TB Guidelines

U.S. Immigration, HIV, and Tuberculosis Screening and Treatment Information

As of January 4, 2010, HIV is no longer considered a “communicable disease of public health significance” in the immigration process to the U.S. Prior to that a waiver was required for any person with HIV, including internationally adopted children, to obtain a U.S. visa. Since this has changed, the waiver for HIV is no longer needed for anyone with HIV seeking immigration to the U.S, including children being adopted. When completing the visa application (DS 230 or DS 260, do not check that the immigrant/ child has a “communicable disease of public health significance” (question 40a) based on the child’s HIV status. You should not be asked to complete an I601 waiver based on the immigrant/ child having HIV alone.

However, in 2007, the U.S. Centers for Disease Control began implementing new protocols for tuberculosis (TB) screening and treatment of immigrants to the United States. These guidelines have special relevance to immigrants with HIV. Immigrants (including children) with HIV are presumed to have a higher risk of TB and a higher likelihood of testing negative on the initial screening tests. Thus the TB screening and treatment guidelines are different for people with HIV, even though HIV has been removed from the health conditions that used to trigger a visa denial that was overcome with the I601 waiver. Because internationally adopted children are considered immigrants, they fall under these guidelines. The new TB guidelines have been and continue to be rolled out in various countries over time. A current list of the countries implementing the 2007 guidelines can be found here. As they began to be rolled out in various countries, they caused unexpected delays in the processing of many immigrant visas, including those for international adoption. They were modified for children 10 years and younger in 2009, and they are also slightly modified for intentionally adopted children.

If you are adopting from a country that does is not listed in the previous link (e.g. Ukraine, Russia), the following guidelines do not affect your immigration visa processing. Your child will be screened for TB under the 1991 TB technical guidelines, which do not require sputum testing for children with HIV.

Because TB screening can take longer for children with HIV and unexpected positive results at the time of the visa physical can cause delays in treatment and family unification, it is advisable to be proactive about identification of possible TB early in the process. However, per CDC guidance, “tuberculosis treatment should not be initiated for applicants who are smear- and culture-negative unless the chest x-ray and clinical findings are highly suggestive of tuberculosis disease.”

Because this process can present complications that can arise near the time of traveling to adopt or while in country, families adopting children with HIV or TB should consider completing a G-28 form, which allows Equality for Adopted Children and Project HOPEFUL to advocate with the Federal agencies regarding complications in the waiver processing, when they arise.

Important to know

Immigrant children who have HIV

Age 2-10

Age 11-14

=15">Age >=15

Immigrant children who do not have HIV

Important to know:

According to the Technical Instructions, any applicant for whom the clinical suspicion of tuberculosis is high enough to warrant treatment for tuberculosis disease, regardless of laboratory results, is considered to have tuberculosis disease and is Class A for Tuberculosis.” So if a child has been diagnosed and treated for TB, regardless of any subsequent lab results, the child will be considered to have TB and be Class A for TB. According to the CDC guidelines, “Tuberculosis treatment should not be initiated for applicants who are smear- and culture-negative unless the chest x-ray and clinical findings are highly suggestive of tuberculosis disease.” If treatment is begun, they will be Class A and require a certain length of treatment prior to applying for an I601 waiver.
“Prior receipt of Bacille Calmette-Guérin (BCG) vaccination does not change the screening requirements or the required actions based on tuberculin skin test results.” So even if the immigrant/ child has had the BCG vaccine, that does not change the TB screening requirements or actions based on the TB screening requirements.”
Countries utilizing the 2007 guidelines: For all children with HIV and some children who do not have HIV, three sputum samples are taken to conduct TB smear and culture tests. For a sputum smear, a small amount of mucus collected from deep in the lungs is smeared on a slide and viewed under a microscope to look for TB germs. This result is back within a few days. A culture involves putting a sputum sample in a petri dish to see if TB germs grow. This generally takes 6-8 weeks. If children are not able to cough enough to produce sputum samples, gastric aspiration is done to obtain samples from the stomach for smear and culture testing.
Even if a child is cleared for a visa/ travel, they may have a classification that requires subsequent follow-up examinations and paperwork, by the CDC, health department, and/or medical provider. Don’t be surprised if you are contacted by the local health department and/or your doctor is contacted by the CDC or health department for additional paperwork about the child’s follow-up for tuberculosis screening and/or treatment.

Immigrant children who have HIV

Immigrant children with HIV who are 2-10:

Required to have a medical history, physical, and TB skin test. Because they have HIV, they are also required to have a chest xray and to have three sputum samples taken to conduct TB smear and culture tests. Some children may not have a forceful enough cough to produce sputum samples, so gastric aspiration is done to obtain samples from the stomach for smear and culture testing.
Children who are 10 or younger who have a negative smear result can travel to the U.S. without further delay, while the TB culture is still growing. The CDC will follow up with their health provider to ensure that there is follow up on the culture results and any needed treatment.
Children who are 10 or younger who had a gastric aspiration done and had positive smear results can travel while the culture results are pending (because they do not have forceful enough cough to transmit TB to others.) The CDC will follow up with their health provider to ensure that there is follow up on the culture results and any needed treatment.
If the culture is positive, drug susceptibility testing is conducted. Directly observed therapy (DOT) for TB must be received prior to being given a visa to come to the United States. They are given a Class A Tuberculosis classification and can apply for an I601 waiver once treatment has begun.

For a child who is 10 or younger who has a positive smear result, chest xray showing on one or more cavities or widespread TB disease in the lungs, a forceful and productive cough, or contact with a person who has multi-drug resistant tuberculosis (MDR-TB), the child must wait for the TB culture to come back (6-8 weeks). If this TB culture is negative, the child can receive a visa.
Children who are 11 or older who had a positive TB test and xray suggestive of TB have three sputum samples taken for smear and culture results. However they must wait until for the culture to come back negative (6-8 weeks) in order to be cleared to travel.

Immigrant children with HIV who are 11-14:

Required to have a medical history, physical, and TB skin test.
Because they have HIV, they are also required to have a chest xray and to have three sputum samples taken to conduct TB smear and culture tests. Some children may not have a forceful enough cough to produce sputum samples, so gastric aspiration is done to obtain samples from the stomach for smear and culture testing.
If the culture is positive, drug susceptibility testing is conducted. Directly observed therapy (DOT) for TB must be received prior to being given a visa to come to the United States. They are given a Class A Tuberculosis classification and can apply for an I601 waiver once treatment has begun.

They must wait until for the culture to come back negative (6-8 weeks) in order to be cleared to travel.

=15">Immigrant children with HIV who are >=15

Required to have a medical history, physical, and chest x-ray.
All children with HIV >= 15 must also provide three sputum samples for a smear and culture for TB.
If the culture is positive, drug susceptibility testing is conducted. Directly observed therapy (DOT) for TB must be received prior to being given a visa to come to the United States. They are given a Class A Tuberculosis classification and can apply for an I601 waiver once treatment has begun.

Children who do not have HIV

Immigrant children without HIV who are 2-10

Required to have a medical history, physical, and TB skin test.
Children who have a positive skin test can still travel as long as the other TB tests do not suggest they are likely to spread TB to others. They will need to be evaluated for latent TB once they enter the U.S. Visa TB Classification: Class B2 TB, LTBI Evaluation.
If this skin test is positive (>=10 mm), a chest x-ray is required. If the chest xray suggests the child has TB, three sputum samples are taken to conduct TB smear and culture tests. Some children may not have a forceful enough cough to produce sputum samples, so gastric aspiration is done to obtain samples from the stomach for smear and culture testing.
Children who are 10 or younger who have a negative smear result can travel to the U.S. without further delay, while the TB culture is still growing. The CDC will follow up with their health provider to ensure that there is follow up on the culture results and any needed treatment.
Children who are 10 or younger who had a gastric aspiration done and had positive smear results can travel while the culture results are pending (because they do not have forceful enough cough to transmit TB to others.)
If the culture is positive, drug susceptibility testing is conducted. Directly observed therapy (DOT) for TB must be received prior to being given a visa to come to the United States. They are given a Class A Tuberculosis classification and can apply for an I601 waiver once treatment has begun.

For a child who is 10 or younger who has a positive smear result, chest xray showing on one or more cavities or widespread TB disease in the lungs, a forceful and productive cough, or contact with a person who has multi-drug resistant tuberculosis (MDR-TB), the child must wait for the TB culture to come back (6-8 weeks). If this TB culture is negative, the child can receive a visa.

Immigrant children without HIV who are 11-14

Required to have a medical history, physical, and TB skin test.
Children who have a positive skin test can still travel as long as the other TB tests do not suggest they are likely to spread TB to others. They will need to be evaluated for latent TB once they enter the U.S. Visa TB Classification: Class B2 TB, LTBI Evaluation.
If the culture is positive, drug susceptibility testing is conducted. Directly observed therapy (DOT) for TB must be received prior to being given a visa to come to the United States. They are given a Class A Tuberculosis classification and can apply for an I601 waiver once treatment has begun.

Children who are 11 or older who had a positive TB test and xray suggestive of TB have three sputum samples taken for smear and culture results. Some children may not have a forceful enough cough to produce sputum samples, so gastric aspiration is done to obtain samples from the stomach for smear and culture testing. They must wait until for the culture to come back negative (6-8 weeks) in order to be cleared to travel.

=15">Immigrant children without HIV who are >=15

Required to have a medical history, physical, and chest x-ray.
If the chest x-ray is suggestive of tuberculosis, or the child has signs or symptoms of tuberculosis, he or she must also provide three sputum samples for a smear and culture for TB. They must wait until for the culture to come back negative (6-8 weeks) in order to be cleared to travel.
If the culture is positive, drug susceptibility testing is conducted. Directly observed therapy (DOT) for TB must be received prior to being given a visa to come to the United States. They are given a Class A Tuberculosis classification and can apply for an I601 waiver once treatment has begun.

Travel clearances are valid for 3 months from the time the evaluation is complete for applicants who are Class B1 TB, Pulmonary or Class B1 TB, Extrapulmonary or who have HIV infection. Applicants who do not travel within the clearance period will need to restart the tuberculosis screening process.

Treatment:

Immigrants who are on treatment for TB due to identification during screening or prior treatment.

All applicants with pulmonary or laryngeal tuberculosis disease who need treatment overseas will need to complete directly observed therapy (DOT) prior to U.S. immigration.

Applicants diagnosed with possible tuberculosis disease who are smear and culture negative should not have treatment begun overseas unless the chest x-ray and clinical findings are highly suggestive of tuberculosis disease.

Applicants, including children, who are diagnosed with possible tuberculosis disease but have negative sputum smears and negative cultures, can be given consideration for not initiating therapy prior to departure. Treatment should only be initiated only if the CXR and clinical findings are highly suggestive of tuberculosis disease. Applicants who begin therapy under these circumstances should be re-evaluated clinically and radiographically after 2 months of treatment. Treatment should be continued only if there is evidence of clinical and/or radiographic improvement.

Applicants who present for the medical examination already on tuberculosis treatment begun elsewhere or applicants diagnosed with tuberculosis should transfer into a DGMQ-designated DOT program. As soon as patients transfer into the DOT program, they should provide three sputum specimens for AFB analysis and culture. Positive isolates should undergo drug susceptibility testing. If drug resistance is detected, the patient’s regimen should be modified accordingly. The patients should continue their treatment regimen according to the ATS/CDC/IDSA guidelines and provide sputum monitoring as described in the TB Technical Instructions.

Applicants treated at non-DGMQ-designated treatment sites will need to provide documentation of their treatment summary to demonstrate having completed tuberculosis treatment. A letter from a physician stating they were treated is not sufficient. Documentation of treatment should include: medication names, dosages of medications, dates of delivery of each medication, results of sputum smear, culture, and DST results performed by the nondesignated treatment center, reports of chest x-ray performed by the nondesignated treatment center. Without this documentation, the applicant may not be further considered for travel to the United States

TB Classifications

The tuberculosis classifications and descriptions are listed below. Applicants may have more than one TB Classification. However, they cannot be classified as both Class B1 TB and Class B2 TB. In addition, applicants cannot be classified as Class B3 TB, Contact Evaluation if they are Class A or Class B1 TB, Extrapulmonary.

No TB Classification: Applicants with normal tuberculosis screening examinations.

Class A TB with waiver : All applicants who have tuberculosis disease and have been granted a waiver.

Class B1 TB, Pulmonary: No Treatment: Applicants who have medical history, physical exam, or CXR findings suggestive of pulmonary tuberculosis but have negative AFB sputum smears and cultures and are not diagnosed with tuberculosis or can wait to have tuberculosis treatment started after immigration.

Class B1 TB, Pulmonary: Completed treatment: Applicants who were diagnosed with pulmonary tuberculosis and successfully completed directly observed therapy prior to immigration. The cover sheet should indicate if the initial sputum smears and cultures were positive and if drug susceptibility testing results are available.

Class B1 TB, Extrapulmonary: Applicants with evidence of extrapulmonary tuberculosis. The anatomic site of infection should be documented.

Class B2 TB, LTBI Evaluation: Applicants who have a tuberculin skin test ≥10 mm or positive IGRA but otherwise have a negative evaluation for tuberculosis. The size of the TST reaction or IGRA result, the applicant’s status with respect to LTBI treatment, and the medication(s) used should be documented. For applicants who had more than one TST or IGRA, all dates and results and whether the applicant’s TST or IGRA converted should be documented. Contacts with TST ≥5 mm or positive IGRA should receive this classification (if they are not already Class B1 TB, Pulmonary).

Class B3 TB, Contact Evaluation: Applicants who are a recent contact of a known tuberculosis case. The size of the applicant’s TST reaction or IGRA response should be documented. Information about the source case, name, alien number, relationship to contact, and type of tuberculosis should also be documented.

All medical documentation, including original laboratory reports, must be included with the required DS Forms.

All Class A and Class B1 tuberculosis conditions should be reported to the U.S. Embassy upon detection.

Only immigrants with a Class A Tuberculosis classification need to complete an I601 Application for Waiver of Grounds of Inadmissibility

I601 Waiver of Grounds of Inadmissibility

The I601 waiver form and supporting documents are required to obtain a visa for an immigrant who has a Class A Tuberculosis classification. This includes patients identified during the immigration screening process and those who have previously been identified as having TB and receiving treatment for TB.

Make sure you have the current form I-601 http://www.uscis.gov/files/form/i-601.pdf which can be found at the forms page of www.uscis.gov.

Applicants diagnosed with tuberculosis disease who are both smear-and culture-negative and will be traveling to the United States prior to start of treatment do not need to complete the waiver process.

In exceptional medical situations, a provision allows applicants undergoing pulmonary tuberculosis treatment to petition for a Class A waiver. Form I-601 must be completed. These petitions are reviewed by the Department of Homeland Security (DHS) (USCIS) on an individual basis and considered in situations with extenuating medical circumstances and also sent to the CDC for review. The CDC reviews the application and provides an opinion regarding the case to the requesting entity (Department of State or Department of Homeland Security). DHS (USCIS) then has the final authority to adjudicate the waiver request. “Because tuberculosis disease in young children is very challenging, CDC supports the filing of waiver requests for young children with tuberculosis disease so that the waiver request may be reviewed and adjudicated in a timely manner.”

All requests for waivers need to be accompanied by prior notification and approval by the U.S.-based physician accepting responsibility for the applicant’s continued care and treatment and the U.S. health department with jurisdiction.

Information about the process for the I601 waiver for health conditions can be found here: http://tinyurl.com/kpe7jl

I601 forms and instructions can be found here: http://tinyurl.com/2bexo7

I601 Application for Waiver of Grounds of Inadmissibility Instructions

Page 1

Section A- "The applicant" is the child. Unless you already have your final adoption decree, leave this area blank. This information will be about the child being adopted, but the spelling of names, birth date, etc. should match the official documents, so if you do not have the official documents when you are filling this out, leave it blank and you can fill it in later. The address is the child’s address in their country of origin. Question 10 a) Check “I have a communicable disease of public health significance.” (Only based on Class A tuberculosis classification.)

Page 2

Do not check anything.

Page 3

In the box, write that the child is inadmissible due to their Class A tuberculosis classification based on diagnosis and treatment of TB.

Page 4

Section A. Enter N/A or none in all of the sections, as applicable.

Section B is about the adoptive parents. If a married couple is adopting, use the parent's name that you listed as "the petitioner" on your I600A and I600 or I800a and I800. Relationship to applicant is adoptive father or adoptive father. Immigration status: usually U.S. citizen but could be permanent resident.

Section C is about the other adoptive parent. (If a single parent is adopting, leave this section blank.)

Page 5

Section C can be left blank.

Section D. If the child is 14 or older, he or she will sign and date. If the applicant is less than 14, the qualified relative/ legal guardian (section B on Page 4) should sign and date here.

Page 6: To be Completed by Applicants with Class A Tuberculosis Condition

Section A- Children who are 14 or older sign. If the child is younger than 14, the adoptive parent listed in on Page 4 Section B signs and dates.

Section B- Completed and signed by the physician, health department, or military hospital that will care for the child’s tuberculosis. A letter must also be attached on the facility’s letterhead that states that arrangement for treatment has been made for the applicant by his or her sponsor (family). Complete contact information must be included so the CDC can send this provider the necessary follow-up paperwork.

Section C- Address where the child will live in the U.S.

Section D- Should be signed by a state or local (county or city) public health department official responsible for the jurisdiction where the applicant will be living. Often you can find this person by looking up the public health department for your state or county (or in some cases, city), then looking for the part of the health department that handles tuberculosis surveillance or immigrant health. If nothing else, you can call this department and ask them who handles tuberculosis treatment and surveillance for the department and how to contact them. An officer from this department will need to sign and date this section and provide the complete contact information for the department.

The next 5 pages are exactly the same as pages 1-5 and should be completed the same way.

The waiver must be submitted with the current fee, $585 as of November 23, 2010.

Required "Supporting Evidence"

Evidence of applicant's relation to petitioner- Your adoption decree will fulfill this requirement.

Evidence of petitioner's legal status in the United States- Your I171H (or equivalent document) proves your US citizenship and will be presented with your waiver. Other proof would be a U.S. passport or permanent resident card.

Letter from the Department of Health and Human Services, Center for Disease Control, indicating they do not object to the alien's admission to the United States- You do not need to do anything for this. The Consular Section initiates this letter from the CDC.

Letter from the physician, health department, or military hospital that will be responsible for the child’s tuberculosis care. Must be on the facility’s letter head and state that arrangements for treatment have been made for the child by his or her sponsor (family). Complete contact information must be included so that the CDC can send this provider thenecessary follow-up paperwork.

These letters should be dated and addressed to "To Whom it May Concern". They do not have to be notarized..

G-28

The G-28 form allows Project HOPEFUL and an associated organization, Equality for Adopted Children, to contact the Federal agencies (usually USCIS, the State Department, and/or the CDC) on behalf of the affected child/ family in order to find out what is causing the waiver or processing of the child’s case to be delayed, with the aim of advocating for the efficient processing of these cases. Without a G-28 on file, we can not contact these Federal agencies. When complications arise while familes are in-country, it is at times difficult to quickly obtain the G-28 back from the family due to need for emailing and faxing and differences in time zones. Families may consider completing a G-28 in advance of travel when these complications are likely to occur (especially when a child with HIV needs a TB waiver completed).

Please contact Project HOPEFUL if there are any questions about this or if you will need to complete a G-28 form. Complete a separate G-28 form for each child for whom you may need assistance.

Other tips

It is a good idea to have a trusted person in the U.S. who is going to be available to call on your behalf if you need extra help (Senator's office, CDC, etc), and in that case you should also write another letter for that person stating that they can inquire on your behalf in regard to your adoption and immigration of your child/ children.

Since some email servers filter out “suspicious emails” or do not get through, when important communication is sent via email from outside of the U.S., set up and use more than one email address, for example a gmail and yahoo or gmail and hotmail, or combination of personal and work emails.

Resources:

Information about the CDC Tuberculosis screening and treatment guidelines can be found here: http://www.cdc.gov/immigrantrefugeehealth/exams/ti/panel/tuberculosis-panel-technical-instructions.html

CDC Frequently Asked Questions document on International Adoptees and Tuberculosis screening: http://www.cdc.gov/immigrantrefugeehealth/exams/adoptees-tuberculosis-screening-faq.html