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EXCELLENCE EXPERTISE INNOVATION

TechnicalInstructions

KathleenMoser,MDMay11,2017

TB IntensiveMay 9‐12, 2017San Antonio, TX

• No conflict of interests

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

KathleenMoser,MD,hasthefollowingdisclosurestomake:

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Thursday May 11, 2017

Kathleen Moser, MDUS-Mexico Unit

Division of Global Migration and Quarantine (DGMQ)Centers for Disease Control and Prevention

Overseas Medical Screening

National Center for Emerging and Zoonotic Infectious Diseases

Division of Global Migration and Quarantine

Learning Objectives

Overseas Screening Process

After this session, you should understand the role of DGMQ in the:

Tuberculosis Technical Instructions (TBTIs)

Class B Notification and Follow-up Process

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Overseas Screening Process

Quarantine and CDC

Public Health Service Act of 1944 Established federal government’s

quarantine authority PHS given responsibility for preventing the

introduction, transmission, and spread of communicable diseases from foreign countries into the United States

Quarantine moved to CDC in 1967 Division of Global Migration and Quarantine (DGMQ)

current holder of these authorities Quarantine and “health-related grounds for

inadmissiblity” always separate from “immigration”

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Background Each year, approximately 400,000 immigrants and

50,000 refugees enter the United States DGMQ has regulatory authority to stipulate the

requirements of the overseas medical examination via Technical Instructions

The Bureau of Population, Refugees, and Migration (BPRM) is the US State Department Bureau responsible for refugee resettlement

BPRM contracts the International Organization for Migration (IOM) to perform the medical screening for approximately 80% of the refugees

Panel physicians are using Technical Instructions for Tuberculosis (TB TIs) issued 2007

Estimated Annual International Arrivals, U.S.A. 2015

Non-immigrant admissionsTemp. Workers and Families – 3.7 M

Students Visa – 1.9 M Others - 175 M

Immigrants>1,000,000

Refugees69,920

Source: U.S. Department of Homeland Security

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Tuberculosis Cases, United States, 1996-2015

0%

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2015 TB rates:Total 3.0 per 100,000

US-born 1.2 per 100,000Foreign-born 15.1 per 100,000MDR TB: 86.3% Foreign-born

Top 15 Source Countries of Foreign Born Populations in the United States, 2010

Source: American Community Survey 2006-2010

Country No. of FB % of US FB Population

Mexico 11,566,960 29.9%

China 2,047,251 5.3%

Philippines 1,751,981 4.5%

India 1,696,057 4.4%

Vietnam 1,174,884 3.0%

El Salvador 1,133,462 2.9%

Korea 1,071,527 2.8%

Cuba 1,003,052 2.6%

Canada 826,000 2.1%

Dominican Republic 802,001 2.1%

Guatemala 777,073 2.0%

Jamaica 641,849 1.7%

Germany 627,569 1.6%

Colombia 625,906 1.6%

Haiti 542,091 1.4%

Other 12,387,110 32.0%

Total of Top 15 Birth Countries 26,287,663 68.0%

Total US Foreign-born population 38,674,773

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TB Technical Instructions (TIs)

Susan Maloney et. al. Arch Intern Med. 2006;166:234-240

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Culture and Directly Observed Therapy TB Technical Instructions

Sputum smears and cultures (3)

All (-) One or more (+)Valid for travel

within 3 months

DOT until cured

Class A Waiver

If TB rate ≥20/100,000 and

2-14 years of age:TST ≥10 mm or positive IGRA

HIV orTB signs or symptoms

NoninfectiousClass B1

InfectiousClass A

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Implementation Strategy

Globally

Initially target large-volume, high-burden source countries

Ultimately implement in all countries

In country

Develop culture and DOT infrastructure

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Laboratory Testing

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Panel Physician Laboratory Capacity Building

New laboratories China (5), India (5), Kenya, Malaysia,

Mexico, Nepal, Thailand (2), Vietnam

Greatly expanded laboratories Dominican Republic, Ethiopia, Ghana,

India (2)

Laboratories performing 2nd line DST China (Guangzhou), Kenya, Mexico, Nepal,

Thailand, Vietnam

Directly observed therapy for tuberculosis

TB Treatment Programs

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Education Programs Basic tuberculosis education Regional Training and Medical Consultation

Centers (RTMCC) “Clinical Intensive” courses Attended by >50 panel physicians since 2009

Annual Training Summits – 12 since 2008 International Panel Physicians Association (IPPA)

Webinars 12 conducted since 2010 Accessible through LinkedIn

Panel Physicians Portal: http://www.cdc.gov/panelphysicians/index.html

Online training modules

2016

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MAP Trips During FY 2016

AsiaBurmaIndia (2)Nepal (2)Malaysia (2)Indonesia (lab)Taiwan (lab)South Korea (lab)Vietnam (lab) Thailand (lab)

Middle EastEgypt (lab only)Pakistan (lab only)

EuropeItalyCzech RepublicUkraineGreece*

AmericasDominican

Republic (2)

El Salvador

Honduras

Mexico

Peru

Bolivia*Africa

Rwanda (2)

Zambia

Morocco (2)

South Africa

Kenya

Tanzania

Sierra Leone*

Morocco (lab)

Egypt (lab)

28 Countries Visited

2014 TB Indicators

631,100 applicants screened 3.9% chest radiographs suggestive of TB

1,450 applicants with TB disease Rate 230 per 100,000 screened

1,131 culture-positive TB cases 802 (71%) were smear-negative

Drug resistance 276 (19%) resistant to ≥1 drug

44 MDR-TB (3%)

1 XDR-TB (0.07%)

Preliminary data courtesy Ms. Michelle Russell, DGMQ

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Tuberculosis and MDR TB Rates, WHO and U.S. Screening

CountryFY 20151

Arrivals

WHO – Country of screening2

US Screening3

TB Rateper 100,000

MDR TBRate

TB Rate per 100,000

MDR TB Rate

Mexico 81,122 21 2.6% 41 2.4%

Dominican Republic 43,187 60 3.0% 66 0%

Philippines 35,935 322 2.6% 1133 1.2%

China 38,025 65 6.6% 255 3.1%

India 27,798 278 2.5% 78 7.7%

Vietnam 24,757 137 4.1% 952 3.8%

1Department of Homeland Security, October 1, 2014 through September 30, 2015  2WHO Country Profiles, 2015.  MDR TB rate is rate among new cases. 3TB Indicator data, all Class A TB cases, January 1, 2015 – December 31, 2015 

Worldwide, panel physicians diagnose >1,500 cases yearly ≈72% smear-negative, culture-positive

Liu et al. Annals of Internal Medicine 2015.

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Class B Notification and Follow-up Process

What is the Electronic Disease Notification (EDN) System?

DGMQ has responsibility to provide information to receiving health departments (HD) of arrivers with a TB condition

An electronic system to fulfill DGMQ’s regulatory responsibility

Provide HD access to medical forms from Panel/IOM examinations

Provide HD with an electronic system to record outcome of domestic follow-up evaluations

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EDN

Overseas U.S.

Data Entry CenterCDC HQ - Atlanta

EDN – DATA ENTRY

OverseasScreening

OverseasForms

Local/State Health Departments

EDN – WEBEDN-IOM Interface

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EDN

Health Departments and Quarantine Stations contact IRMH with problems or request additional information

IRMH has direct contact with panel physicians and consular sections overseas

Health Departments provide feedback on medical packages which need immediate follow-up

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What’s Next for Tuberculosis?

eMedical

Overseas U.S.

OverseasScreening

Local/State Health Departments

EDN – WEBEDN-IOM Interface

eMedical

Data Entry CenterCDC HQ - Atlanta

EDN – DATA ENTRY

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0%

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U.S.‐born Foreign‐born % Foreign‐born

2007-2013: New CDC TB Technical

Instructions published and implemented

Recent Upgrades to the TB Screening Infrastructure Confirm It Can Be Successfully Modernized and Improve Prevention

Update to Tuberculosis Technical Instructions

Update panel physician TB TI

Improve readability and clarity

Address important issues: Role of tuberculin skin test and interferon gamma release

assay

LTBI testing of applicants ≥15 years of age

Role of molecular tests

Referrals to health departments

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Implementation of Updated TB TI

Receive input from TB TI Working Group

Develop new Technical Instructions over next several months

If changes require additional panel physician resources –

Implement October 1, 2018

Panel physicians use IGRA

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Immigrant and Refugee Children with LTBI, 2010

• Taylor EM, et al. J Immigrant Minority Health 2015 DOI 10.1007/s10903-015-0273-2

Children diagnosed overseas8,231

Post-arrival evaluation5,749 (70%)

LTBI diagnosed or confirmed stateside3,299 (57%)

LTBI therapy initiated2,258 (68%)

LTBI therapy completed680 (30%)

Preventing TB Overseas Pilot Study (PTOPS)

Latent Tuberculosis Infection Testing and Voluntary Treatment for U.S-Bound Immigrants from Vietnam

Purpose: assess the acceptability and feasibility of offering LTBI treatment to U.S.-bound immigrants prior to U.S.-arrival

Partners CDC Division of Global HIV/AIDs and Tuberculosis

CDC Division of Tuberculosis Elimination

CDC Division of Global Migration and Quarantine

Cho Ray Hospital Visa Medical Department

Vietnam NTP- UCSF Research Collaboration

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Long-Term Visitor Screening

Estimated Annual International Arrivals, U.S.A. 2015

Non-immigrant admissionsTemp. Workers and Families – 3.7 M

Students Visa – 1.9 M Others - 175 M

Immigrants>1,000,000

Refugees69,920

Source: U.S. Department of Homeland Security

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Implementation Requirements

Policy Coordination with other Federal departments

• Department of State (DOS)

Regulatory change may be needed

Overseas Build panel physician capacity

Train panel physicians

Evaluate and monitor

Acknowledgments

• Immigrant, Refugee, and Migrant Health Branch,

Medical Assessment and Policy Team

– Zack White

– Mary Naughton

– Drew Posey

– Joanna Regan