Japan Pre-Entry TB Screening

Technical Instructions Version 1.2 February 2023

Tuberculosis and Infectious Disease Control Division

Health Service Bureau
Ministry of Health, Labour and Welfare, Government of Japan
List of Abbreviations
BCG Bacille Calmette-Guérin
CJPQA Centre for Japan-Pre-entry TB Screening Quality Assessment
CXR chest X-ray
DST drug susceptibility testing
J-IMS JPETS Information Management System
IGRA interferon-gamma release assays
INH isoniazid
JPETS Japan Pre-entry TB Screening program
LTBI latent tuberculosis infection
NAATs Nucleic Acid Amplification Tests
PZA pyrazinamide
QFT QuantiFERON
RIF rifampicin
TB tuberculosis
TST tuberculin skin test
WHO World Health Organization

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 Table of Contents
Section Section title Page
Introduction to the pre-entry TB screening program for Applicants to the
1 3
Certificate of Eligibility/visa for mid- to long-term stay
2 Role of an appointed physician of the Panel Clinic 5
3 The screening process for TB in Applicants 7
4 Consent for screening 17
5 Identification 18
6 Chest radiography 19
7 Laboratory examination for Mycobacterium tuberculosis 22
8 Outcome of screening 25
9 Validity period of the TB Clearance Certificate 28
Annex A Administrative arrangements 29
Annex B TB Clearance Certificate* 32
Annex C Informed Consent Form* 33
Annex D Pre-Entry Tuberculosis Screening Results Report 34
Annex E Sputum Collection 35
Annex F Tuberculosis Treatment Certificate* 39
(to be issued by a physician-in-charge of TB treatment for Applicant, upon completion of TB treatment)
Tuberculosis Treatment Report* (to be issued by a Panel Physician to Applicant who has
Annex G 40
undergone TB treatment, following diagnosis per the JPETS)
Annex H List of ID documents approved by JPETS 41
Annex I Technical details of radiographic exams 42
Annex J Radiological interpretations of CXRs 44
Annex K CXR Report* 47
Annex L Referral letter for TB treatment* 48
Documents marked with an asterisk (*) must be produced directly from the JPETS Information
Management System (J-IMS).

2
1. Introduction to the pre-entry TB screening program for Applicants to
the Certificate of Eligibility/visa for mid- to long-term stay

• According to the Act on the Prevention of Infectious Diseases and Medical Care for Patients with
Infectious Diseases of Japan, active tuberculosis is grouped under Category II Infectious
Diseases. Under the Immigration Control and Refugee Recognition Act, aliens diagnosed with
infectious diseases under Category II shall be denied permission for landing in Japan.

• This document is intended to provide technical guidance to those who are authorised by the
Government of Japan to conduct tuberculosis (TB) screening.

• The Centre for Japan Pre-entry TB Screening Quality Assessment (CJPQA), located within the
Research Institute of Tuberculosis, Japan, has been designated by the Government of Japan to
oversee the management of Japan’s pre-entry TB screening program (JPETS). For any queries
regarding the screening program, send an email to both the Ministry of Health, Labour, and
Welfare, Japan (tb_screening@mhlw.go.jp) and CJPQA (center_jpqa@jata.or.jp). Do not send X-
ray film or the Applicant’s personal identifiable information within the email.

• Throughout this document, the term “screening” denotes the process of screening individuals
who apply for the Certificate of Eligibility or visa for mid- to long-term stay in Japan (the
“Applicant”) for active TB. The purpose of TB screening is to detect the suspected presence of
active TB, as well as to contribute to Applicants’ health and TB control in their home countries of
Applicants by early diagnosis and appropriate treatment of TB.

• TB is a disease caused by an infection with a member of the Mycobacterium tuberculosis

complex. It may exist as an active disease, with clinical signs or symptoms, or as a latent infection
(i.e., latent TB infection, LTBI) where the infection has not progressed to active disease. This
screening program is intended to identify bacteriologically positive pulmonary, tracheobronchial,
pharyngeal, and laryngeal TB cases. However, Applicants with any other form of active TB that
requires TB treatment, if nonetheless detected in the process of the screening, will be required
to complete TB treatment before entering Japan. This screening program is not intended to
identify LTBI cases.

• The screening is applicable to nationals of countries with a high caseload of TB patients

diagnosed in Japan (China, Indonesia, Myanmar, Nepal, the Philippines, and Vietnam) who wish
to stay in Japan for over 3 months as mid- or long-term residents, as prescribed in Article 19-3 of
the Immigration Control and Refugee Recognition Act (except for holders of diplomatic and official

3
passports, those with re-entry permission, those whose present address is outside the above-
mentioned countries, those participating in the Japan Exchange and Teaching Programme/short-
and long-term JICA training courses, and students receiving grants under the Project for Human
Resource Development Scholarship). However, the Government of Japan may, where
appropriate, require any person from a country other than the ones mentioned above seeking
permission to enter Japan to be screened.

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2. Role of an appointed physician of the Panel Clinics

• The Applicants will be screened by physicians who have been designated and registered by
medical facilities (as “Panel Physicians”) that have been designated by the Government of Japan
(as “Panel Clinics”). The Panel Clinics will provide a list of registered Panel Physicians to the
Government of Japan and inform immediately if any change(s) are made to the list. Details of the
administrative arrangements for Panel Physicians and Panel Clinics are provided in Annex A.

• The Panel Physician will screen the Applicants as per the Technical Instructions. On occasions
where the Panel Physician determines that the Applicant does not have active TB, the Panel
Physician shall issue a TB Clearance Certificate (“the Certificate”, see Annex B). Only the
Certificate issued via the JPETS information management system, J-IMS, will be acceptable (see
below for the description of J-IMS).

• The Panel Physician must issue one original Certificate for the purpose of submission to the
diplomatic missions abroad or the Regional Immigration Bureau in Japan, together with
application forms for Certificate for Eligibility/visa to Stay, and one copy as a personal copy for
the Applicant. The Certificate will not be issued if active TB is suspected. In cases of doubt, it is
the Panel Physician’s responsibility to take the necessary steps to resolve the issue (see Section
8).

• The Panel Physician will be responsible for and oversee the entire screening process of each
Applicant, confirm the identification of the Applicant, and make a professional judgement as to
whether or not the Applicant should be issued the Certificate.

• On all occasions where active TB is detected during the screening process, the Panel Physician
must ensure that the Applicant is given clear and unambiguous advice about the need to start TB
treatment immediately at the Panel Clinic or refer the Applicant to a TB medical facility which is
capable of providing TB treatment according to the requirements of the WHO guidelines and
national TB guidelines, using quality-assured anti-TB drugs (“TB Medical Facility”).

• If drug-resistant cultures are identified on the laboratory test of the Applicant (see Section 7), the
Panel Physician will share this information with the TB Medical Facility, where the Applicant shall
receive TB treatment without delay.

• On occasions where the public health authority must be notified about active TB cases as per

5
 local law, the Panel Physician must also share the diagnosis of active TB with the local, regional,
or national authorities in the Applicant’s home country and record this fact at the Panel Clinic that
the Panel Physician belongs to.

• When the diagnosis of active TB is confirmed after referral to a TB Medical Facility, the Panel
Physician will request that the physician-in-charge at the TB Medical Facility share this fact with
the local health authority.

• Panel Clinics are required to record and manage all relevant information, including the Applicants’
biodata, test results, and treatment outcomes, using the J-IMS. The Panel Physician holds the
ultimate responsibility for the accuracy of the information, and the data entered into J-IMS. See
the Manual for JPETS Information Management System for details.

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3. The screening process for TB in Applicants

1) General arrangements
• The Panel Clinic must be able to schedule an Applicant’s appointment within 5 working days.

• The Panel Physician shall provide a briefing to all Applicants on the purpose, nature, and extent
of the TB screening process. Information leaflets may need to be used as necessary.

• The Applicant must complete an Informed Consent Form (see Section 4 and Annex C).

• Where Applicants are family members intending to travel together, the Panel Physician shall
arrange for all family members to be screened together as much as possible.

• A minor must be accompanied by a legal guardian. The definition of “a minor” shall be in

accordance with the legislation of the Applicants’ home country in which judicial decisions are
made in the event of a dispute regarding the screening and obtaining consent.

• The screening is based on chest radiography (“CXR”). Other tests such as a Tuberculin Skin Test
(Mantoux method) or Interferon Gamma Release Assays (IGRA) are not acceptable alternatives
to CXR for Applicants aged 5 years and above, even when the Applicant is willing to pay for such
tests.

• Prior receipt of Bacille Calmette-Guérin (BCG) vaccination does not change the screening
process, requirements, or required actions.

• If neither active nor old TB is suggested by the interview, physical examination, and CXR results,
it will be judged that the Applicant does not have active TB disease and the Certificate shall be
issued. The Panel Physician must complete the “Pre-Entry Tuberculosis Screening Results
Report” (see Annex D) for all Applicants and attach it to the Certificate.

• All Applicants suspected of active or old TB according to the results of any one of the interviews,
physical examinations, and CXR shall undergo Mycobacterium tuberculosis tests using three
sputum specimens collected each day for 3 consecutive working days (see Section 7 and Annex
E).

• If any of the sputum test results positive for Mycobacterium tuberculosis complex from an
Applicant, the Applicant shall be diagnosed as having active TB and the Certificate shall not be
issued.
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• The Panel Physician is under no obligation to treat the Applicant; however, in case the Panel
Physician agrees to carry out TB treatment, such treatment shall be in accordance with the WHO
treatment guidelines as well as any national TB protocol, using only quality-assured drugs in
accordance with the WHO’s recommended guidelines.

• The Panel Clinic is not responsible for the quality of the TB treatment provided outside the Panel
Clinic itself. However, irrespective of where the Applicant decides to receive TB treatment, the
Panel Physician remains responsible for monitoring the TB treatment and collecting, to the best
of his/her effort, relevant information regarding the treatment, including treatment start date,
treatment regimen, laboratory test results, and treatment outcome of the Applicant.

• Treatment completion of Applicants with pulmonary TB must be verified with at least two sputum
culture-negative results within 30 days after the end of the treatment. The two sputum specimens
must be submitted to a laboratory designated by the Panel Clinic for laboratory testing as per the
JPETS (“Panel Laboratory”).

• Treatment completion of Applicants with extra-pulmonary TB will be confirmed by the physician-

in-charge who provides treatment and care to the Applicant diagnosed with extra-pulmonary TB.

• Regarding the process to be followed when active TB is suspected despite negative sputum test
results, see Section 8.

2) Screening categories and processes

There are different sets of screening items for the four categories of Applicants: general Applicants
aged 15 years and above, children aged 5 to 14 years, children aged under 5 years, and pregnant
women.

General screening items

While the general screening items are applicable to all categories, some considerations will be made
for pregnant women, children aged 5 to 14 years, and children aged under 5 years. The general
screening items are as follows:

• Interview, which must collect information on the following:

⮚ Symptom(s) in the last 3 months: cough, sputum expectoration, haemoptysis, night sweats,
weight loss, and fever.

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 ⮚ History of previous TB:
The Panel Physician must collect the “TB Treatment Certificate” (see Annex F) and complete
the “TB Treatment Report” (see Annex G) for Applicants who undergo repeat screening after
diagnosis of TB and treatment completion at the first round of screening (regardless of where
the Applicant received his/her treatment). “TB Treatment Report” (see Annex G) is intended to
provide information regarding the Applicant’s TB treatment that was provided within the JPETS
program, to healthcare providers in Japan, in the event that the Applicant seeks medical
attention after arriving in Japan.

⮚ History of close contact with a case of active pulmonary TB within the past 2 years:
* Ask if anyone in the Applicant’s household has been diagnosed with active pulmonary TB
within the past 2 years.
* Ask if the Applicant had a history of close contact with a case of active pulmonary TB within
the past 2 years (i.e., shared the same enclosed airspace, household, or other enclosed
environments frequently or over a prolonged period of days or weeks).

⮚ Immunodeficiency:
* Ask if the Applicant has a history (within the past 6 months) of immunocompromised status or
is currently immunocompromised (e.g., HIV infection, chronic renal failure, malignant tumour,
etc.).
* Ask if the Applicant has a history (within the past 6 months) of using or is currently using
immunosuppressant agents (e.g., corticosteroids, anti-cancer drugs, anti-rheumatic drugs,
etc.).

• Physical examinations including the following items:

⮚ Chest auscultation (breath sound)
⮚ Examinations of the neck (inspection, palpation)
⮚ Other examinations which the Panel Physician judges necessary.

• CXR (except for children aged under 5 years)

• Sputum examination (for Applicants with suspected active TB based on interview, physical
examination, and/or CXR)

Considerations in pregnant women

• During pregnancy, there is a small risk of radiation exposure to the unborn baby, particularly in
the first trimester. It is not recommended to take CXRs during the first trimester. Therefore,
pregnant women have two options:
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 (1) Postpone taking CXR (and application process) until after delivery.
(2) Continue with taking CXR with double-layer lead shielding.
Regardless of the options, the pregnant Applicant must be counselled and informed consent
must be obtained and retained appropriately in the Applicant’s record.

• As a special measure, if a pregnant woman has undergone CXR within the last 3 months at the
same Panel Clinic in which she is currently receiving TB screening, the previous CXR may be
used for clearance purposes provided that she meets both of the following conditions: (1) she
has no signs or symptoms of TB, and (2) she has had no close contact with an active pulmonary
TB patient within the past 2 years. No CXR taken in any other clinic may be used, nor any other
screening test.

Considerations for children aged below under 5 years

• The screening items for those aged under 5 years include symptoms, history of previous TB,
history of household contact with a case of active pulmonary TB, and immunodeficiency or current
use of immunosuppressant agents. If any one of the above items is present, the children must
undergo CXR, as with general Applicants. Those with unknown history of previous TB and
unknown history of household contact with a case of active pulmonary TB must also undergo
CXR.

• However, children aged under 5 years who do not have signs and symptoms suggestive of active
TB, AND history of TB, AND history of household contact with an active pulmonary TB patient,
AND is neither immunodeficient nor on immunosuppressant agents, must undergo a Tuberculin
Skin Test (Mantoux method) or Interferon-Gamma Release Assay (IGRA). The TST results should
be interpreted according to the guidelines of the US CDC or the national TB control guidelines.
The IGRA results should be judged according to the criteria provided by the manufacturer.

• If the TST/IGRA results are negative, the Certificate will be issued.

• If the TST/IGRA results are indeterminate/invalid, the final result must not be considered
negative. In the case of indeterminate or invalid results from the IGRA, the Panel Physician should
preferably repeat the examination using a different test from that used at the initial test (i.e., if
QuantiFERON [QFT] was used at the initial test, T-SPOT would be used at the repeat test). If a
different test is not available, the Panel Physician may repeat the examination using the same
test.
• If the result of the second test is indeterminate/invalid again, CXR must be performed. If the CXR
findings do not suggest active TB, then the Applicant should be considered clear of TB disease,
and as the infection status is unknown, referral for further assessment of prophylaxis treatment

10
 for LTBI is not required. The Certificate can be issued. If the CXR indicates abnormal findings,
the children will undergo a sputum examination, as with general Applicants (see Section 7).

• In case of borderline results from T-SPOT, the Panel Physician should repeat the examination
preferably using a different test, i.e., QFT, if possible. If a different test (or QFT) is not available,
the Panel Physician may repeat the examination using the same test. If the result of the second
test using T-SPOT is borderline again, the result is interpreted as negative if the number of spots
is five and as positive if the number of spots is six or seven. If the result of the second test is
positive, CXR must be conducted. If it is negative, the Certificate can be issued.

• If the TST/IGRA results are positive, the children must undergo CXR. If the CXR does not
indicate abnormal findings, the Certificate can be issued. However, when the Panel Physician
judges that the Applicant needs LTBI treatment in accordance with the national TB guidelines,
i.e., if the Applicant has any of the risk factors to develop active TB such as household contact
history for the past 2 years or immunocompromised condition for the past 6 months, he/she must
provide adequate information about LTBI to the children and the guardian and refer the children
to a TB Medical Facility that is capable of providing LTBI treatment according to the WHO
treatment guidelines as well as national TB guidelines for further assessment regarding the
possible options for prophylactic treatment (see Section 8). If the CXR indicates abnormal
findings, the children will undergo a sputum examination, as with general Applicants (see Section
7).

Considerations for children aged from 5 to 14 years

• For children aged between 5 and 14 years, who have any chronic disease, a history of previous
thoracic surgery or cyanosis, or respiratory insufficiency that limits activity, a sputum examination
can be performed, regardless of the CXR findings, at the discretion of the Panel Physician.

3) Sputum examination
• A sputum examination consists of a sputum smear microscopic examination and culture
examination. It is also recommended that WHO-recommended nucleic acid amplification tests
(NAATs) such as Xpert MTB/RIF or Xpert MTB/RIF Ultra or TB-LAMP is added once, if available
(see Section 7).

• Where the CXR is suggestive of either active or old TB, as indicated in Section 6, a sputum
examination must be performed. Additionally, sputum examination is required for individuals with
signs or symptoms suggestive of active TB, regardless of CXR findings.

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• The Applicant is required to submit three sputum specimens collected on each day for 3
consecutive working days to the Panel Clinic or the Panel Laboratory.

• See Section 7 in case of difficulty in collecting sputum specimens.

• The interpretation guide of the sputum test positive results is as follows:

⮚ When any of the WHO-recommended NAATs is applied to one of the sputum specimens:
 Smear-positive result(s) with NAATs negative result is suggestive of non-tuberculosis
mycobacterium (NTM) infection or contamination; hence the Panel Physician may wait
for the culture test result(s).
 Smear-positive or negative results with NAATs positive result indicates a definite
bacteriologically-positive active TB. Hence the Panel Clinic will start anti-TB treatment
for the Applicant or will refer the Applicant to a TB Medical Facility for anti-TB treatment
while waiting for the culture test results.
⮚ When any of the WHO-recommended NAATs is NOT applied, but the smear-positive result(s)
is(are) obtained:
 The Panel Physician should consider CXR findings, the NTM infection history, and other
relevant clinical findings. The Panel Physician has the discretion to make or suggest an
active TB and refer the Applicant to a TB Medical Facility for anti-TB treatment depending
upon only sputum-smear positive result(s).
 If the culture test result(s) is(are) positive and identified as M. tuberculosis, it is a definite
diagnosis with active bacteriologically-positive active TB; hence the TB Medical Facility
should complete the anti-TB treatment.
 If the culture test result(s) is(are) positive and identified as an NTM, the TB Medical
Facility may terminate the anti-TB treatment.
 Even if the culture test result(s) is(are) negative or unknown, the TB Medical Facility may
continue the anti-TB treatment until the end of the treatment course because active TB
is not clinically excluded.

• Overview of the screening process flow is shown in Figures 1 and 2.

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Figure 1 JPETS algorithm for general Applicants

Booking an appointment,
arrival and registration at the Panel Clinic
(ID verification, explanation, and informed consent)

Interview and physical examination

No signs and symptoms Signs and symptoms

suggestive of active TB1 suggestive of active TB1

CXR 2 CXR 2

Findings compatible with Findings compatible with

Normal active or old TB
Normal active or old TB

Sputum testing 3

Treatment

Negative Positive 4

Not suggestive Highly suggestive Referral to a TB

of TB of TB 5 Medical Facility 6

Diagnosed as Diagnosed as
not TB7 active TB

Issue Certificate, Pre-Entry Tuberculosis Screening Results Report8, CD-ROM with

CXR image data and CXR Report9, and TB Treatment Report (for those who
underwent TB treatment)10.
13
1. Signs and symptoms include the following: 1) symptoms of active TB, 2) history of TB, 3) history of
household contact with a patient with active pulmonary TB in the past 2 years, and 4) immunodeficiency
or current use of immunosuppressant agents.
2. For pregnant women, see “Consideration for pregnant women” under Section 3.
3. It is also recommended that WHO recommended NAATs such as Xpert MTB/RIF or Xpert MTB/RIF Ultra
or TB-LAMP is added once, if available.
4. Positive results in either smear, culture or NAATs. The sputum-smear positive result(s) with NAATs
negative result may indicate the non-tuberculosis mycobacterium (NTM) infection or contamination.
Hence, the Panel Physician may wait for the culture test results before making an active TB diagnosis or
referring the Applicant to a TB Medical Facility for diagnosis and treatment.
5. Interview, physical examination, or CXR results are highly suggestive of active TB.
6. TB Medical Facility for diagnosis and treatment can either be a Panel Clinic or a medical facility, as
indicated in Section 2. The Panel Physician should consider CXR findings, the non-tuberculosis
mycobacterium (NTM) infection history, and other relevant clinical findings. The Panel Physician has the
discretion to make or suggest an active TB diagnosis and refer the Applicant to a TB Medical Facility
depending upon only sputum-smear positive result(s) among sputum tests.
7. The TB Medical Facility will refer the Applicant to the Panel Clinic if he/she determines the Applicant is
NOT diagnosed with active TB. The Panel Clinic will re-assess the diagnosis considering the judgement
made by the TB Medical Facility. However, NAATs or culture test positive result(s) should be a definite
diagnosis with active TB requiring prompt and uninterrupted anti-TB treatment.
8. See Section 3 and Annex D.
9. See Section 6 and Annex K.
10. See Section 8 and Annex G.

TB: tuberculosis, TST: tuberculin skin testing, IGRA: Interferon gamma release assay, CXR: chest X-ray. NAATs:
Nucleic Acid Amplification Tests

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 Figure 2 JPETS algorithm for children aged under 5 years

Booking an appointment,
arrival and registration at the Panel Clinic
(ID verification, explanation, and informed consent)

Interview and physical examination

TST/IGRA

Negative NOT negative CXR

Findings compatible with

Normal active or old TB
Issue Certificate and Pre-Entry Hereinafter follow the
same procedure as the
Tuberculosis Screening Results
for the general
Report2 Applicants

Issue Certificate, Pre-Entry Tuberculosis Issue Certificate, Pre-Entry Tuberculosis

Screening Results Report2, and CD-ROM Screening Results Report2, and CD-ROM
with CXR image data and CXR Report 3 if with CXR image data and CXR Report3 AND
TST/IGRA result was indeterminate or refer to a TB Medical Facility if positive
invalid. TST/IGRA result and judged necessary in
accordance with the national TB protocol4.

15
1. The Applicant must have negative results for ALL of the following items to proceed to TST/IGRA: 1)
symptoms of active TB, 2) history of TB, 3) history of household contact with a patient with active
pulmonary TB in the past 2 years, and 4) immunodeficiency or current use of immunosuppressant
agents.
2. See Section 8 and Annex D.
3. See Section 6 and Annex K.
4. The Panel Physician should re-confirm if the Applicant has any of the risk factors to develop active TB
such as household contact history for the past 2 years or immunocompromised condition for the past 6
months.

TB: tuberculosis, TST: tuberculin skin testing, IGRA: Interferon gamma release assay, CXR: chest X-ray.

16
4. Consent for screening

• The Panel Physician may designate a person who will explain the Informed Consent to the
Applicants, but it is the responsibility of the Panel Physician to ensure that Applicants are given
sufficient information about the screening in a language that they understand (or steps are taken
to ensure they understand), opportunity to ask questions, and time to reflect on answers; the
Informed Consent Form must be completed before the screening process starts (see Annex C).
Information provided to Applicants should cover the purpose of the TB screening, the entire
screening process, its benefits and disadvantages, such as serious risks associated with the
screening, and potential outcomes.

• Applicants are to be informed that they are entitled to withdraw their consent at any time after
signing the form up to the completion of TB screening. However, the Panel Physician or the
person designated by the Panel Physician to explain the Informed Consent must help the
Applicants clearly understand that the Certificate will not be issued if they do not accept the
examination instructed by the Panel Physician, which in turn may obstruct the application process
for the Certificate of Eligibility/visa.

• The Panel Physician or the person designated by the Panel Physician to explain the Informed
Consent, must ensure t

• hat Applicants also understand and accept that any screening results and any relevant personal
information collected during the assessment process, including health records and CXR, may be
shared with the Government of Japan and CJPQA.

• Where the Applicant is a minor or mentally incapacitated, the Informed Consent Form is only valid
if it is signed by his/her legal guardian.

• Where the Applicant is mentally competent to give consent but is unable to sign the Informed
Consent Form for physical reasons, the Panel Physician or the person in charge should request
an independent witness (i.e., someone who is not a Panel Clinic staff member) in order to confirm
that the Applicant has given consent whether orally or non-verbally and to sign the form on behalf
of the Applicant.

• The Panel Physician must retain the Informed Consent Form for 5 years and make the Form
available to the Government of Japan upon request.

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5. Identification

• The Panel Physician holds the overall responsibility in the identification process of the Applicant.

• The identity of the Applicant must be verified by the Panel Physician, or an appropriate staff
member designated by the Panel Physician, at the following stages of the screening: registration,
interview and physical examination, CXR, sputum collection, and issuance of the Certificate or
referral to a TB Medical Facility.

• As the proof of identification, the Applicant must present a valid passport. If the Applicant does
not possess a valid passport, it can be substituted by any of the identification documents specified
by the Government of Japan (see Annex H).

• At each stage, as mentioned above, the staff must take all reasonable steps to check the validity
of the passport (or other relevant documents) by ensuring that the photograph and date of birth
are consistent with the appearance of the Applicant.

• When there are doubts about the identity of the Applicant, the Panel Physician should request
the Applicant to provide further documents to substantiate his or her identity and keep them on
record. The Panel Physician must not issue the Certificate until the doubts are cleared.

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6. Chest radiography (CXR)

• CXR should be performed on the day when the Applicant is interviewed and undergoes a physical
examination at the Panel Clinic.

• Applicants aged 15 years and above should undergo a standard postero-anterior view CXR.
Applicants who are unable to stay in the position for the standard postero-anterior view may
undergo an antero-posterior CXR. Applicants aged under 15 years should undergo CXR in the
standard lateral-view as well as postero-anterior view. Further details of the radiological process
are provided in Annex I.

• The CXR image should be digitally captured and the CXR image data should be digitally
managed.

• The CXR images should be interpreted by a radiologist registered with the Panel Clinic (“Panel
Radiologist”) and reviewed by the Panel Physician.

• The Panel Radiologist should record the details of all abnormalities observed, whether due to TB
or otherwise. Further guidance is provided in Annex J.

• The CXR should be repeated if the initial CXR image is suboptimal due to technical factors. The
Applicant should not leave until the Panel Radiologist confirms that no additional CXR images
are required. The Panel Radiologist may request the Applicant to undergo further CXR from a
different view at no additional cost.

• Documents on which the interpretation results of the CXR are recorded must contain the full
name, date of birth, and passport number or number of any other identification document of the
Applicant; the dates on which the images were obtained and interpreted; and names of the Panel
Radiologist and of the Panel Physician.

• When interpreting the CXR findings, the Panel Radiologist shall have the discretion to compare
the results of the current CXR with any previous CXR taken for that Applicant, if available.

• When there is a disagreement between the Panel Radiologist and the Panel Physician, the Panel
Physician must discuss the results with the Panel Radiologist who provided the first reading. The
Panel Radiologist can review the CXR again and make corrections, if necessary. After discussion,
the Panel Radiologist’s final interpretation (along with the Panel Physician remarks) will be
released.
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• In a rare event where the Panel Physician still has queries on the reading even after discussing
with the Panel Radiologist, the Panel Physician can send the case to the IOM Teleradiology
Quality Control Center for another reading. The radiologist from the IOM Teleradiology Quality
Control Center will review the image and concerns of the Panel Physician and provide his/her
opinion. The Panel Radiologist will be involved in the re-reviewing process, if he/she is available.
The final interpretation (along with the Panel Physician’s remarks) made by the radiologist from
the IOM Teleradiology Quality Control Center will be released, even if it disagrees with the Panel
Radiologist’s reading or the Panel Radiologist is not involved in the re-reviewing process.

• The IOM teleradiology monitoring radiologist will discuss with the Panel Physician and the Panel
Radiologist after the re-reviewing process as necessary.

• Applicants with signs and symptoms and/or any radiological findings compatible with active or
old TB shall not be issued with the Certificate and must be asked to proceed to laboratory sputum
testing (see Annex J for CXR interpretation, and Annex E for details on laboratory sputum
testing).

• “Radiological findings compatible with active or old TB” that require laboratory sputum testing
include the following:
i. radiological findings under section A and B in Annex J, or
ii. radiological findings under section C in Annex J if the Applicants show any signs and
symptoms, irrespective of the duration, that are suggestive of pulmonary TB, or
iii. radiological findings under section D in Annex J, if the Applicants show any signs and typical
symptoms, irrespective of the duration, that are suggestive of pulmonary TB, for example,
prolonged cough for 2 weeks or longer.
Applicants with no abnormal CXR findings may also be requested to submit three sputum
specimens if they show signs and typical symptoms suggestive of pulmonary TB.

• Applicants without signs and symptoms of TB and whose CXR are confirmed to be free of any
radiological findings compatible with active or old TB will be issued a Certificate by the Panel
Physician.

• In a rare event whereby the Panel Physician judges from the interview, physical examinations, or
the CXR findings that the Applicant requires the immediate attention of a specialist, the Panel
Physician may refer the Applicant to a specialist immediately for further assessment or treatment
before sputum examination results become available, if conducted. In this case, the screening
process will be held temporarily. Once the patient returns from the specialist and the Panel
Physician confirms that the Applicant is cleared of TB, the Certificate may be issued.
20
• The Panel Physician should record the following items when resuming the screening process
after medical treatment for other diseases:
(1) Confirmed or tentative diagnosis (other than active or old TB) that was suspected based on
the CXR findings.
(2) Final diagnosis and details of treatment, if provided.
(3) Whether or not the sputum examination for TB was conducted and the results.

• The Panel Physician provides the digital CXR image data that is saved in a CD-ROM and the
printed CXR Report (see Annex K) to the Applicant in addition to the Certificate.

• Digital CXR data must be saved in a standardised Digital Imaging and Communications in
Medicine (DICOM) format in compliance with the Portable Data for Imaging (PDI) profile, as
specified by the Integrating the Healthcare Enterprise (IHE).1

1
https://www.ihe.net/resources/technical_frameworks/#radiology
21
7. Laboratory examination for Mycobacterium tuberculosis

• Laboratory examination for active TB in the screening may only be conducted in Panel
Laboratories.

• Laboratory examination for active TB must consist of three sputum specimens – one specimen
collected each day for three consecutive working days in the early morning. It is however
acceptable to collect the first sputum specimen on the first day as a spot when the Applicant visits
the Panel Clinic.

• The 3 consecutive days may include a break over the weekend.

• The Panel Physicians will issue the Certificate to the Applicant after the sputum examinations
only when the results of the culture examination for three sputum specimens are negative.

• The Panel Physicians must promptly start TB treatment at the Panel Clinic or refer the Applicant
to a TB Medical Facility if any of the sputum examination results are positive or any of the
available information strongly suggests the presence of active TB.

1) Specimen collection
• The Panel Physician must either perform on-site sputum specimen collection or arrange the
collection in a Panel Laboratory. Specimens collected at other locations (e.g., at the Applicant’s
house) cannot be accepted.

• If the Panel Physician delegates this procedure to a nurse or assistant, the Panel Physician
remains accountable for the integrity of this part of the screening procedure, regardless of where
the sputum collection takes place.

• Sputum collection must commence within 7 days of CXR. If three specimens have NOT been
collected within this time frame, then the collection should be started from the eighth day. If this
process is not completed within the next 7 days, the Applicant will forfeit the chance of the
Certificate being issued.

• The specimens should be securely and promptly transported to the Panel Laboratory with
appropriate provision for cool-chain integrity (no exposure to high temperature or risk of freezing).
The Applicants should not be allowed to transport specimens. If transportation requires more than
1 hour, the specimens must be refrigerated (but not frozen). The specimens should be processed
and examined within 24 hours of receipt by the Panel Laboratory.
22
• For the Applicants who are unable to produce sputum specimens, alternative methods of sputum
collection (e.g., sputum induction by hypertonic saline inhalation or aspiration of early morning
gastric fluid) can be used. A Certificate cannot be issued to Applicants who have been requested
to undergo a sputum examination but have failed to submit the necessary sputum specimens.

• Further details of the procedure for correct sputum collection are provided in Annex E.

2) Laboratory practice
• Each specimen must be examined by smear microscopy for acid-fast bacilli (AFB) by auramine
staining or Ziehl–Neelsen staining and by culture on liquid or solid media for mycobacteria. If
organisms suspected of mycobacteria are detected from culture, it is essential to identify the
mycobacterial species at least up to the M. tuberculosis complex level. It is also recommended
that WHO recommended NAATs such as Xpert MTB/RIF or Xpert MTB/RIF Ultra or TB-LAMP is
added once, if available.

• However, the WHO recommended NAATs cannot replace culture examinations of three sputum
specimens.

 Smear microscopic tests should be performed according to the WHO guideline

(“Mycobacteriology Laboratory Manual”) . Further details regarding reading smear are provided
2

in Annex E.

• The specimens must be cultured for a minimum of 6 weeks in liquid media and 8 weeks in solid
media unless a positive result was obtained earlier. The culture results, whether positive or
negative, should be reported to the Panel Physician as soon as the results are known.

• Positive M. tuberculosis cultures should undergo drug susceptibility testing (DST) in the Panel
Laboratory in accordance with the WHO guidelines. If any drug resistance is detected, the Panel
Laboratory should report it to the Panel Physician without delay. The Panel Physician must also
share the DST results with the physician-in-charge of TB treatment at the TB Medical Facility
immediately. For details, see Section 8.

 The DST should include isoniazid (INH) and rifampicin (RIF). Additional DSTs covering at least
pyrazinamide (PZA) and one of the fluoroquinolones, such as levofloxacin, should be
conducted if there is resistance to either INH or RIF.

2
https://www.who.int/tb/laboratory/mycobacteriology-laboratory-manual.pdf
23
• See Section 8 for cases where culture results are indeterminate (e.g., due to bacterial
contamination) or when there is a discrepancy between the results from culture and smear
microscopy or WHO recommended NAATs.

24
8. Outcome of screening

• Applicants who refuse the screening process shall not be issued the Certificate.

Applicants aged under 5 years:

1) Whose TST or IGRA results are negative:
• The Panel Physician shall issue the Certificate so that Applicants may proceed with their
application process for the Certificate of Eligibility / visa for mid- to long-term stays.

2) Whose TST or IGRA results were indeterminate or invalid, but whose CXR was free of any
radiological findings compatible with active or old TB:
• The Panel Physician shall issue the Certificate, attached with CXR data saved in a CD-ROM and
“CXR Report” (see Annex K), so that Applicants may proceed with their application process for
the Certificate of Eligibility / visa for mid- to long-term stay.

3) Whose TST or IGRA results were positive, but whose CXR was free of any radiological
findings compatible with active or old TB:
• The Panel Physician shall issue the Certificate, attached with CXR data saved in a CD-ROM and
“CXR Report” (see Annex K), so that Applicants may proceed with their application process for
the Certificate of Eligibility / visa for mid- to long-term stay.

• The Panel Physician must re-confirm whether the Applicant with TST or IGRA -positive result has
any of the following risk factors for developing active TB, namely household contact history for
the past 2 years or immunocompromised condition for the past 6 months, and determine whether
the Applicant should be referred to a TB Medical Facility for further assessment.

• If the Panel Physician determines that the Applicant requires a referral to a TB Medical Facility
for further assessment, the Panel Physician must provide adequate health education and
information about LTBI regarding possible options for prophylactic treatment to the Applicant and
the guardian and refer the Applicant to a TB Medical Facility that is capable of providing LTBI
treatment according to the WHO treatment guidelines as well as any national TB guidelines.

• The Panel Physician should, to the best of his/her effort, collect the following information
regarding TST/IGRA-positive Applicants who have been referred to a TB Medical Facility:
whether or not the Applicant has started LTBI treatment; and if yes, the treatment regimen and
expected treatment duration.

4) Who have been diagnosed with active TB

25
• The Certificate is not to be issued. The same procedure as that for other Applicants diagnosed
with active TB will be applied. See below for details.

All other Applicants:

1) Applicants whose culture results of all three specimens are negative:
 The Panel Physician or the physician-in-charge will judge whether the Applicants do not have
active TB when all culture test results are negative. Then, the Panel Physician will issue the
Certificate.

2) Applicants whose sputum examination results of all three specimens are indeterminate (due
to bacterial contamination, for example):
• The Panel Physician should request the Applicant to submit additional three sputum specimens
for examination. However, no additional costs shall be charged in such cases.

3) Applicants with suspected active TB with signs or symptoms or CXR findings despite all
negative sputum test results:
• The Panel Physician should write a letter of referral to a TB Medical Facility after providing
adequate and sufficient explanation to the Applicant (see Annex L). In such cases, the Panel
Physician postpones issuing the Certificate and the screening process. The Panel Physician may
resume the screening process when he/she receives a diagnosis report from the TB Medical
Facility indicating that the Applicant does not have active TB. The diagnosis report must be
obtained directly from the physician responsible for making the diagnosis, and not via the
Applicant.

4) Applicants who have been diagnosed with active TB, either based on interview, physical
examinations, CXR, or sputum examination results:
• The Certificate is not to be issued and the Panel Physician must give the Applicant clear and
unambiguous advice about the need to start TB treatment immediately; TB treatment should be
started at the Panel Clinic or the Applicant must be referred to a TB Medical Facility.

• If the Applicant decides to receive TB treatment at a TB Medical Facility outside the Panel Clinic,
the Panel Physician should share the culture and DST results with the physician-in-charge of the
Applicant’s TB treatment as soon as the results become available.

• The Panel Physician or the physician-in-charge at the TB Medical Facility will notify the authorities
responsible for TB control in the case of active TB, according to the national TB guidelines.

• The Panel Clinic is not responsible for the quality of the TB treatment provided outside the Panel
26
 Clinic itself. However, irrespective of the sites where the Applicant decides to receive TB
treatment, the Panel Physician remains responsible for monitoring the TB treatment status and
collecting, to the best of his/her effort, relevant information regarding the treatment, including the
treatment start date, treatment regimen, laboratory test results, and treatment outcomes.

• When the Panel Physician refers the Applicant to a TB Medical Facility for TB treatment, the Panel
Physician must request the TB Medical Facility to provide the relevant information about the
Applicant’s TB treatment, as mentioned above, to the Panel Physician, and request to issue a
“TB Treatment Certificate” (see Annex F) upon TB treatment completion.

• For Applicants intending to re-start the screening process after treatment completion, the Panel
Clinic must receive and verify the “TB Treatment Certificate” (see Annex F) issued from the TB
Medical Facility.

• For Applicants with pulmonary TB intending to re-start the screening process after treatment
completion, treatment completion must be verified by at least two negative sputum culture results
of sputum specimens obtained within 30 days after treatment completion. The sputum specimens
must be submitted to a Panel Laboratory. Treatment completion of Applicants with extra-
pulmonary TB is dependent upon the judgement of the physician-in-charge who provided
treatment and care to the said Applicant.

• The Applicant may only re-start the TB screening process after “treatment completion” is
confirmed by the Panel Physician, and only at the same Panel Clinic, but not within 6 months of
the previous examination, at an additional fee (standard test fee). Under exceptional
circumstances, whereby the initial Panel Clinic is no longer able to provide screening services,
the Applicant may choose another Panel Clinic. In that case, the Panel Clinic re-starting the
screening process must notify the CJPQA of the change for its authorisation.

• The Panel Physician and the Panel Radiologist shall compare the CXR films obtained before and
after treatment and take the findings of the interview and the physical examination into
consideration. When the Panel Physician determines that the Applicant no longer has active TB,
that is, with no progression findings on the CXR and no significant findings in the interview and
the physical examination, the Certificate may be issued. If undetermined, the Panel Physician
may request the Applicant to submit another set of three sputum specimens (see Section 7).

• The Panel Physician must also complete the “TB Treatment Report” (see Annex G) and attach
it to the Certificate.

27
9. Validity period of the TB Clearance Certificate

The Certificate shall be valid for 180 days from the date of the CXR.

When the Applicant, who has been cleared of active TB, meets either of the following conditions, the
validity period of the Certificate is reduced from 180 days to 90 days.
1) One or more family member(s), who lived with the Applicant, had been diagnosed with active
infectious pulmonary TB within 2 months before the Applicant underwent CXR.
2) The Applicant has shared the same enclosed airspace, household, or other enclosed
environments for a prolonged period (days or weeks) with a person who had been diagnosed
with active infectious pulmonary TB within 2 months before the Applicant underwent CXR.

Acknowledgement
This Technical Instructions was drafted by the Government of Japan with reference to the “UK
Tuberculosis Technical Instructions,” provided by Public Health England, September 2013, Version 6,
and March 2019, Version 7. The Government of Japan is grateful for the comments and advice from
the International Organization for Migration (IOM) in preparation for the publication of the Technical
Instructions.

28
Annex A. Administrative arrangements

 Each medical facility that intends to conduct pre-entry TB screening needs to be designated as a
Panel Clinic by the Government of Japan. Accordingly, all physicians in charge of the screening
(“Panel Physician”), radiologists in charge of interpreting the CXR image (“Panel Radiologist”),
and laboratories in charge of conducting laboratory testing (“Panel Laboratory”) need to be
registered in advance by the Government of Japan and the CJPQA. In case of any change(s)
made to the registration list, the Panel Clinic shall promptly notify the Government of Japan and
CJPQA.

 Panel Clinics must follow the guidelines set out in the Technical Instructions when providing TB
screening for JPETS. All staff, including physicians, radiologists, radiological and medical
technologists, and administrative staff of both Panel Clinics and Panel Laboratories must
familiarise themselves with the Technical Instructions and ensure that they are aware of any
updates or changes made to the Instructions.

 Panel Physicians must have a valid medical doctor license under the law of the country concerned
and have sufficient experience in diagnosing TB (preferably 5 years or more).

 Panel Radiologists must have a valid medical doctor licence under the law of the country
concerned and sufficient experience in the interpretation of CXR images.

 Radiological technologists and medical technologists must have a valid licence under the law of
the country concerned and sufficient experience in performing CXR and laboratory examinations,
respectively.

 All staff, including physicians, radiologists, radiological and medical technologists, and
administrative staff of both Panel Clinics and Panel Laboratories, must not have any pre-existing
conflicts of interest. Should any emerge during the course of designation, they must be brought to
the attention of the Government of Japan immediately.

 All staff, including physicians, radiologists, radiological and medical technologists, and
administrative staff of both Panel Clinics and Panel Laboratories, must protect the privacy of the
Applicants, with regard to personal and medical information, in accordance with privacy laws in
Japan.

 Panel Laboratories registered by the Panel Clinic must receive external quality assurance
approved by the Government of Japan.

29
 TB Medical Facilities shall carry out TB diagnosis and treatment according to the WHO or national
TB guidelines for TB diagnosis and treatment and with the use of high-quality drugs and devices
in accordance with the WHO’s recommended standards.

 Panel Physicians must comply with the code of conduct in that country.

 The Panel Physician should comply with medical and health services and any other relevant
regulations in the country concerned.

 The Panel Physician holds the ultimate responsibility for the entire process of the pre-entry TB
screening, including activities not conducted by the Panel Physician (e.g., bacteriological
examinations).

 The Panel Clinics must respond to audit requests by the Government of Japan. They also must
submit data necessary for assessment and monitoring of the screening (e.g., medical record,
CXR images, laboratory examination results) and the data necessary to follow the Applicant after
entering Japan (e.g., passport number, identification number) when requested by the
Government of Japan or the CJPQA.

 The Panel Clinic shall securely retain the CXR images, medical record, Informed Consent Forms
as well as all laboratory results, referral letters, and details of treatment for 5 years and make
them available when the Government of Japan or the relevant authorities request them.

 The Panel Physician must provide the digital CXR data saved in a CD-ROM and the “CXR report”
(Annex K) to all Applicants who undergo CXR, together with the Certificate.

 The Panel Physician must provide the Pre-Entry Tuberculosis Screening Results Report (Annex
D) to all Applicants, together with the Certificate.

 The Panel Physician must provide the TB Treatment Report (Annex G) to all Applicants who are
diagnosed with active TB during the course of the screening, initiated and completed TB
treatment, and are cleared of TB at the end of the second round of screening, together with the
Certificate.

 The Government of Japan or the CJPQA may evaluate the Panel Clinic and Panel Laboratory
by auditing the processes of TB screening through a visit and assessment of the data of TB
screening. The Government of Japan may guide the Panel Clinic based on the results of audits
and evaluations and can request the Panel Clinic to remove certain registered Panel Physicians,
30
 Panel Radiologists, radiological technologists, medical technologists, or Panel Laboratories. The
Government of Japan can also remove Panel Clinic based on the results of the audits and
evaluations.

Costs
 The Applicant shall be responsible for the cost of pre-entry TB screening, including, but not limited
to, the administration, counselling, examination, CXR, and laboratory testing, including
bacteriological tests, TST, IGRA, CXR report, CD-ROM for CXR imaging, and, where relevant,
the issuance of the Certificate.

 The cost of screening does not include the cost of treatment for active TB or LTBI.

 The cost of screening shall be categorised by age (“general Applicants aged 5 years and above,”
and “children aged under 5 years”). The cost may be different for the two age groups, but all
examination procedures within the same age group shall cost the same amount.

 The amount charged for screening must be in line with the accepted standards for the specific
country.

 The Panel Clinics shall inform the Government of Japan of the full charge they intend to claim
from the Applicant, including any disbursements, and immediately inform the Government of
Japan of any changes, and ensure that the cost is clearly understandable and made visible to
Applicants at the reception and/or websites. If the Government of Japan determines that there
is a significant difference in the screening expenses at different Panel Clinics in the same country,
the Government of Japan may ask for a correction.

31
 Annex B. TB Clearance Certificate

Only the TB Clearance Certificate that is issued from the J-IMS is accepted.

The following items are included on the TB Clearance Certificate:

1) Certificate number
2) Photograph of the Applicant
3) First, middle and family name of the Applicant
4) Date of birth of the Applicant
5) Sex of the Applicant
6) Nationality of the Applicant
Either 7) or 8)
7) If the passport is used as the personal identification document, the passport number, expiry
date, and country of issue must be mentioned
8) If a document other than the passport is used as the personal identification document, the name
of the document, number, expiry date, and country of issue must be mentioned
9) A check box and a statement: “I certify that all above statements regarding the Applicant are
true”.
10) A check box and statement: “I certify that this Applicant has been screened for TB and has not
been found to have active TB”.
11) Name of the Panel Clinic
12) Panel Clinic ID
13) Name of the Panel Physician
14) Signature of the Panel Physician
15) Date when the Certificate was issued
16) Expiry date of the Certificate
17) Statement: “IMPORTANT NOTICE TO THE APPLICANT: This Certificate is to be submitted to
diplomatic missions abroad or the Regional Immigration Bureau in Japan, together with
application forms for the Certificate for Eligibility/visa to Stay. This Certificate contains
information in connection with your application to Certificate for Eligibility/visa to Stay for Japan
and does NOT constitute a diagnosis or assurance of health. Issuance of the Certificate does
not mean that your application for Certificate for Eligibility/visa to Stay will be successful.”

32
Annex C. Informed Consent Form

33
34
35
Annex D. Pre-Entry Tuberculosis Screening Results Report

36
37
Annex E. Sputum collection
Administrative arrangements
• Confirm the identity of the Applicant.
• Ensure accurate specimen identification using non-removable labels.
• Explain the collection procedure to the Applicant.
• Use appropriate disposable equipment.
• Safe storage and disposal of clinical waste.

Sputum collection
• Collect a sufficient amount of sputum specimen (4 mL at least).

• Preferably collect the specimens early in the morning.

• Three specimens must be collected at least 24 hours apart, preferably on consecutive days. The
first spot specimen out of three specimens can be collected under supervision in the laboratory on
the day when the Panel Physician requests the Applicant to submit sputum specimens.

• Sample collection must be directly supervised in a Panel Laboratory. A screw-cap container must
be used for sputum collection.

• Must be collected in a safe environment and not at the Applicant’s home.

• Applicants should rinse their mouths with purified water before providing sputum specimens.
Check that sputum, not just saliva, is collected.

• The collector or supervisor of the laboratory or the laboratory technician preparing the specimen
can discard any specimen that is saliva and not sputum. In this case, the Applicant must return
the following day for collection.

• All Applicants must be instructed to take three deep breaths and cough on the fourth deep breath.
The cough should involve an abdominal contraction, not just the upper chest or throat.

• The collector needs to listen to the Applicants coughing to ensure that a cough comes from the
stomach and not from the chest or throat. If an Applicant continues to cough from the throat or is
unable to cough from the stomach, the Applicant should be asked to return the following day.

• Applicants must not submit their nasal passages into the back of their throat as a sputum specimen.
38
 • Specimens must never be pooled.

Use of induced and aspirated sputum

 If Applicants find it difficult to produce sputum, the following method can be used to obtain
specimens: inhalation of an aerosol of sterile hypertonic saline (3–6%), usually produced by an
ultrasonic nebuliser, can be used to stimulate the production of sputum, followed by aspiration of
sputum. Sputum induction and aspiration can be used for children as young as 3 years of age.

 A gastric aspirate can be collected from Applicants of all ages and may be especially helpful for
young children who find it difficult to provide a sputum specimen.

Specimen handling
• The collector should wear an appropriate mask not a surgical mask, but N95 and well-fitting
gloves during the collection process.

• The specimens must be sent to the laboratory in a metal container with a sealed lid. All specimens
must arrive at the Panel Laboratory within 4 hours of collection. If sputum specimens cannot be
sent to the Panel Laboratory within 1 hour, they must be refrigerated (no freezing).

• If the specimens need to be transported to another site, they must be sent as soon as possible
in a cold container containing ice packs.

• The specimens should be placed in a rack to prevent spillage and should be protected from
heat at all times. The specimens must not be frozen.

Safety measures
• Preferably, collection should take place outside in a sunny, well-ventilated area. To protect the
privacy of the Applicant, the collection location should be private and free of passers-by and
onlookers.

• The waiting area should be separated from the collection area, and Applicants should be allowed
to sit before collection and read the collection technique instructions.

• All collectors must wear an appropriate mask (not a surgical mask, but N95) and well-fitting
gloves for the process.

39
 • If specimens must be collected inside, they must be collected in a booth or room with negative
airflow. There should be 12–18 complete room air changes per hour. A small strip of single-layer
tissue paper can be placed on the door of the booth at least once a day, and if the paper moves
45 ° toward the door, it means adequate ventilation is provided.

• Phenol- or alcohol-based disinfectant solutions can be used to disinfect both surfaces.

• Ultraviolet (UV) light can also be used provided that it is cleaned once a week to prevent dust
build-up and it emits light at wave-lengths of 254 nm. The UV light must be on for 1 hour after
work has finished in the booth. It must be noted that this only disinfects the surfaces in the booth
so benches should be kept to a minimum in the area, and the booth must be free of all other
materials. The UV light should be replaced regularly in accordance with the manufacturer’s
instructions.

Sputum specimen processing

• Sputum specimens should be centrifuged before the smears are performed. Standard
preparation methods according to the WHO guidelines or National TB guidelines should be
applied.
• Results of microscopic examination of the smear should be judged according to the modified WHO
guideline in the table below (“LABORATORY DIAGNOSIS OF TUBERCULOSIS BY SPUTUM
MICROSCOPY: THE HANDBOOK”3).

Table: AFB smear reading (modified WHO guideline)

Fluorescence Microscopy
Brightfield Microscopy (x1000) Report
(x200) (x400)
0 AFB/ 100 field 0 AFB/ One length 0 AFB/ One length Negative
1-4 AFB/ One length 1-2 AFB/ One length Confirmation required*
1-9 AFB/ 100 field 5-49 AFB/ One length 3-24 AFB/ One length Scanty
10-99 AFB/ 100 field 3-24 AFB/ One field 1-6 AFB/ One field 1+
1-10 AFB/ One field, check 50 fields 25-250 AFB/ One field 7-60 AFB/ One field 2+
>10 AFB/ One field, check 20 fields >250 AFB/ One field >60 AFB/ One field 3+
*Confirmation required by another technician or preparation and reading of another smear with Ziehl–Neelsen stain

• Liquid and solid cultures should be observed for 6 and 8 weeks, respectively, under suitable
conditions.

3
https://stoptb.org/wg/gli/assets/documents/tb%20microscopy%20handbook_final.pdf
40
• A combination of liquid and solid cultures is preferred. When only solid culture is used, two
tubes should be applied to each specimen.

• Either of the following three combination patterns is preferable:

⮚ One liquid culture tube and one or two solid culture tube(s) can be applied to each of the
three sputum specimens, i.e., three liquid culture tubes and three or six solid culture tubes
will be used altogether.
⮚ One liquid culture tube can be applied to two (two of the first, second, or third) sputum
specimens; then, two solid culture tubes can be applied to the other sputum specimen, i.e.,
two liquid culture tubes and two solid culture tubes will be used altogether.
⮚ One liquid culture tube can be applied to one (either the first, second, or third) sputum
specimen, and two solid culture tubes can be applied to each of the two other sputum
specimens, i.e., one liquid culture tube and four solid culture tubes will be used altogether.

• Any of the following combination patterns are acceptable:

⮚ Two solid culture tubes can be applied to each of the three sputum specimens, i.e., six
solid culture tubes will be used altogether.
⮚ One liquid culture tube can be applied to each of the three sputum specimens, i.e., three
liquid culture tubes will be used altogether.

41
Annex F. Tuberculosis Treatment Certificate

42
43
Annex G. Tuberculosis Treatment Report

44
45
46
Annex H. List of ID documents approved by JPETS

China
Resident Identity Card (中华人民共和国居民身份证)

Philippines
PhilSys ID
Driver’s License (Student permit, non-professional or professional)
Social Security System Card
Government Service Issuance Card
Unified Multi-Purpose Identification Card
Professional Regulatory Commission ID
Overseas Workers Welfare Administration E-card
Commission on Elections Voter’s ID
Senior Citizen ID
Philippines Postal ID
Voters ID (with photo)
Professional License ID (with photo)
NBI Clearance (with photo)

Indonesia
Katu Identitas Pendatang (KTP)
Kartu Keluarga
Kartu Identitas Anak

Nepal
National Identity Card
Driver’s License Card
Minor Identity Card

Myanmar
National Registration Card (NRC)
Driving License
Birth Certificate
Oversea Workers Identification Card

Vietnam
Citizen Identity Card

47
Annex I. Technical details of radiographic exams
1. Radiographic techniques
• All CXRs should be taken in postero-anterior (PA) projections to reduce cardiac magnification. In
a correctly exposed film, the penetration should be such that one should be able to see the first
four (4) vertebral bodies well (T1-T4), and the ribs, while the rest of the vertebrae should be
visible through the heart shadow.

• Routine CXRs should be taken in full inspiration.

• All CXRs should include the costophrenic angles. Apices should be clearly visible (without overlying
clavicles).

• Chest rotation should be avoided. The scapulae should be clearly demarcated from the lung
fields.

• The distance from the CXR tube to the film must be 4.5–6.5 feet (140–200 cm).

• Artefacts must be excluded.

2. Special views
• CXR should be performed in apical lordotic view and lateral decubitus view, if necessary.
• Antero-posterior CXR can be performed if the Applicant is unable to stay in the position for
standard postero-anterior CXR.
• For children aged under 15 years, CXR should be performed in the lateral and postero-anterior
views.

3. Radiation safety
Ensure the following:
• Routine use of lead shielding for all Applicants and double-layer lead shielding for children and
pregnant women.
• Selection of correct collimation.
• Additional CXRs must not be performed unless clinically indicated.

4. CXR image identification

• The CXR image must bear the Applicant’s name in English, the name of the clinic, the date of
the CXR in Gregorian calendar, and anatomical side markers.

48
5. Women
• The Panel Physician must explain to all female Applicants that appropriate radiation safety is
secured. Physicians have an ethical obligation to ensure that these Applicants are adequately
protected. Be vigilant in avoiding unnecessary radiation exposure. For considerations of pregnant
women, see Section 3. “2) Screening categories and processes”.

6. Children
• Radiation exposure should be maintained at a minimum level. Collimation should include only
the chest, and abdominal shielding should be used.

7. Quality assessment of chest radiography

• The quality of the CXR images obtained at the Panel Clinics must be assessed by the IOM
Teleradiology Quality Control Center, Manila, in accordance with the standard procedures set
by the IOM.

8. Others
• Abdominal shielding should be properly used.
• Privacy of the Applicants should be respected.
• Belongings should be properly managed to avoid the loss of valuables.
• The CXR image should be digitally captured, and the image data should be digitally managed.

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Annex J. Radiological interpretations of CXRs

1. CXR image and reports

• The CXR image must bear the Applicant’s name in English, the name of the clinic, the date of
the CXR in Gregorian calendar, and anatomical side markers.

• Examine the so-called hidden areas in the postero-anterior view:

⮚ behind the heart,
⮚ the apices,
⮚ costophrenic angles,
⮚ both the hila,
⮚ paratracheal regions, and
⮚ below the diaphragms.

• If a nodule in the lower zones is difficult to differentiate from nipple shadow, the CXR must be
repeated with nipple markers for confirmation.

2. Requirements for examining radiologists

Panel Radiologists must ensure the following:
• They should accurately record the date and place of examination, name of the Applicants, and
results of their radiological examination, along with the results of any additional investigations.
The Panel Radiologist’s name should also appear clearly. This information must be either
handwritten or printed in a manner such that it cannot be tampered.

• When reading the CXR on a monitor screen, the Panel Radiologist must use a high-resolution
diagnostic monitor (≥2 MP).

• The extent and likely activity of any disease should be described, and further investigations
must be recommended.

• Panel Radiologists as primary readers, should report all abnormalities in the CXR films and their
possible interpretations and causes. If significant abnormalities, such as changes suggestive of
active TB, are detected, the Panel Radiologist should report this to the Panel Physician
immediately.

• The Panel Physician, as a secondary reader, should read the CXR image in light of the findings
of the Panel Radiologist and either “Agree” or “Disagree” with the interpretation of the Panel
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 Radiologist. The Panel Physician should discuss the CXR findings with the Panel Radiologist
before selecting the “Disagree” option.

• If the Panel Physician selects the “Disagree” option even after a discussion with the Panel
Radiologist, he/she must seek a third opinion from the IOM Teleradiology Quality Control Center
to reach a final decision (see Section 6).

• The Panel Radiologist assumes responsibility for the integrity and quality of the radiological
examination process.

• The Government of Japan, or CJPQA may audit all or part of radiological examinations, and any
evidence of failure to maintain the integrity and quality of the examination will result in revocation
of registration of the Panel Radiologist.

3. Recording of radiological findings

If any of the following abnormalities are present, radiologists are required to annotate their reports
using the following numerical codes:

A. Findings likely to suggest active TB:

A-1 Cavitary lesions
A-2 Consolidation or ill-defined soft tissue infiltration
A-3 Miliary lesions
A-4 Multiple / single ill-defined nodules or masses
A-5 Soft-tissue hilar or mediastinal mass / lymphadenopathy
A-6 Pleural effusion

B. Findings sometimes seen in active TB:

B-1 Fibronodular / fibrocalcific / fibrocystic lesions or localised multiple calcific nodules with or without
volume loss
B-2 Multiple / single well-defined pulmonary nodules or masses (non-calcified)
B-3 Notable apical pleural capping (rough or ragged inferior border) and / or pleural thickening ≥1
cm at any point

C. Minor findings which may be associated with old / healed TB:

C-1 Solitary calcified nodule
C-2 Calcified hilar lymph node(s)
C-3 Multiple calcified pulmonary nodules with distinct borders (scattered)

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 C-4 Calcified pleural lesions
C-5 Costophrenic angle blunting (either side above the horizontal)*
*Note: Conduct lateral decubitus CXR if effusion is suspected.

D. Minor findings likely not associated with TB:

D-1 Single linear streak
D-2 Smooth pleural thickening, apical and / or lateral (<1-cm thickness at all points)
D-3 Unilateral or bilateral costophrenic angle blunting (below the horizontal)*
D-4 Others, specify ( )
*Note: Conduct lateral decubitus CXR if effusion is suspected.

E. Suggestive of significant non-TB findings:

(Choose the applicable anatomical part(s) below and describe the findings in the remarks.)
E-1 Soft tissue and bones
E-2 Heart and great vessels
E-3 Diaphragm, costophrenic angles, and pleura
E-4 Hilar and mediastinum
E-5 Lung fields
E-6 Others, specify ( )
*Note: The cut-off point for cardiomegaly is CTR of ≥55% for adults and ≥60% for children.
Specific chamber enlargement should also be considered abnormal even if the CTR is normal.
Remarks (Describe all abnormal findings in the chest X-ray film):
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INSTRUCTIONS TO PANEL PHYSICIANS:

The Panel Physician should request the Applicant to submit a set of three sputum specimens in
the following scenarios:

1. If any of the CXR findings under A or B are identified.

2. If any of the CXR findings under C are identified and the Applicant shows clinical signs and
symptoms suggestive of pulmonary TB, irrespective of the duration.

3. If any of the CXR findings under D, E, or normal CXR findings are identified and the Applicant
shows typical signs and symptoms suggestive of pulmonary TB, such as prolonged cough for
2 weeks or more.

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Annex K. CXR Report

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Annex L. Referral letter for TB treatment

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