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For decades now, tuberculosis (TB) has been a major public health hazard contributing to the
considerable loss of productive man-hours. Hence, controlling TB to a level where it is no longer a
public health problem is a priority under the Health Sector Reform Agenda. This, in turn, is envisioned
to contribute significantly to the poverty reduction efforts of the government.
Successful TB control depends largely on the capacity of various health care facilities to
administer TB management based on technically sound, evidence-based, and consistent policies and
procedures. Adopting standardized TB management protocols and guidelines facilitates effective program
implementation in all parts of the country. Hence, Executive Order No. 187, series of 2003, institutionalized
the Comprehensive and Unified Policy for Tuberculosis.
The National Tuberculosis Control Program (NTP) Manual of Procedures (MOP) is decidedly
a milestone in the implementation of standardized management protocols and guidelines for all healthcare facilities in the country involved in TB cure and prevention. This revised version (4thedition) of the
MOP embodies new strategies and initiatives designed to contribute to national targets of 70-per-cent
case detection and 85-per-cent cure rate. Among these initiatives are: a) collaboration with key partners
through installation of Public-Private Mix DOTS (PPMD) units; b) expansion of DOTS services to cover
other health related sectors like teachers and school personnel, the military, and those in prisons; c)
shift from single-dose to fixed-dose combination anti-TB drugs, which aims for improved treatment
compliance and better logistics management; d) adoption of a quality assurance system formore reliable
sputum microscopy; e) strengthening of TB Diagnostic Committees to support the management of less
infectious cases; and f) adoption of policy statementsgoverning monitoring, supervision, and evaluation,
as well as advocacyactivities on TB cure and prevention.
The MOP has undergone a series of revisions involving partners/implementers as external
reviewers and sources of critical technical and editorial inputs. The NTP is extremely grateful to all those
who contributed to the development and revision of the MOP, which aims to contribute to more effective
ways of implementing the NTP throughout the Philippines. For their technical expertise and financial
assistance in making this product a success, acknowledgment goes to the following: The Global Fund
to fight AIDS, Tuberculosis and Malaria (GFATM); Japan International Cooperation Agency (JICA);
Local Enhancement and Development for Health Project Management Sciences for Health (LEAD-
MSH); MedicosDel Mundo (MDM); Philippine Coalition Against Tuberculosis (PhilCAT); Philippine
Tuberculosis Initiatives in the Private Sector (PhilTIPS); Tropical Disease Foundation, Incorporated
(TDFI); United States Agency for International Development (USAID); World Health Organization (WHO);and World Vision Development Foundation, Incorporated (WVDFI).
We hope that the MOP will be a tool for unifying our efforts towards the attainment of our vision
of a TB-free Philippines.
HON. FRANCISCO T. DUQUE III, MD, MSc.
Secretary of Health
Department of Health December 2005
Republic of the Philippines
Foreword
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A publication of the Department of Health (DOH), Government of the Philippines, in cooperation with
the following local and international key stakeholders and partners:
Board of Advisers:
1. Dr. Myrna Cabotaje, NCDPC, DOH
2. Dr. Jaime Lagahid, IDO, DOH
3. Dr. Jennifer Ann Mendoza-WI, PhilCAT
Publications Staff
1. Dr. Ma. Theresa Velasco, Technical Editor
2. Ms. Laila Garcia, Assistant Technical Editor
3. Ms. Rose Gonzales, Creative Director
Technical Working Group (TWG)
Department of Health
1. Dr. Anna Marie Celina Garfin, NCDPC
2. Dr. Ernesto Bontuyan Jr., NCDPC
3. Ms. Agnes del Rosario, NCDPC
4. Mr. Ferdinand La Puebla, NCDPC
5. Ms. Ellen Melia Castillo, NTRL
6. Ms. Edna Nito, NCHP
Centers for Health Development
1. Dr. Lydia Rogando, CHDBicol
2. Dr. Flor Elona, CHDEastern Visayas
3. Dr. Willie Cabauatan, CHDCagayan Valley
4. Ms. Joy Tabotabo, CHDCentral Visayas
5. Ms. Gemma Tan, CHDIlocos
Local Government Units
1. Dr. Niela Jorvina, Laguna Provincial Health Office
2. Dr. Christina Giango, Cebu Provincial Health Office
3. Ms. Evangeline Rambuyon , Negros Provincial Health Office
4. Ms. Letty Rivera, Batangas Provincial Health Office
Partners
1. Dr. Michael Voniatis, WHO
2. Dr. Tomohiro Shirahama, JICA
3. Dr. Arthur Lagos, JICA
4. Dr. Marilyn Gorra, PhilTIPS
5. Dr. Charles Yu, PhilTIPS
6. Mr. Jose Ibarra Angeles, PhilTIPS
7. Ms. Elaine Umali, WVDFI
Technical Review Panel (TRP)
Department of Health
1. Dr. Rosalind Vianzon, NCDPC
2. Ms. Cirila Negad, NCDPC
3. Ms. Arlene Rivera, NCDPC
4. Dr. Vivian Lofranco, LCP
5. Dr. Nora Cruz, NTRL
6. Ms. Paz Rostrata, NTRL
Centers for Health Development
1. Dr. Sylvia Somontan, CHDCaraga
2. Dr. Eloisa Segura, CHDDavao
3. Dr. Amelia Medina, CHDNCR
4. Dr. Edith Caloyloy, CHDWestern Visayas
5. Ms. Marilou Gecosala, CHDNorthern Mindanao
Local Government Units
1. Dr. Bernard Caspe, Iloilo City Health Office
2. Dr. Ma. Lourdes San Juan, Pasay City Health Office
3. Dr. Marian Isiderio, Eastern Samar Provincial Health Office
4. Ms. Teresita Puente, Pasig City Health Office
5. Ms. Myla Espino, Pasig City Health Office
6. Ms. May Fernando, Bulacan Provincial Health Office
Partners
1. Dr. Mariquita Mantala, LEAD for Health Project
2. Dr. Jubert Benedicto, PhilCAT
3. Ms. Amelia Sarmiento, PhilCAT
4. Mr. Albert Angelo Concepcion, PhilCAT
5. Dr. Maria Rubio, MDM
6. Dr. Jose Luis Portrero, MDM
7. Dr. Ma. Imelda Quelapio, TDFI/GFATM
8. Dr. Melvin Magno, WVDFI
Credit Page
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FOREWORD i
CREDIT PAGE iiMANUAL OUTLINE iii
LIST OF ACRONYMS v
LIST OF TABLES viii
LIST OF FIGURES ix
GLOSSARY x
CHAPTER I INTRODUCTION
Prevalence of TB In the Country 1
History of TB Control in the Philippines 2
Vision, Mission, and Goal of the NTP 9
NTP Objectives and Strategies 9
Roles of Collaborating Agencies 11
Functions of Health Workers 13
CHAPTER II CASE FINDING
I. Objective 18
II. Definition of Terms 18
III. Policies 18
IV. Procedures 19
V. Quality Assurance for DSSM 27
CHAPTER III CASE HOLDING
I. Objective 28
II. Definition of Terms 28
III. Policies 31
IV. Procedures 35
V. Treatment Outcome 50
VI. Summary Guide 50
CHAPTER IV RECORDING AND REPORTING
I. Objective 53
II. Policies 53
III. NTP Recording Forms 54IV. Persons Responsible for the Recording Forms 73
V. NTP Reporting Forms 74
iii
Manual Outline
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CHAPTER V LOGISTICS MANAGEMENT
I. Product Selection 82
II. Procurement 83
III. Distribution and Storage 83
IV. Rationale Use, Monitoring, and Evaluation 85
CHAPTER VI MONITORING, SUPERVISION, AND EVALUATION
I. Objective 90
II. Policies 91
III. Procedures 92
IV. Monitoring Forms 94
CHAPTER VII OVERVIEW OF THE HEALTH PROMOTIONPROGRAM FOR THE NTP 101
ANNEXES
1 Guidelines for Implementing Tuberculosis 105
Control Program in Children (AO No. 178 Series of 2004)
2 Sample Packages of FDCs & SDFs 115
3 The TB Diagnostic Committee (TBDC) 117
vi
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AFB Acid Fast Bacilli
BCG Bacille Calmette-Guerin
BFAD Bureau of Food and Drug
BHS Barangay Health Station
BHW Barangay Health Worker
CDR Case Detection Rate
CHD Center for Health Development
CHO City Health Officer or City Health Office
CIDA Canadian International Development Agency
Collaboration in Rural and Urban Sites to Halt Tuberculosis
CUP Comprehensive and Unified Policy for TB Control in the Philippines
CXR Chest X-ray
DILG Department of Interior and Local Government
DOH Department of Health
DOT Directly Observed Treatment
DOTS Directly Observed Treatment, Short Course
DRS Drug Resistance Survey
DSSM Direct Sputum Smear Microscopy
E Ethambutol
EP Extra pulmonary Tuberculosis
EPI Expanded Program for Immunization
EQA External Quality Assessment
FDC Fixed Dose Combination
FEFO First Expiry, First Out
FHSIS Field Health Services Information System
FM Family Member
GDF Global Drug Facility
GFATM Global Fund to Fight AIDS, Tuberculosis, and Malaria
H Isoniazid
List of Acronyms
CRUSH TB
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HSRA Health Sector Reform Agenda
IEC Information, Education and Communication
JICA Japan International Cooperation Agency
LCE Local Chief Executive
LCP Lung Center of the Philippines
LGU Local Government Unit
MC Memorandum Circular
MDR-TB Multiple Drug Resistant TB
MHC Main Health Center
MHO Municipal Health Officer
MOP Manual of Procedures
MT Medical Technologist
National Coordinating Committee for PPMD
NCDPC National Center for Disease Prevention and Control
NCHP National Center for Health Promotion
NGO Non-Government Organization
NHIP National Health Insurance Program
NIT National Institute of Tuberculosis
NPS National TB Prevalence Survey
NTP National Tuberculosis Control Program
NTRL National Tuberculosis Reference Laboratory
OIF Oil Immersion Field
PAS Para-Amino Salicylate
PCCP Philippine College of Chest Physicians
PD Presidential Decree
PhilCAT Philippine Coalition Against Tuberculosis
PHO Provincial Health Office
PMA Philippine Medical Association
PPMD Public-Private Mix DOTS
PSMID Philippine Society for Microbiology and Infectious Disease
PTB Pulmonary Tuberculosis
PTSI Philippine Tuberculosis Society, Inc.
NCC-PPMD
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QA Quality Assurance
QC Quality Control
QI Quality Improvement
R Rifampicin
RA Republic Act
RAD Return After Default
Regional Coordinating Committee for PPMD
RHM Rural Health Midwife
RHU Rural Health Unit
S Streptomycin
SCC Short Course Chemotherapy
SDF Single Drug Formulation
TB Tuberculosis
TBCS TB Control Service
TBDC Tuberculosis Diagnostic Committee
TCL Target Client List
UNICEF United Nations Childrens Fund
USAID United States Agency for International Development
UST University of Santo Tomas
WB World Bank
WHO World Health Organization
WPRO Western Pacific Regional Office
Z Pyrazinamide
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RCC-PPMD
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Table 1.1 Comparative Data between 1981-1983 NPS and 1997 NPS
Table 3.1 Classification of TB Cases
Table 3.2 Types of TB Cases
Table 3.3 Recommended Category of Treatment Regimen
Table 3.4 Treatment Regimen for Categories I & III: 2HRZE/4HR (FDC)
Table 3.5 Treatment Regimen for Category II: 2HRZES/HRZE/5HRE (FDC)
Table 3.6 Treatment Regimen for Categories I & III: 2HRZE/4HR (SDF)
Table 3.7 Treatment Regimen for Category II: 2HRZES/HRZE/5HRE (SDF)
Table 3.8 Drug Dosage per KG Body Weight
Table 3.9 Schedule of DSSM Follow-up for Categories I and III
Table 3.9.a Schedule of DSSM Follow-up for Category II
Table 3.10 Treatment Modifications for New PTB Smear-Positive Cases Based on the Results
of DSSM Follow-up for Category I Treatment Regimen Without Extension
Table 3.10.a Treatment Modifications for New PTB Smear-Positive Cases Based on Results of
DSSM Follow-up for Category I Treatment Regimen With Extension
Table 3.10.b Treatment Modifications for PTB Smear-Positive Cases Based on the Results of DSSMFollow-up for Category II Treatment Regimen Without Extension
Table 3.10.c Treatment Modifications for PTB Smear-Positive Cases Based on DSSM Follow-up
Results for Category II Treatment Regimen With Extension
Table 3.11 Guide in Managing Adverse Reactions to Anti-TB Drugs
Table 3.12 Treatment Modifications for New Smear-Positive Cases Who Interrupted Treatment
Table 3.12.a Treatment Modifications for Relapse and Treatment Failure Cases Who Interrupted
Treatment
Table 4.1 Persons Responsible for the Recording Forms
Table 5.1 Computation for Quarterly Drug Requirement for Stop TB Kits
Table 5.2 Computation for Quarterly FDC BP Drug Requirement
Table 5.3.a Computation for Quarterly SDF BP Drug Requirement
Table 5.3.b Computation for Quarterly SDF Tablets Drug Requirement
Table 5.4 Computation for Annual Estimated Supplies for DSSM
Table 5.5 Computation for Annual Estimated Recording and Reporting Forms
Table 6.1 Program Indicators
Table 7.1 Health Promotion Activities for Addressig Various Tasks
List of Tables
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Figure 1.1 Flow of NTP Activities
Figure 2.1 Flow Chart for the Diagnosis of Pulmonary TB
Figure 2.2 Flow Chart for the Diagnosis of Smear-Negative Pulmonary TB
Figure 2.3 Guide to Case Finding
Figure 2.4 Guide to Diagnosis and Initiation of Treatment
Figure 3.1 Category I Treatment Modification Based on DSSM Follow-up Results
Figure 3.2 Category II Treatment Modification Based on DSSM Follow-up Results
Figure 3.3 Category III Treatment Modification Based on DSSM Follow-up Results
Figure 3.4 Guide to Case Holding
Figure 3.5 Guide to Ensuring Treatment
Figure 5.1 Anti-TB Drug Management Cycle
Figure 6.1 Flow of Reporting
List of Figures
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Active Case Finding Purposive effort by a health worker to find TB cases from among TB
symptomatics in the community who do not consult in a DOTS facility
Communicating with other people to gain their support for an issue
and influence their behavior in a specified way
An activity to discover or find TB cases
An activity to treat TB cases through proper treatment regimen and
health education
It is a continuous and sustained process of educating the people for
them to understand and develop their critical consciousness of their
existing conditions. It entails organizing the people to work collectively
and efficiently on their immediate and long-term problems andmobilizing people to develop their capability and readiness to respond
to and take action on their immediate/long-term needs.
Number of new smear-positive pulmonary TB cases registered in a
specified period who were cured divided by the total number of new
smear-positive pulmonary TB cases registered in the same period
multiplied by 100.
Directly Observed Treatment [A trained DOTS facility worker (or
treatment partner) personally observes the smear-positive patient
take anti-TB medicines everyday during the whole course of treatment.]
Directly Observed Treatment Short-Course (A comprehensive strategy
to control TB). The five components of DOTS are:
1. Government commitment to ensuring sustained, comprehensive
TB control activities;
2. Case detection by DSSM among symptomatic patients self-
reporting to health services (passive case finding);
3. Standard short-course chemotherapy using regimens of six to
eight months, for at least all confirmed smear-positive
cases; complete drug taking through DOT supervised by DOTS
facility workers during the whole course of treatment for all smear-
positive cases;
4. A regular, uninterrupted supply of all essential anti-tuberculosis
drugs and other materials; and
5. A standard recording and reporting system that allows assessment
of case finding and treatment results for each patient and of the
tuberculosis control programs overall performance.
Any facility providing DOTS services; includes BHS/BHC, RHU/MHC,
PPMD unit, hospital-based DOTS facility, and DOTS implementing
units, e.g., prisons, schools, HMOs, military facilities, etc.
Advocacy
Case Finding
Case Holding
Community Organizing
Cure Rate
DOT
DOTS
DOTS Facility
Glossary
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The part of health care that is concerned with promoting health
behavior (It helps people understand their behavior and how it affects
their health. It also encourages behavior that promotes health,
prevents illness, cures disease, and facilitates rehabilitation. It is
also a process by which individuals and groups of people learn to
behave in a manner conducive to promotion, maintenance, or
restoration of health.)
A process of enabling people to take action to improve health (It is
needed in order to build health public policy, create supportive
environment, develop personal skills, reorient health services, and
strengthen community action.)
What people do in order to maintain health and/or return to health,
ranging from individual behavior to collective behavior; includes what
is done and why it is done (It concerns specific steps taken; it is
sometimes called hierarchy of resort.)
A process of generating information or release of ready-madeinformation or prototypes, as well as distribution through all selected
channels of communication
A condition which is resistant against at least Isoniazid and Rifampicin
A process of linking up with individuals, groups, and institutions on
the basis of a common objective
Finding a case of tuberculosis from among TB symptomatics who
present themselves at the DOTS facility
Over-all in charge of running and operating the DOTS facility for the
private-initiated PPMD; includes rural health physicians, municipalhealth officers, and hospital-based physicians
The act of pledging or giving an obligation among Local Chief
Executives, such as Governors, Mayors, and other government
officials
Person responsible for coordinating DOTS activities for the private-
initiated PPMD
Private facility, with private referring physicians, providing DOTS
services
Public facility, with private referring physicians, providing DOTS
services
Groups of people who provide support or sustain one another by
discussing common problems, such as tuberculosis, alcoholism, etc.
When a DSSM has all three negative results
When a DSSM has at least two positive results
xi
Private-Initiated PPMD
Information, Educationand Communication (IEC)
MDR-TB
Health Education
Health Promotion
Health-seeking Behavior
Networking
Passive Case Finding
Political Commitment
Public-Initiated PPMD
PPMD Coordinator
Physician
Sectoral Support
Smear-Positive
Smear-Negative
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An adaptation of commercial marketing, sales concepts, and techniques
to the attainment of social goals (It seeks to make health-related
information products easily available and affordable to low-income
populations and those at risk while promoting the adoption of healthy
behavior.)
A process of engaging people in action, redirecting existing or creatingnew resources to achieve a societys or a communitys social goals (It
implies wide-scale participation. It is also a process of bringing together
all feasible and practical inter-sectoral and social allies to raise peoples
awareness of the demand for a particular development program, to
assist in the delivery of resources and services, and to strengthen
community participation for sustainability and self-reliance.)
DSSM done for TB symptomatics to establish a diagnosis of TB (Three
sputum specimens should be collected.)
DSSM done to monitor the sputum status of a patient after treatment
is initiated (Only one sputum specimen is collected, preferably the earlymorning phlegm.)
Material from the respiratory tract brought out by coughing (This material
is used for DSSM.)
A brand name for DOHs re-energized fight against TB (It is a systematic
and nationwide movement spearheaded by DOH to control TB. It is
considered the official communication handle of NTP.)
Any person exhibiting symptoms or signs suggestive of tuberculosis, in
particular cough of long duration (two or more weeks), and with or
without one or more of the following symptoms: fever; chest and/or back
pains not referable to any musculo-skeletal disprders; hemoptysis or
recurrent blood-streaked sputum; significant weight loss; and other
symptoms, such as sweating, fatigue, body malaise, and shortness of
breath
Mycobacterium tuberculosisthat causes tuberculosis (It is acid-fast
stained with Ziel-Nielsen staining method.)
Note: The definitions in this section apply only to the terms usage in this Manual of Procedures.
Social Mobilization
Sputum Microscopy forDiagnosis
Sputum Microscopy for
Follow-up
Sputum Specimen
TB Network
TB Symptomatic
Tubercle Bacillus
Social Marketing
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PREVALENCE OF TB IN THE COUNTRY
Tuberculosis (TB) has been a m ajor public health problem in the Philippines for the past several
decades. Research has show n that while TB is curable, the disease adversely affects a large segm ent
of the population, particularly the econom ically productive sector. The causal agent,M ycobacterium
tuberculosis, is easily transm itted through airborne droplet nuclei when patients with pulm onary TB
cough or sneeze. If left untreated, TB could lead to a disabling condition and even death. Also, partial
treatm ent of cases m ay cause drug resistance that could lead to non-cure.
In 2002, TB was the sixth am ong the 10 leading causes of death and the 10 leading causes of
illness in the country. W hile the m ortality rate from TB has decreased in the past 20 years (from 206
deaths per 100,000 population in 1982 to 36 deaths per 100,000 in 2002), still around 75 Filipinos die
of TB everyday. Globally, the Philippines is one of 22 countries identified by the W orld Health Organization
(W HO) as having a high burden of TB, ranking at ninth worldw ide. It ranks third in term s of new sm ear-
positive TB notification rate in the W HO -W estern Pacific R egion (W H O Report 2003).
Com parative data gathered from two N ational Tuberculosis Prevalence Surveys (1981-1983
and 1997) reflect an encouraging trend in TB control in the country, although the changes have not been
dram atically significant (Table 1.1). The annual risk of TB infection, or the probability of a child getting
infected with TB within a year, declined very slightly in 15 years, from 2.5 per cent in 1982 to 2.3 per
cent in 1997. This m easure is generally accepted as a sensitive indicator. The percentage of the
population afflicted with TB decreased from 6.6/1,000 in 1981-1983 to 3.1/1,000 in 1997. The prevalence
of culture-positive cases likewise declined very slightly from 8.6/1,000 to 8.1/1,000. Percentage of
radiographic findings suggestive of TB has rem ained the sam e at 4.2% in the 15 years between the two
surveys. The 1997 NPS also revealed that TB cases were about three tim es m ore com m on am ong
m ales than fem ales and m ost of these cases were in the 30- to 59-year-old age bracket representing
the econom ically productive age group in the country.
1
Introduction
Introduction
Table 1.1. Comparative Data between 1981-1983 NPS and 1997 NPS
1981-1983 1997
1.Annual risk of TB infection 2.5% 2.3%
2.Prevalence of sputum sm ear-positive cases 6.6/1,000 3.1/1,000
3.Prevalence of culture-positive cases 8.6/1,000 8.1/1,000
4.Radiographic findings suggestive of TB 4.2% 4.2%
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HISTORY OF TB CONTROL IN THE PHILIPPINES
The Beginnings
TB control efforts in the Philippines reflect a continuous struggle to curb the spread of a curable
but highly infectious disease w ith great im plications on the nations productivity.
The earliest organized initiative on TB control in the Philippines can be traced to a private
organization, the Philippine Islands Anti-Tuberculosis (precursor of the Philippine Tuberculosis Society,
Inc. or PTSI), way back in 1910. The Society put up a TB hospital in Quezon City; this was later re-nam ed
Quezon Institute after President M anuel L. Quezon, who was afflicted with the disease. The period 1910-
1929 was largely devoted to case finding and in-patient services at a tim e when the only treatm ent
regim en available consisted of bed rest, isolation, or hospitalization.
The 1930s and 1940s witnessed a m ore organized approach to TB control in the wake of the
increasing incidence of TB cases in the country. The TB Com m ission under the Philippine Health Service
was established in 1932 through Republic Act (RA) 3743. The Bureau of Health took over the powers
and duties of the TB Com m ission in 1933. M ore laws were later enacted to bolster the anti-TB initiatives.
RA 4130 (Sweepstakes Law) established the Philippine Charity Sweepstakes O ffice (PCSO) prim arily
to raise funds to support PTSIs operations. M ost notable am ong PCSOs initial achievem ents were the
setting up of Chest Clinics in selected areas of the country and acceleration of in-patient activities.
From the 50s onw ard, dram atic strides in TB cure have been taken worldw ide. Streptom ycin
injection was first used as part of TB treatm ent in 1949. W ith assistance from the United Nations Childrens
Fund (UNICEF), the BCG vaccination program was introduced in the Philippines between 1951 and 1952
as a preventive m easure against TB. Triple therapy, consisting of the anti-TB drugs Isoniazid (INH), Para-
am ino salicylate (PAS), and streptom ycin, was initiated in 1954.
Organizational changes to step up the TB control program were also effected in the 50s and
60s. In 1950, the TB Com m ission evolved into the Division of Tuberculosis under the supervision of the
Secretary of Health. The Division in turn established the TB Center at the DOH Com pound and collaborated
with the TB W ard of San Lazaro Hospital. The m ove allowed for expanded services, which included chest
x-ray, sputum and bronchial washing exam inations, and case holding. Treatm ent at that tim e consisted
of streptom ycin injection plus oral PAS tablets.
Congress passed RA 1136 (Tuberculosis Law) in 1954. This becam e the basis for the creation
of both the Division of Tuberculosis under an appointed Director and the N ational Tuberculosis Center
of the Philippines (NTCP) established at the DOH Com pound. The NTP received a boost from RA 1136
with the provision of funds to support its operations.
The first ever TB prevalence survey, the M inglanilla Prevalence Survey, was conducted in 1964
in Cebu province. Survey results placed the prevalence of sm ear-positive cases at 4/1,000. During this
period, Quezon Institute was operating at its largest bed capacity at 1,350 beds.
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Expansion of the TB Control Program
The late 60s through to the m id-70s witnessed a vigorous nationwide expansion of the TB
program through accelerated and expanded control activities at the rural health units (RHUs), which
were established under RA 1086. The strengthened RHUs increasingly took on greater responsibility
for TB control efforts. PTSI launched the dom iciliary care program in 1973, a m ove which eventually
led to the reduction of Quezon Institutes bed capacity to 700. As the new TB Control Program was
im plem ented in all RHUs, the adm issions at Quezon Institute began to be lim ited only to the seriously
ill cases.
It was also in 1973 that the Philippine College of Chest Physicians (PCCP) was form ed as an
accredited non-governm ent organization (NGO) society of the Philippine M edical Association (PM A)
with TB as one of its initial prim ary concerns. The partnership between DOH and PTSI was intensified
as the two organizations defined, com plem ented, and supported each others roles in TB control. The
new thrust em phasized the follow ing: 1) im portance of BCG vaccination; 2) case finding through sputum
m icroscopy; and 3) case holding/treatm ent through dom iciliary m eans.
The partnership likewise paved the way for the establishm ent of the National Institute of
Tuberculosis (NIT) in 1976, with support from W HO and UNICEF. NIT focused on hum an resource
developm ent, in the process carrying out operational researches and providing training to local and
foreign health workers on TB control using the prim ary health care approach. The year was also
highlighted by the issuance of a Presidential Decree (PD) requiring com pulsory BCG vaccination, which
becam e a prim e com ponent of the Expanded Program for Im m unization (EPI). Two years later, in 1978,
PTSI adopted the NTP policies and guidelines in its catchm ent areas.
Nearly two decades after the M inglanilla survey, NIT conducted the first National TB Prevalence
Survey (NPS) in 1982-1983, with assistance from W HO and UNICEF. Another significant developm ent
during this period was the establishm ent of the Lung Center of the Philippines (LCP) as a tertiary hospital.
LCP becam e a referral center for pulm onary cases, including TB.
Contemporary Milestones
The 80s through to the 90s and the beginning years of the new m illennium witnessed the
im plem entation of significant organizational and technical strategies that further strengthened TB control
efforts in the Philippines. This was also the tim e when the NTP M anual of Procedures w as developed
and revised.
3
Introduction
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Organizational Strategies
The reorganization of the D epartm ent of Health after the People Power revolution in 1986,
through Executive O rder 119, paved the way for the establishm ent of the TB Control Service (TBCS)
under the Office for Public Health Services. A year later, the Strengthened National TB Control Program
was launched. Under this program , the TBCS was given a P200-m illion budget for drugs.
The NTP got a big boost in 1990 with the financial and technical support from the Italian
governm ent and W orld Bank (W B) under the five-year Philippine Health Developm ent Project.
In the early 1990s, the Local G overnm ent Code of 1991 paved the way for the devolution of
health services, including delivery of TB services, from DOH to the LG Us. W hile DOH rem ained at the
helm of policy developm ent, regulation, and provision of technical and financial assistance, the LGUs
m anaged the TB program and delivered their services to their constituents through the RHUs and the
Barangay Health Stations (BHSs).
A showcase of this new health service delivery paradigm was the TB control project in Cebu.
The Cebu project, with technical and financial support from JICA, tested the W HO-recom m ended policies
and guidelines, im proved laboratory facilities with the establishm ent of the Regional TB Laboratory in
Cebu City and upgrading of m icroscopy centers, and system atized TB data collection and recording.
A council created in 1993 by PCCP to act as its working arm for TB successfully released in
1994 a set of algorithm s on the diagnosis and treatm ent of TB. An external evaluation of the NTP done
in 1993 noted that while case-finding activities im proved trem endously, problem s in case holding persisted.
In 1995, the TBCS issued through Adm inistrative Order No. 1-A series of 1995 the revised policies and
guidelines on the diagnosis and m anagem ent of TB which, in essence, adopted the W HO-recom m ended
policies. The thrust adopted by NTP was to im prove case holding activities.
The forging of partnerships and active interactions am ong the various sectors engaged in the
fight against TB becam e m ore evident in the 90s. The Philippine Coalition Against Tuberculosis (PhilCAT)
was organized in 1994 to serve as coordinating body for the various governm ent and non-governm ent
agencies, private groups, academ e, and other concerned institutions involved in TB control. The
organizations that banded to form PhilCAT include PCCP, DOH, Philippine Society for M icrobiology and
Infectious Disease (PSM ID), PTSI, Cure TB, and the Am erican College of Chest Physicians-Philippine
Chapter.
The joint advocacy of these organizations was largely responsible for the issuance of Proclam ation
No. 840 issued by the President of the Philippines in 1996. The proclam ation declared August 19 of
every year as the National TB Day. M arch 24, on the other hand, is observed as W orld TB Day. On both
occasions, DOH, in collaboration w ith PhilCAT and other partners, conducts activities that would draw
public attention to the organized fight against TB.
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In Septem ber 1998, the NTP becam e one of the DOH flagship program s. M em orandum Circular
(M C) No. 98-155 issued by the President, then concurrent secretary of the D epartm ent of Interior and
Local Governm ent (DILG ), pronounced the TB Control Program as the highest priority health program
of the LG Us and prescribed the DOTS strategy.
The Health Sector Reform Agenda (HSRA) adopted by DO H in 1999 m ade the National TB
Control Program one of the top priorities am ong the public health program s. The organizational reform s
under the HSRA led to the clustering of various public health program s, m erging of offices, and significant
reduction in m anpower, all designed to im prove delivery of health services. The following specific
objectives of the H SR A w ere likew ise seen to im pact positively on the TB sector:
To secure funding for priority public health program s; To prom ote the developm ent of local health system s and to ensure their effective perform ance; To provide fiscal autonom y to governm ent hospitals; To strengthen the capacities of health regulatory agencies; and To expand the coverage of the National Health Insurance Program (NHIP).
Technical Strategies
In 1986, a new treatm ent regim en was introduced in the National TB Control Program -- the
Short-Course Chem otherapy (SCC), which highlighted use of Rifam picin, 2HRZ/4HR. During this period,
a fourth drug streptom ycin or etham butol was also being used for the intensive phase of treatm ent
regim en at the Quezon Institute for confined or in-patients. The SCC was adopted nationwide in 1987.
To ensure treatm ent com pliance, the various drugs were packaged in blister-packs, an innovative strategy
that was later adopted by neighboring countries.
5
Introduction
Over the years, greater com pliance with the NTP through a standard national policy to guide
all stakeholders has been perceived as a pressing need. The Com prehensive and Unified Policy (CUP)
for Tuberculosis Control in the Philippines was developed jointly by DO H and PhilCAT in 2003. As
specified in Executive Order No. 187 series of 2003, the CUP is an instrum ent to harm onize and unify
TB control efforts in the Philippines in the public and private sectors. The CUP, am ong other provisions,
em phasizes the adoption of the NTPs DO TS (Directly O bserved Treatm ent, Short Course) strategy.
Im plem entation of the DOTS strategy goes back to the m id-1990s when an intensified national
cam paign to increase awareness about TB and to m obilize support for its prevention and control was
launched. In 1995, the TB Clinic of the University of Santo Tom as (UST) initiated the use of DOTS in
m anaging its out-patient TB cases. DOH piloted the D OTS strategy in three areas in 1996 through the
CRUSH TB (Collaboration in Rural and Urban Sites to Halt Tuberculosis) project. DOTS was pilot-tested
in Iloilo City, Antique, and Batangas. Results from this project becam e the basis for expansion of the
new NTP to other areas and m ade possible the subsequent nationwide im plem entation of DO TS.
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The N TP officially adopted DO TS strategy with the issuance of Adm inistrative Order No. 24
series of 1996. DOTS im plem entation hinges on five com ponents: 1) political com m itm ent; 2) diagnosis
by sputum m icroscopy; 3) Directly O bserved Treatm ent (DOT), i.e., supervised treatm ent; 4) uninterrupted
drug supply; and 5) standardized recording and reporting.
DO TS was subsequently replicated in 30 areas in 1997-1998 and in all public-sector health
facilities in the country by 2001. DOTS expansion w as facilitated by the active participation of LGUs,
the im plem entation of DOTS with BHW s as treatm ent partners, and the support from various international
agencies, such as W HO, W B, JICA, W orld Vision-Canadian International Developm ent Agency (CIDA),
Australian Aid (AusAID), and M edicos del M undo. It has also gained access to international resources,
such as the Global Drug Facility (GDF) and G lobal Fund on AIDS, TB and M alaria (GFATM ), to augm ent
supply of anti-TB drugs in the country.
The second NPS was conducted in 1997. In 1999, a new consensus on TB diagnosis, treatm ent,
and control was forged through a consultative process coordinated by PSM ID, PCCP, and D OH under
the auspices of PhilCAT.
Initiatives to strengthen the NTP included delivery of quality DOTS services through expansion
of DO TS im plem entation in all governm ent health facilities. The National TB Reference Laboratory
(NTRL) was established in 2002 to im prove quality assurance of m icroscopy through the established
network of m icroscopy facilities. It is also spearheading the national drug resistance survey (DRS).
The NTRL also spearheads the im plem entation of the External Q uality Assessm ent (EQ A)
nationwide. The EQA refers to a system of periodic independent m easurem ent of perform ance throughcollaboration with another com petent laboratory; it aim s to m aintain high quality results from the m icroscopy
centers.
To im prove the quality of diagnosis am ong sputum sm ear-negatives with chest x-ray findings
suggestive of PTB, the NTP initiated the creation of TB Diagnostic Com m ittees. The TBDCs are
established at the provincial and city levels to review the sputum sm ear-negatives with chest x-ray
findings suggestive of PTB. The TBDC is chaired by the NTP m edical coordinator, with m em bers from
both the public and private sectors. TB experts, who represent various disciplines, also sit on the
com m ittee. The TBDC evaluates, by consensus, the appropriate recom m endations for quality patientm anagem ent.(Refer to Annex 3 for m ore inform ation on the TBDC.)
By the end of 2002, public sector DOTS coverage has reached alm ost 100 per cent. Despite
this achievem ent, case detection rate (CDR) has rem ained below the 70-per-cent target. It was learned
from the 1997 N PS and other local studies that a significant num ber of TB cases sought care from the
private sector. In this context and within the DOTS expansion strategy, DOH adopted in 2003 the national
strategy of Public-Private M ix DOTS (PPM D).
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The PPM D is a strategy designed to increase case detection and to synchronize the m anagem ent
of TB both in the public and private sectors. A PPM D unit can be public- or private-initiated depending
on where DOTS service provision is offered. In a public-initiated PPM D unit, DOTS services are centered
in a public DOTS facility with the private physicians referring patients for services. In a private-initiated
PPM D, the operations and m anagem ent of DO TS services are centered on a privately owned and
m anaged DOTS facility. W hether public- or private-initiated, PPM D units im plem ent DOTS in consonance
with the approved operational policies, standards, and technical guidelines of the NTP (Refer to
O perational G uidelines for Public Private M ix DO TS in the Philippines, DO H and PhilCAT, 2004).
W ith PhilCATS support, the strategy was im plem ented to further m obilize private sector
physicians, professional societies and academ icians, and other NGOs. In addition, additional resources
were secured for PPM D im plem entation through international donors.
Certification of DO TS facilities is an initiative to ensure that quality DO TS is im plem ented in
both public and private facilities. Guided by the Sentrong Siglafram ework, it provides an assurance to
health seekers from the public and private sectors that a TB DOTS Center is capable of providing safe
and effective DOTS services. M oreover, certification ensures standardization of the provision of DOTS
services through a uniform set of standards. DOTS certification is a prerequisite to PhilHealth accreditation
and a m eans for the facility to avail itself of the PhilHealth TB outpatient benefit package.
In 2003, the NTP also started the shift from single dose form ulation (SDF) to fixed dose
com bination (FDC) drugs. This sim plifies treatm ent, prevents developm ent of drug resistance, and
ensures regular and com plete drug delivery to DOTS centers. The NTP is also upgrading the various
CHD TB Reference Centers to im prove its m icroscopy com ponent.
Another m ilestone in the NTP, DOTCh (DOT in Children), was piloted in three areas between
2002 and 2005. The pilot phase paved the way for testing the guidelines developed by the Task Force
for TB in Children com posed of experts from the public and private sectors.(Details about the strategy
m ay be found in Annex 1: Adm inistrative Order 178).
7
Introduction
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Development of the NTP Manual of Procedures
The NTP M anual of Procedures (M OP) is the basis for NTP im plem entation in all DOTS facilities.
Early developm ent of the NTP M anual of Proceduresdates back from 1969 however, the first
NTP M anual of Procedures (M O P)was developed in 1980. This M O P highlighted the use of sputum
m icroscopy as the prim ary diagnosis tool and the introduction of the Standard Drug Regim en for TB
treatm ent.
In 1988, the first M O P was revised. This 2ndedition presented the results of the 1981- 1983
First National TB Prevalence Survey (NPS). This also m arked the adoption of the Short Course
Chem otherapy (SCC) for the m anagem ent of TB cases under the NTP.
In 1997, the Technical G uidelines of the New TB Control Program was developed by the
Departm ent of Health (DOH), in collaboration with DOH-JICA (Japan International Cooperation Agency)
Public Health Developm ent Project and the W HO W estern Pacific Regional Office (W PRO), in accordance
to the recom m endations from the external evaluation conducted by W HO in 1993. This docum ent
em phasized on D.O.T.S. (Directly Observed Treatm ent-Short Course) or Tutok G am utan as the NTPs
core fram ework for a nationwide TB control strategy. Subsequently, the start of rapid expansion of DOTS
in the country in 1997 em bodied, as well, the im plem entation of this m aterial/docum ent.
The NTP M anual of Procedures (M O P)3rdedition was written in 2001. The change from the
previous Technical Guidelines reflected that the publication was useful, not only for training , but also
in providing instructions or procedures to all health personnels in their delivery of TB services. This M OP
also served as a vital tool in the orientation/training of the private sector and other governm ent agencies
in their im plem entation of NTP-DOTS.
In 2004, the Departm ent of Health initiated the fourthrevision of the M OP in the light of current
initiatives and policy changes in the NTP. These initiatives included the use of fixed dose com bination
anti-TB drugs, EQ A, adoption of the Public-Private M ix D O TS, strengthening of the TB Diagnostic
Com m ittees, DOTS facility certification and accreditation, and developm ent of the health prom otion plan
specific to TB. Thus, with all these developm ents, it is but rational for the NTP to recast the M OP into
its current presentation.
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VISION, MISSION, AND GOAL OF THE NTP
Vision: A country where TB is no longer a public health problem
M ission: Ensure that TB DOTS services are available, accessible, and affordable to the com m unities
in collaboration with the LGUs and other partners
Goal: To reduce prevalence and m ortality from TB by half by the year 2015 (M illennium
Developm ent Goals)
TARG ETS:
1. Cure at least 85 per cent of the new sputum sm ear-positive TB cases discovered
2. Detect at least 70 per cent of the estim ated new sputum sm ear-positive TB cases
NTP OBJECTIVES AND STRATEGIES
The NTPs four-pronged set of objectives calls for im provem ent of access to and quality of
services, enhancem ent of patients health-seeking behavior, sustainability of support for TB control
activities, and strengthening m anagem ent of TB control services at all levels.
Objective A:
Im prove access to and quality of services provided to TB patients, TB
sym ptom atics, and com m unities by health care facilities and providers
Strategies:
1. Enhance quality of TB diagnosis.
Adopt quality assurance system for direct sputum sm ear exam ination, including externalquality assurance.
Establish m ore TB Diagnostic Com m ittees and expand their functions to include TB inchildren
Strengthen the network of quality laboratory services in accordance with NTRLroles/functions.
2. Ensure TB patients treatm ent com pliance.
Im plem ent an efficient drug supply m anagem ent system . Adopt directly observed treatm ent (DOT) through treatm ent partners.
3. Ensure public and private health care providers adherence to the im plem entation of national
standards of care for TB patients.
Establish and sustain public-private m ix DOTS, including the public-public m ix DOTS. Expand hospital-based DOTS. Advocate for the widespread adoption of a com prehensive and unified policy on TB.
9
Introduction
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4. Im prove access to services through innovative service delivery m echanism s for patients living in
challengingareas (geographically isolated com m unities, with peace and order problem , culturally-
different, and those in institutions like prisons).
Objective B:
Enhance the health-seeking behavior on TB by com m unities, especially the TB sym ptom atics
Strategies:
1. Develop effective, appropriate, and culturally-responsive IEC/ com m unication m aterials.
2. Organize barangay advocacy groups.
Objective C :
Increase and sustain support and financing for TB control activities
Strategies:
1. Facilitate im plem entation of TB-DOTS facilities certification and accreditation.
2. Build TB coalitions am ong different sectors.
3. Advocate for counterpart input from local governm ent units.
4. M obilize/extend other resources to address program lim itations.
Objective D :
Strengthen m anagem ent (technical and operational) of TB control services at all levels.
Strategies:
1. Enhance m anagerial capability of all NTP program m anagers at all levels.
2. Establish an efficient data m anagem ent system for both public and private sectors.
3. Im plem ent a standardized recording and reporting system .
4. Conduct regular m onitoring and evaluation at all levels.
5. Advocate for political support through effective local governance.
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Introduction
ROLES OF COLLABORATING AGENCIES
Department of Health
1. Form ulate plans, policies, and standards.
2. Advocate for political com m itm ent and awareness of TB control in the com m unity.
3. Oversee program im plem entation in coordination with the LGUs.
4. Provide logistics assistance in term s of:
Anti-TB drugs; Laboratory supplies; Prototypes of educational m aterials; and NTP recording and reporting form s.
5. Provide technical assistance, including training of LGU staff.
6. M onitor and evaluate regularly NTP activities, including Quality Assurance System and TBDC
im plem entation/operation.7. Collate and analyze data from all reports and feedback findings and recom m endations to LGU staff
concerned.
8. Collaborate with PhilCAT, NGOs, and the private sector to prom ote and im plem ent the PPM D
strategy.
9. Initiate, through the CHDs, DOTS certification at the regional level.
10. Im plem ent hospital-based DOTS for DOH-retained hospitals.
11. Together with the National Center for Health Prom otion, orchestrate the developm ent of
inform ation/education/com m unication (IEC) m aterials.
International Partners
1. Provide technical assistance in the developm ent or revision of policies, guidelines and standards.
2. Provide financial support to augm ent the fund gap of the NTP.
3. Participate in key activities of the NTP such as m onitoring and evaluation.
4. Participate as technical advisors in the existing organizational structures of the NTP as necessary.
Local Government Units (LGUs)
1. Develop local policies and work for passage of resolutions on program im plem entation.
2. Develop a local plan on TB control, in consultation with DOH/CHD and other stakeholders.
3. Designate a Provincial/City M edical NTP Coordinator and/or other staff, such as nurses and m edical
technologists.
4. Assign the NTP M edical and Nurse Coordinators as the Chairperson and Secretariat of the TBDC,
respectively.
5. Ensure the presence of physicians, nurses, m idw ives, and com m unity volunteers at the m unicipal-
level facility.
6. Im plem ent the plan and provide resources for the following:
M onitoring/supervision/evaluation; Capability building; Drugs for Category 3 patients and SDF for patients who develop adverse drug reactions; Augm entation of laboratory supplies NTP reporting form s, referral form s, laboratory request form s;
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TBDC activities; Local IEC m aterials; M anpower; and Quality assurance activities.
7. Evaluate and m onitor im plem entation of plan.
8. Im plem ent hospital-based DOTS and referral system in LG U hospitals.
9. Prepare, analyze, and subm it quarterly reports.
10. Im plem ent External Quality Assurance for laboratory.
11. Plan, initiate, and im plem ent PPM D activities in accordance w ith the National Strategy on PPM D.
PhilCAT and Other Private Partners
1. Participate in the form ulation of plans, policies, guidelines, and standards.
2. Advocate DOTS in the private sector.
3. Participate in the initiation and im plem entation of PPM D through the following activities:
Advocacy; Training; M onitoring and evaluation; Developm ent of advocacy m aterials; and Operations research.
4. Assist in m obilization and m anagem ent of resources, including hum an resources, in the
establishm ent of PPM D.
5. Participate in certification of private DOTS facilities.
Multi-sectoral Agencies
1. National Coordinating Com m ittee for PPM D (NCC-PPM D)
The function of the NCC-PPM D is to discuss and resolve adm inistrative and technical issues related
to PPM D im plem entation, in cooperation with the RCC-PPM D. These involve:
a. Policy developm ent for Im plem entation of PPM D;
b. Technical advice to the RCC-PPM D;
c. M onitoring and supervision of PPM D units; and
d. Ensuring availability, adequacy, and regularity of drug supply.
2. Regional Coordinating Com m ittee for PPM D (RCC-PPM D)
The function of the RCC-PPM D, in coordination with the National Coordinating Com m ittee (NCC-
PPM D), is to discuss and resolve m anagerial and technical issues related to launching and
im plem enting PPM D units at the regional level. These involve:
a. Technical adviceto PPM D Units;
b. Trainings and advocacy activities;
c. M onitoring and supervision of PPM D units;
d. Ensuring availability, adequacy, and regularity of drug supply; and
e. Participation in DOTS certification.
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FUNCTIONS OF HEALTH WORKERS
DOH - NTP Staff
1. Develop national policies and plans.
2. Allocate budget for program im plem entation, including logistics.
3. Prom ote advocacy activities to foster political com m itm ent and com m unity awareness.
4. Exercise overall coordination am ong all NTP stakeholders.
5. Coordinate logistics m anagem ent.
6. Provide NTP drugs and laboratory supplies.
7. Provide regular technical assistance to CHDs and LGUs, specifically in the areas of training,
m onitoring, supervision, and evaluation.
8. Collate and analyze Q uarterly Reports for planning and policy developm ent.
9. Set standards for DOTS certification.
10. Conduct operational research on TB.
CHD NTP Coordinators (Physician/Nurse/MT)
1. Develop W ork and Financial Plan at CHD level.
2. Prom ote advocacy activities to foster political com m itm ent at the LGU level, as well as com m unity
awareness.
3. Exercise overall coordination am ong all NTP stakeholders at the regional level.
4. Ensure adequacy ofNTP drugs and supplies at the local level.
5. Provide regular technical assistance in the areas of training and planning.6. M onitor and evaluate the im plem entation of NTP and recom m end rem edial m easures to each LGU.
7. Collate and analyze NTP reports for planning purposes.
8. Subm it regularly all consolidated Quarterly Reports to DOH (Central).
National TB Reference Laboratory (NTRL) Staff
1. Develop a national plan and policies for NTP laboratory managem ent.
2. Develop and oversee im plem entation of QA system nationwide.
3. Carry out capability building m easures in partnership with the CHDs.
4. Conduct m onitoring and supervision in coordination with the CHDs.
5. Provide technical assistance to regional laboratories and to private laboratories engaged with the
NTP, e.g. PTSI.
6. M onitor drug resistance level.
7. Perform EQA to the m icroscopy centers of CHD-NCR 4A and 4B.
Regional TB Reference Laboratory
1. Oversee the im plem entation of the NTPs External Quality Assurance System (EQA) on m icroscopy
at the regional level.
2. Provide technical assistance to the QA centers and m icroscopy centers.
3. Develop laboratory m anagem ent plan on NTP to be integrated with the respective CHD NTP plans.
4. Conduct m onitoring, supervision and evaluation of QA centers and m icroscopy centers on a regular
basis.
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Introduction
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Provincial/City NTP Coordinators (Physician/Nurse/MT)
1. Organize provincial planning, budgeting, and evaluation activities.
2. Im plem ent advocacy activities to generate political com m itm ent and com m unity awareness.
3. Coordinate all NTP activities within the province/city.
4. Ensure availability and adequacy of NTP supplies. M anage drug and laboratory supply system .
5. Conduct trainings to ensure success of program im plem entation.
6. M onitor, supervise, and evaluate the im plem entation of NTP and Q A and execute corrective or
rem edial m easures.
7. Collate and analyze quarterly reports of all DOTS facilities.
8. Consolidate all quarterly reports and subm it these to CHD NTP coordinator.
9. Im plem ent QA for quality laboratory work at all DOTS facilities.
10. M obilize resources for TBDC and serve as chairperson/s of the TBDC (NTP m edical coordinator).
Serve as secretariat (NTP nurse-coordinator).
11. Assess and refer chronic TB cases to higher level of care.
Physicians
1. Organize planning and evaluation of NTP activities in DOTS facilities.
2. Utilize available resources in the area for TB control activities.
3. Supervise health staff to ensure proper im plem entation of NTP policies, such as:
a. Identification, exam ination, and classification of TB cases;
b. Im plem entation of case holding m echanism s, such as DOT;
c. Analysis and subm ission of quarterly reports to the PHO/CHO;d. Referral of TB cases to the TB Diagnostic Com m ittee or other health facilities,if needed;
e. Ensuring proper procedure in the collection and transport of sputum specim en to m icroscopy
center; and
f. Ensuring adequacy of NTP drugs and supplies.
4. Attend to all diagnosed TB cases for clinical assessm ent, prescription of appropriate treatm ent
regim en, and m anagem ent of adverse drug reactions, if any.
5. Provide continuous health education to all TB patients placed under treatm ent and encourage fam ily
and com m unity participation in TB control.
6. Coordinate with local chief executives (LCEs) to ensure funds and personnel for program
im plem entation.
Nurses
1. Together with other NTP staff / workers, m anage the procedures for case-finding activities.
2. Open the NTP treatm ent card.
3. Assign and supervise a treatm ent partner for patient who will undergo DOTS.
4. Supervise rural health m idwives (RHM s) to ensure proper im plem entation of DOTS.
5. M aintain and update the TB Register.
6. Facilitate requisition and distribution of drugs and other NTP supplies.
7. Provide continuous health education to all TB patients placed under treatm ent and encourage fam ily
and com m unity participation in TB control.
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8. In coordination with the physician, conduct training of health workers.
9. Prepare, analyze, and subm it the quarterly reports to PHO/ CHO.
Midwives
1. Together with other health staff, im plem ent the following case-finding activities:
a. Identify TB sym ptom atics and collect sputum specim ens for m icroscopy.
b. Refer all diagnosed TB cases to physician or nurse for clinical evaluation and initiation of
treatm ent.
c. M aintain and update NTP Treatm ent Cards. (Use of TB Sym ptom atics M asterlist/ TB Sym ptom atics
Target Client List is optional).
2. Im plem ent DOT with treatm ent partners.
a. Provide continuous health education to all TB patients placed under treatm ent and encourage
fam ily and com m unity participation in TB control activities.
b. Conduct regular consultation m eetings (preferably weekly) with the assistance of the physician
or nurse during the course of treatm ent.
c. Collect sputum specim en for follow-up exam ination on the scheduled date/s during the
course of treatm ent.
d. Report and retrieve defaulters within two (2) days.
e. Refer patients with adverse drug reactions to physician for further evaluation and m anagem ent.
f. Supervise and instruct com m unity health volunteers who would be the treatm ent partners to
ensure proper im plem entation of DOT.
Medical Technologists or Microscopists*
1. Do DSSM for diagnosis and follow-up.
2. Inform the physician, nurse, or m idwife of the DSSM result.
3. M aintain and update the NTP Laboratory Register.
4. Prepare quarterly report on laboratory activities and subm it this to the physician or nurse.
5. Prepare and subm it the quarterly laboratory supplies requirem ent to the physician.
6. Store sputum sm ears to allow sam pling by the provincial or city NTP coordinator for blindedre-checking as part of the External Quality Assessm ent.
* M icroscopists are m edical or param edical regular staff of the DOTS facility that is trained to do basic sputum m icroscopy.
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Introduction
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Barangay Health W orkers (BHW s) and other com m unity health volunteers are key players in the
im plem entation of DOTS.
1. Refer TB sym ptom atics to the DOTS facility for sputum collection.
2. Im plem ent DOT, together with the health personnel.
3. Keep and update the NTP ID C ards.
4. Report and retrieve defaulters within two (2) days.
5. Attend regular consultation m eetings with the health personnel, together with the patient and
treatm ent partner.
6. Refer patients with adverse reactions, if any, to the health personnel.
7. Provide health education to the patient, fam ily m em bers, and the com m unity.
Hospital-based NTP Coordinators
1. Coordinate all NTP activities in the hospital with the assistance of the CHD and Provincial NTP
coordinators.
2. Supervise hospital NTP health workers to ensure proper im plem entation of the following NTP
policies:
a. Identification and exam ination of TB sym ptom atics with DSSM ;
b. Im plem entation of DOT for identified cases;
c. Ensuring availability and adequacy of anti-TB drugs and supplies;
d. Referral of patients to RHU/M HC for continuation of treatm ent
(NTP Referral Form should be properly filled out by physician or nurse.); and
e. Provision of continuous health education to all patients placed under DOT.
3. Encourage patients fam ily mem bers to participate in TB control activities.
16
Barangay Health Workers (BHWs) and other Community Health Volunteers
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Figure 1.1. Flow of NTP Activities
Symptom s of TB
Cough for two or m ore w eeks, with or without:
Fever
Chest and/or back pains not referable to any
m usculo-skeletal disorders
Hem optysis or recurrent blood-streaked sputum
Significant weight loss
Other sym ptom s, such as sweating, fatigue, body m alaise, shortness of
breath
Sputum specim ens (3 specim ens) with NTP Laboratory Request Form
for Direct Sputum Sm ear Microscopy
Diagnosis
Case Finding
Initiation of Treatment
(Results of the DSSM . If results are Sm ear negative and with chestx-ray suggestive of TB, refer to TBDC for evaluation. )
Case Holding with DOTS Sputum specim en (1 specim en) with LaboratoryRequest Form for DSSM
Treatment Completion
Report Treatment Outcome / Request Supplies
Monitoring and Supervision
COMMUNITY
DOTS FACILITY
17
Introduction
TBDC
MICROSCOPY CENTER
MICROSCOPY CENTER
Results(DSSM for follow-up)
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Case Finding
Case finding, which is the identification and diagnosis of TB cases am ong individuals with
suspected signs and sym ptom s of TB, is a basic step in TB control. Fundam ental to case finding is the
detection of infectious cases through direct sputum sm ear m icroscopy (DSSM ). DSSM isthe principal
diagnostic m ethod adoptedby the NTP because:
1. It provides a definitive diagnosis of active TB;
2. The procedure is sim ple;
3. It is econom ical; and
4. A m icroscopy center could be put up even in rem ote areas.
DSSM results serve as bases for categorizing TB sym ptom atics according to standard case
definition. These are also used to: a) m onitor progress of patients with sputum sm ear-positive TB while
they are receiving antiTB treatm ent; and b) confirm cure at the end of treatm ent.
I. OBJECTIVE
Early identification and diagnosis of TB cases
II. DEFINITION OF TERM S
TB sym ptom atic any person with cough for two or m ore weeks with or without the
following sym ptom s: fever; chest and/or back pains not referable to any m usculo-skeletal disorders;
hem optysis or recurrent blood-streaked sputum ; significant weight loss; and other sym ptom s, such
as sweating, fatigue, body m alaise, shortness of breath
Active case finding a health workers purposive effort to find TB cases (am ong TB
sym ptom atics in the com m unity) who do not consult with personnel in a DOTS facility
Passive case finding finding TB cases am ong TB sym ptom atics who present them selves
in a DOTS facility
III. POLICIES
1. DSSM shall be the prim ary diagnostic tool in NTP case finding.
2. All TB sym ptom atics identified shall be asked to undergo DSSM for diagnosis before start of
treatm ent, regardless of whether or not they have available X-ray results or whether or not they
are suspected of having extra-pulm onary TB. The only contraindication for sputum collection
is hem optysis; in w hich case, DSSM will be requested after control of hem optysis.
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3. Pulm onary TB sym ptom atics shall be asked to undergo other diagnostic tests (X-ray and/or
culture), if necessary, only after they have undergone DSSM for diagnosis with three sputum
specim ens yielding negative results. The TBDC will evaluate the results of the chest X-ray,
together with the clinical history and findings, and will recom m end whether or not the case will
be started on treatm ent.
4. Since DSSM is the prim ary diagnostic tool, no TB diagnosis shall be m ade based on the results
of X-ray exam inations alone. Likewise, results of the skin test for TB infection (PPD skin test)
should not be used as bases for TB diagnosis in adults.
5. All m unicipal and city health offices shall be encouraged to establish and m aintain at least one
sputum m icroscopy unit in their areas of jurisdiction.
6. Private-initiated Public-Private M ix DOTS (PPM D) units shall each have an in-house m icroscopy
service.
7. Passive case finding shall be im plem ented in all DOTS facilities.Concom itant active case
finding shall be encouraged only in areas where a cure rate of 85 per cent or higher has been
achieved, or in areas where no sputum -sm ear positive case has been reported in the last three
m onths.
8. Only trained m edical technologists or m icroscopists shall perform DSSM (sm earing, fixing, and
staining of sputum specim ens, as well asreading, recording, and reporting of results). However,
in far flung areas, BHW s or other com m unity health volunteers m ay be allowed to do sm earing
and fixing of specim ens, as long as they have been trained and are supervised by their respective
NTP m edical technologists/m icroscopists.
IV. PROCEDURES
A. Identification of TB Sym ptom atics
(To be accom plished by DOTS facility staff)
1. Identify TB sym ptom atics consulting at the DOTS facility.Look out for thosehaving cough
for two or m ore w eeks, with or without one or m ore of the following signs and sym ptom s:
a. fever;
b. chest and/or back pains not referable to any musculo-skeletal disorders;
c. hem optysis or recurrent blood-streaked sputum ;
d. significant weight loss; and
e. other sym ptom s, such as sweating, fatigue, body m alaise, and shortness of breath.
2. M otivate TB sym ptom atic toundergo DSSM .Explain im portance of the procedure and
that of subm itting three sputum specim ens. Obtaining results from three sputum specim ens
increases the probability of finding acid fast bacilli.
3. Record details of each specim en subm ission (nam e of TB sym ptom atic, date of subm ission,
and result) in the TB Sym ptom atics M asterlist/TB Sym ptom atics Target Client List.
4. Encourage household m em bers of identified TB cases, who are also TB sym ptom atics,
to undergo DSSM .
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B. Collection and Transport of Sputum Specim ens to the Microscopy Center
(To be accom plished by DOTS facility staff)
1. Explain the im portance of subm itting three sputum specim ens taken within two days.
a. First specim en, also referred to as spot specim en, is collected at the tim e of consultation,
or as soon as the TB sym ptom atic is identified.
b. Second specim en is the very first sputum produced early in the m orning im m ediately after
waking up. It is collected by the patient according to instructions given by the DOTS facility
staff.
c. Third specim en, or second spot specim en,is collected when the TB sym ptom atic com es
back to the DOTS facility to subm it the second specim en.
d. All specim ens should be collected according to instructions given by the DOTS facility
staff. The first and third specim en collections are supervised by the DOTS facility staff to
ensure quality sputum specim en collection. If quality sputum is not collected within two
days, the patient is given one week to com plete the three-specim en collection. If the patient
fails to com plete the three-specim en collection within one week, another set of three should
be collected.
2. Prepare sputum cup and request form . Label body of sputum cup, indicating patients com plete
nam e, and order of specim en (1st, 2
nd, or 3
rd).
3. Dem onstrate how to produce quality sputum . Advise patient to:
a. Rinse his/her m outh with water.
b. Breathe deeply, hold breath, then exhale slowly. Repeat the entire sequence twice.
c. Cough strongly at the height of deep inspiration after inhaling deeply for the third tim e, and
spit the sputum in the container.
Observe precautions against infection during the dem onstration. Stay behind the patient.
Collect specim en outside the D OTS facility where aerosols containing TB bacilli are diluted and
sterilized by direct sunlight.
4. Collect specim en and check quantity and quality of sputum .
5. Seal sputum specim en container, pack it securely, and transport it to a m icroscopy center orlaboratory, together with the com pletely filled up NTP Laboratory Request Form for DSSM .Do
this as soon as possible or within four days after collection.
6. If specim en cannot be sent to a m icroscopy unit early enough, store it in a cool, dark, and safe
place. No specim en shall rem ain unexam ined over the weekend.
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C. Sm earing, Fixing, and Staining of Sputum Specim en and Reading, Recording, and Reporting
of Results
(To be accom plished by m edical technologist or m icroscopist)
1. Record the inform ation in the NTP Laboratory Register, including the type of sputum specim en
subm itted, i.e., m ucoid, purulent, blood-streaked, or salivary.
2. Sm ear, fix, and stain each slide.
3. Read each slide and interpret the result as follows:
0- No AFB seen in 300 oil im m ersion field (OIF)
+n 1-9 AFB seen in 100 O IF
1+ - 10 99 AFB seen in 100 OIF
2+ - 1-10AFB /OIF in at least 50 fields
3 + -m ore than 10 AFB/OIF in at least 20 fields
4. Interpret the results of the three specim ens and write the final laboratory diagnosis in the lower
portion of the N TP Laboratory Request Form for DSSM and on the R em arks colum n of the
NTP Laboratory Register. Laboratory diagnoses are classified as follows:
a. Sm ear-positive- at least two positive sputum sm ear results
b. Doubtful-only onepositive out of three sputum specim ens exam ined (Request for another
set of three sputum specim ens).
If at least one specim en from the second set of specim ens is positive, laboratorydiagnosis is positive.
If all three specim ens from the second set of specim ens are negative, laboratorydiagnosis is negative.
c. Sm ear-negative - all three sputum sm ear results negative
5. Send request form back to requesting unit.
D. Decision on Patients Diagnosis Based on Laboratory Results
(To be accom plished by DOTS facility staff)
1. Inform patient of result.
If positive, refer patient to physician for assessm ent and initiation of treatm ent; and, Encourage household m em bers with signs and sym ptom s of TB to consult at DOTS facility. If doubtful, ask patient to subm it another three sputum specim ens within one w eek. If negative, refer patient to physician for further assessm ent.
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E. Diagnosis of Sm ear-negative Patients with Persistent Sym ptom s
(To be accom plished by physician)
1. Re-assess sm ear-negative patients with persistent sym ptom s of TB. (Refer to Flow Chart 2.1
& 2.2)
2. Refer patient for X-ray exam ination, if warranted.
3. If X-ray findings are suggestive of TB, refer patient to the TBDC. In areas where there is no
TBDC, physician m ay m anage the patient.
F. Referral to TBDC
(To be accom plished by physician)
1. Fill up TBDC Referral Form and send it to TBDC, together with all available chest X-ray film s.
2. W ait for TBDC evaluation of results, which is sent back to the DOTS facility.
3. Carry out TBDC recom m endations.
For detailed inform ation about TBDC, refer to Annex 2.
G. Sum m ary of Procedure
The following four flow charts sum m arize the procedure for TB case finding:
1. Flow Chart for the Diagnosis of Pulm onary Tuberculosis;
2. Flow Chart for the Diagnosis of Sm ear-Negative Pulm onary Tuberculosis;
3. Guide to Case Finding; and
4. Guide to Diagnosis and Initiation of Treatm ent.
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Figure 2.1. Flow Chart for the Diagnosis of Pulm onary TB
TB Sym ptom atic(cough for 2 w eeks or m ore)
Three (3) sputum collection
A. 2 or 3 Sm ear-Positive B. Only one (1) Sm ear-Positive
Classify asSm ear-Positive TB
Collect another 3 SputumSpecim ens Inm m ediately
If at least one (1) Sm ear-Positive If all Sm ear-Negative
Classify as sm ear-Positive TB Request for CXR
If consistent with active TB If not consistent with active TB
Classify as sm ear-positive TB
Observation/further exam .,
If necessary
C. All 3 Sm ear-Negative
Refer to Physician(Observe him /her with
Sym ptom aticTreatm ent for 2 or 3 w eeks)
If sym ptom s persist,request for CXR
(Refer to the flow charton the next page.)
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Figure 2.2. Flow Chart for the Diagnosis of Sm ear-Negative Pulm onary TB
This flow chart assists the physicians in m aking a decision for sm ear-negatives.
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Classify as
Sm ear-
Negative TB
C. All 3 Sm ear-Negative
Refer to Physician(Sym ptom atic Tx for 2-3 w ks)
If sym ptom s persist, request for CXR
Consistent
with active TB
Not
Consistent
with active TB
Observation/
further exam .
Abnorm alfindings on
CXR
No Abnorm alfindings onCXR
TB DiagnosticCom m ittee
Observation/further exam .
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Figure 2.3. Guide to Case Finding
SPUTUM CO LLECTION UN IT
(To be accom plished by DO TS facility staff)
1. (Optional) Register patient in TB Sym ptom atics M asterlist (or TB Sym ptom atics Target
Client List) (see Chapter IV, p. 54).
2. Explain the im portance of three sputum collections to the TB sym ptom atics.
3. Label each sputum container (nam e and order no.1,2,3).
4. Collect three quality sputum specim ens (1stspot, early m orning, 2ndspot).
5. Fill-up NTP Laboratory Request Form for DSSM (see C hapter IV, p. 56).Confirm three sputum collections.
TB Sym ptom atics are those
with cough for 2 or m ore weeks
with or without 1 or m ore of the
following:
Fever Chest and/or Back pains Hem optysis Significant weight loss Other sym ptom s, such as
sweating, fatigue, body
m alaise, shortness of
breath
M ICRO SCO PY CENTER
(To be accom plished by the m edical technologist/m icroscopist)
1. Register in the NTP Laboratory R egister (see chapter IV. p. 59)
2. Record date received and Laboratory Serial No. in the Laboratory Request Form for
DSSM (see chapter IV. p. 56)
3. Perform DSSM : sm earing, fixing, staining, and reading slides.
4. Record results in the Laboratory Request Form for DSSM (see chapter IV. p. 56) and
in the NTPLaboratory Register (see chapter IV. p. 59)
5.Send back accom plished Laboratory Request Form for DSSM to the collection unit (see chapter IV. p. 56)
SPUTUM CO LLECTION UN IT
(To be accom plished by DO TS facility staff)
1. (Optional) Record results in the TB Sym ptom atics M asterlist (or TB Sym ptom atics
Target Client List) (see Chapter IV, p. 54).
2. Explain result to the patient (If doubtful, im m ediately collect another 3 specim ens forconfirm ation).
3. Refer to physician/nurse.
DIAG NO SIS A ND
INITIATIO N OF TREATM EN T
6. Pack and send specim en/s to the M icroscopy Center, together with the
com pletely filled up NTP Laboratory Request Form for DSSM .
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Figure 2.4. Guide to Diagnosis and Initiation of Treatm ent
CLINICAL DIAGNOSIS
To determ ine patient type and classification; done by D OTS facility staff
1. Verify inform ation gathered on case finding.
Sym ptom s/condition of patient
Results of sputum exam inationsResults of further exam ination (i.e., CXR, TBDCs recom m endations, culture, etc.) Source of infection
2. Verify DSSM results.
3.Review history of previous treatm ent.
W hen w as previous treatm ent taken? For how long?
W here was the previous treatm ent taken?
W hat anti-TB drugs were taken?
W hat was the DSSM result? W hat was the treatm ent outcome?
To be done by INITIATION OF TREATM ENT
Physician 1. Physical assessm ent and prescription of appropriate
category of treatm ent regim en for TB patient according to
patient classification and type
Nurse 2. Registration
Fill up NTP Treatm ent Card (see Chapter IV, p. 60).
Fill up two NTP ID Cards (see Chapter IV, p. 63), one
for treatm ent partner and one for patient.
Register in the TB Register (see Chapter IV, p. 65).
Designated DOTS Facility Staff 3. Health education w ith em phasis on key m essages,
such as:
TB is infectious.
TB can be cured but cure requires regular drug intake.
Irregular drug intake im pedes cure and results in chronic
cases.
Anti-TB drugs have side-effects.
It is im portant to have follow-up DSSM exam inations.
Fam ily/treatm ent partner support is im portant.
Nurse 4. Intake of first dose Record date when treatm ent started. Record due date of the first DSSM follow-up in the
NTP Treatm ent Card (see Chapter IV, p. 60) and
NTP ID Cards (see Chapter IV, p. 63).
Designated DOTS Facility Staff/
Treatm ent Partners
5. DO T
Assign a treatm ent partner.
Do DOT for both intensive and continuation phases of
treatm ent.
Conduct weekly consultation m eetings at the
DOTS facility during the whole course of treatm ent.
6. Record keeping
M aintain and update TB Register. M aintain and update NTP Treatm ent Card at the DOTS facility.
See to it that both treatm ent partner and patient m aintain, update, and keep NTP ID Cards.
Nurse/M idwife
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V. QUALITY ASSURANCE FOR DSSM
The quality assurance (QA) program is a series of regular activities carried out to m onitor
the laboratorys overall perform ance towards m aintaining high quality results. DSSM results are
highly significant not only to the patient but also to the entire NTP. As such, it is essential for the
Q A program to: 1) ensure that the reported results are accurate; 2) identify practices that are
potential sources of error; and 3) ensure that appropriate corrective actions are initiated.
A. OBJECTIVE
27
Assurance of high quality DSSM services in NTP
B. CO M PON ENTS
QA for DSSM includes the following:
1. Quality Control (QC) is the system atic internal m onitoring of working practices, technical
procedure, equipm ent, and m aterials, including quality of stains. These are perform ed
regularly by the NTP m edical technologist or m icroscopist.
2. External Quality Assessm ent (EQA) is a system of periodic independent m easurem ent
of perform ance through collaboration with another com petent laboratory at a higher level
(province or city). The trained NTP provincial or city coordinators and controllers are
responsible for EQA.
3. Quality Im provem ent (QI) is a process by which the com ponents of sm ear m icroscopy
diagnostic services are analyzed by trained NTP provincial or city coordinators. This is
a continuous undertaking designed to identify and address problem areas, which in turn
will help ensure quality of DSSM services.
C. POLICIES
1. In the DOTS facility, the NTP-trained m edical technologist/m icroscopist shall m aintain
QC of routine work.
2. A Quality Assurance Center shall be established in every province and highly urbanized
city to ensure that QA activities are m aintained in all DOTS facilities. Provincial/city health
offices are responsible for EQA, which includes blinded slide rechecking and on-site
evaluations by persons identified to perform such activities.
3. CHDs and their regional laboratories shall support the provincial/city QA centers.
Procedures and form s are found in the M anual on the Quality Assurance for Sputum Sm ear
M icroscopy, M arch 2004.
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Case H olding
C
ase
H
olding
Case holding is the procedure which ensures that patients com plete their treatm ent. Chem otherapy
is currently the only way to stop the transm ission of TB. W hile effective anti-TB drugs are available in
the country, there are still m any TB patients who are not cured. This is because m any patients stop
taking anti-TB drugs or they take their drugs irregularly. Patients are usually rem iss in drug intake due
to the long duration of treatm ent. The shortest duration of treatm ent is six m onths.
Treatm ent com pliance is necessary to cure TB and avoid developm ent of drug resistance. It
is useless to search for cases if they could not be treated properly after they have been found. It would
only encourage false hopes on the part of the patient.
Poor treatm ent com pliance m ay lead to the following outcom es: chronic infectious illness; drug
resistance; or death. Second-line anti-TB drugs for drug resistant cases are very expensive and m ost
are not available in the country. The best way to prevent the occurrence of drug resistance is through
regular intake of drugs for the prescribed duration. The strategy developed to ensure treatm ent
com pliance is called Directly Observed Treatm ent (DOT).It is one of the key com ponents of DOTS
towards achieving sufficient cure rate and preventing drug-resistant TB. DOTworks by assigning a
responsible person to observe or watch the patient take the correct m edications daily during the whole
course of treatm ent.
I. OBJECTIVE
Effective and com plete treatm ent of TB cases, especially pulm onary sputum sm ear-positive cases
II. DEFINITION of TERM S
A. Classification of TB cases -TB cases shall be classified based on the location of lesions,
as well as the result of DSSM (Table 3.1).
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B. Types of TB cases -TB cases shall be categorized based on the history of anti-TB treatm ent
(Table 3.2). A thorough understanding of the types of TB cases is necessary in determ ining the
correct category of treatm ent regim en.
Table 3.1 Classification of TB Cases
Location of Lesion Definition of Term sDSSM Result
Pulm onary TB
(PTB)
Sm ear-Positive
1. A patient with at least two sputum
specim ens positive for AFB, with or without
radiographic abnorm alities consistent with
active TB
OR
2. A patient with one sputum specim en
positive for AFB and w ith radiographic
abnorm alities consistent with active
pulm onary TB as determ ined by a
physician
OR
3. A patient with one sputum specim en
positive for AFB and sputum culture
positive for M . tuberculosis
Sm ear-Negative
A patient with at least three sputum specim ens
negative for AFB with radiographic abnorm alities
consistent with active TB,andthere has been
no response to a course of antibiotics and/or
sym ptom atic medications,andthere is a decision
by a physicianand /or TBDC to treat the patient
with a full course of anti-TB chem otherapy
Extra-Pulm onary
TB (EP)
1. A patient with at least one m ycobacterial sm ear/culture positive
from an extra-pulm onary site (organs other than the lungs: pleura,
lym ph nodes, genito-urinary tract, skin, joints and bones, m eninges,
intestines, peritoneum , and pericardium , am ong others)
OR
2. A patient with histological and/or clinical evidence consistent with
active extra pulm onary TB and there is a decision by a physician
to treat the patient with anti-TB drugs
Note: All EP cases shall undergo DSSM prior to treatm ent.
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Table 3.2. Types of TB Cases
Note:*Tre