IGRA is the preferred test in those that have received prior BCG vaccination as results are not affected by prior vaccination. In addition, IGRA is the required test for the applicant medical exam. Prior BCG vaccination does not factor into the decision to treat LTBI.

According to the CDC Tuberculosis Technical Instructions for Civil Surgeons, an indeterminate test result must be documented as indeterminate and not result in repeat testing by the civil surgeon, chest x-ray, or B2 classification. However, applicants with an indeterminate test result should be advised to have a repeat test. The IGRA test used and results must be documented in Part 8, A. 1 of the I-693, even for those with negative or indeterminate results.

Per the CDC Tuberculosis Technical Instructions for Civil Surgeons, “Women who are pregnant and have a positive IGRA or any of the other conditions listed above are required to have a chest x-ray to adjust status. Women who are pregnant may postpone the required chest x-ray (and status adjustment medical examination) until after pregnancy but are required to have a chest x-ray to adjust status if they meet one of the above criteria. Civil surgeons must obtain consent from pregnant women before performing a chest x-ray. Pregnant women undergoing chest radiographs must be provided abdominal and pelvic protection with two lead shields that fully wrap around their abdomen and pelvis.”

Although immune-suppressive medications, including TNF-alpha inhibitors or steroids, may reduce the accuracy of an IGRA result, there are no specific recommendations in the Technical Instructions regarding applicants receiving these drugs. A person on biologics or steroids with a negative IGRA should be given a careful medical evaluation and physical exam looking for signs and symptoms of TB; if none are present, the applicant does not need additional testing or reporting/referral to a local health department.

IGRA specificity (i.e., the ability to correctly identify persons without TB infection) is excellent; depending on the type of IGRA test, it is usually reported as >95%. Particularly when used in a population with higher TB risk (e.g., those born or residing in TB endemic countries), this means that false positives are uncommon. The test’s specificity is not impacted by prior BCG vaccination, making IGRAs preferable to TB skin tests (TSTs) for diagnosing LTBI in people born outside the U.S. and who may have previously received BCG.

Any applicant who had to provide sputum specimens for TB evaluation, cannot be cleared until the applicant returns from the local health department or designated referring provider with documentation of the final results of his or her tuberculosis disease evaluation.

Per the CDC Tuberculosis Technical Instructions for Civil Surgeons, “applicants who have documentation of being diagnosed and completing treatment for LTBI prior to the civil surgeon examination must have a chest x-ray as part of the civil surgeon evaluation. If the chest x-ray is negative and the applicant does not have signs or symptoms of tuberculosis disease or known HIV infection, the applicant does not have to be diagnosed with LTBI or reported to the health department and can be classified as “No Class A or Class B TB.”” Note that applicants that have documentation of LTBI treatment, but do not have documentation of IGRA, will require both an IGRA and a chest x-ray (regardless of IGRA results) as part of the status adjustment process.

There is no time limit for when an applicant was treated for LTBI, however civil surgeons need to confirm appropriate documentation of testing/treatment and perform a chest x-ray in all of these applicants.

For the purposes of the Civil Surgeon Exam, civil surgeons can perform the IGRA without regard to vaccinations, including COVID-19 vaccine. Per the CDC, testing for TB infection can be done before, after, or during the same encounter as COVID-19 vaccination.

It is important to provide LTBI education and strongly encourage treatment to applicants who are recently diagnosed. This may include explaining the differences between LTBI versus TB disease, benefits of treatment, and provide treatment or linkage to care options.

Civil surgeons are required to notify the applicants that their LTBI diagnosis will be reported to the health department. It is advised that civil surgeons let applicants know that the health department might be contacting them for follow-up, as some health departments will conduct outreach to those with LTBI.

LTBI treatment is not required to complete the status adjustment process; however, civil surgeons are required to: 1) communicate positive IGRA results to the applicant; 2) inform applicants that their LTBI diagnosis has been reported to the health department; 3) report the LTBI diagnosis and results to the local health department of the applicant’s jurisdiction; and 4) advise the applicant that follow-up treatment is important to prevent TB disease.

While LTBI treatment cannot be enforced, civil surgeons can play an important role in providing education to applicants on their LTBI diagnosis, their risk for TB disease, the LTBI treatment options and the recommendation that they receive and complete treatment.

Information on LTBI treatment regimens, along with dosing information can be found at: https://www.cdc.gov/tb/topic/treatment/ltbi.htm.

Similar to when using INH alone, vitamin B6 (pyridoxine) supplementation is recommended in the presence of conditions associated with or at risk of developing neuropathy (e.g., diabetes, renal failure, alcoholism, pregnancy or breastfeeding women). Pyridoxine can be administered once weekly with the rest of the 3HP regimen.

The above description is of an applicant with LTBI. Effective treatment options include: 1) rifampin daily for 4 months; 2) INH + rifapentine weekly for 3 months; or 3) INH daily for 6-9 months. In determining the best regimen to prescribe, the civil surgeon should evaluate an applicant’s co-morbidities, drug-drug interactions, length of treatment and the likelihood of adherence. In general, the shorter regimens are preferred, due to the convenience, lower risk for hepatotoxicity and greater chance for completion of treatment. Additional information on LTBI treatment options can be found at: Treatment Regimens for Latent TB Infection (https://www.cdc.gov/tb/topic/treatment/ltbi.htm) and LTBI Treatment (https://www.cdph.ca.gov/Programs/CID/DCDC/Pages/TB-LTBI-Treatment.aspx).

Please note that the evaluation of a person living with HIV is to refer the applicant to the local health department for sputum collection. If the applicant is eventually diagnosed with LTBI based on sputum results, then the preferred LTBI treatment is INH x9 months; however, the shorter course LTBI regimens may be possible after consultation with an HIV specialist. Additional information of LTBI treatment in persons living with HIV can be found at: https://hivinfo.nih.gov/understanding-hiv/fact-sheets/hiv-and-tuberculosis-tb#:~:text=What%20is%20the%20connection%20between,TB%20in%20people%20with%20HIV

There are no specific age limitations for LTBI treatment; however, providers should consider several factors when recommending LTBI treatment to elderly applicants:

A) What is the risk of progression to active TB?

Applicants who have a newly positive test within 2 years of a negative test, recent contacts to individuals with active TB disease, individuals with immunosuppression (HIV, chemotherapy, transplant, TNF-antagonist, steroids) and persons with diabetes should be given high priority for LTBI treatment. One should also consider the predicted lifespan of an individual and the likelihood that they will develop additional risk factors (e.g., diabetes, immunosuppression, renal disease) that increase the chance for reactivation TB.

B) What are the risks for toxicity of LTBI treatment?

Providers should consider an applicant’s underlying risk for toxicity (e.g., liver, drug-drug interactions) and determine if this outweighs the individual’s risk for reactivation of TB.

Baseline laboratory testing is not routinely indicated for most applicants. However, baseline hepatic chemistry is recommended for applicants with specific conditions (e.g., HIV, liver disorders/disease, hepatitis B/C, alcohol use, immediate postpartum; consider for older persons or those taking other potential hepatotoxic medications). Baseline testing in applicants taking medications for chronic medical conditions should also be considered.

Providers should consider performing baseline hepatitis B, hepatitis C, HIV, and diabetes screening as this may affect treatment decisions, duration and monitoring. Applicants with abnormal hepatic chemistry or increased risk for hepatic disease should be monitored at regular intervals.

Applicants receiving LTBI treatment should be counseled on the signs and symptoms of hepatoxicity and evaluated at least monthly for adherence, signs and symptoms of TB disease and adverse reactions.

Additional information on baseline labs and monitoring can be found at: https://www.cdph.ca.gov/Programs/CID/DCDC/Pages/TB-LTBI-Treatment.aspx, https://ctca.org/guidelines/guidelines-latent-tuberculosis-infection-guideline/, or https://www.cdc.gov/tb/topic/treatment/ltbi.htm.

There are no specific requirements of the civil surgeon following LTBI treatment completion. LTBI treatment completion is not a requirement to complete the I-693 form and civil surgeons should not delay the completion of this form based on LTBI treatment outcomes. Repeat IGRA after LTBI treatment completion is not recommended as many applicants will remain positive following adequate treatment. We strongly encourage treating providers (whether the civil surgeon or other provider) to communicate LTBI treatment start and completion information to the local health department, using the “Referral and Treatment Report for LTBI” form found here: https://ctca.org/civil-surgeons/linkage-to-care-and-ltbi-referrals/. If the civil surgeon is the treating provider, they can also update treatment information in the CalREDIE provider portal.

Providers should consider performing baseline hepatitis B, hepatitis C, HIV, and diabetes screening as this may affect treatment decisions, duration and monitoring. Applicants with abnormal hepatic chemistry or increased risk for hepatic disease should be monitored at regular intervals.

Applicants receiving LTBI treatment should be counseled on the signs and symptoms of hepatoxicity and evaluated at least monthly for adherence, signs and symptoms of TB disease and adverse reactions.

Additional information on baseline labs and monitoring can be found at: https://www.cdph.ca.gov/Programs/CID/DCDC/Pages/TB-LTBI-Treatment.aspx, https://ctca.org/guidelines/guidelines-latent-tuberculosis-infection-guideline/ or https://www.cdc.gov/tb/topic/treatment/ltbi.htm

If the civil surgeon is not the treating provider (e.g., the civil surgeon referred the applicant to the health department or to another provider for consideration of LTBI treatment), then the civil surgeon does not need to confirm that the treatment was initiated or completed.

The civil surgeon should document the applicant’s status with respect to LTBI treatment (e.g., treatment or referral plans) on page 7 of the I-693 form. Note: civil surgeons can treat or refer applicants for LTBI treatment, but applicants do not have to start or complete treatment before they are medically cleared and their I-693 forms are completed, because LTBI is not a Class A condition.

If an applicant may have completed LTBI treatment in the past prior to the Civil Surgeon exam, having a history of LTBI, the Civil surgeon examination must have a clear chest x-ray as part of the civil surgeon evaluation. If the chest x-ray is negative and the applicant does not have signs or symptoms of TB disease or known HIV infection, the applicant does not have to be diagnosed with LTBI or reported to the health department and can be classified as “No Class A or Class B TB.” However, the prior treatment of LTBI should be documented.

The Tuberculosis Technical Instructions for Civil Surgeons states the following regarding Class B2 TB, Latent TB Infection within the Tuberculosis Classifications section:

Class B2 TB, Latent TB Infection

Applicants who have a positive IGRA, or history of a positive IGRA, and a chest x-ray not suggestive of tuberculosis disease. The IGRA result, the applicant’s status with respect to LTBI treatment, and the medication(s) used must be documented. For applicants who had more than one IGRA, all dates and results must be documented. All of these applicants must be reported to the health department of jurisdiction. The civil surgeon can treat these applicants for LTBI or refer them for treatment elsewhere, but the applicants do not have to complete treatment before they are medically cleared and their I-693 forms are completed, because LTBI is not a Class A condition.

Documentation should reflect whether applicants have received, completed, or declined recommended LTBI treatment for completion of the I-693 form.

Documentation of LTBI treatment should be completed on the I-693 form whether with a remote history of treatment, if treatment was received prior to Civil Surgeon exam, or declined as referred by the Civil Surgeon/recommended by the Health Department.

From CDC’s standpoint, for the I-693 Medical Examination, all components should be current and completed by the civil surgeon. This includes the physical examination, all required testing, as well as the next dose of any age-appropriate required vaccines. All tests, including the chest x-ray, should be ordered and completed at the time of the I-693 medical examination and those results should be reported on the I-693 medical examination form.

Further, any laboratory testing should be performed only at the civil surgeon’s designated laboratory. Outside chest x-rays and laboratory testing are not accepted for the purposes of this exam. The examination is essentially a snapshot in time and the tests should reflect the applicant within that snapshot and should also be performed with safeguards to prevent fraud.

All components of the I-693 exam completed by a civil surgeon are valid for 1 year; if the results are over a year old, they will need to be repeated by the civil surgeon. Exceptions include applicants with written documentation from a physician of a previous positive IGRA. For past positive IGRA results, the written documentation must include date of the test, type of IGRA performed, test results in standard units of measurement, the test interpretation (e.g., positive, negative, indeterminate, borderline), and the testing physician’s name, signature, and office information.

The Civil Surgeon should be directed to the Tuberculosis Technical Instructions to Civil Surgeons to understand the instructions for tuberculosis screening and treatment of all applicants. If there are no medical records available, a complete screening medical examination for tuberculosis disease should be performed. This includes medical history, physical examination, interferon gamma release assay (IGRA) if 2 years old or older, chest radiography (chest x-ray) when required, and referral to the health department of jurisdiction when required.

All applicants <2 years of age must have a physical examination and history provided by a parent or responsible adult who knows the child best. Those applicants who have signs or symptoms suggestive of tuberculosis disease or have known human immunodeficiency virus infection (HIV) infection must have a TST or IGRA, must have a chest x-ray (anteroposterior or posteroanterior view and a lateral view), and must be reported to the health department of jurisdiction for further evaluation.

Yes. Per USCIS, civil surgeons are required to provide a copy of the completed I-693 to applicants.