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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 activities

DMC

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 Programme implementation

After Noon

Six

Fore Noon

Module 5 (complete)

 

After Noon

Open house session

 

Seven

Fore Noon

Field visit Treatment and programme performance activities

TB Unit

After Noon

Field visit for TB-HIV collaborative 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 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

Training Course for Program Manager Module 1 Introduction to Tuberculosis and Revised National Tuberculosis Control

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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Training Course for Program Manager lungs. Subsequently, the bacilli multiply and invade the hilar lymph

Training Course for Program Manager

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 1015%, 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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Training Course for Program Manager

Magnitude of TB - Global and Indian scenario*

Manager Magnitude of TB - Global and Indian scenario*   Incidence of Prevalence of   HIV
 

Incidence of

Prevalence of

 

HIV prevalence among incident cases

disease

disease

Mortality

 

9.4 million

11.1

million

1.32 million

 

Global

(139/lakh/year)

(165/lakh/year)

(19.6/lakh/year)

15%

 

1.98 million

2.18

million

2.76 lakhs

 

India

(168/lakh/year)

(185/lakh/year)

(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 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, 310% 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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Training Course for Program Manager rapidly than with a single infection. Amongst the AIDS cases,

Training Course for Program Manager

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 (XDRTB) 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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Training Course for Program Manager

Training Course for Program Manager Revised National Tuberculosis Control Programme Following an external review of the

Revised National Tuberculosis Control Programme

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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Training Course for Program Manager special efforts have been made to involve all medical colleges

Training Course for Program Manager

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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Training Course for Program Manager

8. Operational

research

collaborative activities.

to

improve

the

implementation

and

impact

activities. to improve the implementation and impact of TB/HIV RNTCP and DOTS-Plus services for MDR-TB RNTCP

of

TB/HIV

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

8

Training Course for Program Manager the JALMA Institute of Leprosy and other Mycobacterial Diseases, Agra.

Training Course for Program Manager

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

9

Training Course for Program Manager in the field of medicine and research, Central TB Division

Training Course for Program Manager

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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Training Course for Program Manager

Training Course for Program Manager Sub-District Level (Tuberculosis Unit Level) The creation of a sub-district level

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.

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Training Course for Program Manager

Training Course for Program Manager Peripheral Health Institutions (PHIs) For the purpose of RNTCP, a PHI

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, DGHS, Mo H& FW Deputy Director General -TB Chief Medical Officers National
Central TB Division,
DGHS, Mo H& FW
Deputy Director General -TB
Chief Medical Officers
National Lab Committee
National TWG for TB-HIV
National DOTS Plus committee
NTF for medical colleges, National
OR committee
State TB Cell
STO, Deputy STO, MO,
Epidemiologist, Secretarial Assistant,
DEO, Accountant, IEC Officer,
Secretarial Assistant, DEO, Accountant, IEC Officer, District TB Centre DTO, MO-DTC, DEO, support staff.
District TB Centre

District TB Centre

District TB Centre DTO, MO-DTC, DEO, support staff. District TB-HIV & DOTS Plus Supervisor
District TB Centre DTO, MO-DTC, DEO, support staff. District TB-HIV & DOTS Plus Supervisor
District TB Centre DTO, MO-DTC, DEO, support staff. District TB-HIV & DOTS Plus Supervisor
District TB Centre DTO, MO-DTC, DEO, support staff. District TB-HIV & DOTS Plus Supervisor
District TB Centre DTO, MO-DTC, DEO, support staff. District TB-HIV & DOTS Plus Supervisor
District TB Centre DTO, MO-DTC, DEO, support staff. District TB-HIV & DOTS Plus Supervisor
District TB Centre DTO, MO-DTC, DEO, support staff. District TB-HIV & DOTS Plus Supervisor
District TB Centre DTO, MO-DTC, DEO, support staff. District TB-HIV & DOTS Plus Supervisor
District TB Centre DTO, MO-DTC, DEO, support staff. District TB-HIV & DOTS Plus Supervisor
District TB Centre DTO, MO-DTC, DEO, support staff. District TB-HIV & DOTS Plus Supervisor
District TB Centre DTO, MO-DTC, DEO, support staff. District TB-HIV & DOTS Plus Supervisor
District TB Centre DTO, MO-DTC, DEO, support staff. District TB-HIV & DOTS Plus Supervisor

DTO, MO-DTC, DEO, support staff. District TB-HIV & DOTS Plus Supervisor

DTO, MO-DTC, DEO, support staff. District TB-HIV & DOTS Plus Supervisor
DTO, MO-DTC, DEO, support staff. District TB-HIV & DOTS Plus Supervisor
DTO, MO-DTC, DEO, support staff. District TB-HIV & DOTS Plus Supervisor
District TB Centre DTO, MO-DTC, DEO, support staff. District TB-HIV & DOTS Plus Supervisor
support staff. District TB-HIV & DOTS Plus Supervisor Tuberculosis Unit MO-TC, STS, STLS MO, LT National
Tuberculosis Unit

Tuberculosis Unit

Tuberculosis Unit MO-TC, STS, STLS
Tuberculosis Unit MO-TC, STS, STLS
Tuberculosis Unit MO-TC, STS, STLS
Tuberculosis Unit MO-TC, STS, STLS
Tuberculosis Unit MO-TC, STS, STLS
Tuberculosis Unit MO-TC, STS, STLS
Tuberculosis Unit MO-TC, STS, STLS

MO-TC, STS, STLS

Tuberculosis Unit MO-TC, STS, STLS
Tuberculosis Unit MO-TC, STS, STLS
DOTS Plus Supervisor Tuberculosis Unit MO-TC, STS, STLS MO, LT National institutes (NTI, TRC, LRS,

MO, LT

National institutes

(NTI,

TRC,

LRS,

JALMA)

State TB Training and Demonstration centre / SDS / IRL

Nodal centre for TB control in the district

Nodal centre for TB control in the district

One per 5 lakh population / 1 per 2.5 lakh in tribal, hilly and difficult areas

One per 5 lakh population / 1 per 2.5 lakh in tribal, hilly and difficult areas
One per 5 lakh population / 1 per 2.5 lakh in tribal, hilly and difficult areas
One per 5 lakh population / 1 per 2.5 lakh in tribal, hilly and difficult areas
One per 5 lakh population / 1 per 2.5 lakh in tribal, hilly and difficult areas
One per 1 lakh population / 1 per 0.5 lakh in tribal, hilly, desert and

One per 1 lakh population / 1 per 0.5 lakh in tribal, hilly, desert and difficult areas

One per 1 lakh population / 1 per 0.5 lakh in tribal, hilly, desert and difficult
One per 1 lakh population / 1 per 0.5 lakh in tribal, hilly, desert and difficult

Designated Microscopy Centre

lakh in tribal, hilly, desert and difficult areas Designated Microscopy Centre Peripheral Health Institutions MO 12

Peripheral Health Institutions

Peripheral Health Institutions
Peripheral Health Institutions MO
Peripheral Health Institutions MO
Peripheral Health Institutions MO
Peripheral Health Institutions MO

MO

Peripheral Health Institutions MO
Peripheral Health Institutions MO

12

Training Course for Program Manager

Work exercises

Training Course for Program Manager Work exercises 1. District X has a population of 2 million,

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

Training Course for Program Manager

Training Course for Program Manager POINTS TO REMEMBER • TB is the number one killer of

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

Exercise workbook E1

46

Exercise workbook E2

49

Exercise workbook E3

52

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

Training Course for Program Manager

Training Course for Program Manager Module - 2 LABORATORY DIAGNOSIS OF TB AND QUALITY ASSURANCE SECTION-

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

Training Course for Program Manager

Training Course for Program Manager Such patients should be selected and subjected for sputum examination. This

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

Training Course for Program Manager

Training Course for Program Manager Screening of pulmonary TB suspects Patients attending health institutions - governm

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

Training Course for Program Manager

Training Course for Program Manager 4. Daily new adult OPD of at least 60-100 and /

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

Training Course for Program Manager

Training Course for Program Manager • 40% patients diagnosed as having TB by x-ray alone may

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) medium

Liquid culture medium – Commercial automated MGIT 960.

or agar based 7H11/10

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

Training Course for Program Manager

Training Course for Program Manager Process of diagnosis of Pulmonary TB Medical Officers of health care

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

Training Course for Program Manager

Training Course for Program Manager Diagnostic Algorithm of Pulmonary TB COUGH OF 2 WEEKS OR MORE

Diagnostic Algorithm of Pulmonary TB

COUGH OF 2 WEEKS OR MORE

Algorithm of Pulmonary TB COUGH OF 2 WEEKS OR MORE 2 Sputum smears 2 Negatives Antibiotics

2 Sputum smears

of Pulmonary TB COUGH OF 2 WEEKS OR MORE 2 Sputum smears 2 Negatives Antibiotics 10-14
of Pulmonary TB COUGH OF 2 WEEKS OR MORE 2 Sputum smears 2 Negatives Antibiotics 10-14
2 Negatives
2 Negatives

Antibiotics 10-14 days

OR MORE 2 Sputum smears 2 Negatives Antibiotics 10-14 days Cough persists Repeat 2 sputum Examinations

Cough persists

smears 2 Negatives Antibiotics 10-14 days Cough persists Repeat 2 sputum Examinations 1 or 2 positives

Repeat 2 sputum Examinations

10-14 days Cough persists Repeat 2 sputum Examinations 1 or 2 positives Smear positive TB (Initiate
10-14 days Cough persists Repeat 2 sputum Examinations 1 or 2 positives Smear positive TB (Initiate

1 or 2 positives

Smear positive TB (Initiate treatment regimen for TB)

Negative
Negative
1 or 2 positives
1 or 2 positives

1 or 2 positives

1 or 2 positives
X-ray
X-ray

X-ray

X-ray
X-ray
X-ray
X-ray
X-ray
treatment regimen for TB) Negative 1 or 2 positives X-ray Suggestive of TB Smear negative TB
treatment regimen for TB) Negative 1 or 2 positives X-ray Suggestive of TB Smear negative TB

Suggestive of TB

for TB) Negative 1 or 2 positives X-ray Suggestive of TB Smear negative TB (Initiate treatment

Smear negative TB (Initiate treatment regimen for TB)

Non-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

Training Course for Program Manager

Training Course for Program Manager Patients with two or atleast one out of two s putum

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

Training Course for Program Manager

Training Course for Program Manager Diagnosis of TB among children The extent of TB in children

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

Training Course for Program Manager

Training Course for Program Manager Diagnostic algorithm for pedi atric pulmonary Tuberculosis Pulmonary TB Suspect •

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

TB Is expectoration present? If no, refer to Pediatrician If yes, examine 2 sputum smears 1
If yes, examine 2 sputum smears
If yes, examine 2 sputum smears
If yes, examine 2 sputum smears

If yes, examine 2 sputum smears

If yes, examine 2 sputum smears
If yes, examine 2 sputum smears
If yes, examine 2 sputum smears
If yes, examine 2 sputum smears
no, refer to Pediatrician If yes, examine 2 sputum smears 1 or 2 Positives Sputum-Positive TB
no, refer to Pediatrician If yes, examine 2 sputum smears 1 or 2 Positives Sputum-Positive TB

1 or 2 Positives

Sputum-Positive TB (Anti-TB Treatment)

2 Negatives

Sputum-Positive TB (Anti-TB Treatment) 2 Negatives Antibiotics 10-14 days Cough Persists Repeat 2 Sputum

Antibiotics

10-14 days

TB (Anti-TB Treatment) 2 Negatives Antibiotics 10-14 days Cough Persists Repeat 2 Sputum Examinations Negative X-ray

Cough Persists

2 Negatives Antibiotics 10-14 days Cough Persists Repeat 2 Sputum Examinations Negative X-ray + Mantoux 1
Repeat 2 Sputum Examinations

Repeat 2 Sputum Examinations

Repeat 2 Sputum Examinations
Repeat 2 Sputum Examinations
Repeat 2 Sputum Examinations
Repeat 2 Sputum Examinations
Repeat 2 Sputum Examinations
Repeat 2 Sputum Examinations
Repeat 2 Sputum Examinations
Negative X-ray + Mantoux
Negative
X-ray +
Mantoux
Repeat 2 Sputum Examinations Negative X-ray + Mantoux 1 or 2 Positives Sputum Positive TB (Anti
Repeat 2 Sputum Examinations Negative X-ray + Mantoux 1 or 2 Positives Sputum Positive TB (Anti
Repeat 2 Sputum Examinations Negative X-ray + Mantoux 1 or 2 Positives Sputum Positive TB (Anti

1 or 2 Positives

Sputum Positive TB (Anti TB Treatment)

1 or 2 Positives Sputum Positive TB (Anti TB Treatment) Suggestive of TB Sputum-Negative TB (Anti-TB
1 or 2 Positives Sputum Positive TB (Anti TB Treatment) Suggestive of TB Sputum-Negative TB (Anti-TB

Suggestive of TB

Sputum Positive TB (Anti TB Treatment) Suggestive of TB Sputum-Negative TB (Anti-TB Treatment) Negative for TB

Sputum-Negative TB (Anti-TB Treatment)

Negative for TB

Sputum Positive TB (Anti TB Treatment) Suggestive of TB Sputum-Negative TB (Anti-TB Treatment) Negative for TB
Sputum Positive TB (Anti TB Treatment) Suggestive of TB Sputum-Negative TB (Anti-TB Treatment) Negative for TB

26

Training Course for Program Manager

Training Course for Program Manager Extra-pulmonary T B Extra-pulmonary TB comprises 10% - 15% of t

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.

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Training Course for Program Manager

Training Course for Program Manager Intermittent 6-month SCC regime n has been proven to be very

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

If lymph node enlargement persists, suspect TB lymphadenitis Pus from sinus / Fine Needle Aspiration Cytology

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

/ aspirate 2. Histopathological changes suggestive of TB Excision biopsy, if FNAC results are inconclusive Start

Excision biopsy, if FNAC results are inconclusive

Start treatment

2. Histopathological changes suggestive of TB Excision biopsy, if FNAC results are inconclusive Start treatment 28

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Training Course for Program Manager

Training Course for Program Manager Diagnosis of Pleural TB Tubercular plueral effusion is considered as extra

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- primary TB

Often resembles primary 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.

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Training Course for Program Manager

Training Course for Program Manager Intensified TB case finding at ICTC s, ART and Communi ty

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.

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Training Course for Program Manager

Training Course for Program Manager • These two samples should be collected within a day or

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.

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Training Course for Program Manager

Training Course for Program Manager Age The age of the patient is written in the space

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 if patient is having cough and the specimen is sputum.

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

Reason for examination

The diagnosis box is ticked ( ) 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 ( ) in such cases. In follow- up cases, follow-up of anti-TB treatment box is ticked ( ) 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 ( ) 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.

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Training Course for Program Manager

Training Course for Program Manager Name and signature of the referring person/official The name and signature

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 Sent on: 8/9/09

 

DMC: PHI 237

For DMC use Received on: 8/9/09 Examined on:

 

Health Worker who collected specimen: Raju

 

Result sent back on:

Specimen Identification 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 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

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Training Course for Program Manager

Training Course for Program Manager Results The lower portion of the form deals with the information

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.

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Training Course for Program Manager

Training Course for Program Manager 3. Tasks performed after sputum collection The person collecting the sputum

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.

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Training Course for Program Manager

Training Course for Program Manager REVISED NATIONAL TUBERCUL OSIS CONTROL PROGRAMME Laboratory Form for Sputum

REVISED NATIONAL TUBERCULOSIS CONTROL PROGRAMME

Laboratory Form for Sputum Examination

Name of Referring Health Facility:

Name of patient:

Complete address:

Contact Phone number / Mobile No.:

Type of suspect / disease:

Pulmonary Extra-pulmonary

Age:

Date:

Site:

Sex: M F

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 appropriate box):

New cases

previously treated

MDR-TB

Patient’s TB

(Name and signature of referring person/ official)

If sputum samples are being transported:

Specimen identification No.:

Specimen Collector’s name and signature

Date of sputum collection:

RESULTS (To be completed in the laboratory of DMC)

Name of DMC:

Lab. Serial No.:

   

Visual appearance (M, B, S)*

Results

 

Positive (grading)

Date of examination

Specimen

(Neg or

 

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

Date:

Signature of Lab. Technician

The completed form (with results) should be sent to the referring PHI within a day of the examination.

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Training Course for Program Manager

Training Course for Program Manager MANAGEMENT OF PATIENTS AFTER RECEIVING THE SPUTUM RESULTS When the referring

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.

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Training Course for Program Manager

Training Course for Program Manager 5. Sita Devi (Patient G) of 2586 Gali No. 3, Gobind

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 28 th 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

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Training Course for Program Manager

Training Course for Program Manager Ziehl–Neelsen staining procedure: 1. A new unscratched slide is selected and

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.

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Training Course for Program Manager

Importance of Grading of smears

Course for Program Manager Importance of Grading of smears • Grading of smears is a tool

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 be examined

Grading

Result

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 field

20

3+

Pos

*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

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Training Course for Program Manager

Training Course for Program Manager Consequences • Patients suffering TB may be missed and he may

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

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Training Course for Program Manager • Phone number (land line and Mobile) • Name of the

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 colum