MDR-TB Suspects Referral Form

Transcription

DETECT CASES OF MDR-TB
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Detect Cases
of MDR-TB
Acknowledgements
National Library of the Philippines Cataloguing in Publication Data
Management of Drug-resistant Tuberculosis Training for Health Facility
Staff in the Philippines
1) Tuberculosis (Disease) – Multidrug-Resistant Tuberculosis
2) Training Modules
ISSN # 2012-2675
Recommended citation:
Tropical Disease Foundation and Department of Health, Philippines,
2008. Management of Drug-resistant Tuberculosis Training for Health
Facility Staff in the Philippines
© Tropical Disease Foundation (TDF) and Department of Health,
Philippines (DOH) 2008.
All rights reserved. Copying and/or transmitting portions or all of this
work without permission, or selling this material or portions of this
material for profit, may be a violation of applicable law. The publishers
encourage dissemination of these modules and will normally grant
permission to reproduce portions of this work. The published material
is being distributed without warranty of any kind, either expressed
or implied. The responsibility for the interpretation and use of the
material lies with the reader. In no event shall the Tropical Disease
Foundation and the Department of Health, Philippines be liable for
damages arising from its use.
Requests for permission to reproduce, in part or in whole, or to
translate the training modules should be addressed to either of the
agencies below:
Tropical Disease Foundation, Philippine International Center for
Tuberculosis, Amorsolo corner Urban Avenue, Makati 1229, Philippines,
Fax No. (+63 2) 810 2874; email: tetupasi@tdf.org.ph
Center for Infectious and Degenerative Diseases, National Center for
Disease Prevention and Control, Department of Health, 3rd Floor, Bldg.
13, San Lazaro Compound, Sta. Cruz, Manila, Philippines, Fax: (632)
711-6804, email: rgvianzon10@yahoo.com
Cover and text design: Digix Design Studio / Alexdesigns.ph
Printed in the Philippines
These training modules for Drug-resistant Tuberculosis will
be used by the National TB Program, Infectious Disease
Office, National Centers for Disease Prevention and Control,
Philippine Department of Health and its partners in the Local
Government Units in the integration of the Programmatic
MDR-TB Management into the National TB Program.
The documents were prepared by the core team of the
Programmatic Management of Drug-Resistant TB (PMDT)
Program of the Tropical Disease Foundation, Philippines with
the technical assistance from the WHO:
Ma. Imelda D. Quelapio, MD, PMDT Executive Officer
& Program Manager
Nona Rachel Mira, RN, MPH, Training Officer
Virgil Belen, RN, Nurse Clinical Coordinator
Ruth Orillaza-Chi, MD, Medical Clinical Coordinator
Albert Angelo L. Concepcion, RN, MHSS, Program
Coordinator
Nerizza Múñez, RPh, Drugs and Supplies Management
Coordinator
Grace Egos, RMT, MSPH, Laboratory Manager
Thelma E. Tupasi, MD, Program Director
Jacob H. Creswell, MPH, WHO Consultant
With contributions from:
Michael Evangelista, RMT – PMDT Laboratory Coordinator
John Stuart Pancho, RN – Training Assistant
Roberto Belchez, RN - Field Coordinator
Gail de las Alas, RSW, MSSW – Social Worker Coordinator
The contributions from the following are also acknowledged:
The technical inputs, editorial review and coordination
provided by Dr. Michael N. Voniatis, WHO Medical Officer for
Stop TB in the Philippines; the guidance provided by
Ms. Karin Bergstrom of the Stop TB Department, WHO–HQ,
Geneva; the technical support of the Stop TB Unit of
the WHO Western Pacific Regional Office (WPRO); the
collaboration and support of the technical and managerial
staff of the National TB Programme, Department of Health,
Philippines, in particular Dr. Rosalind G. Vianzon, National
TB Program Manager and Dr. Vivian Lofranco, focal point on
MDR-TB at DOH; the Center for Health Development, the
National Capital Region, the NTP Coordinators of the local
government units in Metro Manila, Philippines, the MDR-TB
Treatment Center staff, and other partners.
The production of the module is supported by WHO Regional
Office for the Western Pacific and WHO Headquarters, with
funding from Eli Lilly and the United States Agency for
International Development. The opinions expressed herein
are those of the authors and do not necessarily reflect the
views of the World Health Organization and the donors.
Contents
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Objectives of this module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
1. Identify MDR-TB suspects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Exercise A: Written exercise . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
1.1 Refer MDR-TB suspects to the appropriate Treatment Center . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Exercise B: Written exercise . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
2. Collect and record patient data for the MDR-TB suspect . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
2.1 Fill out the MDR-TB Screening Form . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
2.2 Fill out the PMDT Acknowledgement Form . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
2.3 Fill out the TB Symptomatics Masterlist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Exercise C: Written exercise . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
2.4 Make a referral to the Consilium if necessary and enter the patient in the Category IV Register . . . 58
3. Discuss the “Paunawa” or Terms of Understanding with the patient . . . . . . . . . . . . . . . . . . . . . . . . 60
3.1 Provide patient education on MDR-TB and the diagnostic process . . . . . . . . . . . . . . . . . . . . . . . . . 60
3.2 Obtain patient’s signature in Panawa or Terms of Understanding . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
4. Collect sputum for smear, culture and DST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
4.1 Enlist the MDR-TB suspect’s cooperation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
4.2 Fill out the Mycobacteriology Request Form . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
4.3 Collect sputum samples from the MDR-TB suspect . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
4.3.1 Alternative methods of sputum collection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
4.4 Pack the sputum samples and send to the laboratory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
4.4.1 Prepare the Laboratory Receiving Form for Specimens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
Exercise D: Written exercise . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
5. Receive and record the smear and culture results
in the TB Symptomatics Masterlist and decide on the appropriate action . . . . . . . . . . . . . . . . . . . 72
5.1 Record the smear results in the TB Symptomatics Masterlist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
5.2 Decide on the appropriate action in response to the smear results . . . . . . . . . . . . . . . . . . . . . . . . . . 76
5.3 Record the culture results in the TB Symptomatics Masterlist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
5.4 Decide on the appropriate action in response to the culture results . . . . . . . . . . . . . . . . . . . . . . . . . 78
6. Receive and record the DST results in the TB Symptomatics Masterlist,
Category IV Register and Consiliumex . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
6.1 Record DST results in the TB Symptomatics Masterlist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
Exercise E
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
3
MODULE B
6.2 Assign a Pre-enrollment number to the patient if confirmed to have MDR-TB . . . . . . . . . . . . . . . . . 92
6.3 Record the results in the patient’s chart and in Consiliumex . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93
6.4 Schedule a case for presentation at the next Consilium meeting . . . . . . . . . . . . . . . . . . . . . . . . . . . 93
Example of a Consiliumex showing Consilium decision on treatment regimen.. . . . . . . . . . . . . . . . 95
6.5 Return an updated Acknowledgement Form to the referring DOTS facility. . . . . . . . . . . . . . . . . . . . . 99
7. Inform MDR-TB suspects of laboratory test results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101
7.1 Patients with drug resistance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101
7.2 Patient with no drug resistance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101
8. Trace household contacts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102
8.1 Obtain a written consent from the patient in Kasunduan/”Contract” for treatment
and interview the patient’s household contacts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102
8.2 Complete the list of the patient’s contacts on the Contact Initial Investigation Form
and conduct interviews . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105
8.3 Instruct patients’ symptomatic household contacts to receive appropriate care and follow-up . . 107
8.4 Evaluate children by physical exam, chest x-ray and TST. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107
Summary of important points . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108
Self-assessment questions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 110
Answers to self-assessment questions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113
Annexes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113
Annex A. Proper Collection of Specimen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113
Annex B. Procedures for Obtaining Sputum Specimens in Children. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117
Annex C. Proper Labeling, Sealing and Transportation of Specimen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120
4
Introduction
The detection of multidrug-resistant TB (MDR-TB) is more complex and time-consuming than the detection of a case
of TB that is susceptible to first-line drugs. To stop transmission, early detection of MDR-TB is important. Failure to
detect MDR-TB will lead to the spread of the drug-resistant strain to others, intake of incorrect treatment regimens,
amplification of drug resistance and poor treatment outcomes.
Patients with pulmonary TB (PTB) excrete tubercle bacilli that can be detected by examining their sputum under
a microscope, that is, by direct sputum smear microscopy (DSSM). However, drug resistance cannot be diagnosed
with DSSM alone. This is because a positive smear of drug-resistant TB (DR-TB) looks the same as a positive smear of
drug-susceptible TB. They are caused by the same organism, Mycobacterium tuberculosis (M. tuberculosis).
To detect if the strain of TB is resistant or not, a culture and drug susceptibility test (DST) must be done. This
laboratory procedure determines if the M. tuberculosis strain does not grow in the presence of anti-TB drugs. If the
strain grows, it is said to be resistant to that drug. The sputum must therefore be cultured, and a DST of the isolated
M. tuberculosis from the culture must be done. MDR-TB demonstrates resistance to at least isoniazid and rifampicin,
the two most powerful anti-TB drugs, with or without resistance to other anti-TB drugs. All patients with suspected
MDR-TB must therefore have culture and DST in addition to smear, to confidently diagnose MDR-TB or any type of
drug resistance.
Ideally, all TB symptomatics should undergo DSSM, culture and DST. However, given the limited resources available
in the Philippines at the moment, this is not possible for all of the TB suspects in the country. To more efficiently
diagnose those patients who have MDR-TB, a list of risk groups for MDR-TB will be described in detail in the following
pages. To detect cases of resistance early, health facilities should check for MDR-TB risk factors in all TB patients or
persons who present with symptoms suggestive of PTB, primarily cough. All persons presenting at a DOTS facility
who are found to be at high risk should be referred to an MDR-TB Treatment Center for diagnosis.
Confirmed MDR-TB cases by DST, as well as those highly suspected of MDR-TB, still unconfirmed but needing
immediate treatment must be presented to the consilium for further discussion and possible initiation of a
Category IV regimen. The consilium is a multi-disciplinary case management committee composed of program
staff, physicians, nurses and other relevant health care workers with expertise on MDR-TB management. This
committee meets regularly to confirm the diagnosis, determine treatment regimens, assess response to treatment,
and determine final outcome through a consensus using standards based on the WHO Guidelines for Programmatic
Management of Drug-resistant TB.
Pulmonary MDR-TB patients are generally infectious cases since they are often chronic cases, and have more
extensive lung damage. They discharge tubercle bacilli into the air by coughing, sneezing, etc. Close contacts of
MDR-TB cases, e.g., in the home, can become infected with a drug-resistant strain of TB when they breathe in a
significant amount of tubercle bacilli. The longer MDR-TB cases are untreated, the greater will be the likelihood that
they will infect their close contacts.
Early identification of MDR-TB suspects should be a priority for every DOTS facility, in order to promptly treat the
infectious cases before they spread the drug-resistant strain to others. Early treatment of these cases increases the
likelihood of a favorable outcome and minimizes destruction of the lungs by the microorganism. It also limits the
amplification of resistance and prevents the emergence of extensively drug-resistant TB (XDR-TB).
5
MODULE B
Objectives of this module
Participants will learn to:
t
t
t
t
t
t
t
t
t
t
Identify MDR-TB suspects
Refer MDR-TB suspects for screening using the MDR -TB Suspects Referral Form
Collect and record patient data from the MDR-TB suspect
Fill out and use the MDR-TB Screening Form, the Acknowledgement Form,
and the TB Symptomatics Masterlist
Make an early referral to the Consilium
Provide patient education using the Paunawa or Terms of Understanding
Collect sputum samples and request the necessary tests
Use laboratory results to identify MDR-TB cases
Inform MDR-TB suspects of the results and begin additional care as needed
Check household contacts of MDR-TB cases
If you need to look up an unfamiliar word, refer to the glossary in Module A.
6
Refer to section:
1
1
2
2
2
2
4
5, 6
7
8
MODULE B
1. Identify MDR-TB suspects
MDR-TB suspects are TB symptomatics with an identified risk to develop MDR-TB. To detect these patients, high-risk
groups for MDR-TB based on findings from the DOTS-Plus pilot project and the nationwide drug resistance survey
(DRS) have been identified as shown in Box 1. In general, previous anti-TB treatment is a risk factor for resistance
and therefore, all previously treated patients should be referred to the MDR-TB Treatment Center for screening and
diagnosis.
By asking a few basic questions to TB suspects and by correctly monitoring current TB patients, DOTS facilities will
be able to detect a large number of patients with high risk for MDR-TB in a timely manner.
The symptoms of pulmonary TB are the same as for MDR-TB, in particular, cough for two weeks or more. Other
symptoms of TB include fever, chest and/or back pain, hemoptysis (coughing up of blood), weight loss and others
such as night sweats, fatigue, body malaise, and shortness of breath. Being a contact of an MDR-TB case puts both
new and retreatment patients at high risk for MDR-TB. Experience at the Tropical Disease Foundation (TDF) showed
that among 1,737 MDR-TB contacts, 251 (14%) had radiographic evidence of TB. From these, 181 who submitted
sputum and had available results, 42 (23%) turned out culture-positive, with MDR noted in 24 (57.1%), drug
resistance other than MDR-TB in 7 (16.7%) and pan-susceptibility in 11 (26.2%).
For retreatment cases, some patient types have higher MDR-TB prevalence than others. In the Philippines,
information regarding this is still being gathered, and all retreatment cases are considered at risk of being MDR-TB.
Among patients receiving DOTS Category II treatment, MDR-TB is suspected if there is non sputum smear-conversion
on the third month of treatment. A limited study from the TDF DOTS-Plus pilot project showed that of 22 Category
II non-converters among 226 enrolled patients, MDR-TB was noted in 73% (16). On the other hand, of 36 Category I
non-converters on month 2 among 181 enrolled cases, MDR-TB was noted in only 6%.
Additionally, if a patient presents to a DOTS facility with TB and reports that he has already received two or more
courses of anti-TB treatment that were self-administered upon prescription of a doctor, that patient should be
suspected of having MDR-TB and be referred to an MDR-TB Treatment Center. A treatment course is defined as at
least a month of intake of anti-TB drug(s) excluding prophylactic treatment.
While HIV is not by itself a risk factor for MDR-TB, since TB/HIV coinfected patients usually have negative sputum
smear results, HIV-positive individuals who have TB symptoms should be investigated for resistance using culture
and DST. Furthermore, HIV co-infection with MDR-TB is a severe disease with a very high mortality rate and should
be diagnosed promptly for immediate treatment.
Without proper detection and treatment of persons who are at high risk for DR-TB, there is a great danger that DR-TB
will continue to spread in the community.
7
MODULE B
The following table describes the high-risk groups for MDR-TB.
BOX 1: High-risk groups for MDR-TB
A. Retreatment cases
1. Failure
– Category I failure: a patient who remains (or becomes) sputum smear-positive on the 5th month or
later of DOTS Category I treatment
– Category II failure (chronic TB case): a patient who remains (or becomes) smear-positive on the
5th month or later of DOTS Category II treatment or who remains sputum-positive at the end of a
retreatment regimen
2. Relapse of category I or II: a patient who has been declared cured or treatment completed, and is
diagnosed with bacteriologically (smear or culture) positive TB
3. Return after default: a patient who returns to treatment with positive bacteriology (smear or culture)
following interruption of treatment for two months or more
4. “Other” type of patient: a patient with one month or more of anti-TB drug intake under the DOTS strategy
that cannot be classified into any type of retreatment, or a patient with one month or more of non-DOTS
treatment.
a) Non-DOTS patient whether sputum-positive or sputum-negative
b) “Other-positive”: a sputum-positive patient with one month or more of DOTS treatment who
cannot be typed as Treatment failure, Relapse, or Return after default. For example, a patient
who is smear-negative initially then turned out to be positive at sputum follow-up during DOTS
treatment .
c) “Other negative:” a sputum-negative patient with one month or more of DOTS treatment who
cannot be typed as Treatment failure, Relapse, or Return after default. For example, a patient
who returns to TB treatment with negative bacteriology (smear or culture) following interruption
of treatment for two months or more
*A treatment course is defined as at least a month of intake of anti-TB drug(s) excluding primary and
prophylactic treatment.
5. Non-converter of Category II: a patient who remains smear-positive at the end of the third month of
DOTS Category II treatment
B. New or retreatment cases
6. Symptomatic contact of a confirmed or suspected drug-resistant patient: A “contact” refers to a
household contact who is a person who normally sleeps in the same dwelling unit as the drug-resistant
index case for at least three months and has a common arrangement for preparation and consumption of
food. This patient has a higher risk of contracting the drug-resistant strain of the index case.
7. HIV-positive patient who has pulmonary or extra-pulmonary TB symptoms or has chest x-ray findings
suggestive of TB: HIV infection by itself is not a risk factor specifically for MDR-TB, but for TB, in general.
Since HIV-infected patients with MDR-TB have high mortality, early diagnosis through culture and DST are
recommended.
8
MODULE B
Now do Exercise A – Written Exercise
When you have reached this point in the module, you are now ready to do
Exercise A. Follow the instructions for Exercise A. Do this excercise by yourself.
Then discuss your answers with a facilitator.
Exercise A: Written exercise
Identify MDR-TB Suspects
In this exercise you will identify those patients that should be considered high-risk for having MDR-TB. Read each
of the cases below. For each case, put a check on “Yes” for those who should be considered MDR-TB suspects and
determine to which high-risk group they belong. Put a check on “No” for those who are not considered MDR-TB
suspects.
Case 1
A 34 year old female patient, who took only 4 months of Category I treatment last year, has returned to the DOTS
facility. The patient was sputum smear (-) on the 2nd and 4th months of follow-up but thereafter stopped treatment
since she was already feeling better. Now the patient complains of a persistent cough for the last 4 weeks with back
pain, hemoptysis and weight loss. Sputum examination result was smear-positive.
MDR-TB suspect? Yes
High-risk group
No
Case 2
A female patient who has received 3 different courses of TB medications over a period of many years with a private
doctor has come to your facility for consultation. The patient said she took all of the medicines and completed
treatment each time but now has a cough and fears it may again be TB. She also has weight loss, hemoptysis,
occasional fever, chest pain and night sweats. She has come to the DOTS facility because she no longer has money
to pay for treatment.
MDR-TB suspect? Yes
High-risk group
No
Case 3
A 55 year old male has been complaining of cough for three weeks, night sweats and fatigue. When interviewed, he
says that he has not been sick for a long time but his wife told him he must come in to be checked because their 25
year old son who lived in the same house with them died of MDR-TB last year. The patient has no history of TB and
has a normal chest x-ray.
MDR-TB suspect? Yes
High-risk group
No
9
MODULE B
Case 4
A 17 year-old female student has come to your DOTS facility for cough of more than two weeks and fever of five
days. She has never been diagnosed or treated for TB in the past. She denies exposure to anybody with TB in the
home or in school. You examine her and she has rales on both lower lung fields.
MDR-TB suspect? Yes
High-risk group
No
Case 5
A female patient, 18 years old, who is being treated for HIV in one of the treatment hubs in Metro Manila develops
fever, and weight loss. The DOTS facility recognized her to be the sister of a non-converting Category II patient who
has been going to this health center for TB treatment.
MDR-TB suspect? Yes
High-risk group
No
Case 6
A Category II (relapse) male patient just finished the third month of treatment and is still smear-positive. He still has
cough and back pain and has been losing weight. The patient has had no adverse events and complies with the
treatment schedule.
MDR-TB suspect? Yes
High-risk group
No
When you have finished this exercise,
please discuss your answers with a facilitator.
10
MODULE B
1.1 Refer MDR-TB suspects to the appropriate Treatment Center
Once a patient has been identified to be an MDR-TB suspect in a DOTS facility, he should be referred to the
appropriate MDR-TB Treatment Center using the MDR-TB Suspects Referral Form. This form is available in DOTS
facilities.
To complete the MDR-TB Suspects Referral Form, the referring DOTS facility fills in the date, the suspect’s name and
the demographic information. Write the name of your DOTS facility and the Treatment Center to which the patient is
being referred. Write the reasons for referring, e.g., factors that make the patient at risk for MDR-TB. Write the details
being asked for on the TB history and treatment.
If the patient being referred has been on DOTS treatment, a photocopy of the DOTS Treatment Card should be sent
along with the MDR-TB Suspects Referral Form. If not, a referral note should be sent along which details the TB history
including the history of use of anti-TB drugs. Instruct the patient to present the MDR-TB Suspects Referral Form and
the copy of the DOTS Treatment Card or referral note when he or she visits the Treatment Center for assessment.
Depending on the location of the local government unit or city/municipality where the DR-TB suspect resides or is
identified, the referring DOTS facility will send the patient to the designated Treatment Center guided by the zoning
map (Figure 1). This illustrates the location of the different Treatment Centers currently limited to Metro Manila. Table
1 shows the details of the zoning map and is just a guide which may be modified to suit the patient’s convenience,
in case his residence is nearer another Treatment Center than the one suggested in the map. If the patient was
identified as an MDR-TB suspect at an MDR-TB Treatment Center itself, the MDR-TB Suspects Referral Form need not
be accomplished. An example of the form is shown on page 14. See Reference Booklet for instructions on how to fill
it out.
FIGURE 1. Zoning map for referral of MDR-TB suspects
1
DJNRMH DOTS Center,
(formerly TALA Hospital)
Caloocan City
2
LCP- PHDU DOTS Center,
Quezon City
3
KASAKA-QI MDR-TB
Housing Facility ,
Quezon City
4
PTSI Tayuman DOTS
Center, City of Manila
5
TDF-MMC DOTS Clinic,
Makati City
6
Treatment Center in MMSouth (to be set-up)
1
2
3
4
5
6
DJNRMH: Dr. Jose N. Rodriquez Memorial Hospital
KASAKA-QI: Kabalikat sa Kalusugan – Quezon Institute
LCP-PHDU: Lung Center of the Philippine – Public Health
Domiciliary Unit
PTSI: Philippine Tuberculosis Society, Inc.
TDF-MMC: Tropical Disease Foundation – Makati Medical
Center
DOTS facilities, whether public or private, from all over Metro Manila may refer their MDR-TB suspects to any of the
Treatment Centers shown above. The Treatment Center which is most proximal to the patient’s residence or address
would be most convenient to the patient and should be selected.
11
MODULE B
A flow chart for the referral of MDR-TB suspects is illustrated in Figure 2, page 14.
TABLE 1. Zoning of local government units and MDR-TB Treatment Centers
ZONE
LGU
Caloocan:
North
Bayan
1
Malabon
Navotas
MDR-TB Treatment Centers
Dr. Jose N. Rodriguez Memorial Hospital (DJNRMH) DOTS Center
KASAKA-QI MDR-TB Housing Facility
PTSI Tayuman DOTS Center
Valenzuela
LCP-PHDU DOTS Center
Marikina
Pasig
Pateros
2
Taguig
QC
3
TDF-MMC DOTS Clinic
Manila
Tondo
Sta. Mesa
Sampaloc
Others
LCP –PHDU DOTS Center
DJNRMH Treatment Center
TDF-MMC DOTS Clinic
Makati
TDF-MMC DOTS Clinic
Mandaluyong
San Juan
KASAKA-QI MDR TB Housing Facility
Las Pinas
Muntinlupa
4
Paranaque
TDF-MMC DOTS Clinic
Treatment Center in MM-South
Pasay
FIGURE 2. Flow chart for the referral of MDR-TB suspects
12
MODULE B
Programmatic Management of Drug - Resistant TB
(PMDT)
Example of an MDR-TB Suspects Referral Form
Date of Referral (mm/dd/yy)
Name
4 / 25/ 05
Balagtas
Jose
Last
First Name
Age 50 y/o
Sex Male
Address 2425 Buendia St.
( House # and name of street)
City/Province Manila
Region
NCR
Be guided
by the zoning
Amorsolo map on
Middle name
Figure 1 and
Table 1 when
identifying the
Brgy. Balut, Tondo appropriate
Treatment
(02) 244-6847
Tel. No.
Center
Referring Health Center or DOTS facility:
Sampaguita H.C.
Name of HC/PPMD/ DOTS facility:
Address of Facility:
City Manila
#3436 Balut Tondo
Region
NCR
Tel. No. (02) 244-6999
Fax No. (02) 244-6999
Dr. A. Madrid
Referring MD
Referred to (Please check)
MMC/TDF Clinic
Dr. Jose N. Rodriguez Memorial Hospital (TALA)
KASAKA QI
PTSI Tayuman
Lung Center of the Philippines (LCP)
Others, pls. specify _________________________
Reason/s for referring MDR-TB suspect
Category I failure
Non-converter of category II
Category II failure
Symptomatic contact of confirmed or
Relapse Category I
suspected drug-resistant index case
Relapse Category II
HIV-positive with TB symptoms
Return After Default (RAD)
Other:
Non-DOTS patient that does not fit above
The reason for referral is clearly
checked based on TB history
and previous treatment.
Other (+)
Other (-)
TB History and treatment
Date start of tx.
Where
1997
Rosal Health Center
Sampaguita Health Center
2003
September 14,
2004
By whom
Anti-TB drugs taken and duration
Outcome
2 HRZE
4 HR
Unknown
2HRZES
4HRZE
Failed
3 HRZES 3 HRZE
Failed
To the referring facility: Kindly attach a photocopy of the NTP Treatment Card.
13
MODULE B
x
x
MDR-TB suspects
Retreatment cases
R Failure:
Category I
Category II
R Relapse
Category I
Category II
R Return after default
R “Other”
R Non-converter of Category II
New or retreatment cases
R Symptomatic contact of MDR-TB patients
R HIV (+) patient
FORMS USED
x
Refer to MDR-TB Treatment Center (TC)
Suspect assessed by TC physician
MDR-TB Suspects
Referral Form
x
Non-MDR-TB
suspect:
Refer back
to referring
physician/DOTS
facility
Confirmed MDR-TB suspect
MDR-TB Screening
Form
x Acknowledgement
Form
x “Paunawa” or Terms of
Understanding
x TB Symptomatics
Masterlist
x
Mycobacteriology
Request Form
x Laboratory Receiving
Form (Specimens)
Submit 2 sputum specimens
for smear, culture and DST
Suspect is not seriously ill
Suspect is seriously ill
Await laboratory results
Refer to Consilium
x
Consiliumex
x
Release of results:
DSSM: 4-5 days after the last specimen collection

Culture: 3-3.5 months after specimen collection

DST: 4-5 months after specimen collection
Smear and culture
result
x DST result
x Laboratory Releasing
Form (Results)
x
Inform referring facility of results
14
Acknowledgement Form
MODULE B
Now do Exercise A – Written Exercise
When you have reached this point in the module, you are ready to do
Exercise B. Turn to the next page and follow the instructions for Exercise B.
Do this exercise by yourself. Then discuss your answers with a facilitator.
Exercise B: Written exercise
Filling out the MDR-TB Suspects Referral Form
The purpose of this exercise is to practice completing an MDR-TB Suspects Referral Form. Use the blank MDRTB Suspects Referral Form provided for each of the cases below. This form is important so that identified MDR-TB
suspects are correctly referred to Treatment Centers for the proper tests. The cases for this exercise are the cases you
encountered in Exercise A. Assume that you are the referring physician and write your name on the space provided
in the Form.
Case 1
34 year old female patient, Sonia Santos Sariwa, with present address at # 23 Santol St., Barangay San Antonio, Cavite
City. Tel. No. (046) 431-4086.
Date of birth: August 18, 1973
She finished 4 months of Category I treatment in your DOTS facility, Santol Health Center in the patient’s own
barangay. She started in June of 2002 and was sputum smear (-) on the 2nd month. After 2 months of HR, she was
again smear (-) on the 4th month of follow-up. The patient felt better and decided to abandon treatment despite
your strong advice.
Today is November 29, 2007 and the patient has returned complaining of a persistent cough for the last 4 weeks
with back pain, hemoptysis and weight loss. Sputum was smear-positive.
The contact telefax number of your health center is (046) 431-25253.
15
(PMDT)
Name
Last
Age
First Name
Middle name
Sex
Address
Brgy.
City/Province
Region
Tel. No.
Tel. No.
Fax No.
City
Region
Referring MD
MMC/TDF Clinic
KASAKA QI
PTSI Tayuman
Category I failure
Category II failure
Relapse Category I
Relapse Category II
Other:
Other (+)
Other (-)
Date start of tx.
Where
By whom
16
Outcome
MODULE B
Case 2
Rolanda Ramirez Reloz, 49 years old, has received 3 different courses of TB medications over a period of many years
with Dr. A. Reyes as her private doctor.
The patient’s treatment history started in:
t August 2003: Myrin P Forte x 3 months and Myrin x 3 months
t 2nd treatment: August 2005: Myrin P Forte x 6 months
t 3rd treatment: December 2006: 3 months of Econokit- MDR and 4 months of Econopack
She said she took all the medicines and claimed to have finished treatment each time but now has a cough and
fears it may again be TB. She also has weight loss, hemoptysis, occasional fever, chest pain and night sweats. She
has come to your DOTS facility today, December 3, 2007, because she no longer has money to pay for treatment.
Chest x-ray done a week ago showed a cavitary lesion on the right upper lobe, infiltrates on the left lower lobe and
minimal pleural effusion, right.
Mrs. Reloz is presently residing at 44526 Jhonny St., Brgy. Pio del Pilar, Makati City. Tel: 989014301. Date of birth is
September 2, 1958. Your facility is Pio del Pilar Health Center, Brgy Pio del Pilar, Makati City. Telephone no. 8889045
17
(PMDT)
Name
Last
Age
First Name
Middle name
Sex
Address
Brgy.
City/Province
Region
Tel. No.
Tel. No.
Fax No.
City
Region
Referring MD
MMC/TDF Clinic
KASAKA QI
PTSI Tayuman
Category I failure
Category II failure
Relapse Category I
Relapse Category II
Other:
Other (+)
Other (-)
Date start of tx.
Where
By whom
18
Outcome
MODULE B
Case 3
Santiago Suma Santos, a 55 year old male with present address at 2062-1 Anak Bayan, Paco, Manila. Tel. 530-55555,
has been complaining of cough for three weeks, night sweats and fatigue. When interviewed, he says that he has
come upon his wife’s advice considering that their 25 year old son died of MDR-TB last year. He has had no history of
TB but now has minimal infiltrates on the left upper lobe on the film done December 1, 2007.
Date of birth: April 2, 1952
Your DOTS facility is J. Fabella Health Center, San Andres, Manila. Telefax. no. 530-444444.
Today is December 5, 2007.
19
(PMDT)
Name
Last
Age
First Name
Middle name
Sex
Address
Brgy.
City/Province
Region
Tel. No.
Tel. No.
Fax No.
City
Region
Referring MD
MMC/TDF Clinic
KASAKA QI
PTSI Tayuman
Category I failure
Category II failure
Relapse Category I
Relapse Category II
Other:
Other (+)
Other (-)
Date start of tx.
Where
By whom
20
Outcome
MODULE B
Case 5
A female patient, Susana Sandok Sarmiento, 18 years old, who is being treated for HIV in one of the treatment hubs
in Metro Manila develops fever, and weight loss. Your staff at the Quirino Health Center recognized her to be the
sister of a non-converting Category II patient who has been going to this health center for TB treatment. Chest x-ray
of Susana done on October 8, 2007 showed a normal result.
Date of birth: June 18, 1989
Present address is at 1598 Interior 86 P. Quirino Avenue, Pandacan, Manila with telephone number 589-63636.
Your Health Center is located in Quirino Ave., Pandacan, Manila with telephone no. 599-0001.
21
(PMDT)
Name
Last
Age
First Name
Middle name
Sex
Address
Brgy.
City/Province
Region
Tel. No.
Tel. No.
Fax No.
City
Region
Referring MD
MMC/TDF Clinic
KASAKA QI
PTSI Tayuman
Category I failure
Category II failure
Relapse Category I
Relapse Category II
Other:
Other (+)
Other (-)
Date start of tx.
Where
By whom
22
Outcome
MODULE B
Case 6
Patient Rodolfo Remo Robles, 30 years old, was declared cured from Category I treatment which started on June
1, 2006 in Poblacion Health Center. However, he went into relapse for which the 2nd treatment was started on
September 3, 2007. Treatment with Category II is ongoing at your DOTS facility, Poblacion Health Center in the same
street and barangay where the patient resides.
Today, December 7, 2007, the patient is on his 3rd month of treatment and the follow-up smear result came out
positive. He still has cough and back pain and has been losing weight. The patient has had no adverse events and
complies with the treatment schedule.
Present address is at 276281 Poblacion Sn Vicente St., Bayanan, Muntinlupa City. Tel 5305555.
Date of birth: March 28, 1977
Tel no. of your health center is 8098420.
23
(PMDT)
Name
Last
Age
First Name
Middle name
Sex
Address
Brgy.
City/Province
Region
Tel. No.
Tel. No.
Fax No.
City
Region
Referring MD
MMC/TDF Clinic
KASAKA QI
PTSI Tayuman
Category I failure
Category II failure
Relapse Category I
Relapse Category II
Other:
Other (+)
Other (-)
Date start of tx.
Where
By whom
24
Outcome
MODULE B
25
MODULE B
2. Collect and record patient data for the MDR-TB
suspect
The Treatment Center will receive the MDR-TB suspect referred by the DOTS facility and if you work at the Treatment
Center, you will proceed to obtain and record information about the suspect and his condition and medical history.
This background information will be recorded on the MDR-TB Screening Form. Later, this patient will be registered in
the TB Symptomatics Masterlist.
2.1 Fill out the MDR-TB Screening Form
The MDR-TB Screening Form is an individual form for each MDR-TB suspect that holds a large amount of background
information about the patient. It is necessary that the Treatment Center staff fills out the form completely and
accurately to provide the most precise information for each patient’s record. The Treatment Center physician is
responsible for monitoring the completeness and accuracy of the MDR-TB Screening Form.
The MDR-TB Screening Form is a record of the following:
I.
II.
III.
IV.
V.
VI.
VII.
MDR-TB suspects’ demographics and contact information
MDR- TB suspects’ present medical complaint and symptoms
MDR-TB suspects’ past medical history especially previous TB treatment and exposure; co-morbid conditions
such as HIV, diabetes mellitus, kidney or liver disease, etc.
Social history
Doctor’s physical examination findings and laboratory procedures
Assessment or initial diagnosis and the specific type of suspect and risk factors for drug-resistance
Plan for diagnosis and/or treatment
The Screening code is the unique identification number assigned to every TB symptomatic who undergoes
the process of screening at the Treatment Center (See table below). This number is given once the patient is
entered in the TB Symptomatics Masterlist for PMDT. See Reference Booklet for instructions on how to fill out
the TB Symptomatics Masterlist.
TABLE 2 :Screening code (TC-YY-MM-NNNN)
Code
TC
YY
MM
NNNN
Description
Treatment Center:
01– TDF-MMC DOTS Clinic
02– KASAKA-QI MDR-TB Housing Facility
03– LCP-PHDU DOTS Center
04– Dr. Jose N. Rodriguez Memorial Hospital (DJNRMH)- DOTS Center
05– Philippine Tuberculosis Society Inc. (PTSI) Tayuman DOTS Center
Current year the patient was screened, e.g., 08 for 2008
Current month the patient was screened, e.g., 01 for January
Accrual number that begins with 0001 at the start of every month
The example on page 28 shows that the patient, Jose Balagtas, with Screening Code 02-05-04-0081 was screened
in KASAKA-QI MDR-TB Housing Facility in April 2005 and was the 81st TB or MDR-TB suspect to be screened since
the start of the month in that Treatment Center. Permanent address is the address where the patient has stayed on
a long-term basis, e.g., in the province, while the current address is the residence where he can be contacted while
undergoing diagnosis for TB or MDR-TB, e.g., relocation address in Metro Manila.
t
t
t
26
Elaborate on the patient’s symptoms including duration, and other details, e.g., quantification of weight
loss, or blood during hemoptysis, etc.
Write the patient’s past TB treatment: what drugs were taken, where treated, whether DOTS or non-DOTS,
and the outcome of such treatments; exposure to active TB or MDR-TB; comorbid illnesses, allergy, etc.
Write the smoking, alcohol and drug use, and sexual history.
MODULE B
t
t
t
Write the physical examination findings, and laboratory procedures that were done prior to the screening,
the radiographic findings including an illustration of where the radiographic lesions are found in the
lungs.
Finally, write down your assessment of the patient, whether TB or non-TB, and if new or retreatment. If the
patient is a retreatment case, specify what category, whether failure of category I or II, return after default,
relapse of category I, II or IV, or “other”. Specify also if there are risk factors other than a history of treatment,
e.g., being a contact of an MDR-TB case, non-conversion of Category II treatment, TB symptomatic HIVpositive, or whether he has had 2 or more treatment courses.
Write the management plans, e.g., what sputum examinations to make and how many specimens for
each.
A filled out MDR-TB Screening Form is shown on the following pages. See Reference Booklet for instructions on how
to fill this out.
27
(PMDT)
Example of an MDR-TB Screening Form
MDR - TB SCREENING FORM
Mark with check ( ) if symptom is present, PE is done and disease is present,
otherwise, mark with (X). Please ensure the completeness of all information.
Screening
code:
TC: 02= KASAKA
KASAKA
Screened at:
MMC/TDF
LCP
Others, specify
YY:/05=
04 /28
052005
Screening code: (TC-YY-MM-NNNN) 02-05-04-0081
Date:
MM: 04= April
(mm/dd/yy)
0081: 81st
patient to be
I. Demographics
screened in
Balagtas
Jose
Amorsolo
Name:
KASAKA in April
Surname
Given Name
Middle
Name
2005
Sex:
Male
Date of birth:
Age:
50 y/0
Place of birth:
Nationality: Filipino
Permanent
address is the
patient’s long2425
Permanent
term
address address:
Religion: Roman
Catholic
Married
Civil status:
Single
Widowed
Living together
Divorced/ legally separated
Buendia St., Balut, Tondo, Manila
zip code 1772
Tel. no.:
(02) 244-6847
area code+ tel #
Same as above
zip code
E-mail address:
Occupation:
Office
Cityaddress:
Manila
(mm/dd/yy)
Female
City address:
01/20/ 55
Tel. no.:
area code+ tel #
None
None
None
Family monthly income:
N/A
Employer:
Tel. no.:
N/A
area code+ tel #
address
Joy Balagtas
(02) 244-6847
Spouse:
Address/ Contact #:
is the
Father:
Mother: Lorna Balagtas (Deceased)
address Eduardo Balagtas (Deceased)
in Metro
Parent’s
address:
Tel. no.:
Manila
area code+ tel #
Daughter
whereto
the
Person
notify in case of emergency: Marites Balagtas
Relationship:
patient is 2425 Buendia St., Balut, Tondo, Manila
Address:
Tel. No.:
staying
area code+ tel #
to access
Referred
by: HC
Govt Inst
PPMD
FBO
NGO
Pvt MD/Institution
diagnosis
Sapaguita
Health
Center
Specify name,
and
#3436 Balut, Tondo, Manila
possibleof referring facility:
Address
treatment.
2 More than 10 yrs old:
3
Number of household contacts: 5
Less than or equal 10 yrs old:
Persistent
coughing
with
fresh
blood
Chief Complaint/s:
II. Review of Symptom/s
Cough
Fever
Back/ chest pain
Hemoptysis
Weight loss
Night sweats
Other symptoms:
Dyspnea at rest
Dyspnea on exertion
Pedal edema
28
Duration in month/s
> 6 months
3 weeks
> 6 months
4 Months
6 months
3 weeks
> 1 month
> 6 months
Comments
With expectoration of yellowish sputum
Remittent, usually in the afternoon
Right upper back pain
Last episodes 4/23/05 2 TBSP
Approximately 10 kg
MDR - TB SCREENING FORM | page 2 of 4
Programmatic Management of Drug - Resistant TB (PMDT)
III. Past Medical History:
Historythe
of previous TB treatment: (from first to last)
Validate
information
in the MDRRegimen and duration
Treatment facility
DOTS
Start date
TB Suspects
( mm/dd/yyyy )
( mos.)
(Y/N)
Referral
Form by
2HRZES 4HRZE
Rosal Health Center
doing
actual
1. 2003
interview
of
2003
2HRZES
4HRZE
2.
the patient’s
2HRZES 3HRZE
3. 9/14/04
TB treatment
4.
history.
5.
6.
7.
Exposure to active TB:
No
Co- morbidities
If Yes
2
Drugs:
1. None
Y
Y
Y
5
3
3
Non MDR
Duration
Diabetes Mellitus
Cancer
HIVinfection/AIDS
Kidney disease
Lung disease
Epilepsy
Psychiatric condition
Others
Allergy:
MDR
Outcome
(1=cured, 2=tx completed,
3=failed, 4=defaulted,
5=unknown)
Comments: (drugs taken, status, etc.)
year (s)
year (s)
year (s)
year (s)
year (s)
year (s)
year (s)
year (s)
NA
Glibenclamide 5mg TID
Status
Check for other drugs used by
the patient to help identify comorbidities.
Type of reaction:
2.
Concomitant drugs / Duration:
NA
NA
Previous surgery:
None
Date of surgery:
Complications:
/
Pneumonectomy/ Lobectomy
Others, specify
/
IV. Social History:
Tobacco/ Cigarettes
Current
Past
Never
Sticks/day x yrs
20 sticks/day x 31yrs
Women: LMP
Alcohol
Current
Past
Never
Type /bottles /day x yrs
/
/
(mm/dd/yy)
Beer 2/day x 35yrs
G
Contraceptive use (for women only):
Sexual History: Had
Drug Abuse
Current
Past
Never
Type (shabu, marijuana, etc)
P
No
yes, specify
two partners other than wife / commercial sex workers
29
V. Physical examination and laboratory procedures:
Height: 167 cm
Vital Signs: Temp: 37.4 Celsius
BP: 120/80
mmHg
Weight: 49. 2 Kg.
PR/ HR: 90 / min
O2 sat by Pulse oximeter:
0 = Not done
1 = Normal
2 = Abnormal
System examination:
2
2
General Health:
Skin:
BCG scar:
1
1
2
Oropharynx:
Cardiovascular:
Thorax & Lungs:
Use of accessory muscles:
Abdomen:
Genito-Urinary:
Extremities:
Neurological:
Lymph Nodes:
Endocrine:
2
1
1
1
1
1
1
28
RR at rest:
Describe abnormalities
Ambulatory, cachectic
Poor skin turgor
Present
(+) wheezing, bilateral lung ¿elds, decreased breath sounds on R lung ¿eld
(+) SCM, intercostal retractions
Laboratory procedures:
Smear, Culture and DST results from other laboratory
Date
AFB 2+
02/ 15 / 05
Other laboratory results:
Liver function tests
Renal function tests
CBC
FBS, etc.
30
None
/min
%
Always ask for
results of smear,
culture & DST
done prior to
consultation, if
available.
/
/
/
/
MODULE B
Chest X-ray: Date:
04 / 17
MODULE B
/ 2005
Right Lung
Left Lung
1
8
2
2
0 - Normal
7 - Fibrosis
1 - Cavitary
8 - Fibrothorax
2 - Infiltrate
9 - Bullae
3 - Nodule
10 - Pleural effusion
4 - Miliary TB
11 - Pneumothorax
5 - Intrathoracic
lymphadenopathy
12 - Bronchiectasis
6 - Endobronchial
spread
14 - Consolidation
13 - Atelectasis
15 - Mass
VI. Assessment:
Based on the patient’s TB treatment history, select the
appropriate category.
TB suspect
New
Retreatment
If retreatment, check any of the following types.
Drug-resistant TB suspect (Categories)
Category I Failure
Category II Failure
Return after Default (RAD)
Category I Relapse
Category II Relapse
Category IV Relapse
Other
If new or retreatment, check any of the following risk
factors.
None
Symptomatic contact of confirmed/
Based on
suspected MDRTB patient the patient’s
Non-converter of Categorybackground,
II
Symptomatic HIV-positive symptoms, HIV
status,
Category
2 or more non-DOTS treatment
course
II conversion,
and number
of treatment
courses, select
the appropriate
risk factors for
drug resistance.
Non-DOTS
Other (+)
Other (-)
Disease other than TB, specify
VII. Plan:
The plan for diagnosis and treatment indicates the
sputum tests to be performed and how many samples
are needed in order to confirm the assessment.
2
For smear x
For TB culture x 2
For Drug susceptibility testing
Start TB treatment, specify regimen:
Prescribe ancillary drugs or drugs for co-morbidity, or symptomatic treatment
The Treatment Center physician ensures the completeness of
data on the MDR-TB Screening Form.
Others
Attending MD:
Dr. Dan Rivera
Date:
4 / 28 / 05
31
MODULE B
2.2 Fill out the Acknowledgement Form
After the patient has been interviewed and examined by the Treatment Center physician with all data recorded
on the MDR-TB Screening Form, he will fill out the Acknowledgement Form in duplicate copies. Tick the box for
“initial diagnosis”. This form is used to inform the referring DOTS facility or doctor that the MDR-TB suspect has
been received and examined by the Treatment Center. The Treatment Center physician addresses the form to the
referring physician or DOTS facility, writes down the pertinent data including relevant history, past treatment, patient
type and physical examination findings. He also writes down the initial diagnosis, and management plans such
as laboratory procedures to confirm the diagnosis, or any symptomatic treatment being given. See the Reference
Booklet for instructions on how to fill out the Acknowledgment Form.
There are some patients for whom the treatment of TB needs to be stopped while waiting for the DST results.
This depends on the suspect’s history of TB treatment or the outcome he had from these treatments. There are
also patients who will be referred back to the referring DOTS facility for continuation of DOTS treatment while
waiting for DST results. The Treatment Center physician will be the one to advise the patient on what to do with his
current treatment and will write this advice down on the Acknowledgement Form. All previously treated patients,
symptomatic contacts of drug-resistant cases, whether new or retreatment, are suspects for drug resistance; hence,
these patients are candidates for sputum culture and DST in addition to smear. HIV patients with TB symptoms
should also have culture and DST because of the high mortality in TB/HIV co-infection.
DOTS facilities are advised to refer all their previously treated symptomatic patients, whether smear-positive or
smear-negative, Category II non-converters, symptomatic contacts of confirmed or suspected drug-resistant cases,
and HIV cases with TB symptoms to MDR-TB Treatment Centers. The following table will guide the Treatment Center
when giving advice to patients. This decision table may undergo some changes as more evidence on this matter is
gathered from the experience in the Philippines.
TABLE 3: Decision table for patients awaiting DST results
Type of suspect
Action to take
–
–
–
–
Relapse
Return after default
Category I failure
“Other” with only one previous treatment
Start Category II regimen while awaiting DST. If
smear non-converter on Category II (on month 3),
stop treatment and refer back to the MDR-TB Treatment Center and await DST.
–
–
Category II failure
Previously treated patients with two or more treatment
courses in the past
Stop treatment and await DST.
–
Symptomatic contact of a confirmed or suspected drugresistant case
Action will depend on consilium decision guided
by smear result, previous history and clinical status
HIV positive with TB symptoms
Start Category I regimen, if new
Start Category II or Category IV, if previously
treated, depending on joint decision of consilium
and HIV doctor.
–
MDR-TB suspects who are noted to be critically ill at the time of screening or are clinically deteriorating are
immediately referred to the Consilium for case discussion and possible expedited treatment using the appropriate
regimen. This is discussed in more detail in section 2.4 in this module.
After completing the Acknowledgement Form, give one copy to the patient to be given back to his referring physician
or facility and attach the other copy to the MDR-TB Screening Form which remains at the Treatment Center. There are
occasions when the patient is unable to give this back to the referring physician. Hence, a copy of the accomplished
Acknowledgement Form may need to be sent directly by telefax, if the contact number is known. An example of a
PMDT Acknowledgement Form is shown on the next page.
Later when DST results have been received by the Treatment Center, another Acknowledgement Form is completed
and sent to the referring physician or facility this time with the box for “final diagnosis” ticked and updated
information on the patient given.
32
MODULE B
(PMDT)
Example of the Acknowledgement Form
Date:
4/28/05
To:
Dr. A. Madrid
Initial Diagnosis
Final Diagnosis
Duplicate copy of PMDT
Acknowledgement Form must always be made.
Tondo, Manila
Thank you for referring your patient
diagnosis/management.
Jose A. Balagtas
, for further TB
The patient must give the duplicate
copy to the referring MD.
Pertinent findings/ Laboratory examinations:
Received anti –TB treatment since 1997
Failure of category II treatment on two occasions.
(+) wheezing, bilateral lung ¿elds, decreased breath sounds on R lung ¿eld
To consider Multidrug-resistant TB
Plans/Recommendations:
For AFS/TBC and DST
Await DST result prior to initiation of treatment
Clinic Physician:
Contact numbers:
Dr. Dan Rivera
742-1534/ 781-3761 to 65 loc. 146
Treatment Center: KASAKA QI Treatment Center
33
MODULE B
2.3 Fill out the TB Symptomatics Masterlist
Proceed to register the patient in the TB Symptomatics Masterlist.
The TB Symptomatics Masterlist is a record of ALL TB suspects, including TB and MDR-TB suspects seen at the MDRTB Treatment Center. It is particularly useful for monitoring case detection activities and the results of all sputum
examinations requested for screening from the laboratory. See Module G: Monitoring MDR-TB Case Detection and
Treatment for a discussion about how to use this register for monitoring MDR-TB case detection.
Whenever you identify a TB or an MDR-TB suspect, list this patient in the TB Symptomatics Masterlist. An example of
an accomplished Masterlist is shown on the next pages.
Be sure to complete the screening code, date of screening as well as the complete name and address, date of birth
and sex of the patient. The complete address will enable the staff at the Treatment Center to locate the patient once
the results of the tests confirm TB or MDR-TB and the patient does not return.
34
SALCEDO, Myrna Cortez
TAN, Vincent Lim
SANTOS, Sylvia Gomez
MANYO, Avelina Corazon
LEGAZPI, Agapito Rivera
SALDUVERA, Manny Manuel
02-05-04-0082 04/28/05
02-05-04-0083 04/28/05
02-05-04-0084 04/29/05
02-05-05-0001 05/02/05
02-05-05-0002 05/02/05
02-05-05-0003 05/10/05
(1) TX Centers:
01 - TDF-MMC DOTS Clinic
02 - KASAKA-QI MDR-TB Housing Facility
03 - LCP-PHDU DOTS Center
04 - DJNRMH DOTS Center
05 - PTSI Tayuman DOTS Center
06 - ________
07 - ________
BALAGTAS, Jose Amorsolo
Last, First and Middle name
(3)
02-05-04-0081 04/25/05
Screening Code Date screened
TC-YY-MM-NNNN mm/dd/yy
(1)
(2)
Name
08/03/85
19
12/23/67
39
12/23/67
39
02/02/78
27
03/28/83
23
05/26/58
48
01/20/55
50
Date of birth
(mm/dd/yy)
(5)
Age (completed yrs)
This refers to the facility or MD/ who
/
referred the patient to the Treatment
/
Center not necessarily the one/ who
gave the last TB treatment.
Unit 555, Rancher's Appartle,
Kakarong St., Brgy. Sta. Cruz, Makati
City, NCR
#2 ABC cmpd. Mabuhay St., Payatas,
Manila NCR
#2 ABC cmpd. Mabuhay St., Payatas,
Manila NCR
47 National Road, Brgy. San Vicente,
Bacacay Albay Bicol Region
Arlegui St. Malacanang cmpd,
Manila NCR
75 Sta Mesa Heights, Sta Mesa,
Manila NCR
2425 Buendia St. Balut Tondo,
Manila NCR
No. of street, street, City, Region
(4)
Address
(6)
DETECT
Detect
CASES
CasesOFofMDR-TB
MDR-TB
3
0
5
3
4
2
(8) Funding:
0- Gen fund
2- Round 2
5- Round 5
99- Others; specify
____________
(6) Sex:
1- Male
2- Female
1
1
2
2
1
2
3
(7)
Sex
1
No. of previous
TB treatment
TB Symptomatics Masterlist
(PMDT)
5
5
5
5
5
5
5
(8)
Sta. Cruz HC
patient Merlie
Camias
Vergonville
DOTS Center
Dr. Artemis
Malunsay
Sta Monica
Hospital
Greenview Dots
Center
Sampaguita HC
Name of Health
facility/ Private
MD
NCR
Dr. Reyes
0
0
Dr. Lauro
Macandog
Philippine
General Hospital
Greenview Dots
Center
Sampaguita HC
Health facility/
Private MD
1 - New
2 - After Cat I failure
3 - After Cat II failure
4 - After Cat IV failure
5 - After default
6 - Cat I relapse
7 - Cat II relapse
1
1
7
10.1
10.1
5
3
Registration
group
(12)
8 - Cat IV relapse
9 - Transfer-in
10 - Other patient w/
10.1 Non-DOTS
10.2 Other (+)
10.3 Other (-)
NCR
Makati
NCR
Manila
NCR
Las
Pinas
5
Albay
NCR
Manila
NCR
Manila
NCR
Manila
City/
Region
Site where last treated for
TB (11)
(12) Registration group
Makati
NCR
Manila
NCR
Las Pinas
5
Albay
NCR
Manila
NCR
Manila
NCR
Manila
City/ Region
Referring site or referring doctor
(10)
(9) Source of referral
1- Govt. DOTS facility
2- Govt. Non-DOTS Facility
3- Private DOTS Facility
4- Private Non-DOTS Facility
5- Faith-based unit/NGO DOTS Facility
6- Faith-based unit/NGO Non-DOTS
Facility
7- Walk - in
1
7
1
4
2
3
1
(9)
Source of
referral
Page 1 of the TB Symptomatics Masterlist
Funding
35
/
2+ / MTB
04/28/05
1+ /MTB
04/28/05
0 /MTB
04/29/05
4+ /MTB
05/02/05
1+ /MTB
05/02/05
0 / MTB
05/10/05
/
1,2,8
04 / 17 / 05
1,2
03/ 21 /05
1,15
01 /22 /05
1,2,3
04/02/05
1,2
04 /27 /05
2
04 /25 /05
1,2
05/05/05
1, 2, 3,
4, 5, 6
1,3,4
1,3,4,5
1
1, 2, 3, 4,
5, 6
1,3
1, 2, 3, 4,
5, 6
2
1
4
4
4
0
1
(13) Risk factors
0 - None
1 - Household contact of MDR
2 - Non-converter cat II
3 - HIV-positive
4- ≥ 2 non-DOTS treatment courses
/
/
/
/
/
/
05 / 02 / 05
0 /MTB
3+ /MTB
05 / 2/05
04 / 29 / 05
0 / MTB
4+ / MTB
04/26/05
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
(15) CXR results
0 - Normal
1 - Cavitary
2 - Infiltrate
3 - Nodule
4 - Miliary TB
5 - Intrathoracic lymphadenopathy
6 - Endobronchial spread
7 - Fibrosis
8 - Fibrothorax
/
/
for DOTS.
/local health center
/
/
/
/
/
/
S
R
R
R
R
H
9 - Bullae
11 - Pneumothorax
12 - Bronchiectasis
13 - Atelectasis
14 - Consolidation
15 - Mass
16 - others, specify
______________
/
/
/ /
/
/
A/ pansusceptible
case is/ referred
to/ the
(14) Symptoms:
0- None
1- Cough
2- Fever
3- Chest/back pain
4- Hemoptysis
5- Weight loss
6- Night sweats
/
/
/
3+ / MTB
05/03/05
1+ / MTB
05/03/05
1+ / MTB
05/11/05
3+ / MTB
04/25/05
(15)
Date sputum collected (mm/dd/yy)
(14)
Date done
(13)
Screening (DSSM/ culture results) (16)
Risk factors
Symptoms
36
CXR results
TB SYMPTOMATICS MASTERLIST | page 2 of 2
Page 2 of the TB Symptomatics Masterlist
S
R
R
R
R
R
S
S
R
S
R
S
S
Pending
S
R
S
S
Km
S
S
R
S
S
Ofx
S
S
R
S
S
Cfx
S
S
S
S
S
Lfx
ND
ND
ND
ND
ND
H - Isoniazid
R - Rifampicin
Z - Pyrazinamide
E - Ethambutol
S - Streptomycin
Km - Kanamycin
Ofx - Ofloxacin
Cfx - Cifloxacin
Lfx - Levofloxacin
/
/
/
/
/
/
8/31/05
9/23/05
10/5/05
9/14/05
10/10/05
Date DST
released
/
/
/
/
/
/
9/6/05
9/6/05
9/27/05
10/11/05
9/20/05
10/18/05
Consilium
date
Registration date
(mm/dd/yy)
(18)
4.
5.
6.
7.
8.
Suspects with at least 1 culture positive result
Suspects with DST results
Suspects with HR resistance
Number of suspects with pre-enrollment number
Number of patients with treatment start date
05-0079
8/10/2005
09/07/05
Referred to LHC
05-0080
8/30/2005
10/4/2005
05-0097
05-0098
11/8/2005
Lost before enrollment
05-0096
05-0099
11/24/2007
Enrolled? If YES, indicate treatment
start date. If NO, indicate reason.
Pre-enrollment No. (19)
(YY-NNNN)
/
/
A Pre-enrollment No.
is/assigned
to/ all TB symptomatics
who are either a) proven MDR-TB by DST, or b) decided
Summary
by the consilium to start treatment
even without DST
1. Number of DR-TB suspects
confirmation
due to high clinical suspicion. Both groups
2. Suspects with 2 sputum specimens tested
are3. all
forwith
start
treatment.
Suspects
at leastof
1 culture
results
ND
ND
ND
ND
ND
Other Other
Make sure MDR –TB confirmed
patients are immediately presented
to the consilium for regimen design
and start of treatment.
S
R
R
S
R
E
(17) DST results
S = susceptible
R = resistant
ND = not done
S
S
R
S
S
Z
DST results (17)
MODULE B
For Treatment Site Staff
When you have reached this point in the module, your facilitator will show you
a sample of the TB Symptomatics Masterlist. After a short discussion, continue
reading on page 58.
For Treatment Center Staff Exercise C – Written Exercise
Exercise C. See instructions below for Exercise C. Do this exercise by
yourself.
Exercise C: Written exercise
Recording in the TB Symptomatics Masterlist
In this exercise each of you will be given a TB Symptomatics Masterlist. Use the patient data provided in the MDR-TB
Screening Forms in the following pages, enter each TB suspect and complete the TB Symptomatics Masterlist. Work
individually on this exercise. Ask your facilitator for help if you do not understand what to do.
t
t
t
t
List each of the 5 MDR-TB suspects presented below in the TB Symptomatics Masterlist and fill out Columns
1-15.
Assign each, in sequence, a Screening code. Assume that the last code in the Masterlist was TC-YYMM-096.
Funding source is Round 5 GFATM.
Assume that the patients went to the Treatment Center on the day that you as the referring MD made the
MDR-TB Suspects Referral Form.
37
(PMDT)
Case 1:
Screened at:
MMC/TDF
KASAKA
LCP
Others, specify
Screening code: (TC-YY-MM-NNNN)
Date:
11/29/2007
(mm/dd/yy)
I. Demographics
Sariwa
Name:
Sonia
Surname
Sex:
Male
Female
Nationality:
Santos
Given Name
Date of birth:
Middle Name
August 18, 1973
Age:
(mm/dd/yy)
Filipino
Permanent address:
Religion:
Catholic
34
Place of birth:
Cavite
Civil status: Single
Married
Widowed
Living together
23 Santol St., Barangay San Antonio, Cavite City
zip code 4100
Tel. no.:
(046) 431-40086
area code+ tel #
City address:
zip code
E-mail address:
Occupation:
Office address:
none
none
none
Tel. no.:
10
Employer:
Tel. no.:
Spouse: none
Address/ Contact #:
Eufronio
Sariwa
(deceased)
Sofriana Sariwa
Father:
Mother:
Parent’s address: 23 Santol St., Barangay San Antonio, Cavite City
Tel. no.:
Person to notify in case of emergency: Sofriana Sariwa
Address: 23 Santol St., Barangay San Antonio, Cavite City
Relationship:
Tel. No.:
area code+ tel #
000 Php
area code+ tel #
(046) 431-40086
area code+ tel #
mother
(046) 431-40086
area code+ tel #
Govt Inst
PPMD
FBO
NGO
Pvt MD/Institution
HC
Specify name, Santol Health Center
Address of referring facility: Barangay San Antonio, Cavite City
3
Number of household contacts:
Less than or equal 10 yrs old: 0
More than 10 yrs old:
persistent cough with hemoptysis
Chief Complaint/s:
Referred by:
Cough
Fever
Back/ chest pain
Hemoptysis
Weight loss
Night sweats
Other symptoms:
Dyspnea at rest
Dyspnea on exertion
Pedal edema
38
Duration in month/s
1
1
1
1
3
Comments
productive, minimal amt., whitish in color
on both upper lung area, greater in right
dark red in color, 4 episodes for the last 2 wks
approximately 5 kg
History of previous TB treatment: (from first to last)
Outcome
Start date
Regimen and duration
( mm/dd/yyyy )
( mos.)
1. June
2.
3.
4.
5.
6.
7.
2002
No
Co- morbidities
Allergy:
Santol Health Center
If Yes
MDR
Y
5=unknown)
4
Non MDR
Duration
year (s)
year (s)
year (s)
year (s)
year (s)
year (s)
year (s)
year (s)
Diabetes Mellitus
Cancer
HIVinfection/AIDS
Kidney disease
Lung disease
Epilepsy
Others
DOTS
(Y/N)
2 HRZE / 2 HR
Treatment facility
Drugs:
Status
Type of reaction:
No known food or drug allergies
1.
2.
Previous surgery:
Date of surgery:
Complications:
None
/
Others, specify
/
IV. Social History:
Tobacco/ Cigarettes
Current
Past
Never
Sticks/day x yrs
Women: LMP
Alcohol
Current
Past
Never
11
/ 29 / 2007
(mm/dd/yy)
G
Sexual History:
sexually active
Drug Abuse
Current
Past
Never
0
No
P
0
yes, specify
pills
39
Vital Signs:
Height: 155
cm
Temp: 37.5
Celsius
BP: 130/90
mmHg
System examination:
General Health:
Skin:
BCG scar:
Oropharynx:
Cardiovascular:
Thorax & Lungs:
Abdomen:
Genito-Urinary:
Extremities:
Neurological:
Lymph Nodes:
Endocrine:
Weight: 43 Kg.
PR/ HR: 98 / min
0 = Not done
1 = Normal
2 = Abnormal
2
2
0
0
2
1
0
1
0
2
0
25
RR at rest:
%
distressed, cachectic, generally weak
(+) pallor of skin, conjunctiva, palms, & nail beds
(-) BCG scar
(+) crackles heard on both upper lung ¿elds, more on the right
(+) use of accessory muscles
(+) papable cervical lymph nodes
DSSM 0 / 2+ / 1+
CBC
FBS, etc.
40
/min
Date
11
/ 25 / 2007
/
/
/
/
Chest X-ray: Date:
/
MODULE B
/
Right Lung
Left Lung
0 - Normal
7 - Fibrosis
1 - Cavitary
8 - Fibrothorax
2 - Infiltrate
9 - Bullae
3 - Nodule
4 - Miliary TB
11 - Pneumothorax
5 - Intrathoracic
lymphadenopathy
12 - Bronchiectasis
6 - Endobronchial
spread
14 - Consolidation
13 - Atelectasis
15 - Mass
VI. Assessment:
TB suspect
New
Retreatment
Category I Failure
Category II Failure
Category I Relapse
Category II Relapse
Category IV Relapse
Other
factors.
None
suspected MDRTB patient
Non-converter of Category II
Symptomatic HIV-positive
2 or more non-DOTS treatment course
Non-DOTS
Other (+)
Other (-)
VII. Plan:
2
For smear x
2
For TB culture x
Category II Treatment while awaiting DST;
Start TB treatment, specify regimen: stop treatment if non-converter on 3rd month
Others
Attending MD:
Dave Verzosa, MD
Date:
11/29/2007
41
(PMDT)
Case 2:
Screened at:
MMC/TDF
KASAKA
LCP
Others, specify
Date:
12/03/2007 (Saturday)
(mm/dd/yy)
I. Demographics
Reloz
Name:
Rolanda
Surname
Sex:
Male
Female
Nationality:
City address:
Date of birth:
September 02, 1958
Middle Name
Age:
(mm/dd/yy)
Filipino
Permanent address:
Ramirez
Given Name
Religion:
Catholic
49
Place of birth:
Makati
Civil status:
Single
Married Widowed
Living together
44526 Jhonny St., Pio del Pilar, Makati City
zip code 1230
zip code 1230
Tel. no.:
989014301
area code+ tel #
Tel. no.:
989014301
area code+ tel #
E-mail address:
Occupation:
Office address:
none
50 000 Php
Manager
Mano
Mano
Manufacturing Company
Employer:
Tel. no.:
Spouse: Rolly Reloz (deceased)
Address/ Contact #:
Christian
Ramirez
Father:
Mother: Sarah Ramirez
Parent’s address: Purok 31, Barangay Pampanga, Davao City, Davao del Sur
Tel. no.:
Person to notify in case of emergency: Rolex Reloz
Address: 44526 Jhonny St., Pio del Pilar, Makati City
area code+ tel #
none
area code+ tel #
Son
Relationship:
Tel. No.: 989014301
area code+ tel #
Govt Inst
PPMD
FBO
NGO
Pvt MD/Institution
HC
Specify name, Pio del Pilar Health Center
Address of referring facility: Barangay Pio del Pilar, Makati City
5
Less than or equal 10 yrs old: 3
More than 10 yrs old:
persistent cough
Chief Complaint/s:
Referred by:
Cough
Fever
Back/ chest pain
Hemoptysis
Weight loss
Night sweats
Other symptoms:
Dyspnea at rest
Dyspnea on exertion
Pedal edema
42
Duration in month/s
2 wks
1 wk
1
1
1
2
Comments
usually in the afternoon
on both lung area, greater in right upper area
dark red in color, 1 episode for the last wk
approximately 7 kg
Outcome
Start date
( mm/dd/yyyy )
( mos.)
1. Aug. 2003
2. Aug. 2005
3. Dec. 2006
4.
5.
6.
7.
No
Co- morbidities
If Yes
Allergy:
MDR
5
5
5
year (s)
year (s)
year (s)
year (s)
year (s)
year (s)
year (s)
year (s)
Drugs:
N
N
N
5=unknown)
Non MDR
Duration
Diabetes Mellitus
Cancer
HIVinfection/AIDS
Kidney disease
Lung disease
Epilepsy
Others
DOTS
(Y/N)
3 Myrin P Forte / 3 Myrin Dr. A. Reyes (private MD)
6 Myrin P Forte
Dr. A. Reyes (private MD)
3 Econokit / 4 Econopack Dr. A. Reyes (private MD)
Treatment facility
Status
Type of reaction:
1.
2.
Previous surgery:
Date of surgery:
Complications:
None
/
Others, specify
/
IV. Social History:
Tobacco/ Cigarettes
Current
Past
Never
Sticks/day x yrs
Women: LMP
Alcohol
Current
Past
Never
11
/ 25 / 2007
(mm/dd/yy)
G
5
Drug Abuse
Current
Past
Never
P
5
yes, specify
No
sexually inactive_for more than a year
Sexual History:
43
Vital Signs:
Height: 157
Temp: 37.5
BP: 130/90
System examination:
General Health:
Skin:
BCG scar:
Oropharynx:
Cardiovascular:
Thorax & Lungs:
Abdomen:
Genito-Urinary:
Extremities:
Neurological:
Lymph Nodes:
Endocrine:
cm
Celsius
mmHg
Weight: 44 Kg.
98 / min
PR/ HR:
0 = Not done
1 = Normal
2 = Abnormal
2
2
0
0
2
1
0
1
0
2
0
24
RR at rest:
distressed, cachectic
(+) pallor of skin, conjunctiva, palms, & nail beds
(-) BCG scar
(+) crackles heard on both lung ¿elds
(+) use of accessory muscles
(+) palpable cervical lymph nodes
CBC
FBS, etc.
44
/min
%
Date
/
/
/
/
/
/
Chest X-ray: Date:
11
/
26
MODULE B
/
2007
Right Lung
Left Lung
1
2
10
0 - Normal
7 - Fibrosis
1 - Cavitary
8 - Fibrothorax
2 - Infiltrate
9 - Bullae
3 - Nodule
4 - Miliary TB
11 - Pneumothorax
5 - Intrathoracic
lymphadenopathy
12 - Bronchiectasis
6 - Endobronchial
spread
14 - Consolidation
13 - Atelectasis
15 - Mass
VI. Assessment:
TB suspect
New
Retreatment
Category I Failure
Category II Failure
Category I Relapse
Category II Relapse
Category IV Relapse
Other
factors.
None
Non-DOTS
Other (+)
Other (-)
VII. Plan:
2
For smear x
2
For TB culture x
Others
Await DST results prior to initiation of treatment if DSSM (+). If DSSM (-), refer to TBDC.
Attending MD:
Dave Verzosa, MD
Date:
12/03/2007
45
Case 3:
(PMDT)
MODULE B
Screened at:
MMC/TDF
KASAKA
LCP
Others, specify
Date:
12/05/2007
(mm/dd/yy)
I. Demographics
Santos
Name:
Santiago
Surname
Sex:
Male
Female
Nationality:
City address:
Date of birth:
Middle Name
April 02, 1952
Age:
(mm/dd/yy)
Filipino
Permanent address:
Suma
Given Name
Religion:
Catholic
Makati
Tel. no.:
53055555
area code+ tel #
zip code
none
Accounting Clerk
Padre Burgos St., Manila
Place of birth:
Civil status:
Single Married
Widowed
Living together
2062-1 Anak Bayan, Paco, Manila
zip code 1007
2062-1 Anak Bayan, Paco, Manila
E-mail address:
Occupation:
Office address:
55
1007
Tel. no.:
53055555
30
Employer: Manila City Hall
Tel. no.:
Spouse: Luzviminda Santos
Address/ Contact #:
John
Santos
Father:
Mother: Diana Santos
Parent’s address: 2062-1 Anak Bayan, Paco, Manila
Tel. no.:
Person to notify in case of emergency: Luzviminda Santos
Address: 2062-1 Anak Bayan, Paco, Manila
Relationship:
Tel. No.:
area code+ tel #
000 Php
5247141
area code+ tel #
53055555
area code+ tel #
53055555
area code+ tel #
Referred by:
HC
Govt Inst
PPMD
FBO
NGO
Pvt MD/Institution
Specify name, J. Fabella Health Center
Address of referring facility: San Andres, Manila
3
persistent cough
Chief Complaint/s:
Cough
Fever
Back/ chest pain
Hemoptysis
Weight loss
Night sweats
Other symptoms:
Dyspnea at rest
Dyspnea on exertion
Pedal edema
46
Duration in month/s
3 wks
1
1
3
Comments
on left upper lung area; aggravated by cough
MODULE B
Outcome
Start date
( mm/dd/yyyy )
( mos.)
DOTS
(Y/N)
No previous TB treatment
1.
2.
3.
4.
5.
6.
7.
No
Co- morbidities
Treatment facility
If Yes
MDR
Non MDR
Duration
year (s)
year (s)
year (s)
year (s)
year (s)
year (s)
year (s)
year (s)
Diabetes Mellitus
Cancer
HIVinfection/AIDS
Kidney disease
Lung disease
Epilepsy
Others
Allergy:
Drugs:
5=unknown)
Status
Type of reaction:
1.
2.
Previous surgery:
Date of surgery:
Complications:
None
/
Others, specify
/
IV. Social History:
Tobacco/ Cigarettes
Current
Past
Never
Sticks/day x yrs
Women: LMP
Alcohol
Current
Past
Never
/
/
(mm/dd/yy)
G
Sexual History:
sexually inactive for a year
Drug Abuse
Current
Past
Never
P
No
yes, specify
47
Vital Signs:
Height: 169
Temp: 37.3
BP: 130/80
System examination:
General Health:
Skin:
BCG scar:
Oropharynx:
Cardiovascular:
Thorax & Lungs:
Abdomen:
Genito-Urinary:
Extremities:
Neurological:
Lymph Nodes:
Endocrine:
cm
Celsius
mmHg
Weight: 60 Kg.
PR/ HR: 84 / min
0 = Not done
1 = Normal
2 = Abnormal
1
1
0
0
2
1
0
1
0
2
0
22
RR at rest:
%
(+) BCG scar
(+) crackles heard on left upper lung ¿eld
CBC
FBS, etc.
48
Date
/
/
/
/
/
/
/min
MODULE B
Chest X-ray: Date:
12
/
01
MODULE B
/
Right Lung
2007
Left Lung
2
0 - Normal
7 - Fibrosis
1 - Cavitary
8 - Fibrothorax
2 - Infiltrate
9 - Bullae
3 - Nodule
4 - Miliary TB
11 - Pneumothorax
5 - Intrathoracic
lymphadenopathy
12 - Bronchiectasis
6 - Endobronchial
spread
14 - Consolidation
13 - Atelectasis
15 - Mass
VI. Assessment:
TB suspect
New
Retreatment
Category I Failure
Category II Failure
Category I Relapse
Category II Relapse
Category IV Relapse
Other
factors.
None
Non-DOTS
Other (+)
Other (-)
VII. Plan:
2
For smear x
2
For TB culture x
Others
Present to consilium
Attending MD:
Dave Verzosa, MD
Date:
12/05/2007
49
Case 5:
(PMDT)
MODULE B
Screened at:
MMC/TDF
KASAKA
LCP
Others, specify
Date:
12/06/2007
(mm/dd/yy)
I. Demographics
Sarmiento
Name:
Susana
Sandok
Surname
Given Name
Middle Name
Sex:
Male
Female
Nationality:
Date of birth:
Age:
(mm/dd/yy)
Filipino
Permanent address:
City address:
June 18, 1989
Religion:
Catholic
18
Married
Widowed
Living together
1598 Interior 86 P. Quirino Avenue, Pandacan, Manila
zip code 1011
Tel. no.: 599-00001
zip code 1011
E-mail address:
Occupation:
Office address:
none
none
Spouse: none
Father: Sergio
Parent’s address:
Manila
Place of birth:
area code+ tel #
Tel. no.:
20
Employer:
Tel. no.:
599-00001
area code+ tel #
000 Php
area code+ tel #
Address/ Contact #:
Sarmiento
Marie Sarmiento
Mother:
Tel. no.:
Person to notify in case of emergency: Marie Sarmiento
Address: 1598 Interior 86 P. Quirino Avenue, Pandacan,
Manila
Relationship:
Tel. No.:
599-00001
area code+ tel #
mother
599-00001
area code+ tel #
Referred by:
HC
Govt Inst
PPMD
FBO
NGO
Pvt MD/Institution
Quirino
Health
Center
Specify name,
Address of referring facility: Quirino Avenue, Pandacan, Manila
7
fever and weight loss
Chief Complaint/s:
Cough
Fever
Back/ chest pain
Hemoptysis
Weight loss
Night sweats
Other symptoms:
Dyspnea at rest
Dyspnea on exertion
Pedal edema
50
Duration in month/s
2 wks
1
Comments
worsens in the afternoon
approx. 10 kg
3
MODULE B
Outcome
Start date
( mm/dd/yyyy )
( mos.)
DOTS
(Y/N)
No previous TB treatment
1.
2.
3.
4.
5.
6.
7.
No
Co- morbidities
Treatment facility
If Yes
Non MDR
Duration
Diabetes Mellitus
Cancer
HIVinfection/AIDS
Kidney disease
Lung disease
Epilepsy
Others
Allergy:
MDR
1
Drugs:
5=unknown)
year (s)
year (s)
year (s)
year (s)
year (s)
year (s)
year (s)
year (s)
Status currently being treated for HIV at a treatment hub
Type of reaction:
1.
2.
Previous surgery:
Date of surgery:
Complications:
None
/
Others, specify
/
IV. Social History:
Tobacco/ Cigarettes
Current
Past
Never
Sticks/day x yrs
Women: LMP
Alcohol
Current
Past
Never
11
30 / 2007
/
(mm/dd/yy)
G
sexually inactive for a year
Sexual History:
0
No
Drug Abuse
Current
Past
Never
shabu
P
0
yes, specify
51
Vital Signs:
Height: 157
Temp: 37.8
BP: 130/80
System examination:
General Health:
Skin:
BCG scar:
Oropharynx:
Cardiovascular:
Thorax & Lungs:
Abdomen:
Genito-Urinary:
Extremities:
Neurological:
Lymph Nodes:
Endocrine:
Weight: 42 Kg.
PR/ HR: 100 / min
cm
Celsius
mmHg
0 = Not done
1 = Normal
2 = Abnormal
2
2
0
0
1
26
RR at rest:
%
cachectic, in distress, generally weak
(+) skin pallor
(+) BCG scar
1
0
1
0
2
0
CBC
FBS, etc.
52
Date
/
/
/
/
/
/
/min
MODULE B
Chest X-ray: Date:
10
/
08
MODULE B
/
Right Lung
2007
Left Lung
0
0
0
0
0
0 - Normal
7 - Fibrosis
1 - Cavitary
8 - Fibrothorax
2 - Infiltrate
9 - Bullae
3 - Nodule
4 - Miliary TB
11 - Pneumothorax
5 - Intrathoracic
lymphadenopathy
12 - Bronchiectasis
6 - Endobronchial
spread
14 - Consolidation
13 - Atelectasis
15 - Mass
VI. Assessment:
TB suspect
New
Retreatment
Category I Failure
Category II Failure
Category I Relapse
Category II Relapse
Category IV Relapse
Other
factors.
None
Non-DOTS
Other (+)
Other (-)
VII. Plan:
2
For smear x
2
For TB culture x
Start TB treatment, specify regimen: Start Catergory I while awaiting culture and DST results
Others
Continue HIV treatment.
Attending MD:
Dave Verzosa, MD
Date:
12/06/2007
53
Case 6:
(PMDT)
MODULE B
Screened at:
MMC/TDF
KASAKA
LCP
Others, specify
Date:
12/07/2007
(mm/dd/yy)
I. Demographics
Robles
Name:
Surname
Sex:
Male
Female
Nationality:
Date of birth:
Remo
Middle Name
March 28, 1977
Age: 30
(mm/dd/yy)
Filipino
Permanent address:
Rodolfo
Given Name
Religion:
Catholic
Place of birth:
Manila
Married
Widowed
Living together
1919 Mekeni St., Barangay Mahayahay, Apalit, Pampanga
zip code 2016
Tel. no.: none
area code+ tel #
City address:
276281 Poblacion, San Vicente St., Bayanan, Muntinlupa City
zip code 1772
Tel. no.: 123-4567
E-mail address:
Occupation:
Office address:
area code+ tel #
none
laborer
Spouse: none
Father: Pablo Robles
Parent’s address:
20 000 Php
Employer:
Tel. no.:
area code+ tel #
Address/ Contact #:
Rita Robles (deceased)
Mother:
Tel. no.:
(deceased)
Person to notify in case of emergency: Romeo Robles
Address: 1598 Exterior 86 P. Quirino Avenue, Pandacan,
area code+ tel #
Manila
Relationship:
Tel. No.:
brother
599-10001
area code+ tel #
Referred by:
HC
Govt Inst
PPMD
FBO
NGO
Pvt MD/Institution
Specify name, Poblacion Health Center
Address of referring facility: Sn. Vicente St., Putatan, Muntinlupa City
0
persistently
symptomatic
Chief Complaint/s:
Cough
Fever
Back/ chest pain
Hemoptysis
Weight loss
Night sweats
Other symptoms:
Dyspnea at rest
Dyspnea on exertion
Pedal edema
54
Duration in month/s
3
0
Comments
productive, minimal in amt., whitish color
3
both in the upper lung area
1
approx. 10 kg
MODULE B
Outcome
1.
2.
3.
4.
5.
6.
7.
Start date
( mm/dd/yyyy )
( mos.)
06/01/06
09/03/07
No
Co- morbidities
If Yes
Allergy:
Poblacion Health Center
Poblacion Health Center
MDR
1
ongoing
year (s)
year (s)
year (s)
year (s)
year (s)
year (s)
year (s)
year (s)
Drugs:
Y
Y
5=unknown)
Non MDR
Duration
Diabetes Mellitus
Cancer
HIVinfection/AIDS
Kidney disease
Lung disease
Epilepsy
Others
DOTS
(Y/N)
2 HRZE / 4 HR
2 HRZES / 1 HRZE
Treatment facility
Status
Type of reaction:
1.
2.
Previous surgery:
Date of surgery:
Complications:
None
/
Others, specify
/
IV. Social History:
Tobacco/ Cigarettes
Current
Past
Never
Sticks/day x yrs
Women: LMP
Alcohol
Current
Past
Never
/
/
(mm/dd/yy)
G
Sexual History:
sexually inactive
Drug Abuse
Current
Past
Never
P
No
yes, specify
55
Vital Signs:
Height: 160
Temp: 37.4
BP: 130/80
System examination:
General Health:
Skin:
BCG scar:
Oropharynx:
Cardiovascular:
Thorax & Lungs:
Abdomen:
Genito-Urinary:
Extremities:
Neurological:
Lymph Nodes:
Endocrine:
Weight: 45 Kg.
PR/ HR: 93 / min
cm
Celsius
mmHg
0 = Not done
1 = Normal
2 = Abnormal
2
2
0
0
2
23
RR at rest:
cachectic, in distress
(+) skin pallor
(–) BCG scar
(+) crackles heard over both upper lung ¿elds
1
0
1
0
2
0
DSSM 2+
CBC
FBS, etc.
56
/min
%
Date
12 /
03 / 2007
/
/
/
/
MODULE B
Chest X-ray: Date:
/
MODULE B
/
Right Lung
Left Lung
0 - Normal
7 - Fibrosis
1 - Cavitary
8 - Fibrothorax
2 - Infiltrate
9 - Bullae
3 - Nodule
4 - Miliary TB
11 - Pneumothorax
5 - Intrathoracic
lymphadenopathy
12 - Bronchiectasis
6 - Endobronchial
spread
14 - Consolidation
13 - Atelectasis
15 - Mass
VI. Assessment:
TB suspect
New
Retreatment
factors.
Category I Failure
Category II Failure
Category I Relapse
Category II Relapse
Category IV Relapse
Other
None
Non-DOTS
Other (+)
Other (-)
VII. Plan:
2
For smear x
2
For TB culture x
Others
Stop current treatment and await DST.
Attending MD:
Dave Verzosa, MD
Date:
12/07/2007
57
MODULE B
2.4 Make a referral to the Consilium if necessary and enter the patient in the Category IV Register
The diagnosis of MDR-TB through laboratory tests takes a number of months. In general, patients wait for confirmation
of the diagnosis of MDR before they are prepared for the start of treatment. However, there are occasions that the
MDR-TB suspect may be critically ill at the time of first consultation. The physician having interviewed the patient
and made a physical examination must be able to assess the patient’s general condition. Some patients may need to
be started on treatment urgently before the DST results are available or they will be at risk of dying. These patients
should be recognized by the physician, and these cases should be presented immediately to the Consilium.
The Consilium must approve for start of treatment all patients who require MDR-TB treatment. These are patients
who have either been confirmed MDR-TB by DST, or are clinically suspected MDR-TB needing urgent treatment even
prior to DST results.
DST results together with other factors in the patient’s history allow the design of treatment regimens that are
tailored to the specific resistance pattern of the patient to increase the likelihood of treatment success. To present
cases to the consilium, the Treatment Center physician must fill out the Consiliumex for every patient. He will then
present these cases in a Consilium meeting. An example of the Consiliumex and a discussion of the necessary steps
to present a case to the Consilium can be found in section 6 of this module. See the Reference Booklet for instructions
on how to fill out the Consiliumex.
The following criteria must be met among MDR-TB suspects screened to qualify for urgent treatment without the
benefit of DST results:
1.
2.
3.
The patient must first be sputum smear-positive (at least two) and/or culture-positive (at least once) if
pulmonary, but not necessarily for children and for extra-pulmonary TB (EPTB).
The patient must be suspected to be MDR-TB based on history and risk factors.
The patient must have any ONE of the criteria for Category IV treatment listed in Table 4 below.
TABLE 4: Criteria for initiation of Category IV treatment without DST results
Criteria
Condition
1.
Acute respiratory failure and on mechanical ventilation
2.
Clinical signs and symptoms without
any other condition as likely cause,
with the following vital signs (any
one).
a.
b.
c.
Hypotension
RR > 28/min or 02 < 90% at room air
PR > 100/min with RR > 28/min or 02 sat <90% at room
air
With or without significant weight loss
58
MODULE B
4.
Massive hemoptysis due to TB
a.
b.
c.
> 600 cc/24 hours
> 300 cc/episode
Any amount w/ signs and symptoms of hemodynamic
compromise: hypotension, and/or anemia
4.
Progression of chest x-ray findings
(new lesions)
a.
b.
c.
d.
Infiltrates
Cavities
Pneumothorax
Pleural effusion, etc.
PLUS any one of the above clinical signs and symptoms (no. 2
above)
5.
Significant co-morbidity such as any
immunosuppressed state
a.
b.
c.
d.
HIV-positive
Cancer
Post-organ transplant
On any immunosuppressive agent
5.
EPTB that is life-threatening with or
without bacteriologic evidence
Intracranial lesions including abscess, meningitis, POTT’s
disease, etc.
6.
Children with any one of the ff three:
a) positive tuberculin skin test (equal or more than 10 mm) OR
b) positive family contact OR
c) a chest x-ray finding consistent with TB
PLUS three of the five of the following symptoms of TB in children:
a) chronic cough or wheeze for > 2 weeks
b) unexplained fever > 2 weeks
c) weight loss/ failure to gain weight/loss of appetite
d) failure to respond to 2 weeks appropriate antibiotic for lower respiratory infection
e) failure to regain previous state of health 2 weeks after a viral infection or exanthem, e.g., measles.
For pulmonary TB, the decision for empiric Category IV treatment must require at least sputum smear-and/or culturepositive results. However, this is not required for children and for patients with EPTB who are MDR-TB suspects.
All patients with a Consilium decision for expedited treatment must be started at once on Category IV regimen.
Once started on treatment, he must be entered into the Category IV Register.
59
MODULE B
3. Discuss the Paunawa or Terms of Understanding with
the patient
The MDR-TB suspect will most likely not understand what MDR-TB is and what the process is for diagnosis and
treatment. Because of the complex nature of the diagnosis of MDR-TB, we need to explain to the patient the lengthy
diagnostic steps which he will undergo and the prospect of treatment. After the patient is informed about MDR-TB
and the next steps in the diagnostic workup, he will be asked to sign the Paunawa or Terms of Understanding to
indicate that he has been informed of the steps in the diagnosis and possible treatment, and is agreeable to receive
treatment
3.1 Provide patient education on MDR-TB and the diagnostic process
Inform the MDR-TB suspect clearly and in a sensitive way about the possibility of having MDR-TB. This may be the
first time you will discuss MDR-TB with the patient and the MDR-TB suspect may be quite scared or nervous about
what he has. All communication must be kind, supportive and medically correct. You should provide information
on:
t
t
t
t
t
Steps in the diagnosis of MDR-TB; diagnostic tests to be done (DSSM, culture, DST)
Possibility of stopping present TB treatment to prevent amplification of resistance
Timelines for receiving test results: Patient must call for results after the expected timeline for the release of
results:
t DSSM: 4-5 days after specimen collection
t Culture: 3-3.5 months after specimen collection
t DST: 4-5 months after specimen collection
Contact numbers of the MDR-TB Treatment Center where screening was done; other contact numbers which
patients can call
Ways to prevent transmission of TB to household contacts
The Paunawa or Terms of Understanding should be read to the patient and explained in a way that the patient can
understand. The Paunawa or Terms of Understanding form can be found in the Reference Booklet. For more information
about how to speak with a patient at this stage, see Module D: Inform Patients about MDR-TB.
3.2 Obtain patient’s signature in Paunawa or Terms of Understanding
Once the MDR-TB suspect has been informed about MDR-TB and the diagnostic process, the patient’s signature must
be obtained to signify that he understands and is in agreement with the diagnostic procedures and the possible
long and complicated treatment for MDR-TB.
Patients may not want to sign or may be wary about doing so. You should explain to him the significance of his
signature. If he signs, this means that:
t he is in agreement to undergo the sputum test and that he pledges to adhere to the requirements of
diagnosis.
t he understands that since the treatment for MDR-TB is complex, accurate diagnosis is crucial.
t he is aware of the prospect of MDR-TB treatment and that cure requires strict adherence to treatment.
Reassure the MDR-TB suspect that the signature is required to ensure that both the health worker and the patient
are together committed to the best possible outcome and this information is meant to make him aware of the rather
complicated process and prevent any misunderstanding.
60
MODULE B
4. Collect sputum for smear, culture and DST
Upon screening, every MDR-TB suspect should submit two sputum specimens at the Treatment Center for DSSM
and culture to be done at the assigned Culture Center and for DST to be done at the DST Center. Just like the zoning
for Treatment Centers in Table 1, there is also Culture Center assignment per Treatment Center and DST Center
assignment per Culture Center (see Table 5). While sputum collection will be done at the Treatment Center and
culture at a Culture Center, DST will be done at a DST Center.
TABLE 5: Designated Culture and DST centers for each Treatment Center
Treatment Center
Culture Center
DST Center
TDF-MMC DOTS Clinic
TDF TB Laboratory
TDF TB Laboratory
NTRL if patient is coming from
Muntinlupa, Las Pinas, Paranaque
and Pasay
NTRL if coming from Muntinlupa,
Las Pinas, Paranaque and Pasay
KASAKA-QI MDR-TB Housing
Facility
PTSI Laboratory
NTRL
LCP Laboratory
DJNRMH DOTS Center
LCP Laboratory
PTSI Laboratory
Treatment Center – MM South (to
be identified)
NTRL
TDF TB Laboratory
NTRL: National TB Reference Laboratory
TDF: Tropical Disease Foundation
NTRL
NTRL
LCP: Lung Center of the Philippines
PTSI: Philippine Tuberculosis Society, Inc.
The diagnosis of MDR-TB is crucial and must be accurate since treatment required is very long with expensive drugs
that have many side effects. Hence, even if an MDR-TB suspect has culture and DST results from other referral sites,
he must submit 2 more sputum samples at the MDR-TB Treatment Center for DST confirmation by a laboratory
with quality assurance from a supranational laboratory. At present, these laboratories include the Tropical Disease
Foundation (TDF) TB Laboratory, and the National TB Reference Laboratory (NTRL). The Cebu Regional Reference
Laboratory (CRRL) will also be undergoing DST proficiency testing as well as other laboratories in the Philippines and
will become future DST Centers for PMDT.
4.1 Enlist the MDR-TB suspect’s cooperation
Explain the reason for sputum examination and enlist the MDR-TB suspect’s cooperation. Explain that sputum smear
and culture are essential for detecting MDR-TB and are the first two steps needed in order to run a DST.
4.2 Fill out the Mycobacteriology Request Form
All MDR-TB suspects should have a culture and DST done in addition to smear. The Mycobacteriology Request Form is
used to request for sputum laboratory tests for detecting MDR-TB. One Mycobacteriology Request Form can be used
to request for all three tests of one patient. Specimens other than sputum obtained from other parts of the body
with suspected TB may also be sent for smear, culture and DST using this form.
Write the Screening code in the Mycobacteriology Request Form. The Category IV Registration No. is not yet applicable
at the time of screening since this number is assigned only once treatment is started. Complete the demographics.
No need to write the complete address, just indicate the city/province. Tick the Culture Center to do the DSSM
and culture, and the DST Center to do the DST; tick what kind of specimen is being sent, the examination being
requested for and the number of specimens being sent for each procedure. For screening, it is recommended that
61
MODULE B
specimens are sent to the Culture Center on the day of collection; hence, write DSSM X 1 and culture X 1 for this first
collection and fill out another request form for the second collection.
For the example below who was referred as a Category II failure, DSSM, TB culture and DST are ticked with the
number of specimens needed for DSSM and culture. Under “Schedule”, Screening refers to the first time the patient
is being seen as a TB suspect. Baseline refers to the time when a patient is about to be started on Category IV
treatment or has just been started on treatment (30 days before treatment and 7 days after start of treatment).
Follow-up refers to the sputum examination requested after Category IV treatment has started beyond 7 days.
Post-treatment refers to the period after a final outcome of cured or completed has been declared. Fill out
the date the sputum was collected not the date when the sputum was sent. Indicate whether the specimen
was collected as a spot specimen collected at the Treatment Center or at the patient’s home or elsewhere.
(PMDT)
The receiving laboratory will fill out the portion on Laboratory No., Volume and Consistency.
MYCOBACTERIOLOGY REQUEST FORM
Screening Code: 02-05-04-0081
4/28/05
Date requested:
Category IV Registration No.:
(if enrolled)
Name: Balagtas, Jose A.
Age/Sex: 50/M
Requesting physician: Chi-Orillaza, Ruth M.D.
Address: Tondo, Manila
(City/ Province)
DST center:
Culture center:
TDFI
LCP
PTSI
CTRL (Cebu)
NTRL
TDFI
Specimen:
Sputum
NTRL
Extrapulmonary
specimen,
specify:
CTRL
Requested procedure:
2
DSSM x
TB culture x 2
DST
Contact tracing patient?
Yes
No
Others
Schedule:
Screening
Enrolled:
Yes
Baseline
Follow-up: month of tx:
No
Months post-treatment:
New
Category:
Retreatment
1st specimen
2nd specimen
3rd specimen
Type of collection
(Please encircle)
Spot
Spot
Spot
Laboratory No.
02-P-058283-1
02-P-058283-2
Salivary
Muco-purulent
Date of collection
Home
Home
To be filled in by the laboratory
Volume
Consistency
62
10ml
8ml
Home
MODULE B
4.3 Collect sputum samples from the MDR-TB suspect
Follow the guidelines for sputum collection as would happen with any TB patient. Refer to Annex A: Proper collection
of specimen for the diagnosis of TB. Two sputum samples should be collected during a two-day period.
t
Sample one is collected “on the spot.” Give instructions to the patient. Explain why the sputum is needed
and show the MDR-TB suspect how to cough up sputum and handle the labeled container. The MDR-TB
suspect goes outdoors or to a well-ventilated place or to a sputum collection booth, if available, to collect
the sample. Observe and guide the MDR-TB suspect during sample collection. Instruct the patient to collect
5-10 ml of sputum. After the MDR-TB suspect gives the sample to you, give him another labeled container
to take home and use the next morning, while you tightly close the lid of the first container.
t
For labeling, use color-coded stickers:
0 A blue label indicating that the sample is for smear, culture and DST should show the
name of the Treatment Center, the patient’s name, and date of collection. This is attached
to the body of the cup, and not on the lid.
0 A green label means the request is for smear and culture only.
0 A white label means the request is only for smear, e.g., in some months of the follow-up
period.
PMDT
Tx center: __________________
MMC
Lab No.: ___________________
Name: ____________________
Jose Balagtas
Date collected: _____________
May 5, 2008
t
Sample two is collected at home by the MDR-TB suspect upon waking up the next morning. The patient
brings this second sample to you at the Treatment Center right after collection.
Remember:
t
t
t
t
t
Attach the label on the container (not the lid) before collecting the sputum samples.
Collect sputum in a well-ventilated area, preferably outdoors or in a sputum collection
booth.
Check whether the sample contains sufficient sputum (5-10ml), not saliva. If not, ask the
MDR-TB suspect to add more.
After collecting the sputum, be sure that the lid is closed tightly.
Wash your hands thoroughly with soap and water.
Remind the MDR-TB suspect when to return for the results and inform him that the specimen regardless of the
DSSM results, will be cultured.
4.3.1 Alternative methods of sputum collection
There may be MDR-TB suspects who are unable to produce sputum for examination. Examples of these are children,
patients with minimal cough, the HIV-positive patients, etc. In these cases alternative measures to collect sputum
should be used. Although it is beyond the scope of this document to describe in detail each process, a general
description of some alternate sputum collection methods are described on the next page. See also Annex B:
Procedures for Obtaining Sputum Specimens in Children.
63
MODULE B
Sputum induction: is a simple procedure for obtaining a sputum sample through deep 15-minute inhalation of a
salt solution or hypertonic saline (3% NaCl) with the help of a nebulizer to induce a deep cough, which allows the
coughing up of lung secretions. These samples are usually diluted or watery and should be labeled as “induced” so
they will not be mistaken for saliva at the laboratory.
Induction can be used for patients who cannot expectorate effectively or provide a quality sample, particularly
those who are asymptomatic but have evidence of TB disease such as an abnormal chest x-ray, e.g., in children, or
persons with HIV/AIDS. Patients should have fasted for 3-4 hours prior to the procedure to prevent vomiting and
aspiration. Induction should be carried out in a well-ventilated place and all personnel in the room should use an
N95 mask to avoid infection.
Gastric aspiration is performed by inserting a tube through the patient’s nose and introducing it into the stomach.
The idea is to obtain a sputum sample that has been coughed up and then swallowed. The procedure is usually
performed first thing in the morning as the patient tends to swallow sputum during the night. Generally, it is
performed only when a sample cannot be obtained through expectoration or induction. Most often, it is used to
obtain samples from children. It is recommended that children should not have had food intake in the past 2-3
hours. For logistic reasons gastric aspiration is usually carried out in a hospital setting or in a procedure room that
has the necessary materials.
Bronchial aspiration with fiberoptic bronchoscopy is done for the collection of bronchial secretions by
aspiration, through the fiberoptic bronchoscope (which is an instrument used for this procedure) performed by a
bronchoscopist. These samples are usually diluted or watery and should be labeled as “bronchoscopy specimens” so
they will not be rejected at the laboratory. Bronchoscopy should be carried out in a procedure room with infection
control measures. This is usually the last resort when sputum is very difficult to collect.
4.4 Pack the sputum samples and send to the laboratory
Once the sample is collected, it must be packed and sent to the laboratory immediately. Refer to Annex C: Proper
labeling, sealing and transportation of specimens. A smooth packaging and delivery process is vital to ensure that
the specimens are processed correctly and in a timely manner. Keep the samples in a refrigerator or in an icebox
with refrigerants. If the specimens become too warm, the sputum can degrade and the TB bacteria may not survive,
become overgrown by other bacteria in the sputum, thereby diminishing the chances of recovering the bacilli.
From the refrigerator, transfer the sputum containers into a transport box. The Treatment Center will list all the
samples for dispatch to a Culture Center on a Laboratory Receiving Form for Specimens. The sputum samples will
go together with the individual Mycobacteriology Request Forms for each patient and the Laboratory Receiving Form
for Specimens. The latter form should be signed by the messenger or person picking up the transport box. Send
the samples to the Culture Center as soon as possible. The delivery process must ensure that the specimens reach
the Culture Center within 24 hours of collection. If the samples will not be picked up by the messenger on the
same day, keep the samples refrigerated or in the transport box with refrigerants. Make sure the refrigerants are
replaced periodically to keep the specimens cool at all times. A sample of a Laboratory Receiving Form is shown in
the following pages.
4.4.1 Prepare the Laboratory Receiving Form for Specimens
The Treatment Center prepares the Laboratory Receiving Form for Specimens. Tick the box for “Treatment Center”
where the specimens are coming from and write the name of your center. Then tick the box for the Culture Center
where the specimens are being sent to and write the name of the Culture Center. Table 5 on page 61 of this Module
shows the designated Culture Center for each Treatment Center. Fill out column 1 of the table with a consecutive
number from 1-25. Should you require more sheets, use another Laboratory Receiving Form and adjust the numbers
from 26 onwards. For screening patients, leave blank the columns on “Category IV Registration No.” and the
“Laboratory No.” The “Category IV Registration No.” is applicable only to patients who are started on Category IV
treatment, while the “Laboratory No.” is applicable only for culture isolates that are being sent from the Culture
laboratory to a DST Center. Write the patient’s name, the sputum specimen # over total # required specimens and/
or isolates being transported for each patient, the date of collection of the first specimen (if 2/2) and the requested
64
MODULE B
procedures (for screening patients: DSSM, culture and DST). At the bottom, the one preparing the form signs on the
space for “Endorsed by” with the date and the one picking up the box signs on the space provided for “Received by”
with the date. See the Reference Booklet for more instructions on how to fill out this form.
Later when the culture turns out positive for TB at the Culture Center, the isolate is sent to the DST Center. The
Culture Center fills out the Laboratory Receiving Form, also keeps blank the Category IV Registration No. but writes
the Laboratory No. assigned which is TC-C-YY-NNNN-nth specimen.
TABLE 6. Laboratory No. (TC-C-YY-NNNN-Nth specimen)
Code
Description
TC
Treatment Center (see Table 2)
C
Culture Center
T for TDF TB Laboratory
N for NTRL
L for LCP Laboratory
P for PTSI Laboratory
YY
The year the patient was screened
NNNN
The consecutive specimen accrual that begins with 0001 at the start of every year
Nth specimen
Whether the specimen is the 1st or the 2nd specimen
For example, the Laboratory No. 02-P-050021-2 means that the Treatment Center origin of the specimen is the
KASAKA-QI MDR-TB Housing Facility, and was sent for smear and culture to PTSI Laboratory in 2005; was the 21st
specimen received by the laboratory for the year, and was the second isolate for the patient.
Before sending the transport box to the laboratory, the Treatment Center must check the following:
–
–
–
The number of sputum specimens listed in the Laboratory Receiving Form for Specimens are consistent with
the actual number of specimen cups in the transport box.
The names of patients listed on the Laboratory Receiving Form are consistent with the ones written on the
labels on the sputum cups in the transport box.
Individual Mycobacteriology Request Forms are enclosed for each of the specimens being sent.
Once the above are done, close and seal the transport box carefully. Then, put the Laboratory Receiving Form
for Specimens in an envelope together with the individual Mycobacteriology Request Forms and attach the
envelope to the top cover of the transport box or hand it directly to the receiving person.
At the Culture Center, the laboratory staff receiving the transport box will check the contents of the box against
the Laboratory Receiving Form for Specimens and sign the form and keep a file copy at the Culture Center. If all
specimens and requests in the list are accounted for, he will affix his initials on the form and date and keep a file
copy at the Culture Center. If there is a discrepancy, he will call the Treatment Center for verification, document on
the Form whatever discussion or agreement was made before filing this form at the Culture Center. The same is done
at the DST Center when receiving culture isolates from the Culture Center.
A delivery schedule will be arranged with the laboratory receiving the sample to make sure that the samples can be
quickly transported and processed once they are received. On the following page is an example of the Laboratory
Receiving Form for Specimens.
65
(PMDT)
Laboratory Receiving Form for specimens
Laboratory Receiving Form For Specimens
From:
KASAKA-QI Treatment Center (TC)
To:
NTRL
Culture Center (CC)
Culture Center (CC)
Sputum
Isolates
Name
No. of
specimens
/ isolates
Date
collected
(mm/dd/yy)
Remarks/
Request
1
Balagtas, Jose
2/2
4/28/05
DSSM, TBC, DST
2
Salcedo, Myrna
½
4/28/05
DSSM, TBC
3
Tan, Vincent
½
4
Santos, Sylvia
1/1
5
Roces, Maria
2/2
6
Benito, Gerald
½
7
Cortez, Juan
1/1
4/28/05
DSSM
8
Uy, Susan
1/1
4/28/05
DSSM
9
Mendoza, Tina
2/2
4/28/05
DSSM, TBC, DST
No.
Category IV
Registration
No.
DST Center
Laboratory no.*
(Applicable to ISOLATES
only c/o Culture Center
If two4/28/05
specimens are
4/28/05
being submitted
together,
write
4/28/05
the date of
collection
of the
4/28/05
FIRST specimen.
DSSM, TBC, DST
DSSM, TBC
DSSM, TBC, DST
TBC
10
11
12
13
14
15
16
17
18
19
20
21
22
Not applicable
for screening
cases.
Applicable
only for
enrolled cases
with followup specimens
being sent.
Not applicable
to Treatment
Centers.
Applicable
only to Culture
Centers
submitting
isolates to DST
Centers.
Make sure this list
is consistent with
the names on
the sputum cup
labels submitted
to the Culture
Center.
Verify this
information
against the
Mycobacteriology Request
Form.
23
24
25
* Laboratory no. : TC-C-YY, NNNN - Nth specimen
66
Mar Rocha (TDF messenger)
Endorsed by: ___________________________
4/29/05
Date: _________________________
Francia GOnzales (PTSI)
Received by: ____________________________
4/29/05
Date: _________________________
MODULE B
For Treatment Site Staff
Group Discussion
When you have reached this point in the module, your group will briefly discuss
the designated Culture and DST Center for each Treatment Center where you will
refer MDR-TB suspects. Use the table on page 61. After the discussion, continue
reading on page 72.
For Treatment Center Staff
– Written Exercise
When you have reached this point in the module, you are ready to do Exercise D.
Turn to the next page and follow the instructions for Exercise D. Do this exercise
by yourself. Then discuss your answers with a facilitator.
Exercise D: Written exercise
Filling out a Mycobacteriology Request Form
The purpose of this exercise is to practice completing the Mycobacteriology Request Form for patients that have been
identified as MDR-TB suspects.
The following four cases (Cases 1, 2, 3, 5) were the cases you identified as suspects in the previous exercise. Use
the data provided in the MDR-TB Screening Forms which have been previously given to you. Completing the
Mycobacteriology Request Form is important to ensure that the proper examinations are requested and DR-TB is
appropriately detected.
Work on this exercise individually.
1.
For each of the following patients, fill out the Mycobacteriology Request Form.
2.
Please refer to page 61 for the designated Culture and DST center for the different Treatment Centers.
Assumptions:
t All first specimens were collected spot at the Treatment Center while the second specimen was collected
at the patient’s home.
t All first samples of the patients were collected on the day of screening and the second samples on the
following day except for Case #2 who first came on a Saturday and came back for his second sample on the
following Monday.
t The date the MDR-TB Suspect’s Referral Form from the DOTS facility was filled out is the date of screening at
the Treatment Center.
67
MODULE B
Case 1
(PMDT)
Patient Information: Patient is Sonia Santos Sariwa.
Today is November 29, 2007.
Screening Code:
Date requested:
(if enrolled)
Age/Sex:
Name:
Requesting physician:
Address:
(City/ Province)
DST center:
Culture center:
TDFI
LCP
PTSI
CTRL (Cebu)
NTRL
Specimen:
TDFI
NTRL
CTRL
Sputum
Extrapulmonary
specimen,
specify:
DSSM x
TB culture x
DST
Yes
No
Others
Schedule:
Enrolled:
Screening
Yes
Baseline
No
Category:
New
Retreatment
1st specimen
2nd specimen
3rd specimen
Spot
Spot
Spot
Date of collection
Type of collection
(Please encircle)
Home
Home
Laboratory No.
Volume
Consistency
68
Home
MODULE B
Case 2
(PMDT)
Patient is Rolanda Ramirez Reloz.
Today is December 3, 2007(Monday)
Screening Code:
Date requested:
(if enrolled)
Age/Sex:
Name:
Address:
(City/ Province)
DST center:
Culture center:
TDFI
LCP
PTSI
CTRL (Cebu)
NTRL
Specimen:
TDFI
NTRL
CTRL
Sputum
Extrapulmonary
specimen,
specify:
DSSM x
TB culture x
DST
Yes
No
Others
Schedule:
Enrolled:
Screening
Yes
Baseline
No
Category:
New
Retreatment
1st specimen
2nd specimen
3rd specimen
Spot
Spot
Spot
Date of collection
Type of collection
(Please encircle)
Home
Home
Home
Laboratory No.
Volume
Consistency
69
MODULE B
Case 3
(PMDT)
Patient is Santiago Suma Santos.
Screening Code:
Date requested:
(if enrolled)
Age/Sex:
Name:
Address:
(City/ Province)
DST center:
Culture center:
TDFI
LCP
PTSI
CTRL (Cebu)
NTRL
Specimen:
TDFI
NTRL
CTRL
Sputum
Extrapulmonary
specimen,
specify:
DSSM x
TB culture x
DST
Yes
No
Others
Schedule:
Enrolled:
Screening
Yes
Baseline
No
Category:
New
Retreatment
1st specimen
2nd specimen
3rd specimen
Spot
Spot
Spot
Date of collection
Type of collection
(Please encircle)
Home
Home
Laboratory No.
Volume
Consistency
70
Home
MODULE B
Case 5
(PMDT)
Patient is Susana Sandok Sarmiento
Screening Code:
Date requested:
(if enrolled)
Age/Sex:
Name:
Address:
(City/ Province)
DST center:
Culture center:
TDFI
LCP
PTSI
CTRL (Cebu)
NTRL
Specimen:
TDFI
NTRL
CTRL
Sputum
Extrapulmonary
specimen,
specify:
DSSM x
TB culture x
DST
Yes
No
Others
Schedule:
Enrolled:
Screening
Yes
Baseline
No
Category:
New
Retreatment
1st specimen
2nd specimen
3rd specimen
Spot
Spot
Spot
Date of collection
Type of collection
(Please encircle)
Home
Home
Home
Laboratory No.
Volume
Consistency
Then read until the next stop sign.
71
MODULE B
5. Receive and record the smear and culture results in
the TB Symptomatics Masterlist and decide on the
appropriate action
The staff at the Culture Center will record the results of the DSSM and the culture in the PMDT Laboratory Register.
The Culture Center will then individually print out the results of the smear on the appropriate Result Form for DSSM
and Culture as soon as available for each patient and send these back to the Treatment Center together with a
Laboratory Releasing Form for Results. The latter provides a summary list of all the sputum results, whether smear or
culture, being sent back to the Treatment Center. This is done similarly by the DST Center as soon as DST results are
available.
DSSM results are released as they are available and should not wait for culture results. The Culture Center staff
will tick “From” and write the Culture Center’s name. He then ticks “To” and writes the Treatment Center to which
the results are being released. On each row he writes the Laboratory No. (TC-C-YYNNNN-nth) and the name of the
patient, the test that is being released and the date the sputum was collected. The Culture Center staff who prepared
the list signs on the space for “Endorsed by” with the date and the person picking this up will sign on the space
provided for “Received by:” and the date. Upon receipt of the results at the Treatment Center, the staff will check
the individual results against the Laboratory Releasing Form. If there is no discrepancy, the Treatment Center staff
will affix his initials and date on the form and file it. If there is a discrepancy, he will call the Culture Center or the
DST Center and document their agreement on the Laboratory Releasing Form and file it. No DST results are released
to Culture Centers, only to Treatment Centers. Below is a sample of the Laboratory Releasing Form being sent to the
KASAKA-QI MDR-TB Housing Facility.
72
(PMDT)
MODULE B
Laboratory Releasing Form for Results
Laboratory Releasing Form For Results
From:
PTSI
Culture Center (CC)
To:
KASAKA-QI Treatment Center (TC)
DST Center
No.
1
2
3
4
5
6
7
8
9
10
Laboratory no.*
Name
Test requested
Date
collected
mm/dd/yy
02-P-050001-2
Balagtas, Jose
TBC
04/28/05
02-P-050002-1
Tan, Vincent
TBC
04/28/05
02-P-050004-1
Roces, Maria
TBC
02-P-050005-1
Benito, Jamora
TBC
04/28/05
02-P-050007-1
Uy, Susan
DSSM
04/27/05
02-P-050002-1
02-P-050003-1
02-P-050007-1
02-P-050006-1
02-P-050007-2
Salcedo, Myra
TBC
Santos, Sylvia
04/28/05
DSSM
Mendoza, Tina
04/26/05
04/28/05
TBC
Cortez, Juan
04/28/05
DSSM
Mendoza, Tina
Remarks
04/27/05
TBC
04/28/05
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
DSSM
Culture (TBC)
DST
* Laboratory No. : TC-CC-Year, Accession No-1st or 2nd specimen
Francia Gonzales(PTSI)
Endorsed by: ___________________________
07/30/05
Date: _________________________
Mar Rocha (TDF Messenger)
Received by: ____________________________
07/30/05
Date: _________________________
73
MODULE B
5.1 Record the smear results in the TB Symptomatics Masterlist
Upon receipt of results at the Treatment Center, find the suspect’s name in the TB Symptomatics Masterlist (see
example on page 81). Record the results of DSSM for each of the samples in column 16 “Screening (DSSM/culture
results)” and write the date (mm-dd-yy) of sputum collection on the row below this. Note that the Laboratory
Releasing Form will indicate that a combination of DSSM and culture results are being released at the same time
and all results whether DSSM or culture must be recorded on the TB Symptomatics Masterlist promptly as they are
received.
The messenger assigned to transport specimens is also assigned to pick up the results.
To record DSSM results, write “0” if negative and write the grading “1+”, “2+”, or “3+”, if positive.
On the next page is an actual DSSM result of a patient, Maria Morelos, that has been released to the LCP-PHDU DOTS
Center on February 12, 2007 by the LCP Laboratory. Sputum was collected at the Treatment Center on February 7
and 8, 2007. Results show that the first specimen was 2+ and the second was 3+.
74
(PMDT)
Yes
mm/dd/yy
2/12/07
DSSM
No
3+
On-going
2+
On-going
Laboratory Technician
Claire Macugay, RMT
2/8/2007
2/7/2007
Retreatment
01-L-070080-2
03-L-070080-1
New
2nd specimen
Category:
Months post-treatment
1st specimen
TB Culture
Baseline
Date collected
3rd specimen
DST center:
LCP laboratory
Culture center:
Laboratory Supervisor
Lawrence Laqiundanum, RMT
On page 81, column 16 of the TB Symptomatics Masterlist is filled out. It shows 2+ on February 7, 2007 and 3+ for February 8, 2007.
Date Released:
TB culture
DSSM
Date of collection
Lab No.
Screening
EXAMINATION DONE:
Enrolled:
Schedule:
Requesting physician: Raymund, Lawrence M.D.
Age/Sex: 45/F
Sputum
Specimen:
Patient’s name: Morelos, Maria
Treatment center:
Category IV Registration No.
DSSM AND CULTURE RESULT
MODULE B
75
MODULE B
5.2 Decide on the appropriate action in response to the smear results
Even if an MDR-TB suspect’s DSSM results are negative, the Culture Center will automatically process the specimens
to isolate and identify M. tuberculosis. There are many cases of smear-negative but culture-positive cases of TB and
when MDR-TB is suspected, it is critical to confirm the suspicion with a DST.
As culture results are available, the Culture Center will fill out individual results using the DSSM and Culture Result
Form.
t
If any of the sputum specimens is smear-positive, this result means that the MDR-TB suspect has
infectious pulmonary TB. This result does not signify anything about the possibility of drug resistance for
the MDR-TB suspect. The MDR-TB suspect should be informed of the results and reminded to follow up for
the culture results in 3-3.5 months from sputum collection. The MDR-TB suspect should also be educated
on the infection control precautions to take while at home to avoid spreading TB to those around him.
Important messages to give to the patient are described in Module D: Inform Patients about MDR-TB.
t
If all specimens are smear-negative, the Culture Center also automatically processes them for culture. The
MDR-TB suspect can call the Treatment Center for the culture results on or after 3-3.5 months from sputum
collection.
5.3 Record the culture results in the TB Symptomatics Masterlist
Upon receipt of culture results at the Treatment Center, find the suspect’s name in the TB Symptomatics Masterlist
(see example on page 81). Record the results of culture for each of the samples in column 16 “Screening (DSSM/
culture results)”. These entries on culture should already have DSSM results and dates of sputum collection entered
previously when the DSSM results were received.
To record culture results, write “0” if negative and write ‘Mtb’ if positive. If the result is less than 10 colonies, write the
number of colonies as reported in the result form.
The culture result of the patient Maria Morelos, the example used in Section 5.1 is shown below. This was received by
the LCP-PHDU DOTS Center on June 5, 2007 showing both specimens to be positive for M. tuberculosis.
76
(PMDT)
Yes
Date Released:
mm/dd/yy
Claire Macugay, RMT
MTB
MTB
TB culture
06/04/07
3+
2+
Date of collection
Lab No.
DSSM
Retreatment
2/8/2007
2/7/2007
New
03-L-070080-2
TB Culture
Category:
03-L-070080-1
2nd specimen
DSSM
No
Baseline
Date collected
1st specimen
Screening
EXAMINATION DONE:
Enrolled:
Schedule:
Requesting physician: Raymond, Lawrence M.D.
Age/Sex: 45/F
Sputum
Specimen:
Patient’s name: Morelos, Maria
3rd specimen
DST center:
LCP laboratory
Culture center:
Lawrence Laqiundanum, RMT
Treatment center:
MODULE B
77
MODULE B
As soon as this is received at the Treatment Center, write “Mtb” for the February 7 and 8, 2007 specimens after putting
a slash to separate this from the DSSM result. See how this is done on page 81, column 16 of the TB Symptomatics
Masterlist.
5.4 Decide on the appropriate action in response to the culture results
If a patient has at least one positive sputum culture for M. tuberculosis, this means that the MDR-TB suspect has
confirmed pulmonary TB.
t
If the culture is positive (10 or more colonies), the Culture Center will send the culture isolate to the DST
center.
t
If one sputum culture yields a count of < 10 colonies, the second sputum culture must also have a
growth of at least < 10 colonies for the culture to be interpreted as positive. Between these two isolates
with both < 10 colonies each, send the isolate with more colonies or more luxuriant growth to the DST
Center while keeping the other one at the Culture Center.
t
If one sputum culture has <10 colonies and the second culture has negative growth, DST will still be
performed on the isolate with < 10 colonies as this is a diagnostic specimen. This is not done for follow-up
specimens.
t
If both culture results are negative or have no growth, no further test will be done.
t
If culture result is negative and smear result is positive, refer to the consilium for further discussion and
decision on management.
For screening and baseline specimens, the isolates are sent to the DST Center for DST. However, for follow-up
specimens, the isolates are simply kept at the Culture Center unless otherwise requested for DST by the Treatment
Center.
When the patient with a positive culture calls the Treatment Center for the results, he should be informed that the
culture was positive and that the result of the final stage of diagnostic testing will be available in the following
weeks. The patient is advised to make a follow-up call 1-2 months after to find out the results of the DST and asked
to come in for further examination.
The Culture Center will send the isolates to the DST Center along with the other isolates for DST. All isolates are
listed one by one on the Laboratory Receiving Form for Specimens. Tick the “Isolates” box; write down the names of
the patients with positive culture results, indicate the laboratory numbers of the isolates. All isolates will be packed
in a biobottle and prepared according to guidelines on proper packing and transportation of infectious materials.
The person receiving the box signs the form and brings the box to the DST Center. The DST Center staff will carefully
unpack the package in a safety hood and check the isolates against the Laboratory Receiving Form for Specimens. If
there is no discrepancy, he affixes his initials and date on the form and files it. However, if there is a discrepancy, the
DST Center will call the Culture Center and document their agreement on the form. He then files the form at the DST
Center.
78
MODULE B
6. Receive and record the DST results in the TB
Symptomatics Masterlist, Category IV Register and
Consiliumex
DST results received at the Treatment Center must be immediately relayed to the referring Treatment Center
physician. Should there be any delay in the pick up of results, the DST Center must relay the results of confirmed
MDR-TB cases by facsimile or SMS (text message) with the official DST Result Form to follow. Just like the release of
culture results, all DST results are also summarized in the Laboratory Releasing Form for Results by the staff at the
DST Center. This will be signed by the messenger and brought to the Treatment Center. The staff at the receiving
Treatment Center will check the individual results against the Laboratory Releasing Form and contact the DST Center
in case of any discrepancy.
6.1 Record DST results in the TB Symptomatics Masterlist
If the DST result shows that the M. tuberculosis is “resistant” to a certain drug, this means that the TB bacilli grew
despite the presence of the drug in the culture medium. Drug resistance in the DST test signifies that the patient
should not receive that drug as part of the anti-TB regimen because the drug will not have any effect on the strain
of bacilli that the patient has. If the result was “susceptible”, this means that the DST test found that the specific drug
in the culture medium inhibited the growth of the bacilli and that generally, that specific drug can be expected to
help cure the patient of TB when given as part of the TB regimen. The Consilium will make the final decision on the
TB regimens that patients must receive for MDR-TB treatment. (See Module C: Treat MDR-TB Patients)
To record the DST results, find the MDR-TB suspect’s name in the TB Symptomatics Masterlist. If susceptible to a drug,
write “S” and if resistant, write “R”. Record the results for each drug tested under Column 17 “DST Results”.
Since DST is the final step in confirming that a patient is MDR-TB, the date when the Treatment Center received
this information is very important. Hence, upon receipt of DST results, the Treatment Center should mark this date
on the individual DST result form and record this on the TB Symptomatics Masterlist column 18 “Registration date”
sub-column “Date DST released”. This should also be recorded in the Category IV Register column 16 which will be
discussed later.
79
(PMDT)
45/F
Screening
Yes
mm/dd/yy
6
6
Ǖ'
5
Retreatment
Disc Elution / 7H10
New
Michael S. Evangelista
Levofloxacin (Lfx)
6
Pyrazinamide (Z) ______
07/10/07
Ciprofloxacin (Cfx )
6
Ethambutol (E) 5ug/ml
Date Released:
Ofloxacin (Ofx)
5
Rifampicin (R) 5ug/ml
2/7/2008
Date collected
Claudette Guray
Amikacin (Ak)
Other 2nd line drugs:
Kanamycin (Km) 6ug/ml
TDF Laboratory
DST center:
LCP Laboratory
6
6
Culture center:
Specimen:
Sputum
03-L-070080-1
Laboratory ID no.
Treatment center:
METHOD USED:
Category:
Streptomycin (S)
Drug Susceptibility Testing
5
No
Baseline
Isoniazid (H) 0.1ug/ml
EXAMINATION DONE:
Enrolled:
Schedule:
Raymund, Lawrence M.D.
Morelos, Maria
Age/Sex:
Patient’s name:
As soon as the DST result is received, staff at the LCP-PHDU DOTS Center should fill out Column no. 17 “DST Results“ of the TB Symptomatics Masterlist with “S” to mean
“susceptible” and “R” to mean “resistant”.
80
DRUG SUSCEPTIBILITY TEST (DST) RESULT
The DST result of the same patient, Maria Morelos, in Section 5.3 is shown below. This was received by the LCP-PHDU DOTS Center on July 10, 2007 showing that the
patient was resistant to H, R and S and susceptible to Z, E, Km, Am, Cfx and Lfx.
MODULE B
Symptoms
(14)
1,2,3,4,5,6
Risk factors
(13)
4
/
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/
/
/
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/
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02/07/07
/
02/08/07
2+ / MTB
1,2,7
2/2/07
3+ / MTB
/
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/
/
/
/
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/
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Date sputum collected (mm/dd/yy)
Screening (DSSM/ culture results) (16)
/
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/
R
H
R
R
S
Z
S
E
R
S
S
Km
ND
Ofx
DST results (17)
S
Cfx
S
Lfx
S
Other
Other
Am
/
/
/
/
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/
/
7/10/07
/
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/
/
/
7/12/07
Consilium
date
Registration date
(mm/dd/yy)
(18)
Date DST
released
(15)
Date done
CXR results
TB Symptomatics Masterlist
(PMDT)
7/21/07
07-0419
Enrolled? If YES, indicate treatment
start date. If NO, indicate reason.
Pre-enrollment # (19) YY-NNNN
Column 18 “Registration date” refers to the date that confirmed the need for Category IV treatment either by a) the DST result or, b) consilium decision even without the
DST result by virtue of a high clinical suspicion for MDR-TB. For the latter group of patients, write the date when the Consilium decided to start Category IV treatment
under “Consilium date” of the same column, and keep blank the boxes for “DST results” and “Date DST released”. Both groups, when presented to the Consilium, are
generally approved for treatment and all patients belonging to either group will be assigned a Pre-enrollment No. which will be explained in the next few pages.
Below, you will find the completed Columns 16, 17 and 18 of the TB Symptomatics Masterlist for patient, Maria Morelos.
MODULE B
81
MODULE B
For Treatment Site staff, skip Exercie E and continue reading from section 6.2, page 92
until the Summary of important points and tell your facilitator
when you have reached that point.
Exercise E – Written Exercise
Exercise E. Follow the instructions for Exercise E. Do this exercise by
yourself.
Exercise E
Recording Results on the TB Symptomatics Masterlist
In this exercise you will practice recording the results of the laboratory tests in the TB Symptomatics Masterlist for
three patients. Use the information written on actual result forms provided to you. Work individually on this exercise.
If any of the instructions are unclear, ask a facilitator for clarification.
The DSSM, culture and DST results for Cases 1, 2 & 3 who were MDR-TB suspects listed on the TB Symptomatics
Masterlist in Exercise C page 37 are shown in the next pages. The results for the other MDR-TB suspects, Cases 5 & 6
have not yet been released.
Record the results of the sputum examination of the patients on columns 16, 17 and 18 of the TB Symptomatics
Masterlist provided to you in the previous exercise.
82
(PMDT)
34/F
Yes
Date Released:
TB culture
DSSM
Date of collection
Lab No.
DSSM
No
mm/dd/yy
Sputum
ʭʬ
2QJʝʖQɒ
ʭʬ
2QJʝʖQɒ
John Umali, RMT
2nd specimen
Retreatment
7
1st specimen
New
Specimen:
7
Category:
3rd specimen
TDF Laboratory
Culture center:
Claudette Guray, RMT
TDF-MMC DOTS Clinic
Treatment center:
TB Culture
Baseline
12/07/07
Screening
EXAMINATION DONE:
Enrolled:
Schedule:
Requesting physician: Verzosa, Dave, MD
Age/Sex:
Patient’s name: Sariwa, Sonia S.
DSSM result:
MODULE B
83
(PMDT)
84
49/F
Yes
Date Released:
TB culture
DSSM
Date of collection
Lab No.
DSSM
No
mm/dd/yy
2QJʝʖQɒ
2QJʝʖQɒ
John Umali, RMT
ʬ
ʬ
Retreatment
7
7
New
2nd specimen
Category:
1st specimen
TB Culture
Baseline
12/08/07
Screening
EXAMINATION DONE:
Enrolled:
Schedule:
Age/Sex:
Patient’s name: Reloz, Rolando R.
Sputum
Specimen:
3rd specimen
TDF Laboratory
Culture center:
TDF-MMC DOTS Clinic
Treatment center:
DSSM result:
MODULE B
(PMDT)
45/M
Yes
Date Released:
TB culture
DSSM
Date of collection
Lab No.
DSSM
No
mm/dd/yy
Sputum
ʬ
2QJʝʖQɒ
2QJʝʖQɒ
John Umali, RMT
7
ʬ
Retreatment
7
2nd specimen
New
Specimen:
1st specimen
Category:
3rd specimen
TDF Laboratory
Culture center:
TDF-MMC DOTS Clinic
Treatment center:
TB Culture
Baseline
12/10/07
Screening
EXAMINATION DONE:
Enrolled:
Schedule:
Age/Sex:
Patient’s name: Santos, Santiago S.
DSSM result:
MODULE B
85
(PMDT)
86
34/F
Yes
Date Released:
TB culture
DSSM
Date of collection
Lab No.
DSSM
No
mm/dd/yy
Sputum
ʭʬ
0ʃɊ
ʭʬ
0ʃɊ
John Umali, RMT
2nd specimen
Retreatment
7
1st specimen
New
Specimen:
7
Category:
3rd specimen
TDF Laboratory
Culture center:
TDF-MMC DOTS Clinic
Treatment center:
TB Culture
Baseline
03/15/08
Screening
EXAMINATION DONE:
Enrolled:
Schedule:
Age/Sex:
Patient’s name: Sariwa, Sonia S.
Culture result:
MODULE B
(PMDT)
49/F
Date Released:
TB culture
DSSM
Date of collection
Lab No.
mm/dd/yy
03/25/08
DSSM
1HJDʤʖɃɏ
0ʃɊ
John Umali, RMT
ʬ
ʬ
Retreatment
7
7
New
2nd specimen
Category:
1st specimen
TB Culture
No
Yes
Baseline
Screening
EXAMINATION DONE:
Enrolled:
Schedule:
Age/Sex:
Sputum
Specimen:
Patient’s name: Reloz, Rolando R.
3rd specimen
TDF Laboratory
Culture center:
TDF-MMC DOTS Clinic
Treatment center:
Culture result:
MODULE B
87
(PMDT)
88
45/M
Santos, Santiago S.
Yes
Date Released:
mm/dd/yy
John Umali, RMT
0ʃɊ
0ʃɊ
TB culture
03/17/08
Date of collection
Lab No.
DSSM
Retreatment
ʬ
ʬ
New
7
TB Culture
Category:
7
Sputum
Specimen:
2nd specimen
DSSM
No
Baseline
3rd specimen
TDF Laboratory
Culture center:
TDF-MMC DOTS Clinic
Treatment center:
1st specimen
Screening
EXAMINATION DONE:
Enrolled:
Schedule:
Age/Sex:
Patient’s name:
Culture result:
MODULE B
(PMDT)
Yes
mm/dd/yy
Levofloxacin (Lfx)
6
Pyrazinamide (Z)
04/20/08
5
Ethambutol (E)
Date Released:
Ofloxacin (Ofx)
5
Rifampicin (R)
New
6
6
Ǖ'
5
Retreatment
METHOD USED: Disc Elution / 7H10
Streptomycin (S)
Category:
5
No
Baseline
Isoniazid (H)
Screening
EXAMINATION DONE:
Enrolled:
Schedule:
Claudette Guray
Amikacin (Am)
Kanamycin (Km)
DST center:
Date collected
TDF Laboratory
TDF Laboratory
Sputum
11/29/2007
Culture center:
Specimen:
Patient’s name: Sariwa, Sonia
Age/Sex: 34/F
01-T-079781-1
TDF-MMC DOTS Clinic
Laboratory ID no.
Treatment center:
DST result:
6
6
MODULE B
89
(PMDT)
90
Yes
Levofloxacin (Lfx)
6
Pyrazinamide (Z)
mm/dd/yy
6
Ethambutol (E)
Date Released: 04/25/08
Ofloxacin (Ofx)
5
Rifampicin (R)
New
6
6
Ǖ'
6
Retreatment
Claudette Guray
Amikacin (Am)
Kanamycin (Km)
TDF Laboratory
12/3/2007
DST center:
Date collected
Category:
Streptomycin (S)
5
No
Baseline
Isoniazid (H)
Screening
EXAMINATION DONE:
Enrolled:
Schedule:
Age/Sex: 49/F
TDF Laboratory
Sputum
Specimen:
Patient’s name: Reloz, Rolanda
01-T-079781-1
Culture center:
Laboratory ID no.
TDF-MMC DOTS Clinic
Treatment center:
DST result:
6
6
MODULE B
DST result:
(PMDT)
Yes
mm/dd/yy
Levofloxacin (Lfx)
6
Pyrazinamide (Z)
04/28/08
5
Ethambutol (E)
Date Released:
Ofloxacin (Ofx)
5
Rifampicin (R)
New
6
6
Ǖ'
6
Retreatment
12/5/2007
Date collected
Category:
Streptomycin (S)
5
No
Baseline
Isoniazid (H)
Screening
EXAMINATION DONE:
Enrolled:
Schedule:
Requesting physician: Verzosa, Dave M.D.
Age/Sex: 45/M
Sputum
Claudette Guray
Amikacin (Am)
Kanamycin (Km)
TDF Laboratory
DST center:
TDF Laboratory
Culture center:
Specimen:
Patient’s name: Santos, Santiago
01-T-079783-1
Laboratory ID no.
Treatment center:
TDF-MMC DOTS Clinic
6
6
MODULE B
91
MODULE B
Read through until the Summary of important points in the module and tell your
facilitator when you have reached that point.
6.2 Assign a Pre-enrollment No. to the patient if confirmed to have MDR-TB
A patient confirmed to be MDR-TB either by DST or by consilium decision should be put on treatment as soon as
possible. However, this does not always happen for various reasons, e.g., the patient may have a) gone back to the
province and cannot be located (“early default”), b) died, or c) refused treatment.
It is important to track the waiting time of patients from consultation or screening to diagnosis to the time they
are treated as MDR-TB. If this is too long, the Treatment Center will have to review its process of diagnosis and
enrolment.
The last column, Column 19, of the TB Symptomatics Masterlist is entitled “Pre-enrollment No.”. Not all patients will
be assigned this number. As discussed in section 6.1 above, the Pre-enrollment No. is given only to two groups of
patients entered in the TB Symptomatics Masterlist, namely a) those who have been confirmed to be MDR-TB by DST
and b) those with consilium decision to treat even if not confirmed to be MDR-TB by DST but highly suspected to
be MDR-TB from the clinical standpoint. The latter includes critically ill patients who have either pending culture or
DST results and cannot wait for these results to be released and immediate treatment needs to be started. This also
includes patients who have negative cultures due to intake of drugs with anti-TB action prior to sputum collection,
and those with non-viable or contaminated culture in the laboratory.
If the patient with the Pre-enrollment No. is enrolled, write the treatment start date under the Pre-enrollment No.
If the patient is not enrolled, indicate the reason why under the Pre-enrollment No. These reasons can be that the
patient is lost or has gone back to the province, the patient has died while waiting for treatment, or has decided not
to start the treatment at all for whatever reason, etc.
The Pre-enrollment No. is coded as YY (current year)-NNNN (accrual number which starts with 0001 at the start of
every year). For example, a patient bearing the Pre-enrollment No. 08-0329 means that the patient qualified for start
of treatment in year 2008 and was the 329th patient to be given a Pre-enrollment number in 2008.
Once a patient with a Pre-enrollment No. is started on treatment, he is entered into the Category IV Register. All
patients put on treatment will be entered into the Category IV Register and each one is assigned a unique Category
IV Registration No. See Module C: Treat MDR-TB Patients and the Reference Booklet for instructions on how to fill out
the Category IV Register.
92
MODULE B
6.3 Record the results in the patient’s chart and in the Consiliumex
Patients who are confirmed to be MDR-TB by DST and those who are critically ill and highly suspected for MDRTB need to be presented to the Consilium. The consilium determines treatment regimens, assesses response to
treatment and treatment outcome through a consensus utilizing WHO Guidelines for drug-resistant TB.
The Treatment Center physician will fill out the Consiliumex for one case in preparation for presentation to the
Consilium. An example of the Consiliumex can be found on the following pages. There are many sections of the
Consiliumex. At this point, the physician will be completing first the patient’s general information, TB treatment
history, DST pattern and chest x-ray results, then Consilium Discussion 001 – Recommendation on Enrollment
Regimen.
6.4 Schedule a case for presentation at the next Consilium meeting
The Consilium normally meets every week to discuss cases. The Treatment Center physician must prepare the
necessary documents such as the Consiliumex, laboratory results and x-ray films and schedule the case to be
presented in the next meeting. The Consilium will make the final decision on what the course of action for the MDRTB patient will be, particularly the MDR-TB regimen design following the principles in the WHO guidelines.
An example of how to fill out the Consiliumex can be found on the following two pages.
93
National Tuberculosis Program
MODULE B
CONSILIUMEX
Category IV Registration No:
Must be completely filled out by the Treatment Center physician
prior
to consilium
presentation
GENERAL
INFORMATION:
NAME
Balagtas
Jose
(Last)
50
(First)
SEX
METRO MANILA ADDRESS
Amorsolo
M
F
(Middle)
WEIGHT ON SCREENING
49.2
KGS
2425 Buendia Street, Balut Tondo, Manila
(No., street, barangay, district, city, ZIP code)
Same as above
PERMANENT ADDRESS
(No., street, barangay, district, city, ZIP code)
REGION
NCR
TREATMENT CENTER
KASAKA
MD IN CHARGE
DAR (initials of Dr. Dan A. Rivera)
TB treatment history is
important in making
decisions regarding the
patient’s regimen design.
TB TREATMENT HISTORY, CHEST X-RAY RESULTS AND DST PATTERN:
TB TREATMENT
HISTORY AND
REGISTRATION
GROUP
1997 – 2HRZE, 4HR Government hospital, non-DOTS, unknown
2003 – 2HRZES, 4HRZE, health center DOTS, failed
2004 – 3HRZES, 3HRZES, health center DOTS, failed
After cat II failure
CHEST X-RAY RESULTS
Cavity on upper right lung, in¿ltrates BLL and ¿brothorax on LUL
NAME OF OTHER
LABORATORY
LCP
DST RESULT
DATE DST RELEASED
Resistant to: HRES
10 / 10 / 05
Susceptible to: Z Km Lfx Clr
CULTURE CENTER
(Screening)
TDF
DATE SPECIMEN
COLLECTED
10/18/06
DST CENTER
(Screening)
TDF
DATE DST RELEASED
02/26/07
DST RESULT
(Screening)
Resistant to:
HRES
Susceptible to:
Z Km Cfx Ofx Lfx
DST RESULT (Baseline)
Resistant to:
Note: to be filled in
Not available
once available
Susceptible to:
Not available
WEIGHT MONITORING: (TO BE CONSTANTLY UPDATED EVERY CONSILIUM MEETING BY THE SECRETARIAT)
94
CONSILIUM
DISCUSSION
DATE
WEIGHT (KGS)
CONSILIUM
DISCUSSION
001 (E)
03 / 01 / 07
49.2
006
002
007
003
008
004
009
005
010 (TO)
DATE
WEIGHT (KGS)
MODULE B
Example of a Consiliumex showing Consilium decision on treatment regimen.
CONSILIUM DISCUSSIONS
CONSILIUM DISCUSSION 001 – RECOMMENDATION ON ENROLMENT REGIMEN
RECOMMENDED REGIMEN AND DRUG INTRODUCTION GUIDE:
LATEST WEIGHT
49.2
SECOND-LINE DRUG
ZKmOfxPtoCs
MD IN CHARGE
DAR
KGS
REGIMEN
SYMBOL
DAY 1
DAY 2
DAY 3
DAY 4
DAY 5
DAY 6
DAY 7
Cycloserine
Cs
1 cap
1 cap
1 cap
2 caps
2 caps
2 caps
FD
Prothionamide
Pto
1 tab
1 tab
1 tab
2 tabs
2 tabs
2 tabs
FD
PASER
PAS
1 sachet
1 sachet
1 sachet
2 sachets
2 sachets
2 sachets
2 sachets
DRUGS IN REGIMEN (USE SYMBOL)
PREPARATION
NO. OF UNITS PER DAY
Z
500 mg
5
Ofx
200 mg
Km
1G
Pto
250 mg
Cs
250 mg
750
4
2
Clearly indicate the
2 regimen and
recommended
dosage for the patient
Make sure all consilium decisions are signed by the
Consilium Officer who ensures that all entries are correct.
COMMENTS:
For enrollment
CONSILIUM OFFICER
Ma. Imelda D. Quelapio MD
DATE
03 / 01 / 07
An example of a completed Category IV Register is shown in the next few pages.
95
96
/
/
/
/
11 / 24/ 05
11 / 08/05
10/4/2005
Treatment
start date
mm/dd/yy
(3)
Patient’s unique Category
IV Registration No. is given
once treatment is started.
/
02-05-0097
4/25/2005
/
02-05-0096
4/28/2005
/
02-05-0095
4/29/2005
/
Category IV
Registration No.
TC-YY-NNNN
(2)
Date
screened
mm/dd/yy
(1)
JOSE AMORSOLO
(5) Sex
1- Male
2- Female
/
/
8– Fibrothorax
9– Bullae
10– Pleural effusion
11– Pneumothorax
12– Bronchiectasis
13– Atelectasis
14– Consolidation
15– Mass
16– Others, specify
_______________
P
P
P
Site of
disease
(8)
1-New
2-After Cat I failure
3-After Cat II failure
4-After Cat IV
failure
5-After default
6-Cat I relapse
7-Cat II relapse
8-Cat IV relapse
9-Transfer-in
/
/
10.1 Non-DOTS
10.2 Other (+)
10.3 Other (-)
3
10.3
10.1
1- New
2- First line drugs only
3- First and second-line
drugs
/
/
/
/
/
/
04/28/05
/
/
/
/
/
/
04/27/05
/
/
/
/
/
/
04/29/05
Date DST
specimen
collected
mm/dd/yy
(12) t
(11) Previous TB treatment
2
3
2
Registration Previous TB
group
treatment
(10)
(11)
10-Other patient w/
/
/
10/21/05
1,2,8
11/08/05
1, 15
10/03/05
1,2,3
Date done
mm/dd/yy
Chest x-ray
result
(9)
(10) Registration group
Tondo, Manila, NCR
(9) Chest x-ray result
/
/
01 / 20 / 55
0– Normal
1– Cavitary
2– Infiltrate
3– Nodule
4– Miliary TB
5– Intrathoracic
lymphadenopathy
6– Endobronchial spread
7– Fibrosis
1
2425 Buendia St., Balut
50
BALAGTAS,
Arlegui St., Malacanang cmpd
23
Manila, NCR
Bacacay, Albay, Bicol Region
47 National Road, Brgy San Vicente
27
02 / 02 / 78
Street no. and name
Brgy. City, Region
Date of birth
mm/dd/yy
Address (7)
03/28/83
1
2
Sex
(5)
Age (yrs)
(6)
VINCENT LIM
TAN,
SYLVIA GOMEZ
SANTOS,
Last name
First name and middle name
Name
(4)
Category IV Register
(PMDT)
Category IV Register/ Page 1 of 3
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
04/28/05
/
/
04/27/05
/
/
R
R
R
R
S
R
S
Z
S
R
R
S
S
R
S
Km
S
R
S
Ofx
R - Resistant
S
R
S
Cfx
S
S
S
Lfx
ND
ND
ND
Other
ND - Not Done
ND
ND
ND
Other
10/10/05
10/5/05
9/23/05
Date DST
released
mm/dd/yy
(14)
Row 1: DST available at start of treatment,
usually the DST result at screening. The next
rows are for the DST result at baseline and
DSTs done while on treatment, if applicable.
R
R
R
E
S - Susceptible
Drug Susceptibility Testing (DST) (13)
Rows 3 and 4: Other DSTs during treatment
H-Isoniazid
Km-Kanamycin
R-Rifampicin
Ofx-Ofloxacin
Z-Pyrazinamide
Cfx-Ciprofloxacin
E-Ethambutol
Lfx-Levofloxacin
S-Streptomycin
Row 2: Baseline DST or DST done within 30 days prior to treatment start
or 7 days post-treatment start (result not yet available upon treatment)
Row 1: Screening DST or DST result available pre-treatment
(13) Drug Susceptability Testing (DST)
R
R
04/29/05
/
H
R
Date DST
specimen
collected
mm/dd/yy
(12)
10/11/05
10/10/05
9/26/05
Date received by
Tx center
mm/dd/yy (15)
mm/dd/yy
s/c
mo 0
s/c
09/29/05
09/28/05
2+/MTB
11/07/05
11/04/05
3+/MTB
/ /
/ /
/ /
/ /
10/22/05
10/21/05
4+/MTB
CATEGORY IV REGISTER | page 2 of 3
2+/MTB
3+/MTB
3+/MTB
/ /
/ /
/ /
/ /
12/22/2005
/ /
/ /
1/25/2006
0/0
/ /
/ /
mm/dd/yy
s/c
mo 3
The two baseline DSSM
and culture results are
recorded.
/ /
/ /
11/24/2005
0/0
/ /
/ /
02+/0
mm/dd/yy
s/c
mo 2
mm/dd/yy
s/c
mo 1
/ /
/ /
2/23/2006
0/0
/ /
/ /
mm/dd/yy
s/c
mo 4
/ /
/ /
3/24/2006
0
/ /
/ /
mm/dd/yy
s/c
mo 5
/ /
/ /
/ /
/ /
/ /
mm/dd/yy
s/c
mo 7
s/c
mo 8
/ /
/ /
/ /
/ /
/ /
mm/dd/yy
Monthly DSSM and
culture results are
recorded.
/ /
/ /
4/20/2006
0
/ /
/ /
mm/dd/yy
s/c
mo 6
Follow-up DSSM and culture monitoring during treatment (16)
/ /
/ /
/ /
/ /
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CATEGORY IV REGISTER | page 3 of 3
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Post-treatment
follow-up monitoring
(18)
HIV status
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0-Negative
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2
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Date of last
intake of
Ff up 1 Ff up 2 Ff up 3 Ff up 4 (19)
meds
Treatment
outcome
(17)
(18) Post-treatment follow-up
Row 1: Date : mm/dd/yy
Row 2: Symptoms:
S- Symptomatic As- Asymptomatic
Row 3: Smear/ culture result
Row 4: CXR compared with last film done
1 - Improved
2- Progressed, specify using codes in (9)
3 - Stable
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For a transfer out patient, contact the receiving
/ Treatment
/ / Center
/ / to find/ out
/ final treatment
/ /
/ /
outcome.
mm/dd/yy
s/c
mo 18
Follow-up DSSM and culture monitoring during treatment (16)
mo 15
Interim Outcome
1. Culture-positive at month 0
2. Culture-negative at month 6
Final Outcome
1. Cured
2. Treatment completed
3. Died
4. Failed
5. Defaulted
Still receiving treatment
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s/c
mo 14
MODULE B
MODULE B
6.5 Return an updated Acknowledgement Form to the referring DOTS facility
As soon as a definitive diagnosis has been made at the Treatment Center, you need to inform the referring DOTS
facility of the diagnosis and plan for the patient. This is done using the same Acknowledgement Form that is used
during screening. This is accomplished in duplicate copies, one for the referring facility through the patient and
the other attached to the patient’s records in the Treatment Center. Tick the box for “Final diagnosis”. On this form
the physician writes the name of the referred patient, the pertinent laboratory findings particularly DST, the final
diagnosis, and the recommendations. If however, the patient has not called or returned to the Treatment Center
to pick up his results, the Acknowledgement Form will be sent by facsimile to the referring facility with request for
assistance to locate the patient. All efforts should be done to contact the patient, e.g., by land or cell phone, or by a
visit. An example of the Acknowledgement Form for final diagnosis is shown in the next page.
99
(PMDT)
MODULE B
Date:
October 11, 2005
To:
Dr. A. Madrid
Initial Diagnosis
Tick final diagnosis for
patients with results of
sputum test
Tondo, Manila
Thank you for referring your patient
diagnosis/management.
Final Diagnosis
Jose A. Balagtas
, for further TB
Pertinent findings/ Laboratory examinations:
AFS
4/25/05
4/26/05
3+
4+
Culture
M. tuberculosis
M. tuberculosis
}
DST (released Oct.10, 2005)
Resistant to H,R,E,S
susceptible to Z Km, Cfx, Ofx, Lfx
Notify referring MD/ treatment facility
regarding the patient’s diagnosis and
plan of treatment.
Plans/Recommendations:
Final diagnosis is MDR-TB
For category IV treatment
Please inform patient that he is ready for enrollment.
Please contact the number below for any queries and further instructions.
Clinic Physician:
Dr. Dan. A. Rivera
Contact numbers: 742-1534/ 781-3761 to 65 loc. 146
Treatment Center: KASAKA-QI MDR-TB Housing Facility
To be accomplished In duplicate copies:
One copy for the Referring physician or facility and one copy attached
to the Screening Form at the Treatment Center
100
MODULE B
7. Inform MDR-TB suspects of laboratory test results
7.1 Patients with drug resistance
If the TB suspect has confirmed drug resistance to one or more TB drugs, inform him clearly and in a sensitive way.
It is important to inform the DR-TB suspect as soon as possible about drug resistance and the next steps that will be
taken to start treatment. If a DR-TB suspect does not call or return to the Treatment Center to find out the results on
the scheduled time, and the DST result shows drug resistance, a highly proactive search to find the patient needs
to be done. All efforts should be made to contact or locate him as soon as possible. Call the patient or his contacts
using the numbers recorded in the TB Symptomatics Masterlist within that week. Or you can call the referring DOTS
facility to help locate the patient. This may also require you to visit the patient’s address. Patients with MDR-TB who
are left untreated can infect many others; moreover, delays in treatment can lead to worse treatment outcomes.
Hence, it is imperative not to lose confirmed MDR-TB cases.
7.1.1 Inform the patient of the results and explain the Consilium process
When you inform the patient that the DST showed resistance to TB drugs, explain in simple terms what drug
resistance is, and what that means for treatment. Reassure the patient that MDR-TB can be cured, but that it will
take dedication and many months of treatment. Drug-resistant TB is a very serious disease but it can be cured and,
treatment is given free of charge. It is also important to ensure that the patient will be ready to start treatment once
his case has been discussed and is approved for enrollment. Explain that this process may take some time but that
they should be ready to begin treatment in the near future.
This is a very important meeting with the MDR-TB patient. At this initial discussion, you will begin to provide
important information and support and tell the patient about the future treatment. This is the beginning of a long
relationship with the patient, one that is essential for the successful treatment of the disease. All communication
must be kind, supportive and medically correct.
Inform the patient about MDR-TB, supervised treatment, the treatment regimen, possible adverse drug reactions,
TB transmission, etc. Discuss the patient’s main worries or doubts and answer any questions clearly and positively
to encourage him as he prepares to start a long and difficult treatment course. See Module D: Inform Patients about
MDR-TB.
7.2 Patient with no drug resistance
A patient who has positive culture but does not show resistance to TB drugs can begin treatment for TB according to
the standard guidelines of the National TB Program. The Treatment Center physician should refer the patient to the
appropriate DOTS facility to begin treatment immediately, explaining well to the patient why treatment need not be
done at the MDR-TB Treatment Center.
101
MODULE B
8. Trace household contacts
8.1 Obtain a written consent from the patient in Kasunduan/”Contract” for treatment and
to interview the patient’s household contacts
The MDR-TB patient will now be asked to sign a contract for treatment. Read the Kasunduan/Contract to the patient
and his family member or relative in a way that they can understand. This Contract with the patient is very important
because it is another opportunity to explain to the patient what MDR-TB treatment entails, that MDR-TB, although
difficult to treat, is curable, and that his adherence to treatment is crucial to treatment success. Answer any questions
that the patient might have. Also explain to the patient his rights and responsibilities as a TB patient.
The patient should also be informed of the possibility that his or her household contacts have been infected with a
drug-resistant strain of TB and the need to interview and examine all these contacts particularly:
1.
all children aged less than five years even without symptoms
Studies have shown the increased vulnerability to TB of children less than five years of age among family
contacts and the increased estimated risk of progression to disease after infection. Hence, even without the
manifestation of symptoms, children of this age group should be screened
2.
five years and above who have cough of greater than two weeks
Cough of more than two weeks is a cardinal symptom of TB and any person regardless of age manifesting with
such should be investigated.
If you are sure that the patient has no more questions, ask him to affix his signature on the second page with the
date. The family member or relative should also sign together with the Treatment Center staff. For more information
about how to speak with a patient see Module D:Inform Patients about MDR-TB.
Before any contact tracing can be performed, a Kasunduan/Contract must be signed by the patient. Patients may
not want to sign or may be wary about doing so. You should explain to the patient the reasons for asking for his
signature.
t In order to talk to contacts of the patient, consent is required to respect the patient’s privacy.
t If the patient signs in agreement to undergo treatment, it means that he understands the potential side effects
of the drugs, pledges to adhere to the requirements of treatment and follow-up.
t Each patient has certain rights and responsibilities when receiving treatment for MDR-TB and these need to be
explained and agreed upon.
The Kasunduan/Contract is shown on the next page and can also be found in the Reference Booklet.
102
MODULE B
(PMDT)
KASUNDUAN/ “CONTRACT” PARA SA PASYENTENG MAY MDRTB
1. Ako si _____________________ay napaliwanagan na may sakit na Multidrug-resistant tuberkulosis.
¾ Ito ay nakakahawa sa iba.
¾ Ito ay di madaling gamutin at nangangailangan ng mahabang panahong gamutan (18-24 buwan o higit pa).
2. Upang gumaling:
¾ Kinakailangan kong magpagamot sa pamamagitan ng pag-inom ng gamot araw-araw sa itinakdang TREATMENT
CENTER para sa akin. Kung ako ay di nakatira sa Lungsod kung saan nandoon ang Treatment Center, kinakailangang
lumipat ako ng tahanan na malapit dito sa loob ng dalawang taon o higit pa upang mas maging madali para sa
akin ang pagpunta sa klinika.
¾ Kung hindi posible para sa akin ang paglipat ng tahanan ay mananatili ako pansamantala sa half way house sa loob
ng 6 na buwan o hanggang sa itinakdang araw sa akin ng klinika.
¾ Iinom ako ng 4 o higit pang klaseng gamot (> 10 tableta o kapsula) sa loob ng 18 buwan o higit pa, at bibigyan din
ako ng ineksyon araw-araw sa loob ng anim na buwan o higit pa depende sa aking timbang at kondisyon.
¾ Ang mga gamot ay maaaring makapagdulot ng mga kakaibang pakiramdam o side effects kung kaya’t kailangan
kong makipagtulungan at ipagbibigay alam agad sa mga staff ng klinika upang malunasan ang mga ito.
3. Kung di ko itutuloy o kukumpletuhin ang paggagamot:
¾ Maaari kong mahawa ang aking pamilya at ang mga taong nakapaligid sa akin. Ako ay makakahawa sa pamamagitan
ng aking pag-ubo, pagbahin, pagsasalita at pagkanta.
¾ Ang patigil-tigil na pag-inom ay mas lalong makakapagpalala ng aking kalagayan.
4.
Ang mga gamot na tinatawag na second-line drugs para sa tuberkulosis na gagamitin para sa akin ay mahal at di
madaling bilihin at nagkakahalaga ng P200,000 o higit pa.
¾ Ito ay galing pa sa ibang bansa at kinakailangan pa ng tulong ng Green Light Committee (GLC) at ng World Health
Organization (WHO) upang makamit.
5. Upang masubaybayan ang aking paggaling ako ay:
¾ Kukunan ng plema buwan-buwan.
¾ Ipinaliwanag sa akin na ang eksaminasyong ito ay nagkakahalaga ng higit pa sa 900 Piso bawat isa.
¾ Kukunan ng dugo sa braso kada 3 o 6 na buwan o kung kinakailangan. Ipinaliwanag sa akin na ito’y nagkakahalaga
ng mahigit-kumulang 2000 piso, ngunit ako’y hindi na pagbabayarin ukol dito upang tulong ng DOTS clinic sa
akin.
¾ Kukunan ng x-ray sa baga kada anim na buwan o kung kinakailangan habang ako ay nagpapagamot at kada anim
na buwan sa loob ng dalawang taon matapos ang panahon ng aking paggagamot.
¾ Babalik sa klinika kada anim na buwan sa loob ng dalawang taon matapos ang panahon ng aking paggagamot
(ibig sabihin apat na beses pagkatapos ng aking gamutan).
6.
Ang mga sakit katulad ng diabetes, high blood at iba pang sakit na walang kinalaman sa TB ay di na sakop ng klinikang
ito. Ito’y maaaring ipakonsulta at ipagamot sa ibang doktor.
7.
Ang aking kalagayang pinansyal ay aalamin ng mga social worker upang maging basehan ng kakayahan ko
sa pagpapatuloy sa aking gamutan at kakayahang tustusan ang iba ko pang pangangailangan habang ako ay
nagpapagamot.
8. Kabutihang dulot ng paggagamot:
¾ Malaki ang pag-asa ko na ako ay gumaling at hindi na makakahawa pa sa iba.
¾ Ako ay makakabalik sa aking trabaho at magiging kapakipakinabang sa aking pamilya at komunidad.
¾ Ngunit kung malaki na ang sira ng aking baga dahil sa TB, maaaring hindi na ito bumalik sa normal kagaya ng dati
kahit ang aking TB ay nagamot na.
KASUNDUAN/ “CONTRACT” PARA SA PASYENTENG MAY MDRTB | page 1 of 2
103
KASUNDUAN/ “CONTRACT” PARA SA PASYENTENG MAY MDRTB | page 2 of 2
9.
MODULE B
Upang mas lalong masiguro ang aking kalusugan at kalusugan ng aking mga kasambahay, dadalhin ko ang aking mga
kasambahay sa itinakdang Treatment Center upang suriin sa sakit na tuberkulosis. Kukunan ng x-ray at eksaminasyon
sa plema ang aking mga kasambahay kung kinakailangan.
10. Kung ako ay titigil sa gamutan:
¾ ipapaalam sa aking mga kasambahay, katrabaho, barangay official for health o sa pinakamalapit na health center
sa aming komunidad ang aking kalagayan upang matulungan akong makabalik sa klinika.
¾ at nagdesisyon na muling bumalik para magpagamot, maaaring ang tsansang ibinigay sa akin upang makakuha
ng libreng gamutan ay mawala na.
11. Hihingin sa akin ang lokasyon at adres ng health center na pinakamalapit sa aking tinitirahan:
¾ upang matulungan ang klinika na pabalikin ako sa paggagamot kung sakaling lumiban ako sa pag-inom.
¾ Para sa posibilidad na ako ay maendorso upang ipagpatuloy ang aking gamutan sa health center.
12. Kapag ang smear at culture ng aking plema ay negatibo na, ipagpapatuloy ko ang aking gamutan sa pinakamalapit
na health center sa aming lugar.
Jose A. Balagtas
Oct. 23, 2005
Pangalan at lagda ng Pasyente
Petsa
Oct. 23, 2005
Normando C. Cuervo
Pangalan at lagda ng Clinic Staff
Marites S. Sisaldo
Pangalan at lagda ng kamag-anak o
kasambahay ng pasyente
Petsa
Oct.
2005
Make sure that both
the 23,
patient
and family
members understand the importance
of daily DOT
Petsa
and completion of treatment.
Treatment Center Staff to please check accordingly and write the telephone and address.
104
TDF - MMC DOTS Clinic
Tel: 893-6066
DJNRMH DOTS Center (TALA Hospital)
Tel: 962-9877 loc. 217
Address:
Address:
KASAKA - QI MDR-TB Housing Facility
Tel: 742-1534 / 781-3761 to 65
PTSI - Tayuman DOTS Center
Tel:
Address:
PTSI Compound, E. Rodriguez Ave,
Quezon City
LCP - PHDU DOTS Center
Tel: 929-8324
Address
Address:
Address:
Others, please specify,____________________
Tel:
MODULE B
8.2 Complete the list of the patient’s contacts on the Contact Initial Investigation Form and conduct
interviews
A Contact Initial Investigation Form (CIIF) records all of the patient’s household contacts eligible for contact tracing
which include a) all children less than five years even without symptoms, and b) five years and above who have
cough for more than 2 weeks. Information on each of the patient’s eligible household contacts should be recorded
on the CIIF as shown in the example on the next page.
On the right upper corner of the CIIF, note the total number of contacts regardless of criteria for contact tracing.
From this number, note the number eligible for contact tracing and list their names down. Then, note how many
among the eligible were actually traced since not all contacts will be able to come.
105
106
Address:
Telephone Number/s:
(4)
(5)
4
Angelo Balagtas
4.
8.
7.
6.
*Eligibility Criteria for contact tracing:
(a) <5 yrs old with or without symptoms**
(b) ≥5 yrs with cough of > 2 wks
Normando Cuervo
_____________________________________
Interviewer
M
M
F
F
Sex
(M/F)
son
son
16
31
39
49
Weight
( kgs )
1, 3
1
1,4
10/21/05
10/21/05
10/21/05
10/21/05
Symptoms Date of interview
1
Mtb
ND
ND
ND
Date
TST
17
mm
4– Non-response to antibiotic
for lower resp. tract infection
5– Failure to regain previous
state of health 2 wks after
viral infection
0 Normal/Negative
1 Cavitary
2 Infiltrate
3 Nodule
4 Miliary Tb
5 Intrathoracic
lymphadenopathy
6 Endobronchial
spread
7 Fibrosis
8 Fibrothorax
9 Bullae
10 Pleural effusion
10/21/05
10/21/05
10/21/05
5
4
4
3
7
0
2
3
7
0
2
Initial Official
/
0/P
0/P
/
For TBDC/
Pedia
For TBDC
For TBDC
Other
comments
ND Not done
R Refused
P Pending
For ALL
Procedures
0/P
0/P
0/P
Result
0/P
BACTERIOLOGY
Smear Culture
0
0
1+
MTB
2+
3+
4+
10/21/05
10/21/05
ND
10/21/05
Date
Smear/ Culture
1 ≥5 yrs old: ____
3
<5 yrs old: ____
# of eligible contacts evaluated
11 Pneumothorax
12 Bronchiectasis
13 Atelectasis
14 Consolidation
15 Mass
16 Others,
specify _____
CXR
(11)
# of contacts identified
(10) # of eligible contacts for tracing
(9)
SUMMARY:
10/21/05
Date
mendations.
_______________________________________________________________________________________________________________
Retrieve old CXR ¿lm of Joy Balagtas for comparative reading & presentation to TBDC/ Follow up TBDC recomREMARKS: _______________________________________________________________________________________________________
0– None
1– Cough / wheezing >2wks
2– Unexplained fever >2 wks
3– Loss of weight or appetite/
Failure to gain weight
CHEST X-RAY READING
First, note the total number of contacts regardless of
eligibility, then note the number who are eligible; and lastly,
those who were actually traced.
96
157
150
153
Height (cm)
HRES
Negative
Negative
Susceptible: ZCfxOfxLfxKm
DST: Resistant:
Culture
Smear
Positive
11/24/2007
Baseline mycobacteriology
Date enrolled:
Information on this form is confidential.
(8)
(7)
(6)
SYMPTOMS for children <5 yrs old**
daughter
wife
Relationship
List only the household
contacts that are eligible for
contract tracing.
11/4/01
5/3/91
4/13/87
9/14/53
Date of
Birth
DEFINITIONS
MDRTB household contact:
Someone who sleeps in the same dwelling unit with common
arrangement for food preparation & consumption with an
MDR-TB patient for at least 3 months.
14
Paul Balagtas
5.
18
Marites Balagtas
48
Age
3.
Joy Balagtas
Name(s) of contacts eligible
for tracing*
(02) 244-6847
2.
1.
#
Date of birth:
(3)
02-05-0097
1/20/1955
Age: 50 Sex: M
F
2425 Buendia Street, Balut Tondo, Manila
Index name:
(2)
Jose A. Balagtas
Category IV Registration Number:
(1)
Contact Initial Investigation Form
(PMDT)
Contact Initial Investigation Form/ Page 1 of 2
MODULE B
MODULE B
8.3 Instruct patients’ symptomatic household contacts to receive appropriate care and follow-up
A household contact of an MDR-TB patient with symptoms possesses a risk factor for MDR-TB. He is therefore
regarded as an MDR-TB suspect and because he has symptoms, he will need to be entered into the TB Symptomatics
Masterlist during screening. This household contact must begin the process of TB detection as other patients in the
high-risk groups for MDR-TB. If the contact is confirmed MDR-TB or will be empirically treated with second-line drugs
after Consilium approval, then the contact will be entered in the Category IV Register.
All household contacts of a confirmed MDR-TB patient should be interviewed at the Treatment Center for symptoms
of TB. Those who are eligible for contat tracing should be evaluated by a physician by history and physical
examination.
For all ages with cough of more than two weeks, sputum smear and culture will be done.
For children less than five years old with or without symptoms, the following procedures will be done:
t
t
t
An evaluation by a physician, including history and physical examination.
Tuberculin skin testing (TST)
Chest x-ray examination (antero-posterior and lateral position)
TB and to a greater extent, MDR-TB are very difficult to diagnose in children. Many times children are unable to
produce or expectorate sputum on their own for examination. Other methods of collection such as sputum
induction and gastric aspiration are necessary. See Annex B: Procedures for obtaining sputum specimens in children.
8.4 Evaluate children by physical exam, chest x-ray and TST
Evaluation of children who are contacts of MDR-TB patients aims to detect those who are infected and those who
have active disease. A TST is first done to determine infection, not disease. If TST induration is 10 mm or greater, TST
is positive. This child may need preventive therapy (when the appropriate regimen becomes available) if he has no
symptoms and if the chest x-ray is normal. Otherwise, if he has three of five symptoms listed below, or he has an
x-ray consistent with TB disease, he may need to be treated.
The five symptoms of TB in young children can be nonspecific, manifesting as any of the following:
1.
2.
3.
4.
5.
Chronic cough or wheeze for >2 weeks
Unexplained fever for >2 weeks
Weight loss/failure to gain weight/loss of appetite
Failure to respond to 2 weeks appropriate antibiotic for lower respiratory infection
Failure to regain previous state of health 2 weeks after a viral infection or exanthem, e.g., measles
A child may also have extrapulmonary (EPTB) disease and may manifest with enlarged perihilar lymph nodes by
chest x-ray examination.
Patients with three of the five clinical symptoms should be entered into the TB Symptomatics Masterlist. Once all of
the diagnostic information has been obtained (physical exam, TST and chest x-ray results) the attending physician in
concurrence with the Consilium will come up with a consensus decision as to diagnosis for young children.
All children approved by the Consilium for MDR-TB treatment will be assigned a Pre-enrollment No. recorded on
Column 19 of the TB Symptomatics Masterlist. Once enrolled, the treatment start date will be written under the Preenrollment No. and as in adults, the patient will be entered in the Category IV Register and a Category IV Registration
No. will be assigned. All patients entered in the Category IV Register should have been entered first into the TB
Symptomatics Masterlist.
107
MODULE B
Summary of important points
t
Health workers should keep in mind that all previously treated patients, as well as non-converters of Category
II, symptomatic contacts of MDR-TB, and HIV-positive patients with symptoms of TB, are considered MDR-TB
suspects.
t
Any person in these high-risk groups for MDR-TB should be immediately referred to the appropriate Treatment
Center using the MDR-TB Suspects Referral Form for screening and diagnosis.
t
At the Treatment Center, screen every MDR-TB suspect and fill out an MDR-TB Screening Form. This includes
a physical examination by a physician and his preliminary diagnosis and plans for further diagnosis and/or
treatment.
t
Be sure to write down the complete name and complete address of every MDR-TB suspect in the TB
Symptomatics Masterlist, so that the TB suspect can be located once the results of the various tests show that
the patient has TB and in case the TB suspect does not return.
t
Inform the MDR-TB suspect about the process and discuss the Paunawa or Terms of Understanding with him to
continue the diagnosis.
t
Collect two sputum samples from every MDR-TB suspect for diagnosis. Use the Mycobacteriology Request Form
and the Laboratory Receiving Form for Specimens to request for sputum examinations and to send the samples
to the corresponding Culture Center. When the results of the smear, culture and DST are received from the
laboratory, record the results in the TB Symptomatics Masterlist.
–
–
–
–
–
All specimens will be cultured at the Culture Center automatically regardless of the smear result.
If culture results are positive, the culture isolate will be sent for DST to a DST Center
If the culture results are negative, the treatment center Physician may refer the patient to the Consilium
for clinical assessment on whether or not sputum should be recollected or empiric treatment should be
given.
If the DST shows that the DR-TB suspect has confirmed MDR, the patient will be assigned a Pre-enrollment
No. by the Treatment Center.
Likewise, a patient not confirmed to be MDR-TB by DST but highly suspected to be MDR and decided by the
Consilium to start treatment will be assigned a Pre-enrollment No. by the Treatment Center.
t
A patient who has confirmed drug resistance or MDR-TB or those decided by the Consilium to be started on
treatment must be informed immediately. If he does not call or visit the Center, locate this patient as soon as
possible. Assign a Pre-enrollment No.
t
Present MDR-TB cases confirmed by DST to the Consilium to be able to start treatment immediately to prevent
the spread of the disease to others in the household and community and to improve the condition of the
patient. Assign a Pre-enrollment No.
108
MODULE B
t
Present also to the Consilium cases highly suspected to be MDR-TB even without DST confirmation as not
all patients can wait for DST results and there are some culture-negative patients who deserve Category IV
treatment.
t
A patient who is started on treatment is entered into the Category IV Register and is assigned a Category IV
Registration No.
t
Ask patients with confirmed drug resistance to bring to the DOTS facility all his contacts for interview of
symptoms.
t
The following household contacts will be checked for TB and MDR-TB
– Children less than five years regardless of symptoms
– Those five years and above who have cough for more than 2 weeks
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MODULE B
Self-assessment questions
1.
List 7 different high-risk groups for MDR-TB who should be referred for testing.
2.
How many sputum samples are needed for examination for diagnosis? ___________
When and where are these samples collected? ____________
3.
The __________________________________ is an individual form for each MDR-TB suspect that holds a large
amount of background information about the patient. The __________________________________ is a record
of all TB suspects, including TB and MDR-TB suspects seen at the MDR-TB Treatment Center.
4.
List the data recorded in the TB Symptomatics Masterlist before sputum examination.
(For TC staff only)
5.
What are the three tests that are generally to be performed to diagnose MDR-TB?
Under what circumstances can a patient be enrolled in treatment without these tests?
6.
If an MDR-TB suspect’s DST results show resistance to H, R and E, the __________________ should be completed
to present the case to the _____________ in order to make a decision about treatment. (for TC staff only)
7.
What should the health worker tell the patient, if an MDR-TB suspect’s DST results show resistance to H, R
and E ?
8.
If an MDR-TB suspect’s culture result is negative but the patient is clinically deteriorating, what should you do?
9.
If culture results show that an MDR-TB suspect is positive for TB and the DST results show resistance to H and R,
but the suspect does not return to the health facility, what should the health worker do?
Why is it important for the health worker to take this action?
10. An MDR-TB suspect who is found to have confirmed MDR-TB may have infected other people with MDR-TB. Who
should the confirmed MDR-TB patient ask to come to the health facility to be screened for MDR-TB?
Now compare your answers with
those on the next page.
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MODULE B
Answers to self-assessment questions
1.
The following groups are considered high risk for MDR-TB and should be referred for testing at a Treatment Center
Retreatment cases
1. Failure
- Category I failure
- Category II failure (chronic TB case)
2.
Relapse of category I or II
3.
Return after default
4.
“Other” type of patients:
a) Non-DOTS patients
b) “Other –positive”
c) “Other-negative”
5.
Non-converters of category II
New or retreatment cases
6.
Symptomatic contacts of a drug-resistant case
7.
HIV-positive patients who have pulmonary or extra-pulmonary TB symptoms or have chest x-ray
findings suggestive of TB
2.
Two samples are needed. They are collected as follows:
t First sample (spot sputum specimen): on Day 1 at the Treatment Center.
t Second sample (early morning sputum specimen): on Day 2 at the MDR-TB suspect’s home, first thing after
waking.
3.
The MDR-TB Screening Form is an individual form for each MDR-TB suspect that holds a large amount of
background information about the patient. The TB Symptomatics Masterlist is a record of all TB suspects,
including TB and MDR-TB suspects seen at the MDR-TB Treatment Center.
4.
Screening Code, date of screening, complete name and address, age, date of birth, and sex, no. of previous
TB treatment, source of referral (site or doctor), site where last treated for TB, registration group, risk factors,
symptoms, chest x-ray results (if available)
5.
Smear, Culture and DST –
Clinically deteriorating patients may need to be started on treatment urgently before the DST results are available
or they will be at risk of dying. These patients should be identified by the physician, and their cases presented to the
Consilium immediately.
6.
If an MDR-TB suspect’s DST results show resistance to H, R and E, the Consiliumex should be completed to
present the case to the Consilium in order to make a decision about treatment.
7.
Inform the patient clearly and in a sensitive way. It is important to inform the MDR-TB suspect as soon as possible
about drug resistance and the next steps that will be taken to start treatment.
8.
The physician must present the case to the Consilium immediately. Either the culture needs to be repeated or empiric
treatment needs to be started.
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MODULE B
9.
All efforts should be made to contact or locate the person. Call the patient or his contacts within the week. You may
ask the referring DOTS facility to help locate the patient. This may require you to visit the patient’s address recorded
in the TB Symptomatics Masterlist.
Patients with MDR-TB who are left untreated can infect many others with MDR-TB and delays in treatment can lead
to worse treatment outcomes.
10. If possible, all household contacts of a confirmed MDR-TB patient should be interviewed at the Treatment center
for symptoms of TB. All those with symptoms regardless of age, and all children less than five years even without
symptoms should be evaluated by a physician by history and physical examination. For all ages with cough of more
than two weeks, sputum smear and culture will be done.
End of Module B
Congratulations on finishing this module!
112
MODULE B
References
1.
Guidelines for the Programmatic Management of Drug-resistant Tuberculosis, World Health Organization,
Geneva, Switzerland, 2006. (WHO/HTM/TB/2006.361)
2.
National Tuberculosis Control Program Revised Manual of Procedures. Manila, Department of Health, 2005.
3.
Balane, G. I., Pancho, J. S. R., Tupasi, T. E., et al. Tuberculosis among household contacts of infectious multi-drug
resistant TB patients. The International Journal of Tuberculosis and Lung Disease. Vol. 11, No. 11, (November)
2007, Supplement 1: S252
4.
Quelapio, M. I. D., Auer, C., Tupasi, T. E., et al. Mainstreaming DOTS-Plus to DOTS: when is culture indicated in
DOTS? The International Journal of Tuberculosis and Lung Disease. Vol. 9, No. 11, (November) 2005, Supplement
1: S291
5.
Auer, C., Lagahid, J. Y., Tupasi, T. E., et al. Smear positivity at two/three months of treatment: does it indicate
MDR-TB? The International Journal of Tuberculosis and Lung Disease. Vol. 9, No. 11, (November) 2005,
Supplement 1: S245
6.
Concepcion, A. A. L., Maramba, E. K., Tupasi, T. E., et. al. Internal consilium: a standardized approach for MDRTB management. The International Journal of Tuberculosis and Lung Disease, Vol. 10, No. 11, (November) 2006,
Supplement 1: S126
7.
Concepcion, A. A. L., Quelapio, M. I. D., Tupasi, T. E., et. al. Case management discussions in an internal
consilium. The International Journal of Tuberculosis and Lung Disease, Vol. 10, No. 11, (November) 2006,
Supplement 1: S125
8.
Concepcion, A. A. L., Quelapio, M. I. D., Tupasi, T. E., et. al. Impact of Union Management Courses: Internal
Consilium – opportunity for learning, coordination and peer support. The International Journal of Tuberculosis
and Lung Disease, Vol. 11, No. 11, (November) 2007, Supplement 1: S203
9.
Orillaza – Chi, R. B., Concepcion, A. A. L., Tupasi, T. E., et. al. Internal consilium for programmatic MDR-TB
management: Makati, Philippines. The International Journal of Tuberculosis and Lung Disease. Vol. 11, No. 11,
(November) 2007, Supplement 1: S263
10. Guidelines for National TB Programmes on the Management of TB in Children, World Health Organization,
Geneva, Switzerland, 2006. (WHO/HTM/TB/2006.371; WHO/FCH/CAH/2006.7)
11. Rieder, H. L. Contacts of TB patients in high-incidence countries. The International Journal of Tuberculosis and
Lung Disease. 2003, S333 – S336
12. van Rie, A., Beyers, N., Gie, R. P., et. al. Childhood TB in an urban population in South Africa: burden and risk
factors. Arch Dis Child. 1999, 80: 433 – 437
13. Miller, F. J. W., Seal, R. M. E., & Taylor, M. D. (1963). Tuberculosis in children. Boston: Little, Brown and Co.
14. Guidelines for the Implementation of the Programmatic Management of Drug-resistant Tuberculosis (PMDT).
Administrative Order No. 2008-0018. Department of Health, Manila, Philippines, May 26, 2008.
Annexes
A: Proper collection of specimen for the diagnosis of TB
B: Procedures for obtaining sputum specimens in children
C: Proper labeling, sealing and transportation of sputum
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MODULE B
Annex A.
PROPER COLLECTION
OF
SPECIMEN
FOR THE DIAGNOSIS
OF
TB
What is TB ?
“TB” (tuberculosis) is a disease that is caused by a bacterium known as Mycobacterium tuberculosis.
It can affect any organ of the body, with the lungs being the most common causing “pulmonary TB” or TB of the
lungs.
It is an infectious disease that can be acquired / transmitted by airborne spread of infectious droplets.
A person with TB of the lungs who is coughing is a source of infection.
What is AFB smear/DSSM?
Acid-fast bacilli (AFB) smear is a microscopic examination of the patient’s sputum for the presence of bacteria. It is
a preliminary test and results are obtained within 24 hours after collection. If positive for AFB, it is a presumptive
indication of an infection.
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MODULE B
What is TB culture?
TB culture is a procedure that detects the presence of the bacteria causing TB by allowing it to grow in a system
designed for its isolation. Since it grows very slowly compared to other disease-causing bacteria, it may take eight
(8) weeks or two (2) months for its growth to be detected. If it is positive for growth, an additional four (4) weeks is
required for its final identification.
To be able to do the test, clinical samples from the patient suspected to have TB are collected. Sputum (“phlegm”) is
the most common and the specimen of choice.
Collection of sputum samples
Two (2) consecutive early morning sputum samples are preferred but “spot-collection” is acceptable since the finding
of the organism is greater with two (2) sputum samples (Diagnostic specimens) than a single collection only.
Proper collection:
1.
2.
3.
4.
5.
Rinse your mouth with sterile distilled water before entering the collection booth.
Once inside the collection booth, take about three (3) deep breaths and cough forcefully simultaneously
upon exhale with the third deep breath.
Hold the sputum cup close to the lips and expectorate into it gently after a productive cough.
Collect about 5-10ml. (At least up to the first line of the container).
Collect only sputum not saliva. Sputum is usually thick and mucoid and produced from deep in the lungs.
Saliva is thin, clear and is of little diagnostic value for tuberculosis.
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MODULE B
6.
7.
8.
When the required volume has been collected, close the container tightly to avoid spilling of contents.
Allow one minute to stand.
Leave the collection booth immediately and submit the specimen to the medical technologist in-charge.
When the physician requests for sputum induction:
When the patient is totally unable to expectorate sputum, induction with saline solution can be done. The attending
physician will indicate in the request if there is a need for such procedure:
1.
2.
3.
4.
5.
Rinse your mouth with sterile distilled water before entering the collection booth.
Collect sputum inside the collection booth.
Inhale the vapor coming out of the induction machine for about 10 minutes.
Forcefully cough and collect about 5-10ml sample.
The sample will appear like saliva but it is acceptable since it is an “induced sputum.
(For the health-care worker)
Proper labeling of specimen:
1.
2.
3.
4.
Use the PMDT sticker to label the sputum cup.
Indicate the following on the label:
Patient’s name
Name of the Treatment center
Date of collection
Lab ID number
Paste the label on the body of the cup, not on the cover.
Transport the sputum cup with the collected specimen in an ice box to maintain the viability of the
organisms – a styropore box with ice or refrigerants will do.
Keep the sputum cups in upright position during transport.
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MODULE B
Annex B. Procedures for Obtaining Sputum Specimens in
Children
(Ref: Guidance for National TB Programmes on the Management of TB in Children, WHO/HTM/TB/2006.371; WHO/FCH/
CAH/2006.7)
Procedures for obtaining clinical samples for smear microscopy
This annex reviews the basic procedures for the more common methods of obtaining clinical samples from children
for smear microscopy: expectoration, gastric aspiration and sputum induction.
A. Expectoration
Background
All sputum specimens produced by children should be sent for smear microscopy and, where available,
mycobacterial culture. Children who can produce a sputum specimen may be infectious, so, as with adults, they
should be asked to do this outside and not in enclosed spaces (such as toilets) unless there is a room especially
equipped for this purpose.
Procedure (adapted from Laboratory services in tuberculosis control. Part II. Microscopy (1))
1.
2.
3.
4.
5.
Give the child confidence by explaining to him or her (and any family members) the reason for sputum
collection.
Instruct the child to rinse his or her mouth with water before producing the specimen. This will help to remove
food and any contaminating bacteria in the mouth.
Instruct the child to take two deep breaths, holding the breath for a few seconds after each inhalation and then
exhaling slowly. Ask him or her to breathe in a third time and then forcefully blow the air out. Ask him or her to
breathe in again and then cough. This should produce sputum from deep in the lungs. Ask the child to hold the
sputum container close to the lips and to spit into it gently after a productive cough.
If the amount of sputum is insufficient, encourage the patient to cough again until a satisfactory specimen is
obtained. Remember that many patients cannot produce sputum from deep in the respiratory tract in only a
few minutes. Give the child sufficient time to produce an expectoration which he or she feels is produced by a
deep cough.
If there is no expectoration, consider the container used and dispose of it in the appropriate manner.
B. Gastric aspiration
Background
Children with TB may swallow mucus which contains M. tuberculosis. Gastric aspiration is a technique used to collect
gastric contents to try to confirm the diagnosis of TB by microscopy and mycobacterial culture. Because of the
distress caused to the child, and the generally low yield of smear-positivity on microscopy, this procedure should
only be used where culture is available as well as microscopy. Microscopy can sometimes give false-positive results
(especially in HIV-infected children who are at risk of having nontuberculous mycobacteria). Culture enables the
determination of the susceptibility of the organism to anti-TB drugs.
Gastric aspirates are used for collection of samples for microscopy and mycobacterial cultures in young children
when sputa cannot be spontaneously expectorated nor induced using hypertonic saline. It is most useful for young
hospitalized children. However, the diagnostic yield (positive culture) of a set of three gastric aspirates is only about
25–50% of children with active TB, so a negative smear or culture never excludes TB in a child. Gastric aspirates are
collected from young children suspected of having pulmonary TB. During sleep, the lung’s mucociliary system beats
mucus up into the throat. The mucus is swallowed and remains in the stomach until the stomach empties. Therefore,
the highest-yield specimens are obtained first thing in the morning.
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MODULE B
Gastric aspiration on each of three consecutive mornings should be performed for each patient. This is the number
that seems to maximize yield of smear-positivity. Of note, the first gastric aspirate has the highest yield. Performing
the test properly usually requires two people (one doing the test and an assistant). Children not fasting for at least 4
hours (3 hours for infants) prior to the procedure and children with a low platelet count or bleeding tendency should
not undergo the procedure.
The following equipment is needed:
t gloves
t nasogastric tube (usually 10 French or larger)
t 5, 10, 20 or 30 cm3 syringe, with appropriate connector for the nasogastric tube
t litmus paper
t specimen container
t pen (to label specimens)
t laboratory requisition forms
t sterile water or normal saline (0.9% NaCl)
t sodium bicarbonate solution (8%)
t alcohol/chlorhexidine.
Procedure
The procedure can be carried out as an inpatient first thing in the morning when the child wakes up, at the child’s
bedside or in a procedure room on the ward (if one is available), or as an outpatient (provided that the facility is
properly equipped). The child should have fasted for at least 4 hours (infants for 3 hours) before the procedure.
1.
2.
3.
4.
Find an assistant to help.
Prepare all equipment before starting the procedure.
Position the child on his or her back or side. The assistant should help to hold the child.
Measure the distance between the nose and stomach, to estimate distance that will be required to insert the
tube into the stomach.
5. Attach a syringe to the nasogastric tube.
6. Gently insert the nasogastric tube through the nose and advance it into the stomach.
7. Withdraw (aspirate) gastric contents (2–5 ml) using the syringe attached to the nasogastric tube.
8. To check that the position of the tube is correct, test the gastric contents with litmus paper: blue litmus turns
red (in response to the acidic stomach contents). (This can also be checked by pushing some air (e.g. 3–5 ml)
from the syringe into the stomach and listening with a stethoscope over the stomach.)
9. If no fluid is aspirated, insert 5–10 ml sterile water or normal saline and attempt to aspirate again.
t If still unsuccessful, attempt this again (even if the nasogastric tube is in an incorrect position and water or
normal saline is inserted into the airways, the risk of adverse events is still very small).
t Do not repeat more than three times.
10. Withdraw the gastric contents (ideally at least 5–10 ml).
11. Transfer gastric fluid from the syringe into a sterile container (sputum collection cup).
12. Add an equal volume of sodium bicarbonate solution to the specimen (in order to neutralize the acidic gastric
contents and so prevent destruction of tubercle bacilli).
After the procedure
1.
2.
3.
4.
5.
Wipe the specimen container with alcohol/chlorhexidine to prevent cross-infection and label the container.
Fill out the laboratory requisition forms.
Transport the specimen (in a cool box) to the laboratory for processing as soon as possible (within 4 hours).
If it is likely to take more than 4 hours for the specimens to be transported, place them in the refrigerator (4–8
°C) and store until transported.
Give the child his or her usual food.
Safety
Gastric aspiration is generally not an aerosol-generating procedure. As young children are also at low risk of
transmitting infection, gastric aspiration can be considered a low risk procedure for TB transmission and can safely
be performed at the child’s bedside or in a routine procedure room.
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MODULE B
C. Sputum induction
Note that, unlike gastric aspiration, sputum induction is an aerosol-generating procedure. Where possible, therefore,
this procedure should be performed in an isolation room that has adequate infection control precautions (negative
pressure, ultraviolet light (turned on when room is not in use) and extractor fan).
Sputum induction is regarded as a low-risk procedure. Very few adverse events have been reported, and they include
coughing spells, mild wheezing and nosebleeds. Recent studies have shown that this procedure can safely be
performed even in young infants (2), though staff will need to have specialized training and equipment to perform
this procedure in such patients.
General approach
Examine children before the procedure to ensure they are well enough to undergo the procedure. Children with the
following characteristics should not undergo sputum induction.
t
t
t
t
t
t
Inadequate fasting: if a child has not been fasting for at least 3 hours, postpone the procedure until the
appropriate time.
Severe respiratory distress (including rapid breathing, wheezing, hypoxia).
Intubated.
Bleeding: low platelet count, bleeding tendency, severe nosebleeds (symptomatic or platelet count <50/ml
blood).
Reduced level of consciousness.
History of significant asthma (diagnosed and treated by a clinician).
Procedure
1.
2.
3.
4.
5.
Administer a bronchodilator (e.g. salbutamol) to reduce the risk of wheezing.
Administer nebulized hypertonic saline (3% NaCl) for 15 minutes or until 5 cm3 of solution have been fully
administered.
Give chest physiotherapy as necessary; this is useful to mobilize secretions.
For older children now able to expectorate, follow procedures as described in section A above to collect
expectorated sputum.
For children unable to expectorate (e.g. young children), carry out either: (i) suction of the nasal passages to
remove nasal secretions; or (ii) nasopharyngeal aspiration to collect a suitable specimen.
Any equipment that will be reused will need to be disinfected and sterilized before use for a subsequent patient.
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MODULE B
Annex C. Proper Labeling, Sealing and Transportation of
Specimen
1.
Use wide-mouthed sterile
screw-capped container
8.
Ready for transport to Culture
center.
7.
Place the sputum container in an
upright position.
6.
Prepare an ice box or ice pack.
5.
Secure in a plastic so that specimen
does not leak in case of spillage.
PMDT
Tx center: __________________
Lab No.: ___________________
Name: ____________________
Date collected: _____________
2.
3.
120
Prepare label with Treatment
center, Lab ID no, Patient Name,
Date
Attach label on the container, do
not put the label on the cover.
4.
Tighten cap
121
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A
Introduction B
Detect Cases of MDR-TB
C
Treat MDR-TB Patients
D
Inform Patients about MDR-TB
E
Ensure Continuation of MDR-TBTreatment
F
Manage Drugs and Supplies for MDR-TB
G
Monitor MDR-TB Case Detection andTreatment
H
Field Exercise – Observe MDR-TB Management
Reference Booklet on the Management of MDR-TB
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