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MODULE 1 to 4

Module 1 : Introduction to Tuberculosis and Revised National Tuberculosis Control Program (RNTCP) Module 2 : Laboratory Diagnosis of TB and Quality Assurance Module 3 : Treatment Services Module 4 : Registering Cases and Monitoring Treatment

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Course Introduction
About the Training Course
Tuberculosis (TB) remains a major public health problem in India. This course 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 coinfection, 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 One Session Fore Noon Pretest Module 1 Topic and activities Introduction to Tuberculosis and the Revised National Tuberculosis Control Programme Diagnosis of TB

After Noon

Module 2 Module 2 Presentation on Quality Assurance on lab services


Two Three

Fore Noon After Noon Fore Noon After Noon Fore Noon After Noon Fore Noon After Noon Fore Noon After Noon Fore Noon After Noon

Module 2 Module 3 Field visit - Microscopy activities

Quality assured Lab services Treatment strategy and service DMC

Four Five Six Seven

Module 3 Module 3 (complete) Module 4 Module 5 Module 5 (complete) Open house session Field visit Treatment and programme performance activities Field visit for TB-HIV collaborative activities Module 6 Module 6 (complete) Module 7 Module 7 (complete) Module 8 and Module 9 Open house session / field visit Presentation Post test Discussion on post test Any other topic Concluding session

Registering cases and monitoring of treatment Monitoring of the programme Programme implementation TB Unit DMC, ICTC and ART centers Programme implementation Logistics management including preventive maintenance Supervision and evaluation

Eight Nine Ten Eleven Twelve

Fore Noon After Noon Fore Noon After Noon Fore Noon After Noon Fore Noon After Noon Fore Noon After Noon

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........................................................................................... Introduction ....................................................................................................... Pathogenesis of TB ........................................................................................... Post Primary TB ................................................................................................ Extent of TB problem in India ............................................................................ Annual Risk of Tuberculosis Infection (ARTI) .................................................... HIV co-infection among TB patients .................................................................. Multidrug-resistant tuberculosis (MDR-TB) ....................................................... Pediatric TB....................................................................................................... Socio-economic impact of TB............................................................................ Goal and Objectives of RNTCP ......................................................................... Directly Observed Treatment Short Course (DOTS) Strategy ........................... Stop TB Strategy ............................................................................................... Involvement of Medical Colleges ....................................................................... Public Private Mix .............................................................................................. TB-HIV Collaborative activities .......................................................................... RNTCP and DOTS-Plus services for MDR-TB.................................................. Advocacy, Communication and Social Mobilization (ACSM)............................. National Level ................................................................................................... State Level ........................................................................................................ District Level ...................................................................................................... Sub-District Level ............................................................................................. Peripheral Health Institution (PHIs) ................................................................... Work Sheet ....................................................................................................... 1 1 1 2 2 3 3 4 4 4 5 5 6 6 7 7 8 8 8 10 10 11 12 13

Training Course for Program Manager

Module 1 Introduction to Tuberculosis and Revised National Tuberculosis Control Programme

Learning Objectives
In this module participants will learn about: Pathogenesis of Tuberculosis (TB),

Extent of TB problem in the National and Global context, Evolution of the Revised National Tuberculosis Control Programme (RNTCP) and its objectives, the DOTS Strategy and the STOP TB Strategy. Organizational structure and functions of RNTCP.

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

Pathogenesis of TB
Source of infection and exposure Tuberculosis is an infectious disease caused predominantly by Mycobacterium tuberculosis. Patients suffering from smear positive pulmonary TB (PTB) constitutes the most important source of infection. The infection occurs most commonly through droplet nuclei generated by coughing, sneezing etc., inhaled via the respiratory route. The chances of getting infected depend upon the duration, the frequency of exposure and the immune status of an individual. The programme gives priority in detecting and treating smear positive PTB, thereby aiming to cut the chain of transmission of infection. However, it needs to be remembered that under RNTCP all types of TB cases are treated. Primary Infection Entry and establishment of bacilli in human body constitutes infection. It usually takes 6 - 8 weeks for the establishment and manifestation of infection. Infection is indicated by a positive reaction to a tuberculin skin test (Mantoux test). Primary infection is an infection occurring for the first time in susceptible individuals who are exposed to tubercle bacilli. Droplet nuclei that are inhaled into the lungs, are so small (< 5m) that they avoid the muco-ciliary defenses of the bronchi and lodge in the terminal bronchiole or alveoli of the 1

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 hosts 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.

Training Course for Program Manager Magnitude of TB - Global and Indian scenario* Incidence of disease Global India 9.4 million (139/lakh/year) 1.98 million (168/lakh/year) Prevalence of disease 11.1 million (165/lakh/year) 2.18 million (185/lakh/year) Mortality 1.32 million (19.6/lakh/year) 2.76 lakhs (23/lakh/year) HIV prevalence among incident cases 15% 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 3

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 retreatment 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 lifeyears 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 Indias 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. 4

Training Course for Program Manager

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 governments 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. 5

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. 7

Training Course for Program Manager 8. Operational research to improve the implementation and impact of TB/HIV collaborative activities.

RNTCP and DOTS-Plus services for MDR-TB


RNTCP reaffirms that the prevention of the MDR-TB is the priority task which can be achieved only through the implementation of a good quality DOTS programme. Available information suggests that prevalence of MDR-TB is relatively low in India. However, this translates into a large absolute number of cases, estimated at over 99,000 in 2008. The country is slowly gearing up to manage tens of thousands of MDR-TB patients annually by 2012-13. Specific measures are being taken by RNTCP for the diagnosis and management of MDR-TB cases, based on a framework organized around similar five components as those of the DOTS strategy. RNTCP reached a landmark achievement with the launching of RNTCP DOTS-Plus services for the management of MDR-TB patients in the states of Gujarat and Maharashtra in 2007. Specific guidelines have been formulated for the implementation of DOTS-Plus activities in a phased manner across the country. RNTCP aims to establish a network of accredited, quality assured culture and drug susceptibility testing laboratories across the country by 2012-13.

Advocacy, Communication and Social Mobilization (ACSM)


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

Organizational structure and functions


The structure of RNTCP comprises of five levels: National level, State level, District level, Sub-district level and Peripheral health institution level (refer to flow chart below).

National Level
At the central level, the Revised National TB Control Programme is managed by the Central TB Division (CTD) of the Directorate General of Health Services, the technical arm of the Ministry of Health and Family Welfare (MoH&FW). A national programme manager - Deputy Director General-TB (DDG-TB), is in-charge of RNTCP nation-wide. The respective Joint Secretary of Health from the administrative arm of the MoH&FW looks after the financial and administrative aspects of the programme. The CTD is assisted by 4 national level institutes, namely the National TB Institute in Bangalore, the TB Research Centre in Chennai, the Lala Ram Sarup Institute of TB and Respiratory Diseases in New Delhi and 8

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 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) supports 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 fulltime 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

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

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 National institutes (NTI, TRC, LRS, JALMA) State TB Training and Demonstration centre / SDS / IRL 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 1 lakh population / 1 per 0.5 lakh in tribal, hilly, desert and difficult areas State TB Cell 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 STO, Deputy STO, MO, Epidemiologist, Secretarial Assistant, DEO, Accountant, IEC Officer,

District TB Centre

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

Tuberculosis Unit

MO-TC, STS, STLS

Designated Microscopy Centre

MO, LT

Peripheral Health Institutions

MO

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Training Course for Program Manager

Work exercises
1. District X has a population of 2 million, with 5 lakhs population residing in hilly tribal areas. What is the number of TUs and DMCs that the district is expected to have in place? 2. List five major responsibilities of a. STO i.________________________________________________________ ii.________________________________________________________ iii._______________________________________________________ iv._______________________________________________________ v.________________________________________________________ b. DTO i.________________________________________________________ ii.________________________________________________________ iii._______________________________________________________ iv._______________________________________________________ v.________________________________________________________ c. MOTC i.________________________________________________________ ii.________________________________________________________ iii._______________________________________________________ iv.______________________________________________________ v.________________________________________________________ Q.3 Q.3 Q.4 Q.5 Q.6 Q.7 A. B. What is the impact of HIV on TB control programme? What is the impact of TB infection on HIV?

Mention important activities under TB-HIV coordination Define MDR-TB Enlist the components of WHO Stop TB Strategy What is prevalence of TB among children?

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Training Course for Program Manager

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. burden

A well managed TB control programme will save many lives and reduce the economic 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

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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

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

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Training Course for Program Manager 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

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Training Course for Program Manager

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 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 1015% culture-positive cases remain undiagnosed (under reading) 20

Training Course for Program Manager

40% patients diagnosed as having TB by x-ray alone may not have active TB disease (over reading). Sputum smear microscopy is the primary tool for diagnosing TB as it is more specific and has less inter and intra-reader variability than X-ray.

Diagnosis of Drug Resistant-TB Culture of mycobacterium tuberculosis bacilli is a very sensitive and specific tool. It is the gold standard for evaluating other tools of diagnosis. It is mainly used for the diagnosis of drug resistant TB as it is expensive (liquid culture systems) and time consuming (solid culture). Drug susceptibility testing using the proportion susceptibility method is the accepted gold standard. Diagnostic tools for MDR-TB / XDR TB: Drug resistant TB (MDR/XDR and other types) is a laboratory based diagnosis either phenotypically i.e., growing the bacteria (culture) and demonstrating the ability of bacteria to grow in the presence of the anti-TB drugs (drug sensitivity testing - DST) or genotypically by demonstrating the presence of resistance genes using molecular methods. The conventional and newer rapid tools used for diagnosis are: Solid culture medium - (Egg-based Lowenstein Jensen) or agar based 7H11/10 medium Liquid culture medium Commercial automated MGIT 960.

Newer rapid diagnostic tools include: Non-commercial solid culture methods Nitrate Reductase Assay using the property of M.Tb to reduce nitrate to nitrite as means of detection of drug resistance. Non-commercial liquid culture methods include Microscopic observation of drug susceptibility assay (MODS) using 7H9 medium in microtitre wells and observing growth using an inverted microscope for both culture and DST. Liquid culture system Mycobacteria growth indicator tube system (MGIT) available in automated (MGIT-960) and MGIT manual systems. This can detect growth of mycobacteria as early as 4 days from inoculation and DST will be available in 21-28 days. Molecular Assays PCR based technologies using various modifications are used for detecting the presence of putative resistance genes (rpo 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

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Training Course for Program Manager

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 smearpositive pulmonary tuberculosis, the diagnosis may be missed, and the patient may continue to spread the infection to others. The LT should label the sputum container properly by writing the patients laboratory 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 smearpositive 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

Diagnostic Algorithm of Pulmonary TB


COUGH OF 2 WEEKS OR MORE

2 Sputum smears

1 or 2 positives

2 Negatives

Antibiotics 10-14 days

Cough persists

Repeat 2 sputum Examinations

1 or 2 positives

Negative X-ray

Suggestive of TB

Non-TB

Smear positive TB (Initiate treatment regimen for TB)

Smear negative TB (Initiate treatment regimen for TB)

The diagnostic algorithm given above should be strictly followed. If not followed, patients may either be treated unnecessarily based upon X-ray results or left untreated. 23

Training Course for Program Manager 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 xray 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

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Training Course for Program Manager

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.

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Training Course for Program Manager

Diagnostic algorithm for pediatric pulmonary Tuberculosis


Pulmonary TB Suspect Fever and / or cough 2 weeks Loss of wt/No wt gain History of contact with suspected Or diagnosed case of active TB

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

1 or 2 Positives

2 Negatives
Antibiotics 10-14 days

Cough Persists

Repeat 2 Sputum Examinations

Negative

1 or 2 Positives Sputum Positive TB (Anti TB Treatment)

X-ray + Mantoux

Sputum-Positive TB (Anti-TB Treatment)

Negative for TB

Suggestive of TB

Sputum-Negative TB (Anti-TB Treatment)

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Training Course for Program Manager

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) (b) (c) (d) (e) (f) Fine Needle Aspiration Cytology (FNAC) and direct smear examination Excision / Biopsy of specimen for histopathological examination Fluid for cytology , biochemical analysis and smear examination X-ray of the involved region Ultra Sonography for Abdominal Tuberculosis Culture for Mycobacterium tuberculosis (M.Tb)

Precise diagnosis of some forms of extra pulmonary tuberculosis is a challenge to the physicians as they present symptom complex with extraordinary diversity. Delay in the diagnosis can be fatal or result in life threatening sequelae as in the case of meningeal TB. Patients with symptoms suggestive of extra pulmonary tuberculosis should be referred to the respective speciality for further investigations.

TB lymphadenitis
This form of TB is more common in children and adults who are less than 30 years of age and more so among women. Though, lymph nodes in the neck are more frequently involved, it is not rare to find TB in mediastinal and abdominal lymph nodes. Axilla/groin are infrequent sites for occurrence of tuberculosis. TB lymphadenitis usually presents as slowly progressive, painless enlargement of the lymph nodes in the neck and it is rare to find involvement of more than one group of lymph nodes. Individual nodes are firm and discrete though matting of nodes may occur and progress to abscess and sinus formation if left untreated. Tubercular abscess is also called cold abscess. The commonest form of extra-pulmonary TB is Tubercular Lymphadenitis In addition, constitutional symptoms like fever, malaise, weight loss, anorexia, etc. may or may not be present. Diagnosis based on clinical findings alone can lead to over-diagnosis in a high proportion of cases. Therefore, attempt should always be made to confirm by cytological or histopathological diagnosis by undertaking fine needle aspiration cytology (FNAC) or excision biopsy. This procedure can be undertaken wherever facilities are available. In addition, chest X-ray taken incidentally may reveal mediastinal widening suggestive of hilar adenitis. 27

Training Course for Program Manager Intermittent 6-month SCC regimen has been proven to be very effective in the treatment of TB lymphadenitis. During treatment, paradoxical reactions in the form of persistence or enlargement of existing nodes or appearance of new nodes or abscess formation may occur in about one third of the cases. Repeat non-dependent aspiration should be undertaken in such cases.These reactions do not indicate treatment failure and this represents host immune response to the release of mycobacterial antigens caused by the rapid bactericidal activity due to treatment. Therefore, extension or modification of treatment is not warranted as they usually regress spontaneously. Residual lymphadenopathy, after treatment completion has also been reported in about one third of patients. Studies have shown that re-treatment is required only if residual lymph node biopsy is bacteriologically confirmed as positive by culture for Mycobacterium tuberculosis. As culture facilities are not available everywhere, FNAC may be resorted to. However the granulomatous changes may persist for a long time even after adequate treatment. Hence, the decision to start re-treatment can not be based on histo-pathological evidence alone. The relapse rates after SCC are reported to be quite low. Diagnostic algorithm for TB lymphadenitis
Lymph node enlargement of > 2 cm in one or more sites, with or without periadenitis, evidence of TB elsewhere, abscess, discharging sinus

Prescribe a course of antibiotics for two weeks

If lymph node enlargement persists, suspect TB lymphadenitis

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

Diagnosis confirmed if the pus / aspirate from FNAC shows: 1. ZN smear positive for AFB in pus / aspirate 2. Histopathological changes suggestive of TB

Excision biopsy, if FNAC results are inconclusive

Start treatment

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Training Course for Program Manager

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 Early Clinical Picture Sputum Smear Result Chest X-ray Appearance Often resembles postprimary TB Often Positive Often cavities Stage of HIV Infection Late Often resembles primary TB Often Negative 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

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 23 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 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 patients 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 patients full name (also nickname, if any) is written in the space provided. 31

Training Course for Program Manager Age The age of the patient is written in the space provided. Sex The letter M is ticked if the patient is a male. The letter F is ticked if the patient is a female. Complete address Complete address of the patient with landmarks is written in the space provided. It is very important to write the complete address of the patients, so that they can be easily traced when they do not return to the laboratory or the outpatient department of the hospital for their results. The contact telephone number (landline or mobile) has to be obtained and recorded in the form. Only ONE Laboratory Form for Sputum Examination is filled out for two sputum specimens collected from an individual patient

Type of suspect / disease Pulmonary box is ticked 3 if patient is having cough and the specimen is sputum. Extra-pulmonary (EP) box is ticked 3 if sputum specimen is collected from a suspect/patient with cough of any duration. EP TB

Reason for examination


The diagnosis box is ticked (3) if the sputum specimen is collected from a tuberculosis suspect. A patient who had both sputum samples negative for AFB and was given 10-14 days of broad spectrum antibiotics but did not improve again will have to undergo repeat sputum examination. Repeat Examination box is to be ticked (3) in such cases. In followup cases, follow-up of anti-TB treatment box is ticked (3) and TB number of the patient is also recorded. Follow up examinations: This is to be filled up by the MO / Health Care Worker while referring the patient for follow up examination . For new, previously treated cases or MDRTB cases, the month of follow up examination may be indicated in the space provided. Treatment Regimens : Treatment regimen given viz., regimen for new cases, regimen for previously treated and MDR DOTS Plus treatment being administered to the patient may be indicated by (3) in appropriate box provided. Patients TB Number. This is to be filled up only for patients who are undergoing follow-up sputum examination. This is not available for patients undergoing the process of diagnosis. The TB number for the patients diagnosed will be available after the process of registration in the TB register is completed.

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Training Course for Program Manager

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 patients sputum results. After the laboratory form for sputum examination is filled up, this number is written on the side of the patients 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 Health Worker who collected specimen: Raju Specimen Identification No. C1, C2 D1, D2 E1, E2 F1, F2 Name Lakshmi Kumari Lakshmi Pati Rao Girija Devi Kailash Nath Age 46 50 32 35 Sex F M F M Address 223 Gandhi Dham 223 Gandhi Dham 225 Gandhi Dham 225 Gandhi Dham DMC: PHI 237 For DMC use Received on: 8/9/09 Examined on:________ Result sent back on: Date of collection of sputum 6/9/09,7/9/09 6/9/09,7/9/09 6/9/09,7/9/09 6/9/09,7/9/09

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Training Course for Program Manager

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 patients 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 followup 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 (23 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

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

REVISED NATIONAL TUBERCULOSIS CONTROL PROGRAMME


Laboratory Form for Sputum Examination Name of Referring Health Facility: __________________________ Date: ___________ Name of patient: _____________________________________ Age: ____ Sex: M F Complete address: _______________________________________________________ ________________________________________________________________________ Contact Phone number / Mobile No.: ________________________________________ Type of suspect / disease: Pulmonary Extra-pulmonary Site: ______________

Reason for examination: Diagnosis Repeat Examination for Diagnosis Follow-up examinations

For new and previously treated cases - Month of follow-up . For MDR-TB cases Month of follow-up

Treatment Regimens (tick 9 appropriate box): New cases previously treated MDR-TB Patients TB No. ____________ (Name and signature of referring person/ official) If sputum samples are being transported: Specimen identification No.: ___________ Date of sputum collection: __________ Specimen Collectors name and signature _________________________________ RESULTS (To be completed in the laboratory of DMC) Name of DMC: ___________________________________________________ Lab. Serial No.: __________________________________________________
Date of examination Specimen A B * M = Mucopurulent, B = Blood stained, S = Saliva ** Write actual count of AFB seen in 100 oil immersion fields Visual appearance (M, B, S)* Results (Neg or Pos) Positive (grading) 3+ 2+ 1+ Scanty**

Signature of Lab. Technician Date: ______________

____________________

The completed form (with results) should be sent to the referring PHI within a day of the examination. 36

Training Course for Program Manager

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-yearold female student with non-tender swelling of the lymph nodes in the anterior and posterior areas of the left side of the neck. She reports that she has occasional cough for the past 5 days. 3. Lakshmi Kumari (Patient C) of 223 Gandhi Dham, Bapu Nagar, is a 46-year old woman who has had cough for two months with fever, sweats at night, and occasional coughing up of blood. The patient is being attended to at a remote health facility (PHI 101). Sputum will be transported to the Designated Microscopy Centre (PHI 237). 4. Kailash Nath (Patient F) of 225 Gandhi Dham, Bapu Nagar, is the 35 year old husband of E. He came to health facility PHI 101 only to meet C, D and his wife E. He wants to go back home before it gets late. He is coughing and spitting blood. When asked, he reports that he has been coughing for several years. 37

Training Course for Program Manager 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-yearold woman who complains of rash on her scalp and trouble sleeping at night. 10. Kiran Kumar (Patient O) of No.15 Gulmohar Park is a 37 year old man. He has had a cough for two months. Though he is able to carry on work, occasionally he feels feverish and has lost weight. He had come to PHI 237 on 28th August and underwent sputum examination and his 2 smears were found negative for AFB. His cough has not subsided in spite of 2 weeks of antibiotics. POINTS TO BE REMEMBERED Undiagnosed and untreated pulmonary sputum smear-positive TB cases are the source of infection in the community and have the potential to transmit infection to others. The most common symptom of pulmonary TB is a persistent cough for 2 weeks or more. In RNTCP, sputum smear microscopy is the main tool for the diagnosis of TB cases. Two sputum smears should be examined (SpotEarly 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 23% 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

ZiehlNeelsen 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. 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. 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. Smears should be prepared near a flame as it sterilizes an area of six inches around the flame and disinfects the aerosols generated. The slide is allowed to air dry for 1530 minutes to clear air bubbles which would spurt while heating to fix the smear. The smear is fixed by passing the slide over a flame 35 times for 34 seconds each time. Coagulation of the proteineceous material in the sputum will facilitate fixing of the smear. 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. 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. 25% sulphuric acid is poured and allowed to stand for 2 4 minutes. This will facilitate decolourisation of background except that of the bacilli.

2.

3. 4. 5. 6.

7.

8. 9.

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 13 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


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 AFB in 100 oil immersion fields 1-9 AFB per 100 oil immersion fields 10-99 AFB per 100 oil immersion fields 1-10 AFB per oil immersion field More than 10 AFB per oil immersion field No. of fields to be examined 100 100 100 50 20 Grading 0 Scanty* 1+ 2+ 3+ Result Neg Pos Pos Pos 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 40

Training Course for Program Manager

Consequences
Patients suffering TB may be missed and he may continues to spread the disease in the community. Wrong categorization Intensive phase treatment may not be extended for the correct duration, resulting in inadequate duration of treatment Errors in declaring treatment outcome. Patients and the community may lose confidence in the programme Unnecessary repetition of investigations

Reasons for False-positive smear results


Faulty sputum collection (presence of food particles or fibers) Using old scratched slides / already used slide Using unfiltered carbol fuschin Inadequate decolorization with sulphuric acid Contamination due to transfer of bacilli from one smear to another Not wiping the oil immersion lens after examination of a positive slide Reading and reporting errors

Consequences
Patients without TB may be put on anti-TB treatment unnecessarily Treatment may continue beyond the recommended duration Medicines are wasted Patients and the community may lose confidence in the programme

Documentation of smear microscopy


Tuberculosis laboratory register
The Tuberculosis Laboratory Register is a document maintained in a DMC for recording the details of the sputum smear examinations. The Laboratory Technician is responsible for maintaining and updating the laboratory register. A Laboratory Serial Number is assigned to each patient who has been referred for sputum examination. The following information about the patient is recorded in the register. Laboratory serial number Date of sputum smear examination, Full name, Age & Gender Complete address 41

Training Course for Program Manager Phone number (land line and Mobile) Name of the health facility (PHC, Medical College, private practitioner, NGO) requesting the examination. Reason for examination {diagnosis, repeat diagnosis and follow-up (mention category and month of follow-up) of chemotherapy}. Results of sputum examinations (results of specimens a and b can be recorded). Signature of Laboratory Technician and Remarks

For TB suspect being evaluated, the technician ticks the Diagnosis column under Reason for Examination. In case patients are undergoing repeat sputum examination for diagnosis, the laboratory technician should write RE in the column for diagnosis and for patients undergoing follow-up sputum examination, follow-up column under reason for examination is ticked. Also mention the month of follow-up sputum examination and category of treatment. The column for signature is to be signed by Laboratory Technician. The remark column can be used for recording the following:

TB number Treatment regimen being given to smear positive patients residing in the same TU Action taken, in brief, for patients belonging to other TU/districts, (e.g., Referred to Udaipur districtt In this case, as soon as the TB No. is received from Udaipur district, the TB No. along with treatment regimen is entered in the remarks column, e.g., 234/04 New case smear positive). Referral details and remarks on un-blinded rechecking of slides during OSE visits by the STLS, etc.

Assistance of STS/STLS can be sought for recording entries in the remarks column. Using the Tuberculosis Laboratory Register Every week the MO in Charge (or his designate) of the DMC should review the Tuberculosis Laboratory Register to ensure that correct numbers of sputum smear examinations (i.e., 2 per TB suspect) are being performed for diagnosis. Results recorded in the laboratory register, treatment cards and the TB register are verified and ensured that they are consistent. It is the responsibility of the MO to ensure that all smear-positive patients diagnosed are started on treatment or are referred for treatment. If any smear-positive patients are not entered in the Tuberculosis Register and are on treatment, they should be registered. For patients who have not been put on treatment it should be ensured that they are traced, put on treatment immediately and registered. 42

Training Course for Program Manager The results of examination of up to TWO sputum specimen can be recorded for each patient in one line of the Tuberculosis Laboratory Register.

Accuracy of the Tuberculosis Laboratory Register


The accuracy of recordings in the TB laboratory register should be checked by the laboratory staff. Laboratory register should not be used for recording results of any test / investigation other than sputum. All results of sputum smear examinations done in a Designated Microscopy Centre should be written only in Tuberculosis Laboratory Register, and not in any other register. Duplicate registers should not be maintained. It is to be ensured that Tuberculosis Laboratory Register is filled completely and correctly. The MO PHI to ensure all smear-positive patients are started on treatment.

LTs should ensure that correct laboratory serial number is recorded. A new number should be assigned to every TB suspect whose sputum is to be examined. The Laboratory Serial Number should begin with a new serial (number 1) every calendar year. The Laboratory Serial Number is also written in the Tuberculosis Register as well as the TB Treatment Card. It can be used as a cross-reference when the MO of the DMC cross-checks the results of the sputum examination in the Tuberculosis Register with that of Tuberculosis Laboratory Register and the TB Treatment Card. By using the name of the patient and his Laboratory Serial Number from the Tuberculosis Register, the MO of the DMC can easily locate the results of sputum examinations in the Tuberculosis Laboratory Register. Without this Laboratory Serial Number, it would be tedious to go through many pages of the Tuberculosis Laboratory Register for sputum results. The MO of DMC should check the Tuberculosis Laboratory Register and make sure all the columns have been completed. For example, it may be found that a patients address or name of referring health facility is missing or incomplete in the Tuberculosis Laboratory Register.

43

Training Course for Program Manager The MO should emphasize on laboratory technicians, the importance of recording the complete addresses of patients examined for diagnosis. This facilitates tracing and initiation of treatment. If the sputum smear examination is intended for diagnosis or for repeat examination for diagnosis, the name of the health facility referring the patient should be written in the column meant for name of referring health facility (e.g. Dr CU Shah, Private Practitioner, or XYZ Hospital). If the TB suspect has attended the OPD of the DMC on his own, the name of the DMC should be mentioned in this column. If the patient has been referred from ICTC or ART centre, the same should be mentioned in this column. If the sputum smear examination is for follow-up examination, the name of the health facility where the patient is undergoing the treatment should be written in the Name of Referring Health Facility column. The Tuberculosis Number of all TB patients, with their respective category of treatment, should be recorded in the remarks column, and the Tuberculosis Number of all patients whose sputum is examined for follow-up must be written in the space provided.

Recording of results of sputum smear examinations


LTs should understand the importance of accurate recording of results of sputum smear examinations on the Laboratory Form for Sputum Examination. The Lab Technician should be informed that patients are put on appropriate regimen based on the results of the sputum examinations and further management of patients also depends upon the results of the follow-up sputum examination and at the end of the treatment.

A LABORATORY SERIAL NUMBER is assigned to a PATIENT, not to a sputum specimen


Limiting administrative errors
If the patients sputum specimens are not labeled properly at the health facility or if the Laboratory Form for Sputum Examination gets separated from the specimens, the laboratory technician may not know whose sputum specimens are in the containers when they reach the laboratory. The LTs should ensure that the Laboratory Serial Number on the Laboratory Form for Sputum Examination matches with what is written on the side of the sputum container and on the slide used for smear preparation. Other health facilities which collect specimens and transport them to the DMC should assign Specimen Identification Numbers and write it on the side of the containers.

Documentation for referral for treatment


Information regarding referral of a patient should be noted in the Referral for Treatment register as well as the remarks column of the Tuberculosis Laboratory Register.

44

Training Course for Program Manager A Referral for Treatment register (dealt in detail in the next module) should be maintained in DMCs situated in bigger hospitals including that of medical colleges that are referring large number of patients to other health facilities for treatment.

Monthly summary
The laboratory technician should summarize the information on sputum smear examinations done during that month. This information should be summarized in the prescribed format at the end of each month, printed in the Laboratory Register itself. The STLS should write the monthly supervisory abstract after the last entry of the month. A new page is used every month for recording the sputum examination undertaken. Ensure that two sputum samples are examined for both diagnosis and follow- up cases irrespective of the results of the first sample If only one sputum specimen was examined, patient should be traced and second sample should be examined. MOs are responsible for ensuring that the patient is traced. A smearpositive patient may be missed if the second sputum is not collected and examined. To minimize the proportion of false smear-negative patients, at least 2 smear-negative sputum specimens should be available. Accuracy of the results of follow-up sputum smear examinations recorded in the Tuberculosis Register, should be ensured by comparing with those in the TB Lab Register. Such comparisons especially for patients who were smear-positive at the beginning of treatment should be made. Once a sputum specimen reaches a laboratory the laboratory technician gives a Laboratory Serial No. The number is subsequently entered a) In the Laboratory Form for Sputum Examination b) On the side of the sputum cup c) On the slide d) In the TB Laboratory Register e) In the Treatment Card f) In the TB Register g) Patient identity card

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Training Course for Program Manager

EXERCISE WORKBOOK E1: LABORATORY FORM FOR SPUTUM EXAMINATION


Complete the Laboratory Form: Bottom Section Start with Laboratory Serial Number 501. The appearance of the specimen is given in brackets. Specimens are examined on 4 September 2009. Sign your own name.

Patient

No. of AFB seen (visual appearance)


30 AFB are seen in 100 oil immersion fields (mucopurulent) 6 AFB are seen in 100 oil, immersion fields (mucopurulent)

B. Parvathi Sinha

C. Lakshmi Kumari

150 AFB are seen in 50 oil immersion fields (bloody) 80 AFB are seen in 50 oil immersion fields (mucopurulent)

F. Kailash Nath

300 AFB are seen in 20 oil immersion fields (bloody) 200 AFB are seen in 50 oil immersion fields (bloody)

J. Bhola Ram

400 AFB are seen in 50 oil immersion fields (bloody) 60 AFB are seen in 100 oil immersion fields (mucopurulent)

O. Kiran Kumar

0 per 100 oil immersion fields x 2 (saliva, mucopurulent)

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REVISED NATIONAL TUBERCULOSIS CONTROL PROGRAMME LABORATORY REGISTER


Reasons for Examination*
Results a b Signature Remarks Diagnosis
TB No. Month Regimen NT/PT

Age Complete address (for new patients) Phone No. Name of referring Health Facility Follow-up

Lab. Serial No.

Date

Name in Full

Sex M/F

If sputum is examined for diagnosis, put a tick (3) mark in the space under Diagnosis sputum is examined for repeat diagnosis, put RE in the space under Diagnosis If sputum is for follow-up of patients on treatment, write the patients TB No. in the space under Follow up, treatment regimen and month of follow up Points to be mentioned in the remarks column: date of starting treatment, treatment regimen, TB No, Referral details, MDR-TB suspect identified and remarks on unblinded rechecking of slides during OSE visits by the STLS, etc.

Monthly abstract of the Laboratory activities

Month Year 20 Follow-up patient examined Total slides Examined Total positive slides Total negative slides

TB suspects Examined for Diagnosis TB suspects found positive on Repeat Examination Patients positive on followup

TB Suspects found positive

TB suspects undergoing Repeat Sputum Examination

Signature of LT and STLS

Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Total Signature of the MO

Training Course for Program Manager

Exercise 2
Review the sample page of the Tuberculosis Laboratory Register on the following page and identify the errors for each patient registered.
Lab Sl.No. Name of the patient Errors identified

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REVISED NATIONAL TUBERCULOSIS CONTROL PROGRAMME LABORATORY REGISTER


Reasons for Examination*
Results a
Neg Neg Scanty 20 102 Neg 1+ PT 5th month 2+ 2+ Neg 1+ 1+ Neg 1+ Neg 2+ Neg Joshi Joshi 2+ Joshi Joshi Joshi Joshi Joshi Referred out
MDR-TB suspect

Lab. Serial No. Diagnosis


TB No. Month Neg Joshi Joshi RE Regimen NT/PT

Date b

Name in Full

Age

Sex M/ F Follow-up Signature

Complete address (for new patients) Phone No. Name of referring Health Facility
211, Pocket 3, Mayur Vihar 40 Sector II, Jamnagar

Remarks

499

30/3

Sita Dixit

500 225, Block 4, Bapu Nagar

30/3

Krishna Kanth

54

9 9

501

30/3

Aswani Rai

39

502

30/3

Abdul Hazan

44

Modern TB Clinic Jamnagar Health Centre Jamnagar Health Centre Aligarh Dispensary

503

01/4

Rama

38

504

01/4

Alex chopra

45

Gali No.7, JJ Ram Rani Coloni 422, Sector III, Rohini M.G. Road

9 9 9 9
RE

504 BB22/Block 4, Nehru Place

Renu Sharma

37

505

02/4

Kumar Bhatia

58

506 62, Lane No. 820, Kailash Colony

02/4

28

Modern TB Clinic ART Centre KRH Jamnagar Health Centre Jamnagar Health Centre ICTC KRH

507

02/4

Deepak Dhawan Preeti Chandra

26

* If sputum is examined for diagnosis, put a tick (3) mark in the space under Diagnosis * if sputum is examined for repeat diagnosis, put RE in the space under Diagnosis * If sputum is for follow-up of patients on treatment, write the patients TB No. in the space under Follow up, treatment regimen as NT (new cases) or PT (previously treated cases) and month of follow up. Points to be mentioned in the remarks column: date of starting treatment, treatment regimen, TB No, Referral details, MDR-TB suspect identified and remarks on unblinded rechecking of slides during OSE visits by the STLS, etc.

Exercise 2: Complete the pages of the Laboratory Register using the laboratory form you have completed in Exercise workbook 1

REVISED NATIONAL TUBERCULOSIS CONTROL PROGRAMME LABORATORY REGISTER


Reasons for Examination*
Results a b Signature Remarks Diagnosis
TB No. Month Regimen NT/PT

Lab. Serial No. Follow-up

Date

Name in Full

Age

Sex M/ F

.Complete address (for new patients) Phone No. Name of referring Health Facility

* If sputum is examined for diagnosis, put a tick (3) mark in the space under Diagnosis * if sputum is examined for repeat diagnosis, put RE in the space under Diagnosis * If sputum is for follow-up of patients on treatment, write the patients TB No. in the space under Follow up, treatment regimen as NT (new cases) or PT (previously treated cases) and month of follow up. Points to be mentioned in the remarks column: date of starting treatment, treatment regimen, TB No, Referral details, MDR-TB suspect identified and remarks on unblinded rechecking of slides during OSE visits by the STLS, etc.

Training Course for Program Manager EXERCISE 3 1. 2. A laboratory technician wants to know about the usefulness of sputum smear grading. Can you explain it to him? An STLS supplied 100 slides to a PHI. The laboratory technician listed 120 smearnegative cases and 20 smear-positive cases in the Tuberculosis Laboratory Register. Please comment. Tick the correct answer. Once a sputum specimen reaches a laboratory the laboratory technician gives a Laboratory Serial No. The number is subsequently entered a. b. c. d. e. f. g. h. 4. In the Laboratory Form for Sputum Examination On the side of the sputum cup On the slide In the TB Laboratory Register In the Treatment Card In the TB Register Patient identity card All of the above

3.

In Ziehl-Neelsen staining (i) (ii) (iii) Concentration of carbol fuchsin used is (a) 5% (b) 3% (c) 1% (d) 10% Concentration of sulphuric acid used is (a) 25% (b) 10% (c) 1% (d) 15% Concentration of methylene blue used is (a) 1% (b) 0.1% (c) 10% (d) 1.5%

5.

Ram is a laboratory technician, who has assigned a Laboratory Serial No. to each sputum specimen. What is your comment?

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Training Course for Program Manager

Section B: Quality Assured Laboratory Services


Introduction:
An effective quality assurance (QA) system of sputum smear microscopy network is crucial for reliability of data generated under RNTCP. QA is a system consisting of internal quality control (QC), external quality assessment (EQA), and continuous efforts for quality improvement (QI) of laboratory services. The system also provides credibility of laboratory results and motivation of staff for further improvement of their efficiency.
Quality assurance = Internal Quality Control + External Quality Assessment +Quality Improvement

A nation-wide network of RNTCP quality assured designated sputum smear microscopy laboratory is in place which provides appropriate and accessible quality assured laboratory services. RNTCP has established a system to monitor laboratory activities based on international guidelines which includes NRLs, STDCs / IRLs & DTC / TU. In this section of the module the participants will learn about Structure of RNTCP laboratory network Quality assurance for smear microscopy Maintenance of adequate supply of quality laboratory consumables Supervisory visit to DMC Infection control : Safe disposal of contaminated materials Annexures , Checklist and IQC documents

Structure of RNTCP laboratory network A wide national network of Designated Microscopy Centres (DMCs) with competency in smear microscopy has been established, to provide diagnostic services with an easy access for the entire population under RNTCP. The network of DMCs is supported by larger State TB Training and Demonstration Centres (STDCs), also referred to as Intermediate Reference Laboratories (IRLs), and overseen by four National Reference Laboratories (NRLs), viz., Tuberculosis Research Centre (TRC), Chennai, (SNRL), National TB Institute (NTI), Bangalore, LRS Institute of TB and Respiratory Diseases, New Delhi and Central JALMA Institute, Agra. The Central TB division is advised on all technical issues by the National Laboratory Committee which includes members from all the four NRLs and representatives from WHO & CTD. The different levels of laboratories under RNTCP are as follows: National Reference Laboratory: Each NRL will supervise sputum microscopy EQA of states designated under them. The NRL will ensure proficiency of RNTCP staff for carrying 53

Training Course for Program Manager out good quality diagnosis by providing technical training to the STOs, STDC Directors, Microbiologists and Lab Technicians of States. Intermediate Reference Laboratory: The states will designate one Intermediate Reference Laboratories in the STDC or Medical College or in any Public Health Laboratory of the state. The IRL should be a facility deemed fit for accreditation by the respective NRL looking after the state. The designated IRL will conduct sputum microscopy EQA for the state and occasionally for a neighbouring state or union territory. The IRL will provide technical training to district and sub-district technicians and STLS. Designated Microscopy Centre: Sputum microscopy diagnostic services under RNTCP are provided by Designated Microscopy centres (DMC) established for every one lakh population (50,000 population in tribal, hilly and remote areas). In addition the DMCs are also established at Medical colleges, Corporate hospitals, ESI, Railways, NGOs, large private hospitals, and other major hospitals. Laboratory Network under RNTCP

Bold line indicates direction of feedback and dotted line indicates reporting direction

Quality Assurance (QA) for smear microscopy


Quality assurance system includes 1. Internal Quality Control (IQC) 2. External Quality Assessment(EQA) 3. Quality Improvement(QI)

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Training Course for Program Manager Internal Quality Control (IQC)


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

Staining reagents: Preparation of 1% Carbol Fuchsin:


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

Preparation of 25% Sulphuric Acid


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

Preparation of 0.1 % Methylene Blue 1. Ensure dye content is mentioned on the bottle while procurement 2. Potency to be corrected before preparing the stain General points for all staining reagents: The prepared stain may be stored for a maximum period of 3 month Each batch of Stain to be prepared only to the capacity of the glassware available (pooling of batches should not be done, even if prepared on the same day) Each batch should be given a new batch number and to be validated separately using a different set of QCP (Quality Control Positive) & QCN (Quality Control Negative) for every batch. Water bath and electronic weighing balance to be used as per the specifications

Manufacturing QCP and QCN by STLS: o QCP & QCN slides to be prepared by the STLS only o QCP slides may be prepared by pooling 3+ grade sputum samples o QCN slides may be prepared by pooling Negative sputum samples with adequate number of pus cells( approximately 20 cells /field)

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

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Training Course for Program Manager

External quality assessment (for lab quality assurance)


1. The activities of NRL: a. b. c. On-site evaluation of STDC/ IRL Labs Manufacture of Panel testing slides and panel testing of STDC/ IRL Lab staff Training of STDC supervisory staff in: i. ii. iii. iv. d. e. On site evaluation of STLS Manufacture of panel slides Assessment of blinded re-checking of DMC slides at DTC Facilitating the training of STLS for External Quality Assessment (EQA)

Re-training of STDC/ IRL supervisory staff, if required. Prompt reporting of the results of activities and feedback to STO/ DDG TB.

2. The activities of STDC/ IRL: a. b. c. d. e. f. Training of EQA for STLS, DTO, MO-TC On-site evaluation of DTC Labs and a sample DMCs Manufacture of Panel testing slides and panel testing of DTC Lab supervisors including all STLS of the district Assessment of blinded re-checking of DMC slides at DTC Re-training of DTC LT/ STLS, if required. Prompt reporting the results of activities by Director STDC/ IRL to STO, CTD & NRL.

3. The activities of DTC/ TU: a. b. c. d. e. On-site evaluation of DMC Labs Unblinded re-checking of DMC slides at DMC Random Blinded re-checking (RBRC) of DMC slides at DTC Prompt reporting of the results of activities to LT and MO of DMC as well as STDC/ IRL. Panel testing and re-training of DMC LTs, if required.

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

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Training Course for Program Manager When poor performance is identified through any of the above-mentioned activities, additional visits by trained laboratory personnel from the higher level laboratory (the STDC/ IRL or NRL laboratory Supervisors) are mandatory for evaluation of all laboratory procedures. The visit includes a comprehensive assessment of laboratory safety procedure, conditions of equipment, adequacy of supplies as well as the technical components of AFB smear microscopy, which includes preparation, staining and reading of smears. Sufficient time must be allotted for the visit to include observation of all the work associated with AFB smear microscopy. On-site evaluation at DMCs should also include examining five positive and five negative smears to observe the quality of smear and staining as well as condition of the microscope. At the DMC, the LT arranges all the slides in the slide box serially as per laboratory register and preserves all the slides after examination (LT has to preserve all the slides till RBRC process is complete and feed-back is given). The supervisor (STLS) re-checks monthly in an unblinded manner, on his onsite evaluation visits, 5 positive and 5 negative slides selected from the lab register by systematic random sampling procedure. STLS marks in the Laboratory register with a small x sign and makes entries in his OSE-checklist and remarks column of the lab register. STLS should discuss discrepant slides with the LT, identify the cause of error, if any and provide specific corrective measures. Checklists used during OSE (discuss the checklist in detail) Checklists are developed to assist both laboratory and non-laboratory supervisors during the field visit and to allow for the collection and analysis of standard data for subsequent remedial action. Checklists may be refined to focus on problems that are frequently identified or most likely to occur, such as preparation of stains or errors in grading. Copies of the checklist should be left behind in the unit receiving the on-site evaluation. This will provide written documentation of the visit and findings and will also assist subsequent evaluations to monitor improvements. When poor performance is identified through any of the above-mentioned activities,additional visits by STLS are mandatory for evaluation of all laboratory procedures. Comprehensive checklist for on-site evaluation of DMCs is provided in the annexure A. The checklist contains open, non-leading questions and recommended observations along with objective criteria for acceptable practices. Use of a simple standardized checklist even by well-trained district supervisors (e.g. DTO), can reduce the time necessary to evaluate a laboratory effectively. B. Panel Testing Panel testing is a method of EQA that is used to determine whether a laboratory technician can adequately perform AFB smear microscopy. This method evaluates individual performance in staining and reading, and not all the laboratory activities. Utilization of panel testing for EQA is considered to be less effective than random blinded re-checking of routine slides because it does not monitor routine performance. Panel testing is a useful supplement to the system of re-checking of slides. It provides information on the capabilities of the peripheral laboratories prior to implementing a rechecking programme. It can also be used to assess the level of performance or to quickly 58

Training Course for Program Manager detect problems associated with very poor performance. The proficiency of laboratory technicians after training can be evaluated. Panel testing under RNTCP is used for supervisory lab staff of STDCs/ IRLs and DTCs, and will be conducted under the supervision of the visiting lab team during their annual onsite evaluation visit. A panel will consist of 5 unstained smears per laboratory personnel. Panel testing is not performed as a routine in the DMCs, as they will have regular on-site evaluation and blinded re-checking. C. Random Blinded Re-Checking of Routine Slides (RBRC) Blinded rechecking is a process of rereading a statistically valid sample of slides from a laboratory to assess whether that laboratory has an acceptable level of performance. This activity is performed once a month for every DMC. Random blinded re-checking must ensure that: The sample contains a sufficient number of randomly selected slides to be representative of all slides of the DMC, The supervisor (STLS) of the laboratory (first controller), must not be aware of the original result of peripheral laboratory technician to prevent bias, i.e. results are blinded, Minor false errors are included with major errors for the purpose of obtaining a smaller sample size. The smaller sample size facilitates implementation and sustainability of rechecking Discrepant results are resolved by a second controller (umpire). There must be a system to provide timely periodic feedback and improvements to the laboratories that are supervised.

Random blinded re-checking of routine slides from the DMCs is implemented throughout the RNTCP laboratory network. A system utilizing Lot Quality Assurance Sampling (LQAS) method is used to calculate the sample size (See Table 1). The STLS selects from lab register RBRC sample slides for random blinded rechecking (RBRC) on the advice of the DTO These slides are selected using a systematic random blinded sampling procedure and the results of the slides selected are circled in the Lab register by STLS. The LT will enter the slide numbers that are selected by STLS in Annexure B along with results; Encloses the annexure B in a sealed envelope; Arranges the slides in a separate box supplied by DTO and marks on the top of box as well as envelope with the title: RBRC slides, Name of DMC, TU and the month & year. STLS picks up the box and envelop and hands them over to DTO. DTO conducts RBRC and gives feed-back and corrective actions to LT through MODMC. 59

Training Course for Program Manager The activities to be performed by DTO at DTC are briefly given below. Every calendar month, DTO instructs all STLS to collect appropriate number of slides from LTs of DMC in a slide box (See Table 1). 1. DTO receives sealed envelopes with Annexure B and slide boxes from the respective STLS. 2. DTO will code the boxes A, B, C, D or 1, 2, 3, 4.etc as per his convenience. Same DMC should not get same code every month. Coding of boxes is an important activity of DTO and blinding of slides must be ensured by DTO. 3. DTO should maintain a register where he would enlist the codes given to each DMC for each of their RBRC months. The register should also show how DTO has allotted the codes to the STLSs. STLSs should be allotted the coded DMC boxes taking care to see that DMC allocation is not repeated to the same STLS who is supervisor of that DMC. Rotation of DMCs amongst different STLSs should also be ensured over consecutive RBRC monthly cycles. 4. DTO retains sealed Annexure B in his possession. 5. DTO will make a roster from 11th of the OSE month onwards giving one or two or three days (based on no. of samples to be re-checked) for each STLS to come to DTC for the re-checking. No two STLS should come for re-checking at the same time. All STLSs are informed of the OSE months Blinded re-checking roster. 6. STLS to read and record results for slides as per Annexure C - one slide box at a time. 7. After getting results from STLS, DTO transfers the results of LT from Annexure-B to Annexure-C (for each DMC). 8. DTO identifies the discordant slides. Discordance for the purposes of identifying the slides for re-checking by second controller (called Umpire reader) is any slide with positive smear result of LT (of any grade) being read as negative by STLS and viceversa and for positive slides having a difference of more than one grade between LT and first controller. 9. DTO takes out the discordant slides in a separate box and gives it to an Umpire reader who could be any STLS. Umpire has to de-stain and re-stain the slides before reading. De-staining is performed by dipping the slides in absolute alcohol for 5 mins. These are re-stained by ZN staining method. The format for giving these results to Umpire reading is as follows, which is maintained in a separate note book with DTO. Results 1 and 2 should not indicate the identity of the either LT or STLS and are interchanged frequently to maintain the confidentiality of the original readers.
DMC Code Discordant slide number Umpire reading

RBRC Sl. No. month

Result 1

Result 2

Signature

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Training Course for Program Manager 10. STLS/DTO/MO-TC to evaluate results and give feedback to each DMC (MO and LT) as per annexure D, with information to the CMO/Civil Surgeon. 11. DTO receives a copy of the monthly on-site supervision report from STLS through MOTC and decides on the next course of action in consultation with MO-TCs. 12. DTO sends a copy of the monthly report on random blinded rechecking to STDC/ IRL/STO every month (as per annexure E), Monthly lab abstract of district, DMC-wise (Annex M for district) and a copy of OSE summary report of EQA (Annex F) to STDC/ IRL every quarter and percentage of DMCs with high false error in the district, in district PMR report to STO/Central TB Division every quarter. 13. The pattern of errors that are likely to occur, possible causes for these errors and suggested investigation steps to be taken by the RNTCP Lab supervisors including DTOs/ MO-TCs/ STLS are given in Annexure K 14. DTOs and MO-TCs should familiarize themselves with these in order to effectively supervise the DMCs under their area. 15. The DTOs and MO-TCs have to report the EQA activities in their respective Quarterly report on Programme Management. Quality improvement ( QI ) : A process by which all components of smear microscopy diagnostic services are carefully analyzed with the aim of looking for ways to permanently remove obstacles to success. Appropriate data collection, data analysis, correct interpretation of the results and creative problem solving are the key components of this process. Involves continued monitoring, identifying defects, followed by remedial action including retraining when needed, to prevent recurrence of problems. Relies on effective on site evaluation

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Training Course for Program Manager Table 1 Recommended Annual Sample Size i (80% sensitivity, 100% specificity and 0 acceptance number) Number of negative slides in the DMC in a year 2.5-4.9 Slides positivity rate (SPR%)

5.0 ii 7.49

7.5-9.9

10-14.9

15

Annual sample size of both positive and negative slides (Monthly sample size iii in parenthesis) 301 iv-500 243(21) 154(13) 114(10) 89(8) 62(6)

501-1000 >1000

318(27) 456(38)

180(15) 216(18)

128(11) 144(12)

96(8) 104(9)

66(6) 69(6)

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

Suggested Reading 1. Central TB Division: RNTCP Laboratory Network: Guidelines for Quality Assurance of smear microscopy for diagnosing tuberculosis, 2004. External Quality Assessment for AFB Smear Microscopy, IUATLD, WHO, JATA, and KNCV, the CDC and APHL, 2002

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Training Course for Program Manager STLS On-site evaluation visit at least once in a month Designated microscopy centre

1. 2. 3. 4. 5.

Inspect microscope, supplies and laboratory as per checklist TU-OSE Re-examine 5 positive and 5 negative slides by systematic random method Give feedback on quality of smear, stain, reading and reporting Collect systematically selected LQAS slides in serial order and sealed envelopes with Annexure B from LT Ensure that the name of DMC, TU, District and the month and year is clearly written on the slide box and the sealed envelope

DTC

1. 2. 3. 4. 5.

DTO receives sealed envelopes with Annexure B and slide boxes DTO codes and interchanges slide boxes among STLS, retaining sealed Annexure B in his possession STLS read and record results for slides per Annexure C - one slide box at a time Umpire reading will be by another STLS and organized at DTC by the DTO STLS/DTO/MO-TC evaluate results and give feedback to each MC under information to the CMO/Civil Surgeon

The Senior TB Laboratory Supervisor should: Visit DMCs at least once a month Crosscheck 5 positive and 5 negative slides Test the quality of smear preparation, staining, reading and recording of the LT Collect sample of slides for blinded rechecking at the district level

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Training Course for Program Manager

Maintenance of adequate supply of quality consumables


The MO of DMC is responsible for determining the amount of reagents and other materials the DMC needs every month. The STLS will make sure these supplies are distributed in a timely manner, usually on a monthly basis or as and when required. It is made sure that there is an adequate stock of reagents and other materials in the at all levels. It is very important for the laboratory to maintain an adequate stock of reagents and other laboratory materials. If the laboratory has less stock of any items, it is ensured that supplies are provided to the laboratory from the district or sub-district stock. LTs are reminded to exhaust the old supplies before starting to use the new supplies. Old reagents should not be mixed with the new supplies. They should be kept in separate containers. It is ensured that the reagents are of good quality. It should be freshly prepared at the DTC and supplied to the DMCs on monthly basis. In case the TU has adequate infrastructure and equipments (Weighing balance, water bath, round bottom flasks etc,), the reagents may be prepared at TU level as well. The LTs himself should stain and examine the Quality Control slides supplied to him by STLS after receiving the fresh batch of reagents. Reagents should not be used beyond 3 months from the date of its preparation. Commercially available readymade laboratory reagents should not be used. It is ensured that the binocular microscope is in good working condition. Regular arrangements have to be made by the DTO for maintenance of the microscope through Annual Maintenance Contract. In case the microscope is under warranty, the supplier may be contacted for undertaking its repair. The following laboratory materials should always be available in the laboratory:
Chemical & Reagents Carbol fuchsin (1%), Sulphuric acid (25%), Methylene blue (0.1%), Synthetic immersion oil, Methylated spirit 5% phenol / 40% phenolic compound (proprietary Phenyl) diluted to 5% Absolute alcohol to be available at the DTC only for de-staining discrepant slides during umpire reading. Silica gel (hygroscopic agent) to maintain the microscope in moisture free environment (to be placed in the cabinet for Binocular Microscope) Stationery Laboratory Forms for Sputum Examination Laboratory Register Referral for Treatment Forms Consumables Glass slides for microscopy, and slide-boxes for storing slides Diamond markers (for marking the slides) and marking pens or grease pencils (for marking the sputum containers) Broom sticks (thick enough to make good smears) Transparent glass bottles for reagents (with self-adhesive labels stating date of preparation of reagents) Plastic tumblers/mugs Glass (or metal) rods (for holding slides during the staining process) Staining racks (for drying the slides) Sputum containers Spirit lamp or bunsen burner Foot-operated bin (for disposal of contaminated materials) Timer (stop-watch) Fine Silk and Lint cloth Lens paper (for wiping the oil immersion lens after examination of each slide) Whatmann filter paper No 1 Filter paper ( to drain the oil from the slides

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Training Course for Program Manager Estimated quantity of reagents and materials required for 1000 smears
Carbol fuchsin (1%) Methylene blue (0.1%) Sulphuric acid (25%) Immersion oil Phenol 5 % / 40% Phenolic compound (phenyl) diluted to 5% Methylated spirit Filter paper (Whatmann No. 1, pack of 100)** Filter paper Lens paper (book of 50 leaves) Lint cloth (15 cm x 15 cm); or Fine silk (15 cm x 15 cm)* Diamond marker* Grease pencils or marking pens Sputum containers Broom sticks New glass slides Slide Box (100 Slides)* Black/ Red disposal bags of bio-degradable material Silica Gel* * These items are reusable 5000 ml 3000 ml 6000 ml 50 ml 200 Litres 1000 ml 1 pack 20 sheets 20 books 5 4 4 1100 1100 1100 11 100 100 gms

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

Supervisory visits to designated microscopy centres


Designated microscopy centres are supervised by STLS from the sub-district. The DTO/MO-TC/MO will coordinate with the STLS to ensure that tuberculosis-related laboratory services are properly performed and recorded by the laboratory technician. Prior to the visit to the designated microscopy centre, one has to plan thoroughly. In this section, DTO/MO-TC/MO will learn how to prepare for visits to designated microscopy centre, review the items to be checked during the visit to a laboratory and will develop a checklist to use the same during supervision visit.

Preparation for visits to designated microscopy centre


1. The DTO/MO-TC has to decide when to visit each designated microscopy centre in the TU/district. The visit is planned in advance so that a DTO can visit all DMCs in his/her district at least every quarter and a MO-TC can visit all DMCs in his TU at least every month. Decide what to check. Some important items to check are listed under point 4 (below). Review the recommendations made during previous visits and the actions taken.

2.

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Training Course for Program Manager 3. Decide when to check each item. Some items, such as the Tuberculosis Laboratory Register, should be checked during each visit. Other items including stocks of sputum containers, slides and reagents may be checked periodically. Decide how to check each item. Depending on the time available for the visit, decide the best ways to collect information: (i) Review the Tuberculosis Laboratory Register. Check the Tuberculosis Laboratory Register to make sure it is filled completely and accurately. Make sure that all smear-positive patients in the Tuberculosis Laboratory Register have either the TB No. mentioned in the remarks column or have the name of the PHI where the patient has been referred (if s/he belongs to another TU/district). Verify that patients who were examined for diagnosis had correct number of sputum specimens examined. Also verify that the details of follow up examination (TB no., regimen and month) have been entered in the reasons for examination column. Make sure that LT is writing the monthly summary correctly. Lastly verify whether in the remarks column there are any entries mentioning about MDR suspects and sample sent for C & DST

4.

(ii) Talk with the laboratory technicians. Make sure that they understand the importance of examining the correct number of sputum specimens. Also, make sure that they understand the importance of limiting administrative errors and accurately recording the results of sputum smear examinations on the Laboratory Form for Sputum Examination. In addition, make sure that the laboratory technicians keep the examined sputum smear slides of all patients until the EQA procedure is completed. Reiterate that regarding every follow up positive, LT should inform the treating physician immediately. (iii) Examine supplies. Check to see if there are adequate numbers of sputum containers, slides, reagents, forms and other laboratory supplies. 5. Develop a checklist. Once it is decided what to look for when one goes to the designated microscopy centre and how to check each item, it will be helpful to organize the information into a checklist. In general, the checklist should be just long enough to remind the supervisor about the important items/activities that needs to be checked. It should be easy to use. Include important general information, such as the name of the centre and supervisor, and date of the visit. A more comprehensive checklist is given below. Review it now. This checklist is longer than the one that should be used during supervisory visits, but is provided for reference. You should develop your own checklist based on this.

Conduct the visit


Information should be given to the STS and STLS (particularly the latter) in advance about the visit to the designated microscopy centre. If possible, STLS and STS should be available during the visit. In the DMC, the checklist that you have prepared should be used. If you find that there is any problem, work with the STLS and STS to solve them.

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Training Course for Program Manager

Checklist for laboratory supervision


Review of resources
Please write Yes/No in the column Observation
No 1 2 3 4 5 6 7 8 9 10 11 Check-points Is at least one trained Medical Officer available in the health facility? Is a full-time trained Laboratory Technician (LT) available for sputum microscopy? Have provisions been made for sputum collection when LT is absent? Is a functional binocular microscope available? Has the binocular microscope undergone any servicing during last 12 months? Are all essential lab consumables available adequately, enough to last at least for one month? Is running water available for sputum microscopy? Is electricity available for the binocular microscope? Have civil works been done in the Lab as per RNTCP guidelines? Are printed reference materials on standard operating procedures available? Are all the samples collected at collection center and transported to the DMC are documented and examined? Observations

Review of forms, registers, records and reports


1 2 3 4 5 6 7 8 9 10 11 12 13 14 Are the Lab Forms for Sputum Exams filled correctly, completely and legibly? Is the Lab Register filled correctly, completely and legibly? Is the Lab Serial Number entered correctly, starting with 1 on 1st January of the year and continuing until 31 December? Are results correctly recorded? Are there 2 sputum smears for diagnosis ? Are there 2 sputum smears for follow-up? Are positive results written as scanty, 1+, 2+ or 3+ in red and negative in black/blue? Are results up-to-date? Does the Lab register have the summary abstract completed at the end of each month? Is there a duplicate Lab Register? Are copies of supervisory reports of Senior TB Lab Supervisor available with LT? Is there evidence of supervision by STLS on lab register? Is monthly PHI-level report on sputum microscopy and logistics being submitted by the health facility? Does the Tuberculosis Register contain all the smear-positive patients recorded in the Tuberculosis Laboratory Register? If the Tuberculosis Laboratory Register contains names of smear- positive patients which are not found in the Tuberculosis Register, do these patients belong to another TU/district? Is the Lab register consistent with the treatment cards and TB register? (Check information for at least 4-6 randomly selected new smear -positive patients.) Review the OSE reports and Annexure D kept at the laboratory

15 16

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Training Course for Program Manager


17 18 19 Review whether all MDR-TB suspects were identified? Review whether the sputum sample collection was done from all identified MDR-TB suspects? Review whether the QC usage register is being maintained ?

Observe the Lab technician during the sputum-collection procedure


1 2 3 4 5 6 7 Did the LT check to ensure that the Lab Form was complete and correct? Is the sputum container clearly labeled on the side and not on the lid? Are each set of sputum samples from a single patient given a single Lab Serial Number? Is the Tuberculosis Number written in the space provided for all patients whose reason for examination is follow-up of treatment? Does the LT demonstrate to patients how to bring up sputum? Does the LT supervise patients when they provide spot sputum specimens? Does the LT visually examine the sputum provided to determine if it is sputum or saliva only?

Observe the Lab technician preparing smears for examination


1 2 3 4 5 6 7 8 9 10 11 12 Does the LT use only new slides? Does the LT engrave the Lab Serial Number on each slide with a diamond marker? Does the LT use a different broom stick for each sputum smear? Are the sputum smears made on the slide of the correct size (2 cm X 3 cm) and thickness? Does the LT wait for the slide to dry before heating the slide to fix it? When the Lab technician fixes the slide by heating, does s/he do it for the proper duration of time? Is only freshly prepared carbol fuchsin being used, instead of ready-made commercially-available solutions? Is the carbol fuchsin free of particles and properly filtered at least every month? When the LT heats the carbol fuchsin, does s/he do it properly, avoiding boiling and allowing the slides to stand for 5 minutes after heating? Does the LT tilt the slides after rinsing with water to remove excess water? Is the sulphuric acid allowed to stand on the slide for the appropriate time period (24 minutes)? Is the methylene blue allowed to stand on the slide for the appropriate time period (30 seconds)?

Observe the Lab technician examining slides under the microscope


1 2 3 While placing immersion oil on the slide, does the LT take care to avoid touching the slide with the applicator? While examining the slide with the X100 lens, does the LT take care to make sure that the lens does not touch the slide? Does the LT examine negative sputum smear slides for at least 5 minutes?

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Training Course for Program Manager


4 5 6 7 8 9 10 Does the LT have correct knowledge about grading? Does the LT see 100 fields before declaring the smear as negative? Does the LT correctly complete the Lab Form for Sputum Examination and Lab Register? Does the LT clean the X100 lens with lens paper/fine silk after completing the examination? Are slides correctly cleaned and maintained serially in slide boxes for review by the supervisor? Are all smear-positive results recorded in red ink in the Lab Register? After examining the slides, does the LT put the sputum containers and lids (with lids removed) along with the broom sticks, into a foot-operated bucket containing 5% phenol? Does the LT break all the remaining slides of the previous month after The EQA procedure is completed? Does the LT ensure that smear-positive as well as smear-negative slides are not being re-used for AFB microscopy?

11 12

Exit-interviews of at least 2 patients undergoing sputum microscopy


1 2 3 4 Do the patients know how to cough out good quality sputum properly? Do the patients know when they should return for the next sputum exams? Do the patients find the timings and location of the Lab convenient? Do the patients face any difficulties for undergoing sputum microscopy?

EXERCISE 5 Be sure to include the following information in the checklist: The date of visit A space for the name and location of the laboratory Key recommendations of the previous visit The procedures you will check and whether they are correctly or incorrectly performed The method to be used to check each item/procedure A short list of the questions to ask when you are speaking to the Laboratory technician(s) A space for comments about any problems identified and possible causes A space for recommendations, and a space for your signature

Part A A site visit to a designated microscopy centre may occur during this training. If so, your facilitator will give the details of the visit. Use the checklist you have developed. After the site visit, there will be a group discussion about any problems your group found and the solutions you recommend.

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

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Training Course for Program Manager

SECTION C INFECTION CONTROL


There is the risk of transmission of tuberculosis infection occurring in health care facilities including the laboratory when patients remain undiagnosed and untreated for tuberculosis. This may be curtailed by early diagnosis and immediate initiation and adherence to RNTCP treatment regimens. This prompt and timely action will make infectious TB patients rapidly non-infectious. It is now mandatory that any Infection Control plan of the facility should include infection control for TB and TB/ HIV. Broadly, infection control needs to be addressed at three different levels: administrative, environmental and personal. Administrative control normally relies on the extent of complete implementation of RNTCP diagnostic and treatment guidelines in the health care facility. TB infection control plan includes the following: Giving priority for patients with cough for clinical and laboratory investigations for early detection of smear-positive pulmonary tuberculosis patients Reducing delay in starting appropriate RNTCP treatment once diagnosed Avoiding unnecessary admission for inpatient care Assessment of health care workers training needs requirements under RNTCP

Sputum collection should ideally be done outside the facility and away from the people. It should not be done in closed areas such as toilets and in ill-ventilated rooms. Processing specimens for smear microscopy (after sputum collection) has not been documented to cause any increased risk to laboratory personnel. However, TB suspects amongst health care workers should be subjected to screening procedures. Second priority is environmental control, which is used to reduce the generation and concentration of droplet nuclei in the air in high-risk areas. High-risk areas that increase transmission include exposure in relatively small, enclosed rooms in health facilities, which lack adequate cross ventilation in the form of open windows and doors to clean the environment through dilution or removal of infectious droplet nuclei. Hence, the TB IC plan should also include educating the patients regarding cough hygiene (covering the face while coughing and avoiding indiscriminate spitting), frequent identification of risk areas within the facility and providing good cross-ventilation to the area. Wearing of surgical masks made of cotton wool/ gauze/ paper for personal protection does not protect the person who is wearing the mask from inhaling the droplet aerosols and hence is not recommended as a means to prevent hospital infection. As mentioned above, early identification and prompt initiation of RNTCP treatment under direct observation would protect all health care workers from hospital TB infection. The key to reducing the risk of tuberculosis transmission at health facilities is early diagnosis and prompt initiation of RNTCP treatment regimens until cure. Infectious TB patients become rapidly non-infectious once they are started on directly observed treatment under RNTCP.

71

Training Course for Program Manager All health care workers working at the district level should receive onsite training at least once in two-years regarding the basic concepts of M. tuberculosis transmission and airborne infection control. The training should include the following: Signs and symptoms of TB, increased risk of TB disease in persons who have HIV infection and other immunosuppressive conditions and prevention of airborne infection with M. tuberculosis. An Infection control plan for TB-HIV may include precautions to be observed for HIV, in addition to that observed for TB, especially when streptomycin injections are being provided. The risk of acquiring HIV following percutaneous exposure (needle stick/ needle prick with inoculation) from an HIV-positive source is extremely low: 0.25- 0.3%. This is because the concentration of HIV in peripheral blood is extremely low (104 infectious virions /ml). On the other hand, the risk of acquiring hepatitis virus (HBV) following similar exposure ranges from 9-30% because the concentration of HBV in blood is high (>10,000,000 infectious doses /ml). The chance of acquiring Hepatitis C is approximately 310%. Disposable/ adequately sterilized needles and syringes should be used for streptomycin injection. Following streptomycin injection needles should be destroyed using needle cutters/ destroyers wherever available. Needles and syringes should be disposed using prevailing hospital waste management system. Health care workers can effectively prevent infections acquired through contaminated blood by the adoption of Universal Precautions or Bio-safety Precautions.

Bio-Medical Waste Management under RNTCP by PHIs:


The Government of India (GoI) under its Environment Protection Act (1986), passed the Biomedical Waste (Management and Handling) Rules in 1998 and a subsequent amendment followed in 2000. The rules form the legal framework for the collection, segregation, transportation, treatment and disposal of biomedical waste throughout the country. The State Pollution Control Boards (SPCBs) in the states and the Pollution Control Committees (PCCs) in the Union Territories are monitoring the compliance to the rules in the respective states. The RNTCP is integrated into the general health system of the states. Waste management is a component of overall facility management of the respective state health system institutions where RNTCP centres are located. Accordingly, the waste generated by RNTCP should not be viewed in isolation, but is to be integrated in the broad framework of the peripheral institutions waste management practices. The peripheral health institutions would be responsible for disposal of the wastes and reporting to their respective PCBs. Types of wastes generated by the RNTCP Human/biological waste (sputum); Sharp waste (needles, glass slides etc.); Used blister packs, drug packaging material; Plastic waste (waste generated from disposable syringes, cups and glasses); and Laboratory and general waste such as liquid waste, broomsticks, and paper waste; and Construction waste (waste generated from civil work activities). 72

Training Course for Program Manager Waste Management for RNTCP Waste generated under RNTCP will be discarded with the overall waste of the health facility in which services under RNTCP are provided. The staff carrying out RNTCP activities like LTs and DOT providers in PHIs will adopt infection control techniques as detailed in these guidelines and will take action to integrate waste generated under RNTCP into the waste management activities of the concerned PHI. The activities by the PHIs will include organized waste collection, information dissemination, reporting and monitoring of disposal of the waste.

Disposal of sputum container with specimen and wooden sticks


Step 1: Step 2: After the smears are examined, remove the lids from all the sputum cups. Put the sputum cups, left over specimen, lids and wooden sticks in foot operated plastic bucket/bin with 5% phenol or phenolic compound diluted to 5%. The cups and lids should be fully immersed in the solution. Keep it overnight/ for about 12 hours. Next day/ at the end of the day, drain off the phenol solution in to the drain. Take out the sputum cup/lid/wooden sticks and put into a reusable metal or autoclave-able plastic container or red bag. The red bag should have a biohazard symbol and adequate strength so that it can withstand the load of waste and be made of non-PVC plastic material. Put this container/bag into the autoclave with other autoclavable BMW and the contents should be autoclaved at 121C at 15 psi pressure for 15 20 minutes. The autoclave shall comply with the standards stipulated in the rules. Under certain circumstances, if autoclaving is not possible, boil such waste in a pressure cooker of approximately 7 litre capacity containing adequate amount of water to submerge the contents and boiled for at least 20 minutes using any heating source, electrical or non-electrical. However the District Hospital/CHC/PHC etc. shall ultimately be expected to make the necessary arrangements to impart autoclaving treatment on regular basis. After adequate cooling, the material can be safely transported to a common waste treatment facility for mutilation/shredding/disposal.

Step 3: Step 4:

Step 5:

Step 6:

lf a common waste treatment facility is not available in the area, the sputum cups/lids/ wooden sticks after autoclaving, can be buried in a deep burial pit. LTs and support staff handling biological waste should wear gloves.

Disposal of stained slides


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

Step 2 :

Under no circumstances should the slides should be broken.

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Training Course for Program Manager

ANNEXURE A : RECORDING AND REPORTING FORMATS FOR EQA


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

II Data on Slide volume for the last month: This information is necessary to (i) select slides for Blinded Rechecking for the current month and as cumulative number for (ii) next annual SPR, (iii) next annual negative slides and (iv) annual total slides.
Sl. No. 1 2 3 Type of slide (Includes diagnosis and follow up slides) Positive slides Negative slides Total Number

III Action required as per the previous visit:

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Training Course for Program Manager IV Current visit particulars


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

Within expiry date Y / N Within expiry date Y / N Within expiry date Y / N

32 33

Y/N Y/N

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Training Course for Program Manager


Sl. No 34 35 36 37 38 39 40 Item Personnel Training status Has each staff member participated in refresher training within past two years Safety Practices General order / cleanliness Timely reporting of results to clinicians Does the TB Register contain all smearpositive patients recorded in the TB Lab Register Are the smear results for follow up patients in the TB Lab Register the same as the results recorded in the TB Register Are all slides kept as required by the RNTCP EQA Programme? Are slides collected for EQA, do the number in the slide box correlate with the number in the Lab Register Adequate/ Acceptable Y/N Y/N Y/N Y/N Y/N Y/N Y/N Problems Identified

41

Y/N

42 43

Yes Yes

No No

76

Training Course for Program Manager V. Review of five positive and five negative slides from RNTCP TB Lab Register: (Systematic sampling, separately for positive and negative slides) a) Of the 5 Pos slides, number re-read as positive by STLS __________ b)
Sl. No. Slide No.

Of the 5 Neg slides, number re-read as negative by STLS __________


AFB result / Grade by
STLS LT of DMC

Tick appropriate column or write letter as indicated below table


Specimen Quality
10 WBC/ field < 10 WBC/ field

Staining
Good Poor (U/O)

Size
Good Poor (B/S)

Thickness
Good Poor (K/N)

Evenness
Good Poor

1 1 2 3 4 5 6 7 8 9 10

1: Write smear and grade 2: Tick appropriate column 3: Tick if good; write U if under-decolourized, O if over-decolourized 4: Tick if good; write B if too big, S if too small 5: Tick if good; write K if too thick, N if too thin 6: Tick appropriate column

* Please carefully review all discordant slides with the LT Overall summary (please tick appropriate alternative):
Specimen quality: Smear size: Smear thickness: Smear evenness: Staining: Needs improvement Yes No Needs improvement Yes No Needs improvement Yes No Needs improvement Yes No Needs improvement Yes No

Name of STLS: Name of LT: Name of MO-in-charge: Date:

Signature of STLS: Signature of LT: Signature of MO-in-charge:

77

Training Course for Program Manager On-site evaluation summary of EQA of Smear Microscopy of DMC by DTO (a copy of this summary to be submitted by DTO to MO of DMC for corrective actions)
DMC:

Date of visit: (dd/mm/yyyy) Visiting STLS: Action required as per the previous visit:

Summary
a) Operational problems (both pending and new)

b)

Technical problems (both pending and new)

c)

Overall remarks

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Training Course for Program Manager

d)

Action Required

Name of STLS: _________________ Date_____________ Remarks by DTO

Signature of STLS: _________________

Signature of DTO Copy to CMO of the District

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Training Course for Program Manager

LT SMEAR RESULTS SHEET FOR BLINDED RECHECKING (ANNEXURE B)


Microscopy Centre: ________________________ Name of TU: ______________________________
Sl. No. Lab No.

District: _____________________ Month & Year: ________________

Result of LT of DMC, including grade for positive smears

1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21. 22. 23. 24. 25.

Name of Lab. Technician: __________________________________________

Signature: _________________________________ Date: _______________

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Training Course for Program Manager

ANNEXURE C: RNTCP EQA of Sputum Microscopy


Worksheet for RBRC
Microscopy Centre Code: _______________________ District: ______________________________________
Sl. No. Slide No. STLS AFB result / Grade by MC 1 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 Total Umpire Specimen Quality 10 < 10 WBC/ WBC/ field field 2

TU _____________________ Month and Year:__________

Tick appropriate column or write letter as indicated below table


Staining Good 3 Poor (U/O) Size Good 4 Poor (B/S) Thickness Good 5 Poor (K/N) Evenness Good 6 Poor

1: MC result to be entered under supervision of DTO only after form completed by STLS 2: Tick appropriate column 3: Tick if good; write U if under-decolourized, O if over-decolourized 4: Tick if good; write B if too big, S if too small 5: Tick if good; write K if too thick, N if too thin
Overall remarks:

Specimen quality: Smear size: Smear thickness: Smear evenness: Staining:


Remarks:

Needs improvement Yes No Needs improvement Yes No Needs improvement Yes No Needs improvement Yes No
Needs improvement Yes No

Date of examination: ____________________

Signature of first controller: ________________

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Training Course for Program Manager

ANNEXURE D: RNTCP Quality Assurance Report on Sputum Microscopy


Microscopy centre: _____________________ TU and District: ______________ Month/Year: _________________
Result of MCLT Negative 1-9 AFB/ 100 fields 1+ 2+ 3+ Result of controller * Negative Correct LFP HFP HFP HFP 1-9 AFB/ 100 fields LFN Correct Correct QE QE 1+ HFN Correct Correct Correct QE HFN QE Correct Correct Correct 2+ HFN QE QE Correct Correct 3+

* Enter the number of slides on each box


No. of False result False (-)ve False(+)ve Slide No. / Error

Name and signature of STLS of concerned DMC: ____________________ Reporting Date: _______________ Signature of DTO: _______________

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ANNEXURE E: District Monthly Report to IRL on Randon Blinded Re-checking


Slide positively rate (SPR)* Nos. of HFP slides rechecked during the months@ HFN LFP LFN QE Total number of errors Remarks

District monthly report to IRL on random blinded rechecking

SI No.

DMC name

Annual Slide volume*

Annual positive slides*

Total for the district

*For the previous year. @ Monthly sample size calculated from Annual sample size for 80% Sensitivity. 100% Specificity and d=0 and Confidence limit = 95%

Training Course for Program Manager

DTOs On-site evaluation Quarterly report of EQA to IRL (ANNEXURE F)


District: Quarter _____ Year _____

Details of corrective actions recommended and taken


Sl. No. DMC Corrective actions recommended Corrective actions taken Remarks

D) Any other remarks.

Signature of the DTO

84

Annexure G
Information on Slides Annual positive slides* HFP HFN LFP LFN QE HFP HFN Both HFP & HFN No. of slides rechecked during year@ Number and type of erros in slides Rechecked cumulative in the district during the year Number of DMCs in the district with HF errors % of DMCs with HF errors % of DMCs with HFP errors Information on DMCs

IRL annual report to CTD and NRL on random blinded rechecking

SI. No.

Name of the district

Total number of DMCs

Information on Slides

Annual slide Volume*

Total

* For the previous year ** Each HFP or HFN error committing DMC is counted only once in the reporting year @ LQAS Annual sample size for 80% sensitivity, 100% Specificity and d=0 confidence limit = 95%

Training Course for Program Manager

Annexure H: EQA standard Guidelines for reagents and equipment


1) Standards for Reagents a. Specifications: i. Basic fuchsin 1. The chemical name: Pararosaniline hydrochloride 2. The chemical structure: C19H18N3Cl 3. Molecular Wt: 323.8 4. Colour: Metallic green 5. Dye content: Should be available on the container. Approximately 85% - 88% (to calculate the required amount of Basic fuchsin, divide the actual amount by dye content. For example: Dye content = 85%, actual amount = 10 gms, required amount = 10/0.85 = 11.76 gms.) ii. Carbolic acid: 1. The chemical name: Phenol 2. The chemical structure: C6H5OH 3. Molecular Wt: 94.11 4. Melting point: 40oC+2 5. Purity: 99.5% 6. Please note: The critical concentration of Phenol in Carbol fuchsin is 5%. 7. Phenol is highly corrosive, handle with extreme care. Methylated spirit 1. Chemical name: Ethanol denatured + 5% Isopropyl alcohol + 5% Methanol 2. Molecular structure: C2H5OH 3. Molecular wt: 46.07 4. Purity: 90% Sulphuric acid: 1. Chemical structure: H2SO4 2. Molecular wt: 98.08 3. Purity: 95-97% 4. Colour: Clear Methylene blue: 1. The chemical name: Methylthionine chloride 2. The chemical structure: C16H18ClN3S. 3. Molecular Wt: 319.9 4. Dye content: Should be available on the container. Approximately 82% (to calculate the required amount of Methyl blue, divide the actual amount by dye content. For example: Dye content = 82%, actual amount = 1 gms, required amount = 1/0.82 = 1.22 gms.)

iii.

iv.

v.

86

Training Course for Program Manager b. Immersion oil: i. Immersion oil supplied by the manufacturer of microscope with refractive index closer to that of Glass or 1.515 ii. Liquid paraffin (heavy), refractive index of 1.48, a colourless, odourless, transparent, free from fluorescence in day light with relative density of 0.827 to 0.890, viscosity of 110 to 230 mPa s., specific gravity of 0.76-0.78 at 15.5oC. 2) Shelf life of prepared reagents: Carbol fuchsin, sulphuric acid, methylene blue reagents may be kept for a maximum period of 4 months. 3) Identification: All reagents should have a label with name of the reagent, name of the TU, name of MC, the date of preparation and the expiry date. The containers of Carbol fuchsin, Sulphuric acid, Methylene blue reagents should in addition have the name of the person preparing the reagent. Freshly prepared reagents should not be mixed with old stock. 4) Equipment: a. Slides: i. Size: 76 mm x 26 mm, ii. Thickness: 1.3 mm iii. Edges: Polished iv. Sealed in a moisture absorbing dessicant pack b. Balance: i. Type: Electronic or Analytical balance 1. Electronic balance: a. General purpose table top laboratory balance, 220-230 V, stainless steel platform, keypad auto calibration function, auto off, prolonged battery life, overload and under load, low battery LCD indicator. b. Range: Wide range, 0.01 120 gms, (two digit decimal) c. Resolution: 0.01 gm 2. Analytical balance: a. Enclosed in a glass box with shutters, dimensions of the box in cms: 46 x 34 x 20 b. Oscillator type of balance, with levelling screws, two aluminium pans, plumb line for adjusting horizontal level c. Weighing capacity: 1 mg to 200 gms, with fractional weight and regular weight in boxes including rider and forceps to handle weights. c. Binocular microscopes: i. Specifications: As per Expert Committee recommendations.

87

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

3.

Objectives

4.

Nose piece

5.

Stage

6.

Sub-stage condenser

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Training Course for Program Manager


irisdiaphram, The condenser should have a filter holder and removable/swinging/out blue filter (suitable for bright field Microscopy) 1. The system should have a built-in variable light source (Illuminator). This light source should have a 20W, 6V Halogen lamp. The circuitry for the light source should include a constant voltage supply. The system should be provided with a step down transformer and an on/off switch and intensity control. The lamp should be provided with a lamp socket which has the facility for easy replacement of the bulb. The housing of the light source should be such that it will prevent dispersion of light and heating up of the body of the microscope. 2. Power supply. o Voltage: 220V, 50 Hz AC o should have one on-off power switch, 3 core power cord with a 3 point male plug. 3. The system should have an inbuilt protective/safety device to withstand fluctuations of voltage from 140V to 280V. 4. A plano-concave mirror in fork mounting should be supplied which would be attachable to the base of field use. (where power is not available.) 5. The fuse for the halogen lamp should be easily accessible to the operator. 6. The Illuminator should have a built-in field diaphragm for Kohler illumination. Binocular eye piece tubes, inclined at 45 degrees, rotatable through and angle of 360 degrees, having inter-pupillary distance range of 54-74 mm or wider, covering the above mentioned range. Co-axial coarse and fine focusing knobs capable of smooth fine focusing movement over the full range of coarse travel. The fine focusing movement should have sensitivity of two microns or less (finer) over the entire coarse focusing range. The focusing knob should be on both sides. A focusing stop safety arrangement should be provided. i). All optical parts including objectives, eye pieces and prisms should have anti-reflective coating which also gives anti fungal property. ii). All metallic parts should be corrosion-proof, acid-proff and stainproof. iii). All parts of the microscope (including removable parts) should have insignia of the manufacturer engraved on it. iv). The supplier will supply the complete assembled microscope in a wooden box along with dust free cover. The box carrying the microscope should be made of well-seasoned wood or teak ply or board. The box should be suitably padded from inside of eliminate the risk of shock during transportation. It should be complete with lock and key arrangement, a suitable locking screw for securing the microscope and a cross-piece to retain it in position during transit. The box should be of an appropriate design with a carrying handle at the top and appropriate internal receptacles for holding the objectives, eyepieces and accessories. It should contain a bag of activated silica gel to keep the interior moisture-free. v). Each assembled microscope should be accompanied by an authorized list of accessories and spare parts. vi). Technical brochure (catalogue) and working manual should be provided with each microscope. vii). A bottle of a least 25ml immersion oil, a roll of lens tissue paper

7.

Sub-stage illuminator

8. 9.

Eye piece tubes Focusing knob

10.

General

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Training Course for Program Manager


and lens cleaning solution (100 ml) should be provided with each microscope. viii). One piece of anti static cleaning brush should be provided with each microscope for cleaning purpose. ix). Each microscope should be supplied with Blue filter. The blue filter should be packed in the box and not fixed on the microscopes. Each microscope should be supplied with spare parts as under: (as mentioned in Schedule of Requirement) i). 100x oil immersion objective (as per the specifications given under B3)-One ii). Halogen bulb, (6 volts, 20w)-6 Nos. iii). Fuses 6 Nos. Performance warranty of three years from the date of supply. For any malfunction, the supplier shall replace the parts or repair the same at the user site free of cost within 15 days of the receipt of the complaints. During warranty period all services/replacement ensuring smooth functioning of the Microscopes must be done free of cost by the supplier. The supplier should have adequate after sale service facilities covering all region of the country. They should have the infrastructure and trained manpower to attend to any complaints within 15 days of receipt of the complaint. i). ii). The successful vendor should supply a type test-certificate of the relevant optical & mechanical tests from a recogniszed competent authority at the time of supply. The manufacture/supplier shall provide duly calibrated (by accredited authority) measure instruments and demonstrate specifications for the purpose of inspection.

11.

Spare parts

12.

Warranty

13.

14.

Requirement of service centre for after sales services Testing & calibration

90

ANNEXURE K: Investigation of Errors


Possible causes Examine a 3+ using that microscope Check stains and staining procedure Test with clear-cut positive & negative slides and good microscope Exclude other causes Suggested investigation steps

SI No. 1.

Pattern of errors

HFP and HFN

2.

HFP with or without LFP

Unusable microscope Staining problems, poor stains, insufficient staining time or heating Technician cannot recognized AFB Gross neglect, overworked, lack motivation Administrative error Poor registration routine Staining problems/Fading

3.

Many LFP, with or without occasional HFP Administrative error Very thick smears and/or poor light Gross neglect Staining problems

Technician unclear on AFB appearance Problem with controllers Technician unclear on AFB appearance Contaminated stain/reagents

4.

HFN with or without LFN

Poor smearing technique Problems with microscope Careless microscopy 5. Very high proportion LFN. Reading error Concentrated Methylene blue 6. Many QE (too low grading) Poor staining Problems with microscope *Refer RNTCP LT Module, Mannual and STLS Module for causes of False Positive and False Negative results.

Compare lab-register and verify correct slide number and result? Check accuracy of lab-register and other record keeping Check stains and staining procedure, consider re-staining for rechecking. Assess concentration of Phenol, Basic Fuchsin and Methyllene blue. Look for inconsistent result of suspects (regularly single pos / low positive) in lab register. Evaluate controllers Recheck sample of LFP from laboratory register Test stain with known negative smears, check the distilled water used for stain preparation. Compare lab-register with QC-listing: correct slide number & result? Evaluate quality of smear preparation, check microscope Exclude other causes Check stains and staining procedure, consider re-staining for rechecking. Assess concentration of Phenol, Basic Fuchsin and Methylene blue. Test stain with known negative smears Check microscope with positive slide Exclude other causes As above

Annexure L Possible reasons Inadequate referral of suspects Non-involvement of private sector Many DMCs in the area Suggested corrective actions

Possible reasons and suggested corrective actions for DMCs with unacceptable ANSV and SPR

SI No. 1.

Finding

Low ANSV (<500)

2.

Low SPR (<5%)

3. High OPD attendance worlload Slective referral / delayerd identification of TB Suspects More of false positive smear results

Low ANSV and SPR

Improper or over selection of TB suspects More of false negative smear result As above

4. 5.

High ANSV (>5000) High SPR (>15%)

Educate Medical Officers and Health Workers on Chest symptoms Involve private sector, without increasing the number of DMCs in the area Reassess the criteria for selection of DMCs. Generally health facilities with <60 daily new adult OPD attendance should not be involved as DMCs. Educated Medical Officer and Halth Workers on chest symptoms Action as required for frequent HFN and LFN Re-stain and test with known positive slides Evaluate as above and if required consider closing the concerned DMC Train more than one LT for AFB smear microscopy Educate Medical Officers and Health Workers on Chest symptoms Action as required for frequent HFP and LFP / test with known negative slides.

ANNEXURE M: Tuberculosis Monthly Abstract


Tuberculosis Laboratory Monthly Abstract (Record Numbers)
Follow-up patients examined Patients positive in follow up Total slides examined Total positive slides Total negative slides Signature of LT and STLs

Month

Year 200

TB suspects examined for diagnosis

TB suspects found positive

TB TB suspects suspects found undergoing positive on repeat repeat sputum examination examination

Jan

Feb

Mar

Apr

Apr

May

Jun

Jul

Aug

Sep

Oct

Nov

Dec

Total

Signature of the M.O.

Training Course for Program Manager INFECTION Control & Disposal of Wastes- As annexure- Give No. Design for Deep Burial Pits

Pit for onsite disposal of Sharps


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

1.5M

94

Annexure N IQC Formats Control Slide preparation Register (For use at DTC)
No. of slides prepared TU1 Date Date Date Date TU2 TU3 TU4 TU5 No. of pairs of slides distributed (QCP+QCN slides) Date Signature of STLS

Sl. No. QCP Slides QCN Slides

Batch No.

Date of Preparation

Annexure O Format for use of control slides for IQC in DMCs:

Control Slide usage Register for DMCs


QC - Positive Smear Batch Actual Expected Slide No Result Result Batch Slide No QC Negative Smear Actual Expected Result Result Signature of LT

S.No.

Date

CF Batch No

MB Batch No

H2SO4 Batch No

10

11

12

13

14

15

16

17

18

19

20

Annexure P

PREPARATION & VALIDATION OF 25% SULPHURIC ACID


Quantity of conc. H2SO4 (ml) Volume of DW (ml)

Batch No.

Date of preparation

Date of Exp.

Volume of reagent to be prepared (ml)

Results of Quality control smear Positive control Negative control Batch & Batch & Slide Expected Slide Expected Result Result No. Result No. Result

Annexure Q

PREPARATION & VALIDATION OF 1% CARBOL FUCHSIN


Results of Quality control smear Positive control Negative control

Batch No. Alcohol (ml) Result Phenol (g)

Date of prepar ation Dye content (potencv) (%) Add DW upto mark. Batch & Slide No.

Date of Exp.

Volume of stain to be prepared (ml) Expected Result

Dye require d(g)

Amount of Dye powder required after potecny correction .(g) Batc h& Slide No.

Result

Expec ted Result

Table of Contents
Module - 3 Treatment Services
Treatment Services Learning Objectives ............................................................................................................... Gold and Objectives of Treatment ....................................................................................... Scientific basis of Treatment of TB ........................................................................................ Domiciliary Treatment........................................................................................................... Short Course chemotherapy ................................................................................................. Basis of Chemotherapy.......................................................................................................... Directly Observed Treatment (DOT)...................................................................................... Disease classification ............................................................................................................. Treatment regimens .............................................................................................................. Patient wise boxes ................................................................................................................. Treatment of Pediatric TB ..................................................................................................... Non-DOTS (ND) treatment regimen under RNTCP................................................................ Organization of DOT and flow of patients for treatment...................................................... Flow of patients for treatment .................................................................................................... Documentation for referral for treatment .................................................................................. Patient Provider Interaction ........................................................................................................ Filling up of the treatment card ................................................................................................... General Information of Patient.................................................................................................... Data related to DOT ..................................................................................................................... Administration and monitoring of treatment .............................................................................. Retrieval action in interruptions of treatment ............................................................................ Determination of treatment outcome with date ........................................................................ Chemoprophylaxis ....................................................................................................................... HIV related data ........................................................................................................................... Management of patients with treatment interruptions.............................................................. Adverse reaction to Anti-TB drugs ............................................................................................... Management of patient in special situations .............................................................................. Procedures during hospitalization ............................................................................................... Management of Hospitalized Patient .......................................................................................... Multidrug Resistant TB and DOTS-Plus ........................................................................................ Management of MDR-TB ............................................................................................................. Improving Interpersonal Communication skills in RNTCP Training: ............................................ Type of Communication .............................................................................................................. How to use the section ................................................................................................................ Demonstrate good interpersonal skills yourself .......................................................................... Role play for doctors .................................................................................................................... Interpersonal communication .................................................................................................... Role Play Scenarios ..................................................................................................................... Formats of Records Annexure ..................................................................................................

101 101 101 102 102 102 104 105 106 108 109 110 111 113 113 115 118 118 119 120 125 126 128 129 132 134 137 138 139 142 143 148 149 153 154 156 157 163 167

Training Course for Program Manager

MODULE 3
Treatment services
Learning objectives
In this module, the participants will learn about the following:

Goal and objectives of treatment Scientific basis of treatment

The participant should be able to perform / manage the following activities: Disease classification, case definitions and treatment regimens Organization of DOT and flow of patients for treatment Imparting health education and IPC skills Filling up of TB treatment card Management of patients with treatment interruptions Adverse reactions to drugs Special situations and procedures during hospitalization

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

Goal and Objectives of treatment


The goal is to reduce mortality and morbidity associated with tuberculosis and to cut the chain of transmission of infection. This is achieved through the following objectives: Ensuring high cure rates; Preventing emergence of drug resistance; and Minimizing relapses. RNTCP uses short course chemotherapy given intermittently - thrice weekly under Direct Observation for both pulmonary and extra pulmonary tuberculosis patients.

Scientific basis of treatment of TB


The strategies adopted in the treatment of TB are based on both scientific and operational research. The following four components are discussed in brief. Domiciliary treatment Short course chemotherapy 101

Training Course for Program Manager Intermittent regimen Direct observation of treatment

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

Short course chemotherapy


Short course chemotherapy regimens have made it possible to treat and cure TB patients in as short a period as six to eight months. Reduction in the duration of treatment regimens was possible because of the introduction of Rifampicin and Pyrazinamide. Treatment regimens of six months duration either given daily or on intermittent basis have been found to be equally effective and achieve high cure rates, prevent emergence of drug resistance and minimize relapses. The shorter duration has contributed to improvement in the treatment adherence. Intermittent short course chemotherapy regimens of 6-8 months are recommended internationally for all forms of extra-pulmonary TB.

Basis of chemotherapy
(a) Bacteriological basis In an untreated smear positive pulmonary tuberculosis patient, there are naturally occurring drug resistant mutants to different drugs at different frequencies. The larger the bacterial population higher is the probability that resistant mutant strains are present. The number of bacilli are lower in smear negative and extra pulmonary lesions. The number of viable bacilli commonly found inside the cavities sized about 2 centimeters in diameter on an average is likely to be in excess of 100 million (108). As a thumb rule the frequency of occurrence of drug resistant mutants would be roughly ~1 in 106 to isoniazid (H), ~1 in 106 to streptomycin (S) and ~1 in 108 to rifampicin (R). Based on these frequencies, the chances of naturally occurring organisms that is resistant to both H and R would be roughly ~1 in 1014, which is virtually negligible. There would be appreciable numbers of mutants resistant to any single drug before the start of the treatment that are capable of multiplying and will not be affected by a single drug, e.g. isonaizid. This accounts for frequent failures observed with monotherapy of patients harbouring large number of bacilli. Thus, if two or more drugs are given concurrently, in the initial Intensive Phase when the bacterial load is high the chances of survival and selection of drug resistant organism to any drug would be very small as mutants resistant to one drug are as a rule susceptible to other and vice versa. This is the basis for the use of multi-drug therapy in the treatment of tuberculosis.

i. Existence of naturally occurring drug resistant mutants

Role of intensive phase


The objective of combining four drugs in the intensive phase (IP) is to achieve rapid killing of actively multiplying bacillary population. This phase will eliminate naturally occurring drug resistant mutants and prevent the further emergence of drug resistant 102

Training Course for Program Manager mutants. An optimal minimum duration of two months in new cases is essential for achieving smear conversion of 90% and above, thereby significantly reducing the infectiousness of the patient.

Role of continuation phase


Continuation phase (CP) with fewer drugs for a comparatively longer time will ensure elimination of persisters which are responsible for relapses. The optimum duration of continuation phase is four months in new cases.

ii. Existence of sub-bacillary population


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

R A Extra-cellular rapidly multiplying 108

H R S E

Extra-cellular intermittently multiplying <105

D Dormant

No drugs

Intra- and extracellular, acidic environment slowly multiplying <105

The bacillary sub populations B and C are referred as semi-dormant or persisters which are difficult to eliminate and are the source of relapse. Anti-TB drugs have the following three actions: a. Early bactericidal activity b. Sterilizing activity c. Ability to prevent emergence of drug resistance Isoniazid (H): Isoniazid is a potent drug exerting early bactericidal activity, prevents emergence of drug resistant mutants to any companion drug and has low rates of adverse drug reactions. 103

Training Course for Program Manager Rifampicin (R): Rifampicin is a potent bactericidal and sterilizing drug acting on semidormant bacilli which multiply intermittently and causing relapse Pyrazinamide (Z): Pyrazinamide is a bactericidal and sterilizing drug effective in eliminating the semi dormant bacilli multiplying slowly in an acidic environment. Ethambutol (E): Ethambutol is an effective bacteriostatic drug helpful in preventing emergence of resistance to other companion drugs. Streptomycin (S): Streptomycin is a bactericidal drug known to reduce septicaemia and toxicity. The ranking of the drugs with respect to their type of activity is indicated in the following table. Drugs Isoniazid Rifampicin Streptomycin Pyrazinamide Ethambutol Early bactericidal ++++ +++ +++ ++ + Sterilizing activity ++ ++++ +++ Prevention of emergence of drug resistance ++++ +++ ++ + ++

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

Intermittent treatment
Intermittent regimens should only be used in a programme of directly observed treatment (DOT). The formulation of intermittent regimens in the treatment of TB is based on the principle of existence of lag period. There is no need to maintain blood levels of drugs for 24 hours in the treatment of tuberculosis. The ability of the drugs to continue to exert its antimicrobial activity even after their withdrawal is called as lag period, this renders the intermittent regimen possible Advantages of intermittent regimen are: As effective as daily treatment Facilitates DOT Reduction in total quantity of drugs consumed Fewer adverse reactions

Directly Observed treatment (DOT):


Studies in India and many other countries have consistently shown that at least one third of patients do not consume medicines regularly. DOT is a supportive mechanism that ensures the best possible results in treatment of TB. Here a DOT Provider helps the patient in taking 104

Training Course for Program Manager the treatment, thereby ensuring adherence. Many patients who do not receive directly observed treatment stop taking drugs once they feel better. It is neither possible to predict who these patients will be nor to prevent non-adherence through health education. Studies have shown that there will be poor treatment outcome and high death rates in the absence of DOT, even when regular supply of drugs is ensured. Hence, by providing DOT, RNTCP ensures that patients receive the right drugs, in the right doses, at the right intervals and for the right duration.

Disease classification
Tuberculosis cases are classified as either pulmonary or extra pulmonary.

Pulmonary Tuberculosis
Pulmonary TB is characterized by the formation of lesions in the lungs. Pulmonary TB is further subdivided into smear-positive and smear-negative cases.

Smear-positive pulmonary TB
A patient with one or two smears positive for AFB out of the two sputum specimens subjected for smear examination by direct microscopy is classified as having smear positive pulmonary TB.

Smear-negative pulmonary TB
A patient with symptoms suggestive of TB with two smear examination negative for AFB, with evidence of pulmonary TB by microbiological methods (culture positive or by other approved molecular methods) or Chest X-ray is classified as having smear negative pulmonary tuberculosis.

Extra-pulmonary TB
Tuberculosis of organs other than the lungs such as pleura, lymph nodes, intestine, genitourinary tract, joint and bones, meninges of the brain etc., is called as extra-pulmonary TB. Pleural tuberculosis is classified as extra pulmonary. The diagnosis should always be supported by investigations like histopathology, Cytology, Radiological and Bio-chemical examinations. Wherever facilities for culture are available, this can be utilized for the diagnosis. The investigations undertaken for diagnosis have to be mentioned in the appropriate spaces provided in TB treatment card and TB register. A photocopy of the records / investigation reports available with the patients may be kept at PHI along with TB treatment card. If a patient has both smear-positive pulmonary TB and extra-pulmonary TB, the patient is classified as having pulmonary TB and the site of extra-pulmonary TB is recorded as well.

Type of cases
New
A TB patient who has never had treatment for TB or has taken anti-TB drugs for less than one month is considered as a new case. 105

Training Course for Program Manager

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

Treatment after default


A patient, who has received treatment for TB for a month or more from any source and returns for treatment after having defaulted i.e., not taken anti-TB drugs consecutively for two months or more and found to be smear-positive is a case of treatment after default.

Failure
Any TB patient who is smear-positive at 5 months or more after initiation of treatment is considered as failure.

Chronic
A patient who remains smear-positive after completing regimen for previously treated but not initiated on MDR-TB treatment

Relapse
A TB patient who was declared cured or treatment completed by a physician and who reports back to the health facility and is now found to be sputum smear positive is a relapse case. Others A patient who does not fit into the any of the types mentioned above. The reasons for labelling a patient under this type must be specified in the Treatment card and TB Register

Treatment regimens
For the purpose of treatment regimen to be used, TB patients are classified into two groups, namely, New or Previously Treated, based on the history of previous treatment. Regimen for New cases: This regimen is prescribed to all new pulmonary (smear positive and negative), extra pulmonary and others TB patients. The regimen is 2H3R3Z3 E3 / 4 H3R3. Treatment is given in two phases. For New patients, the intensive phase consists of isoniazid (H), rifampicin (R), pyrazinamide (Z) and ethambutol (E) given under direct observation thrice a week on alternate days and lasts for 2 months (8 weeks, 24 doses). This is followed by the continuation phase, which consists of 4 months (18 weeks; 54 doses) of isoniazid and rifampicin given thrice a week on alternate days with at least the first dose of every week being directly observed. If the sputum smear is positive after 2 months of treatment, the intensive phase of four drugs (H, R, Z and E) are continued for another one month (12 doses) and sputum examined after the completion of the extension of intensive phase. Irrespective of the sputum results after this extension of the intensive phase, the 4 months (18 weeks) of the continuation phase is started. If the sputum smear is 106

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

107

Training Course for Program Manager The table below indicates the treatment regimen, type of patients and regimens prescribed.
Treatment groups Regimen Type of patient Sputum smear-positive Sputum smear-negative Extra-pulmonary Others Smear-positive relapse Smear-positive failure Smear-positive treatment after default 2 Others Intensive Phase (IP) 2H3R3Z3E3
1

Continuation Phase (CP) 4H3R3

New*

Previously Treated**

2H3R3Z3E3S3 / 1H3R3Z3E3

5H3R3E3

1. The number before the letters refers to the number of months of treatment. The subscript after the letters refers

to the number of doses per week. The dosage strengths are as follows: Isoniazid (H) 600 mg, Rifampicin (R) 450 mg, Pyrazinamide (Z) 1500 mg, Ethambutol (E) 1200 mg,Streptomycin (S) 750 mg. Patients who weigh 60 kg or more receive additional rifampicin 150 mg. Patients who are more than 50 years old receive streptomycin 500 mg. Patients who weigh less than 30 kg, receive drugs as per Paediatric weight band boxes according to body weight. 2. In rare and exceptional cases, patients who are sputum smear-negative or who have extra-pulmonary disease can have recurrence or non-resonse . This diagnosis in all such cases should always be made by an MO and should be supported by culture or histological evidence of current, active TB. In these cases, the patient should be typed as Others and given treatment regimen for previously treated * New includes former categories I and III ** Previously treated is former category II.

Patient wise drug boxes


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

* Prolongation of IP for one month (12 doses) is given to new cases and previously treated cases at the end of Intensive Phase

108

Training Course for Program Manager Drug dosages for adults in the blister packs 1
Drugs Isoniazid Rifampicin (H) (R) Dose (thrice a week) 600mg 450mg
2

Number of tablets in blister pack 2 x 300 mg 1 x 450 mg 2 x 750 mg 2 x 600 mg -

Pyrazinamide (Z) Ethambutol (E)

1500mg 1200mg 0.75g


3

Streptomycin (S)
1

Adult patients who weigh <30kgs receive drugs in PWBs from the respective weight band suggested for paediatric patients 2 Patients who weigh 60 kg at the start of treatment are given an extra 150 mg of rifampicin 3 Patients over 50 years of age are given 0.5 g of streptomycin

Treatment of Pediatric TB
Pediatric cases are to be treated under RNTCP with the same thrice weekly short course chemotherapy regimens (New or Previously treated) given under DOT as for adult patients. They are to be registered in the respective RNTCP TB Register. Pediatric patientwise boxes are available with different dosages as two product codes to be used under four weight bands for children weighing 6 to 10 kgs, 11 to 17 kgs, 18 to 25 kgs and 26 to 30 kgs.. Wherever possible, before a child is started on the Previously Treated regimen, s/he should be examined by a Pediatrician or TB expert.

Pediatric PWB with dosages


DRUGS Product code (PC) -13 IP CP 24 18 blisters blisters 75 mg 75 mg 75 mg 75 mg Product code (PC) -14 IP CP 24 18 blister blisters 150 mg 150 mg 500 mg 400 mg 150 mg 150 mg PC-15 PC-16

12 blisters

12 blisters

Isoniazid Rifampicin

Prolongation Prolongation of IP for PC of IP for PC 13 14

Pyrazinamide 250 mg Ethambutol 200 mg

109

Training Course for Program Manager Pediatric patient wise boxes for new cases according to weight band Weight band 6-10 Kg 11-17 Kg 18-25 Kg 26-30 Kg* For New cases IP CP PC 13 PC 14 PC 13 + PC 14 PC 14 x 2 Prolongation of IP

PC 15 PC 16 PC 15 + PC16 PC 16 x 2

* For children weighing >30 kgs, adult PWB are to be used

Pediatric patient wise boxes for previously treated cases according to weight band

Weight 6-10 Kg 11-17 Kg 18-25 Kg 26-30 KG

For previously treated cases IP (PC 13+ PC15) + (24 vials inj sm*) (PC 14 + PC16) + (24 vials inj sm*) (PC 13 + PC 14 + PC 15 + PC 16) + (24 vials inj sm*) (PC 14 x 2)+ (PC 16 x 2) + (24 vials inj sm*) CP (PC 13 + 54 Tab E 200 mg) + (PC 15 without Z) (PC 14 + 54 E 400 mg) + (PC 16 without Z) (PC 13 + PC14 + 54 Tab E 600 mg) + (PC 15+ PC 16 without Z) (PC 14 x 2+ 54 Tab E 800 mg) + (2 x PC 16 without Z)

Prolongation of IP PC 15 PC 16 PC 15 + PC 16 PC 16 x 2

* Injection streptomycin 15mg/Kg body weight

DOTS is the recommended strategy for treatment in adults and children All pediatric TB patients should be registered under RNTCP

Non-DOTS (ND) treatment regimen under RNTCP


In rare and exceptional situations, non-DOTS treatment (with a self-administered nonrifampicin containing regimen) may be needed in a few TB cases. Examples include: Those with adverse reactions to rifampicin and / or pyrazinamide New patients who refuse DOT,S despite all efforts To facilitate registration of patients started on non-DOTS regimens, a Tuberculosis Treatment Card should be filled. A maximum of 1% of patients may get non-DOTS 110

Training Course for Program Manager treatment in an RNTCP area. The justification for initiating patient on non-DOTS treatment should be specified in the Remarks column of the treatment card and TB register. This is a treatment regimen of 12-month duration comprising 2 months of SHE and 10 months of HE (2SHE / 10HE). Dosages administered per day in the regimen are: Isoniazid Ethambutol Streptomycin 300 mg 800 mg 750 mg (500 mg for those >50 years of age).

Those who weigh less than 30 kgs receive dosages calculated as per body-weight.

Organization of DOT and flow of patients for treatment


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

Explanation about the disease and assured cure. Modalities of treatment-dosage schedule, duration, follow up, common sideeffects and methods to prevent them importance of directly observed treatment (DOT) Need for screening of children and symptomatic contacts

Identification of suitable DOT Centre and DOT Provider - accessible and acceptable to the patient and accountable to health system Opening of Tuberculosis Treatment Card (in duplicate) and the TB Identity Card Arrangement for shifting patient-wise box to the DOT Centre along with the duplicate TB treatment Card, TB Identity Card and sputum containers for collection of early morning samples for follow-up examinations.

For the purpose of identifying an ideal DOT provider and an appropriate DOT Centre, a DOT Directory should be maintained at PHI level. This directory should contain a localitywise list of DOT Centres / DOT Providers in the area. It should be updated regularly. DOT can be provided by anyone other than the member of patients family. It is the responsibility of the Government field staff (PHWs / MPWs) to organize and ensure DOT for the patient. They would also monitor and supervise the community DOT Providers in their respective sub centres. If the patient is to be given DOT by a Peripheral Health Worker (PHW) / community DOT Provider, a duplicate treatment card will be prepared and given to the PHW. The MO of the PHI will give the patient-wise box containing drugs for the entire duration of treatment to the PHW and records the same in the drug stock register maintained at the PHI.

111

Training Course for Program Manager The PHW visits the house of the patient as soon as possible for confirmation of the residential address and has a detailed dialogue with the patient and other members of the family. Patient should be started on treatment within a week. Emphasis is given to the points similar to the ones mentioned above for the MO-PHI. This opportunity should also be used for screening of contacts. The initial home visit should be recorded in treatment card in the space provided. A convenient location for drug administration and a suitable DOT provider is decided mutually by the PHW and the patient.

112

Training Course for Program Manager

FLOW OF PATIENTS FOR TREATMENT TB Suspects


Referred to DMC with request for sputum examination by MO PHI / PP / NGO / Others

DMC

Registers in lab register LT Collects 2 sputums Sends result to referring physician

Referring Physician

History of previous treatment Prescribes appropriate regimen Treatment card is opened Organizes DOT Identifies DOT provider Sends PWB with duplicate treatment card to DOT Provider Refers to ICTC Address verification Motivation , Contact tracing Arranges for DOT Updates original treatment card at PHI DOT provider provides the DOT Records drug collection Sends for follow-up examination Collects the treatment card records treatment outcome

MO PHI

PHW

DOT Centre

MO-PHI

updated Treatment card is submitted to the TU after completion of treatment

Documentation for referral for treatment


If the patient resides outside the jurisdiction of the referring institution, a copy of the Referral for Treatment Form (annexure) must be sent to the facility where the patient will begin treatment. A Referral for Treatment Register (annexure ) should be maintained in DMCs / DOT Centre of bigger hospitals, including that of medical colleges, that are referring large numbers of patients to other health facilities for treatment (after diagnosis). Information regarding referral of a patient should be noted in the Referral for Treatment Register as well as the Remarks column of the Tuberculosis Laboratory Register. 113

Training Course for Program Manager Peripheral health worker should visit patients residence before the commencement of the treatment. However this should not result in delay in treatment initiation A community DOT provider is a person who has volunteered to administer DOT as per the programme guidelines and is:

from the community where patient resides, but not a Government health worker and not a member of the family

For example a school teacher, shop-keeper, Anganwadi worker, NGO volunteer, priest, ASHA could be the DOT providers. In case, the DOT is organized through a community DOT provider, then duplicate TB treatment card, patient wise boxes and TB identity card are handed over by the PHW. Sputum container for collection of morning samples for follow-up sputum examinations is also provided. The name of the DOT center and name and designation of the DOT provider should be entered in treatment card in the space provided. On the spot training has to be imparted for the community DOT provider, by the PHW, regarding directly observed treatment, adverse reactions, follow-up sputum examination and recording of drug intake, before starting treatment. The DOT provider should also be trained to impart health education to the patient. The PHW is responsible for supervising and ensuring DOT and updating of the original treatment card at the PHI on a fortnightly basis. In case the patient interrupts treatment, PHW will help the community DOT worker in retrieving the patients. The MO of the PHI (where treatment card was opened) and the STS should also supervise DOT on a regular basis. DTO and MO-TC should support them in their efforts through fieldvisits. During the intensive phase of treatment, each and every dose is taken under direct observation of the DOT Provider. DOT is administered at a place which is convenient to both patient and DOT provider. This place is designated as DOT center. However, in situations where patient is bed-ridden, DOT should be administered under supervision at the patients home by the PHW or community DOT Provider. Only under exceptional circumstances, unsupervised drug administration can be allowed for a limited number of doses. For instance, if a patient is being discharged from hospital after initiation of treatment, s/he will have to be provided with maximum three doses of treatment so that the treatment is not interrupted during transfer to a nearby PHI. In such circumstances the entries for unsupervised doses should be encircled in the Tuberculosis Treatment Card and the reason for the same should be stated in the remarks column of the Treatment Card. The DOT provider indicates the drug administration by a tick mark against the days in the appropriate box on the tuberculosis treatment card. Patient is also asked about adverse drug reactions and, if necessary, referred to the MO. Patient is referred to the Designated Microscopy Centre (DMC) for follow-up sputum examinations. When patient reports to the DMC along with an early morning sputum sample on the scheduled day, a spot sputum sample is also collected. 114

Training Course for Program Manager Responsibility of administration of streptomycin injections at the periphery can be entrusted to the Auxiliary Nurse Midwife (ANM) or equivalent at the sub-centre level or to any registered medical practitioner who is acceptable and accessible to the patient. If this is not possible, the patient has to approach the PHC, CHC, or any other nearest health institution. The streptomycin injection should be given using disposable syringes and needles. Waterfor-injection should be made available. During the continuation phase (CP), at least the first dose of the weekly blister must be administered under direct observation. The patient collects rest of the drugs for the week from the DOT Provider and consumes them at home. Patient should be explained the method of taking the remaining part of the blister. When the patient reports for next weekly collection of drugs, empty blister pack of the previous week should be returned to the DOT provider and the same is retained in the PWB. Patient should be referred for follow-up sputum examinations at the prescribed intervals. Patient Provider Interaction The following information regarding the disease and treatment should be provided to the patient:

Diagnosis Cause and spread of disease Treatment related information 1. 2. 3. 4. 5. 6. 7. 8. Reassuring that TB is curable Importance of regular and complete treatment Importance of treatment being given under DOT. Duration of treatment, Intensive phase & Continuation Phase Adherence to follow-up schedules Early disappearance of symptoms is not a sign of cure, treatment to be stopped only when advised by the treating physician. Treatment is available free of cost Other important issues:

Role of isolation, rest and diet Cough hygiene and sputum disposal Provision of transfer facility during treatment Referral for HIV counselling and testing Smoking / alcohol abuse Co-morbid conditions for example diabetes, renal failure, patient on immunosuppressive drugs Sensitization on adverse reactions Importance of screening symptomatic contacts and children below 6 years and chemoprophylaxis 115

Training Course for Program Manager Information is to be provided at the treatment initiation and periodically during the treatment. Patients are reassured that they are being provided effective, high-quality curative care. Patients are encouraged to continue their treatment by drawing their attention to the gain in weight and relief of symptoms. In RNTCP, the patient is the VIP and should be treated accordingly. Divulgence of TB diagnosis: Diagnosis should be revealed in such a way that patient neither gets unduly perturbed nor takes it very casually. Patient should be reassured that TB is completely curable provided the drugs are taken regularly as prescribed for the entire duration. Patients will be informed that they continue to spread TB if they do not take treatment as prescribed. Reassure them frequently that TB is curable. Cause and spread of disease: Efforts should be made to clear the taboos associated with the disease. It should be explained to the patient that TB is caused by Mycobacterium tuberculosis through droplet infection from patient suffering from pulmonary tuberculosis. The disease neither runs in the family (hereditary) nor is a curse. Treatment related information: DOT and its necessity: It is important for the patient to take the drugs under observation. The real purpose of direct observation is to develop a human bond with the patient and not to mechanically watch the patient swallow the drugs. Patients if given self administered treatment are likely to take it irregularly or discontinue the treatment upon relief of symptoms. Early Disappearance of symptoms is not a sign of cure. It is very important for the patient to know the duration of treatment and understand the necessity of taking all prescribed drugs regularly. It is dangerous to take only part of the prescribed drugs because in such cases the disease may become incurable. A place mutually convenient to the patient and the provider can be chosen for provision of DOT. The necessity of direct observation of every dose of drugs taken during the intensive phase and the first dose of the weekly blister pack during the continuation phase should be emphasized to the patient. Patient is also explained about the importance of sputum smear conversion at the end of 2(3) months and at the completion of treatment. Patient should be made aware that treatment services are provided free of cost. Role of rest, special diet and isolation: Patient and family members are made to understand that once the treatment is started, patient ceases to spread the infection and there is no need to isolate him in terms of accommodation, use of utensils and clothes. At the same time, health staff should be careful enough not to over emphasize on special diet and rest. They can be told to take the food they can afford and rest only if constrained by physical weakness. Patient should be impressed that it is the treatment alone which cures. Cough hygiene and sputum disposal: Patient should be educated in exercising the cough hygiene- not resorting to indiscriminate coughing and spitting and covering mouth while coughing or sneezing. Provision of transfer facility during treatment: In case the patient wishes to shift or migrate to other TU / district / state after the initiation of the treatment, patient should be informed that there is a provision of transfer facility for treatment. Any such event should be duly informed to the treating medical officer for completing the formalities for transfer and necessary arrangement for further treatment. 116

Training Course for Program Manager Referral for HIV counselling and testing: All the patients diagnosed as TB cases should be encouraged and referred to the nearest ICTC for HIV testing. Co-morbid conditions for example diabetes, renal failure, patient on immunosuppressive drugs: History regarding the conditions mentioned above and any treatment for the same has to be elicited as these conditions and treatment for the same may adversely interfere with the TB Treatment, Patients are to be referred to the respective speciality and managed appropriately depending upon the co-morbid conditions. Adherence to follow-up schedules: The patients should be impressed upon the necessity of complying with periodic follow-up sputum examination schedule as advised. This will help in objective assessment of response to the treatment. Conversion to smear negativity is a fore-runner of successful treatment. Sensitization on Adverse reactions: In case patients experience any unusual symptoms after initiation / during treatment, they should be instructed to approach the medical officer and report the same. On their own they should not take a decision either to stop or to continue the drugs. Smoking: It should be impressed upon the patient that smoking of tobacco will adversely affect the treatment outcome. The patients should be protected from passive smoking. The environment of the patient has to be smoke free at home / office and at clinic. Smoking status of the TB patient should be checked at every interaction. The Medical Officer has to help the patient with simple tips to quit smoking. However, if this does not yield any positive result, he should be referred to the smoking cessation clinic. Alcohol abuse: History of addiction to alcohol should be elicited. If found alcoholic, the patient should be advised to strictly refrain from alcohol as it would increase the chances of patient developing hepatitis (Jaundice), irregularity in drug intake and adverse treatment outcome. The patients should be encouraged to give up alcohol with the help of frequent motivation, family and social support. Importance of screening symptomatic contacts and children below 6 years: Patients should be encouraged to bring symptomatic adult contacts and all children aged six years and below for screening at health facility. This will facilitate early detection of cases among them and appropriate treatment. Eligible children will be administered chemoprophylaxis.

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Filling up of the treatment card


Treatment Card Each patient who begins treatment for TB must have a tuberculosis treatment card. The information on the patients treatment card should be accurate, reliable, relevant, up to date and legible as this would be the source of information for filling up of the TB register. This card contains important information about patient, including the following details: General information Name of the patient Age and sex Complete address and phone number of the patient Occupation Name, address and phone number of the contact person Data related to DOT TB unit with code TB number with year Name of the PHI Name and designation of DOT provider DOT centre Initial home visit by whom (Name and Designation) with date Treatment related information Disease classification and type Details of sputum examination for diagnosis and follow up Details of x-ray and investigations for diagnosis of EPTB History of previous anti TB treatment Treatment regimen Drug intake in intensive and continuation phase Retrieval actions for missed doses Chemoprophylaxis for contacts aged 6 years HIV related data Treatment outcome with date Remarks

The Tuberculosis Treatment Card is maintained at health facility where the patient is initiated on treatment. For patients receiving treatment in a DOT centre other than the place of treatment initiation, a duplicate treatment card is prepared and maintained at the DOT centre by the DOT provider. The original treatment card at the PHI is to be updated at least once in a fortnight.

General information of patient


Name: Full name of the patient with father/husband name is recorded Age and sex : Age and sex of the patient is recorded. Estimated age is recorded if actual age is not known. Complete address and phone number of the patient: Complete address with land marks is recorded which will facilitate in locating patients residence in case of interruption of treatment. The same has to be verified at the time of initial home visit by the health worker. The telephone numbers both landline and mobile of the patient if available are also to be recorded along with the address. Occupation of the patient: Occupation may be specified. If unemployed, the same may be stated. Nature of occupation will help in arranging suitable DOT facility and retrieval in case of interruptions. For example a truck driver who needs to travel out for a long time, one of his colleagues can be made DOT provider.

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Training Course for Program Manager Name, address and phone number of the contact person: Name and address of a person, identified by the patient and known to him and residing in same locality is recorded. DOT provider and member of the family residing in the same house are not considered as contact person. A relative not from the same household, community/tribal leader, village doctor, community volunteer could be contact persons. This person can be contacted in case the patient is not traceable following interruption of treatment. Relationship of the contract person to the patient may be specified.

Data related to DOT


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

Treatment related information


Disease classification: Box provided for pulmonary or extra pulmonary TB is ticked as the case may be. If extra pulmonary, the site is specified. In patients having both pulmonary and extra pulmonary TB, the box for the pulmonary is ticked and site of extra pulmonary is specified. Recording details of sputum examination: Date of examination, DMC conducting the sputum examination, Laboratory serial number allotted, smear result and patients weight are recorded in the rows meant for pre treatment, end of IP/extended IP, two months in to the CP and end of the treatment sputum examination mentioned under the column titled month. This information is to be transferred from laboratory form for sputum examination to the treatment card.

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Training Course for Program Manager Details of x-ray and other investigations for extra pulmonary TB cases: This block is provided on the left side of the treatment card. In smear negative patients report of the chest x-ray may be mentioned in brief. Similarly, report of relevant investigations in extra pulmonary TB cases is also entered in this space. For example report of FNAC in case of lymph node tuberculosis. History of previous anti TB treatment: This is crucial for deciding the treatment regimen. Patients should be assured that revealing of facts about previous history of treatment for TB is in their best interest. The medical officers should impress upon the patients the importance of providing the complete facts, without any apprehension of discrimination with regard to subsequent treatment. Detailed and carefully elicited previous history of disease and the intake of anti-TB drugs helps in deciding the type of patients and treatment to be administered. While eliciting the history, emphasis should be given for ascertaining the following: Previous history from patients cough blood in the sputum sputum examination/chest X-ray examination consuming drugs which turned urine red/taken injections for >1 month Review of available record / documents sputum examination reports, chest X-ray reports / any other relevant reports / drug prescriptions empty blister packs of anti TB drugs

Treatment Regimen
Usually the MO of the PHI (where the treatment has to be initiated) will decide which treatment regimen a patient should be prescribed. Treatment regimen prescribed for the patient is ticked appropriately in the box provided. Number of tablets of the drugs prescribed in the regimen is also recorded in the boxes provided. In case an extra capsule of 150mg of rifampicin is prescribed for patients weighing 60 kg or more it is denoted as 1+150mg. For recording the administration of Streptomycin injection, the strength of the streptomycin given like 0.5gms / 0.75 gms is indicated in the box meant. Patients aged over 50 years or weighing less than 30 kgs are given 0.5 g of streptomycin.

Administration and monitoring of treatment


Recording of drug administration and monitoring
There are two sections meant for recording the drug administration. One is for the intensive phase of treatment on the front of the card and the other for the continuation phase on the reverse. Intensive phase

Month and year


Month and year of initiating the intensive phase is recorded.

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Training Course for Program Manager Date of initiation of treatment- The date of initiation of treatment regimen prescribed is ticked () on the appropriate box under the date against the month. Subsequently, the dates on which the drugs were consumed under observation are also ticked. In this phase, patient comes three times a week on alternate days. Daily blisters are given either on Mondays, Wednesdays and Fridays or alternatively Tuesdays, Thursdays and Saturdays. The date/day (for example on 10th April) on which patient fails to attend for DOT, is denoted by a circle (0) in the appropriate box. In case the patient attends to collect the drug the next day (for example on 11th April) the drugs missed are administered on that day and continues to take the drugs as per scheduled day (for example on 12th of April). Month / year April 10 1 2 3 4 5 6 S 7 8 9 10 11 12 13 S 14

On the other hand, if the dose is entirely missed and the patient does not report to the health facility even on the next day then the dose is given on the next scheduled day. It should be ensured that all the doses in the intensive phase, should be administered before the continuation phase is initiated. For example, patient was scheduled to come on 17th April but does not turn up on 17th or even on 18th but reports on 19th. Hence, the dose due on 17th is given on 19th and so on and so forth. Month / year April 10 15 16 17 18 19 20 S 21 22 23 24 25 26 27 S 28

Only under exceptional circumstances unsupervised drug administration can be allowed for a limited number of doses. For instance, if a patient is being discharged from hospital after initiation of treatment, s/he will have to be provided with 3 doses of treatment so that her/his treatment does not get interrupted during her/his transfer to a nearby PHI. In such circumstances, the entry for unsupervised doses should be recorded by encircling the tick mark on the Tuberculosis Treatment Card and the reason for the same should be stated in the Remarks column of the treatment card. Continuation phase Drug administration in the continuation phase is recorded on the reverse side of the treatment card. Treatment regimen prescribed for the patient is ticked appropriately in the box provided. Number of tablets of the drugs prescribed in the regimen is also recorded in the boxes provided above the drugs. During the continuation phase of treatment, patients collect the weekly blisters once a week on a designated day. First dose of the weekly blister is administered under direct observation and the remaining doses in the weekly blister are given to the patient for selfadministration. The month and the year in which the patient will be collecting drugs during the continuation phase are written under the Month and year column in the table on the reverse of the Tuberculosis Treatment Card. An X is recorded in the appropriate box (according to the dates of the month 1 31 as the case may be) to indicate the day the drugs were consumed under direct observation. A line is drawn through the remaining days

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Training Course for Program Manager of the week (after the X) to indicate that the drugs for the remaining period of the week have been given (recorded as X------------------------) for self administration. If the patient misses a weekly drug collection in the continuation phase completely, a circle is recorded on the day of the missed collection. On day of the subsequent visit the treatment is given and recorded as follows leaving the boxes blank as shown below: Month / year June 10
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18

S X

Monitoring of drug administration can be done by comparing the stock of drugs available in the patient-wise boxes with the dosages given and marked in the Tuberculosis Treatment Card. Any observed variation should be looked into and remedial measures taken. NON-DOTS treatment (in intensive as well as continuation phases) Date when drugs were collected by the patient is indicated by writing C and drawing a horizontal line (C-----------) to indicate the period for which drugs were supplied for selfadministration. Usually drugs will be provided for a month

Follow-up schedule for sputum examination


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

Extended IP * Give sputum cup Collect sputum # Result by Result by

2 months into CP Give sputum cup Collect sputum # Result by

End of treatment Give sputum cup 17 21 Collect the sputum and Result by end of the treatment 18 22

New ** Previously Treated

22 34

Collect sputum 23 35

Category

24 36

34 46

35 47

36 48

8 8

9 9

10 10

* The Intensive Phase is extended by four weeks (12 doses) in initially smear positive PTB patients who continue to be positive at the end of the2 months of IP. # Early morning and spot specimens will be collected on this day. ** The numbers during the IP represent doses, whereas during the CP they represent weekly blister packs

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Training Course for Program Manager Follow up of sputum smear examinations of patients put on the RNTCP Non-DOTS regimen should be done at the end of 2, 6 and 12 months. It must be ensured that the patients undergo the follow-up sputum smear examination as scheduled and the last follow-up sputum examination is done before the completion of the last dose of treatment.

Recording of initial and follow up sputum examinations in treatment card


The details of the sputum examinations are recorded against the appropriate month (i.e., Pre-treatment / end of intensive phase / extended IP, two months into continuation phase and at the end of the treatment) under date, DMC, lab number and smear results. While recording the results it is ensured that highest grade and earlier date of specimen (Date of 1st sample) is recorded. In situations where smear is positive at the end of the intensive phase either in New or Previously Treated, the row of boxes meant for date, DMC, lab number, smear results, and patient weight have to be split diagonally by a forward slash as shown below. The details of the sputum examination done at the end of two months are entered above the slash. Intensive Phase is extended by one month and the details of the sputum examination done at the end of third month in New and fourth month in Previously Treated cases is entered below the diagonal as depicted below. Month Pretreatment End IP / Extended IP 2 months CP End treatment During follow-up sputum smear examinations, if 2 specimens are examined and one of them is positive, the patient is considered smear-positive. If both specimens are positive, the higher grade out of the two results is written on the patients Tuberculosis Treatment Card. If both specimens are negative, the patient is smear-negative and NEG is recorded in the appropriate space. The results of follow up sputum smear examination done at the end of treatment should be available not later than two week of completion of treatment, so that appropriate outcome for the patient can be given in the TB Treatment Card. The patient is to be seen by the treating physician on the following occasions: 1. 2. 3. 4. 5. 6. Before initiation of the treatment; At the end of IP and the beginning of CP; On declaration of treatment outcome; For management of moderate to severe adverse drug reactions; If frequent interruptions in treatment adherence; and If patient becomes an MDR-TB suspect. 17/3 16/4 Pushkar Ajmer 164 234 Date DMC Lab No. Smear Result 1+ NEG Weight 45 Kg 46 kg

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Training Course for Program Manager Recording of weight: Patient weight is recorded on four occasions corresponding to the schedule of initial and follow-up sputum examinations. Initial weight of the patient is helpful in deciding the dose of Rifampicin. The dosage of drugs remains constant even if patient were to gain weight. Follow up of Paediatric TB cases For the monitoring of treatment, follow-up sputum examinations are to be performed with the same frequency in children as in adults. Clinical or symptomatic improvement is to be assessed at the end of the intensive phase and at the end of treatment. Improvement should be judged by absence of fever or cough, weight gain, etc. Radiological improvement is to be assessed by a chest X-ray examination in all smear-negative pulmonary TB cases at the end of treatment (flowchart below). Radiological changes may persist and may not correlate with clinical improvement and hence should not cause concern.

Clinical monitoring of children with TB


Patient on regimen for New cases

Review at 2 months, satisfactory response assessed by: improvement in symptoms no weight loss and or weight gain

Review at 2 months, non-satisfactory response assessed by: adherence to treatment weight loss worsening of symptoms

Follow up clinically Refer to Pediatrician / TB specialist for assessment (consider sputum examination)

Clinical assessment and X-ray at completion of treatment

Sputum positive

Sputum negative or not available

Failure

review diagnosis extend IP by 1 month

Regimen for previously treated

No improvement = Pediatric non-responder

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Retrieval actions in interruptions of treatment


In case of interruption of treatment, health staff should visit the patient at his home. Reason for interruptions should be reviewed carefully and efforts made to bring the patient back for treatment. This should be done by the DOT-Provider not later than the day after the patient was due to come for treatment irrespective of whether the patient is in IP or CP. It is very important to take prompt action after knowing that the patient has missed the dose. Delays in retrieval actions can lead to irretrievable loss of the patient for treatment. If a patient in the intensive phase (IP) does not take medication as scheduled, s/he should be traced and given the medication on the next day. The medication for the following day is given as per schedule. For example, if a patient is receiving DOT on Mondays, Wednesdays and Fridays, but does not take medication on Wednesday, the patient should be found on Thursday and given medication (late dose), and should take the next dose of medication on Friday, returning to the previous schedule. If a patient entirely misses any dose of medicine (does not come on two consecutive days in IP or 7 days in CP), these doses must be made up at the end of the scheduled period. If the DOT Provider is not successful in retrieving such patients, it should be reported to next higher level of supervisors (e.g. MPW, MO-PHI, STS, MO-TC etc.). If the patient misses DOT on two occasions in the intensive phase, DOT Provider should arrange a visit by the MO-PHI to the patients home. The MO-PHI can review the reasons for the same, give intensive counseling to the patient and, if required, ensure that DOT is made more convenient for the patient. Despite all efforts, if the patient does not return for treatment within 2 months of interruption of treatment, the outcome of treatment should be recorded as Defaulted and the reason should be mentioned in the remarks column of the treatment card and the patient wise box should be returned to the PHI, and thereafter to the DTC for reconstitution Recording of Retrieval actions Action taken to retrieve patients missing doses has to be recorded in the space provided on the reverse of the treatment card with details of date & time, name of the health staff taking retrieval action, person contacted, reasons for missing doses and the outcome of such efforts. The number of doses to be administered must be strictly adhered to. The total duration of interruptions in IP and CP should not exceed two months. In DOT centres with large numbers of patients, Tuberculosis Treatment Cards should be organized according to the day of scheduled drug administration and the phase of treatment (i.e. one box for intensive phase and one box for continuation phase). When the patient consumes the medication under direct observation, the Tuberculosis Treatment Card should be placed behind the divider for the next scheduled observation (e.g. from Monday to Wednesday during the intensive phase). In this manner, the Tuberculosis Treatment Cards of patients who do not present for treatment will be apparent on the same day, facilitating appropriate retrieval action of patients.

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Training Course for Program Manager Patient Transfers: A new treatment card has to be opened while initiating the treatment for transfer in cases. The previous Treatment Cards of such patients have to be retained in the health facility where the patient was originally initiated on treatment till the final outcome is reported. In a case of Transfer in, a Tuberculosis Transfer Form (refer to format of records at the end of the module is filled up and sent along with a copy of the Tuberculosis Treatment Card from the transferring unit, i.e., referring health facility / TU to the receiving unit, i.e., health facility/ TU where the patient will receive further treatment. The transfer form has four parts and should be filled up in triplicate. The first part of the form contains general information of the patient, disease, treatment details and address of the transferring unit. This information should be used to complete a new Tuberculosis Treatment Card for the patient. When the patient reports to the receiving unit, the lower most (fourth) part of the form is completed by the receiving unit and returned to the transferring unit as a receipt of an acknowledgement. The third and second part are meant for communicating the results of sputum at the end of intensive phase and treatment outcome respectively, to the transferring unit.

Determination of treatment outcome with date


There are seven possible treatment outcomes viz., Cured, treatment Completed, Defaulted, Failure, Died, Transferred out and Switched over to MDR TB treatment. Determination of treatment outcome depends upon : - Type of patient - Recording of drug administration - Follow up sputum smear results - DST Reports - Recording in remarks column The relevant outcome along with the date is recorded in the line provided for this on the reverse of the treatment card. A patient will have only one outcome at a time. For determination of Cure and Treatment completed, the date of outcome is the date on which the last tablet in the weekly blister was consumed. For the determination of date of outcome in cases of Failure, the date on which the sputum was found to be positive during the treatment is taken as date of outcome. For Defaulted, Transferred out and Died the date on which the event occurred is taken as a date of outcome. The treatment outcome has to be recorded on the Treatment Card and in the TB register within one month of the event. Declaration of the treatment outcome has to be decided upon and signed with date by the MO.

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Training Course for Program Manager Cured Initially sputum smear positive patient who has completed treatment and had negative sputum smears on two occasions, one of which is at the end of the treatment is declared as cured. Treatment completed

Initially sputum smear positive patient who has completed treatment with negative smears at end of the intensive phase / two months in the continuation phase, but none at the end of treatment, the outcome is declared as treatment completed. or Initially sputum smear negative patient who has received full course of treatment and has not become smear positive at the end of the treatment or Extra pulmonary TB patient who has received full course of treatment and has not become smear positive during or at the end of treatment is also declared as treatment completed.

Died Patient who died during the course of treatment regardless of cause is declared as Died. Failure Any TB patient who is smear positive at five months or more after starting the treatment is considered as Failure. Defaulted A Patient after treatment initiation has interrupted treatment consecutively for >2 months Transferred out A patient who has been transferred to another TU / district / state and whose treatment outcome is not available is considered as Transferred Out. Switched over to MDR-TB Treatment A patient who has been diagnosed as having MDR-TB by an RNTCP accredited laboratory, prior to being declared as Failure, and is placed on the RNTCP MDR-TB treatment regimen is said to have switched over to MDR TB treatment.

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Training Course for Program Manager Determination of date of treatment outcome Outcome Cured or Treatment Completed Date of determination Illustrations The last dose (Pyridoxine) of the Patient administered last DOT in 18th blister in New and 22nd blister continuation phase on 16-06-2010. in Previously Treated cases. Last pyridoxine dose taken on 22-062010. then the outcome will be written as Cured or treatment completed on 22-06-2010. Transferred out is the date on Generally drugs up to one week are which the patient is supposed to given for self administration during have consumed the last dose of transfer maximum of three doses in the drugs provided to him on the intensive or continuation phase. transfer as recorded in the card. Actual date on which transfer form This is only an interim outcome. was filled and sent is 20-06-2010; then The actual outcome as reported the date of transferred out as a from the unit where the patient treatment outcome should be 27-06was transferred will be updated in 2010. This is the date when the 3rd dose handed over during transfer is the card and in the TB register. supposed to have consumed.. The scheduled date of administration of drug when patient interrupted treatment consecutively for 2 months. The date on which the sputum examination was found to be positive for AFB The actual date of death The date on which the patient is started on RNTCP MDR-TB treatment regimen. Patient interrupted treatment on 16-92010 Record outcome as defaulted on 16-9-2010 on or after 17-11-2010 within one month If the smear result is positive on 1805-2010, Failure on 18-05-2010 Patient died on 11-08-2010, Died on 11-08-2010 Patient declared as MDR-TB on 0101-2010 and put on MDR- TB treatment on 21-01-2010. the date for Switched to MDR-TB treatment would be 21-01-2010.

Transferred out

Defaulted

Failure

Died Switched to MDR-TB treatment

A patient will have only one outcome. The outcome which occurs first is considered and recorded in treatment card and subsequently in the TB register.

Chemoprophylaxis
Preventive chemotherapy with isoniazid (H) is administered to all the children aged 6 years and below who are in contact with smear positive pulmonary TB case. The number of such children residing in the household should be enquired during the initial home visit. The parents are advised to bring children to the Health Centre for screening for the evidence of TB. They are examined and investigated to rule out TB disease. If found to be suffering from disease they should be treated appropriately. Children found eligible for chemoprophylaxis after ruling out the TB are to be administered preventive chemotherapy with INH 5mg/kg body weight daily for 6 months.

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Training Course for Program Manager The number of children below 6 years of age, the number screened for TB and the number put on chemoprophylaxis should be mentioned on the reverse of the treatment card (see below). Nos. of children below 6 Yrs Nos. screened for TB Nos. put on chemoprophylaxis

Remarks column The following information has to be recorded in the remarks column Adverse drug reactions, if any Reasons for unsupervised dose(s) Reason for discontinuation of drug collection (e.g., patient transferred to another district) Details of hospitalization if any during the treatment Information on dispatch of sputum for culture of sensitivity tests Any other relevant information about the patient such as smoking, diabetes mellitus, pregnancy status etc.,

HIV related data This box is meant for recording information regarding the HIV status of the patient, and if positive , details of CPT and ART being administered.

Original TB treatment card Information on HIV status, CPT delivery and ART referral and initiation of the TB patient is to be documented on the original TB treatment card and kept confidential within health system. This should not be disclosed to the community DOT provider.

1. 2.

3.

1. HIV Status: i. ii. HIV testing is a voluntary procedure and not mandatory. Patients not willing for HIV testing or sharing their HIV test result should not be forced to undergo testing or disclose their HIV status. If HIV status of the patient is known, tick the appropriate box (Pos or Neg) and record the date of test along with PID Number if available. If the HIV status is not known, dont tick any box initially.

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iii. iv. v.

Patients already on HIV care should not be required to show proof of HIV test result If the HIV status is ascertained during the course of TB treatment, the latest information should be updated on the card. If HIV status of the patient remains unknown at the end of the treatment, tick the appropriate box (unknown), at the time of declaring treatment outcome for the patient.

2. CPT (Cotrimoxazole Prophylactic therapy) delivery i. ii. iii. All known HIV-infected TB patients are to be provided access to CPT. If CPT provided from the PHI, record dates of each monthly delivery in the space provided. In case the TB patient is already on CPT before the initiation of TB treatment, record most recent date of CPT pickup.

3. Referral and initiation on ART 1. All known HIV-infected TB patients are to be referred for ART to the nearest ART Centre. For referred clients record the date of referral. 2. If patient initiated on ART, tick the yes box, and the date of initiation of ART and ART Registration Number should be recorded on the treatment card. 3. In case the TB patient is already on ART before the initiation of TB treatment, tick yes, and record approximate date of initiation.
Exercise 1 Case 1: Raju Review the TB Treatment Card on next page and give your comments

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REVISED NATIONAL TUBERCULOSIS CONTROL PROGRAMME Treatment Card

State: Karnataka Name: Raju

City / District with code: Mysore TB Unit with code_____________ Patient TB No / Year: 4299 F Age: 52 Sex M Occupation_________________

Complete Address & Telephone number ____________________________________________________________________________

____________________________________________________________________________________________________________
___________________________________PHI: __________________________ Signature of MO with date _____________________________
Month Pretreatment End of IP/Extended IP 2 Months X CP End Treatment 4/4 29/5 26/7 30/9 Date DMC A S Lab. No. 128 246 210 506 Patient Weight

Name, Address & Phone No. of contact Person: Krishna Rao, surpanch

Name and designation of DOT provider & Phone.No

Name of DOT Centre __________________________________

Initial home visit by __________ Ph.No.___________Date ________

Disease Classification Relapse Treatment Failure Others Specify)________

Type of Patient

Pulmonary Extra Pulmonary site ______________

New Transfer in TAD

Smear Result 2+ 1+ NEG NEG

H/O of Previous ATT with duration _______________________________________________________________________________ Regimen for Previously Treated 3 times / week H 9 0 S S 0 S S R Z E S S 0

INTENSIVE PHASE - Prescribed regimen and dosages. Tick () appropriate treatment regimen below:

Regimen for new cases

3 times / week

H Month/ year

2 3

5 6

10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 S

April 97 May 97 June 97

Training Course for Program Manager A Tuberculosis Identity Card (Annexure) is completed for each patient initiated on treatment and issued to the patient. Information from the Tuberculosis Treatment Card is used to complete the card. The front portion of the card will have patient information, name and address of the TU / district and treatment details of patient including classification, type, sputum results and treatment regimen. The reverse side of the ID card has the results of follow-up sputum examination, appointment dates for visits for drug administration and treatment outcome. ID card may also include the contact telephone numbers of MO / DOT providers. This information will help to continue treatment in case the patient is transferred, or admitted to any other health facility during the treatment period.

CPT: If the patient is HIV-infected, and not already being provided CPT from any other source, MO (PHI) is to prescribe CPT by ticking in the section on CPT in TB ID Card. Institutional DOT provider on seeing the ticked box provides monthly supply of CPT and records the same on Original treatment card.

Management of patients with treatment interruptions


The factors to be considered for the management of interruptions are i. Type of case Whether new, relapse or failure etc case ii. Treatment regimen administered : regimen for New or Previously Treated cases iii. Duration of treatment taken : Less than one month / more than one month. This helps in deciding whether patients need to be treated as a new case or as previously treated case. iv. Duration of Interruption : Less than two months / more than two months. This helps to decide whether patients is to be declared as defaulted and also necessity for subjecting the patient for sputum examination which arises if the duration of interruption is two months or more. v. Smear status after interruption : Smear negative / Smear positive All the above information elicited will help in choosing the strategy of managing the interruption (see flowchart ).

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Management of patients with treatment interruptions


Treatment Interruption

Interruption of <2 months

Interruption of >2 months (outcome - default)

Continue same treatment to complete all doses

Initial treatment of <1 month

Initial treatment of >1 month Repeat smear examination

Retain original type. Start on treatment afresh with same regimen,

Positive

Negative

Type TAD Start on regimens for previously treated

Type Others Start on regimens for previously treated

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Adverse Reactions to Anti-TB drugs

Adverse Drug Reactions (ADR) observed during treatment for tuberculosis are comparatively less in the intermittent chemotherapy than what is encountered in daily regimens. DOT providers should be aware of the commonly occurring adverse reactions so that they can identify it promptly and refer the patient to the medical officer for further management. Any adverse reactions reported during treatment is recorded in the remarks column of the treatment card. Orange / red discoloration of the body fluids especially urine which is commonly encountered is not an adverse reaction and patient should be made aware of this. Symptom-based approach to evaluation of possible side effects of anti-TB drugs Symptom Drug Action to be Action to be taken by MO (abbreviation) taken by HW Gastrointestinal (vomiting Any oral Reassure Maintain hydration or epigastric discomfort) medication patient. Give Consider treatment with drugs with less anti-emetics (e.g. water and over domperidone) and a longer period proton pump inhibitors of time (e.g. 20 (eg. Omeprazole) minutes). Do not give drugs on an empty stomach If the above fails, refer to MO Itching/Rashes Isoniazid (and other drugs also) Reassure patient If severe, stop all drugs and refer patient to MO Itching without rash or a mild rash Continue treatment and give antihistamines Itching with moderate to severe rash Stop all drugs till symptoms subside Treat with antihistamines Patients with mucosal involvement, fever and hypotension will require treatment with corticosteroids When the reaction subsides reintroduce drugs one by one in this order INH. Rifampicin Pyrazinamide Ethambutol

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Training Course for Program Manager Re-introduce each drug in a small dose and gradually increase over 3 days before introducing the next drug. Give pyridoxine 100 mg/day orally or parenterally until symptoms subside. Patients not responding to pyridoxine will require treatment with amitryptiline Give NSAIDs like paracetamol, Aspirin or ibuprofen and in severe cases Indomethacin for a week to 10 days In severe cases estimate serum uric acid levels o If uric acid levels are significantly raised treat with NSAIDs and colchicine. Allopurinol is not effective o In severe cases with normal or slightly elevated uric acid consider reduction of the dose of Pyrazinamide. Refer to ophthalmologist for evaluation Impaired vision usually returns to normal within a few weeks of stopping ethambutol.

Tingling/burning/numbness Isoniazid in the hands and feet

Refer to MO

Joint pains

Pyrazinamide

Reassure that it is a self limiting condition. Encourage patients to increase intake of liquids. If severe, refer patient to MO for evaluation

Impaired vision

Ethambutol

STOP Ethambutol, refer patient for evaluation

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Training Course for Program Manager Ringing in the ears Loss of hearing Dizziness and loss of balance STOP Streptomycin, refer patient for evaluation Refer to otorhinolaryngologist for opinion As hearing loss is usually not reversible do not restart Streptomycin

Streptomycin

Hepatitis: Anorexia / Nausia / vomiting / Jaundice

Isoniazid, Rifampicin or Pyrazinamide

STOP all anti TB drugs, Refer patient for evaluation

Rule out other causes of hepatitis Do not restart treatment till symptoms resolve and liver enzymes return to baseline levels If liver enzymes cannot be performed wait for 2 weeks after jaundice has disappeared to restart treatment Restart treatment with one drug at a time starting with Rifampicin INH Pyrazinamide. In patients with severe disease in whom treatment cannot be stopped use a non hepatotoxic regimen consisting of Streptomycin and Ethambutol

In cases of jaundice, all anti-TB drugs should be stopped Immediately and the patient referred for evaluation.

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Management of patients in special situations


Situation Hospitalization Management Some of the indications for hospitalization:Extremely ill patients. Patients with frequent haemoptysis, pneumothorax or massive pleural effusion leading to breathlessness Cases requiring surgical intervention. Patient should be referred to the hospital. Streptomycin is to replace ethambutol in IP. The continuation phase should be extended by 3 months in both new and previously treated cases. Steroids should be given initially and gradually tapered over 68 weeks. Streptomycin is absolutely contraindicated during entire pregnancy. Breast feeding can be continued even when mother is on treatment for TB but mother should continue to practice cough hygiene. Child should be administered preventive chemoprophylaxis as per guidelines. Rifampicin, isoniazid and pyrazinamide can be safely given as they are excreted in entero-hepatic circulation. Dosage of streptomycin and ethambutol, should be adjusted according to the creatinine clearance. Rifampicin decreases the efficiency of oral contraceptives by increasing their metabolism. Increase in dosage of the oral contraceptive or switch over to alternate methods of contraception is advisable

Tuberculous meningitis

Treatment of TB during pregnancy and postnatal period Treatment in patients with renal failure Women on oral contraceptive pills

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Procedures during hospitalization


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

Attending physician prescribes RNTCP regimen using prolongation pouches

DOT centre of the hospital is informed

Patient is registered in the local TU of the hospital if the patient is not already registered

If the patient is already registered elsewhere, there is no need for reregistration. On discharge the patient is sent back to his PHI to continue and complete treatment

If the patient is not residing in the same TU area, on discharge patient is transferred to PHI/TU nearest to his/her residence, to continue and complete treatment

If the patient resides in the same TU area, on discharge he is sent to the PHI nearer to his/her residence to continue and complete treatment

All indoor patients treated under RNTCP, should be registered under the local TU where the hospital/Medical College is located. The smear conversion and treatment outcome of all the transferred patients should be sent back by the TU where the patient was transferred to the TU of the hospital/medical college. (Refer to the flow chart below for Management of Indoor Patients).

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Management of Hospitalized patients


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

Treatment of TB disease in HIV-infected patients


Early diagnosis and effective treatment of TB among HIV-infected patients are critical for controlling the disease, minimizing the adverse impact of TB on the course of HIV, and interrupting the transmission of TB in the community. Delays in the diagnosis of TB have been associated with worse outcomes. Hence initiation of treatment is very important soon after the diagnosis of TB among HIV-infected persons. Treatment of TB is same as that in the HIV-negative TB patients. Patients are to be treated with the RNTCP New or Previously Treated regimen according to the patients history of previous anti-TB treatment. In addition to TB treatment under RNTCP, all HIV-infected TB patients must be provided access to care and support for HIV disease, including antiretroviral therapy. ART reduces TB case fatality rates and the risk of recurrent TB. ICTC counsellors and the treating physicians should counsel these patients on the importance of ART and on the free availability of treatment with ART and evaluation. HIV-infected TB patients should be promptly referred to the nearest ART centre by the treating physicians and ICTC counsellors. This visit to the ART centre, should preferably occur at least two weeks after initiation of TB treatment, to ensure reduction in the potential of TB transmission from these patients prior to the visit to the centres being visited by large numbers of HIV-infected persons. TB patients referred to ART centres should be carefully educated on cough hygiene. For details on ART eligibility, reference ART guidelines (available at www.nacoindia.org). NACO recommends that ART be given to: All patients with extrapulmonary TB (stage 4); and All those with pulmonary TB (stage 3) with CD4 count < 350 cells/mm3.

Cotrimaxazole preventative therapy (CPT): Cotrimaxazole preventative therapy has been shown to reduce mortality among HIV-infected TB patients, and is recommended by NACP for all HIV-infected patients. All HIV-infected TB patients should therefore be provided CPT. All the ART Centres should have a minimum provisions of meeting the CPT requirements of atleast for a month for the benefit of those patients who are able to return to the ART centre on a monthly basis. In states implementing RNTCP/NACP Intensified TB/HIV package, CPT should be made available for HIV-infected TB patients at all peripheral health institutions in the districts 139

Training Course for Program Manager having a Medical Officer and an institutional DOT centre. The CPT should be procured, packed and supplied in monthly pouches at the state level. The local distribution is to be supervised by RNTCP staff in coordination with NACP. In this mechanism, CPT is delivered by the peripheral health institute staff, and not community DOT providers, to maintain confidentiality regarding HIV status within the health-care system. Treatment of TB in HIV positive patients on second line ART/ alternate First Line with Protease Inhibitors (PI) based regimen The effectiveness of second-line antiretroviral therapy depends on the introduction of protease inhibitors (PIs) in the new regimen. However, there are significant drug interactions with the PIs and rifampicin. Consequently, the treatment options are limited for TB patients who require PI-based therapy or develop TB while on PIs. PIs should not be used with rifampicin-containing regimens due to hepatic enzyme inducing capacity of rifampicin, which risks rendering PI levels sub-therapeutic. Another rifamycin, Rifabutin is a less potent inducer of CYP 3A4 liver enzyme as compared to rifampicin, while being equally safe and effective for treatment of TB. It can be administered in the presence of PI-containing ART regimen without compromising the efficacy of ART or Anti TB treatment. In the presence of the boosting drug like Ritonavir (PI), rifabutin metabolism is also altered, and less rifabutin is needed than would be without ritonavir. Therefore in patients taking lopinavir/ritonavir (LPV/r) based ART regimens, NACP and RNTCP have recommended the substitution of rifabutin for rifampicin for the duration of TB treatment. The dosage of rifabutin during the administration of second line ART regimen containing LPV/r shall be 150 mg Rifabutin, dosed thrice-weekly for all patients >30 kg weight. The rifabutin will be supplied through the respective State TB Cell on individual basis.

Tobacco smoking and tuberculosis


The diagnosis of TB disease is an opportune moment for imparting behaviour change in the patients smoking habit, with patients more likely to accept the behaviour change needed for improving their health. Tobacco smoking may lead to delayed sputum conversion in sputum smear positive PTB cases, lower treatment success rates and higher rates of relapse of TB disease and death. Hence the past and present history of tobacco smoking (cigarette / beedi / pipe / cigar / hukka) should be elicited from each TB case at the time of initiating treatment. Smoking cessation advice to current smokers should become an integral part of TB case management. Such interventions may help improve outcomes of anti-TB treatment and reduce transmission of infection in the short term, and improve the quality of life of TB cases by preventing chronic respiratory and other disease associated with smoking in the long term. Tobacco cessation advice has been demonstrated to be successful in TB cases even in the absence of costly Nicotine Replacement Therapy. Patients who smoke should be motivated to make an informed decision to stop smoking. All cases should be informed personally about the harmful effects of smoking on health in general and the potential for poorer outcomes of anti-TB treatment with continued smoking. 140

Training Course for Program Manager The potential benefits of stopping smoking to the health of the individual should be suitably communicated. The patients past experience with cessation and relapse of smoking may be discussed in an understanding atmosphere. Patients may be told that they can be successful even if they have not been able to quit smoking at earlier attempts. During the conversation, the patients are asked to identify situations and moods that trigger smoking (working/getting out of bed/having a cup of coffee/pleasant moments/while dealing with personal or professional problems/ group smoking). They are encouraged to devise their own ways to respond to the circumstances that encourage smoking. Patients should also be advised not to smoke in the presence of others, since increased frequency of coughing due to smoking increases the risk of TB infection among their household and other contacts. That smoking is prohibited in public places according to Prohibition of Smoking in Public Places Rules, 2008 may be clearly communicated to them. 5 As Approach to tobacco cessation This is a form of counseling. Before saying anything to motivate the patient to quit tobacco use, the health professional needs to identify the tobacco user and find out the stage of readiness to change that the patient is in, by asking a few questions. 1. Ask the patient if he/she is a tobacco user. 2. Briefly Advise against continuing tobacco use and link the current condition/ailment to continued tobacco use, where possible e.g. Quitting smoking/tobacco use would improve your health and will aid in early recovery. 3. Then Assess readiness to quit by asking the patient whether he or she is ready to quit at this time. e.g. How recently have you thought about quitting tobacco? If the patient appears ready to change (quit), next steps are : 4. Assist the tobacco user in making a quit plan. 5. Arrange for follow-up by setting the next contact. 5 Rs approach for non willing tobacco users If the tobacco user is not yet thinking about quitting tobacco use (pre contemplation), the doctor will promote greater awareness of the relevance to the patient of the advice to quit, the risks of use and rewards (benefits) of quitting. Many tobacco users are largely unaware of the potential harm that tobacco use can do to them. If the patient is not ready to quit, the doctor must not push the patient. People usually need time to change (incremental nature of change). If the patient is at least thinking about (contemplating) quitting, the doctor can find out the patients roadblocks (barriers) to quitting and help the patient see ways to overcome these. This process may be enough to help the patient get ready to quit (without pushing). At the next visit, this process should be repeated so that the information about relevance, risks of continuing and rewards of quitting can sink in a little more and some roadblocks removed.

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Training Course for Program Manager As you can see, the doctor must try to make the tobacco user think about quitting. This is important because there are so many other forces acting that are difficult to control, physiological compulsions to use tobacco, learned habits, social pressures, accessibility etc,. Engaging the mind of the tobacco user, bolstering it with new knowledge and a sense of caring by the person counseling can help motivate him/her to change. Follow-up is important to help keep the tobacco user on track until he or she is confident about remaining tobacco free.

Diabetes and treatment of tuberculosis


There is conflicting evidence on the role of diabetes, its control and response to TB treatment. Some studies suggest that there is no co-relation between the two, whereas others suggest that sputum conversion is delayed and treatment outcomes are poorer in diabetics who are poorly controled during their treatment for TB. However in general the treatment for TB in patients with diabetes is the same as for those patients who are non-diabetic. In a few cases, rifampicin may induce early phase hyperglycemia due to augmented intestinal absorption. Although relapse rates themselves are unchanged, in diabetics who relapse the prognosis is poorer. Principles of the management of co-existent TB and diabetes comprise: 1) Proper care and hospitalization in patients with poor diabetic control; 2) Ideally insulin should be used to control blood sugar during anti-TB treatment, however oral hypoglycaemics can be used if the patient is well stabilized on them; 3) Drug interactions with rifampicin need to be kept in view and recognised if they occur: 4) Glycaemic equilibrium is essential with goals of maintaining fasting blood sugar <100mg% and glycosylated HB <6% should be aimed towards. 5) Monitoring for adverse effects, particularly of hepatic and nervous systems should be done as H may lead to peripheral neuropathy; and 6) Use of potentially neuropathic agents in patients with peripheral neuropathy demands special consideration and administration of pyridoxine.

Multidrug Resistant TB and DOTS-Plus


Prevention of MDR-TB
The management of MDR-TB is very complex, and hence preventing its development by the effective implementation of the DOTS strategy under RNTCP is crucial. Selection of appropriate treatment regimen for patients by medical officer, after eliciting history of previous treatment, is very important. The diagnosed patients should be explained why it is essential to reveal previous TB treatment and to take drugs under direct observation. Similarly, DOT Providers should be educated and convinced about the importance of Directly Observed Treatment (DOT). DOTS has been documented to not only prevent the emergence of multidrug resistant TB, but also to decrease its prevalence in the community. Prevention of MDR-TB is given priority under RNTCP rather than its treatment

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Management of MDR-TB
National guidelines and plans for scaling up the management of MDR-TB have been developed under RNTCP. In the interim, while RNTCP DOTS Plus services are being expanded across the country, all health care providers in the public and private sector managing MDR-TB cases, need to adhere to the national guidelines. MDR-TB management has to be preferably undertaken only at selected health institutions with experience, expertise and availability of required diagnostic and treatment facilities.

Identification of MDR-TB suspects: The following are the criteria to label a patient as
MDR-TB suspect. A new smear positive patient remaining smear positive at the end of fifth month. A new smear negative patient becoming smear positive at the end of fifth month. A patient treated with regimen for previously treated remaining positive at fourth month Smear positive contacts of an established / confirmed MDR-TB case

Diagnosis of MDR-TB
For patients in whom drug resistance is suspected, diagnosis of MDR-TB should be done through culture and drug susceptibility testing from a quality-assured laboratory. On being diagnosed as an MDR-TB case, the patient will be referred to a designated state level DOTS-Plus site. These sites are specialized centres which are limited in number. At least one such center is expected to be in each state which has ready access to an RNTCP accredited culture and DST laboratory. The DOTS-Plus site will be supported by qualified staff available to manage patients using the second-line RNTCP MDR-TB regimen given under daily DOT and standardized follow up protocols. There will be a mechanism to deliver ambulatory DOT after an initial short period of up to one week of in-patient care to stabilize the patient on second line drug regimen. Logistics and standardized information will be made available in such place.

RNTCP MDR-TB treatment regimen


The RNTCP is using a standardised treatment regimen (STR), comprising of 6 drugs (kanamycin [Km], levofloxacin(lvx), ethionamide [Eto], pyrazinamide [Z], ethambutol [E] and cycloserine [Cs] during 6-9 months of an Intensive Phase, and 4 drugs (lvx, Eto, E and Cs) during the 18 months of the Continuation Phase. p-aminosalicylic acid (PAS) is included in the regimen as a substitute drug if any of the drug(bactericidalkanamycin/ethionamide) is not tolerated. Dosages of the drugs are based upon three weight bands (see below table). Drug Km LVX Eto E Z Cs PAS Pyridoxine 16-25 Kg 500 mg (200 mg) 375 mg 400 mg 500 mg 250 mg 5g 50 mg 26-45 Kg 500 mg (500 mg) 500 mg 800 mg 1250 mg 500 mg 10 g 100 mg 143 > 45 Kg 750 mg (750 mg) 750 mg 1000 mg 1500 mg 750 mg 12 g 100 mg

Training Course for Program Manager


Dosage and weight band recommendations

All drugs should be given in a single daily dosage under DOT by a DOT Provider. All patients will receive drugs under direct observation on 6 days of the week. On the 7th day (Sunday), the oral drugs will be administered unsupervised and kanamycin will be omitted. If intolerance occurs to the drugs, ethionamide, cycloserine and PAS may be split into two dosages and the morning dose administered under DOT. The evening dose will then be subsequently self-administered. The empty blister packs of the self-administered doses will be checked the next morning during DOT. 100mg of pyridoxine is administered to all patients on the RNTCP MDR-TB treatment regimen. If a patient gains at least 5kgs of weight during treatment and crosses the weight-bands range, the DOTSPlus site committee may consider moving the patient to the higher weight-band drug dosages. The new higher dosages are provided whenever the patient is due for the next 3-monthly supply of drugs in the normal course of treatment and not as soon as change of weight is noted.
Duration of treatment

At least Intensive Phase (IP) should be given 6 months. It is extended up to seven / eight / nine months in patients who have a positive culture result taken in fourth / fifth / sixth month of treatment correspondingly. Continuation Phase (CP) is given for 18 months following the IP.
Follow-up schedule

Smear examination should be conducted monthly during the IP and at least quarterly during the CP. Culture examination should be done at least at 4, 6, 12, 18 and 24 months of treatment.
Treatment adherence and support

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

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Exercise - 2

COMPLETION OF TUBERCULOSIS TREATMENT CARDS


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

Kailash Nath (Patient C) is a 35-year-old man who weighs 39 kg. He has been treated for

Ghanshyam Singh (Patient D) is a 16-year-old male with extra-pulmonary tuberculosis of

the knee. He has never been treated for tuberculosis previously. He weighs 38 kg. Treatment began on 8 September. He was referred to ICTC on 12 September 09 and found to be non reactive. He was directly observed for all doses as prescribed. He was transferred to district Y after completion of the five weeks of continuation phase.

Kiran Kumar (Patient F) is a 37 year old man with two negative sputum smear

examinations, living at 15, Gulmohar Park, whose cough did not improve after a 10 day course of co-trimoxazole. The sputum examination was repeated on 8th September and again yielded negative results for two samples. Chest X-ray showed infiltrates in the right upper and left lower lung fields and it was decided that he should receive a full course of 145

Training Course for Program Manager anti-TB treatment. He was not treated for Tuberculosis before. His initial weight was 45 Kgs. He began treatment on 15th September. He was referred to ICTC on 22nd September and found to be HIV positive on 23rd September. He was administered CPT from 24th September. He was referred to ART center immediately and his CD4 count was 155/Cmm. He was initiated on ART on 10th October. He missed doses 12 and 18 entirely. His sputum smear is negative at the end of intensive phase (5th November, lab no. 638, 48 Kg) and 6 months (6th March, Lab No. 146, 50 Kg). No collections were missed during the continuation phase.
POINTS TO REMEMBER

Under RNTCP, there is a provision to treat all types of TB patients both in adults and children irrespective of their HIV status. Facilities for treating MDR TB under DOTS Plus is being implemented in phased manner. Eliciting previous history of treatment for tuberculosis is essential for proper allocation of treatment regimen to the patient A suitable DOT provider and DOT centre should be selected in consultation with the patient All doses in the intensive phase and at least the first of the thrice-weekly dose in the continuation phase should be given under observation. Treatment Card should be filled accurately and it must be complete and up-to-date Initial counseling (at the health facility and at patients home) is important to achieve treatment compliance Patients missing doses should be traced and put back on treatment within one day in case of IP and within one week in case of CP Streptomycin injections, where required, should be given after the oral drugs are administered It is mandatory to use disposable syringes and needles to administer streptomycin Contacts aged six years and below of smear-positive patients must be screened for TB. If diagnosed as TB, they should be treated for the same. If not, must be administered chemoprophylaxis. Mothers on treatment for TB can continue to Breast feed their infants irrespective of their sputum status.

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Pulmonary Positive

DEFINITIONS: THE REVISED NATIONAL TUBERCULOSIS CONTROL PROGRAMME Case definitions Type of cases Treatment outcomes

Tuberculosis,

Smear

TB in a patient with atleast one smear positive for AFB out of the two initial sputum smear examination by direct microscopy

Pulmonary Negative

Tuberculosis,

Smear

A patient with symptoms suggestive of TB with two smear examination negative for AFB, with evidence of pulmonary TB by microbiological methods (culture positive or by other approved molecular methods) or Chest X-ray is classified as having smear negative pulmonary tuberculosis

Extra Pulmonary Tuberculosis*

Tuberculosis in any organ other than lungs (eg. pleura, lymph nodes, intestine, genitor-urinary tract, joint and bones, meninges of the brain etc).

Cured Initially sputum smear positive patient who has completed treatment and had negative sputum smears on two occasions, one of which was at the end of the treatment Treatment completed Initially sputum smear positive patient who has completed treatment with negative smears at end of the intensive phase / two months in the continuation phase, but none at the end of the treatment is declared as treatment completed. or Initially sputum smear negative patient who has received full course of treatment and has not become smear positive at the end of the treatment or Extra pulmonary TB patient who has received full course of treatment and has not become smear positive during or at the end of treatment Died Patient who died during the course of treatment regardless of any cause Failure Any TB patient who is smear positive at five months or more after initiation of the treatment and not put on MDR-TB treatment Defaulted A Patient after treatment initiation has interrupted treatment consecutively for >2 months Transferred out A patient who has been transferred to another TU and whose treatment outcome is still not available. Switched over to MDR-TB Treatment A patient who has been diagnosed as having MDR-TB by an RNTCP accredited laboratory, prior to being declared as Failure, and is placed on the RNTCP MDR-TB treatment regimen

The diagnosis should be based on strong clinical evidence with the following investigations Smear / Culture from extrapulmonary sites Histopathological examination or Radiological examination or Biochemical and cytological examination including FNAC

New A TB patient who has never had treatment for TB or has taken anti-TB drugs for less than one month Relapse A TB patient who was declared cured or treatment completed by a physician and who reports back to the health facility and is now found to be sputum smear positive Transferred in A TB patient who has been received for treatment in a Tuberculosis Unit, after starting treatment in another TB unit where s/he has been registered. Treatment after default A patient, who has received treatment for TB for a month or more from any source and returns for treatment after having defaulted i.e., not taken anti-TB drugs consecutively for two months or more and found to be smear-positive Treatment failure Any TB patient who is smear-positive at 5 months or more after initiation of treatment. Chronic A patient who remains smear-positive after completing regimen for previously treated but not initiated on MDR-TB treatment Others A patient who does not fit into the any of the types mentioned above. The reasons for labeling a patient under this type must be specified in the Treatment card and TB Register#

* Pleurisy is classified as extra pulmonary tuberculosis, * A patient diagnosed with both smear positive pulmonary and extra pulmonary TB should be classified as pulmonary TB # Others can come both under new and previously treated.

Training Course for Program Manager

Annexure II IMPROVING INTERPERSONAL COMMUNICATION SKILLS IN RNTCP TRAINING: KEY CONCEPTS AND SAMPLE ROLE PLAYS
The principles of the RNTCP are: Political and administrative commitment Good quality diagnosis, primarily by sputum microscopy (using microscopy to examine sputum smears among patients in health facilities) Uninterrupted supply of Good quality drugs (short-course chemotherapy, patient-wise boxes) Direct Observation of treatment (The right treatment, given the right way) Systematic monitoring and accountability (outcome of each and every case initiated on treatment).

Successful application of each of these principles depends, in part, upon developing and maintaining positive relationships among the individuals who work in the Programme, as well as with the community and patients who are served by the Programme. While technical and clinical aspects of the Programme must be adequately addressed, social and communication dimensions are equally necessary to make this information acceptable, and to encourage Programme participation. Interpersonal communication (IPC) skills are invaluable at all levels of the RNTCP, and are powerful tools to help cure patients, and thereby, to control TB. For example, quite often patients discontinue treatment as soon as they start feeling better. They may not understand about drug-resistant TB and that it can be very difficult to cure. This sort of information needs to be conveyed to patients and their families without causing undue alarm. Service providers should be able to communicate with the patients in a way that makes patients feel comfortable and ensures that patients develop confidence in the service providers and ultimately in the services received. The best way to make a patient comfortable is to communicate in a language that is easily understood by the patient. Sympathy and concern about the patient and his/her disease should invariably emerge during the conversation. Good IPC encourages patients to complete treatment and also consult the service provider in case of any questions or concerns (such as adverse effects of the medications). Willingness to contact the service provider to clarify any apprehensions is an important indicator of good IPC between patients and providers. In addition to improving interactions with patients, good IPC skills will help RNTCP staff obtain participation from officials, laboratory personnel, public sector physicians, and treatment observers. PRINCIPLES OF PATIENT-PROVIDER INTERACTION How we learn to change behaviour People adopt habits and behaviour for a variety of reasons. Changing behaviour is often a gradual and complex process.

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Training Course for Program Manager Information: We often become aware of the need to change behaviours by receiving information. But information alone is rarely enough to bring about the change. We often have information but are still not motivated to change our behaviour. Some reasons for this are: We dont believe the information We dont believe that we are capable of changing We believe that the behaviour is not under our control We believe that the change is not warranted. Motivation: We often actually get started on a change as a result of a personal experience or crisis that provides us with the motivation to try a difficult change. Support: To succeed, most of us receive some form of support. Support comes from something we find within ourselves and/or from peers, family, health workers and others who are important to us. To help people change their behaviour, good IPC, or counseling skills will work toward providing information, motivating, helping people to overcome obstacles, and providing support to try to change. Counseling is a process of enabling/helping someone to overcome a problem; meet a need, make a decision, or accept their situation. Counseling differs from education. Education involves providing information. Counseling is a process of helping others use information and relate it to their own lives. Counseling is not giving advice alone. The aim of counseling is not to solve other peoples problems but to enable people to solve their own problems. Good counseling is client-centered, which means counseling must centre on the clients feelings, thoughts, concerns and needs. Thus, counseling is a process of empowering clients to make their own decisions through defining feelings and providing objective information. Characteristics of effective counseling: Confidential Non-judgmental Non-directive Empathetic Encouraging Reinforcing

Types of Communication
There are two types of communicationverbal and non-verbal. Verbal communication is for correctly providing facts. This is important, but is only one component of communication. The other component is non-verbal communication. Non-verbal communication creates the atmosphere of the interaction. It can create either a welcoming, caring environment that makes the facts acceptable and easy to understand, or

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Training Course for Program Manager a formal, confusing, or even hostile environment that makes it difficult for the facts to be understood or accepted. Effective communication skills include active listening, praise and encouragement, paraphrasing (repeating in slightly different words), questioning, reflecting, and non-verbal communication. Communication is a process by which information, ideas and/or feelings are exchanged between individuals. The ability to communicate effectively can be learnt. The development of good verbal and non-verbal communication by improving IPC skills is the focus of this module. It will help trainers and trainees to develop insights into and improve their own behaviour. Role plays are a good way to practice interacting with others and to improve IPC skills. The skills involved in good interpersonal communication include: Listening and Understanding Demonstrating caring, concern and commitment Problem solving and Motivating

Listening and understanding involve more than simply being present while someone is speaking. Active listening means genuinely hearing the other persons words. Often, we think we are listening, but we actually do not pay close attention or do not really hear what the other person is trying to say. Some key points for improving listening and understanding skills include: DO: Offer a seat before interacting with the patient Allow sufficient time for the interaction If time must be limited, give your full attention during the time you have and the same should be apparent to the patient Be prompt so the other person does not have to wait a long time for your attention Sit with the other person so you are at their level Maintain eye contact Move your head to indicate you are paying attention Apologize for any unforeseen interruptions Ask open-ended questions (questions that cannot be answered with yes or no) such as questions that begin with What, Why or How. These questions require more than just a few words in the answer Periodically summarize what the other person has said to ensure that you have understood; use their own words to repeat the ideas back to them.

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Training Course for Program Manager DONT: Interrupt while the other person is speaking Yell at the other person Ask questions that can be answered with just one word (for example, questions that begin with Do) Perform other activities during the meeting Ask difficult/embarrassing questions ******************* You can demonstrate that you care by expressing your understanding of the feelings and concerns of the other person and by letting them know that you want to help them. You can reflect the other persons emotions back to them with facial expressions that show you are concerned. You can also provide verbal feedback to them to show acknowledgement and recognition of their fears and concerns. Some key points are: DO: Greet the patient Say, Hello, please be seated. Address the person by name or appropriate title but always with respect Acknowledge and respond to each of their concerns Emphasize that your job is to help them Ask about family members Treat the person with respect Smile.

DONT: Minimize or dismiss their concerns Put down the other person Act superior Assume the person knows their way to another person/room/office; give them proper guidance to their next destination Argue with the patient.

******************* After listening, understanding and showing that you care, you can then use your knowledge of the RNTCP to discuss ways you can work together to solve any problem the other person has with participating in the Programme. Some key points for this include:

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Training Course for Program Manager DO: Listen carefully to their point of view Paraphrase and summarize frequently to make sure that you understand the problem Use non-technical words Help them to comply Demonstrate that you are concerned about the patient Convey that you understand their fears and apprehensions Make them comfortable Identify obstacles to their participation

DONT: Assume you know all the answers Use technical words Treat them as your student Tell them to comply Assume you know their condition Expect compliance without explanation. ******************* Finally, you can use all of the knowledge, understanding and trust youve gained during your interaction to continue to motivate each person to maintain involvement in the Programme. Here are some of the main points to keep in mind for motivating:

DO:

Repeat important information in different ways each time you meet Emphasize that your job is to help them Emphasize that they will be cured Use examples from your own experience Tell them that this is what you would recommend to your family members Compliment the other person on what they have done well Recognize their progress Emphasize that their welfare is your concern/job

DONT:

Use technical words Ignore the efforts the other person has made so far Overlook their fear and anxiety Ignore or minimize practical barriers Criticize their omissions/commissions.

*******************
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HOW TO USE THIS SECTION

This section contains role play examples for RNTCP trainers. Groups should perform the role plays in the section that pertains to their defined role in RNTCP. This section must be used throughout the training to ensure that participants receive consistent information. Role plays should be performed at appropriate time in the course of training. The section begins with a role play that should be performed by the trainer(s) to exhibit as many poor IPC skills as possible. The trainer(s) should tell the group to watch this role play looking for poor IPC behaviours. The trainer(s) will perform the scene using many of the DONTs listed earlier and performing as many incorrect IPC skills as possible. Stress these poor behaviours to the point of comedy. It must be made clear that poor IPC behaviours are NOT acceptable for good IPC. After the performance, have the group make a list and discuss the exhibited poor IPC skills. Then, address each of these behaviours in turn, and discuss ways that good IPC skills could be substituted for the poorer ones. Finally, the trainers should perform the same role play again, using only good IPC skills. After this performance, discuss with the participants the differences between the two scenes. Also have the participants discuss how they think each person in the scene felt and the differences in their feelings between the first and second scene. Once this discussion is finished, you will have the participants form smaller groups of no more than six people per group. Then, ask the group members to perform relevant scenes listed in this book using as many effective IPC skills as possible. Participants who play the role of patient or person being supervised should be told that they should freely add/invent details which are realistic. Groups do not need to perform ALL of the scenes listed, but continue to have them perform scenes until you feel the important points have been covered sufficiently and everyone in the group appears to be able to exhibit good IPC skills. Trainers and participants should invent more role play scenes that depict their own experiences and use these in addition to or instead of the role play scenes in this book. Motivate the participants. If they are reluctant to do role plays because they feel they are not actors, tell them that they do indeed act every day. Everyone does. Each time they interact with another person, they are acting. Whenever they try to convince someone to do something, they are acting. If they are tired but must appear energetic toward their boss, they are acting. When they first met their wife or husband and wanted to impress them, they put on their best behaviour. This is normal, natural behaviour and is acting. Give them these and other examples from your own experience to help them realize they already have the skills to do the role plays. During the role plays, observe each group but avoid interrupting them; interrupt only if the participants are having extreme difficulty or are going totally out of context. It will be your job to answer questions, talk with the participants about the role plays, lead group discussions and generally give participants any help they need to successfully develop better IPC skills. To do this, you will need to be very familiar with the material being taught. Ensure that each participant understands what they are expected to do in the role play exercises. By participating in the role play scenes, they will be able to: 153

Training Course for Program Manager observe and practice the desired practical responses to patients and others discuss and share ideas with each other about the situations use what they have practised when they encounter these situations during the course of their own work.

Role plays should be used to sharpen IPC skills so that these skills will come naturally during RNTCP work.

Demonstrate good interpersonal skills yourself


Answer questions from the participants
Encourage the participants to ask questions and make comments. This means that you need to be available when participants are working on the role play. Respond positively to questions (for example, say, Yes, I see what you mean. or Thats a good question.). Avoid facial expressions and comments that convey that the question is trivial. Always spend enough time with each participant to answer their questions fully so that both you and the participant are satisfied. If you cannot answer a question, say so. Get help from others in the group or from a colleague.

Clarify any issues that the participant finds confusing


Role plays allow you to see what participants do and do not understand. Do not always wait for a participant to ask for help. Instead, as you watch the participants, offer help during pauses or breaks, without interrupting. Help the participants understand how to solve practical problems in actual situations. Identify gaps in a participants understanding and skills and provide help to correct them. If a participant has difficulty with the language used, make sure they receive the help needed to understand the concepts. Use language which is familiar to the participants.

Lead group discussions at the end of each role play


Ask questions to spark discussion. Use open-ended questions to get participants to share information and experience. Open-ended questions are questions that require more than a yes or no answer. When you ask a question, pause long enough to give participants a chance to think about their answer and to respond. Allow silences so participants can have time to think before responding.

Check to see if participants are having problems, even if they do not ask for help
If you show interest and give each participant undivided attention, they will be more motivated. Also, if the participant knows that someone is interested in what they are doing, they are more likely to ask for help when they need it. Be available to the participants at all times; remain in the room and look approachable. Answer participants questions willingly and encourage them to ask questions when they arise rather than waiting until a later time. Call the participants by name when you talk with them. Maintain eye contact with the participants. Present information in the form of a conversation rather than by just reading it. Move around the room and use natural hand gestures. Speak clearly. Vary the pace and pitch of your voice. Paraphrase and summarize frequently to keep participants focused and clear on a particular idea and to keep discussions on track. Demonstrate enthusiasm for the work that the participants are doing. 154

Training Course for Program Manager Compliment each participant for improvements in understanding, approach or progress. Get everyone in the group to share experiences so they can learn from each other. Encourage participants to explore how the role plays apply to their activities and how the IPC skills will help them in improving cure and case detection.

Manage
Make sure participants have access to supplies and materials when they need them (for example, chalk and board to write) and that there are no major obstacles to learning (such as too much noise, not enough light or not enough work space). Make the course interesting by giving examples from real work situations. Think about the skills taught in the role plays and how they can be applied to the participants jobs. Add these to the points to be made when introducing or summarizing the role play. Discuss the application of new concepts to real problems. Ask participants whether they can use the skills that were taught, and discuss any potential difficulties in implementation of these skills. Do not summarily reject alternative methods suggested by the participants; discuss alternative methods thoughtfully and positively. Role plays are fun and effective methods of developing good IPC skills. This will benefit all levels of the RNTCP staff to help reach the Programmes goals. The use of this section will serve to improve your own IPC skills as well as those of your colleagues. *******************

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ROLE PLAYS FOR DOCTORS


INTRODUCTION Example Role Play You are a doctor talking to a newly diagnosed TB patient. The Patient does not believe he has TB. He agrees for an X-ray, but not for sputum examination Sample Key Messages Role Play Scenarios 1. Doctor is meeting with a patient diagnosed as having TB by a private doctor on the basis of an X-ray report. The patient wants free drugs without delay and without further examination. Doctor is meeting with a newly diagnosed TB patient, a daily wage-earner and who is reluctant for direct observation because he does not want to miss work Doctor is meeting with a chest symptomatic patient who is reluctant to give 3 sputum samples and is ready to bribe the doctor Doctor is meeting with a newly diagnosed schoolboy who does not want to disclose his illness Doctor is meeting with a newly diagnosed patient who is a truck driver and who says he will have difficulty coming to the local facility for DOTS when he is working Doctor is meeting with a chest symptomatic patient from a tribal area who insists on hospitalization Doctor is meeting with a newly diagnosed married woman who does not want her husband or family to know about her illness Doctor is meeting with the father of a woman who is to be married and he does not want the community to know that his daughter has TB Doctor is meeting with a newly diagnosed TB patient who wants to leave the area Doctor is meeting with an urban, literate patient on previously treated regimen who is afraid of injections because he is afraid of HIV transmission Doctor is meeting with a newly diagnosed sputum-positive TB patient who is reluctant to bring in her family members for examination because she feels guilty about possibly having infected them

2. 3. 4. 5. 6. 7. 8. 9. 10. 11.

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INTERPERSONAL COMMUNICATION
INTRODUCTION For developing good interpersonal communication (IPC) skills, you, the trainer, will need to be aware of the duties that the doctors have to perform. These include explaining to the patient about TB and the importance of continuing treatment. They also include developing a strong bond with the patient to help motivate them to continue participation in the treatment. Doctors also need to be able to gain the trust of the patients family and community. In addition, doctors must provide an example to their staff about how to interact with patients. In this section, you will help the doctor participants become better at these duties through role plays. Through the role plays, poor IPC skills and good IPC skills will be demonstrated. Demonstrating poor IPC skills develops insight into common behaviours that occur in real situations. Identification of these will help in working towards developing good IPC skills. Therefore, for the role plays to be effective, two sessions will have to be done for each scene; one highlighting poor IPC skills and the other showing good IPC skills. In order to help the participants understand the importance and potential pitfalls of non-verbal communication, perform the following exercise: Tell the participants to just observe you without making any comments. Then, sit down in a chair with your arms and legs crossed, your body turned slightly away from the participants, and an annoyed expression on your face. Swing your legs and gaze around the room. After about 30 seconds, ask the participants to describe what they were feeling when you were sitting in front of them. List their responses on the board or flip chart. Then discuss: Do we communicate without words? Describe ways that we communicate without words. Discuss with them that we need to be aware of what we are communicating non- verbally, for example, boredom, dislike, superiority, impatience We also need to be aware of what our patients and others communicate non-verbally, such as fear, embarrassment, discomfort and shame. After this discussion, you will tell the participants that you are going to enact a role play scene for them. Tell them to watch for behaviours that depict poor IPC skills. Next, choose another trainer (if available) or a participant (if no other trainer is available) to play the part of the patient in the following role play. A trainer should play the part of the Doctor. You will then enact the following role play scene using as many poor IPC skills as possible (for example, you will yell at the patient, you will have them stand while you sit, you will tell them facts using big words that they dont understand, and so forth). Role Play Scene Doctor: You are a doctor talking to a newly diagnosed TB patient. Patient: You are a patient who does not believe you have TB. You agree to have an X-ray, but do not agree to have your sputum examined.

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Training Course for Program Manager After you have completed enacting the scene, ask the participants to list the poor IPC skills. Write these on the chalk board or flip chart. Then, go through each item listed and discuss the ways in which the poor behaviours could be improved. Spend as much time as needed to thoroughly discuss the poor behaviours. Be sure to discuss non-verbal communication elements such as eye contact, posture, nodding, encouraging or discouraging sounds, etc. Also discuss the messages about the RNTCP that were conveyed during the scenario. Discuss the accuracy of the messages and, for inaccurate messages, discuss how they could be more accurately conveyed. Once the discussion is finished, perform the scene again using only good IPC behaviours. Afterward, ask the participants to discuss the differences in the two role play scenes. Encourage them to discuss how the two different scenarios made them feel and how they think the patient and Doctor felt in each scene. After this discussion, inform the participants that everyone in the group is now going to practice IPC skills by doing role plays themselves, with the other participants. Tell them that you will be handing out their roles and that they will perform the scene twice; once using poor IPC skills, followed by a group discussion on how the behaviours can be improved, and then again using good IPC skills. Split the group of participants into smaller groups of no more than six people per group. Make sure each small group contains an even number of participants. Then, choose scenarios from the list of Role Play Scenarios for Doctors which can be found at the end of this chapter and write the roles on separate pieces of paper to give to the participants in each small group. You can also use your own experiences to come up with other role play scenarios and roles. Make sure that everyone receives a role. After you have handed out the roles, give the participants a few minutes to think about how they will act out their role. Then, have the participants play each scenario in front of their small group using good IPC skills. During the play by the trainees, circulate to each group to ensure that participants are exhibiting the appropriate IPC skills, such as smiling, sitting with the patient or other person, looking at the other person when speaking, pausing after asking questions, asking openended questions, etc. Also, use the following list of Key Messages to guide you as you watch the role play. After each role play by the participants, stop and have the group discuss the good ideas and IPC skills that were exhibited in the role play scene, and also discuss things that could improve IPC skills and improve the accuracy of RNTCP messages.

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Sample key messages


Listening and understanding
Please sit down. How are you feeling? How many children do you have? Where do you stay? How long have you been residing in this area? What are their ages? How is your wife/husband? Are they doing well? What do you do for a living? Tell me when you first fell sick. Since becoming ill what you have done to feel better? Have you ever been ill like this before? Have you ever had to take injections for over two weeks? Have you ever had to take pills for many months? Do you have a cough? For how long have you been having a cough? Is the cough dry or associated with expectoration? Do you have any fever? What colour is the expectoration? Is it ever blood-stained? Do you get a pain in the chest when you cough? How is your appetite? Have you noticed any weight loss, lethargy or weakness? What other symptoms do you have? What medicines are you taking? What medicines have you taken in the past? Have you ever taken a medicine that turned your urine orange-red? Has anyone in your family had an illness like this before? Does anyone in your family also have cough? Have you heard of TB? What do you understand TB to be? What do you think causes TB? Have you ever seen an X-ray? What do you think X-ray shows? Have you heard of the microscope sputum test to diagnose TB? Have you ever had a blood or sputum test? Do you know that we need to test your sputum three times to confirm whether you have TB? Do you know that TB can be cured? Do you know that TB can spread from one person to another if it is not properly cured? 159

Training Course for Program Manager Do you know that other people in your house can contract TB from you? Do you know that till complete investigations are done we cannot assess the degree of damage that has been caused? The tests to detect TB are simple and will have to be done at regular intervals to monitor improvement in your condition. You will have to take your medicines as prescribed so that your illness does not get worse. If you do not take medicines as prescribed, you can develop a more dangerous form of TB and you will spread the same to your family. Covering your mouth when you cough can prevent the spread of TB to others.

Demonstrating caring
TB is not a disease which should cause worry as it is curable if drugs are taken regularly. We want to make sure that you are completely cured. By following the treatment schedule you will also make sure that you do not spread the disease to your near and dear ones. All treatment is free here, so please dont even think about money. Anti-TB medicines are strong drugs that must be taken under direct observation. This will ensure that you not only take the medicines regularly but also in the right dosage. This way I can know that you are responding well to treatment and if you have any problems. Anti-TB drugs can have side-effects in some people. If you take them under our supervision, we will make sure you do not have any uncomfortable side-effects and if you do we will be able to tackle them at the earliest and prevent any problems. At times people develop resistance to certain drugs and show no improvement when taken irregularly. If you take the medicines under our supervision, we will be able to observe that the drugs are having the required effect and you will continue to constantly getting better. If you have any doubts regarding the duration of treatment, the dosages of the drugs or any side-effects, please feel free to clarify your doubts with me. To make sure that I have explained things well, please show me on this calendar [show the patient a calendar] how long you must take medicines. I want to make sure that I give you the best medicines. That is why a sputum test is so importantso we can be sure that you are getting the right medicines. We dont want to unnecessarily give you a strong medicine, which is why all the tests are important. The tests will tell us how severe your condition is and we can give you the best medicines. If you have any doubts about the disease or the medicines, do not hesitate to ask me. It is my responsibility to cure you. I am not only worried about you, but if you have TB and are not treated then your family may get sick, and obviously I do not want that to happen and I am sure you also dont want that to happen.

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Motivating and Problem solving


An ordinary cough does not last that long. You have been coughing for a month and we must find out why. Only when we know the cause can we cure it completely. A sputum test is very important in diagnosing the type of TB. Only then can we be sure that you are getting the right medicines for the right duration of time. TB is a disease and should not be a cause for worry as it is fully curable now but it should be diagnosed early so that it doesnt spread to other parts of the body or to others. Therefore, it is necessary to have your sputum tested. A chest X-ray will only tell us that you MAY HAVE TB. X-rays are just shadows and, like any shadow, can be caused by many different things. X-ray is not a pucca test for TB. Sputum examinations do not cause any harm or discomfort. You just have to have 3 sputum examinations done as all treatment will be based on their results. If you have any doubts regarding sputum examination or want to know how to bring out sputum, you can either ask me or the laboratory technician. We will be happy to clarify your doubts and help you. If the sputum test confirms your disease you will get regular attention and treatment. A sputum test is very important for us to know what medicines should be given to you. We will start treatment as soon as we get the results of sputum examination. If I or my wife/husband had your symptoms, I would certainly have 3 sputum examinations done. The reason for conducting 3 sputum examinations is because one or two tests may not be enough to detect the TB germs. It is important to understand that the better the diagnosis, the better will be the treatment and faster the cure. And for a good diagnosis you must go through all the tests as prescribed. The test results will help us prescribe the best drugs for you. Yes, as soon as your sputum test results are available, we will also tell you whether you need to bring your family members for examination. Yes, your symptoms suggest that you MAY HAVE TB, but we cannot be sure till we test your sputum. Sputum tests are done free here, and of excellent quality. The test here is better than what you can get even in a private laboratory. The sputum test is much more accurate than an X-ray. We can actually see whether you have TB germs when we look at your sputum with a microscope. It is not just you but everyone like you who has a cough for 3 weeks or more has to go through all the tests, so that we can know exactly what the problem is and treat you accordingly. If it is convenient for you to come for your sputum tests on your off days, we could make adjustments for you accordingly. However, you must come for your tests on the appointed day without fail. To check your progress towards cure we shall again examine your sputum after two months. Tuberculosis is fully curable if complete treatment is given under DOTS. It is very important that the disease does not spread to anyone else, especially to your family members. 161

Training Course for Program Manager After only a few days on the medication, you will stop infecting others, but you will have to continue on your medication for the full duration of 6/9 months. We will arrange for medicines to be provided near your home. I can understand that it is difficult for you to come thrice a week. We will find a treatment observer near your place of work. Or We will arrange for the treatment observer to give you medicines before you go for work. If I had TB, I would certainly come thrice a week for treatment for the first two months and hence you will also be required to come. I understand that you do not want others to know that you have TB. We will be careful about that. But it is equally important that others do not get TB from you. If you do not take your medicines as advised, you will spread TB to others at home and work. Although TB is curable, cure can only take place through constant monitoring. This helps us to assess your response to the drugs. We have to make sure that there is continuous improvement and no untoward effects of medicines and that is why you are required to come on alternate days thrice a week for the first two months. TB can be cured completely only if treatment is uninterrupted. And the only way to ensure regular treatment is to monitor it. Every dose is crucial and the treatment is designed for your complete cure. It is not in your interest to take medicines home. Medicines can be lost. It is also easy to forget to take medicines every day. If you forget to take even a few doses of medicine, you may fall ill again, in which case the dosage and duration of treatment may increase and would be very expensive and your chances of getting fully cured will be reduced. If you come in thrice a week, we can make sure you are getting better and we can observe if you are having any problems with the medicines. Once you are cured you will be able to work much better and earn more. So it is in your interest to complete the entire course and come for regular check-ups as prescribed. These are all aimed at curing you completely. You dont want your wife and children to get tuberculosis from you. So for their sake you should get well and for that you must take the prescribed treatment regularly and completely. If any of them have symptoms of the disease, they also need to be examined and treated. If your children are infected, they will be physically weak and may not be able to help out with the household chores or in the fields. More money will be spent on medications. So it is better that you get yourself fully treated so that the question of their getting infected does not arise and they enjoy good health.

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ROLE PLAY SCENARIOS


(These are only some examples. Use your own experiences to come up with other scenarios and roles.) Scenario 1: Doctor is meeting with a patient diagnosed as having TB by a private doctor on the basis of an X-ray report. The patient wants free drugs without delay and without further examination Write the following instructions on two separate pieces of paper and hand them out to two participants.

Doctor: You are a doctor who is seeing a patient diagnosed as having TB by a private doctor on the basis of an X-ray report. Patient: You are a newly diagnosed TB patient who wants free drugs without further
examination.

******************
Scenario 2: Doctor is meeting with a newly diagnosed TB patient, a daily wage-earner who is reluctant for direct observation because he does not want to miss work

Doctor: You are a doctor who is seeing a newly diagnosed TB patient in your office. Patient: You are a TB patient who is a daily wage-earner and you do not want to come for direct observation because you do not want to miss work.

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Scenario 3: Doctor is meeting with a chest symptomatic patient who is reluctant to give 3 sputum samples and is ready to bribe the doctor

Doctor: You are a doctor who is seeing a new patient in your office. Patient: You are a person who has had a cough for several weeks with blood in your
sputum and you have come to see the doctor. You do not want to give three samples of sputum and you are ready to bribe the doctor to just give you medicines without the sputum samples.

******************
Scenario 4: Doctor is meeting with a newly diagnosed schoolboy who does not want to disclose his illness

Doctor: You are a doctor seeing a schoolboy who has been newly diagnosed with TB. Patient: You are a schoolboy who has been told you have TB and you do not want to
disclose your illness to your family or your friends.

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Training Course for Program Manager Scenario 5: Doctor is meeting with a newly diagnosed patient who is a truck driver and who says he will have difficulty coming to the local facility for DOTS when he is working

Doctor: You are meeting with a newly diagnosed patient in your office. Patient: You are a truck driver and it is difficult for you to come to the local DOTS facility
when you are working.

******************
Scenario 6: Doctor is meeting with a chest symptomatic patient from a tribal area who insists on hospitalization

Doctor: You are meeting with a new patient in your office. Patient: You are a woman who has had symptoms of TB for several weeks and you want
to be hospitalized until you feel better.

******************
Scenario 7: Doctor is meeting with a newly diagnosed married woman who does not want her husband or family to know about her illness

Doctor: You are a doctor meeting in your office with a woman who is a newly diagnosed
TB patient.

Patient: You are a married woman who has been newly diagnosed with TB and you do not
want your husband or family to know about your illness.

******************
Scenario 8: Doctor is meeting with the father of a woman who is to be married and he does not want the community to know that his daughter has TB

Doctor: You are a doctor meeting with a man who is not one of your patients but wants to
talk with you.

Father of TB Patient: You are the father of a woman who is being treated for TB and you
do not want the community to know that your daughter has TB.

******************
Scenario 9: Doctor is meeting with a newly diagnosed TB patient who wants to leave the area

Doctor: You are a doctor meeting in your office with a TB patient. Patient: You are a newly diagnosed TB patient who wants to leave the area.

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Training Course for Program Manager Scenario 10: Doctor is meeting with an urban, literate patient on regimen for previously treated cases who is afraid of injections because he is afraid of HIV transmission

Doctor: You are a doctor meeting in your office with a patient on previously treated
regimen who is to start re-treatment.

Patient: You are an urban, literate patient on regimen for previously treated cases who is

afraid of injections because you know that needles are one of the effective means of HIV transmission.

******************
Scenario 11: Doctor is meeting with a newly diagnosed sputum-positive TB patient who is reluctant to bring in her family members for examination because she feels guilty about possibly having infected them

Doctor: You are a doctor meeting in your office with a newly diagnosed sputum-positive TB patient and you would like her to bring in her family members for examination.
your family members for examination because you feel guilty about possibly having infected them.

Patient: You are a newly diagnosed sputum-positive TB patient who is reluctant to bring in

******************

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FORMATS OF RECORDS - ANNEXURES

REVISED NATIONAL TUBERCULOSIS CONTR4OL PROGRAMME Treatment Card

State________________ City / District with code ___________ TB Unit with code_____________ Patient TB No / Year _____________ Name _______________________________________ Sex M F Age:_______ Occupation________________________

Complete Address & Telephone number ____________________________________________________________________________ _____________________________________________________________________________________________________________ ____________________________________PHI: __________________________ Signature of MO with date _____________________________
Month Pretreatment End of IP/Extended IP 2 Months X CP End Treatment Date DMC Lab. No. Smear Result Patient Weight

Name, Address & Phone No. of contact Person ______________________________________________________________________

Name and designation of DOT provider & Phone.No

Name of DOT Centre __________________________________

Initial home visit by __________ Ph.No.___________Date ________

Disease Classification Relapse Treatment Failure Others Specify)________

Type of Patient

Pulmonary Extra Pulmonary site ______________

New Transfer in TAD

H/O of Previous ATT with duration _____________________________________________________________________________ Regimen for Previously Treated 3 times / week H R Z E S

INTENSIVE PHASE - Prescribed regimen and dosages. Tick () appropriate treatment regimen below:

Regimen for new cases 3 times / week

H R Month/ 1 2 year

E 5 6

9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31

II Continuation Phase Regimen for Previously Treated 3 times / week H R E

Regimen for new cases 3 times / week

Enter X on date when the first dose of drugs have been swallowed under direct observation and draw a horizontal line (x_________) to indicate the period during which medicines will be self administered as shown below 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31

Month/ year

Treatment outcome with date: _______________________________

Details of X ray / EP tests


Household Contacts (Children < 6 Yrs)
No. of children aged <6 Yrs No. put on chemoprophylaxis Number screened for TB

Retrieval Actions for Missed Doses

signature of the MO with date:__________________________ Remarks __________________________________________ __________________________________________________ __________________________________________________


HIV related information
Patient referred to ICTC:

Date

By Whom

Whom contacted

Reason for missed doses

Outcome of retrieval action

Yes No _______
HIV Status:

Date

Unknown

Positive

Negative Date_____

CPT delivered on: (1)

(2) Pt. referred to ART Centre: Initiated on ART:

(3)

(4) No, Yes No Yes

(5)

(6) Date_______ Date & ART No._____

Training Course for Program Manager

Revised National Tuberculosis Control Programme


TUBERCULOSIS IDENTITY CARD
Front Revised National Tuberculosis Control Programme IDENTITY CARD Reverse Follow up sputum examination
Time point
Pretreatment End of IP/extended IP 2 months in CP

Name of Patient: ________________________ Complete address:______________________ ______________________________________ TU / district name ___________________ Sex: M F ,

Date

Lab No.

Result

________________________Ph__________
Age:_____ TB No.____________

End of treatment

PHI:________________________________________

Appointment dates IP
______________ ______________ ______________ ______________ ______________ ______________

Disease Classification Site:______

Pulmonary Extra-pulmonary

Treatment Started on
________________ Date / Month/ Year

Treatment outcome with date: ___________________________________ ___________________________________ Signature and stamp of MO with date: REMEMBER
1. You can be cured if you take treatment as advised. 2. You may infect your near and dear if you do not take your medicines as advised 3. Keep your card safe

_______________ _______________ _______________ _______________ _______________ _______________

CP

Type of Patient
New Relapse Treatment after default Treatment Failure Transfer In Other-Specify _____

Treatment regimen for


New cases
Previously treated cases

CPT

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Revised National Tuberculosis Control Programme Transfer Form


Fill in triplicate with carbon sheet. Send a copy to the TB Unit where patient is transferred, one copy to the patient and retain a copy for the records. Copy of treatment card be given with transfer form to patient

Name and Address of the transferring Unit (District/TB Unit): _______________________________________ Name of the Unit (District/TB Unit) to which patient is transferred (if known): ______________________ Name of the Patient: _____________________________________ Sex: M F Age: ____________ TB No: ____________________________ Date of starting treatment ______________________________

Disease Classification Pulmonary Extra-Pulmonary Site___________

Type of Patient New Relapse TAD Treatment Failure Transfer in Other(Specify)___

Treatment regimens New cases Previously treated cases

Most Recent Sputum Status Date: DMC: Lab NO: Positive Negative

HIV status
Positive Negative Unknown

Number of doses administered before transfer: IP__________ CP___________ Remarks____________________________________________________________________________________________________ Date transferred ______________ Signature:__________________________________ Designation:________________________________ ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------

For use by the receiving District/TB Unit


Name of patent______________________

Treatment outcome with date_______________________

Old TB No (given at transferring TB Unit): ___________________ New TB No (given at receiving unit)______________________ Treatment outcome: Cured Treatment Completed Died Failure Defaulted Transferred Out Switched over to MDR-TB treatment Date ___________________________ Signature ___________________________ (at the end of treatment send this form to the transferring District/TB Unit where the patient was initially registered.) (a copy of treatment card after completion of treatment may be sent to the transferring PHI) ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

For use by the receiving District/TB Unit if patient transferred in IP


Old TB No (given at transferring TB unit) : ______________ Sputum Results at the end of IP : Positive

Name of patient:____________________________________________________________________________________ Grade ________ Negative

Conversion report

New TB No (given at receiving unit):__________________

Date ___________________________ Signature ___________________________ (at the end of Intensive phase this form has to be sent to the transferring District/TB Unit where the patient was initially registered.) -----------------------------------------------------------------------------------------------------------------------------------------

For use by the receiving District/TB unit -

Receipt of acknowledgement

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

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Revised National Tuberculosis Control Programme


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

Patient Name: Name and address of referring PHI: Patients RNTCP TB No. : Name and address of DTC:
Age: Sex: Address with landmark:

Date :

Date of diagnosis / initiation of treatment/ duration of treatment: Treatment given (circle drugs already received): others Signature of MO of DMC: Smear results ( To be entered by LT of DMC and counter signed by MO of DMC) Lab Serial No. DMC : Date of Specimen examination Visual appearance (MM,B, S)* Results (Neg or Pos) Positive(grading) 1+ Scanty H R Z E S

3+

2+

*M= Mucopurulent, B=Blood stained S=Saliva Date: Signature of LT:

** Write actual count of AFB seen in 100 oil immersion fields

Signatures of MO of DMC

DTO

IRL Culture Results


Date Received Specimen Laboratory Specimen No. Smear result

Culture Result(Tick one) Neg 1-19 + ++ Colonies

+++

Contaminated/others

Date: reported by (Name and Signature)

No growth reported Less than 20 colonies 20-100 colonies More than 100 colonies Innumerable or confluent growth

0 Report number of colonies + ++ +++

IRL DST Results: (Note Enter S if Susceptible, and if resistant, include colony count(e.g. for Rifampicin. R25/2560 if 25 colonies are seen in S2 slope with estimated colonies of 560 in S2 drug free slope) Date Taken Laboratory Specimen No. S H R E Z Km Ofx Eth Others

Date:

Reported by Signature)___________________________________________

Copies of completed form with results should be sent promptly from IRL to DOTS-Plus Hospital and DTO

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REVISED NATIONAL TUBERCULOSIS CONTROL PROGRAMME Referral form for treatment


Serial Number
To be filled in triplicate. One copy to be sent to the DTO receiving the patient, one copy to the health facility where the patient is referred to, and one copy to the patient
Name and address of referring health facility _________________________________________________ _______________________________________________________________________________________ Name of health facility to which patient is referred ____________________________________________ Name of patient__________________ Complete Address Age__________ Sex M F _____

_______________________________________________________________________________________

Disease Classification
Pulmonary Extra-Pulmonary Site____________________

HIV status
Positive Negative Unknown

Remarks

Signature Date referred Designation ----------------------------------------------------------------------------------------------------------------------------------------Serial Number______________________________ For use by the health facility where the patient has been referred Name of patient __________________ Age ___________________ Sex M F Name of receiving health facility TB No (if available)__________________________ Date of referral __________________________ Name of TB Unit and District__________

The above patient has reported at this facility on _____________and has been put on __________treatment regimen

Signature Date__________________________

Designation

This portion of the form has to be sent back to the referring unit as soon as the patient has been initiated on RNTCP treatment

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FORMAT FOR REFERRAL FOR TREATMENT REGISTER


Diagnosis

Sl. No.

Name

Age

Sex

Lab Serial No.

Date of Referral

Date of sputum examination2

Complete Address1

Sputum results2

Referred to PHI/TU/District (Name)

P/EP

Type of patients (N/R/F/TAD/O)

1 Complete

address of the patient where he/she will be residing during the course of treatment and can be contacted.

2 In

an extra-pulmonary TB patient, it should be written whether the patient was diagnosed on clinical grounds alone or by an investigation should be specified.

3 The

date of feedback from the receiving health facility and date of initiation of treatment along with the TB number should be written here.

Note: In case of non receipt of feedback from the receiving health facility within 14 days of the referral date, the STS of the referring health facility should be informed, who in turn will take up the matter with the STS of the receiving health facility during the regular meeting.

Treatment regimen (New /previously treated)

Date of Feedback / Date of starting treatment3

Table of Contents
Module - 4 Registering Cases & Monitoring Treatment
Registering Cases ........................................................................................................................ TB Register and Content ............................................................................................................. Ensuring Registration of all patients ............................................................................................ Exercise ........................................................................................................................................ Section 2 Monitoring of Treatment ......................................................................................... Smear Conversion ...................................................................................................................... Follow up schedules for sputum examination ............................................................................. Review of Tuberculosis Register ................................................................................................. Recording of follow up examination ............................................................................................ Recording of Treatment outcome ............................................................................................... Determination of date of treatment outcome ............................................................................ Points to Remember .................................................................................................................... 179 179 185 186 188 189 189 190 191 192 193 195

Training Course for Program Manager

MODULE 4 SECTION I REGISTERING CASES


Learning objectives: in this section the participants will learn about the following: Purpose of registration TB register and contents Person responsible for registering cases Types of cases to be registered Timeline for registration Source of records for registration TB Registration number Cohort of patients Filling up of the TB register Ensuring registration of all TB patients

Introduction
In the previous module, we have learnt about treatment organization and treatment administration under Direct Observation of Treatment. We have also learnt about management of special situations and procedure for hospitalization. In the ensuing module we learn about registration of cases, its importance and monitoring of treatment. Registration is recording of the details of all TB patients who have been initiated on treatment, in the TB register. The information recorded is periodically updated till the declaration of the final treatment outcome for every patient.

Purpose of registration
Helps in keeping a track of all the patients initiated on treatment till the completion of their treatment in a systematic manner which facilitates monitoring of individual patients. treatment outcome and programme management and logistics.

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

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Training Course for Program Manager Left side 1. TB Number 2. Date of registration 3.Name (in full) 4.Sex 5. Age 6.Complete number address and Right side Follow-up sputum exam; 14. End of IP/extended IP, (This is subdivided into four columns ie., Date, DMC, Lab Number, Result) 15. Two months into CP, (This is subdivided into four telephone columns ie., Date, DMC, Lab Number, Result) 16. End of treatment, (This is subdivided into four columns ie., Date, DMC, Lab Number, Result) 17.Treatment outcome with date 18.CPT/ART status (if HIV positive) 19.Remarks

7. Name of the PHI 8. Date of starting treatment 9. Regimen 10.Disease classification 11.Type of patient

12.Pre-treatment sputum examination (This is subdivided into four columns ie., Date, DMC, Lab Number, Result) 13.HIV status (P/N/U)

Summary on case finding (DOTS cases only):


There is provision at the bottom on the left side on each page of the TB register to furnish summary of the case finding.

This section summarizes the cases registered on DOTS on the current page of the TB register to facilitate preparation of quarterly report. All types of cases have been divided into two age groups: 0-14 years and 15 years and gender wise (Male and Female). This will facilitate reporting in the block 1 of quarterly report on case finding.

Summary on treatment outcome (DOTS cases only):


There is a provision at the bottom on the right side of the TB register to furnish summary of the treatment outcome.

Treatment outcomes of cases registered on DOTS only is recorded here. Segregated treatment outcomes of different types of TB patients are shown.

One page of the TB register is sufficient to register a maximum of ten patients.

responsible for registering all TB cases put on treatment under the jurisdiction of their TB Unit. He/She is also responsible for updating and maintenance of the TB register under the overall supervision of the MOTC.

Person responsible for registration: Senior Treatment Supervisor (STS) is

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Types of cases to be registered: All tuberculosis patients put on DOTS or non

DOTS regimen under RNTCP are to be registered. This includes new smear positive, new smear negative, new extra pulmonary, new others and re-treatment cases comprising of relapses, treatment after defaults, failures and others. Besides, transfer-in cases are also to be registered.

Timeline for registration: All tuberculosis patients should be registered within a month

after the initiation of the treatment, after patients home visit by the STS. Under no circumstances the treatment should be delayed pending the registration of the patient. It is reiterated that all indoor patients treated under RNTCP should be registered under the local TU where the hospital/Medical College is located. On discharge, these patients should be transferred out to the TU where the patient resides.

Source of records for registration: Treatment cards prepared after the initiation of the treatment is the important primary record and the same is used for registering the cases. For registration, STS transcribes the information on the Treatment cards maintained at the PHI to the TB register. TB Registration Number: This is a serial number allocated to each TB patient. It begins afresh from 1st January and continues up to 31st December of a calendar year.
After assigning a TB number to the patient it should be transferred to all the relevant records - TB treatment card, treatment box, ID card, Laboratory register.

Cohort of patients: A cohort in RNTCP is a group of TB patients registered in TB

register in a particular quarter/year in the given area (TU/District/State/Country). The date of registration determines the quarter to which the patient belongs. Patients may be diagnosed and put on treatment on 30th December 09 but they may be registered any time in January 2010. These patients are considered to belong to the cohort of first quarter 2010. It is mandatory to follow the calendar dates for determination of four quarters comprising three months each for registration. For eg., the first quarter starts from 1st January and ends on 31st March and so on. In no case, the schedule of the quarter will change. For eg., registration starts on 1st January and the quarter ends on 25th March which is erroneous. Cases registered upto 31st March should be included in the 1st quarter and so on.

Registration of patients in every quarter should start on a fresh page. The patient will be evaluated in a quarter in which he/she has been registered and not in the quarter when he/she begins the treatment.

Filling up of TB register
The relevance of all the columns and the procedure of filling up all the columns are explained below:

Tuberculosis number (TB No.)


Each patient who is being registered is assigned a new Tuberculosis Number (TB No.) and this number is written in the Tuberculosis Register. The number should be started with number 1 (e.g. 01 / 2010) at the beginning of every year and patients are registered 181

Training Course for Program Manager serially. After TB number is written in the TB register, the same is recorded in the treatment card also. TB number facilitates identification of the patient in the TB register and other details pertaining to treatment. An individual TB patient may have more than one TB number if he/she is re-registered (e.g. after declaring him/her as defaulted and restarting on treatment afresh or after declaring as failure and initiating on regimen for previously treated cases, details of which will be recorded in the remarks column). The STS should write the TB number in the following records:

TB register TB treatment card TB laboratory register (Remarks column)

Example:
Suppose today is 14 March and 3 patients are to be registered. The last TB No. in the Tuberculosis Register is 64. The 3 patients are assigned Tuberculosis Numbers 65, 66, and 67.

Date of registration
The date on which the patient is registered is recorded in the Tuberculosis Register. It should be written as: day/month/year (for example 22 May 2010 would be written as 22/5/2010). This is the date used for determining a quarterly cohort for case finding, smear conversion and treatment outcome reports.

Name (in full), Sex, Age, Complete Address and telephone number
This is self explanatory. This information is recorded from patients Tuberculosis Treatment Card. It is ascertained that the information is correct before entering it in the Tuberculosis Register.

Name of PHI
The name of the centre where the patient is initiated on treatment (i.e., where the original card is kept) should be written as available from the treatment card.

Date of starting treatment


This is obtained from the entry made in the treatment card meant for recording drug collection in the intensive phase. The first box that is ticked ) ( is the day on which the patient was started on treatment. The date is entered in dd/mm/yy format. The date of starting treatment will either precede or be the same as the date of registration but will never be after the date of registration. Thus, some patients who may be started on treatment in the last few days of one quarter, say 1st Quarter 2010, may be registered in the next quarter, viz., 2nd Quarter 2010. Such patients would be considered to be a part of the cohort of 2nd Quarter 2010. However, in no case should patients be registered later than one month from date of starting treatment.

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Regimen
Regimen for treatment prescribed is recorded in this column. This information is available in the treatment card. The regimen prescribed in the treatment card would have been ticked either as Regimen for new cases / Regimen for previously treated cases / ND1 / ND2 as the case may be. Patients should be registered within a month of initiation of treatment. The STS registers patients who began treatment in a health facility or hospital during his/her periodic supervisory visit after counseling the patient.

Disease classification
If the patient is classified as pulmonary tuberculosis, it is recorded as P and if extra pulmonary TB it is recorded as EP. This information is available in the Treatment Card under the Disease Classification. In the rare case of a patient who has both pulmonary and extra-pulmonary TB, s/he should be classified as pulmonary and recorded as P.

Type of Patient
This information is available in the box meant for recording type of patient on the front side of the treatment card. Appropriate type - New case / Relapse / Transfer in / Treatment Failure / Treatment After Default / Others is ticked. In case of others it may be specified as New / Previously treated and basis for such classification explained in Remarks column.

Pretreatment Sputum Examination


Details of initial sputum examinations are recorded. The sub columns are date, name of the DMC, Lab Serial number and smear results. This information is available in the Treatment Card. Conventionally, positive smear results should be entered in red ink and negative smear results in black / blue ink.

HIV status

HIV Status as provided in the original TB treatment card should be recorded in the space provided at the time of registration. Status is recorded as P for HIV-positive; N for HIV-negative; U for unknown. At the time of preparation of the quarterly report on case finding, all blank entries in the HIV Status column in the TB register should be considered as 'Unknown' for the purpose of reporting. If the HIV status of the TB patient is initially not known and is later ascertained and updated during the course of TB treatment, the same should be updated in the TB register. Treatment cards and TB register should have been updated with the HIV status information before the preparation of quarterly report on treatment outcome

If the HIV status on the TB treatment card remains blank for any reason it is to be recorded as unknown in the TB register.

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Follow Up Sputum Examinations


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

Treatment Outcome with date


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

Details on CPT and ART


The section is to be filled up for all TB patients known to be HIV-infected and should be left blank for others. CPT and ART information should be recorded on the register at the same time of treatment outcome recording i.e. within a month of TB treatment completion. Record CPT started as yes, with the date, if at least one month of CPT delivery is recorded in the original treatment card. Record ART started as yes if recorded as yes in the original TB treatment card. Record the documented approximate date of ART initiation from the original TB treatment card. For patients who were already taking CPT or ART at the time of TB diagnosis, the dates for CPT and/or ART initiation would be expected to be earlier than the date of initiation of TB treatment. For patients who were already taking CPT or ART at the time of TB diagnosis, the dates for CPT / ART initiation is expected to be earlier than the date of initiation of TB treatment. This date should be taken from the ART records of the patient.

Remarks
This column is meant for recording entries such as: Details of x-ray reports for Smear-negative patients Site involved in case of EPTB Investigations done for EPTB such as histopathology etc. For recording DOT provision by community volunteer as CV

Details regarding transfer

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Training Course for Program Manager In case of patients has been started on Regimen for previously treated cases, previous TB number (i.e. TB number when patient was on Regimen for new cases) and whether treated under RNTCP or otherwise In case of treatment after failure and defaulted patients out of the new cases who are eventually being initiated on Regimen for previously treated cases, the newly assigned TB number is written. Reasons for initiating Non-DOTS regimen and sensitivity examinations

Information on starting patients on MDR-TB treatment regimen, results of the culture Summary on the Left side
A box is provided at the bottom of the left side of the Tuberculosis Register. It is for recording the number of patients, who are on RNTCP DOTS, according to disease classification of all types of cases except transfer in and who are on RNTCP non-DOTS.

Summary on the Right side


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

Ensuring registration of all TB patients


Sometimes we may find that there are patients who have not been registered in the Tuberculosis Register. These are: Patients entered in the Tuberculosis Laboratory Register as smear-positive, but are not receiving treatment Patients receiving treatment and have a Tuberculosis Treatment Card, such as smear negative and extra-pulmonary TB cases which may not find reference in the Lab Register.

It is essential to trace the first type of patients (mentioned above) because they are infectious and not receiving treatment for TB. At least half of the smear-positive patients, if left untreated, would die from TB. In addition, each of these patients would spread TB infection to at least 10-15 healthy uninfected family members and other members of the community per year, as long as they live. These patients must be traced and placed on the appropriate treatment immediately. The designated microscopy centre maintains a Tuberculosis Laboratory Register. If the patient has not been started on treatment, the reason for the same should be mentioned in the Remarks column of this laboratory register. If treatment has been initiated, the patients Tuberculosis Number should be written in the Remarks column of the Tuberculosis Laboratory Register.

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Training Course for Program Manager Ensure that all patients started on treatmentboth DOTS and RNTCP nonDOTSare registered in the same Tuberculosis Register. During supervisory visits the STS and STLS should identify all such patients and make all efforts to have them placed on treatment. There are two ways of making sure that all patients are registered in the Tuberculosis Register: During visits to the microscopy centre, all smear-positive patients who are entered in the Tuberculosis Laboratory Register but not in Tuberculosis Register have to be identified. During supervisory visits to the hospitals and health facilities, any patients with Tuberculosis Treatment Cards who are not registered should be identified and registered.

Exercise -1
Using workbook E3, complete one page of left side of the TB register using five treatment cards you have completed in exercise E2. The registration dates are shown against the names. The last registration in the TB register was 615. Parvathi Sinha (Patient A) Lakshmi Kumari (Patient B) Kailash Nath (Patient C) Ganasham Singh (Patient D) Kiran Kumar(Patient A) 26th September 2008 17th September 2008 26th September 2008 11th September 2008 26th September 2008

Exercise-2
Complete the transfer form for the appropriate patient mentioned in module three.

Exercise -3
1. What information is recorded in the TB Register at the time of registration?

2. Who is responsible for registering patients and within what time should the patient be registered? 3. List the records where the TB No. should be written.

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Training Course for Program Manager 4. How do you identify whether the patient found sputum positive in the DMC lab register has been registered in the TB Register (a) (b) 5. State true or false: a. A patient was started on treatment on 20-3-2010. STS registered the patient on 13-4-2010. The patient will be reported in the cohort of the 2nd quarter 2010. b. Treatment cards and TB register should be updated with the HIV status information before the preparation of quarterly report on treatment outcome c. CPT and ART information should be recorded on the register at the same time of treatment outcome recording i.e. within a month of TB treatment completion

POINTS TO REMEMBER
All patients initiated on treatment for tuberculosis (RNTCP DOTS or RNTCP non-DOTS) must be registered in the TB register and assigned a TB number The STS is responsible for registering patients All patients must be registered within one month of treatment initiation Only one Tuberculosis Register is maintained at each TU

Tuberculosis Register contains patient-related essential information

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SECTION -2 MONITORING OF TREATMENT Learning objectives


In this module the participants will learn about the following Methods of monitoring Smear conversion Follow up schedules for sputum examination Recording of follow up examinations Recording of the treatment outcome and date of treatment outcome Identification of MDR suspects and filling up of Mycobacteriology culture and drug sensitivity test form

Introduction
Monitoring of treatment is a process of watching the response of the patient to the treatment being administered. Monitoring of treatment can be undertaken by several ways. Cases registered in the Tuberculosis Register can be considered as participants in a race. Like watching participants in a foot race, the progress of TB patients can be watched as they move towards the end point, i.e., monitoring their treatment as they progress towards the completion of treatment and cure.

Methods of monitoring:
Monitoring of the treatment of patients can be undertaken in the following ways: 1. Periodic follow up sputum examination: This is an objective method of assessing the response of the patients to treatment. Smear conversion at end IP/ extended - IP is an early indicator of the success of treatment regimen and also the efficiency of DOT administration. 2. Review of drug collections in the treatment card: a. Intensive phase: Review of treatment card for collection / administration of DOT as indicated by may supplement the monitoring of treatment. b. Continuation phase: Review of treatment card for collection / administration of DOT as indicated by X------- may supplement the monitoring of treatment.

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Training Course for Program Manager 3. Review of patient wise boxes versus recording of drug collections : Another important indirect method of monitoring drug intake is to compare the drugs available in the patient-wise boxes vis--vis the drugs shown as consumed in the Tuberculosis Treatment Card. The number of blister packs remaining either in the IP/CP should match with the recording of drug administration in the treatment card and the empty blister packs returned and retained. Any discrepancy, if observed should prompt visit to patients home for further interaction & clarification. 4. Interaction with patients at random, preferably at their residence: Interview of patients regarding the administration of DOT at the time of home visit will validate the recordings in the treatment card and the TB register.

Smear conversion:
Smear microscopy is an objective method of assessing response to treatment. One of the way to monitor the treatment results of a pulmonary smear-positive case is to check for the conversion from smear-positive to smear-negative status. This is an early indicator that the intensive phase of treatment is regular and effective. Smear-positive cases will convert to smear-negative and will remain smear-negative if the patients take their medications under direct observation on a regular basis for the prescribed period. After end IP of treatment, more than 80% of new pulmonary smear-positive cases could become smear-negative, and after entended -IP the rate of sputum conversion could increase to more than 90%. Pulmonary smear-positive relapse cases should have almost same rates of sputum conversion as new pulmonary smear-positive cases. Other smearpositive previously treated cases, such as failures of new sputum smear-positive cases, may have lower sputum conversion rates around 75%, after 3 months of receiving the regimen for previously treated.

Follow up schedules for sputum examination:


Follow up sputum examination is recommended as follows

For New Cases


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

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For Previously treated cases


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

Monitoring regularity of sputum examination


The results of sputum examinations should be verified during supervisory visits to the treatment centers. Prior to supervisory visit to a PHI, the Tuberculosis Register is reviewed to identify cases that should have had their sputum examined as follows: 1. Identify the TB patients who have become eligible for follow up examination at the end of the intensive phase, extended intensive phase, two months into the continuation phase and at the end of the treatment. 2. This can be determined by looking into the date of initiation of the treatment, treatment regimen prescribed and total number of doses administered. 3. The list of patients whose follow up examinations should have been completed and results expected to be available in the health centers is prepared and the health center visited accordingly. For identifying cases whose results of sputum examinations should be recorded, TB register is reviewed. This is to determine whether the proportion of the New and Relapse Pulmonary smear-positive cases at the treatment centre who have become smear-negative by the end of their intensive phase is adequate (90% or more).

Review of Tuberculosis Register


new pulmonary smear-positive, relapse, treatment after default and treatment failure cases are arrived by reviewing their smear status individually at the end of 2/3 months.

a. Smear conversion : Proportion of patients who have become smear negative among

If the smear conversion rate is less than 85% for new cases, at the end of 2(3) months, the reasons needs to be examined and rectified why the conversion rate at 2(3) months is low.

Example:
In Nagpur District 220 New smear-positive patients were registered in a quarter, 190 New smear-positive patients converted to smear-negative at the end of 2 months and another 10 New smear-positive patients converted to smear-negative at the end of 3 months. Therefore, 200 (190 + 10) New smear-positive cases converted to smear-negative. 190

Training Course for Program Manager 200 x 100 = 91% 220 Hence, the smear conversion rate in Nagpur district is 91%.

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

b. Identification of MDR-TB suspects: During the review of the TB register, STS

Recording of follow up examinations Recording in treatment card The details of the follow up examinations are
recorded against the appropriate month (i.e., end of intensive phase / extended IP, two months into continuation phase and at the end of the treatment) under the column heads Date, DMC, Lab Number, Smear Results and Patient Weight. In situations where smear is positive at the end of the intensive phase either in New or Previously treated cases, the row of boxes meant for Date, DMC, Lab Number, Smear Results and Patient Weight have to be split by a forward slash as shown below. The details of the sputum examination done at the end of two months are entered above the slash. Intensive Phase is extended by one month and the details of the sputum examination done at the end of third month in New and fourth month in Previously treated cases are entered below the forward slash as depicted below: Month Pretreatment
End of IP End of IP Extd IP End of IP Extd IP

Date

DMC

Lab No.

Smear Result
End of IP Extd IP

Patient Weight
End of IP Extd IP

End IP / Extended IP 2 months CP End treatment

Extd IP

191

Training Course for Program Manager It is important to ensure that sputum has been examined at the correct intervals during treatment and the results are recorded in the appropriate columns of the Tuberculosis Register. For monitoring the regularity of sputum examination it is necessary to: Regularly identify pulmonary TB cases whose follow-up sputum examination is due and confirm that results of the examination have been recorded in the Tuberculosis Register; During supervisory visits to health facilities, Tuberculosis Treatment Cards (or Laboratory Form for Sputum Examination) are reviewed and compared with the results of sputum smear examinations with those recorded in the Tuberculosis Register. Sometimes, during the visit to health facility, it is observed that the Tuberculosis Treatment Cards are not updated. In such an event, as a backup during supervisory visits by STLS to the DMCs, the details of every patient subjected to follow-up sputum examination should be noted and shared with STS regularly to facilitate updating of the TB register. The same information may be passed on to the concerned health facility to update the records there. The MO of the health facility should be informed about the same with a request to monitor this activity.

Recording in the TB register - The details of the follow up sputum examinations are

also recorded on the right hand side of the TB register under the column heads End of IP/ Extended IP, second month into continuation phase, End of treatment.

Recording of the treatment outcome: Treatment card


The appropriate outcome i.e., cure/treatment completed/transferred out/defaulted /failure/switched over to MDR-TB treatment/died may be recorded on the line provided on the reverse side of the card. Date of outcome is the date on which the patient takes the last dose of treatment (i.e., last pyridoxine tablet in the 18th weekly blister in New and 22nd weekly blister in Previously treated). This date is recorded in the space provided following the treatment outcome. This is applicable in case of recording the treatment outcome as cure and treatment completed only. For other treatment outcomes, refer table below for Determination of date of treatment outcome. treatment outcome is recorded but not later than one month.

TB treatment card should reach the TB unit from the treatment centre as soon as the TB register
Treatment outcome has to be entered in the TB register as recorded in the TB treatment card. The treatment outcome should be recorded in the TB register within one month of the completion of treatment. Similarly, the patients declared as defaulted or died should be recorded within one month of the event. (Example - patients interrupted treatment on 1st March 2010. He was declared defaulted on 2nd May 2010. This should be recorded in the TB register by 2nd June 2010). For transferred out cases it should be ensured that the treatment outcome as declared at the centre where the patient was transferred is obtained and outcome is updated in the TB register. 192

Training Course for Program Manager Before declaring treatment outcome as transferred out all possible efforts should be made to get the actual outcome of the patient from the TU where he/she was transferred to. Data on the cases that were transferred from one district to another should be evaluated in the district in which the patient was first notified and registered. Date of determination Illustrations The last dose (Pyridoxine) of the Patient administered last dose 18th blister in New and 22nd under DOT in continuation blister in Previously treated. phase on 16-06-2010; Last Pyridoxine taken on 22-062010 Cured or treatment completed on 22-06-2010 Transferred out is the date on Generally drugs up to one week which the patient is supposed to (3 blisters in IP and one blister have consumed the last of the in CP) are given for self three doses provided to him at administration during transfer. the time of transfer as recorded Actual date on which transfer in the card. form was filled and sent is 20This is only an interim outcome. The actual outcome as reported 06-2010; then the date of from the TB unit where the transferred out as a treatment patient was transferred will be outcome should be 27-06-2010. updated in the card and in the TB This is the date when the 3rd dose handed over during register upon its receipt. transfer is supposed to have consumed. The scheduled date of drug Patient interrupted treatment on consumption after which the 16-9-2010 Record outcome as patient interrupted treatment defaulted on 16-9-2010 on or either in the intensive phase or in after 17-11-10 but within one the continuation phase. month The date on which the sputum If the smear result is positive on examination was found to be 18-05-2010 Record as failure on 18-05-2010 positive for AFB The actual date of death Patient died on 11-08-2010 Record as Died on 11-08-2010

Determination of date of treatment outcome


Outcome Cured Treatment completed

Transferred out

Defaulted*

Failure Died

* A Patient after treatment initiation has interrupted treatment consecutively for >2 months
A patient will have one and only one outcome. The outcome which occurs first is considered and recorded in treatment card and subsequently in the TB register.

Tuberculosis Treatment Cards should be reviewed as soon as possible after a patient has completed treatment. The reverse of the treatment card is reviewed to verify whether the patient has consumed all his drugs as scheduled. 193

Training Course for Program Manager When Treatment Card, is found to be incomplete this should be enquired into during the supervisory visit. For example, if a Tuberculosis Treatment Card is found to be incomplete in continuation phase and there are no comments under Remarks, it needs to be verified to find out whether the patient has been transferred, defaulted, died or just stopped coming and the reason for the same. Data on cases that were transferred from one district to another should be evaluated in the district in which a patient was first notified and registered. On completion of treatment by the patient, who was transferred into the district, results of the final follow up examination should be sent to the district from where he was transferred along with the treatment card. The best practice would be to obtain the TB number of the transferred patient from the STS of the receiving TB unit within 1 month of the transfer. Thus, the information on follow up sputum examination results can be easily obtained if the TB number assigned at receiving TB Unit is available.

Exercise -4 Part 1
Using workbook E3 and the completed treatment cards in Exercise Workbook E2, complete the right hand side of the Tuberculosis Register.

Part 2
Look at the single page (right and left side) of Exercise Workbook E3 Labeled Tuberculosis Register with Errors. Every line of the Tuberculosis Register contains at least one error in registration or in management. Note down the errors identified in the table below. TB. No. 401 402 403 404 405 406 407 408 409 410 Error (s)

194

Training Course for Program Manager

EXERCISE 5
1. A patient started on regimen for new cases on 13.4.09, treatment stopped on 27.7.09. The MPW reported that the patient expired on 30.10.09. Give the outcome of the patient.

2. What do you need to know to determine schedule for a follow-up sputum examination?

3. If the sputum smear result is positive at the end of the intensive phase of treatment, how will you record this in the TB register?

POINTS TO REMEMBER
Smear conversion at the end of the intensive phase could be an early indication for achieving high cure rates. This has to be ensured by regular monitoring of the treatment. Treatment of smear-negative and extra-pulmonary TB is monitored by regularity of drug intake and clinical improvement. A patient initiated on treatment for tuberculosis will have only one of the seven outcomes (cured, treatment completed, died, failure, defaulted, transferred out or switched over to MRD-TB treatment). While determining the date of outcome in cure and treatment completed, the date on which the last dose of drug consumed is considered and not the last date when drugs were collected Tuberculosis Register contains all patient-related essential information

195

Revised National Tuberculosis Control Programme TB Register Quarter ________ Year ___________
Complete Address & Telephone Number * Regimen: NT New, PT Previously Treated ** Type of Patient (use complete words) New, Relapse, Transferred in, Treatment Failure, TAD, Others HIV Status HIV status as reported before or during TB treatment P Positive, N Negative, U Unknown. Regimen Pre-treatment sputum exam HIV Name Date of CatClass Status of Starting Type** DMC I/CatII/ND1, (P/EP) Date Lab.No. Smear (P/N/U) PHI Treatment Name ND2*

TB No.

Date of Registration

Name (in Sex Age full) (M/F)

Summary for Case Finding (DOTS Cases Only) New Others Relapse Treatment TAD Failure Previously Treated Others

NSP

NSN

NEP

0-14 Yrs. 15 Yrs. Male Female