TB Intensive :: Technical Instructions :: San Antonio, TX :: October 11

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EXCELLENCE EXPERTISE INNOVATION

TechnicalInstructions

JoaquinCervantes,MD,MPHOctober13,2016

TB IntensiveOctober 11‐14, 2016San Antonio, TX

• No conflict of interests

• No relevant financial relationships with any commercial companies pertaining to this educational activity

JoaquinCervantes,MD,MPH,hasthefollowingdisclosurestomake:

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CDC Immigration Requirements:

Technical Instructions forTuberculosis Screening and Treatment

Joaquín Cervantes, MD, MPH

Panel Physician

Tuberculosis Clinical Leader

Clínica Médica Internacional | Fundación Amor‐ProTB

Objectives

•Describe the CDC TB Technical Instructions (TI)

•Understand the application of Tis for TB screening.

•Explain the application of the TIs for Directly Observed Therapy.

•Guidelines of clearance for travel.

•Discuss the impact on US TB care that occurred from implementation of the TIs

• Current Projects (B1/B2) – Panel Site / State Department / CDC

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Disclosures

No Conflict of Interests to Disclose.

Medical Screening Overseas

•The CDC in the U.S. Department of Health and Human Services (HHS),

established requirements for medical examination of aliens before they may be

admitted into the United States.

• U.S. policy focus pre‐entry screening to long term entrants to US; this means

those applying for LPR (legal permanent residency) status (also known as green

card applicants) and refugees.

Centers of Disease Control and Prevention (CDC). Addendum to the Technical Instructions for Medical Examination of Aliens, October 6, 2008.Atlanta, Georgia.

Dr. Barbara Seaworth: Technical Instructions. Slide set May, 2014.

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Panel Physician (Definition)

•Medically trained, licensed and experienced doctor practicing

overseas, who is appointed by the local U.S. Embassy or Consulate

(Private Practice).

•These medical professionals receive U.S. immigration‐focused

training in order to provide examinations as required by the Centers

for Disease Control and Prevention (CDC) and U.S. Citizenship and

Immigration Services. (USCIS)

Role of Panel Physician

•One of the top priorities of the Panel Physician is tuberculosis

screening (B1, B2, B3).

•Panel Physicians must detect and treat tuberculosis disease among

immigrants in order to reduce the spread of TB among the U.S.

population.

Centers of Disease Control and Prevention (CDC). Addendum to the Technical Instructions for Medical Examination of Aliens, October 6, 2008. Atlanta, Georgia.

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Keep in Mind…

“Detection of tuberculosis disease necessitates a combined clinical

and public health response to cure individual tuberculosis patients,

stop transmission and enable safe movement to the United States”.


CDC TI´s 2009

•Technical Instructions (TIs) provide specific instructions for panel

physicians conducting the immigrant visa medical examination.

•The purpose of the Immigration Medical Exam is to identify the

presence of disorders that could result in exclusion from the U.S.

under the Immigration and Nationality Act (INA).

•CDC writes TIs and monitors panel physician compliance and quality.

Olson, Christine. 2013, Transitioning to the Culture and DOT Tuberculosis Technical Instructions: The New U.S. Requirements In Practice. CDC. DGMQ.

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Transition from TIs:2007 to 2009

Procedure 1991 TB TI

TST No

Chest X‐ray ≥ 15 years of age

Laboratory Smear Microscopy

TB TreatmentLimited requirements

DOT not necessary

PregnancyRefuse CXR and recommend TST upon

arrival.

Dr. Barbara Seaworth: Technical Instructions. Slide set May, 2014.

Algorithm for TB Screening(2009)

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Facts from the CDC (DGMQ)

•After 2009 TB TI´s implementation, the incidence of TB among the FB has declined in the US

(should put in a graph showing this)

•Each year, approximately, 450,000 immigrants and 70,000 refugees enter the US after being

screened at a panel site.

•Approximately 1,100 cases of TB were diagnosed during 2012 on their overseas exam. About

60% of those were smear negative/culture positive cases. Of those cases, 14 were MDR.

•Successful implementation of this screening program: savings in excess of $15 million yearly.

Posey, D., Naughton, M., Willacy, E., Russell, M., Olson, C., Godwin, C., . . . Cetron, M. (2014). Implementation of New TB Screening Requirements for U.S. ‐ Bound Immigrants and Refugees ‐ 2007‐2014. Morbidity and Mortality Weekly Report (MMWR), 63(11), 234‐236. Retrieved October 10, 2015, from http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6311a3.htm

More Facts!

•Retrospective study from records of 122 patients with active TB disease

diagnosed at CMI from 2009 – 2012.

•All cases confirmed by culture.

• 80% were smear negative and 20% smear positive.

•8 out of 10 cases would have been missed if sputum smear was the only

diagnostic tool in these patients with abnormal chest X‐rays. (Almost everyone is

asymptomatic at their immigration exam).

Roberto Assael, MD, Joaquin Cervantes, MD, Gerardo Barrera, MD. Smears and cultures for diagnosis of pulmonary tuberculosis in an asymptomatic immigrant population. Clinica Medica Internacional, 2013. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3783499/

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Year B1,TB Pulmonary B2 TB LTBI

2007 133 340

2008 746 2639

2009 380 1079

2010 580 1111

2011 860 1354

2012 1030 1021

2013 747 681

2014 677 565

2015 981 734

2016 182 332

Total 6316 9856

Year Total Applicants Total pTB DST

2012 44,034 201 MDR

1 Monoresistant

2013 37,943 161 Polyresistant2 Monoresistant

2014 34,275 121 MDR

1 INH‐resistant

2015 48,948 221 Monoresistant 1 Polyresistant 1 INH‐resistant

Total 165,200 70 42 x 100,000

TB Classification / Diagnoses at CMI

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Courtesy of Clinica Medica Internacional

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Courtesy of Clinica Medica Internacional

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Application of Technical Instructions for TB Screening.

•There are three main components of the TB screening at a Panel Site.

–Medical History

– Physical Examination.

– Chest Radiography.

•On children 2 ‐ 14 years old, the TST or an IGRA test must be performed.

– Positive TST or IGRA = Chest X‐Ray


Application of Technical Instructions for TB Screening. (Cont´d)

If an applicant has at least one of the following:

◦ Any signs and symptoms of TB.

◦ HIV infection.

◦ Suspicious CXR.

Then, applicant needs to provide three sputum samples for smears

and cultures.


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Application of Technical Instructions for TB Screening. (Cont´d)

If an applicant is 2‐14 years old, only a CXR is required if:

◦ Positive TST (>10mm of induration).

◦ Positive IGRA (Tspot or QF‐gold).

Suspicious CXR or HIV or Signs and symptoms, sputum smears and

cultures are required.


Application of Technical Instructions for Cultures and DOT. •Three sputum specimens should be examined for AFB microscopy AND

cultures.

•Confirmation of Mycobacterium species, at least M. tuberculosis complex

level is required.

•Specimens reported as negative‐smears should be cultured for 6 to 8

weeks.


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Application of Technical Instructions for Cultures and DOT. (Cont´d)

After a positive culture is reported, DST has to be performed at least

for the following:

◦ INH, RIF, EMB, PZA and Streptomycin.

Cultures resistant to INH and RIF should undergo DSTs at least for:

◦ Ethionamide, a Quinolone, Amikacin, Capreomycin and PAS.


Courtesy of: Laboratorios Medicos Especializados (LME)

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Courtesy of: Laboratorios Medicos Especializados (LME)

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•Applicants with positive smears or cultures must be treated prior to

entry into the United States.

•Applicants who DO NOT want to be treated, may NOT be cleared for

travel.

•In this case, local authorities will be notified to assure treatment on

the applicant.


•Applicants diagnosed with active TB disease may undergo treatment

at a DGMQ approved facility.

•Treatment must be compliant with the CDC guidelines and ATS

standards.

•Every Patient with Resistant TB Disease should be managed under

the guidance of a TB consultant from any RTMCC.

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•What if an applicant refuses treatment at DMGQ‐approved

treatment facility?

•Clinic will contact CDC´s CureTB Program in order to assure

connection back to the applicant´s home jurisdiction in Mexico.

•Key point: applicants have connection in the U.S. and it is important

to assure treatment, even if they don´t end up migrating.


•What happens if applicant is not treated at DGMQ‐approved facility?

•Applicant must wait for 1 year after treatment completion in order

to get a visa.

•Panel Physician must follow treatment and assure continuity of care.

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Clearance for Travel

Waivers for Class A patients with TB disease

•A provision allows applicants undergoing pulmonary or laryngeal

tuberculosis treatment to petition for a Class A waiver.

•Any immigrant who has a complicated clinical course and would

benefit from receiving TB treatment in the United States can pursue

a waiver.

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Impact of TI´s in US Domestic TB Care

Rates of Patients with TB in U.S.‐born vs. Foreign‐born Persons, United States, 1993 – 2012*

*Updated as of June 10, 2013.

Cases per 100,000

0.0

5.0

10.0

15.0

20.0

25.0

30.0

35.0

40.0

U.S. Overall U.S.‐born Foreign‐born

Dr. Kathleen Moser: TB Screening and US Follow‐up. Slides March, 2014.

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Number and rate of newly diagnosed TB cases among U.S.‐born and foreign born persons, by year.

*Updated as of March 20, 2015

Centers for Disease Control. Trends in Tuberculosis, 2014.

Impact on US Domestic Tuberculosis Control (2007‐present)

• Diagnose ~1,000 applicants each year in Culture and DOT TB

programs ‐ these applicants are treated overseas

• Prevents approximately ~40 MDR TB patients yearly based on MDR

TB rate of 4%

• Approximate cost savings to US domestic programs

• $13 ‐ $30 millionDr. Christine Olson: Transitioning to the CDOT TB TI. Slides March, 2014.

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Clinical Cases at CMI

*Before CDC´s recommendation on TB Management at a single DGMQ approved facility)

Case #1

• 40 year‐old, HIV‐negative, Hispanic Male.

•History of Cocaine and Crystal Meth use, in sustained remission

since the age of 34.

•History of Pulmonary TB (Smear 1+) 10/21/2013. Treated for 6

months with 1st‐line TB drugs. No Cultures, No DST.

•Apparently treated by DOT (no records available).

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Case #1 (Cont´d)

•Chest X‐Ray:

• Nodular image (1.3x1.0 cm) over left peripheral lung. Alveolar infiltrate and

small fibrotic changes on right upper lobe. Right hilar retraction. Partial

obliteration of right costophrenic angle.

•Three sputum samples were collected:

• Smears were reported negative. Cultures grew positive for MTB complex.

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Case #1 (Cont´d)

•Applicant came to CMI with family members:

•Wife (40 years‐old), Son (18 years‐old) and Daughter (7 years‐old).

•None of them had a significant past medical history and no contact

investigation was ever conducted.

•All of them had Positive IGRA´s (T‐Spot) with a TB Response >20.

Case #1 (Cont´d)

•Chest X‐Rays were normal, with no evidence of active tuberculosis.

•Applicants were classified as Class B2, LTBI Evaluation.

•Intended U.S. City and State: Somerton, Arizona.

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New Project: B1 / B2 Referrals

•Understanding the scope and the purpose of this project.

•Main problem: Applicants can be hard to locate after they enter the United States and, therefore, health

departments may lose the opportunity to follow up

•Information about how to find the entrant provided by:

• Panel Sites –Applicant – Consulate – Custom and Border Protection agents – Quarantine Station – Jurisdiction.

• Identify better system and tools to streamline post‐entry follow‐up

• Expanded information on forms – to help health departments find entrant

• Database from National TB Controllers Assoc?‐ to help entrants locate correct health department

• Educate applicants at Panel Sites – to help them know why post‐entry follow‐up is important

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New Project: B1/B2 Referrals

Sample Form Attached to Visa Packet.

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Conclusions

•The Technical Instructions are a key factor for success of TB

elimination among immigrants screened overseas.

•Panel Physicians are compliant with the CDC and ATS standards for

the diagnosis and treatment of TB.

•New ideas have been created by CMI to strengthen communication

with National and foreign organisms to fight against TB.

And Remember…

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Thank you!

Joaquín Cervantes, MD, MPH

jcervantes@grupo‐cmi.com

Mex: +52 (656) 227‐2807

US: +1 (915) 799‐7311

Documents

TB Intensive :: Technical Instructions :: San Antonio, TX :: October 11