RNTCP Training Course for Program Manager Module 1 to 4

7/25/2019 RNTCP Training Course for Program Manager Module 1 to 4

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MODULE 1 to 4

Module 1 : 1-14

Introduction to Tuberculosis and Revised National TuberculosisControl Program (RNTCP)

Module 2 : 17-98

Laboratory Diagnosis of TB and Quality Assurance

Module 3 : 101-175Treatment Services

Module 4 : 189-196

Registering Cases and Monitoring Treatment


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Course Introduction

About the Training Course

Tuberculosis (TB) remains a major public health problem in India. This course providestraining relevant to managing RNTCP at the state, district and sub-district levels. A set ofnine modules provide uniform training material including management of TB-HIV co-infection, MDR-TB, pediatric and extra-pulmonary TB, private sector involvement and otherrelated aspects

Course for Program Managers

The content of this course has been revised keeping in mind the evolving role of ProgramManagers at the state and district levels. Since the program is taking on newer directionslike TB-HIV, MDR TB etc it is important that the these changes are reflected in RNTCPbasic modular training to aid effective functioning of program managers.

Learning objectives

At the end of this course, participants are expected to effectively manage theprogramme at their respective levels. The specific learning objectives for each of themodules 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 presentationby participants. This course is structured in such a way that each participant performsexercises at his own pace, and is encouraged to discusses with the facilitator, the problemsor questions, if any.

Facilitators: The training will be organized at the National level. Competent facilitatorsare to be drawn from the faculty of the National RNTCP training institutes and State TBTraining and Demonstration Centers. The facilitator-trainee ratio should ideally bearound 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 satisfactorycompletion of the course.


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Schedule for RNTCP modular training

Days Session Topic and activities

One Fore Noon Pretest

Module 1 Introduction to Tuberculosis andthe Revised NationalTuberculosis 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 - Microscopyactivities

DMC

After Noon Module 3

Four Fore Noon Module 3 (complete)

After Noon Module 4 Registering cases and monitoringof treatment

Five Fore Noon Module 5 Monitoring of the programmeProgramme implementationAfter Noon

Six Fore Noon Module 5 (complete)

After Noon Open house sessionSeven Fore Noon Field visit Treatment and

programme performanceactivities

TB Unit

After Noon Field visit for TB-HIVcollaborative activities

DMC, ICTC and ART centers

Eight Fore Noon Module 6 Programme implementation

After Noon

Nine Fore Noon Module 6 (complete)

After Noon Module 7 Logistics management includingpreventive 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:


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Manage the program in a more effective manner , as the modules answer allpertinent questions / issues faced by program managers ( STOs /DTOs, STDC staff,Medical College Professors)

train MOs and health workers to correctly identify patients who should beinvestigated 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 (peripheralhealth workers, community volunteers, etc.)

provide health education to patients and their families and train MOs and healthworkers to do the same

monitor the registration of patients in the Tuberculosis Register

verify that correct number of sputum specimens have been examined at stipulatedintervals and the results have been recorded in the Tuberculosis Register

regularly review Tuberculosis Treatment Cards to assess treatment outcomes and toverify that the treatment outcomes have been recorded correctly in the TuberculosisRegister

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, printedmaterials 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 asthe 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


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Table of Contents

Module 1

Introduction to Tuberculosis (TB) & Revised National TuberculosisControl 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


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Training Course for Program Manager

1

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 comprehensivereview of the NTP in 1992 found that the NTP had not achieved its aims or targets. Basedon the recommendations of the 1992 review, the Revised National Tuberculosis ControlProgramme (RNTCP), incorporating the components of the internationally recommendedDOTS 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 achievenation-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 andunregulated 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 Mycobacteriumtuberculosis. Patients suffering from smear positive pulmonary TB (PTB) constitutes themost important source of infection. The infection occurs most commonly through dropletnuclei generated by coughing, sneezing etc., inhaled via the respiratory route. The chancesof getting infected depend upon the duration, the frequency of exposure and the immunestatus of an individual. The programme gives priority in detecting and treating smearpositive PTB, thereby aiming to cut the chain of transmission of infection. However, it needsto 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 - 8weeks 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 infectionoccurring for the first time in susceptible individuals who are exposed to tubercle bacilli.Droplet nuclei that are inhaled into the lungs, are so small (< 5m) that they avoid themuco-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 thelymphatics. The sub-pleural lung lesion, lymphangitis and hilar adenopathy togetherconstitute a primary complex. In most cases, the hosts immune defenses overcome theprimary infection, which generally passes unnoticed.

Secondary bacillary multiplication that occurs at the regional lymph nodes causesbacillaemia 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 suchenvironments, the bacilli continue to multiply as these environments favour their continuedgrowth and multiplication. In a few cases, the infection may develop into progressiveprimary forms of TB disease such as meningitis and miliary TB. However, in majority of thecases, 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 afterthe primary infection. Disease may occur either due to endogenous reactivation of dormanttubercle bacilli acquired from a primary infection or by exogenous re-infection. Post-primaryTB 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 otherpersons 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 ofbreaking down to disease among those infected with TB is 1015%, which gets increasedto 10% per year amongst those co-infected with HIV. Other determinants such as diabetesmellitus, smoking tobacco products, malnutrition and alcohol abuse also increase the risk ofprogression 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 andmortality.Incidenceis the number of new events (infection or disease) that occur over aperiod of one year in a defined population. Prevalenceis total of new and existing events

(infection or disease) at a given point of time in a defined geographical population.Indiaaccounts for one fifth of the global TB burden i.e. 1.98 million out of 9.4 million new casesannually. In India, more than 40% of population is infected (prevalence of infection)withMycobacterium tuberculosis. It is estimated that there are 3.3 million prevalent case of allforms of TB disease (smear positive PTB, smear negative PTB and Extra-Pulmonary TB).Approximately 75 new smear positive PTB cases (incident cases) occur per lakhpopulation 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 forIndia provided by WHO for the year 2008.


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Magnitude of TB - Global and Indian scenario*

Incidence ofdisease

Prevalence ofdisease

MortalityHIV prevalenceamong incident

cases

Global9.4 million

(139/lakh/year)

11.1 million(165/lakh/year)

1.32 million

(19.6/lakh/year)15%

India1.98 million

(168/lakh/year)2.18 million

(185/lakh/year)

2.76 lakhs

(23/lakh/year)6.7%

*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 withMycobacterium 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 ofinfection (smear positive PTB cases), nutritional status, co-morbidities etc. The ARTI ineffect reflects the overall infectious pool in the community. ARTI of 1.0% is presumed toreflect an incidence of 50 new smear positive pulmonary tuberculosis cases occurring perlakh population per year. From the earlier ARTI survey (2000-2003) it is estimated that inIndia 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 toarrive at current estimates.

HIV co-infection among TB patients

In India, it is estimated that 2.31 million individuals are living with HIV infection, whichequates to approximately 0.34% of the adult population of the country. Based on availablecountry data of 2007, it is estimated that 4.9% of new adult TB patients in India are HIVpositive. Hence, the TB epidemic in India continues to be predominantly driven by the poolof 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 thecourse of HIV disease, even after successful initiation of antiretroviral therapy (ART). InIndia 55-60% of AIDS cases reported had TB, and TB is one of the leading causes of deathin People living with HIV/AIDS(PLHA).

The primary impact of HIV on TB is that the risk of developing TB becomes higher inpatients with HIV. An HIV-infected person newly infected with TB has a 10-30 times higherchances of developing the disease than among patients infected with TB only. AmongstPLHA, 310% of persons develop TB per year. Furthermore, HIV-infected persons with TBsuffer much higher mortality than non-HIV infected persons. Even if TB is successfullytreated, long term post-TB mortality among PLHA is extremely high.

In a TB/HIV co-infected person, the immune response to TB bacilli increases HIVreplication. As a result of the increase in number of viruses in the body, there is rapidprogression 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 opportunisticinfections. 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 commonopportunistic 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) andrifampicin (R), with or without resistance to other drugs. Irregular consumption and frequentinterruption in taking treatment for TB is the most common cause of acquiring multidrugresistance. In India, MDR-TB amongst new cases are estimated at 2- 3% and amongst re-treatment cases at 14-17%. Extensively Drug Resistant TB XDRTB) is a subset ofMDR-TB where the bacilli, in addition to being resistant to R and H, are also resistant tofluoroquinolones and any one of the second-line injectable drugs (namely Kanamycin,Capreomycin or Amikacin). Although XDR-TB has been reported in India, its magnituderemains undetermined as yet due to the lack of laboratories being capable of conductingquality assured second line drug susceptibility testing.

In India, the great concern is the potential threat of drug resistant TB (DR-TB) with theexisting unregulated availability and injudicious use of first and second line anti-TB drugs inthe country.

Pediatric TB

Children in the first five years of their life are likely to suffer from serious and fatal forms ofTB, more so, if not vaccinated with BCG. Globally, it is estimated that about 1.1 million newcases are reported and 1,30,000 deaths occur annually due to TB among children. Reliabledata on the incidence and prevalence of the disease is not available due to the difficulties indiagnosis 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% ofradiological 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 in2006. 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$ 2.0billion, or 7.8%, in absolute terms since 1990. On a per capita basis, the economic burdenof TB has fallen by 31.1% from US$ 29.9 in 1990 to US$ 20.6 in 2006. The majority of theimprovement since the mid-1990s has come through reduced mortality, due to the

implementation of RNTCP. Morbidity has also recorded a large improvement reflecting thedecrease in prevalence. However, TB remains a significant cause of loss in the health andeconomic well-being of Indias population.

TB primarily affects people in their productive age group; with important socio-economicconsequences for the household. Almost 70% of TB patients are aged between 15 and 54years. The disease is more common amongst the poorest and the marginalized sections ofthe community. Whilst two-thirds of cases are male, TB takes a disproportionately larger tollamong young females, with more than 50% of cases occurring amongst females less than34 years of age. In addition there is a devastating social cost with an estimate of more than300,000 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 anaverage, 3-4 months of work-time is lost as a result of TB, resulting in an average potentialloss 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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Revised National Tuberculosis Control Programme

Following an external review of the existing National TB Programme in 1992, the RevisedNational 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 theglobally 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 cutdown 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 diagnosisand 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 governments commitment ismeasured in terms of continued financial assistance, human resources andadministrative support. This priority must be reflected at the National, State, District andlocal levels.

Quality assured diagnosis through sputum microscopy: Under RNTCP, sputummicroscopy is the primary tool for detection of infectious TB cases, facilitatingcategorization of treatment and an objective method for monitoring the response totreatment. Quality assured smear microscopy laboratories are established for thispurpose.

Uninterrupted supply of quality drugs: The policy of procurement and distributionofdrugsensures sufficient quality assured anti-TB drugs available at all levels. The uniquefeature of RNTCP is the use of blister combipacks in patient wise drug boxes foradults and weight bandwise drug boxes for pediatric cases which contain drugs for

the entire course of treatment. Patient wise boxes have not only helped to improvepatient care and treatment adherence but also to streamline drug supply and drug stockmanagement.


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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 medicalcurriculum and up to their involvement in the actual activities of the programme. Foreffective implementation of RNTCP in the medical colleges (both Government & private),

the programme has established a Task Force mechanism at the National, Zonal and Statelevels.

Public Private Mix

The Government is committed to provide quality assured diagnostic and treatment facilitiesfree of cost to all TB patients in the country, irrespective of the health care sector fromwhere they receive care or are referred from. RNTCP lays great emphasis on involving bothgovernment and non-governmental agencies, including private practitioners. An advocacykit containing material and documents for sensitizing these other sectors has beendeveloped to support this.

TB-HIV collaborative activities

The National Framework for Joint TB/HIV Collaborative Activities was first developed in2007, with revisions in February 2008 and October 2009. The National Frameworkextended basic TB-HIV activities nationwide. An intensified TB/HIV package of serviceswas developed to offer additional services in States with the higher burden of HIV-TB tobegin 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 patients5.2. 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 managementof 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-Plusservices for the management of MDR-TB patients in the states of Gujarat and Maharashtrain 2007. Specific guidelines have been formulated for the implementation of DOTS-Plusactivities in a phased manner across the country. RNTCP aims to establish a network ofaccredited, quality assured culture and drug susceptibility testing laboratories across thecountry by 2012-13.

Advocacy, Communication and Social Mobilization (ACSM)

The intensification of ACSM activities is an important component of RNTCP. An effectiveRNTCP ACSM strategy is in place in order to maintain high visibility of TB and RNTCPamongst the policy makers and other stakeholders, opinion leaders and community. ACSMactivities support the efforts for improving case detection and treatment adherence,combating stigma and discrimination, empowering people affected by TB, and for mobilizingpolitical 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 functionsThe 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 CentralTB Division (CTD) of the Directorate General of Health Services, the technical arm of theMinistry of Health and Family Welfare (MoH&FW). A national programme manager - DeputyDirector General-TB (DDG-TB), is in-charge of RNTCP nation-wide. The respective JointSecretary 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 levelinstitutes, namely the National TB Institute in Bangalore, the TB Research Centre inChennai, 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 TBDivision 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 technicaland secretarial staff. The five units are:

1. Supervision, monitoring and epidemiological surveillance unit2. Human resource development unit3. Procurement, supply and logistic unit4. Finance unit and5. Advocacy, communication and social mobilization unit.

An important area of co-ordination at the national level is with the respective office and staffdealing 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 guidancefor programme implementation. These are:

National Laboratory Committee

A central Laboratory Committee has been constituted with the representatives of the fourRNTCP National Reference Laboratories, CTD , WHO India and few other partners as itsmembers. This committee works as a task force to guide and oversee laboratory relatedactivities of the programme

National Technical Working Group for TB-HIVp

The National technical working group comprises of key officials from NACO and CTDdealing with TB/HIV Collaborative activities and experts from WHO. The purpose of theTWG, which meets at least quarterly, is to review, optimize and plan for future TB/HIVCoordination activities. The function of National TWG also includes supervision of TB/HIVcollaborative activities by officials of both programmes, including joint field visits.

National DOTS- Plus committee

National DOTS Plus Committee formulates policies and develops guidelines for allcategories of staff, including monitoring and evaluation mechanisms. Routinely review

implementation status of DOTS-Plus activities and provide recommendations to CTD forimprovement and/or change.

National Task Force for Medical Colleges

A National task Force has been formed for effective implementation of RNTCP in MedicalColleges. DDG (TB) is the Member Secretary of the NTF and the members are one eachfrom CTD, 7 nodal medical colleges, TRC, NTI, LRS and WHO. The main task of NTF willbe to provide leadership and advocacy, coordination, monitoring and policy development onissues related to effective involvement of medical colleges in RNTCP.

National Standing Committee on Operational ResearchThe 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. Thiscommittee provides technical guidance to CTD on the RNTCP OR, provides expertise toidentify OR priority areas for commissioned research. They also serve on panels of expertsfor 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 theguidelines of the State Health Society and CTD. The STO, based at the State TB Cell, isanswerable to their respective State Government, whilst implementing the technical policiesand guidelines issued by the CTD. The STO coordinates with the CTD and the respectivedistricts for execution of their duties mentioned above. It is required that there be a full-timetrained STO for RNTCP in each state.

The State TB Cells have been provided with equipment, infrastructure and RNTCPcontractual 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 EntryOperator The functions of the State TB Cell and the responsibilities of their staff are listed inthe RNTCP Technical and Operational Guidelines

In most of the larger states, a State TB Training and Demonstration Centre (STDC)supports the State TB Cell. The STDC has 3 units: a training unit, supervision andmonitoring unit and an Intermediate Reference Laboratory (IRL). The functions of the STDCare listed in the RNTCP Technical and Operational Guidelines.

It is essential to have a State Drug Store(SDS) for the effective management of anti-TBdrug logistics. For the long-term sustainability of the programme, decentralization to thestates of many aspects of drug management has been undertaken. One SDS per 50 millionpopulation is established in all larger states.

District Level

The district is the key level for the management of the primary health care services. Thedistrict level (or municipal corporation level) performs functions similar to those of the statelevel in its respective area. The Chief District Health Officer (CDHO) / Chief District MedicalOfficer (CDMO) or an equivalent functionary in the district, is responsible for all medical andpublic health activities, including TB control. The District Tuberculosis Centre (DTC) is thenodal point for all TB control activities in the district. In RNTCP, the primary role of the DTChas shifted from clinical to managerial functions. The District TB Officer (DTO) at the DTChas the overall responsibility of management of RNTCP at the district level as per theprogramme guidelines and the guidance of the District Health Society. The DTO is alsoresponsible 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 theCDMO/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 changein 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 RNTCPwork in addition to other responsibilities. There are also two full-time RNTCP contractualsupervisory staff exclusively for tuberculosis work - a Senior TB Treatment Supervisor(STS) and a Senior TB Laboratory Supervisor (STLS). The TU is generally based in aCommunity Health Centre (CHC), DTC, Taluk Hospital (TH) or a Block Primary HealthCentre (BPHC). The team of STS and STLS at the TU level are under the administrativesupervision of the DTO and MO-TC. These TUs cover a population of approximately500,000 (250,000 in tribal, desert, remote and hilly regions).

The TU is responsible for the maintenance of the Tuberculosis Register and the timelysubmission of the RNTCP quarterly reports to the district level. The MO-TC at the TU hasthe 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 expectedto undertake supervisory visits in the TU for 7 days in a month. The functions of the TUteam are given in the RNTCP Technical and Operational Guidelines.

There is one RNTCP Designated Microscopy Centre (DMC) for every 100,000 populationunder a TU (50,000 in tribal, desert, remote and hilly regions). DMCs are also established inMedical Colleges, Corporate hospitals, ESI and Railway health facilities, NGOs, privatehospitals etc, depending upon the requirement.


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Peripheral Health Institutions (PHIs)

For the purpose of RNTCP, a PHI is a health facility which is manned by at least a medicalofficer. At this level, there are dispensaries, PHCs, CHCs, referral hospitals, major

hospitals, specialty clinics or hospitals (including other health facilities), TB hospitals, andMedical colleges within the respective district. All health facilities in the private and NGOsectors participating in RNTCP are also considered as PHIs by the programme. Some ofthese PHIs also function as DMCs.

Peripheral health institutions undertake tuberculosis case-finding and treatment activities asa part of the general health services. In this regard, they are supervised by the TUcontractual paramedical staff (STS and STLS). In situations where more than one MO isposted in any of the peripheral health centres, one of them may be identified and entrustedwith the responsibilities of the RNTCP. The categories of staff involved in TB control at PHIlevel and their principal responsibilities are given in the RNTCP Technical and OperationalGuidelines.

Organizational structure of RNTCP

State TB Cell

Tuberculosis Unit

DTO, MO-DTC, DEO, supportstaff. District TB-HIV & DOTSPlus Su ervisor

Nodal centre for TBcontrolin the district

District TB Centre

STO, Deputy STO, MO,Epidemiologist, Secretarial Assistant,DEO, Accountant, IEC Officer,

Designated

Microscopy CentreOne per 1 lakhpopulation / 1 per 0.5lakh in tribal, hilly, desertand difficult areas

MO-TC, STS, STLSOne per 5 lakhpopulation / 1 per 2.5lakh in tribal, hilly and

difficult areas

MO, LT

State TB Training andDemonstration centre /SDS / IRL

Central TB Division,

DGHS, Mo H& FW

National institutes(NTI, TRC, LRS,JALMA)

Peripheral Health

InstitutionsMO

Deputy Director General -TBChief Medical Officers

National Lab CommitteeNational TWG for TB-HIV

National DOTS Plus committeeNTF for medical colleges, National

OR committee


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Work exercises

1. District X has a population of 2 million, with 5 lakhs population residing in hilly tribalareas. What is the number of TUs and DMCs that the district is expected to have in

place?

2. List five major responsibilities ofa. 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?


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POINTS TO REMEMBER

TB is the number one killerof adults among all infectious diseases, in India.

DOTS strategy is the globally accepted standard for diagnosis and treatment oftuberculosis

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 maintaindetection 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 managedTB control programme will save many livesand reduce the economicburden

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 andTB.

The rate of progression to disease is 10-30 times higher in HIV infected persons.

Impact of TB on HIVTB 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


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Table of Contents

Module 2

Laboratory Diagnosis of TB and Quality Assurance

Introduction ....................................................................................................... 17Symptoms of tuberculosis ................................................................................. 18Pulmonary TB suspects .................................................................................... 18Process of diagnosis of Pulmonary TB .............................................................. 22Diagnostic Algorithm of Pulmonary TB .............................................................. 23Diagnosis of TB among children ....................................................................... 25Diagnostic Algorithm for pediatric Pulmonary Tuberculosis .............................. 26Extra Pulmonary TB .......................................................................................... 27

Diagnosis of Pleural TB ..................................................................................... 29TB in HIV positive patients ................................................................................ 29Collection of sputum from tuberculosis suspects .............................................. 30Transport of sputum specimens ........................................................................ 35Exercise workbook E1 ....................................................................................... 37Ziehl-Neelsen staining procedure ...................................................................... 39Importance of grading of smears ....................................................................... 40Accuracy of the Tuberculosis Laboratory Register ............................................ 43Recording of results of sputum smear examinations ......................................... 44Limiting administrative errors ............................................................................ 44Documentation for referral for treatment ........................................................... 44Monthly Summary ............................................................................................. 45Exercise workbook E1 ....................................................................................... 46Exercise workbook E2 ....................................................................................... 49Exercise workbook E3 ....................................................................................... 52Section 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


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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 oftuberculosis and forms the major source of infection in the community. Every such case ofuntreated case has the potential to spread infection to 10 15 persons annually. From thepublic health point of view, it is of utmost importance to detect and treat such cases as earlyas possible to cut the chain of transmission of disease in the community. Diagnosticservices for other forms of tuberculosis such as smear negative pulmonary TB, extrapulmonary 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 andrapid method of diagnosing PTB, where in the bacilli are demonstrated in the sputumspecimen of a patient suffering from PTB. Chest X-ray is a supportive tool for the diagnosisof 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 orwithout 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


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Such patients should be selected and subjected for sputum examination. This enhances thechances of detection of the bacilli in the smear microscopy.

Extra pulmonary tuberculosisA person with extra-pulmonary TB may have symptoms related to the organs affected alongwith 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 spinalTB)

Signs of raised intra-cranial tension like irritability, headache, vomiting, fever, stiffness ofthe neck and mental confusion in TB meningitis

Painless haematuria or sterile pyuria in renal tuberculosis and infertility in genito-urinaryTB.

Pulmonary TB suspects

Pulmonary smear-positive tuberculosis patients expel tubercle bacilli into the air whilecoughing/sneezing. Contacts of undiagnosed/untreated pulmonary smear-positive patientsbecome 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 weeksor more, with or without othersymptoms, are referred to as pulmonary TB suspect. They should have

2 sputum samplesexamined for AFB.

Importance of properly identifying TB suspectsMost patients with TB attend health facilities promptly for seeking relief of symptoms. It isimportant to suspect tuberculosis among these chest symptomatics and subject them forsputum examination. If TB is not suspected, patients with smear-positive pulmonaryTB will not be identified.These patients will continue to spread the infection and it is likelythat more than half of them die by three years. Hence, every pulmonary TB suspect shouldbe referred for sputum examination in time.

Therefore, all health workers and community volunteers should be encouraged toidentify and refer TB suspects to DMCs for early diagnosis and treatment to prevent

further spread of the infection


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Screening of pulmonary TB suspects

Patients attending health institutions - government/private need to be systematicallyscreened 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 promptlyidentified as pulmonary TB suspects. They are to be referred to the designated microscopycentre (DMC) for sputum examination using the RNTCP laboratory form for sputumexamination.

Expected number of referrals for sputum examination

In a peripheral health institution (PHI) of rural setting, it is expected that atleast 2%of newadult out patients are chest symptomatics (pulmonary TB suspects). However this will varywidely in different settings eg., chest clinics, Medical Colleges and TB hospitals. A goodnumber 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 isexpected that on an average 5-15% of the chest symptomatics subjected for sputumexamination are found to be sputum smear positive following standard operatingprocedures of ZN staining. This percentage varies depending on the clinical/epidemiologicalsettings.

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 tomaximize case detection under the program.

In a PHIof rural settingatleast 2%of new adult out-patients are estimated to be TBsuspects. 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) aresubjected for two sputum examinations. PTB suspects attending peripheral healthinstitutions 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 ofatleast 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 apopulation 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 thanHealth Ministry) which fulfills the criteria.

The DMCs should satisfy the following criteria:

1. A Qualified and RNTCP trained Laboratory technician should be present2. A functional Binocular Microscope should be present in the laboratory

3. Physical infrastructure in Laboratory should meet RNTCP guidelines


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4. Daily new adult OPD of at least 60-100 and / or workload of at least 3-5 sputumsmears 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 facilityappropriately and sent along with the patient for sputumexamination.

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 fordiagnosing smear positive pulmonary TB. Ziehl-Neelsen staining technique is used inRNTCP. 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 intrareader variation. However, it should be used judiciously. It should always be preceded by arepeat sputum smear examination following treatment with antibiotics (refer to diagnosticalgorithm). It is also useful for diagnosing extra pulmonary TB like pleural effusion,pericardial effusion, mediastinal adenopathy and miliary TB. The following are thelimitations of the chest x-ray as a diagnostic tool

High inter and intra-reader variation

No shadow is characteristic of TB

1015% culture-positive cases remain undiagnosed (under reading)


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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 thegold standard for evaluating other tools of diagnosis. It is mainly used for the diagnosis ofdrug resistant TB as it is expensive (liquid culture systems) and time consuming (solidculture). Drug susceptibility testing using the proportion susceptibility method is theaccepted gold standard.

Diagnostic tools for MDR-TB / XDR TB:

Drug resistant TB (MDR/XDR and other types) is a laboratory based diagnosis eitherphenotypically i.e., growing the bacteria (culture) and demonstrating the ability of bacteria togrow in the presence of the anti-TB drugs (drug sensitivity testing - DST) or genotypically bydemonstrating 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 7H11/10medium

Liquid culture medium Commercial automated MGIT 960.

Newer rapid diagnostic tools include:

Non-commercial solid culture methods Nitrate Reductase Assay using the property ofM.Tb to reduce nitrate to nitrite as means of detection of drug resistance.

Non-commercial liquid culture methods include Microscopic observation of drugsusceptibility assay (MODS) using 7H9 medium in microtitre wells and observing growthusing 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 mycobacteriaas 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 fordetecting the presence of putative resistance genes (rpofor rifampicin, katG and inhA forINH etc). The most widely evaluated and used assays are Line Probe Assays (LPA) whichare based on in-situ hybridization on nitrocellulose strips of specific genetic targets forresistance genes. These are now available for RIF and INH resistance (MDR-TB) and willbe shortly available for XDR-TB (resistance to aminoglycosides, polypeptides,fluoroquinolones and ethambutol)

Newer tools under evaluation include, Cepheid GeneXpert a completely closedautomated system using real-time PCR which has a sensitivity of 70-90% even for smearnegative cases and can also detect the presence of rifampicin resistance


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Process of diagnosis of Pulmonary TB

Medical Officers of health care facilities (governmental or non governmental) should identifyall pulmonary TB suspects from patients attending health facilities and refer them for

sputum examination using the RNTCP laboratory request form for sputum examination. InMedical Colleges and other hospitals, indoor-patients suspected of TB should also bereferred by the treating physician using the same RNTCP laboratory forms for sputumexamination.

In the laboratory the patients are given sputum containers with instructions to providequality sputum specimen which are then subjected for smear microscopy examination. Ifthe health facility is transporting the sputum specimen, it should reach the DMC and sputumexamination 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 ofcost at all health facilities under RNTCP

The MO / health worker / laboratory technician (LT) should instruct the patient about propersputum 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 patients laboratory serialnumber 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 orwithin 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 andnot 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 specimenssubjected 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 otherapproved molecular methods) or Chest X-ray is classified as having smear negativepulmonary tuberculosis


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Diagnostic Algorithm of Pulmonary TB

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

COUGH OF 2 WEEKS OR MORE

2 Sputum smears

1 or 2 positives 2 Negatives

Antibiotics 10-14 days

Cough persists

Repeat 2 sputumExaminations

1 or 2 positives Negative

X-ray

Smear positive TB(Initiate treatment

regimen for TB)

Non-TBSuggestive of TB

Smear negative TB(Initiate treatment

regimen for TB)


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Patients with two or atleast one out of two sputum positive smear results are diagnosed bythe physician as having smear-positive pulmonary TB. They are further classified as a newor re-treatment case based on their previous treatment history and appropriate regimen isprescribed.

Patients who are negative for AFB in both the samples, will be prescribed a course ofantibiotics 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 arelikely to improve with antibiotics if they are not suffering from TB. If the symptoms persistafter 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 andprescribed 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 assmear negative pulmonary TB and treated accordingly. If chest x-ray is not suggestive ofTB, 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 betaken to avoid delay in diagnosis of smear negative TB.

Patients whose sputum smears are negative, but with positive test results by culture ormolecular methods from accredited laboratories are also included under the definition ofsmear negative TB.

If good diagnostic practices are followed as indicated above, it is expected that among thenew 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


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Diagnosis of TB among childrenThe extent of TB in children is a reflection of the pool of infectious adult smear-positivepulmonary tuberculosis cases in the community and their ability to transmit infection.

DiagnosisEarly and prompt diagnosis of TB in children is often difficult. A battery of tests is requiredto arrive at accurate diagnosis of TB in children. Generally, diagnosis should be made by aMedical Officer and the existing RNTCP case definitions are to be used for all casesdiagnosed.

High index of suspicion of TB in a child is the first step in the diagnosis. Tuberculosisshould be suspected among children presenting symptoms of prolonged / unexplainedfever and / or cough for more than 2 weeks, with no weight gain or history of failure tothrive. It is to be remembered that cough may not be the predominant and constantsymptom 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 yearsreinforces the suspicion of tuberculosis. Special efforts should be made to elicit the historyof contact with tuberculosis.

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

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

Sputum examination,if found feasible, is a very helpful tool in the diagnosis. It is pertinentto remember that pulmonary TB among children is most often abacillary and there arepractical difficulties in obtaining good quality sputum. Wherever facilities are available, thegastric lavage may be resorted to for isolation of AFB.

Tuberculin skin test using standard tuberculin is one of the reliable and relevant tool in thediagnosis of TB among children. While administering Tuberculin skin test it is to be ensuredthat 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 andabove read after 48-72 hours of properly administered tuberculin indicates that the child isinfected.

Chest X-ray, also aids in the diagnosis of TB among children Features in chest X-rayinclude hilar adenopathy infiltrations, pleural effusion etc.,

See flow chart given belowfor the diagnosis of pediatric TB.


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Diagnostic algorithm for pediatric pulmonary Tuberculosis

X-ray +

Mantoux

Sputum Positive

TB (Anti TBTreatment)

If yes, examine 2 sputum smears

Is expectoration present?

If no, refer toPediatrician

Pulmonary TB Suspect

Fever and / or cough 2 weeks

Loss of wt/No wt gain

History of contact with suspectedOr diagnosed case of active TB

Negative

Antibiotics10-14 days

Cough Persists

1 or 2Positives

1 or 2 Positives 2 Negatives

Suggestive of TB

Repeat 2 SputumExaminations

Sputum-Positive TB(Anti-TB Treatment)

Negative for TB

Sputum-Negative TBAnti-TB Treatment


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Extra-pulmonary TB

Extra-pulmonary TB comprises 10% - 15% of the total TB cases. Tuberculosis of organsother 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 isclassified as extra-pulmonary. Tubercular lymphadenitis and pleural effusion are mostcommon among extra-pulmonary TB.

Diagnosis of Extra Pulmonary TB

Demonstration of AFB in a smear from extra pulmonary site is often difficult because of lowbacillary load. The clinical features pertaining to the system affected should be consideredin the diagnosis of extra pulmonary tuberculosis. However, the following are some of thespecial investigations which are helpful in diagnosing extra pulmonary tuberculosis. Thesemay 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 thephysicians 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 tothe 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 ageand more so among women. Though, lymph nodes in the neck are more frequentlyinvolved, it is not rare to find TB in mediastinal and abdominal lymph nodes. Axilla/groin areinfrequent sites for occurrence of tuberculosis.

TB lymphadenitis usually presents as slowly progressive, painless enlargement of thelymph nodes in the neck and it is rare to find involvement of more than one group of lymphnodes. Individual nodes are firm and discrete though matting of nodes may occur andprogress to abscess and sinus formation if left untreated. Tubercular abscess is also calledcold abscess.

The commonest form of extra-pulmonary TB is Tubercular Lymphadenitis

In addition, constitutional symptoms like fever, malaise, weight loss, anorexia, etc. may ormay not be present. Diagnosis based on clinical findings alone can lead to over-diagnosisin 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 areavailable. In addition, chest X-ray taken incidentally may reveal mediastinal wideningsuggestive of hilar adenitis.


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Intermittent 6-month SCC regimen has been proven to be very effective in the treatment ofTB 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 onethird of the cases. Repeat non-dependent aspiration should be undertaken in suchcases.These reactions do not indicate treatment failure and this represents host immuneresponse to the release of mycobacterial antigens caused by the rapid bactericidal activitydue to treatment. Therefore, extension or modification of treatment is not warranted as theyusually regress spontaneously. Residual lymphadenopathy, after treatment completion hasalso been reported in about one third of patients. Studies have shown that re-treatment isrequired only if residual lymph node biopsy is bacteriologically confirmed as positive byculture for Mycobacterium tuberculosis. As culture facilities are not available everywhere,FNAC may be resorted to. However the granulomatous changes may persist for a long timeeven after adequate treatment. Hence, the decision to start re-treatment can not be basedon histo-pathological evidence alone. The relapse rates after SCC are reported to be quitelow.

Diagnostic algorithm for TB lymphadenitis

Lymph node enlargement of > 2 cm in one or more sites, with orwithout periadenitis , evidence of TB elsewhere, abscess,

discharging sinus

If lymph node enlargement persists, suspect TB lymphadenitis

Pus from sinus / Fine Needle Aspiration Cytology (FNAC)Mantoux test for chi ldren < 14 years

Diagnosis confirmedif the pus / aspirate from FNAC shows:1. ZN smear posit ive for AFB in pus / aspirate2. Histopatholog ical changes suggestive of TB

Excision biopsy, if FNAC results are inconclusive Start treatment

Prescribe a course of antibiotics for two weeks


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Diagnosis of Pleural TB

Tubercular plueral effusion is considered as extra pulmonary tuberculosis. Patients maypresent 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 ofeffusion. Biochemical and cytological analysis of the aspirated pleural fluid will help inconfirming the diagnosis. Pleural fluid is generally an exudate with mainly lymphocytes andfew 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 negativepatients with active pulmonary TB generally manifest similar clinical features, namelycough, fever, night sweats, haemoptysis and weight loss. The presentation may sometimes

vary with the degree of immune suppression. In patients with mild immune suppression, theclinical picture often resembles usual adult post-primary pulmonary TB i.e., the sputumsmear is frequently positive for acid-fast bacilli (AFB), and the chest X-ray (CXR) typicallymay show unilateral or bilateral upper lobe infiltrates, cavitations, pulmonary fibroticchanges, and/or volume loss.

In severely immune suppressed patients, the overall risk of TB is even higher, but it is moredifficult to distinguish TB from other serious chest diseases. In persons with advanced HIVinfection, disseminated and extrapulmonary TB (EPTB) are more common than in early HIVinfection and may be as common as pulmonary TB. The most common forms of EPTB seenare lymphadenitis, pleural effusion, pericarditis, miliary disease and meningitis. In PTB, the

features of the disease are frequently atypical, resembling those of primary TB ashistorically seen in children. Smear-negative TB is as common as smear-positive TB. Thechest x-ray pattern in advanced HIV infection may show any pattern. Hilarlymphadenopathy 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 inthe upper lobes.

Stage of HIV InfectionFeatures of PTB

Early Late

Clinical Picture Often resembles post-primary TB

Often resembles primaryTB

Sputum Smear Result Often Positive Often Negative

Chest X-ray Appearance Often cavities Often inf ilt rates with nocavities

The advent of HIV has made the diagnosis of TB more difficult, and false diagnosis of TBprobably 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 allforms of TB notified and thus do not negate the huge increases observed in TB notificationsin HIV-endemic areas.


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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 whereHIV-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 thesymptoms of TB disease (at pre, post and follow-up counseling). All clients who havesymptoms or signs of TB disease, irrespective of their HIV status, should be referred to thenearest facility providing RNTCP diagnostic and treatment services. The detail guidelinesfor operationalization of Intensified TB case finding at ICTCs is given in the Chapter VI.

Collection of sputum from tuberculosis suspectsTB 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 thepossible 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 anyunavoidable reason, his/her sputum sample should be collected on the same day andsputum microscopy may be done on the following day.

Guidelines for collecting sputum

The patients are given the sputum container with laboratory serial numberwritten on its side. The person collecting the sputum demonstrates how toopen and close the container, takes the patient to an open space away fromother people and demonstrates how to bring out sputum from the depth ofchest. The patient is instructed to inhale deeply 23 times with mouth open,cough out deeply from the chest, open the container and spit out the sputuminto it, and close the container. This is the spot specimenlabeled as a.

Further, patient is given a labeled container with instructions to cough out sputum intothe container early in the morning after rinsing the mouth with water. This is the earlymorning specimen. This is labeled as specimen b.

If the health facility is not a DMC, then the patient is given a sputum container withinstructions 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 totravel to the DMC, then the spot specimen could be collected at the nearest healthfacility or sputum collection centre and transported to the DMC.


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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 mustperform 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 thepatient the reasons for sputum collection. The laboratory form for sputum examinationshould be filled up completely, generally by the MO. This form is sent to the DMC alongwith the sputum specimens. Only one form needs to be filled for two sputum specimenscollected from a patient. The form accompanies the patients sputum specimens when theyare 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 generalinformation 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 ofpulmonary 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 transportingthe sputum specimens to DMCs. This also provides information on date of sputumcollection and specimen identification number and signature of the person collecting thespecimens.

The results section, located on the lower half / reverse of the laboratory form, is completedby the DMC after the sputum examinations. Sputum examination results of both the sputumsamples 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 beingreferred 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, iswritten in the space provided.

Name of patient

The patients full name (also nickname, if any) is written in the space provided.


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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 veryimportant to write the complete address of the patients, so that they can be easily tracedwhen they do not return to the laboratory or the outpatient department of the hospital fortheir results. The contact telephone number (landline or mobile) has to be obtained andrecorded in the form.

Only ONE Laboratory Form for Sputum Examination is filled out for two sputumspecimens collected from an individual patient

Type of suspect / disease

Pulmonary box is ticked if patient is having cough and the specimen is sputum.

Extra-pulmonary (EP) box is ticked if sputum specimen is collected from a EP TBsuspect/patient with cough of any duration.

Reason for examination

The diagnosis box is ticked () if the sputum specimen is collected from a tuberculosissuspect. A patient who had both sputum samples negative for AFB and was given 10-14days of broad spectrum antibiotics but did not improve again will have to undergo repeat

sputum examination. Repeat Examination box is to be ticked ()in such cases. In follow-up cases, follow-up of anti-TB treatment box is ticked ()and TB number of the patient isalso recorded.

Follow up examinations: This is to be filled up by the MO / Health Care Worker whilereferring 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 forpreviously treated and MDR DOTS Plus treatment being administered to the patient may be

indicated by () in appropriate box provided.

Patients 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 iscompleted.


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Name and signature of the referring person/official

The name and signature of the referring person/official who referred the TB suspect orfollow-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 thespace provided.

Specimen Indentification Number

If specimens are being transported to a DMC from another health facility, aSpecimen Identification Number is given at the referring facility, because the

Laboratory Serial Number can only be assigned at the DMC. Sputumspecimens are assigned specific numbers to keep track of each patientssputum results. After the laboratory form for sputum examination is filled up,this number is written on the side of the patients sputum container (If asputum specimen is separated from its laboratory form for sputumexamination, a LT can find out whose specimen it is by using the SpecimenIdentification No. on the sputum container. The laboratory technician can thenlocate the form by using the date and the identification number.) Eachseparate specimen will generally have its own unique Specimen Identification

Number.

Name and signature of the specimen col lector

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 sputumsamples 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 isbeing 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

Sent on: 8/9/09DMC: PHI 237

Health Worker who collected specimen: Raju

For DMC use

Received on: 8/9/09

Examined on:________Result sent back on:

SpecimenIdentification No.

Name Age Sex Address Date of collection

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

Documents

RNTCP Training Course for Program Manager Module 1 to 4