
g) Patient identity card
45
EXERCISE WORKBOOK E1:

LABORATORY FORM FOR SPUTUM EXAMINATION
Complete the Laboratory Form: Bottom Section
Start with Laboratory Serial Number 501. The appearance of the specimen is given in
brackets. Specimens are examined on 4 September 2009. Sign your own name.
Patient No. of AFB seen (visual appearance)
30 AFB are seen in 100 oil immersion fields (mucopurulent)

B. Parvathi Sinha
6 AFB are seen in 100 oil, immersion fields (mucopurulent)
150 AFB are seen in 50 oil immersion fields (bloody)

C. Lakshmi Kumari

F. Kailash Nath

J. Bhola Ram
O. Kiran Kumar 0 per 100 oil immersion fields x 2 (saliva, mucopurulent)
46
LABORATORY REGISTER
Age Complete Name of Reasons for Examination* Results

Lab. Sex
address (for referring Diagnosis Follow-up
Serial Date Name in Full M/F Signature Remarks
new patients) Health a b
No. TB Regimen
Phone No. Facility Month
No. NT/PT
• If sputum is examined for diagnosis, put a tick (3) mark in the space under “Diagnosis” sputum is examined for repeat diagnosis, put
‘RE’ in the space under” Diagnosis”
• If sputum is for follow-up of patients on treatment, write the patient’s TB No. in the space under “Follow up”, treatment regimen and
month of follow up
• Points to be mentioned in the remarks column: date of starting treatment, treatment regimen, TB No, Referral details, MDR-TB suspect
identified and remarks on unblinded rechecking of slides during OSE visits by the STLS, etc.
Monthly abstract of the Laboratory activities
TB TB suspects TB suspects Patients

TB
Month suspects undergoing found Follow-up positive Total Total Total Signature
Suspects
Year Examined Repeat positive on patient on slides positive negative of LT and
found
20 for Sputum Repeat examined follow- Examined slides slides STLS
positive
Diagnosis Examination Examination up
Jan
Feb
Mar
Apr
May
Jun
Jul
Aug
Sep
Oct
Nov
Dec
Total
Signature of the MO
.
Exercise 2
Review the sample page of the Tuberculosis Laboratory Register on the following
page and identify the errors for each patient registered.
Lab Sl.No. Name of the patient Errors identified
49
LABORATORY REGISTER
Complete Reasons for Examination* Results
Name of
Lab. Sex address (for
referring Diagnosis Follow-up
Serial Date Name in Full Age M/ F new Signature Remarks
Health a b
No. patients) TB Regimen
Facility Month
Phone No. No. NT/PT
499 30/3 Sita Dixit F 211, Pocket 3, Modern TB RE Neg Neg Joshi
Mayur Vihar Clinic
500 30/3 Krishna Kanth 54 F 40 Sector II, Jamnagar 9 Neg Joshi
Jamnagar Health
Centre
501 30/3 Aswani Rai 39 F 225, Block 4, Jamnagar 9 Scanty Joshi
Bapu Nagar Health
Centre
502 30/3 Abdul Hazan 44 M Gali No.7, JJ Aligarh 20 PT 5th 2+ 2+ Joshi MDR-TB suspect
Ram Rani Dispensary month
Coloni
503 01/4 Rama 38 422, Sector III, Modern TB 102 Neg Neg Joshi
Rohini Clinic
504 01/4 Alex chopra 45 M M.G. Road ART Centre 9 1+ 1+ Joshi Referred out
KRH
504 Renu Sharma 37 F Jamnagar 9 1+ 2+ Joshi
Health
Centre
505 02/4 Kumar Bhatia 58 M BB22/Block 4, Jamnagar 9 Neg
Nehru Place Health
Centre
506 02/4 Deepak 28 M ICTC KRH 9 1+ 2+ Joshi
Dhawan
507 02/4 Preeti Chandra 26 F 62, Lane No. RE Neg Neg Joshi
820, Kailash
Colony
* If sputum is examined for diagnosis, put a tick (3) mark in the space under “Diagnosis”
* if sputum is examined for repeat diagnosis, put ‘RE’ in the space under Diagnosis
* If sputum is for follow-up of patients on treatment, write the patient’s TB No. in the space under “Follow up”, treatment regimen as NT (new cases) or PT
(previously treated cases) and month of follow up.
• Points to be mentioned in the remarks column: date of starting treatment, treatment regimen, TB No, Referral details, MDR-TB suspect identified and remarks
on unblinded rechecking of slides during OSE visits by the STLS, etc.
Exercise 2: Complete the pages of the Laboratory Register using the laboratory form you have completed in
Exercise workbook 1
LABORATORY REGISTER
.Complete Name of Reasons for Examination* Results
Lab.
Sex address (for referring Diagnosis Follow-up
Serial Date Name in Full Age Signature Remarks
M/ F new patients) Health a b
No. TB Regimen
Phone No. Facility Month
No. NT/PT
* If sputum is examined for diagnosis, put a tick (3) mark in the space under “Diagnosis”
* if sputum is examined for repeat diagnosis, put ‘RE’ in the space under Diagnosis
* If sputum is for follow-up of patients on treatment, write the patient’s TB No. in the space under “Follow up”, treatment regimen as NT (new cases) or PT
(previously treated cases) and month of follow up.
• Points to be mentioned in the remarks column: date of starting treatment, treatment regimen, TB No, Referral details, MDR-TB suspect identified and remarks
on unblinded rechecking of slides during OSE visits by the STLS, etc.
EXERCISE 3
1. A laboratory technician wants to know about the usefulness of sputum smear
grading. Can you explain it to him?
2. An STLS supplied 100 slides to a PHI. The laboratory technician listed 120 smear-
negative cases and 20 smear-positive cases in the Tuberculosis Laboratory
Register. Please comment.
3. Tick the correct answer. Once a sputum specimen reaches a laboratory the
laboratory technician gives a Laboratory Serial No. The number is subsequently
entered
a. In the Laboratory Form for Sputum Examination

b. On the side of the sputum cup
c. On the slide
d. In the TB Laboratory Register
e. In the Treatment Card
f. In the TB Register
g. Patient identity card
h. All of the above
4. In Ziehl-Neelsen staining
(i) Concentration of carbol fuchsin used is

(a) 5% (b) 3% (c) 1% (d) 10%
(ii) Concentration of sulphuric acid used is
(a) 25% (b) 10% (c) 1% (d) 15%
(iii) Concentration of methylene blue used is
(a) 1% (b) 0.1% (c) 10% (d) 1.5%
5. Ram is a laboratory technician, who has assigned a Laboratory Serial No. to each
sputum specimen. What is your comment?
52
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 RNTCP. 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 efficiency.
Quality assurance = Internal Quality Control + External Quality Assessment +Quality Improvement
A nation-wide network of RNTCP quality assured designated sputum smear microscopy

laboratory is in place which provides appropriate and accessible quality assured laboratory
services.
RNTCP has established a system to monitor laboratory activities based on international

guidelines which includes NRLs, STDCs / IRLs & DTC / TU.
In this section of the module the participants will learn about
• Structure of RNTCP laboratory network

• Quality assurance for smear microscopy
• Maintenance of adequate supply of quality laboratory consumables
• Supervisory visit to DMC
• Infection control : Safe disposal of contaminated materials
• Annexures , Checklist and IQC documents
Structure of RNTCP 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 RNTCP. 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 four National Reference
Laboratories (NRLs), viz., Tuberculosis Research Centre (TRC), Chennai, (SNRL), National
TB Institute (NTI), Bangalore, LRS Institute of TB and Respiratory Diseases, New Delhi and
Central JALMA Institute, Agra.
The Central TB division is advised on all technical issues by the National Laboratory
Committee which includes members from all the four NRLs and representatives from WHO
& CTD.
The different levels of laboratories under RNTCP are as follows:

National Reference Laboratory: Each NRL will supervise sputum microscopy EQA of
states designated under them. The NRL will ensure proficiency of RNTCP staff for carrying
53
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 fit for accreditation by the respective NRL
looking after the state. The designated IRL will conduct sputum microscopy EQA for the
state and occasionally for a 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 RNTCP

are provided by Designated Microscopy centres (DMC) established for every one lakh
population (50,000 population in tribal, hilly and remote areas). In addition the DMCs are
also established at Medical colleges, Corporate hospitals, ESI, Railways, NGOs, large
private hospitals, and other major hospitals.
Laboratory Network under RNTCP
Bold line indicates direction of feedback and dotted line indicates reporting direction
Quality Assurance (QA) for smear microscopy

Quality assurance system includes
1. Internal Quality Control (IQC)

2. External Quality Assessment(EQA)
3. Quality Improvement(QI)
54
Internal Quality Control (IQC)
• It’s a systematic internal monitoring of working practices.

• It includes technical procedures, checking instruments, quality of new batches of
staining solution, smear preparation, grading, equipment infection control
measures, waste management etc.
Staining reagents:
Preparation of 1% Carbol Fuchsin:
• Ensure dye content is mentioned on the bottle while procurement

• Potency to be corrected before preparing the stain
• Stain should be filtered ( Whatmann Filter No 1) before use
Preparation of 25% Sulphuric Acid
• Concentrated acid to be stored separately (away from other chemicals) to avoid

accidental spillage.
• 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 flask
containing the required quantity of distilled water. The reaction is exothermic
(generates heat) and hence the flask (Borosil) should be kept in a cold water bath
/ice bath during preparation.
• 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
General points for all staining reagents:

• The prepared stain may be stored for a maximum period of 3 month
• Each batch of Stain to be prepared only to the capacity of the glassware
available (pooling of batches should not be done, even if prepared on the same
day)
• Each batch should be given a new batch number and to be validated separately
using a different set of QCP (Quality Control Positive) & QCN (Quality Control
Negative) for every batch.
• Water bath and electronic weighing balance to be used as per the specifications
Manufacturing QCP and QCN by STLS:

o QCP & QCN slides to be prepared by the STLS only
o QCP slides may be prepared by pooling 3+ grade sputum samples
o QCN slides may be prepared by pooling Negative sputum samples with adequate
number of pus cells( approximately 20 cells /field)
55
o 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)
o 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.
o All Quality control slides should be stored at least for a period of three months.
General maintenance of Binocular Microscope

o Oil to be removed from the objective lens using a soft lens cleaning tissue paper
after examining each slide
o The microscope to be stored inside a microscope box at the end of the day
o The Microscope box should contain Silica Gel and an Electric Bulb of 10-15 Watt
for desiccation to prevent fungal growth on the lens.
o The Silica Gel should be dehydrated periodically under direct sunlight and may be
reused. (Dehydrated gel looks blue in color )
o All Microscopes should be under AMC with routine preventive maintenance.
56
External quality assessment (for lab quality assurance)

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)

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.
57
When poor performance is identified 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. Sufficient 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 five positive and five 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 specific corrective measures.
Checklists used during OSE (discuss the checklist in detail)
Checklists are developed to assist both laboratory and non-laboratory supervisors during
the field visit and to allow for the collection and analysis of standard data for subsequent
remedial action. Checklists may be refined to focus on problems that are frequently
identified 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 receiving the on-site evaluation. This will
provide written documentation of the visit and findings and will also assist subsequent
evaluations to monitor improvements. When poor performance is identified through any of
the above-mentioned activities,additional visits by STLS 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.
B. 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.
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
58
detect problems associated with very poor performance. The proficiency of laboratory
technicians after training can be evaluated.
Panel testing under RNTCP 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.
C. 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:

• The sample contains a sufficient number of randomly selected slides to be
representative of all slides of the DMC,
• The supervisor (STLS) of the laboratory (first controller), must not be aware of the
original result of peripheral laboratory technician to prevent bias, i.e. results are
“blinded”,
• 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
• Discrepant results are resolved by a second controller (umpire).
• 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 RNTCP laboratory network. A system utilizing Lot Quality Assurance Sampling (LQAS)
method is used to calculate the sample size (See Table 1).
• The STLS selects from lab register RBRC sample slides for random blinded rechecking
(RBRC) on the advice of the DTO
• 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.
• The LT will enter the slide numbers that are selected by STLS in ‘Annexure B’ along
with results;
• Encloses the annexure B in a sealed envelope;
• 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.
• STLS picks up the box and envelop and hands them over to DTO.
• DTO conducts RBRC and gives feed-back and corrective actions to LT through MO-
DMC.
59
The activities to be performed by DTO at DTC are briefly given below.

Every calendar month, DTO instructs all STLS to collect appropriate number of slides from
LTs of DMC in a slide box (See Table 1).
1. DTO receives sealed envelopes with Annexure B and slide boxes from the respective
STLS.
2. DTO will code the boxes A, B, C, D or 1, 2, 3, 4….etc as per his convenience. Same
DMC should 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 to see
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.
5. DTO will make a roster from 11th of the OSE 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 OSE month’s Blinded re-checking roster.
6. STLS to read and record results for slides as per Annexure C - one slide box at a time.
7. After getting results from STLS, DTO transfers the results of LT from Annexure-B to
Annexure-C (for each DMC).
8. DTO identifies the discordant slides. Discordance for the purposes of identifying the
slides for re-checking by second controller (called Umpire reader) 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 first controller.
9. 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
confidentiality of the original readers.
DMC Discordant Umpire

RBRC Result 1 Result 2 Signature
Code slide number reading
Sl. No. month
60
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 RNTCP 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.
Quality improvement ( QI ) :
• 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.
• Appropriate data collection, data analysis, correct interpretation of the results
and creative problem solving are the key components of this process.
• Involves continued monitoring, identifying defects, followed by remedial action
including retraining when needed, to prevent recurrence of problems.
• Relies on effective on site evaluation
61
Table 1 Recommended Annual Sample Size i

(80% sensitivity, 100% specificity and ‘0’ acceptance number)
Number of negative slides Slides positivity rate (SPR%)
in the DMC in a year
2.5-4.9 5.0 ii –7.49 7.5-9.9 10-14.9 ≥15
Annual sample size of both positive and negative slides

(Monthly sample size iii in parenthesis)
301 iv-500 243(21) 154(13) 114(10) 89(8) 62(6)
501-1000 318(27) 180(15) 128(11) 96(8) 66(6)

>1000 456(38) 216(18) 144(12) 104(9) 69(6)
1 Based on LQAS method applied to the negative slides with sensitivity of 80%, specificity
of 100%, acceptance number d=0, and 95% confidence Interval. Each sample size was
then increased proportional to the positivity rate to yield the final sample size that include
both positive and negative slides.
1 DMCs with less than 5% SPR should analyze the reasons for the same and should
undertake the necessary corrective action.
1 The monthly sample size has been rounded off to the next higher number and annually
adds up to equal or more than the annual sample size.
1 The status of DMCs with Annual negative slides volume (ANSV) of ≤300 should be
reassessed. If they cannot be improved then they should be discontinued as DMCs. Till
their status is finalized, those DMCs with ANSV less than 301 will use the sample size for
301-500 ANSV as applicable for the respective SPR range. If the ANSV is less than the
indicated Annual Sample Size (ASS), the respective DMCs should submit all their slides for
blinded re-checking. For example, a DMC with ANSV <243 & SPR <4.9%, or ANSV <154 &
SPR 5.0-7.5%, or ANSV <114 & SPR 7.49-9.0%, or ANSV <89 & SPR 10-14.9%, or ANSV
<62 & SPR ≥15% should submit all slides for blinded re-checking.
Suggested Reading
1. Central TB Division: RNTCP Laboratory Network: Guidelines for Quality Assurance of

smear microscopy for diagnosing tuberculosis, 2004.
External Quality Assessment for AFB Smear Microscopy, IUATLD, WHO, JATA, and
KNCV, the CDC and APHL, 2002
62
STLS
On-site evaluation visit at

least once in a month
Designated microscopy
centre
1. Inspect microscope, supplies and laboratory as per checklist TU-OSE

2. Re-examine 5 positive and 5 negative slides by systematic
random method
3. Give feedback on quality of smear, stain, reading and reporting
4. Collect systematically selected LQAS slides in serial order and
sealed envelopes with Annexure B from LT
5. Ensure that the name of DMC, TU, District and the month and
year is clearly written on the slide box and the sealed envelope
DTC
1. DTO receives sealed envelopes with Annexure B and slide boxes

2. DTO codes and interchanges slide boxes among STLS, retaining
sealed Annexure B in his possession
3. STLS read and record results for slides per Annexure C - one slide
box at a time
4. Umpire reading will be by another STLS and organized at DTC by
the DTO
5. STLS/DTO/MO-TC evaluate results and give feedback to each MC
under information to the CMO/Civil Surgeon
The Senior TB Laboratory Supervisor should:

Visit DMCs at least once a month
Crosscheck 5 positive and 5 negative slides
Test the quality of smear preparation, staining, reading and recording of the LT
Collect sample of slides for blinded rechecking at the district level
63
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 equipments (Weighing balance, water bath, round bottom flasks etc,), the reagents
may be prepared at TU level as well. The LTs 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 for storing
• Sulphuric acid (25%), slides
• Methylene blue (0.1%), • Diamond markers (for marking the slides) and marking pens
• Synthetic immersion oil, or grease pencils (for marking the sputum containers)
• Methylated spirit • Broom sticks (thick enough to make good smears)
• 5% phenol / 40% phenolic compound • Transparent glass bottles for reagents (with self-adhesive
(proprietary Phenyl) diluted to 5% labels stating date of preparation of reagents)
• Absolute alcohol to be available at the • Plastic tumblers/mugs
DTC only for de-staining discrepant • Glass (or metal) rods (for holding slides during the staining
slides during umpire reading. process)
• Silica gel (hygroscopic agent) to • Staining racks (for drying the slides)
maintain the microscope in moisture • Sputum containers
free environment (to be placed in the • Spirit lamp or bunsen burner
cabinet for Binocular Microscope) • Foot-operated bin (for disposal of contaminated materials)
Stationery • Timer (stop-watch)
• Laboratory Forms for Sputum • Fine Silk and Lint cloth
Examination • Lens paper (for wiping the oil immersion lens after
• Laboratory Register examination of each slide)
• “Referral for Treatment” Forms • Whatmann filter paper No 1
• Filter paper ( to drain the oil from the slides
64
Estimated quantity of reagents and materials required for 1000 smears
Carbol fuchsin (1%) 5000 ml

Methylene blue (0.1%) 3000 ml
Sulphuric acid (25%) 6000 ml
Immersion oil 50 ml
Phenol 5 % / 40% Phenolic compound (phenyl) diluted to 5% 200 Litres
Methylated spirit 1000 ml
Filter paper (Whatmann No. 1, pack of 100)** 1 pack
Filter paper 20 sheets
Lens paper (book of 50 leaves) 20 books
Lint cloth (15 cm x 15 cm); or Fine silk (15 cm x 15 cm)* 5
Diamond marker* 4
Grease pencils or marking pens 4
Sputum containers 1100
Broom sticks 1100
New glass slides 1100
Slide Box (100 Slides)* 11
Black/ Red disposal bags of bio-degradable material 100
Silica Gel* 100 gms
* These items are reusable

** If cut discs are not available, roll sheets can be procured
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.
65
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 filled completely and accurately. Make sure
that all smear-positive patients in the Tuberculosis Laboratory Register have
either the TB No. mentioned in the remarks column or have the name of the PHI
where the patient has been referred (if s/he belongs to another TU/district). Verify
that patients who were examined for diagnosis had correct number of sputum
specimens examined. Also verify that the details of follow up examination (TB
no., 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 MDR
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 regarding every follow up positive, LT
should inform the treating physician immediately.
(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 STS and STLS (particularly the latter) in advance about
the visit to the designated microscopy centre. If possible, STLS and STS should be
available during the visit. In the DMC, the checklist that you have prepared should be used.
If you find that there is any problem, work with the STLS and STS to solve them.
66
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 Officer available in the health facility?
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 last 12 months?
6 Are all essential lab consumables available adequately, enough to last at least
for one month?
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 RNTCP guidelines?
10 Are printed reference materials on standard operating procedures available?
11 Are all the samples collected at collection center and transported to the DMC
are documented and examined?
Review of forms, registers, records and reports

1 Are the Lab Forms for Sputum Exams filled correctly, completely and legibly?
2 Is the Lab Register filled correctly, completely and legibly?
3 Is the Lab Serial Number entered correctly, starting with 1 on 1st January of the
year and continuing until 31 December?
4 Are results correctly recorded?
5 Are there 2 sputum smears for diagnosis ?
6 Are there 2 sputum smears for follow-up?
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 Does the Tuberculosis Register contain all the smear-positive patients recorded
in the Tuberculosis Laboratory Register? If the Tuberculosis Laboratory
Register contains names of smear- positive patients which are not found in the
Tuberculosis Register, do these patients belong to another TU/district?
15 Is the Lab register consistent with the treatment cards and TB register? (Check
information for at least 4-6 randomly selected new smear -positive patients.)
16 Review the OSE reports and Annexure D kept at the laboratory
67
17 Review whether all MDR-TB suspects were identified?

18 Review whether the sputum sample collection was done from all identified
MDR-TB suspects?
19 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 labeled 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 Tuberculosis Number 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?
4 Are the sputum smears made on the slide of the correct size (2 cm X 3 cm) and
thickness?
5 Does the LT wait for the slide to dry before heating the slide to fix it?
6 When the Lab technician fixes 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 filtered at least every month?
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 (2–4 minutes)?
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?
68
4 Does the LT have correct knowledge about grading?

5 Does the LT see 100 fields 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/fine 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?
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 at least 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 find the timings and location of the Lab convenient?
4 Do the patients face any difficulties for undergoing sputum microscopy?
EXERCISE 5
Be sure to include the following information in the checklist:
• The date of visit

• A space for the name and location of the laboratory
• Key recommendations of the previous visit
• The procedures you will check and whether they are correctly or incorrectly performed
• The method to be used to check each item/procedure
• A short list of the questions to ask when you are speaking to the
• Laboratory technician(s)
• A space for comments about any problems identified and possible causes
• A space for recommendations, and a space for your signature
Part A
A site visit to a designated microscopy centre may occur during this training. If so, your
facilitator will give the details of the visit. Use the checklist you have developed. After the
site visit, there will be a group discussion about any problems your group found and the
solutions you recommend.
69
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
• Tuberculosis Laboratory Register should be used to record information about sputum
smear results only.
• 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 both for diagnosis and
follow-up examination.
• 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 of RNTCP
70
SECTION C
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 RNTCP
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 normally relies on the extent of complete implementation of

RNTCP diagnostic and treatment guidelines in the health care facility. TB infection control
plan includes the following:
• Giving priority for patients with cough for clinical and laboratory investigations for early
detection of smear-positive pulmonary tuberculosis patients
• Reducing delay in starting appropriate RNTCP treatment once diagnosed
• Avoiding unnecessary admission for inpatient care
• Assessment of health care workers training needs requirements under RNTCP
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 identification 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. As mentioned above,
early identification and prompt initiation of RNTCP treatment under direct observation would
protect all health care workers from hospital TB infection.
The key to reducing the risk of tuberculosis transmission at health facilities is early
diagnosis and prompt initiation of RNTCP treatment regimens until cure. Infectious
TB patients become rapidly non-infectious once they are started on directly observed
treatment under RNTCP.
71
All health care workers working at the district level should receive onsite training at least
once in two-years regarding the basic concepts of M. tuberculosis transmission and
airborne infection control. The training should include the following: 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.
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/ adequately sterilized needles and syringes should be used for
streptomycin injection. Following streptomycin injection needles should be destroyed using
needle cutters/ destroyers wherever available. Needles and syringes should be disposed
using prevailing hospital waste management system.
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 RNTCP by 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.
The RNTCP 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 RNTCP centres are located. Accordingly, the waste generated by
RNTCP 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 RNTCP

• Human/biological waste (sputum);
• Sharp waste (needles, glass slides etc.);
• Used blister packs, drug packaging material;
• Plastic waste (waste generated from disposable syringes, cups and glasses); and
• Laboratory and general waste such as liquid waste, broomsticks, and paper waste; and
• Construction waste (waste generated from civil work activities).
72
Waste Management for RNTCP

Waste generated under RNTCP will be discarded with the overall waste of the health facility
in which services under RNTCP are provided. The staff carrying out RNTCP activities like
LTs and DOT providers in PHIs will adopt infection control techniques as detailed in these
guidelines and will take action to integrate waste generated under RNTCP into the waste
management activities of the 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.
73
ANNEXURE A : RECORDING AND REPORTING FORMATS FOR EQA

On-Site Evaluation Checklist for STLS
I General Information
DMC:
District:
Number of Technicians:
Qualifications of current staff:
(Separate sheet to be attached to
indicating information for each of Lab
staff, if they are different from the
previous visit)
Supervisor/MO of DMC:
Date of Visit:
Name of visiting STLS:
II Data on Slide volume for the last month:

This information is necessary to (i) select slides for Blinded Rechecking for the
current month and as cumulative number for (ii) next annual SPR,
(iii) next annual negative slides and (iv) annual total slides.
Sl. Type of slide Number

No. (Includes diagnosis and follow up slides)
1 Positive slides
2 Negative slides
3 Total
III Action required as per the previous visit:
74
IV Current visit particulars

Adequate/ Problems Identified
Sl. No Item
Acceptable
1 Standard Operating Procedure (charts, Y/N
manuals and modules)
2 Separate area for TB Lab work Y/N
3 Separate platform / tables for specimen Y/N
receipt / smear preparation / microscopy
4 Power supply Y/N
5 Running water supply Y/N
6 Waste containers with lid Y/N
7 Waste disposal by Y/N
Autoclave/burning/buried
8 Adequate Stock and Supply of: Specimen Y/N
cups
9 Slides Y/N
10 Lens Tissue Y/N
11 Spirit lamp or Bunsen burner Y/N
12 Filter paper Y/N
13 Smearing / Staining Equipment (staining Y/N
racks, sticks etc)
14 Slide boxes Y/N
15 Staining reagents: Y/N
15 (a) 1% Carbol fuchsin Y/N Within expiry date Y / N
15 (b) 25% Sulphuric acid Y/N Within expiry date Y / N
15 (c) 0.1% Methylene Blue Y/N Within expiry date Y / N
16 Immersion oil
17 Label on sputum container Y/N
18 New slides used for AFB microscopy Y/N
19 Slides labeled with Lab Sl. No. Y/N
20 Number of specimens collected for diagnosis Y/N
and for re-examination for diagnosis
21 Number of specimens collected for follow up Y/N
examination
22 Smears air-dried prior to fixing Y/N
23 Staining procedure Y/N
24 Follow grading chart Y/N
25 Are positive results entered in Red ink Y/N
26 Control smears are used for each new batch Y/N
of stains received at DMC
27 Binocular Microscopes Y/N
28 Maintenance of microscope Y/N
29 Laboratory Register Y/N
30 Write TB number of ‘Follow up’ patients in all Y/N
cases
31 Write TB number and category of smear- Y/N
positive patients in the remarks column when
this becomes available
32 Laboratory forms Y/N
33 Any change in lab staff since last supervisory Y/N
visit.
75
Adequate/ Problems Identified

Sl. No Item
Acceptable
34 Personnel Y/N
35 Training status Y/N
36 Has each staff member participated in Y/N
refresher training within past two years
37 Safety Practices Y/N
38 General order / cleanliness Y/N
39 Timely reporting of results to clinicians Y/N
40 Does the TB Register contain all smear- Y/N
positive patients recorded in the TB Lab
Register
41 Are the smear results for follow up patients in Y/N
the TB Lab Register the same as the results
recorded in the TB Register
42 Are all slides kept as required by the RNTCP
Yes No
EQA Programme?
43 Are slides collected for EQA, do the number
in the slide box correlate with the number in Yes No
the Lab Register
76
V. Review of five positive and five negative slides from RNTCP TB Lab Register:
(Systematic sampling, separately for positive and negative slides)
a) Of the 5 Pos slides, number re-read as positive by STLS __________
b) Of the 5 Neg slides, number re-read as negative by STLS __________
Tick appropriate column or write letter as indicated below table
Sl. Slide AFB result / Specimen
Staining Size Thickness Evenness
No. No. Grade by Quality
≥10 < 10
LT of Poor Poor Poor
STLS WBC/ WBC/ Good Good Good Good Poor
DMC (U/O) (B/S) (K/N)
field field
1 2 3 4 5 6
1
2
3
4
5
6
7
8
9
10
1: Write smear and grade

2: Tick appropriate column
3: Tick if good; write ‘U’ if under-decolourized, ‘O’ if over-decolourized
4: Tick if good; write ‘B’ if too big, ‘S’ if too small
5: Tick if good; write ‘K’ if too thick, ‘N’ if too thin
* Please carefully review all discordant slides with the LT
Overall summary (please tick appropriate alternative):

Specimen quality: Needs improvement Yes No
Smear size: Needs improvement Yes No
Smear thickness: Needs improvement Yes No
Smear evenness: Needs improvement Yes No
Staining: Needs improvement Yes No
Name of STLS: Signature of STLS:

Name of LT: Signature of LT:
Name of MO-in-charge: Signature of MO-in-charge:
Date:
77
On-site evaluation summary of EQA of Smear Microscopy of DMC by DTO

(a copy of this summary to be submitted by DTO to MO of DMC for
corrective actions)
DMC:
Date of visit: (dd/mm/yyyy)

Visiting STLS:
Action required as per the previous visit:
Summary
a) Operational problems (both pending and new)
b) Technical problems (both pending and new)
c) Overall remarks
78
d) Action Required
Name of STLS: _________________ Signature of STLS: _________________
Date_____________
Remarks by DTO
Signature of DTO
Copy to CMO of the District
79
LT SMEAR RESULTS SHEET FOR BLINDED RECHECKING

(ANNEXURE – B)
Microscopy Centre: ________________________ District: _____________________
Name of TU: ______________________________ Month & Year: ________________
Sl. No. Lab No. Result of LT of DMC, including grade for positive
smears
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.
21.
22.
23.
24.
25.
Name of Lab. Technician: __________________________________________
Signature: _________________________________ Date: _______________
80
ANNEXURE – C: RNTCP EQA of Sputum Microscopy

Worksheet for RBRC
Microscopy Centre Code: _______________________ TU _____________________

District: ______________________________________ Month and Year:__________
Tick appropriate column or write letter as indicated below table
Sl. Slide AFB result / Specimen
Staining Size Thickness Evenness
No. No. Grade by Quality
≥10 < 10
Poor Poor Poor
STLS MC Umpire WBC/ WBC/ Good Good Good Good Poor
(U/O) (B/S) (K/N)
field field
1 2 3 4 5 6
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
Total
1: MC result to be entered under supervision of DTO only after form completed by STLS
3: Tick if good; write ‘U’ if under-decolourized, ‘O’ if over-decolourized
4: Tick if good; write ‘B’ if too big, ‘S’ if too small
5: Tick if good; write ‘K’ if too thick, ‘N’ if too thin
Overall remarks:
Specimen quality: Needs improvement Yes No
Smear size: Needs improvement Yes No
Smear thickness: Needs improvement Yes No
Smear evenness: Needs improvement Yes No
Staining: Needs improvement Yes No
Remarks:
Date of examination: ____________________ Signature of first controller: ________________
81
ANNEXURE – D:
RNTCP Quality Assurance Report on Sputum Microscopy
Microscopy centre: _____________________ TU and District: ______________
Month/Year: _________________
Result of controller *
Result of MC-
1-9 AFB/ 100
LT Negative 1+ 2+ 3+
fields
Negative Correct LFN HFN HFN HFN
1-9 AFB/ 100
LFP Correct Correct QE QE
fields
1+ HFP Correct Correct Correct QE
2+ HFP QE Correct Correct Correct
3+ HFP QE QE Correct Correct
* Enter the number of slides on each box

No. of False result Slide No. / Error
False (-)ve
False(+)ve
Name and signature of STLS of concerned DMC: ____________________
Reporting Date: _______________ Signature of DTO: _______________
82
ANNEXURE – E: District Monthly Report to IRL on Randon Blinded Re-checking
District monthly report to IRL on random blinded rechecking
SI No. DMC Annual Annual Slide Nos. of HFP HFN LFP LFN QE Total Remarks
name Slide positive positively slides number
volume* slides* rate rechecked of
(SPR)* during the errors
months@
Total for the district

*For the previous year.
@ Monthly sample size calculated from Annual sample size for 80% Sensitivity. 100% Specificity and ‘d’=0 and Confidence limit =
95%
DTOs On-site evaluation Quarterly report of EQA to IRL

(ANNEXURE – F)
District:
Quarter _____ Year _____
Details of corrective actions recommended and taken

Corrective
Sl. Corrective
DMC actions Remarks
No. actions taken
recommended
D) Any other remarks.
Signature of the DTO
84
Annexure G
IRL annual report to CTD and NRL on random blinded rechecking
SI. No. Name of Total Information on Information on Slides Information on DMCs
the number of Slides
district DMCs
Annual slide Annual No. of slides Number and type of erros in slides Number of DMCs in % of % of
Volume* positive rechecked Rechecked cumulative in the the district with HF DMCs DMCs
slides* during year@ district during the year errors with HF with
errors HFP
errors
HFP HFN LFP LFN QE HFP HFN Both
HFP &
HFN
Total
* For the previous year
** Each HFP or HFN error committing DMC is counted only once in the reporting year
@ LQAS Annual sample size for 80% sensitivity, 100% Specificity and d=0 confidence limit = 95%
Annexure – H: EQA standard Guidelines for reagents

and equipment
1) Standards for Reagents
a. Specifications:
i. Basic fuchsin
1. The chemical name: Pararosaniline hydrochloride
2. The chemical structure: C19H18N3Cl
3. Molecular Wt: 323.8
4. Colour: Metallic green
5. Dye content: Should be available on the container. Approximately
85% - 88% (to calculate the required amount of Basic fuchsin, divide
the actual amount by dye content. For example: Dye content = 85%,
actual amount = 10 gms, required amount = 10/0.85 = 11.76 gms.)
ii. Carbolic acid:

1. The chemical name: Phenol
2. The chemical structure: C6H5OH
4. Melting point: 40oC+2
5. Purity: 99.5%
6. Please note: The critical concentration of Phenol in Carbol fuchsin is
5%.
7. Phenol is highly corrosive, handle with extreme care.
iii. Methylated spirit

1. Chemical name: Ethanol denatured + 5% Isopropyl alcohol + 5%
Methanol
2. Molecular structure: C2H5OH
3. Molecular wt: 46.07
4. Purity: 90%
iv. Sulphuric acid:

1. Chemical structure: H2SO4
2. Molecular wt: 98.08
3. Purity: 95-97%
4. Colour: Clear
v. Methylene blue:
1. The chemical name: Methylthionine chloride
2. The chemical structure: C16H18ClN3S.
4. Dye content: Should be available on the container. Approximately
82% (to calculate the required amount of Methyl blue, divide the
actual amount by dye content. For example: Dye content = 82%,
actual amount = 1 gms, required amount = 1/0.82 = 1.22 gms.)
86
b. Immersion oil:
i. Immersion oil supplied by the manufacturer of microscope with refractive
index closer to that of Glass or 1.515
ii. Liquid paraffin (heavy), refractive index of 1.48, a colourless, odourless,

transparent, free from fluorescence in day light with relative density of
0.827 to 0.890, viscosity of 110 to 230 mPa s., specific gravity of 0.76-0.78
at 15.5oC.
2) Shelf life of prepared reagents: Carbol fuchsin, sulphuric acid, methylene blue
reagents may be kept for a maximum period of 4 months.
3) Identification: All reagents should have a label with name of the reagent, name of
the TU, name of MC, the date of preparation and the expiry date. The containers of
Carbol fuchsin, Sulphuric acid, Methylene blue reagents should in addition have the
name of the person preparing the reagent. Freshly prepared reagents should not be
mixed with old stock.
4) Equipment:
a. Slides:
i. Size: 76 mm x 26 mm,
ii. Thickness: 1.3 mm
iii. Edges: Polished
iv. Sealed in a moisture absorbing dessicant pack
b. Balance:
i. Type: Electronic or Analytical balance
1. Electronic balance:
a. General purpose table top laboratory balance, 220-230 V,
stainless steel platform, keypad auto calibration function,
auto off, prolonged battery life, overload and under load, low
battery LCD indicator.
b. Range: Wide range, 0.01 – 120 gms, (two digit decimal)
c. Resolution: 0.01 gm
2. Analytical balance:
a. Enclosed in a glass box with shutters, dimensions of the box
in cms: 46 x 34 x 20
b. Oscillator type of balance, with levelling screws, two
aluminium pans, plumb line for adjusting horizontal level
c. Weighing capacity: 1 mg to 200 gms, with fractional weight
and regular weight in boxes including rider and forceps to
handle weights.
c. Binocular microscopes:
i. Specifications: As per Expert Committee recommendations.
87
ANNEXURE – J: TECHNICAL SPECIFICATIONS OF BINOCULAR BRIGHT FIELD

MICROSCOPES
(Revised National Tuberculosis Control Programme)
A. PREAMBLE
Binocular Microscopes are required for detecting acid fast bacilli in sputum smear and
other materials for use in Tuberculosis Control Programme laboratories, including those
at Peripheral Health Centres. The usage requires long hours of viewing through the
microscopes.
B. Specifications
1. Body Binocular, sturdy, stable base body with focus adjustment controls in a
position comfortable for prolonged use. The body should be powder
coated.
2. Eye Piece Paired, high quality, (image of the object as seen through the binocular
eyepiece should be well defined centrally in least 2/3 field of view),
achromatic, widefield, 10x without in built pointer. The eyepiece should
be aplanatic and have a minimum field number of 18. Diopter
adjustment must be present on one/both eye pieces or on the eye piece
tube.
3. Objectives Three objectives: 10x, 40x, 100x.
10x and 40x objectives should have numerical apertures of 0.25 and
0.65 respectively and should be of spring loaded type or otherwise.
100x should have numerical aperture of 1.25 and should be of oil
immersion and spring loaded type. Suitable prominent marking should
be provided on 100x for easy identification.
Unbreakable containers to be provided for storing the objectives. All
objectives should be widefield, achromatic and parfocal.
Marking for the Objectives
Each objective should be engraved with the following information:-
a) Name/insignia of the manufacture.
b) Magnification and numerical aperture, for example, 10x/0.25.
c) 100x objective should be engraved with the world ‘Oil’
In Changing from one objective to another or reintroducing the same
objective by rotation of the nosepiece, the object at the center of the
field should not appear displaced by more than 0.02 mm in the object
p[lane in any direction.
4. Nose piece Revolving nose piece to accommodate a minimum of three objectives
with click stops. It should be provided with ribbed grip for easy rotation
mounted on a precision ball bearing mechanism for smooth and
accurate alignment. Extra ports if any should be fitted with dust proof
metallic/ebonite caps.
5. Stage Uniformly horizontal, mechanical stage having dimensions of length 140
mm (+ 20 mm) & breadth 140 mm (+ 20 mm) with fine venire
graduations (minimum reading accuracy of 0.1 mm). The stage should
be provided with spring loaded slide holder for exact positioning of
specimen/slide. It should be designed with convenient sub-stage vertical
coaxial adjustment for slide manipulation. The stage should have ball
bearing arrangement to allow smooth travel in transverse direction i.e.
80 mm (+5mm) and front to back direction, 50 mm (+5mm).
6. Sub-stage Abbe-type condenser, numerical aperature (N.A) 1.25, focusable with
condenser rack and pinion arrangement incorporating an a spherical lens and an
88
irisdiaphram, The condenser should have a filter holder and

removable/swinging/out blue filter (suitable for bright field Microscopy)
7. Sub-stage 1. The system should have a built-in variable light source (Illuminator).
illuminator This light source should have a 20W, 6V Halogen lamp. The circuitry
for the light source should include a constant voltage supply. The
system should be provided with a step down transformer and an
on/off switch and intensity control. The lamp should be provided
with a lamp socket which has the facility for easy replacement of the
bulb. The housing of the light source should be such that it will
prevent dispersion of light and heating up of the body of the
microscope.
2. Power supply.
o Voltage: 220V, 50 Hz AC
o should have one on-off power switch, 3 core power cord
with a 3 point male plug.
3. The system should have an inbuilt protective/safety device to
withstand fluctuations of voltage from 140V to 280V.
4. A plano-concave mirror in fork mounting should be supplied which
would be attachable to the base of field use. (where power is not
available.)
5. The fuse for the halogen lamp should be easily accessible to the
operator.
6. The Illuminator should have a built-in field diaphragm for Kohler
illumination.
8. Eye piece Binocular eye piece tubes, inclined at 45 degrees, rotatable through and
tubes angle of 360 degrees, having inter-pupillary distance range of 54-74 mm
or wider, covering the above mentioned range.
9. Focusing Co-axial coarse and fine focusing knobs capable of smooth fine focusing
knob movement over the full range of coarse travel. The fine focusing
movement should have sensitivity of two microns or less (finer) over the
entire coarse focusing range. The focusing knob should be on both
sides. A focusing stop safety arrangement should be provided.
10. General i). All optical parts including objectives, eye pieces and prisms
should have anti-reflective coating which also gives anti fungal
property.
ii). All metallic parts should be corrosion-proof, acid-proff and stain-
proof.
iii). All parts of the microscope (including removable parts) should
have insignia of the manufacturer engraved on it.
iv). The supplier will supply the complete assembled microscope in a
wooden box along with dust free cover. The box carrying the
microscope should be made of well-seasoned wood or teak ply or
board. The box should be suitably padded from inside of eliminate
the risk of shock during transportation. It should be complete with
lock and key arrangement, a suitable locking screw for securing
the microscope and a cross-piece to retain it in position during
transit. The box should be of an appropriate design with a carrying
handle at the top and appropriate internal receptacles for holding
the objectives, eyepieces and accessories. It should contain a bag
of activated silica gel to keep the interior moisture-free.
v). Each assembled microscope should be accompanied by an
authorized list of accessories and spare parts.
vi). Technical brochure (catalogue) and working manual should be
provided with each microscope.
vii). A bottle of a least 25ml immersion oil, a roll of lens tissue paper
89
and lens cleaning solution (100 ml) should be provided with each
microscope.
viii). One piece of anti static cleaning brush should be provided with
each microscope for cleaning purpose.
ix). Each microscope should be supplied with Blue filter. The blue
filter should be packed in the box and not fixed on the
microscopes.
11. Spare parts Each microscope should be supplied with spare parts as under: (as
mentioned in Schedule of Requirement)
i). 100x oil immersion objective (as per the specifications given
under B3)-One
ii). Halogen bulb, (6 volts, 20w)-6 Nos.
iii). Fuses – 6 Nos.
12. Warranty Performance warranty of three years from the date of supply. For any
malfunction, the supplier shall replace the parts or repair the same at the
user site free of cost within 15 days of the receipt of the complaints.
During warranty period all services/replacement ensuring smooth
functioning of the Microscopes must be done free of cost by the supplier.
13. Requirement The supplier should have adequate after sale service facilities covering
of service all region of the country. They should have the infrastructure and trained
centre for manpower to attend to any complaints within 15 days of receipt of the
after sales complaint.
services
14. Testing & i). The successful vendor should supply a type test-certificate of the
calibration relevant optical & mechanical tests from a recogniszed competent
authority at the time of supply.
ii). The manufacture/supplier shall provide duly calibrated (by
accredited authority) measure instruments and demonstrate
specifications for the purpose of inspection.
90
ANNEXURE – K:
Investigation of Errors
SI Pattern of errors Possible causes Suggested investigation steps
No.
1. HFP and HFN Unusable microscope Examine a 3+ using that microscope
Staining problems, poor stains, Check stains and staining procedure
insufficient staining time or heating
Technician cannot recognized AFB Test with clear-cut positive & negative slides and good microscope
Gross neglect, overworked, lack Exclude other causes
motivation
2. HFP with or without LFP Administrative error Compare lab-register and verify correct slide number and result?
Poor registration routine Check accuracy of lab-register and other record keeping
Staining problems/Fading Check stains and staining procedure, consider re-staining for
rechecking. Assess concentration of Phenol, Basic Fuchsin and
Methyllene blue.
Technician unclear on AFB Look for inconsistent result of suspects (regularly single pos / low
appearance positive) in lab register.
3. Many LFP, with or without occasional Problem with controllers Technician Evaluate controllers
HFP unclear on AFB appearance Recheck sample of LFP from laboratory register
Contaminated stain/reagents Test stain with known negative smears, check the distilled water
used for stain preparation.
4. HFN with or without LFN Administrative error Compare lab-register with QC-listing: correct slide number & result?
Very thick smears and/or poor light Evaluate quality of smear preparation, check microscope
Gross neglect Exclude other causes
Staining problems Check stains and staining procedure, consider re-staining for
rechecking. Assess concentration of Phenol, Basic Fuchsin and
Methylene blue.
Poor smearing – technique Test stain with known negative smears
Problems with microscope Check microscope with positive slide
Careless microscopy Exclude other causes
5. Very high proportion LFN. Reading error As above
Concentrated Methylene blue
6. Many QE (too low grading) Poor staining
Problems with microscope
*Refer RNTCP LT Module, Mannual and STLS Module for causes of False Positive and False Negative results.
Annexure L
Possible reasons and suggested corrective actions for DMCs with unacceptable ANSV and SPR
SI Finding Possible reasons Suggested corrective actions
No.
1. Low ANSV (<500) Inadequate referral of suspects Educate Medical Officers and Health Workers on Chest
symptoms
Non-involvement of private Involve private sector, without increasing the number of
sector DMCs in the area
Many DMCs in the area Reassess the criteria for selection of DMCs.
Generally health facilities with <60 daily new adult OPD
attendance should not be involved as DMCs.
2. Low SPR (<5%) Improper or over selection of Educated Medical Officer and Halth Workers on chest
TB suspects symptoms
More of false negative smear Action as required for frequent HFN and LFN
result Re-stain and test with known positive slides
3. Low ANSV and SPR As above Evaluate as above and if required consider closing the
concerned DMC
4. High ANSV (>5000) High OPD attendance worlload Train more than one LT for AFB smear microscopy
5. High SPR (>15%) Slective referral / delayerd Educate Medical Officers and Health Workers on Chest
identification of TB Suspects symptoms
More of false positive smear Action as required for frequent HFP and LFP / test with
results known negative slides.
ANNEXURE – M:
Tuberculosis Monthly Abstract
Tuberculosis Laboratory Monthly Abstract

(Record Numbers)
Month TB TB TB TB Follow-up Patients Total Total Total Signature
suspects suspects suspects suspects patients positive in slides positive negative of LT and
Year examined found undergoing found examined follow up examined slides slides STLs
200 for positive repeat positive on
diagnosis sputum repeat
examination examination
Jan
Feb
Mar
Apr
Apr
May
Jun
Jul
Aug
Sep
Oct
Nov
Dec
Total
Signature of the M.O.

INFECTION Control & Disposal of Wastes- As annexure- Give No.

Design for Deep Burial Pits
Pit for onsite disposal of Sharps

The treated needles/broken vials should be disposed in a circular or rectangular pit as
shown in figure below. Such rectangular or circular pit can be dug and lined with brick,
masonry or concrete rings. The pit should be covered with a heavy concrete slab, which is
penetrated by a galvanized steel pipe projecting about 1.5 meters above the slab, with an
internal diameter of up to 50mm or 1.5 times the length of vials, which ever is more. The top
opening of the steel pipe shall have a provision of locking after the treated waste sharps
has been disposed in. when the pit is full it can be sealed completely, after another has
been prepared.
1.5M
94
Annexure N
IQC Formats
Control Slide preparation Register (For use at DTC)

Sl. Batch Date of No. of pairs of slides distributed Signature
No. of slides prepared
No. No. Preparation (QCP+QCN slides) of STLS
TU- TU- TU- TU- TU-
QCP Slides QCN Slides 1 Date 2 Date 3 Date 4 Date 5 Date
Annexure O
Format for use of control slides for IQC in DMCs:
Control Slide usage Register for DMCs
S.No. Date CF MB H2SO4 QC - Positive Smear QC Negative Smear Signature of LT
Batch Batch Batch No Batch Actual Expected Batch Actual Expected
No No Slide No Result Result Slide No Result Result
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
Annexure P
PREPARATION & VALIDATION OF 25% SULPHURIC ACID

Results of Quality control smear
Positive control Negative control
Volume of Quantity of Batch & Batch &
Batch Date of reagent to be conc. H2SO4 Volume of Slide Expected Slide Expected
No. preparation Date of Exp. prepared (ml) (ml) DW (ml) No. Result Result No. Result Result
Annexure Q
PREPARATION & VALIDATION OF 1% CARBOL FUCHSIN

Amount of Results of Quality control smear
Dye Positive control Negative control
powder
Volume required
Date of stain Dye after Add Batc
of to be Dye content potecny DW Batch h& Expec
Batch prepar Date of prepared require (potencv) correction Alcohol Phenol upto & Slide Expected Slide ted
No. ation Exp. (ml) d(g) (%) .(g) (ml) (g) mark. No. Result Result No. Result Result
Table of Contents
Module - 3 Treatment Services
Treatment Services
Learning Objectives ............................................................................................................... 101
Gold and Objectives of Treatment ....................................................................................... 101
Scientific basis of Treatment of TB ........................................................................................ 101
Domiciliary Treatment........................................................................................................... 102
Short Course chemotherapy ................................................................................................. 102
Basis of Chemotherapy.......................................................................................................... 102
Directly Observed Treatment (DOT)...................................................................................... 104
Disease classification ............................................................................................................. 105
Treatment regimens .............................................................................................................. 106
Patient wise boxes ................................................................................................................. 108
Treatment of Pediatric TB ..................................................................................................... 109
Non-DOTS (ND) treatment regimen under RNTCP................................................................ 110
Organization of DOT and flow of patients for treatment...................................................... 111
Flow of patients for treatment .................................................................................................... 113
Documentation for referral for treatment .................................................................................. 113
Patient Provider Interaction ........................................................................................................ 115
Filling up of the treatment card ................................................................................................... 118
General Information of Patient.................................................................................................... 118
Data related to DOT ..................................................................................................................... 119
Administration and monitoring of treatment .............................................................................. 120
Retrieval action in interruptions of treatment ............................................................................ 125
Determination of treatment outcome with date ........................................................................ 126
Chemoprophylaxis ....................................................................................................................... 128
HIV related data ........................................................................................................................... 129
Management of patients with treatment interruptions.............................................................. 132
Adverse reaction to Anti-TB drugs ............................................................................................... 134
Management of patient in special situations .............................................................................. 137
Procedures during hospitalization ............................................................................................... 138
Management of Hospitalized Patient .......................................................................................... 139
Multidrug Resistant TB and DOTS-Plus ........................................................................................ 142
Management of MDR-TB ............................................................................................................. 143
Improving Interpersonal Communication skills in RNTCP Training: ............................................ 148
Type of Communication .............................................................................................................. 149
How to use the section ................................................................................................................ 153
Demonstrate good interpersonal skills yourself .......................................................................... 154
Role play for doctors .................................................................................................................... 156
Interpersonal communication .................................................................................................... 157
Role Play Scenarios ..................................................................................................................... 163
Formats of Records – Annexure .................................................................................................. 167
MODULE 3
Treatment services
Learning objectives
In this module, the participants will learn about the following:
 Goal and objectives of treatment
 Scientific basis of treatment
The participant should be able to perform / manage the following activities:

 Disease classification, case definitions and treatment regimens
 Organization of DOT and flow of patients for treatment
 Imparting health education and IPC skills
 Filling up of TB treatment card
 Management of patients with treatment interruptions
 Adverse reactions to drugs
 Special situations and procedures during hospitalization
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

The goal is to reduce mortality and morbidity associated with tuberculosis and to cut the
chain of transmission of infection.
This is achieved through the following objectives:

• Ensuring high cure rates;
• Preventing emergence of drug resistance; and
• Minimizing relapses.
RNTCP uses short course chemotherapy given intermittently - thrice weekly under Direct
Observation for both pulmonary and extra pulmonary tuberculosis patients.
Scientific basis of treatment of TB

The strategies adopted in the treatment of TB are based on both scientific and operational
research.
The following four components are discussed in brief.
• Domiciliary treatment
• Short course chemotherapy
101
• Intermittent 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 benefits 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 to eight months. Reduction in the duration of treatment regimens
was possible because of the introduction of Rifampicin and Pyrazinamide. Treatment
regimens of six months duration either given daily or on intermittent basis have been found
to be equally 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. Intermittent short course chemotherapy regimens of 6-8 months are
recommended internationally for all 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 are lower in smear negative and extra pulmonary lesions. The
number of viable bacilli commonly found inside the cavities sized about 2 centimeters 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 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 mutants 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. isonaizid. 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
102
mutants. An optimal minimum duration of two months in new cases is essential for
achieving smear conversion of 90% and above, thereby significantly reducing the
infectiousness of the patient.
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. The optimum duration of
continuation phase is four months in new cases.
ii. 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 figure below.
A H B
Extra-cellular
R intermittently
Extra-cellular multiplying <105
rapidly S
multiplying ≥108 E
C
Intra- and extra-
cellular, acidic
D No drugs environment slowly
Dormant multiplying
<105
The bacillary sub populations B and C are referred as semi-dormant or persisters which are
difficult 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.
103
Rifampicin (R): 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
Drugs Early bactericidal Sterilizing activity emergence 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.
Intermittent treatment
Intermittent regimens should only be used in a programme of directly observed
treatment (DOT). The formulation of intermittent regimens in the treatment of TB is based
on the principle of existence of lag period. There is no need to maintain blood levels of
drugs for 24 hours in the treatment of tuberculosis. The ability of the drugs to continue to
exert its antimicrobial activity even after their withdrawal is called as lag period, this renders
the intermittent regimen possible
Advantages of intermittent regimen are:

• As effective as daily treatment
• Facilitates DOT
• Reduction in total quantity of drugs consumed
• Fewer adverse reactions
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 DOT Provider helps the patient in taking
104
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, RNTCP
ensures that patients receive the right drugs, in the right doses, at the right intervals and for
the right duration.
Disease classification
Tuberculosis cases are classified as either pulmonary or extra pulmonary.
Pulmonary Tuberculosis
Pulmonary TB is characterized by the formation of lesions in the lungs.
Pulmonary TB is further subdivided into smear-positive and smear-negative cases.
Smear-positive pulmonary TB
A patient with one or two smears positive for AFB out of the two sputum specimens
subjected for smear examination by direct microscopy is classified as having smear
positive pulmonary TB.
Smear-negative pulmonary TB
A patient with symptoms suggestive of TB with two smear examination negative for
AFB, with evidence of pulmonary TB by microbiological methods (culture positive or
by other approved molecular methods) or Chest X-ray is classified as having smear
negative pulmonary tuberculosis.
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 classified as extra pulmonary.
The diagnosis should always be supported by investigations like histopathology, Cytology,

Radiological and Bio-chemical examinations. Wherever facilities for culture are available,
this can be utilized for the diagnosis.
The investigations undertaken for diagnosis have to be mentioned in the appropriate

spaces provided in TB treatment card and TB register. A photocopy of the records /
investigation reports available with the patients may be kept at PHI along with TB treatment
card.
If a patient has both smear-positive pulmonary TB and extra-pulmonary TB, the patient is
classified as having pulmonary TB and the site of extra-pulmonary TB is recorded as well.
Type of cases
New
A TB patient who has never had treatment for TB or has taken anti-TB drugs for less than
one month is considered as a new case.
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Transferred 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 a case of
transferred in.
Treatment after default

A patient, who has received treatment for TB for a month or more from any source and
returns for treatment after having defaulted i.e., not taken anti-TB drugs consecutively for
two months or more and found to be smear-positive is a case of treatment after default.
Failure
Any TB patient who is smear-positive at 5 months or more after initiation of treatment is
considered as failure.
Chronic
A patient who remains smear-positive after completing regimen for previously treated but
not initiated on MDR-TB treatment
Relapse
A TB patient who was declared cured or treatment completed by a physician and who
reports back to the health facility and is now found to be sputum smear positive is a relapse
case.
Others
A patient who does not fit into the any of the types mentioned above. The reasons for
labelling a patient under this type must be specified in the Treatment card and TB Register
Treatment regimens
For the purpose of treatment regimen to be used, TB patients are classified into two
groups, namely, “New” or “Previously Treated”, based on the history of previous treatment.
Regimen for New cases: This regimen is prescribed to all new pulmonary (smear positive
and negative), extra pulmonary and ‘others’ TB patients.
The regimen is 2H3R3Z3 E3 / 4 H3R3.
Treatment is given in two phases. For “New” patients, the intensive phase consists of
isoniazid (H), rifampicin (R), pyrazinamide (Z) and ethambutol (E) given under direct
observation thrice a week on alternate days and lasts for 2 months (8 weeks, 24 doses).
This is followed by the continuation phase, which consists of 4 months (18 weeks; 54
doses) of isoniazid and rifampicin given thrice a week on alternate days with at least the
first dose of every week being directly observed. If the sputum smear is positive after 2
months of treatment, the intensive phase of four drugs (H, R, Z and E) are continued for
another one month (12 doses) and sputum examined after the completion of the extension
of intensive phase. Irrespective of the sputum results after this extension of the intensive
phase, the 4 months (18 weeks) of the continuation phase is started. If the sputum smear is
106
positive after 5 or more months of treatment, the patient is declared as a “Failure” and is
placed on the “Previously Treated” treatment regimen afresh, and sputa sent for culture
and drug susceptibility testing (C&DST) to an accreditated RNTCP C&DST laboratory.
While treating TB meningitis in “New” patients, streptomycin is to be used in place of

ethambutol during the intensive phase (H3R3Z3S3 instead of H3R3Z3E3). The continuation
phase of treatment for patients with TBM or spinal TB is for 7 months. Hence, the total
duration of treatment will be for 9 months. Steroids as adjunctive therapy may be useful in
patients with TB pericarditis and meningeal TB, with an initial high dose tapered downwards
gradually over 6 - 8 weeks.
Regimen for Previously Treated cases: This regimen is prescribed for TB patients who
have had more than one month anti-tuberculosis treatment previously. These patients are
at a higher risk of having drug resistance. Hence, 5 drugs are prescribed in the intensive
phase, and the total duration of treatment is 8 months. Relapses, Treatment After Default,
Failures and Others are treated with this regimen.
The regimen is 2S3H3R3Z3 E3 / 1H3R3Z3 E3 / 5 H3R3 E3.
Treatment is given in two phases. For “Previously Treated” cases, the intensive phase
consists of two months (24 doses, 8 weeks) of isoniazid (H), rifampicin (R), pyrazinamide
(Z), ethambutol (E) and streptomycin (S), followed by one month (12 doses, 4 weeks) of
isoniazid, rifampicin, pyrazinamide and ethambutol, all given under direct observation thrice
a week on alternate days. Patient is subjected for follow up sputum examination at the end
of three months. If the sputum smear is positive at the end of 3 months of treatment, the
intensive phase drugs (H, R, Z and E) are extended for another one month (12 doses, 4
weeks). Irrespective of the sputum results at the end extended intensive phase, 5 months
(22 weeks) of continuation phase is started. If the sputum remains positive at the end of the
extended intensive phase, sputum is sent to an accreditated RNTCP C&DST laboratory for
culture and drug susceptibility testing. The continuation phase consists of 5 months (22
weeks; 66 doses) of isoniazid, rifampicin and ethambutol given thrice a week on alternate
days, with at least the first dose of every week being directly observed.
Experience in India and elsewhere has shown that this treatment regimen, if taken
regularly, is effective and cures most patients. Relapse cases generally have better
outcomes than those who are ‘Failure’ or ‘Treatment After Default’ cases. But even
these latter types of patients generally respond well to treatment, provided they take it
regularly and complete the treatment.
It is very important to elicit history of previous treatment for tuberculosis. It helps in

defining a case; to identify patients with increased risk of acquired drug resistance
and to prescribe appropriate treatment
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The table below indicates the treatment regimen, type of patients and regimens prescribed.
1
Regimen
Treatment
Type of patient Intensive Continuation
groups
Phase (IP) Phase (CP)
Sputum smear-positive
Sputum smear-negative 2H3R3Z3E3
New* 4H3R3
Extra-pulmonary
Others
Smear-positive relapse
Previously Smear-positive failure 2H3R3Z3E3S3
5H3R3E3
Treated** Smear-positive treatment after default / 1H3R3Z3E3
2
Others
1. The number before the letters refers to the number of months of treatment. The subscript after the letters refers
to the number of doses per week.
The dosage strengths are as follows: Isoniazid (H) 600 mg, Rifampicin (R) 450 mg, Pyrazinamide (Z) 1500 mg,
Ethambutol (E) 1200 mg,Streptomycin (S) 750 mg.
• Patients who weigh 60 kg or more receive additional rifampicin 150 mg.
• Patients who are more than 50 years old receive streptomycin 500 mg. Patients who weigh less than 30 kg,
receive drugs as per Paediatric weight band boxes according to body weight.
2. In rare and exceptional cases, patients who are sputum smear-negative or who have extra-pulmonary disease
can have recurrence or non-resonse . This diagnosis in all such cases should always be made by an MO and
should be supported by culture or histological evidence of current, active TB. In these cases, the patient should
be typed as ‘Others’ and given treatment regimen for previously treated
* New includes former categories I and III
** Previously treated is former category II.
Patient wise drug boxes

Drugs are supplied in patient-wise boxes (PWB) containing the full course of treatment, and
packaged in blister packs. The PWB have a color code indicating the two regimen - Red for
“New”, Blue for “Previously Treated”. In each PWB, there are two pouches one for intensive
phase and one for continuous phase. In the intensive phase, each blister pack contains one
day’s medication. For the continuation phase, each blister pack contains one week’s supply
of medication. The drugs for extension of the intensive phase (prolongation pouches) are
supplied separately.
The table below indicates the blisters and doses in the regimen:
Regimen for New cases treatment consists of total 78 doses and for previously treated
cases consists of 102 doses.
IP* CP
Regimen for Extended IP
Blisters Doses blister and Blisters Doses
doses
New cases 24 24 12 18 54
(Cat-I)
Previously 36 36 12 22 66
treated cases
(Cat-II)
* Prolongation of IP for one month (12 doses) is given to new cases and previously treated cases who remain positive
at the end of Intensive Phase
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Drug dosages for adults in the blister packs 1

Dose
Drugs Number of tablets in blister pack
(thrice a week)
Isoniazid (H) 600mg 2 x 300 mg
2
Rifampicin (R) 450mg 1 x 450 mg
Pyrazinamide (Z) 1500mg 2 x 750 mg
Ethambutol (E) 1200mg 2 x 600 mg
3
Streptomycin (S) 0.75g -
1
Adult patients who weigh <30kgs receive drugs in PWBs from the respective weight band suggested
for paediatric patients
2
Patients who weigh ≥60 kg at the start of treatment are given an extra 150 mg of rifampicin
3
Patients over 50 years of age are given 0.5 g of streptomycin
Treatment of Pediatric TB
Pediatric cases are to be treated under RNTCP with the same thrice weekly short course
chemotherapy regimens (“New” or “Previously treated”) given under DOT as for adult
patients. They are to be registered in the respective RNTCP TB Register. Pediatric patient-
wise boxes are available with different dosages as two product codes to be used under four
weight bands for children weighing 6 to 10 kgs, 11 to 17 kgs, 18 to 25 kgs and 26 to 30
kgs..
Wherever possible, before a child is started on the “Previously Treated” regimen, s/he
should be examined by a Pediatrician or TB expert.
Pediatric PWB with dosages

DRUGS Product code Product code PC-15 PC-16
(PC) -13 (PC) -14
IP CP IP CP
24 18 24 18 blister 12 blisters 12 blisters
blisters blisters blisters
Isoniazid 75 mg 75 mg 150 mg 150 mg Prolongation Prolongation

of IP for PC of IP for PC
Rifampicin 75 mg 75 mg 150 mg 150 mg 13 14
Pyrazinamide 250 mg 500 mg
Ethambutol 200 mg 400 mg
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Pediatric patient wise boxes for new cases according to weight band
For New cases Prolongation of IP
Weight band
IP CP
6-10 Kg PC 13
PC 15
11-17 Kg PC 14
PC 16
18-25 Kg PC 13 + PC 14 PC 15 + PC16
26-30 Kg* PC 14 x 2 PC 16 x 2
* For children weighing >30 kgs, adult PWB are to be used
Pediatric patient wise boxes for previously treated cases according to weight band
Prolongation
For previously treated cases
Weight of IP
IP CP
(PC 13+ PC15) (PC 13 + 54 Tab E 200 mg) PC 15
6-10 Kg + +
(24 vials inj sm*) (PC 15 without Z)
(PC 14 + PC16) (PC 14 + 54 E 400 mg) PC 16
11-17
+ +
Kg
(24 vials inj sm*) (PC 16 without Z)
(PC 13 + PC 14 + PC 15 + (PC 13 + PC14 + 54 Tab E 600 PC 15 + PC
18-25 PC 16) mg) 16
Kg + +
(24 vials inj sm*) (PC 15+ PC 16 without Z)
(PC 14 x 2)+ (PC 16 x 2) (PC 14 x 2+ 54 Tab E 800 mg) PC 16 x 2
26-30 + +
KG (24 vials inj sm*) (2 x PC 16 without Z)
* Injection streptomycin 15mg/Kg body weight
 DOTS is the recommended strategy for treatment in adults and children

 All pediatric TB patients should be registered under RNTCP
Non-DOTS (ND) treatment regimen under RNTCP

In rare and exceptional situations, non-DOTS treatment (with a self-administered non-
rifampicin containing regimen) may be needed in a few TB cases. Examples include:
• Those with adverse reactions to rifampicin and / or pyrazinamide
• “New” patients who refuse DOT,S despite all efforts
To facilitate registration of patients started on non-DOTS regimens, a Tuberculosis

Treatment Card should be filled. A maximum of 1% of patients may get non-DOTS
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treatment in an RNTCP area. The justification for initiating patient on non-DOTS treatment
should be specified in the “Remarks” column of the treatment card and TB register.
This is a treatment regimen of 12-month duration comprising 2 months of SHE and 10

months of HE (2SHE / 10HE).
Dosages administered per day in the regimen are:
Isoniazid - 300 mg
Ethambutol - 800 mg
Streptomycin - 750 mg (500 mg for those >50 years of age).
Those who weigh less than 30 kgs receive dosages calculated as per body-weight.
Organization of DOT and flow of patients for treatment

After receipt of the sputum results, the MO of the Peripheral Health Institution (PHI) takes
the following measures:
• Establishment of diagnosis of tuberculosis and decision on type of patient and treatment

regimen
• Motivation of patients :
• Explanation about the disease and assured cure.
• Modalities of treatment-dosage schedule, duration, follow up, common side-
effects and methods to prevent them
• importance of directly observed treatment (DOT)
• Need for screening of children and symptomatic contacts
• Identification of suitable DOT Centre and DOT Provider - accessible and acceptable to
the patient and accountable to health system
• Opening of Tuberculosis Treatment Card (in duplicate) and the TB Identity Card
• Arrangement for shifting patient-wise box to the DOT Centre along with the duplicate TB
treatment Card, TB Identity Card and sputum containers for collection of early morning
samples for follow-up examinations.
For the purpose of identifying an ideal DOT provider 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 / DOT Providers in the area. It should be updated regularly. DOT
can be provided by anyone other than the member of patient’s family. It is the responsibility
of the Government field staff (PHWs / MPWs) to organize and ensure DOT for the patient.
They would also monitor and supervise the community DOT Providers in their respective
sub centres.
If the patient is to be given DOT by a Peripheral Health Worker (PHW) / community DOT
Provider, a duplicate treatment card will be prepared and given to the PHW. The MO of the
PHI will give the patient-wise box containing drugs for the entire duration of treatment to the
PHW and records the same in the drug stock register maintained at the PHI.
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The PHW visits the house of the patient as soon as possible for confirmation of the
residential address and has a detailed dialogue with the patient and other members of the
family. Patient should be started on treatment within a week. 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. The initial home visit should be recorded in treatment card
in the space provided. A convenient location for drug administration and a suitable DOT
provider is decided mutually by the PHW and the patient.
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FLOW OF PATIENTS FOR TREATMENT
Referred to DMC with request for sputum

TB Suspects examination by MO – PHI / PP / NGO /
Others
• Registers in lab register

DMC • LT Collects 2 sputums
• Sends result to referring physician
• History of previous treatment

Referring Physician • Prescribes appropriate regimen
• Treatment card is opened
• Organizes DOT
MO PHI • Identifies DOT provider
• Sends PWB with duplicate treatment card
to DOT Provider
• Refers to ICTC
• Address verification
• Motivation ,
PHW • Contact tracing
• Arranges for DOT
• Updates original treatment card at PHI
• DOT provider provides the DOT

DOT Centre • Records drug collection
• Sends for follow-up examination
• Collects the treatment card

MO-PHI • records treatment outcome
• updated Treatment card is submitted to
the TU after completion of treatment
Documentation for referral for treatment

If the patient resides outside the jurisdiction of the referring institution, a copy of the
‘Referral for Treatment’ Form (annexure) must be sent to the facility where the patient will
begin treatment. A “Referral for Treatment” Register (annexure ) should be maintained in
DMCs / DOT Centre of bigger hospitals, including that of medical colleges, that are referring
large numbers of patients to other health facilities for treatment (after diagnosis).
Information regarding referral of a patient should be noted in the “Referral for Treatment”
Register as well as the “Remarks” column of the Tuberculosis Laboratory Register.
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Peripheral health worker should visit patient’s residence before the commencement
of the treatment. However this should not result in delay in treatment initiation
A community DOT provider is a person who has volunteered to administer DOT as per the
programme guidelines and is:
• from the community where patient resides,
• but not a Government health worker and
• not a member of the family
For example a school teacher, shop-keeper, Anganwadi worker, NGO volunteer, priest,
ASHA could be the DOT providers.
In case, the DOT is organized through a community DOT provider, then duplicate TB
treatment card, patient wise boxes and TB identity card are handed over by the PHW.
Sputum container for collection of morning samples for follow-up sputum examinations is
also provided. The name of the DOT center and name and designation of the DOT provider
should be entered in treatment card in the space provided. On the spot training has to be
imparted for the community DOT provider, by the PHW, regarding directly observed
treatment, adverse reactions, follow-up sputum examination and recording of drug intake,
before starting treatment. The DOT provider 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 field-
visits.
During the intensive phase of treatment, each and every dose is taken under direct
observation of the DOT Provider. DOT is administered at a place which is convenient to
both patient and DOT provider. This place is designated as DOT center. However, in
situations where patient is bed-ridden, DOT should be administered under supervision at
the patient’s home by the PHW or community DOT Provider.
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 three doses of
treatment so that the treatment is not interrupted during transfer to a nearby PHI. In such
circumstances the entries for unsupervised doses should be encircled in the Tuberculosis
Treatment Card and the reason for the same should be stated in the remarks column of the
Treatment Card.
The DOT provider 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, a spot sputum
sample is also collected.
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Responsibility of administration of streptomycin injections at the periphery can be entrusted

to the Auxiliary Nurse Midwife (ANM) or equivalent at the sub-centre level or to any
registered medical practitioner who is acceptable and accessible to the patient. If this is not
possible, the patient has to approach the PHC, CHC, or any other nearest health institution.
The streptomycin injection should be given using disposable syringes and needles. Water-
for-injection should be made available.
During the continuation phase (CP), at least the first dose of the weekly blister must be
administered under direct observation. The patient collects rest of the drugs for the week
from the DOT Provider and consumes them at home. Patient should be explained the
method of taking the remaining part of the blister. When the patient reports for next weekly
collection of drugs, empty blister pack of the previous week should be returned to the DOT
provider and the same is retained in the PWB.
Patient should be referred for follow-up sputum examinations at the prescribed intervals.
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
1. Reassuring that TB is curable
2. Importance of regular and complete treatment
3. Importance of treatment being given under DOT.
4. Duration of treatment, Intensive phase & Continuation Phase
5. Adherence to follow-up schedules
6. Early disappearance of symptoms is not a sign of cure, treatment to be stopped only
when advised by the treating physician.
7. Treatment is available free of cost
8. Other important issues:
• Role of isolation, rest and diet
• Cough hygiene and sputum disposal
• Provision of transfer facility during treatment
• Referral for HIV counselling and testing
• Smoking / alcohol abuse
• Co-morbid conditions for example diabetes, renal failure, patient on immuno-
suppressive drugs
• Sensitization on adverse reactions
• Importance of screening symptomatic contacts and children below 6 years and
chemoprophylaxis
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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 RNTCP, 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 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. 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. It is dangerous to take only part of the prescribed drugs
because in such cases the disease may become incurable.
A place mutually convenient to the patient and the provider can be chosen for provision of
DOT. The necessity of direct observation of every dose of drugs taken during the intensive
phase and the first dose of the weekly blister pack during the continuation phase should be
emphasized to the patient. Patient is also explained about the importance of sputum smear
conversion at the end of 2(3) months and at the completion of treatment. Patient should be
made aware that treatment services are provided free of cost.
Role of rest, special diet and isolation: 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. At
the same time, health staff should be careful enough not to over emphasize on special diet
and rest. They can be told to take the food they can afford and rest 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 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 officer for completing the formalities for transfer and
necessary arrangement for further treatment.
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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.
Co-morbid conditions for example diabetes, renal failure, patient on immuno-

suppressive 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
fore-runner of successful treatment.
Sensitization on Adverse reactions: In case patients experience any unusual symptoms

after initiation / during treatment, they should be instructed to approach the medical officer
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 / office and at clinic. Smoking
status of the TB patient should be checked at every interaction. The Medical Officer 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 smoking cessation clinic.
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 symptomatic contacts and children below 6 years: Patients

should be encouraged to bring symptomatic adult contacts and all children aged six 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.
117
Filling up of the treatment card

Treatment Card
Each patient who begins treatment for TB must have a tuberculosis treatment card. 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 filling up of the TB register. This
card contains important information about patient, including the following details:
General
Data related to DOT Treatment related information
information
• Name of the • TB unit with code • Disease classification and type
patient • TB number with year • Details of sputum examination for
• Age and sex • Name of the PHI diagnosis and follow up
• Complete • Name and designation • Details of x-ray and investigations for
address and of DOT provider diagnosis of EPTB
phone number of • DOT centre • History of previous anti TB treatment
the patient • Initial home visit by • Treatment regimen
• Occupation whom (Name and • Drug intake in intensive and continuation
• Name, address Designation) with date phase
and phone • Retrieval actions for missed doses
number of the • Chemoprophylaxis for contacts aged ≤
contact person 6 years
• HIV related data
• Treatment outcome with date
• Remarks
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
Age and sex : 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 patients residence in case of interruption of
treatment. The same has to be verified 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 specified. If unemployed, the same may be
stated. Nature of occupation will help in arranging suitable DOT facility and retrieval in case
of interruptions. For example a truck driver who needs to travel out for a long time, one of
his colleagues can be made DOT provider.
118
Name, address and phone number of the contact person: Name and address of a
person, identified by the patient and known to him and residing in same locality is recorded.
DOT provider and member of the family residing in the same house are not considered as
contact person. A relative not from the same household, community/tribal leader, village
doctor, community volunteer could be contact persons. This person can be contacted in
case the patient is not traceable following interruption of treatment. Relationship of the
contract person to the patient may be specified.
Data related to DOT

TB unit with code: Name of the TB unit and code allotted are recorded
TB number with year: TB number will be assigned by the STS within a month of initiation
of treatment in the TB register. The same number is reflected in the treatment card. It is
easy to identify the patient by number rather than by name. This number will facilitate
monitoring of the treatment and cross checking the data in other related documents. For
example, it is denoted as 12 / 2008. Here, 12 indicates the TB Number and the 2008
indicates the year in which it was registered.
Name of the PHI: Name of the PHI where the treatment is initiated is recorded.
Name, designation and contact number of DOT provider: Designation of the DOT
provider namely Anganwadi worker/staff nurse/ ANM/ Health Inspector/, ASHA, NGO/,
Health Visitor/ Laboratory technician/ Pharmacist/ is indicated. While identifying the DOT
provider, care is taken to ensure that member of the family is not chosen.
DOT centre: A place which is mutually convenient for the patient and DOT provider where
Directly Observed Treatment can be administered is identified and the same is recorded.
For example a PHI, sub-centre, school, shop, etc.
Initial home visit: Name and designation of the person undertaking the initial home visit for
address verification with date are recorded. This will ensure accountability and authenticity.
Initial home visit will ascertain the reliability, completeness of address and changes if any. It
is necessary to confirm the residential status of the patient from the neighbourhood. The
details regarding the work place will also benefit in retrieving patient in case of interruption
of treatment.
Treatment related information

Disease classification: Box provided for pulmonary or extra pulmonary TB is ticked as
the case may be. If extra pulmonary, the site is specified. In patients having both pulmonary
and extra pulmonary TB, the box for the pulmonary is ticked and site of extra pulmonary is
specified.
Recording details of sputum examination: Date of examination, DMC conducting the

sputum examination, Laboratory serial number allotted, smear result and patient’s weight
are recorded in the rows meant for pre treatment, end of IP/extended IP, two months in to
the CP and end of the treatment sputum examination mentioned under the column titled
month. This information is to be transferred from laboratory form for sputum examination to
the treatment card.
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Details of x-ray and other investigations for extra pulmonary TB cases:

This block is provided on the left side of the treatment card. In smear negative patients
report of the chest x-ray may be mentioned in brief. Similarly, report of relevant
investigations in extra pulmonary TB cases is also entered in this space. For example
report of FNAC in case of lymph node tuberculosis.
History of previous anti TB treatment: This is crucial for deciding 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 officers should impress upon the
patients the importance of providing the complete facts, without any apprehension of
discrimination with regard to subsequent treatment. Detailed and carefully elicited previous
history of disease and the intake of anti-TB drugs helps in deciding the type of patients and
treatment to be administered. While eliciting the history, emphasis should be given for
ascertaining the following:
Previous history from patients Review of available record / documents
• cough • sputum examination reports,
• blood in the sputum • chest X-ray reports / any other relevant

reports /
• sputum examination/chest X-ray • drug prescriptions
examination • empty blister packs of anti TB drugs
• consuming drugs which turned urine
red/taken injections for >1 month
Treatment Regimen
Usually the MO of the PHI (where the treatment has to be initiated) will decide which
treatment regimen a patient should be prescribed. Treatment regimen prescribed for the
patient is ticked appropriately in the box provided. Number of tablets of the drugs
prescribed in the regimen is also recorded in the boxes provided. In case an extra capsule
of 150mg of rifampicin is prescribed for patients weighing 60 kg or more it is denoted as
1+150mg. For recording the administration of Streptomycin injection, the strength of the
streptomycin given like 0.5gms / 0.75 gms is indicated in the box meant. Patients aged
over 50 years or weighing less than 30 kgs are given 0.5 g of streptomycin.
Administration and monitoring of treatment

Recording of drug administration and monitoring
There are two sections meant for recording the drug administration. One is for the intensive
phase of treatment on the front of the card and the other for the continuation phase on the
reverse.
Intensive phase
Month and year
Month and year of initiating the intensive phase is recorded.
120
Date of initiation of treatment- The date of initiation of treatment regimen prescribed is

ticked (√) on the appropriate box under the date against the month. Subsequently, the
dates on which the drugs were consumed under observation are also ticked. In this phase,
patient comes three times a week on alternate days. Daily blisters are given either on
Mondays, Wednesdays and Fridays or alternatively Tuesdays, Thursdays and Saturdays.
The date/day (for example on 10th April) on which patient fails to attend for DOT, is denoted
by a circle (0) in the appropriate box. In case the patient attends to collect the drug the next
day (for example on 11th April) the drugs missed are administered on that day and
continues to take the drugs as per scheduled day (for example on 12th of April).
Month
1 2 3 4 5 6 7 8 9 10 11 12 13 14
/ year
April
10 √ √ √ S √ 0 √ √ S
On the other hand, if the dose is entirely missed and the patient does not report to the
health facility even on the next day then the dose is given on the next scheduled day. It
should be ensured that all the doses in the intensive phase, should be administered before
the continuation phase is initiated. For example, patient was scheduled to come on 17th
April but does not turn up on 17th or even on 18th but reports on 19th. Hence, the dose due
on 17th is given on 19th and so on and so forth.
Month
15 16 17 18 19 20 21 22 23 24 25 26 27 28
/ year
April
10 √ 0 √ S √ √ √ S
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 3 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 Tuberculosis Treatment Card and the reason for the same should be stated in
the Remarks column of the treatment card.
Continuation phase
Drug administration in the continuation phase is recorded on the reverse side of the
treatment card. Treatment regimen prescribed for the patient is ticked appropriately in the
box provided. Number of tablets of the drugs prescribed in the regimen is also recorded in
the boxes provided above the drugs.
During the continuation phase of treatment, patients collect the weekly blisters once a week
on a designated day. First dose of the weekly blister is administered under direct
observation and the remaining doses in the weekly blister are given to the patient for self-
administration. The month and the year in which the patient will be collecting drugs during
the continuation phase are written under the Month and year column in the table on the
reverse of the Tuberculosis Treatment Card. An ‘X’ 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. A line is drawn through the remaining days
121
of the week (after the X) to indicate that the drugs for the remaining period of the week
have been given (recorded as X------------------------) for self administration.
If the patient misses a weekly drug collection in the continuation phase completely, a circle
is recorded on the day of the missed collection. On day of the subsequent visit the
treatment is given and recorded as follows leaving the boxes blank as shown below:
Month /
year 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18
June S
S X S X
10
Monitoring of drug administration can be done by comparing the stock of drugs available in
the patient-wise boxes with the dosages given and marked in the Tuberculosis Treatment
Card. Any observed variation should be looked into and remedial measures taken.
NON-DOTS treatment (in intensive as well as continuation phases)

Date when drugs were collected by the patient is indicated by writing ‘C’ and drawing a
horizontal line (C-----------) to indicate the period for which drugs were supplied for self-
administration. Usually drugs will be provided for a month
Follow-up schedule for sputum examination

The most important method of monitoring the smear-positive PTB cases are by the follow-
up sputum smear examinations which are carried out at the end of the intensive phase, the
extended intensive phase (if applicable), two months into the continuation phase and at the
end of treatment. These results determine the conversion rate from smear-positive to
smear-negative at the end of intensive phase of treatment, and the cure rate at the end of
the treatment. The follow-up sputum smear examination at the end of treatment is very
important for evaluating the results of treatment outcome (to determine the cure rate).
Two sputum samples are to be collected, one as early morning and the other as spot
sample. The follow-up schedule for sputum collection and smear examination is provided
in the table below.
End of IP Extended IP * 2 months into CP End of treatment
Give sputum cup
Give sputum cup

Give sputum cup
Give sputum cup
Collect sputum #
Collect sputum #
#
Result by end of
Collect sputum
the treatment
sputum and
Category
Collect the
Result by
Result by
Result by
New ** 22 23 24 34 35 36 8 9 10 17 18
Previously 34 35 36 46 47 48 8 9 10 21 22
Treated
* The Intensive Phase is extended by four weeks (12 doses) in initially smear positive PTB patients who
continue to be positive at the end of the2 months of IP.
# Early morning and spot specimens will be collected on this day.
** The numbers during the IP represent doses, whereas during the CP they represent weekly blister packs
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Follow up of sputum smear examinations of patients put on the RNTCP Non-DOTS

regimen should be done at the end of 2, 6 and 12 months.
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.
Recording of initial and follow up sputum examinations in treatment card

The details of the sputum examinations are recorded against the appropriate month (i.e.,
Pre-treatment / end of intensive phase / extended IP, two months into continuation phase
and at the end of the treatment) under date, DMC, lab number and smear results. While
recording the results it is ensured that highest grade and earlier date of specimen (Date of
1st sample) is recorded. In situations where smear is positive at the end of the intensive
phase either in New or Previously Treated, the row of boxes meant for date, DMC, lab
number, smear results, and patient weight have to be split diagonally by a forward slash as
shown below. The details of the sputum examination done at the end of two months are
entered above the slash. Intensive Phase is extended by one month and the details of the
sputum examination done at the end of third month in New and fourth month in Previously
Treated cases is entered below the diagonal as depicted below.
Smear
Month Date DMC Lab No. Weight
Result
Pretreatment
17/3 Pushkar 164 1+ 45 Kg
End IP / Extended IP 234
16/4 Ajmer NEG 46 kg
2 months CP
End treatment
During follow-up sputum smear examinations, if 2 specimens are examined and one of
them is positive, the patient is considered smear-positive. If both specimens are positive,
the higher grade out of the two results is written on the patient’s Tuberculosis Treatment
Card. If both specimens are negative, the patient is smear-negative and ‘NEG’ is recorded
in the appropriate space.
The results of follow up sputum smear examination done at the end of treatment should be
available not later than two week of completion of treatment, so that appropriate outcome
for the patient can be given in the TB Treatment Card.
The patient is to be seen by the treating physician on the following occasions:
1. Before initiation of the treatment;

2. At the end of IP and the beginning of CP;
3. On declaration of treatment outcome;
4. For management of moderate to severe adverse drug reactions;
5. If frequent interruptions in treatment adherence; and
6. If patient becomes an “MDR-TB suspect”.
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Recording of weight: Patient weight is recorded on four occasions corresponding to the

schedule of initial and follow-up sputum examinations. Initial weight of the patient is helpful
in deciding the dose of Rifampicin. The dosage of drugs remains constant even if patient
were to gain weight.
Follow up of Paediatric TB cases

For the monitoring of treatment, follow-up sputum examinations are to be performed with
the same frequency in children as in adults. Clinical or symptomatic improvement is to be
assessed at the end of the intensive phase and at the end of treatment. Improvement
should be judged by absence of fever or cough, weight gain, etc. Radiological improvement
is to be assessed by a chest X-ray examination in all smear-negative pulmonary TB cases
at the end of treatment (flowchart below). Radiological changes may persist and may not
correlate with clinical improvement and hence should not cause concern.
Clinical monitoring of children with TB

Patient on regimen for
New cases
Review at 2 months, satisfactory Review at 2 months, non-satisfactory

response assessed by: response assessed by:
 improvement in symptoms  adherence to treatment
 no weight loss and or weight gain  weight loss
 worsening of symptoms
Follow up clinically
Refer to Pediatrician / TB
specialist for assessment
Clinical assessment and X-ray
(consider sputum examination)
at completion of treatment
Sputum positive Sputum negative

or not available
Failure
 review diagnosis
 extend IP by 1 month
Regimen for
previously treated
No improvement = Pediatric
non-responder
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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 DOT-Provider 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 in the intensive phase (IP) does not take medication as scheduled, s/he should
be traced and given the medication on the next day. The medication for the following day is
given as per schedule. For example, if a patient is receiving DOT on Mondays,
Wednesdays and Fridays, but does not take medication on Wednesday, the patient should
be found on Thursday and given medication (late dose), and should take the next dose of
medication on Friday, returning to the previous schedule.
If a patient entirely misses any dose of medicine (does not come on two consecutive days
in IP or 7 days in CP), these doses must be made up at the end of the scheduled period. If
the DOT Provider is not successful in retrieving such patients, it should be reported to next
higher level of supervisors (e.g. MPW, MO-PHI, STS, MO-TC etc.). If the patient misses
DOT on two occasions in the intensive phase, DOT Provider should arrange a visit by the
MO-PHI to the patient’s home. The MO-PHI can review the reasons for the same, give
intensive counseling to the patient and, if required, ensure that DOT is made more
convenient for the patient.
Despite all efforts, if the patient does not return for treatment within 2 months of interruption
of treatment, the outcome of treatment should be recorded as “Defaulted” and the reason
should be mentioned in the “remarks” column of the treatment card and the patient wise
box should be returned to the PHI, and thereafter to the DTC for reconstitution
Recording of Retrieval actions

Action taken to retrieve patients missing doses has to be recorded in the space provided on
the reverse of the treatment card with details of date & time, name of the health staff taking
retrieval action, person contacted, reasons for missing doses and the outcome of such
efforts.
The number of doses to be administered must be strictly adhered to. The total duration of
interruptions in IP and CP should not exceed two months.
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 (i.e. one box for intensive phase and one box for continuation phase). When the
patient consumes the medication under direct observation, the Tuberculosis Treatment
Card should be placed behind the divider for the next scheduled observation (e.g. from
Monday to Wednesday during the intensive phase). 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.
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Patient Transfers:
A new treatment card has to be opened while initiating the treatment for ‘transfer in’ cases.
The previous Treatment Cards of such patients have to be retained in the health facility
where the patient was originally initiated on treatment till the final outcome is reported.
In a case of ‘Transfer in’, a Tuberculosis Transfer Form (refer to format of records at the
end of the module is filled up and sent along with a copy of the Tuberculosis Treatment
Card from the “transferring unit”, i.e., referring health facility / TU to the “receiving unit”, i.e.,
health facility/ TU where the patient will receive further treatment. The transfer form has four
parts and should be filled up in triplicate.
The first part of the form contains general information of the patient, disease, treatment
details and address of the transferring unit. This information should be used to complete a
new Tuberculosis Treatment Card for the patient. When the patient reports to the receiving
unit, the lower most (fourth) part of the form is completed by the receiving unit and
returned to the transferring unit as a receipt of an acknowledgement. The third and second
part are meant for communicating the results of sputum at the end of intensive phase and
treatment outcome respectively, to the transferring unit.
Determination of treatment outcome with date

There are seven possible treatment outcomes –viz., Cured, treatment Completed,
Defaulted, Failure, Died, Transferred out and Switched over to MDR TB treatment.
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 tablet in the weekly blister was consumed.
For the determination of date of outcome in cases of Failure, the date on which the sputum
was found to be positive during the treatment is taken as date of outcome.
For ‘Defaulted’, ‘Transferred out’ and ‘Died’ the date on which the event occurred is taken
as a date of outcome.
The treatment outcome has to be recorded on the Treatment Card and in the TB register
within one month of the event. Declaration of the treatment outcome has to be decided
upon and signed with date by the MO.
126
Cured
Initially sputum smear positive patient who has completed treatment and had negative
sputum smears on two occasions, one of which is at the end of the treatment is declared as
cured.
Treatment completed
• Initially sputum smear positive patient who has completed treatment with negative
smears at end of the intensive phase / two months in the continuation phase, but none
at the end of treatment, the outcome is declared as treatment completed.
or
• Initially sputum smear negative patient who has received full course of treatment and
has not become smear positive at the end of the treatment
or
• Extra pulmonary TB patient who has received full course of treatment and has not
become smear positive during or at the end of treatment is also declared as treatment
completed.
Died
Patient who died during the course of treatment regardless of cause is declared as ‘Died’.
Failure
Any TB patient who is smear positive at five months or more after starting the treatment is
considered as ‘Failure’.
Defaulted
A Patient after treatment initiation has interrupted treatment consecutively for >2 months
Transferred out
A patient who has been transferred to another TU / district / state and whose treatment
outcome is not available is considered as ‘Transferred Out’.
Switched over to MDR-TB Treatment

A patient who has been diagnosed as having MDR-TB by an RNTCP accredited laboratory,
prior to being declared as “Failure”, and is placed on the RNTCP MDR-TB treatment
regimen is said to have switched over to MDR TB treatment.
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Determination of date of treatment outcome

Outcome Date of determination Illustrations
Cured or The last dose (Pyridoxine) of the Patient administered last DOT in
Treatment 18th blister in New and 22nd blister continuation phase on 16-06-2010.
Completed in Previously Treated cases. Last pyridoxine dose taken on 22-06-
2010. then the outcome will be written
as Cured or treatment completed on
22-06-2010.
Transferred Transferred out is the date on Generally drugs up to one week are
out which the patient is supposed to given for self administration during
have consumed the last dose of transfer – maximum of three doses in
the drugs provided to him on the intensive or continuation phase.
transfer as recorded in the card. Actual date on which transfer form
This is only an interim outcome. was filled and sent is 20-06-2010; then
The actual outcome as reported the date of transferred out as a
from the unit where the patient treatment outcome should be 27-06-
was transferred will be updated in 2010. This is the date when the 3rd
the card and in the TB register. dose handed over during transfer is
supposed to have consumed..
Defaulted The scheduled date of Patient interrupted treatment on 16-9-

administration of drug when 2010 Record outcome as ‘defaulted
patient interrupted treatment on 16-9-2010’ on or after 17-11-2010
consecutively for ≥ 2 months. within one month
Failure The date on which the sputum If the smear result is positive on 18-
examination was found to be 05-2010, Failure on 18-05-2010
positive for AFB
Died The actual date of death Patient died on 11-08-2010, Died on
11-08-2010
Switched to The date on which the patient is Patient declared as MDR-TB on 01-
MDR-TB started on RNTCP MDR-TB 01-2010 and put on MDR- TB
treatment treatment regimen. treatment on 21-01-2010. the date for
Switched to MDR-TB treatment would
be 21-01-2010.
A patient will have only one outcome. The outcome which occurs first is considered and
recorded in treatment card and subsequently in the TB register.
Chemoprophylaxis
Preventive chemotherapy with isoniazid (H) is administered to all the children aged 6 years
and below who are in contact with smear positive pulmonary 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 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 5mg/kg body weight daily for 6 months.
128
The number of children below 6 years of age, the number screened for TB and the number
put on chemoprophylaxis should be mentioned on the reverse of the treatment card (see
below).
Nos. of children below 6 Nos. put on chemoprophylaxis
Nos. screened for TB
Yrs
Remarks column
The following information has to be recorded in the remarks column
• Adverse drug reactions, if any
• Reasons for unsupervised dose(s)
• Reason for discontinuation of drug collection (e.g., patient transferred to another district)
• Details of hospitalization if any during the treatment
• Information on dispatch of sputum for culture of sensitivity tests
• Any other relevant information about the patient such as smoking, diabetes mellitus,
pregnancy status etc.,
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.
Original TB treatment card

Information on HIV status, CPT delivery and ART referral and initiation of the TB patient
is to be documented on the original TB treatment card and kept confidential within
health system. This should not be disclosed to the community DOT provider.
1.
2.
3.
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 (‘Pos’ or ‘Neg’) and
record the date of test along with PID Number if available. If the HIV status is not
known, don’t tick any box initially.
129
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. If CPT provided from the PHI, record dates of each monthly 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. For referred clients record the date of referral.
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.
Exercise 1
Case 1: Raju
Review the TB Treatment Card on next page and give your comments
130
Treatment Card
State: Karnataka City / District with code: Mysore TB Unit with code_____________ Patient TB No / Year: 4299
Name: Raju Sex  M  F Age: 52 Occupation_________________
Complete Address & Telephone number ____________________________________________________________________________
____________________________________________________________________________________________________________
Name, Address & Phone No. of contact Person: Krishna Rao, surpanch
Name and designation of DOT provider & Phone.No ___________________________________PHI: __________________________
Name of DOT Centre __________________________________ Signature of MO with date _____________________________
Initial home visit by __________ Ph.No.___________Date ________ Smear Patient
Month Date DMC Lab. No.
Result Weight
Pretreatment 4/4 A 128 2+
Disease Classification Type of Patient End of IP/Extended IP 29/5 246 1+
 Pulmonary  New  Relapse 2 Months X CP 26/7 210 NEG
 Extra Pulmonary site  Transfer in  Treatment Failure End Treatment 30/9 S 506 NEG
______________  TAD  Others Specify)________
H/O of Previous ATT with duration _______________________________________________________________________________

INTENSIVE PHASE - Prescribed regimen and dosages. Tick () appropriate treatment regimen below:
 Regimen for new cases  Regimen for Previously Treated

3 times / week 3 times / week
H R Z E H R Z E S
Month/
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
year
April 97 S    S  0   S    S  
May 97  S   0  S    S    S 0 
June 97
A Tuberculosis Identity Card (Annexure) is completed for each patient initiated on

treatment and issued to the patient. Information from the Tuberculosis Treatment Card is
used to complete the card. The front portion of the card will have patient information, name
and address of the TU / district and treatment details of patient including classification, type,
sputum results and treatment regimen. The reverse side of the ID card has the results of
follow-up sputum examination, appointment dates for visits for drug administration and
treatment outcome. ID card may also include the contact telephone numbers of MO / DOT
providers. This information will help to continue treatment in case the patient is transferred,
or admitted to any other health facility during the treatment period.
CPT:
• If the patient is HIV-infected, and not already being provided CPT from any other
source, MO (PHI) is to prescribe CPT by ticking in the section on CPT in TB ID
Card.
• Institutional DOT provider on seeing the ticked box provides monthly supply of
CPT and records the same on Original treatment card.
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. Treatment regimen administered : regimen for New or Previously Treated cases
iii. Duration of treatment taken : Less than one month / more than one month.
This helps in deciding whether patients need to be treated as a new case or as
previously treated case.
iv. Duration of Interruption : Less than two months / more than two months.
This helps to decide whether patients is to be declared as defaulted and also
necessity for subjecting the patient for sputum examination which arises if the
duration of interruption is two months or more.
v. Smear status after interruption : Smear negative / Smear positive
All the above information elicited will help in choosing the strategy of managing the
interruption (see flowchart ).
132
Management of patients with treatment interruptions
Treatment Interruption
Interruption of <2 months Interruption of >2 months

(outcome - default)
Continue same Initial treatment of <1 month Initial treatment of >1 month
treatment to complete
all doses
Repeat smear examination
Retain original type. Start on Positive Negative

treatment afresh with same regimen,
Type TAD Type Others

Start on regimens for Start on regimens for
previously treated previously treated
133
Adverse Reactions to Anti-TB drugs

Adverse Drug Reactions (ADR) observed during treatment for tuberculosis are
comparatively less in the intermittent chemotherapy than what is encountered in daily
regimens. DOT providers should be aware of the commonly occurring adverse reactions so
that they can identify it promptly and refer the patient to the medical officer for further
management. Any adverse reactions reported during treatment is recorded in the remarks
column of the treatment card. Orange / red discoloration of the body fluids especially urine
which is commonly encountered is not an adverse reaction and patient should be made
aware of this.
Symptom-based approach to evaluation of possible side effects of anti-TB drugs

Symptom Drug Action to be Action to be taken by MO
(abbreviation) taken by HW
Gastrointestinal (vomiting Any oral Reassure Maintain hydration
or epigastric discomfort) medication patient. Give • Consider treatment with
drugs with less anti-emetics (e.g.
water and over domperidone) and
a longer period proton pump inhibitors
of time (e.g. 20 (eg. Omeprazole)
minutes). Do
not give drugs
on an empty
stomach
If the above
fails, refer to
MO
Itching/Rashes Isoniazid (and Reassure Itching without rash or a
other drugs patient mild rash
also) If severe, stop • Continue treatment and
all drugs and give antihistamines
refer patient to Itching with moderate to
MO 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
134
• Re-introduce each drug

in a small dose and
gradually increase over
3 days before
introducing the next
drug.
Tingling/burning/numbness Isoniazid Refer to MO • Give pyridoxine 100
in the hands and feet mg/day orally or
parenterally until
symptoms subside.
• Patients not responding
to pyridoxine will require
treatment with
amitryptiline
Joint pains Pyrazinamide Reassure that • Give NSAIDs like
it is a self paracetamol, Aspirin or
limiting ibuprofen and in severe
condition. cases Indomethacin for
Encourage a week to 10 days
patients to • In severe cases estimate
increase serum uric acid levels
intake of
o If uric acid levels are
liquids.
significantly raised
If severe, refer treat with NSAIDs
patient to MO and colchicine.
for evaluation Allopurinol is not
effective
o In severe cases with
normal or slightly
elevated uric acid
consider reduction of
the dose of
Pyrazinamide.
Impaired vision Ethambutol STOP • Refer to ophthalmologist
Ethambutol, for evaluation
refer patient • Impaired vision usually
for evaluation returns to normal within
a few weeks of stopping
ethambutol.
135
Ringing in the ears • Refer to

Loss of hearing otorhinolaryngologist for
Dizziness and loss of opinion
STOP
balance • As hearing loss is
Streptomycin,
Streptomycin usually not reversible do
refer patient
not restart Streptomycin
for evaluation
Hepatitis: Anorexia / Isoniazid, STOP all anti • Rule out other causes of
Nausia / vomiting / Rifampicin or TB drugs, hepatitis
Jaundice Pyrazinamide Refer patient • Do not restart treatment
for evaluation till 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
In cases of jaundice, all anti-TB drugs should be stopped

Immediately and the patient referred for evaluation.
136
Management of patients in special situations
Situation Management
Hospitalization Some of the indications for hospitalization:-
Extremely ill patients.
Patients with frequent haemoptysis, pneumothorax or
massive pleural effusion leading to breathlessness
Cases requiring surgical intervention.
Tuberculous Patient should be referred to the hospital. Streptomycin is to
meningitis replace ethambutol in IP. The continuation phase should be
extended by 3 months in both new and previously treated
cases. Steroids should be given initially and gradually
tapered over 6–8 weeks.
Treatment of TB Streptomycin is absolutely contraindicated during entire
during pregnancy pregnancy. Breast feeding can be continued even when
and postnatal mother is on treatment for TB but mother should continue to
period practice cough hygiene. Child should be administered
preventive chemoprophylaxis as per guidelines.
Treatment in Rifampicin, isoniazid and pyrazinamide can be safely given
patients with renal as they are excreted in entero-hepatic circulation. Dosage of
failure streptomycin and ethambutol, should be adjusted according
to the creatinine clearance.
Women on oral Rifampicin decreases the efficiency of oral contraceptives by
contraceptive pills increasing their metabolism. Increase in dosage of the oral
contraceptive or switch over to alternate methods of
contraception is advisable
137
Procedures during hospitalization

Indoor patients (refer to flowchart below)
All indoor patients who are found to be suffering from TB are to be treated with RNTCP
regimens using prolongation pouches which will be supplied by DTO. The DOTS Centre of
the respective hospital/Medical College must be informed of the patient’s admission at the
earliest, to enable referral or transfer out of the patient to their respective DOTS Centre on
discharge. On discharge, patients may be given a maximum of three doses (1 weeks drug
supply) to cover the intervening period prior to their resumption of treatment at their
respective DOTS Centre, ensuring uninterrupted treatment.
Patient is admitted with tuberculosis for indications like
significant haemoptysis, pneumothorax or massive pleural
effusion leading to breathlessness
Attending physician prescribes RNTCP regimen using prolongation

pouches
DOT centre of the hospital is informed
Patient is registered in the

local TU of the hospital if If the patient is already registered
the patient is not already elsewhere, there is no need for re-
registered registration. On discharge the patient is
sent back to his PHI to continue and
complete treatment
If the patient is not residing in If the patient resides in the same TU area, on
the same TU area, on discharge he is sent to the PHI nearer to
discharge patient is his/her residence to continue and complete
transferred to PHI/TU nearest treatment
to his/her residence, to
continue and complete
treatment
All indoor patients treated under RNTCP, should be registered under the local TU where
the hospital/Medical College is located. The smear conversion and treatment outcome of all
the transferred patients should be sent back by the TU where the patient was transferred to
the TU of the hospital/medical college. (Refer to the flow chart below for Management of
Indoor Patients).
138
Management of Hospitalized patients
Management of extra-pulmonary tuberculosis:

Intermittent short course chemotherapy regimens of 6-9 months are recommended
internationally for all forms of extra-pulmonary TB. In cases of TBM, initial hospitalization is
recommended. In TBM, ethambutol should be replaced by streptomycin in the intensive
phase and continuation phase of the treatment is for 7 months. Steroids as adjunctive
therapy may be useful in pericardial and meningeal TB.
Treatment of TB disease in HIV-infected patients

Early diagnosis and effective treatment of TB among HIV-infected patients are critical for
controlling the disease, minimizing the adverse impact of TB on the course of HIV, and
interrupting the transmission of TB in the community. Delays in the diagnosis of TB have
been associated with worse outcomes. 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. Patients are to be treated with the RNTCP “New” or
“Previously Treated” regimen according to the patient’s history of previous anti-TB
treatment.
In addition to TB treatment under RNTCP, all HIV-infected TB patients must be provided

access to care and support for HIV disease, including antiretroviral therapy. ART reduces
TB case fatality rates and the risk of recurrent TB. ICTC counsellors and the treating
physicians should counsel these patients on the importance of ART and on the free
availability of treatment with ART and evaluation.
HIV-infected TB patients should be promptly referred to the nearest ART centre by the
treating physicians and ICTC counsellors. This visit to the ART centre, should preferably
occur at least two weeks after initiation of TB treatment, to ensure reduction in the potential
of TB transmission from these patients prior to the visit to the centres being visited by large
numbers of HIV-infected persons. TB patients referred to ART centres should be carefully
educated on cough hygiene.
For details on ART eligibility, reference ART guidelines (available at www.nacoindia.org).

NACO recommends that ART be given to:
• All patients with extrapulmonary TB (stage 4); and

• All those with pulmonary TB (stage 3) with CD4 count < 350 cells/mm3.
Cotrimaxazole preventative therapy (CPT): Cotrimaxazole preventative therapy has

been shown to reduce mortality among HIV-infected TB patients, and is recommended by
NACP for all HIV-infected patients. All HIV-infected TB patients should therefore be
provided CPT. All the ART Centres should have a minimum provisions of meeting the CPT
requirements of atleast for a month for the benefit of those patients who are able to return
to the ART centre on a monthly basis.
In states implementing RNTCP/NACP Intensified TB/HIV package, CPT should be made

available for HIV-infected TB patients at all peripheral health institutions in the districts
139
having a Medical Officer and an institutional DOT centre. The CPT should be procured,
packed and supplied in monthly pouches at the state level. The local distribution is to be
supervised by RNTCP staff in coordination with NACP. In this mechanism, CPT is delivered
by the peripheral health institute staff, and not community DOT providers, to maintain
confidentiality regarding HIV status within the health-care system.
Treatment of TB in HIV positive patients on second line ART/ alternate First Line with
Protease Inhibitors (PI) based regimen
The effectiveness of second-line antiretroviral therapy depends on the introduction of

protease inhibitors (PIs) in the new regimen. However, there are significant drug
interactions with the PIs and rifampicin. Consequently, the treatment options are limited for
TB patients who require PI-based therapy or develop TB while on PIs. PIs should not be
used with rifampicin-containing regimens due to hepatic enzyme inducing capacity of
rifampicin, which risks rendering PI levels sub-therapeutic.
Another rifamycin, Rifabutin is a less potent inducer of CYP 3A4 liver enzyme as compared
to rifampicin, while being equally safe and effective for treatment of TB. It can be
administered in the presence of PI-containing ART regimen without compromising the
efficacy of ART or Anti TB treatment. In the presence of the boosting drug like Ritonavir
(PI), rifabutin metabolism is also altered, and less rifabutin is needed than would be without
ritonavir.
Therefore in patients taking lopinavir/ritonavir (LPV/r) based ART regimens, NACP and
RNTCP have recommended the substitution of rifabutin for rifampicin for the duration of TB
treatment. The dosage of rifabutin during the administration of second line ART regimen
containing LPV/r shall be 150 mg Rifabutin, dosed thrice-weekly for all patients >30 kg
weight.
The rifabutin will be supplied through the respective State TB Cell on individual basis.
Tobacco smoking and tuberculosis

The diagnosis of TB disease is an opportune moment for imparting behaviour change in the
patients’ smoking habit, with patients more likely to accept the behaviour change needed
for improving their health. Tobacco smoking may lead to delayed sputum conversion in
sputum smear positive PTB cases, lower treatment success rates and higher rates of
relapse of TB disease and death.
Hence the past and present history of tobacco smoking (cigarette / beedi / pipe / cigar /
hukka) should be elicited from each TB case at the time of initiating treatment. Smoking
cessation advice to current smokers should become an integral part of TB case
management. Such interventions may help improve outcomes of anti-TB treatment and
reduce transmission of infection in the short term, and improve the quality of life of TB
cases by preventing chronic respiratory and other disease associated with smoking in the
long term. Tobacco cessation advice has been demonstrated to be successful in TB cases
even in the absence of costly Nicotine Replacement Therapy.
Patients who smoke should be motivated to make an informed decision to stop smoking. All
cases should be informed personally about the harmful effects of smoking on health in
general and the potential for poorer outcomes of anti-TB treatment with continued smoking.
140
The potential benefits of stopping smoking to the health of the individual should be suitably
communicated. The patient’s past experience with cessation and relapse of smoking may
be discussed in an understanding atmosphere. Patients may be told that they can be
successful even if they have not been able to quit smoking at earlier attempts. During the
conversation, the patients are asked to identify situations and moods that trigger smoking
(working/getting out of bed/having a cup of coffee/pleasant moments/while dealing with
personal or professional problems/ group smoking). They are encouraged to devise their
own ways to respond to the circumstances that encourage smoking.
Patients should also be advised not to smoke in the presence of others, since increased
frequency of coughing due to smoking increases the risk of TB infection among their
household and other contacts. That smoking is prohibited in public places according to
‘Prohibition of Smoking in Public Places Rules, 2008’ may be clearly communicated to
them.
5 As Approach to tobacco cessation
This is a form of counseling. Before saying anything to motivate the patient to quit tobacco
use, the health professional needs to identify the tobacco user and find out the stage of
readiness to change that the patient is in, by asking a few questions.
1. Ask the patient if he/she is a tobacco user.

2. Briefly Advise against continuing tobacco use and link the current condition/ailment
to continued tobacco use, where possible e.g. “Quitting smoking/tobacco use would
improve your health and will aid in early recovery”.
3. Then Assess readiness to quit by asking the patient whether he or she is ready to
quit at this time. e.g. “How recently have you thought about quitting tobacco?”
If the patient appears ready to change (quit), next steps are :
4. Assist the tobacco user in making a quit plan.

5. Arrange for follow-up by setting the next contact.
5 Rs approach for non willing tobacco users

If the tobacco user is not yet thinking about quitting tobacco use (pre contemplation), the
doctor will promote greater awareness of the relevance to the patient of the advice to quit,
the risks of use and rewards (benefits) of quitting. Many tobacco users are largely unaware
of the potential harm that tobacco use can do to them. If the patient is not ready to quit, the
doctor must not push the patient. People usually need time to change (incremental nature
of change).
If the patient is at least thinking about (contemplating) quitting, the doctor can find out the
patients roadblocks (barriers) to quitting and help the patient see ways to overcome these.
This process may be enough to help the patient get ready to quit (without pushing).
At the next visit, this process should be repeated so that the information about relevance,
risks of continuing and rewards of quitting can sink in a little more and some roadblocks
removed.
141
As you can see, the doctor must try to make the tobacco user think about quitting. This is
important because there are so many other forces acting that are difficult to control,
physiological compulsions to use tobacco, learned habits, social pressures, accessibility
etc,. Engaging the mind of the tobacco user, bolstering it with new knowledge and a sense
of caring by the person counseling can help motivate him/her to change. Follow-up is
important to help keep the tobacco user on track until he or she is confident about
remaining tobacco free.
Diabetes and treatment of tuberculosis

There is conflicting evidence on the role of diabetes, it’s control and response to TB
treatment. Some studies suggest that there is no co-relation between the two, whereas
others suggest that sputum conversion is delayed and treatment outcomes are poorer in
diabetics who are poorly controled during their treatment for TB.
However in general the treatment for TB in patients with diabetes is the same as for those
patients who are non-diabetic. In a few cases, rifampicin may induce early phase
hyperglycemia due to augmented intestinal absorption. Although relapse rates themselves
are unchanged, in diabetics who relapse the prognosis is poorer.
Principles of the management of co-existent TB and diabetes comprise:

1) Proper care and hospitalization in patients with poor diabetic control;
2) Ideally insulin should be used to control blood sugar during anti-TB treatment,
however oral hypoglycaemics can be used if the patient is well stabilized on them;
3) Drug interactions with rifampicin need to be kept in view and recognised if they
occur:
4) Glycaemic equilibrium is essential with goals of maintaining fasting blood sugar
<100mg% and glycosylated HB <6% should be aimed towards.
5) Monitoring for adverse effects, particularly of hepatic and nervous systems should be
done as H may lead to peripheral neuropathy; and
6) Use of potentially neuropathic agents in patients with peripheral neuropathy
demands special consideration and administration of pyridoxine.
Multidrug Resistant TB and DOTS-Plus

Prevention of MDR-TB
The management of MDR-TB is very complex, and hence preventing it’s development by
the effective implementation of the DOTS strategy under RNTCP is crucial.
Selection of appropriate treatment regimen for patients by medical officer, 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, DOT Providers should be educated and convinced about the
importance of Directly Observed Treatment (DOT). DOTS has been documented to not only
prevent the emergence of multidrug resistant TB, but also to decrease its prevalence in the
community.
Prevention of MDR-TB is given priority under RNTCP rather than its treatment
142
Management of MDR-TB
National guidelines and plans for scaling up the management of MDR-TB have been
developed under RNTCP. In the interim, while RNTCP DOTS Plus services are being
expanded across the country, all health care providers in the public and private sector
managing MDR-TB cases, need to adhere to the national guidelines.
MDR-TB management has to be preferably undertaken only at selected health institutions

with experience, expertise and availability of required diagnostic and treatment facilities.
Identification of MDR-TB suspects: The following are the criteria to label a patient as
MDR-TB suspect.
• A new smear positive patient remaining smear positive at the end of fifth month.
• A new smear negative patient becoming smear positive at the end of fifth month.
• A patient treated with regimen for previously treated remaining positive at fourth month
• Smear positive contacts of an established / confirmed MDR-TB case
Diagnosis of MDR-TB
For patients in whom drug resistance is suspected, diagnosis of MDR-TB should be done
through culture and drug susceptibility testing from a quality-assured laboratory. On being
diagnosed as an MDR-TB case, the patient will be referred to a designated state level
DOTS-Plus site. These sites are specialized centres which are limited in number. At least
one such center is expected to be in each state which has ready access to an RNTCP
accredited culture and DST laboratory. The DOTS-Plus site will be supported by qualified
staff available to manage patients using the second-line RNTCP MDR-TB regimen given
under daily DOT and standardized follow up protocols. There will be a mechanism to deliver
ambulatory DOT after an initial short period of up to one week of in-patient care to stabilize
the patient on second line drug regimen. Logistics and standardized information will be
made available in such place.
RNTCP MDR-TB treatment regimen

The RNTCP is using a standardised treatment regimen (STR), comprising of 6 drugs
(kanamycin [Km], levofloxacin(lvx), ethionamide [Eto], pyrazinamide [Z], ethambutol [E] and
cycloserine [Cs] during 6-9 months of an Intensive Phase, and 4 drugs (lvx, Eto, E and Cs)
during the 18 months of the Continuation Phase. p-aminosalicylic acid (PAS) is included in
the regimen as a substitute drug if any of the drug(bactericidal—kanamycin/ethionamide) is
not tolerated. Dosages of the drugs are based upon three weight bands (see below table).
Drug 16-25 Kg 26-45 Kg > 45 Kg
Km 500 mg 500 mg 750 mg
LVX (200 mg) (500 mg) (750 mg)
Eto 375 mg 500 mg 750 mg
E 400 mg 800 mg 1000 mg
Z 500 mg 1250 mg 1500 mg
Cs 250 mg 500 mg 750 mg
PAS 5g 10 g 12 g
Pyridoxine 50 mg 100 mg 100 mg
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Dosage and weight band recommendations

All drugs should be given in a single daily dosage under DOT by a DOT Provider. All
patients will receive drugs under direct observation on 6 days of the week. On the 7th day
(Sunday), the oral drugs will be administered unsupervised and kanamycin will be omitted.
If intolerance occurs to the drugs, ethionamide, cycloserine and PAS may be split into two
dosages and the morning dose administered under DOT. The evening dose will then be
subsequently self-administered. The empty blister packs of the self-administered doses will
be checked the next morning during DOT. 100mg of pyridoxine is administered to all
patients on the RNTCP MDR-TB treatment regimen. If a patient gains at least 5kgs of
weight during treatment and crosses the weight-bands range, the DOTS–Plus site
committee may consider moving the patient to the higher weight-band drug dosages. The
new higher dosages are provided whenever the patient is due for the next 3-monthly supply
of drugs in the normal course of treatment and not as soon as change of weight is noted.
Duration of treatment
At least Intensive Phase (IP) should be given 6 months. It is extended up to seven / eight /
nine months in patients who have a positive culture result taken in fourth / fifth / sixth month
of treatment correspondingly. Continuation Phase (CP) is given for 18 months following
the IP.
Follow-up schedule
Smear examination should be conducted monthly during the IP and at least quarterly during
the CP. Culture examination should be done at least at 4, 6, 12, 18 and 24 months of
treatment.
Treatment adherence and support

Patients initiated on treatment and their family members should be intensively counselled
prior to treatment initiation and during follow-up visits.
To reduce the risk of development of resistance to second-line anti-TB drugs and promote
optimal treatment outcomes, all efforts should be made to administer treatment under direct
observation (DOT) over the entire course of treatment.
If DOT is not possible, attempts to ensure treatment adherence should be made by:
• checking empty blister packs;
• follow-up visits at least every month.
• documentation of treatment
Health care facilities/practitioners managing MDR-TB patients should maintain a systematic

record of treatment regimen, doses, duration, side-effects, result of the investigations and
treatment outcome for all patients initiated on second line treatment.
144
Exercise - 2
COMPLETION OF TUBERCULOSIS TREATMENT CARDS

Use a calendar for 2008 and 2009 and exercise Workbook E2. Treatment begins in 2008.
Neither diagnosis nor treatment is done on Sundays. Use your own state, district and sub-
district names on the Tuberculosis Treatment Card. Be sure to indicate outcome and date
on side II of the Tuberculosis Treatment Card.
Remember that you must make up for missed doses. For this exercise, names and
addresses of contact persons are not given. In practice, the names and addresses of
contact persons must be filled up to aid in retrieving patients who have interrupted
treatment. Use the Laboratory Forms for Sputum Examination you completed in Exercise
Workbook E1 to complete the Tuberculosis Treatment Cards.
Parvathi Sinha (Patient A) is a 16-year-old female who weighs 29 kg. She has never been
treated for tuberculosis before. She has pulmonary and extra-pulmonary (lymph node)
tuberculosis. She started treatment on 8 September. The first 24 doses were all observed
as scheduled except for dose 21 which was given one day late. On follow-up at two
months, she is smear-negative (29 October, Lab No. 612), weighing 45 kg. She then
defaulted on 17 November.
Lakshmi Kumari (Patient B) is a 46-year-old woman who weighs 62 kg. She has never
been treated for tuberculosis before. She started treatment on 15 September and her
sputum is negative at the end of 2 months (31 October, Lab No. 623, 64 kg), 4 months (31
December, Lab No. 720 66 kg) and 6 months (4 March, Lab No. 125, 70 kg). She takes
every dose as prescribed, under direct observation thrice a week in the intensive phase and
once a week under direct observation in the continuation phase.
Kailash Nath (Patient C) is a 35-year-old man who weighs 39 kg. He has been treated for
more than one month for three occasions for TB earlier and has interrupted treatment for
more than 2 months. He starts treatment on 15th September. His drugs are administered
under direct observation in the intensive phase, but doses 12 and 16 were given one day
late. His sputum is positive (1+) at the end of 3 months (3rd December, Lab No. 619, 42 kg).
Dose 40 was given one day late. His sputum is positive at the end of 4 months (2 January,
Lab No. 657). He received all weekly collections in the continuation phase of treatment,
except the fourth week dose which he took one day late. His sputum is positive at the end
of 6 months (23rd February, Lab No. 55, 45 kg) and 9 months (25th May, Lab No. 195, 50
kg). What action should have taken for this patient?
Ghanshyam Singh (Patient D) is a 16-year-old male with extra-pulmonary tuberculosis of

the knee. He has never been treated for tuberculosis previously. He weighs 38 kg.
Treatment began on 8 September. He was referred to ICTC on 12 September 09 and found
to be non reactive. He was directly observed for all doses as prescribed. He was
transferred to district ‘Y’ after completion of the five weeks of continuation phase.
Kiran Kumar (Patient F) is a 37 year old man with two negative sputum smear
examinations, living at 15, Gulmohar Park, whose cough did not improve after a 10 day
course of co-trimoxazole. The sputum examination was repeated on 8th September and
again yielded negative results for two samples. Chest X-ray showed infiltrates in the right
upper and left lower lung fields and it was decided that he should receive a full course of
145
anti-TB treatment. He was not treated for Tuberculosis before. His initial weight was 45
Kgs. He began treatment on 15th September. He was referred to ICTC on 22nd September
and found to be HIV positive on 23rd September. He was administered CPT from 24th
September. He was referred to ART center immediately and his CD4 count was 155/Cmm.
He was initiated on ART on 10th October. He missed doses 12 and 18 entirely. His sputum
smear is negative at the end of intensive phase (5th November, lab no. 638, 48 Kg) and 6
months (6th March, Lab No. 146, 50 Kg). No collections were missed during the
continuation phase.
POINTS TO REMEMBER
• Under RNTCP, there is a provision to treat all types of TB patients both in adults and
children irrespective of their HIV status. Facilities for treating MDR TB under DOTS
Plus is being implemented in phased manner.
• Eliciting previous history of treatment for tuberculosis is essential for proper allocation of
treatment regimen to the patient
• A suitable DOT provider and DOT centre should be selected in consultation with the
patient
• All doses in the intensive phase and at least the first of the thrice-weekly dose in the
continuation phase should be given under observation.
• Treatment Card should be filled accurately and it must be complete and up-to-date
• Initial counseling (at the health facility and at patient’s home) is important to achieve
treatment compliance
• Patients missing doses should be traced and put back on treatment within one day in
case of IP and within one week in case of CP
• Streptomycin injections, where required, should be given after the oral drugs are
administered
• It is mandatory to use disposable syringes and needles to administer streptomycin
• Contacts aged six years and below of smear-positive patients must be screened for TB.
If diagnosed as TB, they should be treated for the same. If not, must be administered
chemoprophylaxis.
• Mothers on treatment for TB can continue to Breast feed their infants irrespective of
their sputum status.
146
DEFINITIONS: THE REVISED NATIONAL TUBERCULOSIS CONTROL PROGRAMME
Case definitions Type of cases Treatment outcomes
Pulmonary Tuberculosis, Smear New
Positive A TB patient who has never had treatment
for TB or has taken anti-TB drugs for less
Cured
TB in a patient with atleast one smear than one month
Initially sputum smear positive patient who has completed treatment and
positive for AFB out of the two initial Relapse
had negative sputum smears on two occasions, one of which was at the
sputum smear examination by direct A TB patient who was declared cured or
end of the treatment
microscopy treatment completed by a physician and
Treatment completed
who reports back to the health facility and
Initially sputum smear positive patient who has completed treatment with
Pulmonary Tuberculosis, Smear is now found to be sputum smear positive
negative smears at end of the intensive phase / two months in the
Negative Transferred in
continuation phase, but none at the end of the treatment is declared as
A TB patient who has been received for
treatment completed. or
A patient with symptoms suggestive of TB treatment in a Tuberculosis Unit, after
Initially sputum smear negative patient who has received full course of
with two smear examination negative for starting treatment in another TB unit where
treatment and has not become smear positive at the end of the treatment
AFB, with evidence of pulmonary TB by s/he has been registered.
or
microbiological methods (culture positive Treatment after default
Extra pulmonary TB patient who has received full course of treatment and
or by other approved molecular methods) A patient, who has received treatment for
has not become smear positive during or at the end of treatment
or Chest X-ray is classified as having TB for a month or more from any source
Died
smear negative pulmonary tuberculosis and returns for treatment after having
Patient who died during the course of treatment regardless of any cause
defaulted i.e., not taken anti-TB drugs
Failure
Extra Pulmonary Tuberculosis* consecutively for two months or more and
Any TB patient who is smear positive at five months or more after initiation
found to be smear-positive
of the treatment and not put on MDR-TB treatment
Tuberculosis in any organ other than Treatment failure
Defaulted
lungs (eg. pleura, lymph nodes, intestine, Any TB patient who is smear-positive at 5
A Patient after treatment initiation has interrupted treatment consecutively
genitor-urinary tract, joint and bones, months or more after initiation of
for >2 months
meninges of the brain etc). treatment.
Chronic
Transferred out
The diagnosis should be based on strong A patient who remains smear-positive after
A patient who has been transferred to another TU and whose treatment
clinical evidence with the following completing regimen for previously treated
outcome is still not available.
investigations but not initiated on MDR-TB treatment
Switched over to MDR-TB Treatment
• Smear / Culture from extrapulmonary Others
A patient who has been diagnosed as having MDR-TB by an RNTCP
sites A patient who does not fit into the any of
accredited laboratory, prior to being declared as “Failure”, and is placed on
• Histopathological examination or the types mentioned above. The reasons
the RNTCP MDR-TB treatment regimen
• Radiological examination or for labeling a patient under this type must
• Biochemical and cytological be specified in the Treatment card and TB
examination including FNAC Register#
* Pleurisy is classified as extra pulmonary tuberculosis, * A patient diagnosed with both smear positive pulmonary and extra pulmonary TB should be classified as pulmonary TB #
Others can come both under new and previously treated.
Annexure II
IMPROVING INTERPERSONAL COMMUNICATION SKILLS IN RNTCP
TRAINING: KEY CONCEPTS AND SAMPLE ROLE PLAYS
The principles of the RNTCP are:
• Political and administrative commitment
• Good quality diagnosis, primarily by sputum microscopy (using microscopy to examine
sputum smears among patients in health facilities)
• Uninterrupted supply of Good quality drugs (short-course chemotherapy, patient-wise
boxes)
• Direct Observation of treatment (The right treatment, given the right way)
• 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 RNTCP, 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 difficult 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 confidence 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 RNTCP staff
obtain participation from officials, 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.
148
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 difficult change.
Support: To succeed, most of us receive some form of support. Support comes from
something we find 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 “counseling” skills will work toward
providing information, motivating, helping people to overcome obstacles, and providing
support to try to change.
Counseling is a process of enabling/helping someone to overcome a problem; meet a need,

make a decision, or accept their situation. Counseling differs from education. Education
involves providing information. Counseling is a process of helping others use information
and relate it to their own lives. Counseling is not giving advice alone. The aim of counseling
is not to solve other people’s problems but to enable people to solve their own problems.
Good counseling is client-centered, which means counseling must centre on the client’s
feelings, thoughts, concerns and needs. Thus, counseling is a process of empowering
clients to make their own decisions through defining feelings and providing objective
information.
Characteristics of effective counseling:

• Confidential
• 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.
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
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a formal, confusing, or even hostile environment that makes it difficult for the facts to be
understood or accepted.
Effective communication skills include active listening, praise and encouragement,

paraphrasing (repeating in slightly different words), questioning, reflecting, 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 sufficient 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.
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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 difficult/embarrassing questions
*******************
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
reflect 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/office; 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 RNTCP 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:
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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.
*******************
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.
*******************
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HOW TO USE THIS SECTION

This section contains role play examples for RNTCP trainers. Groups should perform the
role plays in the section that pertains to their defined role in RNTCP. 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 first and
second scene.
Once this discussion is finished, 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 perform scenes until you feel the important points have been
covered sufficiently 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 first 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 difficulty 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:
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• 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 RNTCP 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 satisfied. 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 finds 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 difficulty 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
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.
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Compliment 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 difficulties in implementation of these skills. Do not
summarily reject alternative methods suggested by the participants; discuss alternative
methods thoughtfully and positively.
Role plays are fun and effective methods of developing good IPC skills. This will
benefit all levels of the RNTCP staff to help reach the Programme’s goals. The use of
this section will serve to improve your own IPC skills as well as those of your
colleagues.
*******************
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ROLE PLAYS FOR DOCTORS

INTRODUCTION
Example Role Play
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 3 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 difficulty 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 an urban, literate patient on previously treated regimen who is
afraid of injections because he is afraid of HIV transmission
11. 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. Identification 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 flip 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).
Role Play Scene

Doctor: You are a doctor talking to a newly diagnosed TB patient.
Patient: You are a patient who does not believe you have TB. You agree to have an
X-ray, but do not agree to have your sputum examined.
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After you have completed enacting the scene, ask the participants to list the poor IPC skills.
Write these on the chalk board or flip 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 RNTCP that were conveyed during the scenario.
Discuss the accuracy of the messages and, for inaccurate messages, discuss how they
could be more accurately conveyed.
Once the discussion is finished, 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 RNTCP
messages.
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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 first 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?”
“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 three times to confirm 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?”
159
“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.”
“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.”
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Motivating and Problem solving

“An ordinary cough does not last that long. You have been coughing for a month and we
must find 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 3
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 confirms 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 3 sputum examinations
done.”
“The reason for conducting 3 sputum examinations is because one or two tests 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 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 3 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.”
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“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 6/9 months.”
“We will arrange for medicines to be provided near your home.”
“I can understand that it is difficult for you to come thrice a week. We will find 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 thrice a week for treatment for the first two 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 alternate days thrice a week for the first two 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.”
“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 thrice a week, 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 fields. 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 office.
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 3
sputum samples and is ready to bribe the doctor
Doctor: You are a doctor who is seeing a new patient in your office.
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 three 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.
163
Scenario 5: Doctor is meeting with a newly diagnosed patient who is a truck driver and who
says he will have difficulty coming to the local facility for DOTS when he is working
Doctor: You are meeting with a newly diagnosed patient in your office.
Patient: You are a truck driver and it is difficult for you to come to the local DOTS facility
when you are working.
******************
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 office.
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 office 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 office with a TB patient.
Patient: You are a newly diagnosed TB patient who wants to leave the area.
164
Scenario 10: Doctor is meeting with an urban, literate patient on regimen for previously
treated cases who is afraid of injections because he is afraid of HIV transmission
Doctor: You are a doctor meeting in your office with a patient on previously treated
regimen who is to start re-treatment.
Patient: You are an urban, literate patient on regimen for previously treated cases who is
afraid of injections because you know that needles are one of the effective means of HIV
transmission.
******************
Scenario 11: 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 office 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.
******************
165
FORMATS OF
RECORDS - ANNEXURES
REVISED NATIONAL TUBERCULOSIS CONTR4OL PROGRAMME
Treatment Card
State________________ City / District with code ___________ TB Unit with code_____________ Patient TB No / Year _____________
Name _______________________________________ Sex  M  F Age:_______ Occupation________________________
Complete Address & Telephone number ____________________________________________________________________________
_____________________________________________________________________________________________________________
Name, Address & Phone No. of contact Person ______________________________________________________________________
Name and designation of DOT provider & Phone.No ____________________________________PHI: __________________________
Name of DOT Centre __________________________________ Signature of MO with date _____________________________
Smear Patient
Initial home visit by __________ Ph.No.___________Date ________ Month Date DMC Lab. No.
Result Weight
Pretreatment
Disease Classification Type of Patient
End of IP/Extended IP
 Pulmonary  New  Relapse
 Extra Pulmonary site  Transfer in  Treatment Failure 2 Months X CP
______________  TAD  Others Specify)________ End Treatment
H/O of Previous ATT with duration _____________________________________________________________________________

INTENSIVE PHASE - Prescribed regimen and dosages. Tick () appropriate treatment regimen below:
H R Z E H R Z E S
Month/
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
year
II Continuation Phase
H R H R E
Enter X on date when the first dose of drugs have been swallowed under direct observation and draw a horizontal line (x_________) to indicate the period during
which medicines will be self administered as shown below
Month/
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
year
x
Treatment outcome with date: _______________________________ signature of the MO with date:__________________________

Details of X ray / EP tests Remarks __________________________________________
__________________________________________________
__________________________________________________
Retrieval Actions for Missed Doses Household Contacts
(Children < 6 Yrs)
By Whom Reason for Outcome of No. of
Date Number No. put on HIV related information
Whom contacted missed doses retrieval action children
screened chemo-
aged
for TB prophylaxis Patient referred to ICTC:  Yes  No Date
<6 Yrs
_______
HIV Status:  Unknown  Positive  Negative Date_____
CPT delivered on: (1) (2) (3) (4) (5) (6)
Pt. referred to ART Centre:  No,  Yes Date_______
Initiated on ART:  No  Yes Date & ART No._____

TUBERCULOSIS IDENTITY CARD
Front Reverse
Revised National Follow up sputum examination
Tuberculosis Control Programme
IDENTITY CARD
Name of Patient: ________________________ Lab
Time point Date Result
No.
Complete address:______________________ Pretreatment
______________________________________ End of IP/extended IP
TU / district name ___________________
________________________Ph__________ 2 months in CP
Sex: M  F , Age:_____ TB No.____________ End of treatment

Appointment dates
PHI:________________________________________ IP CP
______________ _______________
Disease Treatment ______________ _______________
Classification Started on ______________ _______________
 Pulmonary ______________ _______________
 Extra-pulmonary ________________ ______________ _______________
Site:______ Date / Month/ Year ______________ _______________
Treatment outcome with date:
___________________________________
___________________________________
Type of Patient Treatment
• New regimen for Signature and stamp of MO with date:
• Relapse  New cases
• Treatment after default  Previously
• Treatment Failure treated cases REMEMBER
• Transfer In 1. You can be cured if you take treatment as advised.
• Other-Specify _____ 2. You may infect your near and dear if you do not
 CPT take your medicines as advised
3. Keep your card safe
171

Transfer Form
Fill in triplicate with carbon sheet. Send a copy to the TB Unit where patient is transferred, one copy to the patient
and retain a copy for the records. Copy of treatment card be given with transfer form to patient
Name and Address of the transferring Unit (District/TB Unit): _______________________________________

Name of the Unit (District/TB Unit) to which patient is transferred (if known): ______________________
Name of the Patient: _____________________________________ Sex: M  F  Age: ____________
TB No: ____________________________ Date of starting treatment ______________________________
HIV status
Disease Classification Type of Patient Treatment Most Recent  Positive
 Pulmonary  New regimens Sputum Status
 Negative
 Extra-Pulmonary  Relapse  New cases Date:
 Unknown
 TAD  Previously DMC:
Site___________
treated cases Lab NO:
 Treatment Failure
 Positive
 Transfer in
 Other(Specify)___  Negative
Number of doses administered before transfer: IP__________ CP___________

Remarks____________________________________________________________________________________________________
Date transferred ______________ Signature:__________________________________

Designation:________________________________
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------
For use by the receiving District/TB Unit Treatment outcome with date_______________________
Name of patent______________________
Old TB No (given at transferring TB Unit): ___________________ New TB No (given at receiving unit)______________________
Treatment outcome:  Cured Treatment Completed Died Failure
 Defaulted  Transferred Out  Switched over to MDR-TB treatment
Date ___________________________ Signature ___________________________
(at the end of treatment send this form to the transferring District/TB Unit where the patient was initially registered.)
(a copy of treatment card after completion of treatment may be sent to the transferring PHI)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------
-----------------------------------------------------------------------------------------------------------------------------------------------------------
For use by the receiving District/TB Unit if patient transferred in IP Conversion report
Name of patient:____________________________________________________________________________________
Old TB No (given at transferring TB unit) : ______________ New TB No (given at receiving unit):__________________
Sputum Results at the end of IP :  Positive Grade ________  Negative
Date ___________________________ Signature ___________________________
(at the end of Intensive phase this form has to be sent to the transferring District/TB Unit where the patient was initially registered.)
-----------------------------------------------------------------------------------------------------------------------------------------
For use by the receiving District/TB unit - Receipt of acknowledgement

Name of patient _____________________________________________________________________________
Old TB No (given at Transferring TB unit)_______________ New TB No (given at receiving Unit)_____________
Age: ______________________ Sex: M  F  Date of Transfer_____________________________
Name of TB Unit _________________________________ District ____________________________________
The patient reported at the TB unit on: _______________________________________
Signature ________________________________ Designation ___________________________ Date______
(Send this part back to the transferring District/TB Unit as soon as the patient has reported and has been registered in the
receiving TB Unit.)
172

Request form for culture and drug sensitivity testing
Request form and copy of the current treatment card prepared in triplicate by MO-DMC. Two copies to DTO, one copy for file.
DTO sends one copy to IRL.
Patient Name: Date :

Name and address of referring PHI:
Patients’ RNTCP TB No. :
Name and address of DTC:
Age: Sex: Address with landmark:
Date of diagnosis / initiation of treatment/ duration of treatment:

Treatment given (circle drugs already received): H R Z E S
others
Signature of MO of DMC:
Smear results
( To be entered by LT of DMC and counter signed by MO of DMC)
Lab Serial No. DMC :
Date of Specimen Visual Results Positive(grading)
examination appearance (Neg or 3+ 2+ 1+ Scanty
(MM,B, S)* Pos)
*M= Mucopurulent, B=Blood stained S=Saliva ** Write actual count of AFB seen in 100 oil immersion fields
Date: Signature of LT: Signatures of MO of DMC DTO
IRL Culture Results

Culture Result(Tick one)
Date Specimen Laboratory Smear Neg 1-19 + ++ +++ Contaminated/others
Received Specimen result Colonies
No.
No growth reported 0
Date: Less than 20 colonies Report number of colonies
reported by (Name and Signature) 20-100 colonies +
More than 100 colonies ++
Innumerable or confluent +++
growth
IRL DST Results: (Note Enter ‘S’ if Susceptible, and if
resistant, include colony count(e.g. for Rifampicin. R25/2560 if 25 colonies are seen in S2 slope with estimated colonies of 560 in S2 drug
free slope’)
Laboratory
Date Taken Specimen No. S H R E Z Km Ofx Eth Others
Date: Reported by Signature)___________________________________________
Copies of completed form with results should be sent promptly from IRL to DOTS-Plus Hospital and
DTO
173

Referral form for treatment Serial Number
To be filled in triplicate. One copy to be sent to the DTO receiving the patient, one copy to the
health facility where the patient is referred to, and one copy to the patient
Name and address of referring health facility _________________________________________________

_______________________________________________________________________________________
Name of health facility to which patient is referred ____________________________________________

Name of patient__________________ Age__________ Sex M F
Complete Address _____
_______________________________________________________________________________________
Disease Classification HIV status

Pulmonary  Positive
Extra-Pulmonary  Negative
 Unknown
Site____________________
Remarks
Signature
Date referred Designation
-----------------------------------------------------------------------------------------------------------------------------------------
Serial Number______________________________
For use by the health facility where the patient has been referred
Name of patient __________________ TB No (if available)__________________________
Age ___________________ Sex M F Date of referral __________________________
Name of receiving health facility Name of TB Unit and District__________
The above patient has reported at this facility on _____________and has been put on __________treatment
regimen
Signature Designation
Date__________________________
This portion of the form has to be sent back to the referring unit as soon as the patient has been
initiated on RNTCP treatment
174
FORMAT FOR REFERRAL FOR TREATMENT REGISTER
Diagnosis
Sex
Age
Name
Sl. No.
(Name)
Referred to
examination2
Lab Serial No.

PHI/TU/District
Date of sputum
Date of Referral
Sputum results2
Complete Address1
of starting treatment3
Date of Feedback / Date
P/EP
Type of patients
(N/R/F/TAD/O)
Treatment
regimen (New
/previously
treated)
1 Complete address of the patient where he/she will be residing during the course of treatment and can be contacted.
2 In an extra-pulmonary TB patient, it should be written whether the patient was diagnosed on clinical grounds alone or by an investigation should be specified.
3 The date of feedback from the receiving health facility and date of initiation of treatment along with the TB number should be written here.
Note: In case of non receipt of feedback from the receiving health facility within 14 days of the referral date, the STS of the referring health facility should be informed,
who in turn will take up the matter with the STS of the receiving health facility during the regular meeting.
Table of Contents
Module - 4 Registering Cases & Monitoring Treatment
Registering Cases ........................................................................................................................ 179

TB Register and Content ............................................................................................................. 179
Ensuring Registration of all patients ............................................................................................ 185
Exercise ........................................................................................................................................ 186
Section – 2 Monitoring of Treatment ......................................................................................... 188
Smear Conversion ...................................................................................................................... 189
Follow up schedules for sputum examination ............................................................................. 189
Review of Tuberculosis Register ................................................................................................. 190
Recording of follow up examination ............................................................................................ 191
Recording of Treatment outcome ............................................................................................... 192
Determination of date of treatment outcome ............................................................................ 193
Points to Remember .................................................................................................................... 195
MODULE 4
SECTION – I
REGISTERING CASES
Learning objectives: in this section the participants will learn about the following:
• Purpose of registration
• TB register and contents
• Person responsible for registering cases
• Types of cases to be registered
• Timeline for registration
• Source of records for registration
• TB Registration number
• Cohort of patients
• Filling up of the TB register
• Ensuring registration of all TB patients
Introduction
In the previous module, we have learnt about treatment organization and treatment
administration under Direct Observation of Treatment. We have also learnt about
management of special situations and procedure for hospitalization. In the ensuing module
we learn about registration of cases, its importance and monitoring of treatment.
Registration is recording of the details of all TB patients who have been initiated on
treatment, in the TB register. The information recorded is periodically updated till the
declaration of the final treatment outcome for every patient.
Purpose of registration
• Helps in keeping a track of all the patients initiated on treatment till the completion of
their treatment in a systematic manner which facilitates monitoring of individual patients.
• Facilitates preparation of quarterly reports on case finding, sputum conversion,
treatment outcome and programme management and logistics.
TB register and contents

One TB register is maintained at each TB unit. All the columns of the TB register pertaining
to the patients should be filled completely, accurately, legibly and in time.
TB register contains the following information in nineteen main columns spread over two
halves of the page side by side which is considered as one page (left and right hand side of
TB register) and are numbered serially. On the top there is a provision to record the quarter
and the year of registration on each page. This has sufficient number of pages which can
accommodate registration for more than a year. Usually one TB register is used for one
calendar year in a TU for recording the information.
179
Left side Right side

1. TB Number Follow-up sputum exam;
2. Date of registration 14. End of IP/extended IP,
(This is subdivided into four
3.Name (in full)
columns ie., Date, DMC, Lab
4.Sex Number, Result)
5. Age 15. Two months into CP,
6.Complete address and telephone (This is subdivided into four
number columns ie., Date, DMC, Lab
Number, Result)
7. Name of the PHI
16. End of treatment,
8. Date of starting treatment (This is subdivided into four
9. Regimen columns ie., Date, DMC, Lab
Number, Result)
10.Disease classification 17.Treatment outcome with date
11.Type of patient 18.CPT/ART status (if HIV positive)
12.Pre-treatment sputum examination 19.Remarks
(This is subdivided into four columns ie.,
Date, DMC, Lab Number, Result)
13.HIV status (P/N/U)
Summary on case finding (DOTS cases only):

There is provision at the bottom on the left side on each page of the TB register to furnish
summary of the case finding.
• This section summarizes the cases registered on DOTS on the current page of the TB
register to facilitate preparation of quarterly report.
• All types of cases have been divided into two age groups: 0-14 years and ≥15 years
and gender wise (Male and Female). This will facilitate reporting in the block 1 of
quarterly report on case finding.
Summary on treatment outcome (DOTS cases only):

There is a provision at the bottom on the right side of the TB register to furnish summary of
the treatment outcome.
• Treatment outcomes of cases registered on DOTS only is recorded here.

• Segregated treatment outcomes of different types of TB patients are shown.
One page of the TB register is sufficient to register a maximum of ten patients.
Person responsible for registration: Senior Treatment Supervisor (STS) is

responsible for registering all TB cases put on treatment under the jurisdiction of their TB
Unit. He/She is also responsible for updating and maintenance of the TB register under the
overall supervision of the MOTC.
180
Types of cases to be registered: All tuberculosis patients put on DOTS or non

DOTS regimen under RNTCP are to be registered. This includes new smear positive, new
smear negative, new extra pulmonary, new others and re-treatment cases comprising of
relapses, treatment after defaults, failures and others. Besides, transfer-in cases are also to
be registered.
Timeline for registration: All tuberculosis patients should be registered within a month
after the initiation of the treatment, after patient’s home visit by the STS. Under no
circumstances the treatment should be delayed pending the registration of the patient. It is
reiterated that all indoor patients treated under RNTCP should be registered under the local
TU where the hospital/Medical College is located. On discharge, these patients should be
transferred out to the TU where the patient resides.
Source of records for registration: Treatment cards prepared after the initiation of
the treatment is the important primary record and the same is used for registering the
cases. For registration, STS transcribes the information on the Treatment cards maintained
at the PHI to the TB register.
TB Registration Number: This is a serial number allocated to each TB patient. It

begins afresh from 1st January and continues up to 31st December of a calendar year.
After assigning a TB number to the patient it should be transferred to all the relevant
records - TB treatment card, treatment box, ID card, Laboratory register.
Cohort of patients: A cohort in RNTCP is a group of TB patients registered in TB

register in a particular quarter/year in the given area (TU/District/State/Country). The date
of registration determines the quarter to which the patient belongs. Patients may be
diagnosed and put on treatment on 30th December 09 but they may be registered any time
in January 2010. These patients are considered to belong to the cohort of first quarter 2010.
It is mandatory to follow the calendar dates for determination of four quarters comprising
three months each for registration. For eg., the first quarter starts from 1st January and ends
on 31st March and so on. In no case, the schedule of the quarter will change. For eg.,
registration starts on 1st January and the quarter ends on 25th March which is erroneous.
Cases registered upto 31st March should be included in the 1st quarter and so on.
Registration of patients in every quarter should start on a fresh page.
The patient will be evaluated in a quarter in which he/she has been registered and not in
the quarter when he/she begins the treatment.
Filling up of TB register
The relevance of all the columns and the procedure of filling up all the columns are
explained below:
Tuberculosis number (TB No.)

Each patient who is being registered is assigned a new Tuberculosis Number (TB No.) and
this number is written in the Tuberculosis Register. The number should be started with
number ‘1’ (e.g. 01 / 2010) at the beginning of every year and patients are registered
181
serially. After TB number is written in the TB register, the same is recorded in the treatment
card also. TB number facilitates identification of the patient in the TB register and other
details pertaining to treatment. An individual TB patient may have more than one TB
number if he/she is re-registered (e.g. after declaring him/her as ‘defaulted’ and restarting
on treatment afresh or after declaring as ‘failure’ and initiating on regimen for previously
treated cases, details of which will be recorded in the remarks column).
The STS should write the TB number in the following records:

• TB register
• TB treatment card
• TB laboratory register (Remarks column)
Example:
Suppose today is 14 March and 3 patients are to be registered. The last TB No. in the
Tuberculosis Register is 64. The 3 patients are assigned Tuberculosis Numbers 65, 66, and
67.
Date of registration
The date on which the patient is registered is recorded in the Tuberculosis Register. It
should be written as: day/month/year (for example 22 May 2010 would be written as
22/5/2010). This is the date used for determining a ‘quarterly cohort’ for case finding, smear
conversion and treatment outcome reports.
Name (in full), Sex, Age, Complete Address and telephone number
This is self explanatory. This information is recorded from patient’s Tuberculosis Treatment
Card. It is ascertained that the information is correct before entering it in the Tuberculosis
Register.
Name of PHI
The name of the centre where the patient is initiated on treatment (i.e., where the original
card is kept) should be written as available from the treatment card.
Date of starting treatment

This is obtained from the entry made in the treatment card meant for recording drug
collection in the intensive phase. The first box that is ticked√ )( is the day on which the
patient was started on treatment. The date is entered in dd/mm/yy format. The date of
starting treatment will either precede or be the same as the date of registration but will
never be after the date of registration. Thus, some patients who may be started on
treatment in the last few days of one quarter, say 1st Quarter 2010, may be registered in the
next quarter, viz., 2nd Quarter 2010. Such patients would be considered to be a part of the
cohort of 2nd Quarter 2010. However, in no case should patients be registered later than
one month from date of starting treatment.
182
Regimen
Regimen for treatment prescribed is recorded in this column. This information is available in
the treatment card. The regimen prescribed in the treatment card would have been ticked
either as Regimen for new cases / Regimen for previously treated cases / ND1 / ND2 as the
case may be.
Patients should be registered within a month of initiation of treatment. The STS

registers patients who began treatment in a health facility or hospital during
his/her periodic supervisory visit after counseling the patient.
Disease classification
If the patient is classified as pulmonary tuberculosis, it is recorded as P and if extra
pulmonary TB it is recorded as EP. This information is available in the Treatment Card
under the Disease Classification. In the rare case of a patient who has both pulmonary
and extra-pulmonary TB, s/he should be classified as pulmonary and recorded as P.
Type of Patient
This information is available in the box meant for recording type of patient on the front side
of the treatment card. Appropriate type - New case / Relapse / Transfer in / Treatment
Failure / Treatment After Default / Others is ticked. In case of ‘others’ it may be specified as
New / Previously treated and basis for such classification explained in Remarks column.
Pretreatment Sputum Examination

Details of initial sputum examinations are recorded. The sub columns are date, name of the
DMC, Lab Serial number and smear results. This information is available in the Treatment
Card. Conventionally, positive smear results should be entered in red ink and negative
smear results in black / blue ink.
HIV status
• HIV Status as provided in the original TB treatment card should be recorded in the
space provided at the time of registration. Status is recorded as ‘P’ for HIV-positive; ‘N’
for HIV-negative; ‘U’ for unknown.
• At the time of preparation of the quarterly report on case finding, all ‘blank’ entries in the
HIV Status column in the TB register should be considered as 'Unknown' for the
purpose of reporting.
• If the HIV status of the TB patient is initially not known and is later ascertained and
updated during the course of TB treatment, the same should be updated in the TB
register.
• Treatment cards and TB register should have been updated with the HIV status
information before the preparation of quarterly report on treatment outcome
If the HIV status on the TB treatment card remains blank for any reason it is to be recorded
as unknown in the TB register.
183
Follow Up Sputum Examinations

Details of the follow up sputum examinations are recorded under the column titled end of
IP / Extended IP, 2 months into CP Examination and End of the Treatment
examination. The sub columns are date, name of the DMC, Lab Serial number, smear
results. This information is available in the Treatment Card.
Whenever smear results are positive at the end of IP either in new / previously treated
cases, the boxes are split by a forward slash and results and its details at the end of the
intensive phase are entered above the slash and results and its details after the extension
of the intensive phase are entered below the slash.
Treatment Outcome with date

The treatment outcome and the date as declared on the reverse side of the treatment card
are transcribed on to these columns. This should be completed within a month after the
completion of the treatment / event.
Details on CPT and ART

• The section is to be filled up for all TB patients known to be HIV-infected and should be
left blank for others.
• CPT and ART information should be recorded on the register at the same time of
treatment outcome recording i.e. within a month of TB treatment completion.
• Record CPT started as ‘yes’, with the date, if at least one month of CPT delivery is
recorded in the original treatment card.
• Record ART started as ‘yes’ if recorded as ‘yes’ in the original TB treatment card.
Record the documented approximate date of ART initiation from the original TB
treatment card.
• For patients who were already taking CPT or ART at the time of TB diagnosis, the dates
for CPT and/or ART initiation would be expected to be earlier than the date of initiation
of TB treatment.
• For patients who were already taking CPT or ART at the time of TB diagnosis, the dates
for CPT / ART initiation is expected to be earlier than the date of initiation of TB
treatment. This date should be taken from the ART records of the patient.
Remarks
This column is meant for recording entries such as:
• Details of x-ray reports for Smear-negative patients
• Site involved in case of EPTB
• Investigations done for EPTB such as histopathology etc.
• For recording DOT provision by community volunteer as “CV”
• Details regarding transfer
184
• In case of patients has been started on Regimen for previously treated cases, previous
TB number (i.e. TB number when patient was on Regimen for new cases) and whether
treated under RNTCP or otherwise
• In case of treatment after failure and defaulted patients out of the new cases who are
eventually being initiated on Regimen for previously treated cases, the newly assigned
TB number is written.
• Reasons for initiating Non-DOTS regimen
• Information on starting patients on MDR-TB treatment regimen, results of the culture
and sensitivity examinations
Summary on the Left side

A box is provided at the bottom of the left side of the Tuberculosis Register. It is for
recording the number of patients, who are on RNTCP DOTS, according to disease
classification of all types of cases except transfer in and who are on RNTCP non-DOTS.
Summary on the Right side

Another box is provided at the bottom of the right side of the Tuberculosis Register. It is for
recording treatment outcomes of patients registered under DOTS (Cured, Treatment
Completed, Died, Failure, Default, Transferred out and switched over to MDR-TB regimen).
This data is necessary for completing Quarterly Reports on Treatment Outcome.
Ensuring registration of all TB patients

Sometimes we may find that there are patients who have not been registered in the
Tuberculosis Register. These are:
• Patients entered in the Tuberculosis Laboratory Register as smear-positive, but are not
receiving treatment
• Patients receiving treatment and have a Tuberculosis Treatment Card, such as smear
negative and extra-pulmonary TB cases which may not find reference in the Lab
Register.
It is essential to trace the first type of patients (mentioned above) because they are
infectious and not receiving treatment for TB. At least half of the smear-positive patients, if
left untreated, would die from TB. In addition, each of these patients would spread TB
infection to at least 10-15 healthy uninfected family members and other members of the
community per year, as long as they live. These patients must be traced and placed on the
appropriate treatment immediately.
The designated microscopy centre maintains a Tuberculosis Laboratory Register. If the

patient has not been started on treatment, the reason for the same should be mentioned in
the Remarks column of this laboratory register. If treatment has been initiated, the patient’s
Tuberculosis Number should be written in the Remarks column of the Tuberculosis
Laboratory Register.
185
Ensure that all patients started on treatment—both DOTS and RNTCP non-
DOTS—are registered in the same Tuberculosis Register.
During supervisory visits the STS and STLS should identify all such patients and make all
efforts to have them placed on treatment.
There are two ways of making sure that all patients are registered in the Tuberculosis
Register:
• During visits to the microscopy centre, all smear-positive patients who are entered in the
Tuberculosis Laboratory Register but not in Tuberculosis Register have to be identified.
• During supervisory visits to the hospitals and health facilities, any patients with
Tuberculosis Treatment Cards who are not registered should be identified and
registered.
Exercise -1
Using workbook E3, complete one page of left side of the TB register using five treatment
cards you have completed in exercise E2. The registration dates are shown against the
names. The last registration in the TB register was 615.
Parvathi Sinha (Patient A) 26th September 2008
Lakshmi Kumari (Patient B) 17th September 2008
Kailash Nath (Patient C) 26th September 2008
Ganasham Singh (Patient D) 11th September 2008
Kiran Kumar(Patient A) 26th September 2008
Exercise-2
Complete the transfer form for the appropriate patient mentioned in module three.
Exercise -3
1. What information is recorded in the TB Register at the time of registration?
2. Who is responsible for registering patients and within what time should the patient be
registered?
3. List the records where the TB No. should be written.
186
4. How do you identify whether the patient found sputum positive in the DMC lab register
has been registered in the TB Register
(a)
(b)
5. State true or false:

a. A patient was started on treatment on 20-3-2010. STS registered the patient on
13-4-2010. The patient will be reported in the cohort of the 2nd quarter 2010.
b. Treatment cards and TB register should be updated with the HIV status
information before the preparation of quarterly report on treatment outcome
c. CPT and ART information should be recorded on the register at the same time of
treatment outcome recording i.e. within a month of TB treatment completion
POINTS TO REMEMBER
• All patients initiated on treatment for tuberculosis (RNTCP DOTS or RNTCP non-DOTS)
must be registered in the TB register and assigned a TB number
• The STS is responsible for registering patients
• All patients must be ‘registered’ within one month of treatment initiation
• Only one Tuberculosis Register is maintained at each TU
• Tuberculosis Register contains patient-related essential information
187
SECTION -2
MONITORING OF TREATMENT
Learning objectives
In this module the participants will learn about the following
• Methods of monitoring
• Smear conversion
• Follow up schedules for sputum examination
• Recording of follow up examinations
• Recording of the treatment outcome and date of treatment outcome
• Identification of MDR suspects and filling up of Mycobacteriology culture and drug
sensitivity test form
Introduction
Monitoring of treatment is a process of watching the response of the patient to the
treatment being administered. Monitoring of treatment can be undertaken by several ways.
Cases registered in the Tuberculosis Register can be considered as participants in a race.
Like watching participants in a foot race, the progress of TB patients can be watched as
they move towards the end point, i.e., monitoring their treatment as they progress towards
the completion of treatment and cure.
Methods of monitoring:
Monitoring of the treatment of patients can be undertaken in the following ways:
1. Periodic follow up sputum examination:
This is an objective method of assessing the response of the patients to treatment.
Smear conversion at end IP/ extended - IP is an early indicator of the success of
treatment regimen and also the efficiency of DOT administration.
2. Review of drug collections in the treatment card:

a. Intensive phase: Review of treatment card for collection / administration of
DOT as indicated by ‘’ may supplement the monitoring of treatment.
b. Continuation phase: Review of treatment card for collection / administration of
DOT as indicated by ‘X-------’ may supplement the monitoring of treatment.
188
3. Review of patient wise boxes versus recording of drug collections :

Another important indirect method of monitoring drug intake is to compare the drugs
available in the patient-wise boxes vis-à-vis the drugs shown as consumed in the
Tuberculosis Treatment Card. The number of blister packs remaining either in the
IP/CP should match with the recording of drug administration in the treatment card
and the empty blister packs returned and retained. Any discrepancy, if observed
should prompt visit to patients home for further interaction & clarification.
4. Interaction with patients at random, preferably at their residence:
Interview of patients regarding the administration of DOT at the time of home visit will
validate the recordings in the treatment card and the TB register.
Smear conversion:
Smear microscopy is an objective method of assessing response to treatment. One of the
way to monitor the treatment results of a pulmonary smear-positive case is to check for the
conversion from smear-positive to smear-negative status. This is an early indicator that the
intensive phase of treatment is regular and effective. Smear-positive cases will convert to
smear-negative and will remain smear-negative if the patients take their medications under
direct observation on a regular basis for the prescribed period.
After end IP of treatment, more than 80% of new pulmonary smear-positive cases could
become smear-negative, and after entended -IP the rate of sputum conversion could
increase to more than 90%. Pulmonary smear-positive relapse cases should have almost
same rates of sputum conversion as new pulmonary smear-positive cases. Other smear-
positive previously treated cases, such as failures of new sputum smear-positive cases,
may have lower sputum conversion rates around 75%, after 3 months of receiving the
regimen for previously treated.
Follow up schedules for sputum examination:

Follow up sputum examination is recommended as follows
For New Cases

1. At the end of Intensive Phase (2nd month)
2. Two months into the Continuation Phase (4th month)
3. End of treatment (6th month)
New smear positive patients remaining smear positive at the end of 2 months of treatment
and new smear negative cases becoming smear positive at the end of 2 months will have
their intensive phase extended by 4 weeks by administering 12 blisters from prolongation
pouch. They would be subjected for repeat follow up sputum examination at the end of 3
months. Irrespective of the smear results (whether positive or negative) at the end of third
month, continuation phase is started. Subsequently, the patient is subjected for sputum
examination at 2 months into the continuation phase i.e. at the end of 5 months of
treatment. The final follow up sputum examination is done at the end of the treatment. If
patients are found to be positive either at the end of 5 months or at the end of treatment
they are declared as failure and sputum is sent for culture and drug sensitivity testing.
Then, they are registered afresh and put on treatment regimen for previously treated.
189
For Previously treated cases

1. At the end of Intensive Phase (3rd month)
2. Two months into the Continuation Phase (5th month)
3. End of treatment (8th month)
In situations where sputum is positive at the end of 3 months, intensive phase is extended
by 4 weeks by administering additional 12 blister packs and a follow up sputum
examination is undertaken at the end of 4th month. Irrespective of the smear results
(whether positive or negative) at 4th month, continuation phase is started. In case sputum is
positive at the end of the 4th , sputum is sent for culture and drug sensitivity testing.
Subsequently, the patient is subjected for sputum examination at the end of 6th and 9th
month.
Monitoring regularity of sputum examination

The results of sputum examinations should be verified during supervisory visits to the
treatment centers. Prior to supervisory visit to a PHI, the Tuberculosis Register is reviewed
to identify cases that should have had their sputum examined as follows:
1. Identify the TB patients who have become eligible for follow up examination at the end
of the intensive phase, extended intensive phase, two months into the continuation
phase and at the end of the treatment.
2. This can be determined by looking into the date of initiation of the treatment, treatment
regimen prescribed and total number of doses administered.
3. The list of patients whose follow up examinations should have been completed and
results expected to be available in the health centers is prepared and the health center
visited accordingly.
For identifying cases whose results of sputum examinations should be recorded, TB

register is reviewed. This is to determine whether the proportion of the New and Relapse
Pulmonary smear-positive cases at the treatment centre who have become smear-negative
by the end of their intensive phase is adequate (90% or more).
Review of Tuberculosis Register

a. Smear conversion : Proportion of patients who have become smear negative among
new pulmonary smear-positive, relapse, treatment after default and treatment failure cases
are arrived by reviewing their smear status individually at the end of 2/3 months.
If the smear conversion rate is less than 85% for new cases, at the end of 2(3) months, the
reasons needs to be examined and rectified why the conversion rate at 2(3) months is low.
Example:
In Nagpur District 220 New smear-positive patients were registered in a quarter, 190 New
smear-positive patients converted to smear-negative at the end of 2 months and another 10
New smear-positive patients converted to smear-negative at the end of 3 months.
Therefore, 200 (190 + 10) New smear-positive cases converted to smear-negative.
190
200 x 100 = 91%

220
Hence, the smear conversion rate in Nagpur district is 91%.
b. Identification of MDR-TB suspects: During the review of the TB register, STS

should identify the MDR-TB suspects and refer the same to Medical Officer for further
management. The following are the criteria to label a patient as MDR-TB suspect:
• A new smear positive patient who is found to be smear positive at the end of 5th month
or later.
• A new smear negative patient becoming smear positive at the end of 5th month or later.
• A patient treated with regimen for previously treated remaining positive at 4th month
• Smear positive contacts of an MDR-TB case
c. Determination of Treatment outcome: During the review of the TB register,
determination of treatment outcome of individual patient is undertaken by the STS. Results
of the sputum examination done at the end of the intensive phase and at the end of the
treatment for each patient will help in determining the treatment outcome. The date of self
administration of the last pyridoxine tablet of the last blister pack is considered as the date
of treatment outcome for ‘treatment completed’ and ‘cured. The date on which the sputum
examination at the end of the treatment is found to be positive is considered as the date for
the outcome ‘failure’.
Recording of follow up examinations

Recording in treatment card – The details of the follow up examinations are
recorded against the appropriate month (i.e., end of intensive phase / extended IP, two
months into continuation phase and at the end of the treatment) under the column heads
Date, DMC, Lab Number, Smear Results and Patient Weight. In situations where smear is
positive at the end of the intensive phase either in New or Previously treated cases, the row
of boxes meant for Date, DMC, Lab Number, Smear Results and Patient Weight have to be
split by a forward slash as shown below. The details of the sputum examination done at the
end of two months are entered above the slash. Intensive Phase is extended by one month
and the details of the sputum examination done at the end of third month in New and fourth
month in Previously treated cases are entered below the forward slash as depicted below:
Smear Patient
Month Date DMC Lab No.
Result Weight
Pretreatment
End of IP End of IP End of IP End of IP End of IP
End IP /
Extended IP Extd IP Extd Extd Extd Extd
IP IP IP IP
2 months CP
End treatment
191
It is important to ensure that sputum has been examined at the correct intervals during
treatment and the results are recorded in the appropriate columns of the Tuberculosis
Register. For monitoring the regularity of sputum examination it is necessary to:
• Regularly identify pulmonary TB cases whose follow-up sputum examination is due and
confirm that results of the examination have been recorded in the Tuberculosis Register;
• During supervisory visits to health facilities, Tuberculosis Treatment Cards (or
Laboratory Form for Sputum Examination) are reviewed and compared with the results
of sputum smear examinations with those recorded in the Tuberculosis Register.
• Sometimes, during the visit to health facility, it is observed that the Tuberculosis
Treatment Cards are not updated. In such an event, as a backup during supervisory
visits by STLS to the DMCs, the details of every patient subjected to follow-up sputum
examination should be noted and shared with STS regularly to facilitate updating of the
TB register. The same information may be passed on to the concerned health facility to
update the records there. The MO of the health facility should be informed about the
same with a request to monitor this activity.
Recording in the TB register - The details of the follow up sputum examinations are
also recorded on the right hand side of the TB register under the column heads ‘End of IP’/
‘Extended IP’, second month into continuation phase, ‘End of treatment’.
Recording of the treatment outcome:

Treatment card
• The appropriate outcome i.e., cure/treatment completed/transferred out/defaulted
/failure/switched over to MDR-TB treatment/died may be recorded on the line provided
on the reverse side of the card.
• Date of outcome is the date on which the patient takes the last dose of treatment (i.e.,
last pyridoxine tablet in the 18th weekly blister in New and 22nd weekly blister in
Previously treated). This date is recorded in the space provided following the treatment
outcome. This is applicable in case of recording the treatment outcome as cure and
treatment completed only. For other treatment outcomes, refer table below for
Determination of date of treatment outcome.
• TB treatment card should reach the TB unit from the treatment centre as soon as the
treatment outcome is recorded but not later than one month.
TB register
• Treatment outcome has to be entered in the TB register as recorded in the TB treatment
card.
• The treatment outcome should be recorded in the TB register within one month of the
completion of treatment. Similarly, the patients declared as defaulted or died should be
recorded within one month of the event. (Example - patients interrupted treatment on 1st
March 2010. He was declared defaulted on 2nd May 2010. This should be recorded in
the TB register by 2nd June 2010).
• For transferred out cases it should be ensured that the treatment outcome as declared
at the centre where the patient was transferred is obtained and outcome is updated in
the TB register.
192
- Before declaring treatment outcome as transferred out all possible efforts

should be made to get the actual outcome of the patient from the TU where
he/she was transferred to.
- Data on the cases that were transferred from one district to another should be
evaluated in the district in which the patient was first notified and registered.
Determination of date of treatment outcome
Outcome Date of determination Illustrations
Cured The last dose (Pyridoxine) of the Patient administered last dose
Treatment 18th blister in New and 22nd under DOT in continuation
completed blister in Previously treated. phase on 16-06-2010;
Last Pyridoxine taken on 22-06-
2010
Cured or treatment completed
on 22-06-2010
Transferred out Transferred out is the date on Generally drugs up to one week
which the patient is supposed to (3 blisters in IP and one blister
have consumed the last of the in CP) are given for self
three doses provided to him at administration during transfer.
the time of transfer as recorded
in the card. Actual date on which transfer
This is only an interim outcome. form was filled and sent is 20-
The actual outcome as reported 06-2010; then the date of
from the TB unit where the transferred out as a treatment
patient was transferred will be outcome should be 27-06-2010.
updated in the card and in the TB This is the date when the 3rd
register upon its receipt. dose handed over during
transfer is supposed to have
consumed.
Defaulted* The scheduled date of drug Patient interrupted treatment on
consumption after which the 16-9-2010 Record outcome as
patient interrupted treatment ‘defaulted on 16-9-2010’ on or
either in the intensive phase or in after 17-11-10 but within one
the continuation phase. month
Failure The date on which the sputum If the smear result is positive on
examination was found to be 18-05-2010
positive for AFB Record as failure on 18-05-2010
Died The actual date of death Patient died on 11-08-2010
Record as Died on 11-08-2010
* A Patient after treatment initiation has interrupted treatment consecutively for >2 months
A patient will have one and only one outcome. The outcome which occurs first is
considered and recorded in treatment card and subsequently in the TB register.
Tuberculosis Treatment Cards should be reviewed as soon as possible after a patient has
completed treatment.
The reverse of the treatment card is reviewed to verify whether the patient has consumed
all his drugs as scheduled.
193
When Treatment Card, is found to be incomplete this should be enquired into during the
supervisory visit. For example, if a Tuberculosis Treatment Card is found to be incomplete
in continuation phase and there are no comments under Remarks, it needs to be verified to
find out whether the patient has been transferred, defaulted, died or just stopped coming
and the reason for the same.
Data on cases that were transferred from one district to another should be evaluated in the
district in which a patient was first notified and registered. On completion of treatment by
the patient, who was transferred into the district, results of the final follow up examination
should be sent to the district from where he was transferred along with the treatment card.
The best practice would be to obtain the TB number of the transferred patient from the STS
of the receiving TB unit within 1 month of the transfer. Thus, the information on follow up
sputum examination results can be easily obtained if the TB number assigned at receiving
TB Unit is available.
Exercise -4
Part 1
Using workbook E3 and the completed treatment cards in Exercise Workbook E2, complete
the right hand side of the Tuberculosis Register.
Part 2
Look at the single page (right and left side) of Exercise Workbook E3 Labeled ‘Tuberculosis
Register with Errors’. Every line of the Tuberculosis Register contains at least one error in
registration or in management. Note down the errors identified in the table below.
TB. No. Error (s)

401
402
403
404
405
406
407
408
409
410
194
EXERCISE 5
1. A patient started on regimen for new cases on 13.4.09, treatment stopped on 27.7.09.
The MPW reported that the patient expired on 30.10.09. Give the outcome of the
patient.
2. What do you need to know to determine schedule for a follow-up sputum examination?
3. If the sputum smear result is positive at the end of the intensive phase of treatment,
how will you record this in the TB register?
POINTS TO REMEMBER
• Smear conversion at the end of the intensive phase could be an early indication for
achieving high cure rates. This has to be ensured by regular monitoring of the treatment.
• Treatment of smear-negative and extra-pulmonary TB is monitored by regularity of drug
intake and clinical improvement.
• A patient initiated on treatment for tuberculosis will have only one of the seven
outcomes (cured, treatment completed, died, failure, defaulted, transferred out or
switched over to MRD-TB treatment).
• While determining the date of outcome in cure and treatment completed, the date on
which the last dose of drug consumed is considered and not the last date when drugs
were collected
• Tuberculosis Register contains all patient-related essential information
195
Revised National Tuberculosis Control Programme – TB Register Quarter ________ Year ___________
Date Complete Regimen Pre-treatment sputum exam HIV
Name Date of
TB of Name (in Sex Address & Cat- Class Status±
Age of Starting Type** DMC
No. Regis- full) (M/F) Telephone I/CatII/ND1, (P/EP) Date Lab.No. Smear (P/N/U)
PHI Treatment Name
tration Number ND2*
…………… ………………
…………… …………………
…………… …………………
…………… …………………
…………… …………………
…………… …………………
…………… …………………
…………… …………………
………… …………………
Summary for Case Finding (DOTS Cases Only) * Regimen:

Previously NT– New, PT – Previously Treated
New Treatment
NSP NSN NEP Relapse TAD Treated
Others Failure ** Type of Patient (use complete
Others
words)
0-14
New, Relapse, Transferred in, Treatment
Yrs. Failure, TAD, Others
≥ 15
Yrs. ± HIV Status
HIV status as reported before or during
Male TB treatment P – Positive, N – Negative,
Female U – Unknown.

RNTCP Training Course For Program Manager Module 1 To 4

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RNTCP Training Course For Program Manager Module 1 To 4

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MODULE – 1 to 4

Course for Program Managers

Materials and methods:

• Certification: A certificate would be awarded to the trainees upon satisfactory

Days Session Topic and activities

Two Fore Noon • Module 2 Quality assured Lab services

Three Fore Noon • Field visit - Microscopy DMC

After Noon Module 3

Eleven Fore Noon Open house session / field visit

TB can be controlled only with EFFECTIVE SUPERVISION and

Pathogenesis of Tuberculosis (TB),

Risk of developing disease

Extent of TB problem in India

Annual Risk of Tuberculosis Infection (ARTI)

HIV co-infection among TB patients

In a TB/HIV co-infected person, the immune response to TB bacilli increases HIV

Multidrug-resistant tuberculosis (MDR-TB)

Revised National Tuberculosis Control Programme

Goal and Objectives of RNTCP

To achieve and maintain:

Directly Observed Treatment Short course (DOTS) strategy

• Political and administrative commitment: The government’s commitment is

• Quality assured diagnosis through sputum microscopy: Under RNTCP, sputum

• Uninterrupted supply of quality drugs: The policy of procurement and distribution of

Public Private Mix

TB-HIV collaborative activities

Specific TB-HIV collaborative activities undertaken are:

1. Establishment / Strengthening NACP-RNTCP coordination mechanisms at national,

RNTCP and DOTS-Plus services for MDR-TB

RNTCP reached a landmark achievement with the launching of RNTCP DOTS-Plus

Advocacy, Communication and Social Mobilization (ACSM)

Organizational structure and functions

Committees at National level

National Laboratory Committee

National Technical Working Group for TB-HIVp

National DOTS- Plus committee

National Task Force for Medical Colleges

National Standing Committee on Operational Research

Sub-District Level (Tuberculosis Unit Level)

Peripheral Health Institutions (PHIs)

Organizational structure of RNTCP

National Lab Committee

State TB Training and State TB Cell STO, Deputy STO, MO,

Nodal centre for TB District TB Centre DTO, MO-DTC, DEO, support

One per 5 lakh

One per 1 lakh Designated MO, LT

2. List five major responsibilities of

Q.3 A. What is the impact of HIV on TB control programme?

Laboratory Diagnosis of TB and Quality Assurance

LABORATORY DIAGNOSIS OF TB AND QUALITY ASSURANCE

In this section of the module the participants will learn about:

It may be accompanied by one or more of the following symptoms:-

Extra pulmonary tuberculosis

A pulmonary TB suspect is defined as:

• An individual having cough of 2 weeks or more.

Persons having cough of 2 weeks or more, with or without other

Importance of properly identifying TB suspects

Therefore, all health workers and community volunteers should be encouraged to

Screening of pulmonary TB suspects

Expected number of referrals for sputum examination

The number of TB suspects examined can be expressed as numbers / lakh population/

Sustained efforts have to be taken to examine as many TB suspects as possible to

In a PHI of rural setting atleast 2% of new adult out-patients are estimated to be TB

Name of Referring Health Facility: ________________ Date: _