NTP MOP Old

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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)


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

vii

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.

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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


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.

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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


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


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

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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

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