Microsoft Word - RVCT Self-Study Modules Participant Manual Final.doc

CDC Tuberculosis Surveillance Data Training

Report of Verified Case

Report of Verified CaseReport of Verified Case

Report of Verified Case

of Tuberculosis (RVCT)

of Tuberculosis (RVCT) of Tuberculosis (RVCT)

of Tuberculosis (RVCT)

Self-Study Modules

Participant Manual

This manual is designed to help health care staff learn how to accurately complete the

RVCT. Included are the instructions for how to complete each item on the RVCT and

exercises that will help you apply the instructions to life-like situations.

June, 2009

U.S. Department of Health and Human Services

Centers for Disease Control and Prevention

National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention

Division of Tuberculosis Elimination

Mycobacterium tuberculosis

This document was prepared by

The Report of a Verified Case of Tuberculosis (RVCT) Instructions and Self-Study Modules were

prepared by the following branches within the Centers for Disease Control and Prevention (CDC),

Division of Tuberculosis Elimination:

Surveillance, Epidemiology, and Outbreak Investigations Branch

Elvin Magee, MPH, MS

Lilia P. Manangan, RN, MPH

Carla Winston, PhD

Valerie Robison, DDS, MPH, PhD

Thomas R. Navin, MD

Communications, Education, and Behavioral Studies Branch

Cheryl Tryon, MS

Peri Hopkins, MPH

Trang Nguyen, MPH

Sarah Segerlind, MPH

Teresa Goss

Sherry Brown

Blen Mekuria, BA

Field Services and Evaluation Branch

Alstead Forbes

Bruce Heath

Others contributing to the production of this publication:

CDC Reviewers

Phil LoBue, MD, FACP, FCCP

John Jereb, MD

Sundari Mase, MD, MPH

Wanda Walton, PhD, MEd

Kashef Ijaz, MD, MPH

Amera Khan, MPH

Ann Lanner, BA

Marie S. Morgan, BA, ELS

Robert Pratt, BS

Lori Armstrong, PhD

Carla Jeffries, MPH

Jose Becerra, MD, MPH

Allison Maiuri, MPH

Ijeoma Agulefo, MPH

Glenda T. Newell, CSA

National Center for Health Marketing, Division of Creative Services

Sarah Cote

Howard Hall

RVCT Revision Work Group

Members, 2001-2007

RVCT

Reviewers

Janice Boutotte, PhD, RN Cecilia Teresa T. Arciaga

N. Alex Bowler, MPH, FACHE Sherri Austin

James Cobb Angelito Bravo, MD

Theresa Crisp, MPH Gayle L. Canfield, RN

Mayleen Jack Ekiek, MD Smita G. Chatterjee, MS

Kimberly Field, RN, PHN, MSN Christine A. Feaster, M(ASCP)

, M(NRM)

Michael E Fleenor, MD, MPH Kitty B. Herrin, MA, PHD

Lorena Jeske, RN, MN Pat F. Infield, RN

Stephen E. Hughes, PhD Harvey L. Marx, Jr.

Scott Jones Sandra A. Morris, MPH

Yvonne Luster-Harvey, MPH Kathleen Moser, MD, MPH

Debbie Merz, MS Ellen Murray, RN, BSN

Masahiro Narita, MD Rebbie M. Ortega

Mary Naughton, MD, MPH Lillian T. Pirog, RN, BS, PNP

Lynelle Phillips, RN, MPH Vicki Randle, MPH, RN

Shameer Poonja, MPH Paul Regan, PHA

Carol Pozsik, RN, MPH Kristina Schaller

Randall Reves, MD, MSc Gladys Simon

Maria G. Rodriguez Barbara Simpkins

Diana Schneider, DrPH, MA Mary K. Sisk, RN, CIC

Barbara Seaworth, MD Sarah Macinski Sperry, MS

Sharon Sharnprapai, MS Richard A. Stevens, DrPH, MPH, MSHSA, MS

Muriel Silin, MPH Barbara L. Stone, MSPH

Wendy Mills Sutherland, MPH Jason Stout, MD

Jacinthe Thomas, MPH Sharon J. Thompson, RN

Janice Westenhouse, MPH Marie P. Villa, RN

Terri Wilson

Josephine L. Yumul, MSc

Edward Zuroweste, MD

CDC would also like to thank all of the

state and local health departments

whose staff participated in the field tests.

Table of Contents

Contents

ContentsContents

Contents

Page

Introduction

IntroductionIntroduction

Introduction

Introduction 3

Overview of the RVCT Form 6

What Is New in the RVCT 11

Overview of the RVCT Instructions 12

Overview of the RVCT Self-Study Modules 13

Continuing Education 15

To View or Order Materials 16

* Status of Item

New Revised No Change

Page

Module A

Module A Module A

Module A –

––

– RVCT (page 1)

RVCT (page 1) RVCT (page 1)

RVCT (page 1)

1 – Date Reported R 20

2 – Date Submitted R 25

3 – Case Numbers R 27

4 – Reporting Address for Case Counting NC 34

5 – Count Status N 40

6 – Date Counted R 48

7 – Previous Diagnosis of TB Disease NC 51

8 – Date of Birth NC 54

9 – Sex at Birth NC 56

10 – Ethnicity NC 58

11 – Race NC 60

12 – Country of Birth R 63

13 – Month-Year Arrived in U.S. NC 68

14 – Pediatric TB Patients (<15 years old) N 70

15 – Status at TB Diagnosis R 75

16 – Site of TB Disease R 78

Module B

Module B Module B

Module B –

––

– RVCT (page 2)

RVCT (page 2) RVCT (page 2)

RVCT (page 2)

17 – Sputum Smear R 82

18 – Sputum Culture R 85

19 – Smear/Pathology/Cytology of Tissue and Other Body Fluids R 89

20 – Culture of Tissue and Other Body Fluids R 94

21 – Nucleic Acid Amplification Test Result N 99

22A – Initial Chest Radiograph R 103

22B – Initial Chest CT Scan or Other Chest Imaging Study N 106

23 – Tuberculin (Mantoux) Skin Test at Diagnosis R 109

24 – Interferon Gamma Release Assay for Mycobacterium

Tuberculosis at Diagnosis

N 113

25 – Primary Reason Evaluated for TB Disease N 116

* Status of item refers to whether the items in the revised 2009 RVCT form are new, revised, or have no change.

Highlighted items = more complicated

Table of Contents

iii

Status of Item

New Revised No Change

Page

Module C

Module C Module C

Module C –

––

– RVCT (page 3)

RVCT (page 3) RVCT (page 3)

RVCT (page 3)

121

26 – HIV Status at Time of Diagnosis R 122

27 – Homeless Within Past Year NC 125

28 – Resident of Correctional Facility at Time of Diagnosis R 128

29 – Resident of Long-Term Care Facility at Time of Diagnosis NC 131

30 – Primary Occupation Within Past Year R 135

31 – Injecting Drug Use Within Past Year NC 138

32 – Non-Injecting Drug Use Within Past Year NC 140

33 – Excess Alcohol Use Within Past Year NC 143

34 – Additional TB Risk Factors N 145

35 – Immigration Status at First Entry to the U.S. N 149

36 – Date Therapy Started NC 153

37 – Initial Drug Regimen R 155

Mod

ModMod

Module D

ule D ule D

ule D –

––

– Initial Drug Susceptibility Report

Initial Drug Susceptibility Report Initial Drug Susceptibility Report

Initial Drug Susceptibility Report

Follow Up Report

Follow Up ReportFollow Up Report

Follow Up Report–

––

–1

157

38 – Genotyping Accession Number N 158

39 – Initial Drug Susceptibility Testing R 161

40 – Initial Drug Susceptibility Results R 164

Module E

Module E Module E

Module E –

––

– Case Completion Report

Case Completion Report Case Completion Report

Case Completion Report

Follow Up Rep

Follow Up RepFollow Up Rep

Follow Up Report

ortort

ort–

––

–2

169

41 – Sputum Culture Conversion Documented R 171

42 – Moved N 174

43 – Date Therapy Stopped NC 179

44 – Reason Therapy Stopped or Never Started R 182

45 – Reason Therapy Extended > 12 Months N 186

46 – Type of Outpatient Health Care Provider R 188

47 – Directly Observed Therapy (DOT) R 191

48 – Final Drug Susceptibility Testing R 196

49 – Final Drug Susceptibility Results R 199

Appendices

AppendicesAppendices

Appendices

Appendix A – Tuberculosis Case Definition for Public Health Surveillance 203

Appendix B – Recommendations for Reporting and Counting Tuberculosis Cases 205

Appendix C – Anatomic Codes 215

Appendix D – Reporting Area Codes 217

Appendix E – Country Codes 219

Appendix F – Glossary 225

Appendix G – Answer Key for Exercises 231

Note: Use of trade names in this publication is for identification purposes only and does not imply

endorsement by the Centers for Disease Control and Prevention.

Table of Contents

Introduction

IntroductionIntroduction

Introduction

This section provides an introduction to the Report of Verified Case of Tuberculosis and an overview of

the form, the instructions, and the RVCT Self-Study Modules, as well as information on continuing

education and how to order materials.

Introduction

IntroductionIntroduction

Introduction

Topics

TopicsTopics

Topics

Section Page

Introduction

Background

Tuberculosis Surveillance Data

Impact of RVCT Data

Quality Assurance

Purpose of the RVCT Self-Study Modules

Target Audience

Course Objectives

Materials

How the Modules Can Be Used

Overview of the RVCT Form

Required and Recommended Uses of the RVCT

RVCT Form

RVCT Items

Unknown Dates

Pending vs. Unknown Information

Updating of Forms

Additional Reporting Forms

Data Entry and Security

Patient Confidentiality

What Is New in the RVCT

New and Updated Variables

Recurrences of TB

Overview of the RVCT Instructions

Overview of the RVCT Self-Study Modules

How to Work Through the Modules

Estimated Completion Time for Working Through the Modules

Materials Needed for Working Through the Modules

Continuing Education

Continuing Education Units

Continuing Education Registration and Test

Online Registration and Test

Disclosure Statement

To View or Order Materials

List of RVCT Training Materials

Introduction

IntroductionIntroduction

Introduction

Background

Tuberculosis (TB) is a nationally notifiable disease, in that reporting is mandated in all states. In 1953, a

national surveillance system was established to collect information on new cases of active TB. Since

1985, all states have been reporting TB cases to the Centers for Disease Control and Prevention (CDC)

using the Report of Verified Case of Tuberculosis (RVCT), the national TB surveillance form. Data are

collected by state and local TB programs and submitted electronically to CDC, Division of Tuberculosis

Elimination (DTBE). These data are used to monitor national TB trends, identify priority needs, and

create the DTBE annual surveillance report, Reported Tuberculosis in the United States.

To control and eventually eliminate TB, state and local TB control programs must be able to monitor

trends in TB disease in high-risk populations, as well as identify new patterns of disease and possible

outbreaks. The last major revision of the RVCT was completed in 1993. Since 2001, members of a

DTBE-sponsored work group consisting of nearly 30 public health professionals from 15 TB control

programs, DTBE, and the National TB Controllers Association (NTCA) have been working to revise the

RVCT. Modifications to the RVCT data collection now accommodate the changing epidemiology of TB

in terms of risk factors, new drug treatments, and enhanced laboratory capacity for diagnostic tests.

Note: A case of TB is defined as an episode of TB disease in a person meeting the laboratory or clinical

criteria for TB as defined in Appendix A – Tuberculosis Case Definition for Public Health Surveillance.

Tuberculosis Surveillance Data

Some states may use a modified version of the RVCT or a data collection tool that is unique to their

jurisdiction. These forms are used to collect the same data contained in the RVCT. However, just as the

actual RVCT form is not sent to CDC, neither are these locally defined variables or additional data. CDC

should never receive names of persons with TB. Names are retained by the state or local health

department. Locally assigned numbers and characters are used for case identification and are included in

Case Numbers (item 3) for use by CDC. See Case Numbers (item 3) for more information.

Impact of RVCT Data

The revised RVCT will assist TB control programs in gathering accurate and useful data. The additions

and changes made to the variables of the RVCT will enable programs to capture data that are more

inclusive of a variety of risk factors. These additional data will be essential to efficient and effective TB

program management. The following table illustrates how the revised RVCT data can improve TB

programs, and the consequences of having inaccurate or incomplete data.

Impact of Revised RVCT Data

Benefits of RVCT Data Consequences of Inaccurate,

Incomplete, or Unknown RVCT Data

• Increased ability to assess program

performance, completeness of data

collection, and accuracy of reporting

• Improved data for program planning and

policy development (e.g., personnel,

resources, funding)

• Facilitation of patient services (e.g.,

quality of care, continuity of care,

sharing of accurate information with

patient and health facilities)

• Inaccurate follow-up of services to patients

• Inadequate resources (e.g., funding, staff,

facilities, drugs, and supplies)

• Inaccurate evaluation and policy development

• Misrepresentation of the public health burden

of TB

• Inability to measure TB program indicators that

are based on surveillance data

Quality Assurance

Assuring data completeness and quality is encouraged for all case reporting. Each reporting area should

develop its own policy or procedure for reviewing and updating incomplete or incorrect data. These

procedures should ensure that the data are collected and entered in the surveillance system accurately.

Although health departments share TB surveillance data with CDC, the responsibility and authority for

TB surveillance rests with the health department. States vary in the structure and organization of their

surveillance systems, and often in the completeness or quality assurance of their case reporting. As with

any reportable disease, the completeness of TB reporting reflects how actively health departments solicit

case report information. Historically, disease surveillance systems have been categorized as passive or

active.

• Passive surveillance

Health departments passively receive case reports from health care providers, depending on the

health care providers to know and comply with reporting requirements.

• Active surveillance

Health departments actively contact and interact with health care facilities or individual providers

to stimulate disease reporting, sometimes directly assuming the primary responsibility of

reporting cases from large or high-volume institutions.

CDC provides funding and technical assistance to health departments to actively stimulate TB case

reporting, and has encouraged them to take an active rather than passive approach to TB surveillance.

Health departments are encouraged to identify local or private health care facilities that serve TB patients.

Health departments are also encouraged to use other data sources to identify TB cases, including death

certificates and laboratory reports.

Purpose of the RVCT Self-Study Modules

The purpose of these self-study modules is to help participants learn how to accurately complete the

revised RVCT form. The modules can be used either as self-study materials or in a facilitated course.

Target Audience

The target audience includes health care workers who

• Collect the data from patients

• Complete the RVCT form (or local tuberculosis case reporting form specified by the reporting

jurisdiction)

• Enter data from the RVCT into the reporting system

• Monitor TB program data collection accuracy

• Analyze data from the RVCT

Course Objectives

After working through these modules, participants will be able to

• Distinguish between the three reports included in the RVCT form

• Recognize the items on the RVCT form

• Use the RVCT instructions to determine how to complete the RVCT form

• Accurately complete the RVCT form

Materials

You will need the following materials when you work through this course.

• Report of Verified Case of Tuberculosis (RVCT form)

• Report of Verified Case of Tuberculosis Self-Study Modules (these modules)

• Appendices: Tuberculosis Case Definition for Public Health Surveillance, Recommendations for

Reporting and Counting Tuberculosis Cases, Anatomic Codes, Reporting Area Codes, Country

Codes, Glossary, and Answer Key for Exercises

Note: Because some states use their own form (rather than the RVCT), the exercises and posttest are

available in Microsoft Word format so they can be adapted for training purposes.

How the Modules Can Be Used

The Report of Verified Case of Tuberculosis Self-Study Modules can be used in the following ways:

1. For individuals learning through self-study format

Health care workers can use the modules according to their needs

• Working through them at their own pace

o Completing the whole set of modules without interruption

o Completing one module at a time (e.g., one module per day)

• Using them as a reference

2. As part of a facilitator-led training course

The self-study modules can be used as part of a training course that is led by a facilitator.

• Participants work through the modules

• Facilitators lead group discussions about the instructions and the exercises and engage the

participants in learning how to use the RVCT

A facilitator’s guide is available that includes information on the best way to teach this course to

others.

Overview of the

Overview of theOverview of the

Overview of the RVCT

RVCT RVCT

RVCT Form

Form Form

Form

The RVCT form is designed for the collection of information on cases of TB. The expanded RVCT was

approved by the Office of Management and Budget (OMB) in 2008 to become effective January 2009.

Note:

On the RVCT form and throughout this document, the term state is used to refer to the reporting

jurisdiction (or count authority), though not all jurisdictions are states.

Required and Recommended Uses of the RVCT

The following table indicates the required and recommended uses of the RVCT.

Required Use

of the RVCT

Additional Recommended Uses

of the RVCT

Possible Use of the RVCT for

a Suspected Case of TB

The RVCT

must

completed for

all

verified cases of TB

that are to be included

in the reporting area’s

annual morbidity

count.

CDC

recommends

the use of RVCT

forms for the collection of data on the

following:

•

Transfer TB cases (e.g., TB cases

counted in another state or country)

•

TB cases that recur

within

12 months

after the completion of therapy

Reporting areas

may

also use the

RVCT forms for the collection of

data on a suspected case of TB or

on a patient with latent TB

infection (LTBI).

For the purposes of surveillance, a case of TB is defined on the basis of laboratory and/or clinical

evidence of active disease due to M. tuberculosis complex. For more information on the case definition of

M. tuberculosis complex, see Appendix A – Tuberculosis Case Definition for Public Health Surveillance.

Note:

The instructions contained in this document do

not

apply to suspected cases of TB or

patients with latent TB infection (LTBI).

RVCT Form

The expanded RVCT form comprises three data collection reports, which are printed in triplicate on

carbonless paper:

1. Report of Verified Case of Tuberculosis: Complete this form for all patients with a verified case of

TB.

2. Initial Drug Susceptibility Report (Follow-Up Report 1): Complete this form for all patients who

had a culture that was positive for M. tuberculosis complex.

3. Case Completion Report (Follow-Up Report 2): Complete this form for all patients who were

alive when TB was diagnosed.

The two follow-up reports supplement the Report of Verified Case of Tuberculosis.

The three reports in the RVCT form are

• Not necessarily completed for all patients

• Not completed all at one time.

The following table provides a description of each report, for whom it is completed, and when it is

completed.

Note:

It is strongly recommended that the hard copy of the RVCT form be completed by a health care

provider and maintained in the TB patient’s medical record in a secured (locked) area.

The Three Reports Comprising the RVCT Form

Report of Verified Case of Tuberculosis

• Includes data about patient demographics, laboratory results, and risk associated with TB

• Complete for all patients with a verified case of TB disease

• Complete over time (evaluation process and treatment) as the information from the patient, the

laboratory reports, and medical records become available

Page 1

(Items 1 – 16)

Page 2

(Items 17 – 25)

Page 3

(Items 26 – 37)

Initial Drug Susceptibility Report

(Follow Up Report - 1)

Case Completion Report

(Follow Up Report - 2)

• Includes genotyping information and

drug susceptibility testing results

• Complete for all patients who had a

positive culture result for

Mycobacterium tuberculosis complex

• Do not complete for patients with

negative culture or no results for

culture

• Complete after susceptibility test

results are received

• Includes treatment outcomes collected

• Complete for all patients who were alive when TB

was diagnosed

• Complete after treatment ends; the case completion

report is due no later than 2 years after the initial

RVCT

Page 1

(Items 38 – 40)

Page 1

(Items 41 – 46)

Page 2

(Items 47 – 49)

RVCT Items

The revised RVCT form includes 49 items. The characteristics are varied; for example,

• Some items include one variable response

• Some items include more than one response (e.g., Items 3 and 4)

• Each item is delineated in its own box

• Some boxes are grouped together in larger boxes to visually and logically organize the space

Items are not necessarily listed in the order in which you might receive the information

Data are entered on the RVCT form in several ways:

1. Writing in dates and other numbers (e.g., Items 1, 2, and 3)

2. Checking boxes (e.g., Items 9, 10, and 11)

a. Select one

b. Select all that apply

3. Writing in specific information (e.g., Items 12, 14)

4. Writing in comments (e.g., page 3, Follow Up Report–1, or Follow Up Report–2)

Unknown Dates

There are several items that include dates. When entering dates on the form, use “99” for an unknown

month or day, and “9999” for an unknown year. This may vary from what will be entered into a computer

software program.

• 03 99 2009 – for March, unknown day, in 2009

• 99 99 2009 – for unknown month and day in 2009

• 01 02 9999 – for January 2, in a year that is unknown

Note:

For each item that includes dates, read the instructions carefully about entering month, day, and

year. Some items (e.g.,

Date Reported

, Item 1) require that the actual month and year

always

need to be

entered. For those items, the actual month (not 99) should be entered, and the actual year (not 9999)

should be entered.

Pending vs. Unknown Information

Leave the item blank if the information requested is pending (or missing). If a valid value cannot be

determined and there is no check-box labeled Unknown, write the word Unknown inside the box that

encloses the numbered item. This unknown notation will help the person entering the data in the software

to know that the person who completed the form attempted to collect the information but was not able to

do so. The data entry person will thus be better able to distinguish between data that are unknown and

data that are pending (missing). CDC encourages active surveillance or collection of all applicable

information. Therefore “unknown” information should be rare.

Updating of Forms

It may be necessary to update RVCT forms if a case is reopened (e.g., a patient who had been lost to

follow-up is found) or if previously unavailable information is obtained. CDC recommends highlighting

such changes on the hard copy to facilitate data entry into the software system designated by your

jurisdiction. When updated data are entered in an electronic record, the new data will automatically

overwrite the old data.

Additional Reporting Forms

If the reporting area has its own TB case reporting form and uses it to complete the RVCT variables, the

staff should carefully review the RVCT variables and the instructions in this document to ensure that

variables on the reporting area’s form match those on the RVCT form.

Data Entry and Security

Data obtained from RVCT forms are entered in the software system designated by your jurisdiction and

then transmitted electronically to CDC.

Data security is the responsibility of the state or local health department.

Completed RVCT forms

should never be sent to CDC.

Access to the RVCT forms and data entry software should be restricted to individuals authorized to

perform TB surveillance activities. Hard copies should be stored in a secured (locked) area. Access to the

approved data entry software and local databases should be controlled through the use of a local user

identification (user ID) and password. All other electronic surveillance files should also be protected with

passwords known only to designated surveillance staff.

Patient Confidentiality

Case numbers must not include personal identifiers.

Do not use names, initials, Social Security

numbers, addresses, telephone numbers, or other information that could identify a patient.

Because of the sensitive nature of some of the data collected, CDC has provided an Assurance of

Confidentiality for the expanded surveillance system. Information on the RVCT forms and in the TB

surveillance databases that would permit identification of any individual will be held in confidence and

will not be released without the consent of the individual, in accordance with sections 306 and 308(d) of

the Public Health Services Act (42 U.S.C. 242k and 242m).

Local patient identifier information, although collected by state and local health departments, is not

reported to CDC. Surveillance information reported to CDC is used for statistical and analytic summaries

in which no individual can be identified and for special investigations of the natural history and

epidemiology of TB.

What

What What

What I

Is New in the RVCT

s New in the RVCTs New in the RVCT

s New in the RVCT

The RVCT form has items that are either new or revised from the previous RVCT that was published in

1993. To help orient previous RVCT users to the new items, the table of contents (at the beginning of this

document) indicates which items are new, revised, or unchanged.

The RVCT

State Case Number

(item 3), also known as the RVCT number, has been standardized by

adding a 4-digit code for year and a 2-character (alpha) code for state (or jurisdictional code for

jurisdictions that are not states) to the 9-character alphanumeric local identifier, so that each state case

number is unique for year and state. The additions to the State Case Number will help when trying to

identify a TB patient who has been transferred from one health jurisdiction (e.g., state) to another, and

when trying to link TB cases (e.g., recurrences, contact investigations).

New and Updated Variables

Eleven new variables were added to improve data collection. These variables (items) are indicated in the

table below.

New Variables in the Revised RVCT

Item # New Variables

5 Count status

14 Pediatric TB patients

21 Nucleic acid amplification test

22B Initial chest CT scan or other chest imaging study

24 Interferon gamma release assay

25 Primary reason evaluated for TB disease

34 Additional TB risk factors

35 Immigration status

38 Genotyping accession number

42 Moved

45 Reason therapy was extended for more than 12 months

A new variable called

Count Status

(item 5) was added to separate counted and noncountable TB cases.

Data can now be collected on noncountable TB cases to help identify specific cases for analysis and help

measure TB morbidity and case management burden. Noncountable cases are verified TB cases that

cannot be counted because they do

not

meet the surveillance definition of a countable case.

Additional new variables include TB risk factors, such as diabetes, end-stage renal disease,

immunosuppressive therapy, and the use of tumor necrosis factor-alpha antagonists.

Other variables have been updated to reflect the changing field of TB epidemiology and to collect more

accurate data on TB cases. Modified variables include the addition of dates of tuberculin skin testing

(item 23) and of specimen collection for other diagnostic tests, along with result dates by laboratory type

(items 17–21 for smear and culture results).

Recurrences of TB

The new variable,

Count Status

(item 5), allows data collection on the recurrence (more than one separate

and distinct episode) of TB. Most recurrences occur within 6–12 months after the completion of therapy.

For surveillance purposes, a description of how this is counted is illustrated in the following table.

Counting Reported TB Cases

A patient may have more than 1 discrete (separate and distinct) episode of TB disease

TB Disease Recurs

Within a Consecutive 12-month Period

After the Patient Completed Therapy

TB Disease Recurs

More Than 12 Months

After the Patient Completed Therapy

Recurrence is considered the same episode (count

only 1 episode as a case for that year; within a 12-

month period,

not

calendar year).

Recurrence is considered a separate episode.

not

count as a new case.

Count as a new case.

More information about recurrences of TB is provided in

Case Number

(item 3).

Overview of the RVCT Instruction

Overview of the RVCT InstructionOverview of the RVCT Instruction

Overview of the RVCT Instructions

The RVCT instructions provide information on how to complete the 49 items on the RVCT form. The

instructions provide details about each item, explain the nuances of how to answer the items, and also

provide examples to illustrate how to apply the instructions for entering data for a TB case. The

instructions are available in two formats.

• The Report of Verified Case of Tuberculosis Self-Study Modules (these modules).

In the modules, the instructions are integrated with exercises (study questions and case studies).

This provides an opportunity to practice applying the instructions to life-like situations.

• The Report of Verified Case of Tuberculosis Instruction Manual.

This document includes only the instructions (i.e., the exercises are not included) for each item on

the RVCT. It can be used as a reference tool by those who complete the RVCT. For downloading

the Instruction Manual from the internet, see the section below on “To View or Order the

Materials.”

Overview of th

Overview of thOverview of th

Overview of the RVCT Self

e RVCT Selfe RVCT Self

e RVCT Self-

-Study

Study Study

Study Module

ModuleModule

Modules

How to Work Through the Modules (This is IMPORTANT – Be sure to read this)

Please follow these steps to work through the modules:

1. Work through the self-study modules

• Review an item on the RVCT form

• Read how to complete the item in the RVCT instructions

• Complete the exercises (study questions and/or case studies) for the item

• Use the Appendices as needed

2. Check your answers

• Check your answer(s) in Appendix G - Answer Key for Exercises

If something is not clear, then for each item that you answered incorrectly, re-read the RVCT

instructions and try to complete the exercises again.

Estimated Completion Time for Working through the Modules

The Report of Verified Case of Tuberculosis Self-Study Modules comprise a comprehensive curriculum.

The sections of the modules are listed below as well as the estimated completion time for each section.

Sections Estimated

Completion Time

Introduction (this module)

25 minutes

Module A – RVCT (page 1) Items 1 – 16

100 minutes

Module B – RVCT (page 2) Items 17 – 25

45 minutes

Module C – RVCT (page 3) Items 26 – 37

55 minutes

Module D – The Initial Drug Susceptibility Report (Follow Up Report – 1)

Items 38 – 40

20 minutes

Module E – The Case Completion Report (Follow Up Report – 2)

Items 41 – 49

55 minutes

TOTAL Approximate Time

300 minutes

(about 5 hours)

Materials Needed for Working Through the Modules

The following materials are needed to work through the RVCT Self-Study Modules.

• The Report of Verified Case of Tuberculosis form

This is the 49-item form.

• RVCT Self-Study Modules

The modules consist of the following components:

o Instructions for how to complete each item on the RVCT

Each item in the RVCT has detailed instructions that explain how to complete the item. It is

very important to read the instructions for an item before answering the study

questions. The instructions provide information on how to interpret the items and options,

and provide examples that illustrate how to answer in specified situations.

o Exercises

The instructions for each item are followed by exercises that will help you apply the

instructions to life-like situations and practice completing the RVCT.

• Each item on the RVCT has at least one exercise

• Types of exercises include

• Study questions

• Case studies

• Answer choices include

• Multiple choice

• Matching

• Select the ONE BEST ANSWER for ALL questions

• Some items are more complex; those items have several study questions and/or case

studies.

• Because several items are linked to each other (e.g., items 3 and 5 are linked), some

case studies include more than one item. These are designed to help you understand

how the items are linked.

• Appendices

The following appendices provide information and codes that are used to complete the RVCT:

• Appendix A – Tuberculosis Case Definition for Public Health Surveillance

• Appendix B – Recommendations for Reporting and Counting Tuberculosis Cases

• Appendix C – Anatomic Codes

• Appendix D – Reporting Area Codes

• Appendix E – Country Codes

• Appendix F – Glossary

• Appendix G – Answer Key for Exercises

This appendix provides answers to each of the exercises. Answer the questions first and then

check your answers with the key. Explanations for some of the difficult questions are

provided to help you understand the correct answer.

Note: For the purposes of the RVCT Self-Study Modules, use the codes listed in the appendices.

Some software programs used to enter data on the RVCT may NOT use the codes listed in the

appendices. For example, the Anatomic Codes may be a drop-down item where you choose the actual

site rather than enter a code. For more information, see instructions for the software you use.

Continuing Education

Continuing EducationContinuing Education

Continuing Education

Continuing Education Units

The following continuing education units are available free of charge after June 1, 2009, for the RVCT

Self-Study Modules:

• Continuing education units (CEUs)

The Centers for Disease Control and Prevention has been approved as an Authorized Provider by

the International Association for Continuing Education and Training (IACET), 8405 Greensboro

Drive, Suite 800, McLean, VA 22102. CDC is authorized by IACET to offer 0.5 CEUs for this

program.

• Continuing medical education (CME)

CDC is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to

provide continuing medical education for physicians.

CDC designates this educational activity for a maximum of 5.0 AMA PRA Category 1 Credits.

Physicians should only claim credit commensurate with the extent of their participation in the

activity.

• Continuing nursing education (CNEs)

CDC is accredited as a provider of Continuing Nursing Education by the American Nurses

Credentialing Center’s Commission on Accreditation.

This activity provides 5.0 contact hours.

• Continuing education contact hours (CECH)

CDC is a designated provider of continuing education contact hours (CECH) in health education

by the National Commission for Health Education Credentialing, Inc. This program is a

designated event for the CHES to receive 5.0 Category 1 contact hours in health education, CDC

provider number GA0082.

Continuing Education Registration and Test

You can register after June 1, 2009, and take the test for continuing education credits online for the RVCT

Self-Study Modules.

Online Registration and Test

To receive continuing education, you must go to CDC’s Training and Continuing Education (TCE)

Online system to register for this specific course and submit an evaluation.

•

Go to http://www2a.cdc.gov/TCEonline.

•

When you receive your reset password by email, log in as a participant and change the

password.

•

At Participant Services, click on Search and Register, type a keyword from the course title into

the keyword search, and click View. You can also find the course by typing in the course number.

The course number for this activity is SS1502.

•

Click on the title of your course, select the type of credit/contact hours you wish to receive at the

bottom, and click Submit.

•

Verify the demographic information and click Submit at the bottom.

•

Complete the course evaluation.

•

Complete the course post test (if applicable).

•

At Participant Services, click on Certificates and Transcripts and print your continuing education

certificate.

For assistance with the online system, call 1(800)-41-TRAIN Monday through Friday from 8:00 AM

to 4:00 PM Eastern Standard Time or email [email protected].

Disclosure Statement

CDC, our planners, and our presenters, wish to disclose they have no financial interests or other

relationships with the manufacturers of commercial products, suppliers of commercial services, or

commercial supporters.

Presentations will not include any discussion of the unlabeled use of a product or a product under

investigational use.

There was no commercial support received for this activity.

To View or Order the RVCT Materials

To View or Order the RVCT MaterialsTo View or Order the RVCT Materials

To View or Order the RVCT Materials

The chart on the next page describes the materials in detail and indicates how they can be used, lists the

available file formats, and describes how the materials can be ordered and downloaded. There are no

charges for ordering the materials from CDC.

List of RVCT Training Materials

(There are no charges for these materials)

Note: the spaces in the FTP URL

FTP site to download RVCT materials: ftp://ftp.cdc.gov/pub/Software/TIMS/2009 RVCT Documentation/RVCT Training Materials/

CDC/DTBE web site to view and download RVCT materials: www.cdc.gov/tb

File Formats Available

Materials Description

FTP site and

CD ROM

CDC/DTBE

web site

How to Order

RVCT Self-Study

Modules

Participant Manual

(with CD ROM)

Print-based modules to help health care staff learn how to accurately complete

the RVCT. Includes

• Instructions for how to complete each item on the RVCT

• Exercises that will help participants apply the instructions to life-like

situations

Can be used as self-study or part of a training course.

PDF PDF E-mail or Fax RVCT Materials

Order Form (see form for

instructions)

RVCT Self-Study

Modules

Facilitator Manual

(with CD ROM)

Print-based modules for facilitators who will teach health care staff how to

complete the RVCT. Contains the same content as the RVCT Self-Study

Modules Participant Manual plus training materials for facilitators.

• Instructions for how to complete each item on the RVCT

• Exercises that will help participants apply the instructions to life-like

situations

• Facilitator guide, answers to exercises, and other training documents

PDF of manual.

Various formats

for other

training

documents

E-mail or Fax RVCT Materials

Order Form (see form for

instructions)

RVCT Instruction

Manual

Print-based document includes instructions for how to complete each item on

the RVCT. Can be used as a reference guide when completing the RVCT.

(Does

not

include the exercises from the Self-Study Modules.)

PDF PDF

RVCT Self-Study

Modules Exercises

Print-based document includes only the exercises (with answers) used in the

Self-Study Modules Participant Manual. (Does not include the instructions for

how to complete each item on the RVCT.) Exercises can be used and adapted

by local jurisdictions.

Microsoft Word (Available only on the FTP site or

CD ROM)

RVCT Materials

Description

Description of the RVCT materials PDF HTML

RVCT Materials Order

Form

Form used to order the RVCT materials from CDC. Microsoft Word

E-mail or Fax RVCT Materials

Order Form (see form for

instructions)

For those who want to order the CD ROM only. Includes the electronic files of

the following documents:

RVCT Materials

CD ROM

• RVCT Participant Manual

• RVCT Facilitator Manual and

training materials

• RVCT Instruction Manual

• RVCT Self-Study Module

Exercises

• RVCT Materials Description

• RVCT Materials Order Form

Various formats E-mail or Fax RVCT Materials

Order Form (see form for

instructions)

Module

Module Module

Module A

–

––

–

RVCT

VCTVCT

VCT

(page 1

(page 1(page 1

(page 1 of 3

of 3 of 3

of 3)

))

)

Items 1

Items 1 Items 1

Items 1 –

––

– 16

16 16

The RVCT report includes the first three pages of the RVCT data collection form. Pages 1, 2, and 3 of the

RVCT report will be covered in Modules A, B, and C, respectively. Complete this report for all

patients with a verified case of TB disease.

Module A provides instructions and exercises for completing page 1 of the RVCT report. This page

includes data about patient demographics and site of disease.

Date Reported

Primary Purpose: Case management. Data are used to determine when the health department or

counting authority was first notified that a person may have TB. This is important in contact

investigations.

Note:

Item 1 requires that the actual month and year

always

be entered. The actual month (not 99)

should be entered and the actual year (not 9999) should be entered.

Description Comment

Month, day, and year

(e.g., 01/17/2009)

Date that a health department (e.g.,

local, county, state) first suspected

that the patient may have TB.

Date the health department received

notification (verbal or written) from

a health care provider that a patient

was suspected of having TB.

If the day is unknown, enter 99 as the

default value (e.g., 01/99/2009).

In this item, the actual month and

year always need to be entered. Do

not use 99 for the month or 9999 for

the year.

Comment: Date Reported

If the patient had a previous diagnosis of tuberculosis,

Date Reported

applies to the current TB episode.

Note:

On the form and throughout this document, the term state is used to refer to the reporting

jurisdiction (or count authority), though all jurisdictions are

not

states.

Comparison of

Date Reported (Item 1), Date Submitted (Item 2), and Date Counted (Item 6)

There is frequently a lot of confusion between

Date Reported

(it 1),

Date Submitted

(item 2)

and

Date

Counted

(item 6). The following information describes the differences in these three items.

Summary of Events for

Item 1. Date Reported, Item 2. Date Submitted, and Item 6. Date Counted

Comment: Sequence of dates

The Date Reported (item 1) usually occurs before the Date Submitted (item 2). But sometimes they can

occur on the same date. The Date Submitted usually occurs before the Date Counted (item 6). But all 3

dates could occur on the same date if the count authority determines that it is a case of TB on the same

day as the Date Reported and Date Submitted.

Comment: Who determines the dates

In most reporting areas (e.g., state), the state health department has count authority and reviews the

RVCT to determine whether to officially count the case (

Date Counted

). However, a few states have

granted local or county health departments count authority. In these states, the local or county health

departments determine the

Date Counted

(see

Date Submitted

[item 2] and

Date Counted

[item 6]).

Summary of Date Reported, Date Submitted, and Date Counted

Type of Date Who/What

Description of Action

Date Reported (item 1)

TB suspect

Reported to the health department (either by the health

department itself or another health care provider)

Date Submitted (item 2)

RVCT form

Submitted to the reporting area (e.g., state health

department)

Date Counted (item 6)

TB Case

Counted as a case of TB (by the count authority)

te Reported

(

Item 1

)

• Date the health department (local, county, or state) first suspected that a patient has TB

• Date the health department receives notification (verbal or written) from a health care provider

that a patient is suspected of having TB

Often, an RVCT is created by a local or county health department because this is the level at which TB

is first suspected, and that also determines the Date Reported.

Date Submitted

(

Item 2

)

• Date that the RVCT was submitted to the reporting area (e.g., state health department)

Date Counted

(

Item 6

)

• Date that the count authority (usually the state health department, but may be another designated

authority) reviewed the RVCT and determined whether to officially count the case. The count

authority determines the Date Counted.

Comment: Date Reported

Often, an RVCT is created by a local or county health department because this is the level at which TB

is first suspected, and determines

Date Reported

(item 1). If a health care provider suspects that the

patient may have TB and then notifies the local or county health department, the

Date Reported

is the

date the health department received the report (verbal or written notification) from the health care

provider.

Example: Year Reported

A case reported in December may not be counted until the next year. For example, if a case is reported

in December 2008 but not counted until January 2009, the Year Reported for the

case number

would

be 2008.

Exercise

Date Reported

For all questions in the Self-Study Modules, choose the one best answer.

1.1

The Date Reported is the date that the health department …

(circle the one best answer)

First suspects that the patient has TB

Receives notification from a health care provider that the patient is

suspected of having TB

Submits the RVCT to the reporting area

A, B, and C are all correct

Only A and B are correct

1.2

How would January 3, 2009, be entered as the date for Date Reported?

(circle the one best answer)

A. Month Day Year

J A 0 3 2 0 0 9

B. Month Day Year

0 1 0 3 2 0 0 9

ote

Date Reported

(item 1) is frequently confused with

Date Submitted

(item 2) and

Date

Counted (item 6). Read the instructions for each of the items to understand the differences. In

the exercises for item 6, there is a study question and case study that involves all three items to

help you learn the differences.

1.3

How would February 2009 be entered as the date for Date Reported? The exact

day of the month is not known.

(circle the one best answer)

A. Month Day Year

0 2 9 9 2 0 0 9

B. Month Day Year

0 2 0 0 2 0 0 9

Case Study – Rose

On January 6, 2009, Dr. Joseph, a private physician, calls to notify the county health

department about Rose, a patient who has signs and symptoms of TB. On January 10, the

county health department receives a faxed copy of the laboratory results indicating that

Rose’s sputum is AFB smear positive. Then on January 27, the RVCT form is completed

by the county health department and sent to the state TB program.

1.4

Which date would you enter as the Date Reported?

(circle the one best answer)

January 6, 2009

January 10, 2009

January 27, 2009

Date Submitted

Primary Purpose: Programmatic function. Data are used to evaluate the time between case report and

submission to the health department or count authority.

Description Comment

Month, day, and year

(e.g., 01/17/2009)

Date the RVCT form was submitted

to the reporting area (e.g., state

health department).

If the day is unknown, enter 99 as the

default value (e.g., 01/99/2009).

(Note: this may vary from what will

be entered into a computer software

program)

Summary of Date Reported, Date Submitted, and Date Counted

Type of Date Who/What

Description of Action

Date Reported (item 1)

TB suspect

Reported to the health department (either by the health

department itself or another health care provider)

Date Submitted (item 2)

RVCT form

Submitted to the reporting area (e.g., state health

department)

Date Counted (item 6)

TB Case

Counted as a Case of TB (by the count authority)

Comment: Date Submitted

In most cases, the RVCT is completed by the health department (local or county) and submitted to the

reporting area (state health department). In some locations, the RVCT may be completed and the case

counted at the state level.

Note:

On the RVCT form and throughout this document, the term state is used to refer to the reporting

jurisdiction (or count authority), though not all jurisdictions are states.

Exercise

Date Submitted

2.1

The Date Submitted is the date that the…

(circle the one best answer)

Sputum sample is submitted to the laboratory

RVCT is submitted to the reporting area

Laboratory submits a confirmed diagnosis of TB to the health department

A, B, and C are all correct

Only A and B are correct

Case Study – Sue

On June 1, 2009, Sue, the health care worker at a county TB program, completes the

RVCT for a patient from the TB clinic. On June 30, Sue sends the RVCT to the state TB

program. On July 10, 2009, the state TB program determines that it is a case of TB.

2.2

Which date would you enter as Date Submitted?

(circle the one best answer)

June 1, 2009

June 30, 2009

July 10, 2009

Case Numbers

Primary Purpose: Surveillance. A unique number is assigned to each case without personal identifiers.

Note:

On the form and throughout this document, the term state is used to refer to the reporting

jurisdiction (or count authority), though not all jurisdictions are states.

State Case Number

The

State Case Number

is the

official identification number for the case

. If additional communication

about a record is required between CDC and a reporting area, this number is used to identify the record.

The

State Case Number

is commonly known as the RVCT number.

City/County Case Number

List the

City/County Case Number

. Every case reported, whether from a city/county or state

surveillance system, must have a unique case number for identification purposes.

Comment: Case Numbers

A single case may be assigned identical

City/County Case

and

State Case Numbers

. A

City/County

Case Number

may not be assigned to more than one case during a calendar year. Similarly, a

State Case

Number

may not be assigned to more than one case during a calendar year.

Note:

Case numbers must not include personal identifiers

. To maintain patient confidentiality, do

not

use names (either patient or provider), initials, Social Security numbers, addresses, telephone numbers,

or other information that could identify a patient. Case numbers are transmitted to CDC and therefore

must not include personal identifying information.

Assigning case numbers

Both the

State Case Number

and the

City/County Case Number

have 15 alphanumeric characters.

Year Reported (YYYY) State

Code

Locally Assigned Identification

Number

2 0 1 0 G A 0

0 0 1 2 3 4 5 6

Example: Year Reported

A case reported in December may not be counted until the next year. For example, if a case is reported in

December 2008 but not counted until January 2009, the Year Reported for the

case number

would be

2008.

Note:

All countable and noncountable TB cases should receive a unique case number. Documenting

noncountable cases provides evidence of increased workload or burden to programs when cases are

not

countable.

Note: For the purposes of the RVCT Materials, use the codes listed in the appendices. Some software

programs used to enter data on the RVCT may NOT use the codes listed in the appendices. For

example, the Anatomic Codes may be a drop-down item where you choose the actual site rather than

enter a code. For more information, see instructions for the software you use.

Linking State Case Numbers

For the purposes of linking RVCT forms, you

may enter as many as 2 RVCT

State Case Numbers

under

Linking State Case Number

Under

Reason for Linking Case

, explain the purpose of the link by entering one of the single-digit codes

indicated in the table below.

•

Year Reported indicates the year in

which the case is reported (e.g., 2010).

•

Year reported is used rather than the

year counted since there may be a lag

between when states or city/county

areas first suspected that the patient

might have TB and when diagnostic

criteria are verified.

State Code indicates the 2-

letter postal code of the

state reporting this case

(e.g., GA for Georgia) (see

Appendix D – Reporting

Area Codes). This

abbreviation is also known

as the state

code.

Locally Assigned

Identification Number

indicates the 9

numbers/characters that are

locally assigned to identify

this RVCT.

Rationale for Linking RVCT Forms

Reason Code Reason for Linking Case

Recurrence

Previous diagnosis of TB

Epidemiologically linked case, source case, or contact with another case

Case transferred from another area

Examples: Reasons for Linking Case

•

Reason 1 – Recurrence or previous diagnosis of TB*

If you are completing a “recurrence” RVCT for a diagnosis of TB disease in the same patient that

recurred

within

12 months after the completion of therapy, you must enter the RVCT

State Case

Number

of the original TB case under

Linking State Case Number

, and enter 1 as the

Reason

code.

A previous diagnosis of TB can have occurred any time in the past.

A patient is considered to have had a previous diagnosis of TB disease if

TB disease was verified in the past

The patient completed therapy (even if the case-to-case interval is within 12 months)*

The patient was lost to supervision for more than 12 months and now has verified disease

again.

If a patient had previous TB disease anytime in the past, enter 1 as the

Reason

code.

•

Reason 2 – Epidemiologically linked case, source case, or contact with another case

If you have identified the source case for the TB case for which you are completing the RVCT

and the RVCT

State Case Number

of the source case is available, enter the RVCT

State Case

Number

of the source case under

Linking State Case Number,

and enter 2 as the

Reason

code.

Another example of an

Epidemiologically linked case

is transmission of TB from one family

member to another.

•

Reason 3 – Case transferred from another area

If you are managing a TB case counted by another area, enter the RVCT

State Case Number

the case from the transferring jurisdiction under

Linking State Case Number,

and enter 3 as the

Reason

code. Transfer cases are linked when the patient is in therapy and transfers from another

reporting area. The patient could have moved or appeared at a health department in another area

after being lost to follow-up.

*Note: Recurrent cases within 12 months of completion of therapy should be considered noncountable,

regardless of whether the initial and the subsequent genotypes are the same or are different.

Comment: Recurrence of TB

A recurrence (more than one separate and distinct episode) is defined as the return of TB disease in a

patient whose specimen result can be described by either of the options listed in the table below.

Specimen Results Required for Recurrence of TB Disease

Option Specimen Result

at Time of

Diagnosis

Specimen Result

While Receiving

Anti-TB therapy

Specimen Result

After Completion

of Therapy

Option 1 Culture positive

Becomes and

remains

culture negative

Becomes culture positive for M.

tuberculosis complex, or clinical or

radiologic evidence is consistent with

TB disease.

Option 2 Smear negative or

culture negative

(TB diagnosis is based

on clinical evidence)

Remains smear

negative or culture

negative

Becomes culture positive for M.

tuberculosis complex, or clinical or

radiologic evidence is consistent with

TB disease.

The process for reporting a recurrence of TB is illustrated in the table below.

Process for Reporting a Recurrence of TB

A person may have more than 1 discrete (separate and distinct) episode of TB disease

TB Disease Recurs

Within a Consecutive 12-month Period

After the Patient Completed Therapy

TB Disease Recurs

More Than a Consecutive 12-month

Period

After the Patient Completed Therapy

Recurrence is considered the same TB episode

(count only 1 episode as a case for that year; within

a 12-month period,

not

calendar year).

Recurrence is considered a separate TB episode.

not

count as a new case.

Count as a new case.

Count only one TB episode as a case for that year

(within a 12-month period,

not

calendar year).

No updates are needed for the initial RVCT form

because therapy was completed at least 12 months

before the recurrence was diagnosed.

Complete 2 RVCT Forms

(Only the initial TB episode is countable)

1) For the initial countable TB episode:

a) Ensure that

Date Therapy Stopped

(item

43) reflects a date of therapy completion

before TB recurrence.

b) Do not update any other variables on the

RVCT form.

2) For the noncountable TB episode:

a) Use a new RVCT

State Case Number

(item 3), that is, a number that is different

from the

State Case Number

on the

countable TB episode form.

b) Enter the countable TB episode

State Case

Number

under

Linking State Case

Number

and specify as

Reason 1 –

Recurrence or previous diagnosis of TB

that these 2 forms can be linked.

c) Check

Verified Case: Recurrent TB

within 12 months

for the variable

Count

Status

(item 5).

d) Complete the remainder of the RVCT form as

appropriate. This case will not be included in

the TB case count of the reporting area, but will

provide valuable information on recurrences

within

12 months after the completion of

therapy. This allows electronic linkage

between the countable TB episode and data

associated with the recurrence.

Complete 2 RVCT Forms

(Both TB episodes are countable)

1) For the initial countable TB episode:

a.)

Do not update any other variables on the

RVCT form.

2) For the second countable TB episode:

a.)

Enter a new RVCT

State Case Number

(item

3), different from the

State Case Number

the initial RVCT form.

b.)

Enter the initial RVCT

State Case Number

if available, under

Linking State Case

Numbers

and specify as

Reason 1 –

Recurrence or previous diagnosis of TB

that these 2 forms can be linked.

c.)

Check

Count as a TB Case

for

Count Status

(item 5). Do

not

check

Verified Case:

Recurrent TB ≤ 12 months

d.)

Complete the remainder of the RVCT form as

appropriate. This TB case will be counted

because, for surveillance purposes, it is

considered a separate TB episode. Also, it will

provide valuable information on recurrences

more than 12 months after the completion of

therapy. This allows electronic linkage

between the initial TB episode and the new

TB episode.

Exercise

Case Numbers

Case Study – Henry

Henry is diagnosed with TB in June 2008 in Seattle, WA. His TB is counted as a new

case and his 2008 locally assigned identification number is 000080301. He successfully

completes directly observed therapy on December 12, 2008.

In August 2009, Henry presents to the Seattle hospital emergency room with a recent

history of fever, weight loss, and non-productive cough. His subsequent sputum smears

are positive. In 2009 he is reported as having TB disease, but it is NOT counted as a

new TB case (i.e., this is less than 12 months since he completed treatment for his prior

diagnosis of TB). His 2009 locally assigned identification number is 000090056.

3.1

What is Henry’s 2009 State Case Number?

(circle the one best answer)

A. Year Reported

(YYYY)

State

Code

Locally Assigned Identification Number

2 0 0 9 W A 0 0 0 0 9 0 0 5 6

B. Year Reported

(YYYY)

State

Code

Locally Assigned Identification Number

2 0 0 9 W A 0 0 0 0 8 0 3 0 1

3.2

What is his Linking State Case Number?

(circle the one best answer)

A. Year Reported

(YYYY)

State

Code

Locally Assigned Identification Number

2 0 0 8 W A 0 0 0 0 9 0 0 5 6

B. Year Reported

(YYYY)

State

Code

Locally Assigned Identification Number

2 0 0 8 W A 0 0 0 0 8 0 3 0 1

3.3

What is the Reason for the Linking State Case Number?

(circle the one best answer)

Reason 1 – Recurrence or previous diagnosis of TB

Reason 2 – Epidemiologically linked case, source case or contact with another case

Reason 3 – Case transferred from another area

Case Study – Lisa

In May 2008, Lisa is part of a contact investigation for her brother, who has infectious

TB disease. Lisa is evaluated and diagnosed with TB disease also. She starts treatment for

TB in June 2008.

3.4

For Item 3 Case Number, what would you choose as the reason for the Linking

State Case Number for Lisa?

(circle the one best answer)

Reason 1 – Recurrence or previous diagnosis of TB

Reason 2 – Epidemiologically linked case, source case, or contact with another

case

Reason 3 – Case transferred from another area

Reporting Address for Case Counting

Primary Purpose:

Programmatic function. Data are used to document the patient’s address from the

state or jurisdiction that is counting the case.

The Reporting Address for Case Counting is usually the City, County, and ZIP Code of the patient’s

residence at the time of diagnosis. But there are exceptions to this, which are indicated in the Guidelines

to Determine Reporting Address for Case Counting table below. To the extent possible, the address for

case counting should represent the home address (whether permanent or temporary) of the patient.

Recommendations for counting reported TB cases are outlined in Appendix B – Recommendations for

Reporting and Counting Tuberculosis Cases.

Note:

For countable and noncountable cases, enter the TB patient’s address from the state or

jurisdiction that is reporting and documenting the case.

For

Within City Limits

select the best option.

Option

(select one)

Description

Yes

Patient lives within the city limits

Patient does not live within the city limits

Guidelines to Determine Reporting Address

Patient Scenarios How to Count Reporting

Address

Migrant, immigrant (i.e.,

resident alien living in the

United States), U.S. military

personnel, and other

transient persons

Count in the area in which he/she lived

at the time that the TB diagnostic

evaluation was performed or initiated

Enter city, county,

and ZIP Code

where he/she lives

at the time of

diagnosis

Homeless or does not have

a fixed residence

Count in area in which he/she was

living at the time that the TB diagnostic

evaluation was performed or initiated

(e.g., the locality of the shelter or area in

which the patient was living)

Enter city, county,

and ZIP Code of

that locality

Resident of correctional

facility at time of TB

diagnosis (e.g. local, state,

federal, military)

Count in area in which the correctional

facility is located at the time that the TB

diagnostic evaluation was performed or

initiated

Enter city, county,

and ZIP Code of

the correctional

facility

Specific Populations

(these groups supersede Specific Locations,

but not Other People Entering the United States)

Resident of long-term care

facility at time of TB

diagnosis

Count in area in which the long-term

care facility is located at the time that

the TB diagnostic evaluation was

performed or initiated

Enter city, county,

and ZIP Code of

the long-term

care facility

Receives a new TB

diagnosis in the community

that he/she considers home

Count in the morbidity count for that

area

Enter city, county,

and ZIP Code of

residence

Receives a new TB

diagnosis, but is an out-of-

area resident and will

return home for treatment

Count in morbidity count of their home

area

Enter city, county,

and ZIP Code of

his/her home area

Receives a new TB

diagnosis, but is an out-of-

area resident and

completes therapy where

he/she was diagnosed

Count in morbidity count where they

live at the time that the TB diagnostic

evaluation was performed or initiated

Enter city, county,

and ZIP Code

where he/she lives

at the time of

diagnosis

Specific Locations

Staying in a community

only for TB diagnosis and

hospitalization

Count in the morbidity count of his/her

area of residence, not the community

where diagnosed and hospitalized.

Communication between health

departments may be necessary to decide

which jurisdiction will count the case.

Enter city, county,

and ZIP Code of

his/her home area

Foreign visitor who receives a

TB diagnosis in the United

States, is receiving anti-TB

therapy, and has been, or plans

to remain, in the country for

90 days or more

Count in the area in which he/she lived

at the time that the TB diagnostic

evaluation was performed or initiated

Enter city, county,

and ZIP Code of

current residence

Foreign visitor who receives a

diagnosis of TB in the United

States, is receiving anti-TB

therapy, and has been, or plans

to remain, in the country for

less than 90 days

Should not be included in the count of

TB cases in the United States.

Enter city, county,

and ZIP Code of

current residence

Other People Entering the United States

Receives a diagnosis of TB

before arriving in the United

States

Should not be included in the count of

TB cases in the United States. Submit it

as a noncountable case because the case

is considered to have occurred in

another country, even if therapy is

continued or completed in the United

States.

Enter city, county,

and ZIP Code of

current residence

Comment: People Entering the United States

For additional information on immigrants, refugees, permanent resident aliens, border crossers, and

foreign visitors see Appendix B – Recommendations for Reporting and Counting Tuberculosis Cases.

Guidelines for classifying transfer cases

A total of 60 areas are responsible for reporting cases of TB to CDC. These reporting areas are the 50

states, the District of Columbia, New York City, Puerto Rico, American Samoa, the Federated States of

Micronesia, Guam, the Republic of the Marshall Islands, the Commonwealth of the Northern Mariana

Islands, the Republic of Palau, and the U.S. Virgin Islands. Because of the additional (follow-up)

reporting requirements for expanded surveillance, specific instructions are necessary for the completion

of forms for patients who move within a reporting area and for those who move from one reporting area

to another during treatment.

•

To minimize the number of TB patients who are lost to follow-up, update the patient’s street

address regularly during treatment.

•

Periodically, ask patients whether they anticipate moving so that arrangements can be made to

maintain continuity of care and ensure submission of follow-up RVCTs. Encourage patients who

anticipate moving to report their new address, so that necessary patient information can be

forwarded to health care providers, and to the TB control program in the area to which the patient

is moving. Health departments should use the National TB Controllers Association (NTCA)

Interjurisdictional Tuberculosis Notification and Follow-up forms to notify TB control program

staff in another reporting area that a TB patient is moving to their area.

Communication between TB control programs to ensure continuity of care and submission of

follow-up reports regarding a patient who is moving from one area to another should be

conducted as efficiently and securely as possible (e.g., telephone, e-mail, fax, express courier).

Example:

Moves within the reporting area

If a TB patient with an existing RVCT record moves within the reporting area that initially reported the

case (e.g., from county A to county B within a state), communication between county or local health

departments may be all that is necessary to maintain continuity of care and ensure submission of follow-

up reports for the RVCT. In this instance, the responsibility for following the case to closure and for

submitting follow-up reports to CDC remains with the initial reporting area (e.g., the state). To avoid

duplicate case reporting, the state may need to coordinate the submission of forms with counties A and B

so that only one counted case is submitted. County B can complete a noncountable RVCT to gather

surveillance data and demonstrate patient management.

Example:

Moves from one reporting area to another

If a TB patient with an RVCT record moves from one reporting area to another (e.g., from state A

[Louisiana] to state B [Georgia]), the responsibility for submitting follow-up reports to CDC remains with

the state or reporting area that initially reported the case to CDC and counted it (e.g., state A [Louisiana]).

This responsibility remains with the initial area only for surveillance purposes (i.e., to minimize

duplication of case reports and to simplify the reporting of the final disposition of the case). In other

words, state B will conduct case management and follow-up and will then share follow-up surveillance

information with state A, which will officially submit follow-up information to CDC. State B is

encouraged to complete an RVCT for a noncountable transfer case.

To facilitate this process, state A should send the NTCA Interjurisdictional Tuberculosis Notification and

Follow-up forms to state B and should inform state B that the case has been reported to CDC and

counted. State A should also inform state B of the surveillance information that has been reported to CDC

and the information that will need to be collected by state B and forwarded to state A for reporting to

CDC. State B should use the forms to inform state A when or if the TB patient has been located and to

inform state A of the final disposition of the case (e.g., patient completed therapy, patient died).

Comment: Definition for Migrant/seasonal worker

A migrant or seasonal worker is a person who is required to be absent from a permanent place of

residence for the purpose of seeking employment or who may vary their employment for the purpose of

remaining employed while maintaining a permanent place of residence.

Examples:

Migrant/seasonal worker

•

Migratory agricultural worker

•

Seasonal agricultural worker

•

Migrant factory worker

•

Migrant construction worker

•

Migrant service industry worker

•

Migrant sporting worker (e.g., horse racing, dog racing)

Comments: Definitions for Homeless

There are many definitions for homeless (National Coalition for the Homeless). A

homeless

person may be an individual who has

No fixed, regular, and adequate nighttime residence

and

A primary nighttime residence that is

A supervised publicly or privately operated shelter designed to provide temporary living

accommodations, including welfare hotels, congregate shelters, and transitional housing for

the mentally ill

An institution that provides a temporary residence for individuals intended to be

institutionalized

A public or private place not designated for, or ordinarily used as, a regular sleeping

accommodation for human beings.

homeless

person may also be defined as a person who has no home (e.g., is not paying rent, does not

own a home, and is not steadily living with relatives or friends). Persons in unstable housing situations

(e.g., alternating between multiple residences for short stays of uncertain duration) may also be

considered homeless.

homeless

person may be a person who lacks customary and regular access to a conventional dwelling

or residence. Included as homeless are persons who live on streets or in nonresidential buildings. Also

included are residents of homeless shelters and shelters for battered women. Residents of welfare hotels,

and single room occupancy (SRO) hotels could also be considered homeless. In the rural setting, where

there are usually few shelters, a homeless person may live in non-residential structures, or substandard

housing, or with relatives. Homeless does not refer to a person who is imprisoned or in a correctional

facility.

Note:

The homeless category is limited to living conditions in the United States and does

not

apply to

living in refugee camps outside the United States.

Exercise

Reporting Address for Case Counting

Case Study – Laverne

Laverne lives in Chicago, Illinois. On May 1, 2009, she visits her sister Shirley in

Milwaukee, Wisconsin, for a month. During the visit Laverne develops a bad cough and

fever. She goes to the Milwaukee health clinic and is diagnosed with TB disease. On

June 2 Laverne returns home to Chicago, where she completes treatment.

4.1

What reporting address should be entered on the 2009 RVCT for Laverne?

(circle the one best answer)

Chicago, Illinois

Milwaukee, Wisconsin

Case Study – Eduardo

Eduardo, a migrant worker, resides with his family in Sacramento, California. He travels

south to work the strawberry harvest every year beginning in February. During harvest

season, he lives in a boarding facility in the city of Watsonville, California. In May 2009,

Eduardo is diagnosed with TB as part of a Watsonville screening program for migrant

workers and begins treatment. After 2 months of treatment, he returns home to

Sacramento, where he completes treatment.

4.2

What reporting address should be entered on the 2009 RVCT?

(circle the one best answer)

Sacramento

Watsonville

Count Status

Primary Purpose: Surveillance. Data are used to document the number of TB cases and disease trends

that occur in the United States; to determine the burden of TB disease within all areas; and to serve as a

basis for allocation of resources, including funding.

In addition to requiring the completion of an RVCT form for all counted TB cases, CDC recommends

that a reporting area complete an RVCT form for TB patients being managed in that area but counted by

another reporting area, even though the area providing case management cannot include such cases in its

annual morbidity count. This will help indicate the burden of disease within all areas. Moreover, CDC

recommends that a reporting area complete an RVCT form for TB recurrences which are within 12

months after the completion of therapy, which are also not included in the annual morbidity count. For

CDC guidelines on counting TB cases, see Appendix B – Recommendations for Reporting and Counting

Tuberculosis Cases.

Countable TB Case

Option Description

Officially counted as a TB case, by the jurisdiction with count authority

(usually state health department).

Count as a TB case

For a diagnosis to be counted as a TB case, it must meet the following criteria:

1. Is a verified case of TB (see Case Definition for Tuberculosis below)

2. Confirmed that it is NOT counted by another area

3. Meets surveillance definition and is NOT a recurrent case (within 12

months of completion of therapy) of TB

Note: A case of TB is defined as an episode of TB disease in a person meeting the laboratory or

clinical criteria for TB as defined in Appendix A – Tuberculosis Case Definition for Public Health

Surveillance for criteria.

Note:

Communication between TB control programs to ensure continuity of care and submission of

reports regarding a patient who is moving from one area to another should be conducted as securely

and efficiently as possible (e.g., telephone, e-mail, secure fax, express courier).

Noncountable TB Case

If the verified TB case was

not

counted by the jurisdiction with count authority, select one option to

indicate the reason the verified TB case was noncountable.

Option

(select one)

Description Comment

Counted by another

area (e.g., county,

state, or counting

authority)

TB case counted by another U.S. area

such as a state or other counting

authority (e.g., transfer in)

Typically, diagnostic workup has

been completed, and patient is

receiving anti-TB medications.

Count authority includes the U.S.

Territories, U.S. Island Areas, and

U.S. Outlying Areas.

TB treatment

initiated in another

country

TB case counted by another

country

Under Specify, enter the country where

TB treatment was initiated.

It may be difficult to verify whether

a case has been counted in another

country because typically,

diagnostic work-up may have been

completed and patient is receiving

anti-TB medications.

Recurrent TB

within 12 months

after completion of

therapy

Complete a new RVCT form because of

recurrence within 12 months after the

completion of therapy (not when

therapy was initiated)

Completing a new RVCT form

allows the RVCT forms to be linked

and information on the recurrence

to be collected.

Comment: 12 months

The term 12 months refers to 12 consecutive months, not a calendar year.

Comment: U.S. Territories, U.S. Island Areas, and U.S. Outlying Areas

Counted by another area or counting authority

includes the U.S. Territories, U.S. Island Areas, and U.S.

Outlying Areas (e.g., Puerto Rico, American Samoa, Federated States of Micronesia, Guam, Republic of

the Marshall Islands, Commonwealth of the Northern Mariana Islands, Republic of Palau, U.S. Virgin

Islands). These independent countries have Compacts of Free Association with the United States; under

these compacts, the countries are fully sovereign in domestic and foreign affairs, but give responsibility

for their health, education, defense, and other essential operations to the United States.

Counting Recurrent TB Cases

A person may have more than 1 discrete (separate and distinct) episode of TB disease

TB Disease Recurs

Within a Consecutive 12-month Period

After the Patient Completed Therapy

TB Disease Recurs

More Than 12 Months

After the Patient Completed Therapy

Recurrence is considered the same TB episode

(count only 1 episode as a case for that year; within

a 12-month period,

not

calendar year).

Recurrence is considered a separate TB episode.

not

count as a new case.

Count as a new case.

Note: Recurrent cases within 12 months of completion of therapy should be considered noncountable,

regardless of whether the initial and the subsequent genotypes are the same or are different.

Comment: People Entering the United States

For additional information on immigrants, refugees, permanent resident aliens, border crossers and

foreign visitors see Appendix B – Recommendations for Reporting and Counting Tuberculosis Cases.

Exercise

Count Status

Count Status (item 5) can be quite confusing, so there are 13 study questions and case studies

included to help you understand this item.

5.1

What information is needed to determine the Count Status?

(circle the one best answer)

That it is a verified case of TB

Whether the case is countable (meets surveillance definition)

Confirmed that it is NOT counted by another US area

A, B, and C are all correct

Only A and B are both correct

Case Study – Carlos

Carlos is diagnosed with TB in May 2008 after being evaluated at a free clinic for

homeless persons in Springfield, Missouri. He successfully completes directly observed

therapy on December 10, 2008.

In July 2009, Carlos presents to Springfield Hospital, and an astute clinician recognizes

signs of TB disease. Carlos’s chest radiograph is consistent with TB disease. His sputum

smear is AFB-positive and he is started on anti-TB therapy. Later his culture result is

positive for M. tuberculosis complex.

5.2

Does Carlos have a countable case for 2009 national surveillance?

(circle the one best answer)

Yes, because his recurrence of TB disease is more than 12 months after

completion of therapy

Yes, because his recurrence of TB disease is more than 12 months after initial

diagnosis

No, because his recurrence of TB disease is within 12 months of completion of

therapy

No, because his recurrence of TB disease is more than 12 months after initial

diagnosis

Case Study – Carlos (continued)

Instead of having a TB recurrence diagnosed in July 2009, Carlos presents to the hospital

on January 18, 2010. All clinical characteristics remain the same.

5.3

Does Carlos have a countable case for 2010 national surveillance?

(circle the one best answer)

Yes, because his recurrence of TB disease is more than 12 months after

completion of therapy

Yes, because his recurrence of TB disease is more than 12 months after initial

diagnosis

No, because his recurrence of TB disease is within 12 months of completion of

therapy

No, because his recurrence of TB disease is more than 12 months after initial

diagnosis

Case Study for Items 3 and 5 – Raul

Raul lives in El Paso, Texas, and is diagnosed with TB disease in September 2008 and

completes therapy on March 21, 2009. His Texas locally assigned identification number

is 200800121. In December 2009, Raul moves to Arizona. He presents to the Tucson

General Hospital with symptoms of TB on May 1, 2010, and is evaluated for TB. He is

diagnosed with TB disease on May 12, 2010. His Arizona locally assigned identification

number is 201000032.

5.4

What is the State Case Number for Item 3 on the 2010 RVCT?

(circle the one best answer)

Year Reported

(YYYY)

State

Code

Locally Assigned Identification Number

2 0 0 8 T X 2 0 0 8 0 0 1 2 1

B. Year Reported

(YYYY)

State

Code

Locally Assigned Identification Number

2 0 1 0 A Z 2 0 1 0 0 0 0 3 2

5.5

What is the Linking State Case Number for Item 3 on the 2010 RVCT?

(circle the one best answer)

Year Reported

(YYYY)

State

Code

Locally Assigned Identification Number

2 0 0 8 T X 2 0 0 8 0 0 1 2 1

B. Year Reported

(YYYY)

State

Code

Locally Assigned Identification Number

2 0 1 0 A Z 2 0 1 0 0 0 0 3 2

5.6

What is the Reason for the Linking State Case Number for Raul?

(circle the one best answer)

Reason 1 – Recurrence or previous diagnosis of TB

Reason 2 – Epidemiologically linked case, source case, or contact with another

case

Reason 3 – Case transferred from another area

5.7

How would you complete item 5, Count Status, on the 2010 RVCT?

(circle the one best answer)

Count as a TB case

Noncountable – Verified Case: Counted by another U.S. area

Noncountable – Verified Case: TB treatment initiated in another country

Noncountable – Verified Case: Recurrent TB within 12 months after completion of

therapy

Case Study for Items 3 and 5 – Elton

Elton lives in Cut and Shoot, Texas, and is diagnosed with TB disease in June 2009 and

immediately starts therapy. In December 2009, Elton moves to Truth or Consequences,

New Mexico, and continues DOT through the County Health Department.

5.8

What is the Reason for the Linking State Case Number for Elton?

(circle the one best answer)

Reason 1 – Recurrence or previous diagnosis of TB

Reason 2 – Epidemiologically linked case, source case, or contact with another

case

Reason 3 – Case transferred from another area

Case Study for Items 3, 4, and 5 – John

The Tennessee TB program confirms that John is diagnosed with TB on November 1,

2008, and he starts on DOT. Tennessee counts his case as a 2008 case. John receives only

one week of anti-TB therapy while in Tennessee. He is then reported as lost.

In December 2008, John moves to Fulton County, Georgia. He goes to the Fulton County

TB Clinic on February 2, 2009, complaining of a prolonged cough and fever. During the

interview, John reveals that he was treated for TB in the past in Tennessee. The Fulton

County TB clinic evaluates him for TB disease. He is started on anti-TB therapy. The

Fulton County TB Clinic contacts the Tennessee TB program to confirm the information

and to inform the Tennessee program that John is now living in Georgia. On February

16, TB disease is confirmed based on a positive culture, and he completes treatment in

Georgia, in August 2009.

5.9

Which state should count the case?

(circle the one best answer)

Tennessee

Georgia

5.10 What reporting address should be entered on the 2008 RVCT?

(circle the one best answer)

John’s address in Tennessee

John’s address in Georgia

5.11 What is the Reason for the Linking State Case Number of the 2009 RVCT?

(circle the one best answer)

Reason 1 – Recurrence or previous diagnosis of TB

Reason 2 – Epidemiologically linked case, source case, or contact with another

case

Reason 3 – Case transferred from another area

5.12 What reporting address should be entered on the 2009 RVCT?

(circle the one best answer)

John’s address in Tennessee

John’s address in Georgia

5.13 How would you complete item 5, Count Status, on the 2009 RVCT?

(circle the one best answer)

Count as a TB case

Noncountable – Verified Case: Counted by another U.S. area

Noncountable – Verified Case: TB treatment initiated in another country

Noncountable – Verified Case: Recurrent TB within 12 months

Date Counted

Primary Purpose: Surveillance. Data are used by the count authority to tally the official TB case count

for the month, quarter, and year.

Description Comment

Month, day, and year

(e.g., 01/17/2009)

Date that the responsible count

authority (usually the state health

department, but might be another

designated authority)

• Reviewed the RVCT

• Verified the case as TB

and

• Included it in the official TB

case count

If the day is unknown, enter 99 as the

default value (e.g., 01/99/2009).

Summary of Date Reported, Date Submitted, and Date Counted

Type of Date Who/What

Description of Action

Date Reported (item 1)

TB suspect

Reported to the health department (either by the health

department itself or another health care provider)

Date Submitted (item 2)

RVCT form

Submitted to the reporting area (e.g., state health

department)

Date Counted (item 6)

TB case

Counted as a Case of TB (by the count authority)

Comment: Pending results

Suspected cases for which bacteriologic results are pending or for which verification of disease is

questioned for any reason should be counted only after they are determined to be verified TB cases. This

could mean that a case reported in one year may not be counted until the following year.

Example: Date Counted

If a case is reported to the health department in December 2008, but bacteriologic or clinical evidence of

TB is not available until January 2009, the case should be counted in January 2009 (when TB disease was

verified), not in December.

Exercise

Date Counted

For questions 6.1 – 6.3

What is the description for the following items?

(Choose the one best answer by matching the description with the RVCT item. Write the letter

for the description on the line next to the question number.)

Item Description

___

6.1

Item 1, Date Reported

Date the reporting area sends the RVCT to

the counting authority

___

6.2

Item 2, Date Submitted

Date that the count authority verifies the

case as TB and it is included in the official

case count

___

6.3

Item 6, Date Counted

Date that a health department first suspects

that the patient might have TB

Case Study – Richard

On September 3, 2009, Richard is diagnosed with culture-positive TB. It is confirmed

that he has never had TB disease before. The RVCT form is completed by the county

health department on September 12 and sent to the state TB program. On September 21

the state TB program determines that it is a new verified case of TB and reports it to

CDC.

6.4

Which date is the Date Counted?

(circle the one best answer)

September 3, 2009

September 12, 2009

September 21, 2009

Case Study - Items 1, 2, and 6 – Reviewing the RVCT

You are reviewing an RVCT that your colleague Jim completed. You look at the

following dates that were entered for Items 1, 2, and 6. You notice that there is a problem

with the following dates.

Item 1 – Date Reported – May 18, 2009

Item 2 – Date Submitted – May 18, 2009

Item 6 – Date Counted – May 3, 2009

6.5

What is the problem with the dates?

(circle the one best answer)

The Date Reported cannot be the same date as the Date Submitted because the

case cannot be submitted the same day that it was reported.

The Date Counted cannot come before the Date Reported because the case has

to be reported and evaluated before it can be counted.

Previous Diagnosis of TB Disease

Primary Purpose: Case management and surveillance. Data are used to evaluate the patient’s response

to treatment and to analyze drug resistance from a previous episode of TB disease.

Option

(select one)

Description Comment

Patient has received a previous

diagnosis of TB disease.

Do not enter a previous diagnosis of latent

TB infection (LTBI).

Yes

If you selected Yes, enter the year of

previous diagnosis of TB disease

(e.g., 1985).

If the patient had more than 1 previous

episode of TB disease, enter the year of

the most recent previous episode.

Patient has not received a previous

diagnosis of TB disease.

Comments: Yes

A patient is considered to have had a previous diagnosis of TB disease if

•

TB disease was verified in the past

•

The patient completed therapy for TB disease (even if the case-to-case interval is within 12

months)

•

The patient with TB disease was lost to supervision for more than 12 months and now has

verified TB disease again.

Note: Recurrent cases within 12 months of completion of therapy should be considered noncountable,

regardless of whether the initial and the subsequent genotypes are the same or are different.

If the patient had a previous episode of TB that was reported to U.S. surveillance, you should, for the

purposes of linking RVCT forms

•

Contact the state in which the case was counted to ask for the most recent previous diagnosis

•

Enter the most recent previous RVCT

State Case Number

for this case under

Linking State

Case Number

(item 3)

•

Enter the code for the

Reason

linking is desired (e.g., enter 1 for recurrence or previous diagnosis

of TB)

Documentation of Previous Diagnosis of TB Disease

Often, TB disease is confused with latent TB infection (LTBI), which should not be coded as previous TB

disease. Therefore, documentation of the previous episode of TB disease is important. Follow the priority

indicated below.

Oral Report

hen written documentation is

not

available, oral report of

a previous episode of TB disease is acceptable (e.g.,

medications taken, length of course of medication, results

of sputum smear examination).

Written Documentation

Written documentation of the previous episode of TB

disease is ideal. However, if the TB disease episode

occurred years ago or in another location (e.g., other

country), obtaining written documentation may be difficult.

Priority

Written Documentation

If written documentation is

not available use the 2

priority

Priority

Oral Report

Exercise

Previous Diagnosis of TB Disease

Case Study – David

In January 2009, David has a positive tuberculin skin test (TST) result. His sputum result

is smear negative, with a normal chest radiograph, and he is treated for latent TB

infection (LTBI). He completes treatment July 15, 2009. He goes to Cape Town, South

Africa, for international training and returns home August 15, 2009. Four months later

David becomes severely ill and on December 17, 2009, his chest radiographs are

abnormal and consistent with TB. At that time, a sputum sample is sent to the laboratory.

His sputum results indicate both smear and culture positive for M. tuberculosis complex.

7.1

Is David considered to have a Previous Diagnosis of TB Disease?

(circle the one best answer)

Yes, because he had a positive TST

Yes, because he was treated for LTBI

No, because he had LTBI and not TB disease

Date of Birth

Primary Purpose: Surveillance. Data are used to document patient demographic information.

Description Comment

Month, day, and year

(e.g., 04/26/1968)

Patient’s complete date of birth

should be entered (i.e., values

should be entered for month, day,

and year).

Some societies or cultures throughout

the world do not document the day,

month, or even the year of birth.

If the day is unknown, or the month

and the day are unknown, enter 99 as

the default value (e.g., 04/99/1968 or

99/99/1968).

If the month, day, and year of birth

are unknown, enter 99/99/9999.

Exercise

Date of Birth

Case Study – Edris

Your patient Edris is from Iran. When you ask him for his date of birth, he says that he is

born in 1947, but he has never seen his birth certificate and his parents could not

remember when he was born, so he isn’t sure of the month and day. He also mentions

that he sometimes uses March 21, 1947, as his birth date and sometimes February 23 as

the date.

8.1

What would be entered for Edris’ date of birth?

(circle the one best answer)

A. Month Day Year

0 3 2 1 1 9 4 7

B. Month Day Year

0 2 2 3 1 9 4 7

C. Month Day Year

9 9 9 9 1 9 4 7

Sex at Birth

Primary Purpose: Surveillance. Data are used to document patient demographic information.

Option

(select one)

Description

Male

The biological sex of the TB patient was

Male

at birth.

Female

The biological sex of the TB patient was

Female

at birth.

Exercise

Sex at Birth

Case Study – Dahlia

You are meeting with Dahlia and filling out the RVCT form. You ask Dahlia what was

her sex at birth. Dahlia insists that she is a woman. You are suspicious because Dahlia

looks and dresses like a woman, but she has a very deep voice, large hands and feet, and

there appears to be some facial hair. While showing respect for Dahlia and the sensitivity

of the situation, you stress confidentiality and mention that this form is for surveillance

purposes only. You ask her what sex is listed on her birth certificate. Dahlia mentions

that it is male, but she had an operation that brought out her feminine side.

9.1

What do you list as Dahlia’s sex at birth?

(circle the one best answer)

Male

Female

10.

Ethnicity

Primary Purpose: Surveillance. Data are used to detect high-risk groups for TB by ethnicity.

Option

(select one)

Description Comment

Hispanic or Latino

Patient considers himself or herself

Cuban, Mexican, Puerto Rican,

South or Central American, or of

other Spanish culture or origin,

regardless of race.

Some patients prefer the term

“Spanish origin” to Hispanic or

Latino.

Not Hispanic or

Latino

Patient does not consider himself or

herself Hispanic or Latino.

Comment: Self-identity or self-reporting

The response to this item should be based on the patient’s self-identity or self-reporting.

It should

not

be based on appearance or surname.

Example: Not Hispanic or Latino but has a Hispanic name

A patient may have a Hispanic name, but may not be Hispanic or Latino. For example, if a woman who is

not Hispanic marries a Hispanic man, she may self-report as “Not Hispanic or Latino.” Similarly, people

from the Philippines may have Hispanic names, but self-report as “Not Hispanic.”

Exercise

10.

Ethnicity

Case Study – Susy

Susy is a school teacher. She went to the Houston, Texas, Health Department for TB

testing because of an outbreak at her school. She was diagnosed with TB disease. You

ask her ethnicity and she says multi-racial because her father is an American Indian from

Arizona and her mother is Cuban. You explain the difference between race and ethnicity

and you ask her if she considers herself Hispanic or Latino, or not Hispanic or Latino.

Susy says that she is part Hispanic.

10.1 What do you check for Item 10 Ethnicity?

(circle the one best answer)

Hispanic or Latino

Not Hispanic or Latino

11.

Race

Primary Purpose: Surveillance. Data are used to detect high-risk groups for TB by race.

Option

(select one or more)

Description

American Indian or

Alaska Native

Patient has origins in any of the original peoples of North and South

America (including Central America).

Asian

Patient has origins in any of the original peoples of the Far East, Southeast

Asia, or the Indian subcontinent (e.g., including Bangladesh, Cambodia,

China, India, Indonesia, Japan, Korea, Malaysia, Nepal, Pakistan, the

Philippine Islands, Thailand, and Vietnam).

Black or African

American

Patient has origins in any of the black racial groups of Africa.

Native Hawaiian or

Other Pacific Islander

Patient has origins in any of the original peoples of Hawaii, Guam,

American Samoa, or other Pacific Islands.

White

Patient has origins in any of the original peoples of Europe, the Middle

East, or North Africa.

Comment: Self-identity or self-reporting

The response to this item should be based on the patient’s self-identity or self-reporting.

Therefore, patients should be offered the option of selecting more than one racial designation.

Comment: Asian

or Native Hawaiian or Other Pacific Islander

If you selected

Asian

Native Hawaiian or Other Pacific Islander

, use the National Electronic

Disease Surveillance System (NEDSS) Person Race Categories to complete

Specify

. The chart below

indicates who is considered Asian and who is considered Native Hawaiian or Other Pacific Islander.

National Electronic Disease Surveillance System (NEDSS)

Person Race Categories for Asian and for

Native Hawaiian or Other Pacific Islander*

Asian

Native Hawaiian or

Other Pacific Islander

Asian Indian

Bangladeshi

Bhutanese

Burmese

Cambodian

Chinese

Filipino

Hmong

Indonesian

Iwo Jiman

Japanese

Korean

Laotian

Madagascar

Malaysian

Maldivian

Nepalese

Okinawan

Pakistani

Singaporean

Sri Lankan

Taiwanese

Thai

Vietnamese

Carolinian

Chamorro

Chuukese

Fijian

Guamanian

Kiribati

Kosraean

Mariana Islander

Marshallese

Melanesian

Micronesian

Native Hawaiian

New Hebrides

Other Pacific Islander

Palauan

Papua New Guinean

Pohnpeian

Polynesian

Saipanese

Samoan

Solomon Islander

Tahitian

Tokelauan

Tongan

Yapese

*From NEDSS Logical Data Model Data Dictionary: Appendix B, 1. Standardized Vocabulary, 1.4 Person Race Categories and

Codes

(http://www.cdc.gov/nedss/DataModels/NEDSS_LDM_Dictionary_II.pdf;

last updated 11-19-2001)

Exercise

11.

Race

Case Study – Joaquin

You ask Joaquin how he defines his race. You state that there are several options for race

and he can select whatever he thinks is appropriate. Joaquin says his father is African

American and his mother is full-blooded Cherokee Indian, so he thinks he is both of those

races.

11.1 Which of the following do you check for Item 11 Race?

(circle the one best answer)

American Indian or Alaska Native

Asian

Black or African American

Native Hawaiian or Other Pacific Islander

Both A and C

Case Study – Trang

The health care worker asks Trang what race she is. She states that she is Filipino and

Vietnamese.

11.2 Which of the following do you check for Item 11 Race?

(circle the one best answer)

American Indian or Alaska Native

Asian

Black or African American

Native Hawaiian or Other Pacific Islander

Both A and C

12.

Country of Birth

Primary Purpose: Surveillance. Data are used to determine the rate of TB among “U.S.-born” and

foreign-born persons and to identify persons from countries with a high rate of TB.

Note:

This portion of the RVCT asks 2 questions to help classify a person based on where the person

was born.

•

“U.S.-born.”

The U.S. Census Bureau defines a “U.S.-born” person to be someone born in 1 of the

50 states or the District of Columbia, or someone born outside the United States to at least one parent

who was a U.S. citizen. In order to be consistent with the U.S. Census Bureau and to be able to apply

census bureau population data to calculate TB rates, CDC uses the same definition for “U.S.-born.”

•

Country of birth.

In order to distinguish persons who were born in another country (whether or not

they had a parent who was a U.S. citizen) from those who were born in the United States, this

question simply asks to record the actual country of birth. Therefore, a patient who was born in

France and whose father was a U.S. citizen would be “U.S.-born” and their country of birth would be

France.

“U.S.-born” (or born abroad to a parent who was a U.S. citizen)

OPTION

(select one)

Description Comment

Yes

If the person was born

• In 1 of the 50 U.S. states or

the District of Columbia,

• Abroad to a parent who was a

U.S. citizen.

“U.S.-born” does not mean the same as U.S.

citizen, and it does not necessarily mean that the

person was born in the United States.

Not all U.S. citizens (e.g., naturalized citizens) are

“U.S.-born.”

If the person was born

• Abroad

and

• Neither parent was a U.S.

citizen.

Select for any country other than the United

States.

Country of birth

Description

Country of birth (specify)

(e.g., United States, Mexico,

China)

Enter the name of the country in which the person was actually born.

Fill this out for all patients (whether they were “U.S.-born” or not).

Examples of U.S.-Born

Patient Father Mother

U.S.-born U.S. citizen U.S. citizen

Yes No

Description

Yes No Yes No

Yes

Born in 1 of the 50 states or the District of

Columbia

Yes

Born in 1 of the 50 states or the District of

Columbia

Yes

Born in another country

Yes

Born in another country

Yes

Born in another country

Yes

Born in another country

Note:

People born in Puerto Rico, Guam, the U.S. Virgin Islands, or the Commonwealth of the

Northern Mariana Islands are U.S. citizens, but are

only considered “U.S.-born”

if they are born to a

parent who is a U.S. citizen.

Comment: “U.S.-born”

If the patient was born in 1 of the 50 states or the District of Columbia, or born abroad to a parent who

was a U.S. citizen (either the mother or father or both parents), the patient is considered “U.S.-born.”

Select Yes for “U.S.-born.” For country of birth, enter the name of the country where the person was

actually born.

Example: “U.S.-born” and actually born in 1 of the 50 states or the District of Columbia

If the person was actually born in 1 of the 50 states or the District of Columbia, enter

• “U.S.-born” – Yes

• Country of birth – United States

Example: “U.S.-born” and actually born in another country

If the patient is born in Haiti, his mother is Haitian, but his father is a U.S. citizen, enter

• “U.S.-born” – Yes

• Country of birth – Haiti

Example: “U.S.-born” and born to parents who were born in Puerto Rico, Guam, the U.S.

Virgin Islands, or the Commonwealth of the Mariana Islands (people born in these countries are

U.S. citizens)

If the patient was born in Puerto Rico and both parents were born in Puerto Rico (therefore U.S.

citizens), enter

• “U.S.-born” – Yes

• Country of birth – Puerto Rico

Comment: Not “U.S.-born” and born in any country other than the U.S.

If the patient was born in a country other than the United States to parents who were

not

“U.S. citizens,”

enter

•

“U.S.-born” – No

•

Country of birth – name of the country where the person was actually born

Example: Not “U.S.-born” but born in Puerto Rico, Guam, the U.S. Virgin Islands, or the

Commonwealth of the Mariana Islands (people born in these countries are U.S. citizens but not

necessarily U.S.-born)

If the patient was born in Puerto Rico and but neither parent was a U.S. citizen, enter

• “U.S.-born” - No

• Country of birth – Puerto Rico

Example: Not “U.S.-born” and born to parents who are not U.S. citizens

If the patient was born in Russia and both parents are Russian citizens, enter

• “U.S.-born” - No

• Country of birth – Russia

Exercise

12.

Country of Birth

Case Study – Wolfgang

You are completing an RVCT on Wolfgang and you ask him his country of birth. He says

he was born in Germany. His father was born in the United States and is a U.S. citizen.

His mother is a German citizen. They married when his father was stationed in Germany.

12.1 What do you specify for “U.S.-born”?

(circle the one best answer)

Yes

12.2 What do you specify for Country of Birth?

(circle the one best answer)

United States

Germany

Case Study – Bernard

Bernard was born in Tryon, North Carolina. Both of his parents were born in Hungary.

12.3 What do you specify for “U.S.-born”?

(circle the one best answer)

Yes

12.4 What do you specify for Country of Birth?

(circle the one best answer)

United States

Hungary

Case Study – Mayleen

Mayleen was born in Guam. Both of her parents were born in Palau. They had moved to

Guam for one year during the time when Mayleen was born.

12.5 What do you specify for “U.S.-born”?

(circle the one best answer)

Yes

12.6 What do you specify for Country of Birth?

(circle the one best answer)

Palau

Guam

United States

Case Study – Jiguna

Jiguna was born in Kenya. Both his mother and father were Kenyan citizens. The family

moved to the United States when Jiguna was 2 months old.

12.7 What do you specify for “U.S.-born”?

(circle the one best answer)

Yes

12.8 What do you specify for Country of Birth?

(circle the one best answer)

United States

Kenya

13.

Month-Year Arrived in U.S.

Primary Purpose: Programmatic function. Data are used to guide TB programs in developing

strategies for TB prevention and control for persons born outside the U.S.

Description Comment

Month and year

(e.g., 02/1975)

When the patient first arrived in the

United States (1 of the 50 states or

the District of Columbia).

Complete this item if the patient was

born in another country.

If month is unknown, enter 99 as the

default value (e.g., 99/1975).

If neither month nor year is known,

enter 99/9999.

Leave item blank

If patient was born in 1 of the 50

states or the District of Columbia.

Comment: If the patient was born abroad to a parent who was a U.S. citizen

If a patient was born abroad to a parent who was a U.S. citizen, enter the month and year that the patient

first arrived in the United States (1 of the 50 states or the District of Columbia).

Example: If the patient was born abroad to a parent who was a U.S. citizen

If a patient was born in Germany to a parent who was a U.S. citizen, enter the month and year that the

patient first arrived in the United States (1 of the 50 states or the District of Columbia).

Example: If the patient was born abroad to a parent who was a U.S. citizen

If a patient was born in Puerto Rico to a parent who was a U.S. citizen, enter the month and year that the

patient first arrived in the United States (1 of the 50 states or the District of Columbia).

Example: Date that a patient first arrived from another country who enters on student visa

If a patient is a citizen from another country and comes to the United States (1 of the 50 states or the

District of Columbia) on a student visa and returns home, and then later returns to the United States, the

date when the patient first arrived in the United States as a student would be the date that should be

entered, even if the patient doesn’t return for many years.

Exercise

13.

Month-Year Arrived in U.S.

Case Study – Julia

Julia is a citizen of El Salvador. In January 2008 she came to the U.S. on a student visa.

In June 2009 she returned home to El Salvador. In September 2010 she returned to the

United States on another student visa.

13.1 What is the month and year that Julia arrived in the United States?

(circle the one best answer)

A. Month Year

0 1 2 0 0 8

B. Month Year

0 9 2 0 1 0

Case Study – Ken

Ken was born March 16, 2000, in Majuro, Republic of the Marshall Islands (RMI). His

mother is a U.S. citizen and his father is a citizen of the RMI. On December 20, 2009, he

migrated with his family to Arkansas. He is diagnosed with TB on March 5, 2010.

13.2 What do you enter for Ken for Month-Year Arrived in the U.S.?

(circle the one best answer)

A. Month Year

0 3 2 0 0 0

B. Month Year

1 2 2 0 0 9

C. Month Year

0 3 2 0 1 0

D. Month Year

(Leave answer blank)

14.

Pediatric TB Patients (<15 years old)

Primary Purpose: Surveillance. Data are used to capture risk factors for guardians born in countries

that have a high burden of TB and when pediatric patients live in TB endemic countries.

To better capture important information about pediatric TB patients (<15 years old), this variable provides

information on country of birth for primary guardians (or primary care givers) of the pediatric patient and

whether the patient lived outside the United States (1 of the 50 states or the District of Columbia) for an

uninterrupted

period of more than 2 months.

Note: Pediatric TB Patients (item 14) should be completed for all pediatric patients. For all pediatric

patients, ask the country of birth for parents or primary guardians and whether the patient has lived

outside the United States for >2 months consecutively.

Complete this item for

all pediatric

TB patients (<15 years old).

Description

Country of birth for the

primary guardians (e.g.,

mother, father, adoptive or

foster parent, grandparent)

Enter the names of the countries where the primary guardians were

actually born.

Enter as many as 2 parents or primary guardians.

Complete this item for

all pediatric

TB patients (<15 years old).

Option

(select one)

Description Comment

Yes

Pediatric patient lived outside the United

States (1 of the 50 states or the District of

Columbia) for an uninterrupted period of

more than 2 months.

Although it may be difficult to

determine the exact amount of

uninterrupted time that a patient lived

outside the United States, check Yes

and enter the names of the countries if

the period is believed to be more than

8 consecutive weeks (2 months).

Pediatric patient did not live outside the

United States for an uninterrupted period

of more than 2 months.

Unknown

It is not known whether the pediatric patient

lived outside the United States for an

uninterrupted period of more than 2

months.

Comment: Lived outside the United States

Lived outside the United States refers to the place where a person stayed or slept most of the time, or the

place the person considered home during the stated period.

If you selected

Yes

, enter the following information.

Description Comment

Countries

(specify)

Enter the names of the countries where

the pediatric patient lived.

Enter as many as 3 non-U.S. countries in

which the patient most recently lived for a

total of more than 2 uninterrupted

months.

Example: Yes, Lived outside the United States in as many as 3 countries for a total of more than 2

uninterrupted months

From January 1 to March 15, the patient lived outside the United States

•

Lived in Zambia for 10 weeks, then

•

Returned to the United States

Example: Yes, Lived outside the United States in as many as 3 countries for a total of more than 2

uninterrupted months

From January 1 to March 15 the patient lived outside the United States

•

Lived in Zambia for 4 weeks, then

•

Lived in South Africa for 3 weeks, then

•

Lived in Botswana 3 weeks, then

•

Returned to the United States

Example: No, Lived outside the United States in as many as 3 countries for a total of more than 2

months, but travel was interrupted

From January 1 – March 15 the patient lived outside the United States

•

Lived in Zambia for 5 weeks, then

•

Returned to the United States for 2 weeks, then

•

Lived in South Africa for 5 weeks, then

•

Returned to the United States

Exercise

14.

Pediatric TB Patients (<15 years old)

Case Study – Pim

Pim, a pediatric TB patient, was born in Portland, Oregon, on March 6, 2000. Her father

was born in Thailand and immigrated to the U.S. in 1998. Her mother was born in

Burlington, Vermont. The family traveled to Thailand for 3 weeks in 2005, but have not

been out of the U.S. since that time. Pim’s parents were divorced in 2006 and her mother

remarried in 2008. Pim lives with her mother and stepfather who was also born in

Vermont. Her father and mother share joint custody, and Pim stays with her father every

other weekend.

14.1 What would you enter for Country of Birth for the primary guardians?

(circle the one best answer)

Guardian 1 - United States (based on mother)

Guardian 2 - Thailand (based on father)

Guardian 1 - United States (based on mother)

Guardian 2 - United States (based on stepfather)

14.2 What do you specify for Patient lived outside the U.S. for >2 months?

(circle the one best answer)

Yes

Unknown

Case Study for Items 12 and 14 – Antonio

Antonio, a pediatric patient, was born in El Salvador. His father was born in the United

States and living in El Salvador when Antonio was born. His mother was born in El

Salvador and was a citizen of El Salvador. Antonio’s mother died shortly after his birth,

and Antonio was raised mostly by his father.

In January 2003, 8-year-old Antonio moved from El Salvador to Houston, Texas, when

his father could no longer care for him. At that time, his uncle and aunt, the Trujillos,

became his legal guardians and he has lived with them since that time. Both his uncle and

aunt were born in El Salvador, but have been living in the United States for over 30

years.

14.3 For Item 12, what do you select for “U.S.-born”?

(circle the one best answer)

Yes

14.4 For Item 12, what is the Country of Birth for Antonio?

(circle the one best answer)

El Salvador

United States

14.5 For Item 14, what is the Country of Birth for the primary guardians at time of

diagnosis for TB?

(circle the one best answer)

Guardian 1 – US (based on father)

Guardian 2 – El Salvador (based on his uncle and/or aunt)

Guardian 1 – El Salvador (based on uncle)

Guardian 2 – El Salvador (based on aunt)

Case Study for Item 14 – Antonio (cont.)

In 2007, Antonio visited his father in El Salvador during June 5 – September 30. He

returned to the United States on October 1.

14.6 For Item 14, did Antonio live outside the U.S. for >2 months?

(circle the one best answer)

Yes

Unknown

Case Study – Regina

Regina, a pediatric TB patient, visited her grandmother in Russia during April 7 – June 1,

2008. She returned to the United States on June 1.

14.7 For Item 14, did Regina live outside the U.S. for >2 months?

(circle the one best answer)

Yes

Unknown

Case Study – Lisa

Lisa, a pediatric TB patient, traveled with her parents to the Philippines September 1 –

November 1, 2009. They traveled to Taiwan and visited her grandmother November 1 –

November 15. Then they traveled to Vietnam November 15 – December 15. Lisa and her

parents returned to the United States on December 16.

14.8 For Item 14, did Lisa live outside the U.S. for >2 months?

(circle the one best answer)

Yes

Unknown

15.

Status at TB Diagnosis

Primary Purpose: Surveillance. Data are used to examine mortality and to determine if TB was a cause

of death.

Option

(select one)

Description Comment

Alive

Patient was alive at time

• Laboratory results

confirming a TB

diagnosis (e.g., positive

culture or nucleic acid

amplification [NAA]

test result consistent

with TB) were known

to the provider

• TB medications were

started

If the patient

• Was known to be culture or NAA test result

positive consistent with TB prior to the date of

death but did not start TB therapy per

ATS/CDC/IDSA guidelines, classify the patient

as alive at TB diagnosis

• Started empiric therapy for TB disease (per

ATS/CDC/IDSA guidelines), but TB was not

verified until after the patient’s death, classify

as alive at TB diagnosis

• Started TB therapy, regardless of laboratory or

clinical confirmation for TB diagnosis, classify

the patient as alive at TB diagnosis

Dead

Patient was deceased at the

time laboratory results

confirming a TB diagnosis

(e.g., positive culture or

NAA test result consistent

with TB) were known to

the provider

• If diagnostic specimens were collected for

evaluation of TB prior to death, but positive

results to make a diagnosis of TB were not

available until after death, and patient did not

start TB therapy, classify as dead at TB

diagnosis

• If TB diagnosis was made after death based on a

constellation of clinical and other findings (e.g.,

symptoms, TST, and imaging studies) in the

absence of laboratory confirmation, and the

patient did not start therapy, classify as dead at

TB diagnosis

• If patient was receiving treatment for latent TB

infection at death because active TB disease was

not suspected, and TB was diagnosed after

death, classify as dead at TB diagnosis

• If patient was diagnosed at autopsy, classify as

dead at TB diagnosis

Comment:

If a person dies while taking isoniazid as preventive therapy for latent TB infection, and this person is

found after death to have had TB disease, he/she should be classified as

Dead

at TB diagnosis.

If you selected

Dead

at TB diagnosis, enter

date of death

Description Comment

Date of death

(e.g., 01/17/2005)

Month, day, and year patient

died

If day is unknown, enter 99 as the default value

(e.g., 01/99/2005).

If you selected

Dead

at TB diagnosis,

was TB a

cause of death

Option

(select one)

Description Comment

Yes

(related to TB

disease)

TB was

• The immediate cause

• An underlying cause

• Another significant condition

contributing to death (even if

TB was not the main cause

of death)

Written documentation of the cause of death

(e.g., death certificate, autopsy report, medical

record) is recommended. However, oral

information from a reliable source (e.g., a health

care provider) will be accepted.

A death certificate is not necessarily required to

complete this field. In some cases deaths may be

certified before receipt of results of

• Positive M. tuberculosis culture

• Other findings consistent with TB

If the patient died as a result of a surgical

procedure that was indicated for TB, or TB

complicated a surgical procedure not related to

TB.

(unrelated to TB

disease)

TB was not

• The immediate cause

• An underlying cause

• Another significant condition

contributing to death

Unknown

Cause of death is not known.

Every effort should be made to determine if

death was related to TB disease before

classifying as unknown.

Note:

This should reflect current or active TB disease (not LTBI) whenever death certificate or death

documentation is used.

Exercise

15.

Status at TB Diagnosis

Case Study – Thomas

Thomas is admitted to the hospital on August 5, 2009. He is coughing up blood. He

reports having symptoms consistent with TB for the past 7 months and his chest

radiograph shows significant deterioration of both lung lobes. He is placed in a TB

isolation unit and begins isoniazid, ethambutol, rifampin, and pyrazinamide. He dies 1

week later on August 12, 2009.

15.1 What is the Status at TB Diagnosis?

(circle the one best answer)

Alive

Dead

Case Study – Ruth

Ruth comes to the emergency room on April 30, 2009. She is diagnosed with pneumonia,

given antibiotics, and discharged. She dies 2 weeks later on May 15, 2009. At autopsy,

the pathology shows granulomatous changes consistent with TB disease. A lung biopsy

culture is found to be positive for M. tuberculosis complex.

15.2 What is the Status at TB Diagnosis?

(circle the one best answer)

Alive

Dead

15.3 Was TB a cause of death for Ruth?

(circle the one best answer)

Yes

16.

Site of TB Disease

Primary Purpose: Surveillance. Data are used to document site of TB disease.

Option

(select all that apply)

Description Comment

Pulmonary, pleural,

lymphatic, etc.

Select boxes corresponding to the

site(s) of TB disease.

Other: enter

anatomic code(s)

If site of TB disease is a site

other than those listed, enter the

anatomic code(s) (see

Appendix C – Anatomic Codes).

You may enter as many as 3

Other anatomic codes.

Refer to the listings for site of TB

disease and anatomic codes. In

Appendix C – Anatomic Codes,

anatomic codes for Other are marked

with an asterisk (*). Select only from

sites marked with an asterisk (*).

Anatomic codes without an asterisk

are parts of organ systems

corresponding to Site of TB Disease.

Site not stated

If you selected Site not stated, do not

check any other box.

Note: For the purposes of the RVCT training materials, use the codes listed in the appendices. Some

software programs used to enter data on the RVCT may NOT use the codes listed in the appendices.

For example, the Anatomic Codes may be a drop-down item where you choose the actual site rather

than enter a code. For more information, see instructions for the software you use.

Comment: If more than 1 organ or disease site is involved

If there is evidence that more than 1 organ or disease site is involved, check all involved sites of disease.

Comment: Lymphatic intrathoracic

Lymphatic intrathoracic includes hilar, bronchial, mediastinal, peritracheal, and other lymph nodes within

the thorax.

Comment: Miliary TB

Unlike the previous RVCT form, the new form has no place to select miliary TB in

Site of Disease

(item

16). If the report of the initial chest radiograph or the initial chest CT scan indicates “miliary TB or a

miliary or bilateral micronodular pattern,” record this finding under

Initial Chest Radiograph

(item

22A) or

Initial Chest CT Scan or Other Chest Imaging Study

(item 22B), respectively. However,

pulmonary should be selected as

Site of Disease

(item 16) if the chest x-ray or CT scan shows evidence

of nodules consistent with miliary TB.

Miliary TB is a serious type of tuberculosis infection. It is a clinical or radiologic finding, rather than a

site of disease. Miliary TB is the result of a TB lung infection eroding into the bloodstream and from there

disseminating throughout the body to multiple organs. It appears on radiograph as a great number of small

(1- to 2-mm), well-defined nodules that look like millet seeds scattered throughout the lungs, hence the

name “miliary.”

Exercise

16.

Site of TB Disease

Case Study – June

June is 65 years old and has been diagnosed with TB disease. Her chest x-ray shows a

right pleural effusion, a right upper lobe infiltrate, and enlargement of the right

intrathoracic lymph nodes. The pleural biopsy showed granulomas that were AFB

positive and the sputum culture grew M. tuberculosis complex.

16.1 What is (are) the Site(s) of TB Disease?

(circle the one best answer)

Pulmonary

Pleural

Lymphatic intrathoracic

Peritoneal

A, B, and C are all correct

Case Study – Leonard

Leonard is a 47-year-old HIV-positive male with a 3-month history of progressive fatigue

and shortness of breath. His doctor diagnosed severe anemia, and a bone marrow biopsy

showed extensive granulomatous inflammation teeming with AFB. Culture of blood and

bone marrow grew M. tuberculosis complex. His chest x-ray and chest CT scan were

normal.

16.2 What is (are) the Site(s) of TB Disease?

(circle the one best answer)

Bone and/or joint

Other, anatomic code 04

Other, anatomic code 06

A and B are both correct

B and C are both correct

Module

Module Module

Module B

- R

R R

RVCT

VCTVCT

VCT

(page 2

(page 2(page 2

(page 2 of 3

of 3 of 3

of 3)

))

)

Items 17

Items 17 Items 17

Items 17 –

––

– 25

25 25

Module B provides instructions and exercises for completing page 2 of the RVCT report. It includes data

about laboratory results and primary reason the patient was evaluated for TB disease.

17.

Sputum Smear

Primary Purpose: Case management and surveillance. This result is one factor in determining whether

the patient’s disease meets the public health definition of TB.

Option

(select one)

Description Comment

Positive

The result of any sputum examination was

positive for acid-fast bacilli (AFB).

Negative

Results of all examinations were negative.

Not done

Sputum smear examination is known not to have

been done.

Unknown

It is not known whether a sputum smear

examination was performed.

Results are not known for a reason other than

pending results (e.g., result was lost or specimen

was contaminated, and no other specimen can be

obtained).

If an initial sputum specimen

was collected and results are

unknown, but results later

become known, update the

results.

Comments: Sputum

Sputum includes spontaneous and induced sputum. Do

not

include the results of microscopic examination

of pulmonary secretions obtained by tracheal suction, bronchoscopy procedures (e.g., bronchial washing

or lavage, scrapings, biopsies), or gastric aspiration. See

Smear/Pathology/Cytology of Tissue and

Other Body Fluids

(item 19).

Sputum should have been collected during the diagnostic evaluation or shortly thereafter. Do

not

record

specimens collected after the patient has received treatment for more than 2 weeks.

For

Positive

Negative

results of sputum smear examinations, enter the following information.

Description Comment

Month, day, and year the first

sputum specimen with a positive

result was collected (e.g.,

01/17/2009)

If several sputum examinations were done and

the results of 1 or more sputum examinations

were positive, enter the date the first sputum

specimen with a positive result was collected.

Date

collected

Month, day, and year the first

negative sputum specimen was

collected (e.g., 01/17/2009) if all

results were negative

If several sputum examinations were done and

all results were negative, enter the date the first

sputum specimen with a negative result was

collected.

Exercise

17.

Sputum Smear (revised)

Case Study for Items 17 and 18 – James

James is in the hospital from January 13 through January 28, 2009. During that time he is

diagnosed with TB. You subsequently receive laboratory reports from the hospital with

James’ sputum smear results. They are as follows:

• Specimen collected on January 13 - sputum smear result was positive

• Specimen collected on January 16 - sputum smear result was positive

• Specimen collected on January 22 - sputum smear result was negative

• Specimen collected on January 28 - sputum smear result was negative

17.1 What option should be selected for Sputum Smear?

(circle the one best answer)

Positive

Negative

Not done

Unknown

17.2 What is the date collected?

(circle the one best answer)

January 13

January 16

January 22

January 28

18.

Sputum Culture

Primary Purpose: Case management and surveillance. This result is a main factor in determining

whether the patient’s disease meets the public health definition of TB.

Option

(select one)

Description Comment

Positive

The result of any (or the only) sputum

culture was positive for M. tuberculosis

complex.

Negative

Results of all sputum cultures were

negative for M. tuberculosis complex.

Not done

It is known that the sputum culture was not

done.

Unknown

It is not known whether a sputum culture

was performed.

Results are not known for a reason other

than pending results (e.g., result was lost

or specimen was contaminated, and no other

specimen can be obtained).

If an initial sputum specimen was

collected and results are unknown,

but results later become known,

update the results.

Comment: Sputum

Sputum includes spontaneous and induced sputum.

Do not include

the culture results of pulmonary

secretions obtained by tracheal suction, bronchoscopy procedures (e.g., bronchial washing or lavage,

scrapings, biopsies), or gastric aspiration. For more information, see

Culture of Tissue and Other Body

Fluids (

item 20).

Sputum should have been collected during diagnostic work-up or shortly thereafter. Do

not

record

specimens collected after the patient has received treatment more than 2 weeks.

For

positive

negative

results of sputum cultures, enter the following information.

Description Comment

Month, day, and year the first sputum

specimen with a positive culture result was

collected (e.g., 01/17/2009)

If several sputum cultures were

performed and the results of 1 or

more were

positive

for M.

tuberculosis complex, enter the date

the

first

sputum culture with a positive

result was collected.

Date

collected

Month, day, and year the first sputum

specimen with a negative culture result was

collected (e.g., 01/17/2009) if all results were

negative

If several sputum cultures were done

and all results were negative, enter

the date the first sputum specimen

with a negative result was collected.

For the

first

sputum culture reported

positive

for M. tuberculosis complex, enter the following

information.

Description Comment

Date result

reported

Month, day, and year the

laboratory reported the result

(e.g., 01/17/2009)

This date can be found on the laboratory report

as the date the report is released or made

available.

If the day is unknown, enter 99 as the default

value (e.g., 01/99/2009).

For

positive

culture results, select the option that best describes the

reporting laboratory type

Option

(select one)

Description Comment

Public health

laboratory

Any laboratory associated with a

local or a state health department

Commercial

laboratory

Any laboratory that charges

a fee for each specimen

processed or test performed

Other

Any other laboratory that is

not considered a public health

laboratory or a commercial

laboratory

Hospital laboratories (e.g., National Jewish

Health hospital laboratory) or laboratories

associated with federal public health agencies

(e.g., Centers for Disease Control and

Prevention, Veterans Administration, Indian

Health Service [IHS], Tribal Health

Department, or Bureau of Prisons)

National Jewish Health hospital laboratory

sometimes charges for services, but for the

purposes of the RVCT it is categorized as

“Other.”

Exercise

18.

Sputum Culture

Case Study – James (continued from Item 17)

In February you received faxed copies of the final sputum culture results for James from

Forbes Diagnostics Incorporated. These were for the sputum culture specimens collected

while James was in the hospital.

• Specimen collected on January 13 – sputum culture result was negative and result

was received on February 13

• Specimen collected on January 16 – sputum culture result was positive and result

was received on February 16

• Specimen collected on January 22 – sputum culture result was positive, and result

was received on February 22

• Specimen collected on January 28 – sputum culture result was positive, and result

was received on February 28

18.1 What option should be selected for the Sputum Culture?

(circle the one best answer)

Positive

Negative

Not done

Unknown

18.2 What is the date collected?

(circle the one best answer)

January 13

January 16

January 22

January 28

18.3 What is the date that the result is reported?

(circle the one best answer)

February 13

February 16

February 22

February 28

18.4 What reporting laboratory type should be selected?

(circle the one best answer)

Public health laboratory

Commercial laboratory

Other

18.5 What Reporting Laboratory Type should be selected if the sputum sample had

been analyzed by National Jewish Health hospital laboratory? (circle the one best

answer)

Public health laboratory

Commercial laboratory

Other

19.

Smear/Pathology/Cytology of Tissue and Other Body

Fluids

Primary Purpose: Case management and surveillance. This result is a factor in determining whether

the patient’s disease meets the public health definition of TB.

Note: This item is for recording results of a smear, or pathology, or cytology of tissue and/or other

body fluids.

In this

item, “tissue and other body fluids” does

not

include sputum. Examples of tissue

and other body fluids are tracheal aspirate, bronchial cells and fluid, urine, bone marrow, lymph node,

cerebral spinal fluid, lung tissue or fluid, and pleural fluid that are collected from various procedures

(e.g., bronchoscopy, bronchial washing or lavage, biopsy, gastric aspiration, pleural aspiration).

Results from sputum smear examinations and sputum cultures should be entered under

Sputum Smear

(item 17) and

Sputum Culture

(item 18).

Option

(select one)

Description Comment

Positive

Any tissue or body fluid other than sputum that (see

Note above)

• Tested positive by smear examination

• Showed granulomas, granulomatous inflammation,

or other pathologic or histologic findings consistent

with TB disease during a pathologic/cytologic

examination. (Such findings are listed on the

pathology or the cytology report.)

Any positive result

supersedes a negative

result.

Negative

All specimens of tissue or fluid that

• Tested negative by smear examination

• Showed no evidence of granulomas, granulomatous

inflammation, or other pathologic or histologic

findings consistent with TB disease during a

pathologic/cytologic examination. (Such findings

are listed on the pathology or the cytology report.)

Not done

Examinations of tissue or fluids are known not to have

been done.

Unknown

It is not known whether tissue or fluids

• Were examined

• Results are not known for a reason other than

pending results (e.g., result was lost or specimen

was contaminated, and no other specimen can be

obtained).

If an initial specimen was

collected and results are

unknown, but results later

become known, update

the results.

Comment: When to collect specimen

A smear, or pathology, or cytology specimen should have been collected during diagnostic workup or

shortly thereafter. Do

not

record specimens collected after the patient has received treatment more than 2

weeks.

For

positive

negative

results of an examination for a smear or, pathology, or cytology of tissue and/or

other body fluids, enter the following information.

Description Comment

Month, day, and year the first

specimen with a positive result was

collected (e.g., 01/17/2009)

If several specimen (tissue or fluid)

examinations were done and the results of 1

or more examinations were positive, enter the

date the first specimen with a positive result

was collected.

Date

collected

Month, day, and year the first negative

specimen was collected (e.g.,

01/17/2009) if all results were negative

If several specimen examinations were done

and all results were negative, enter the date

the first specimen with a negative result was

collected.

Anatomic

code

Enter appropriate anatomic code (e.g.,

30 for pericardium) from Appendix

C – Anatomic Codes.

Note: For the purposes of the RVCT training materials, use the codes listed in the appendices. Some

software programs used to enter data on the RVCT may NOT use the codes listed in the appendices.

For example, the Anatomic Codes may be a drop-down item where you choose the actual site rather

than enter a code. For more information, see instructions for the software you use.

For

Type of Exam

, select both of the following if applicable.

Option

(select all that apply)

Comment

Smear

Pathology/cytology

Select the type(s) of exam that correspond(s) to the result selected in

item 19.

Comment: Any positive result supersedes a negative result in reporting TB diagnostic criteria

If the results are discrepant (smear negative, pathology positive), then Type of Exam should correspond to

the result captured as positive. If both smear and pathology had been positive, both smear and

pathology/cytology should be checked under Type of Exam. Likewise, if both smear and pathology had

been negative, then both smear and pathology/cytology should be checked under Type of Exam.

Example: Positive result superseding a negative result

If the smear results were negative and the pathology was positive, then Type of Exam selected should be

Pathology. In this case, smear would not be selected because the result was negative.

Reporting TB Diagnostic Criteria

(Positive Result Supersedes Negative Results)

Positive

Positive Diagnosis

(Any TB Test Result Is Positive)

Positive

Positive Negative

Negative Positive

Test

Negative Diagnosis

(All TB Test Results Are Negative)

Negative Negative

Test

Exercise

19.

Smear/Pathology/Cytology of Tissue and Other Body Fluids

Case Study – Tricia

Four-year-old Tricia has a gastric aspiration procedure done on admission to the hospital

on January 7, 2009. The laboratory report indicates that the gastric aspirate smear is

negative for acid fast bacilli (AFB).

19.1 What option should be selected for Smear/Pathology/Cytology of Tissue and

Other Body Fluids?

(circle the one best answer)

Positive

Negative

Not done

Unknown

19.2 What is the anatomic code?

(circle the one best answer)

52 – gastric aspirate

56 – gastric aspirate

68 – gastric aspirate

19.3 What is the type of exam?

(circle the one best answer)

Smear

Pathology/Cytology

Case Study – Sam

Sam has fine needle aspiration to sample lung fluid followed by a lung biopsy. The

laboratory report indicates that the smear of the lung fluid is negative for AFB. However,

the lung tissue shows AFB, inflammation, and granulomas consistent with TB disease.

19.4 What entry should be selected for the results?

(circle the one best answer)

Positive, because the lung tissue shows AFB organisms

Negative, because the smear results of the fluid are negative

Unknown, because there is a discrepancy between the two tests

19.5 What would be selected for the type of exam?

(circle the one best answer)

Smear

Pathology/Cytology

Both A and B are correct

20.

Culture of Tissue and Other Body Fluids

Primary Purpose: Case management and surveillance. This result is a factor in determining whether

the patient’s disease meets the public health definition of TB.

Note:

The term “tissue and other body fluids”

does not include

sputum. Examples of tissue and other

body fluids are tracheal aspirate, bronchial cells and fluid, urine, bone marrow, lymph node, cerebral

spinal fluid, lung tissue or fluid, and pleural fluid collected from various procedures (e.g.,

bronchoscopy, bronchial washing or lavage, biopsy, gastric aspiration, pleural aspiration).

Results from sputum smear examinations and sputum cultures should be entered under

Sputum Smear

(item 17) and

Sputum Culture

(item 18).

Option

(select one)

Description Comment

Positive

The culture results for any tissue or fluid culture

other than sputum (see Note above) was positive

for M. tuberculosis complex.

If an initial specimen was

collected and results are

unknown, but results later

become known, update the

results.

Any positive result supersedes

a negative result.

Negative

The culture results for all tissue or fluid cultures,

other than sputum cultures, were negative for M.

tuberculosis complex.

Not done

It is known that tissue or fluid cultures were not

done.

Unknown

It is not known whether tissue or fluid cultures

were performed

Results are not known for a reason other than

pending results (e.g., result was lost or specimen

was contaminated, and no other specimen can be

obtained).

If an initial specimen was

collected and results are

unknown, but results later

become known, update the

results.

Comment: When to collect specimen

Specimens of tissue and other body fluids should have been collected during diagnostic workup or shortly

thereafter. Do

not

record specimens collected after the patient has received treatment for more

than 2 weeks.

For

positive

negative

result of tissue or fluid culture, enter the following information.

Description Comment

Month, day, and year the first

specimen with a positive result

was collected (e.g.,

01/17/2009)

If cultures were performed on several specimens

of tissue or fluid and the results of 1 or more were

positive

for M. tuberculosis complex, enter the

date the

first specimen with a positive

culture

result was collected.

Date

collected

Month, day, and year the first

specimen with a negative result

was collected (e.g., 1/17/2009)

if all results were negative

If several cultures were done and all results were

negative, enter the date the first specimen with a

negative result was collected.

Anatomic code

Enter appropriate anatomic

code (e.g., 30 for pericardium)

from Appendix C – Anatomic

Codes.

Note: For the purposes of the RVCT training materials, use the codes listed in the appendices. Some

software programs used to enter data on the RVCT may NOT use the codes listed in the appendices.

For example, the Anatomic Codes may be a drop-down item where you choose the actual site rather

than enter a code. For more information, see instructions for the software you use.

For the

first

tissue or fluid culture reported to be

positive

for M. tuberculosis complex, enter the

following information.

Description Comment

Date result

reported

Month, day, and year the result

was reported by the laboratory

(e.g., 01/17/2009)

This date can be found on the laboratory report as

the date the report is released or made available.

If the day is unknown, enter 99 as the

default value (e.g., 01/99/2009).

For

positive

results, select the option that best describes the

reporting laboratory type

Option

(select one)

Description Comment

Public health

laboratory

Any laboratory associated with

a local or a state health

department

Commercial

laboratory

Any laboratory that charges

a fee for each specimen

processed or test performed

Other

Any other laboratory that is

not considered a public health

laboratory or a commercial

laboratory

Hospital laboratories (e.g., National Jewish Health

hospital laboratory) and laboratories associated

with federal public health agencies (e.g., Centers

for Disease Control and Prevention, Veterans

Administration, Indian Health Service [IHS],

Tribal Health Department, and Bureau of Prisons)

National Jewish Health hospital laboratory

sometimes charges for services, but for the

purposes of the RVCT it is categorized as

“Other.”

Exercise

20.

Culture of Tissue and Other Body Fluids

Case Study – Kevin

Kevin is hospitalized for TB meningitis. On October 13, 2009, his cerebral spinal fluid is

collected. On October 20, the test result is returned and indicates that the sample had

been contaminated. On October 25, a second cerebral spinal fluid sample is taken and

sent for culture to the state health laboratory. On November 22, the culture result for the

second sample is reported to the hospital as positive for M. tuberculosis complex. That

same day the result is also reported to the health department.

20.1 What would be selected for Culture of Tissue and Other Body Fluids?

(circle the one best answer)

Positive

Negative

Not done

Unknown

20.2 What is the date collected?

(circle the one best answer)

October 13, 2009

October 16, 2009

October 25, 2009

20.3 What should you enter for date result reported?

(circle the one best answer)

October 16, 2009

October 25, 2009

November 22, 2009

20.4 What reporting laboratory type should be selected?

(circle the one best answer)

Public health laboratory

Commercial laboratory

Other

21.

Nucleic Acid Amplification Test Result

Primary Purpose: Case management and surveillance. This result is a factor in determining whether

the patient’s disease meets the public health definition of TB.

Option

(select one)

Description Comment

Positive

Any NAA test result was positive for M.

tuberculosis complex.

Any positive result supersedes

all other test results (e.g., 1

positive and 2 negatives =

positive; 1 indeterminate and 1

negative and 1 positive =

positive).

Negative

No NAA test results were positive for M.

tuberculosis complex and at least one result was

negative.

A negative result supersedes

indeterminate (e.g., 1 negative

and 1 indeterminate =

negative).

Not done

NAA test was not performed.

Unknown

It is not known whether an NAA test was

performed.

NAA test results are not known or result is not

known for a reason other than pending results.

If an initial specimen was

collected and results are

unknown, but results later

become known, update the

results.

Indeterminate

All NAA tests were indeterminate (e.g.,

inconclusive, inhibitory).

All tests are indeterminate.

100

For

positive

negative

results of NAA testing, enter the following information.

Description Comment

Month, day, and year the

first sputum specimen with

a positive result was

collected (e.g., 01/17/2009)

If several specimens were collected and the NAA

test results of 1 or more were

positive

for M.

tuberculosis complex, enter the date the

first

specimen with a positive result was collected.

Date

collected

Month, day, and year the

first sputum specimen with

a negative result was

collected (e.g., 01/17/2009)

if all results were negative

If several specimens were collected and all NAA

test results were negative, enter the date the first

sputum specimen with a negative result was

collected.

Select the

Specimen Type

on which NAA testing was done.

Option

(select one)

Description Comment

Sputum

Not sputum

Enter appropriate anatomic code (e.g., 30

for pericardium) from Appendix C –

Anatomic Codes

Note: For the purposes of the RVCT training materials, use the codes listed in the appendices. Some

software programs used to enter data on the RVCT may NOT use the codes listed in the appendices.

For example, the Anatomic Codes may be a drop-down item where you choose the actual site rather

than enter a code. For more information, see instructions for the software you use.

For the

first

NAA test result reported

positive

for M. tuberculosis complex, enter the following

information.

Description Comment

Date result

reported

Month, day, and year the result was

reported by the laboratory (e.g.,

01/17/2009)

This date can be found on the

laboratory report as the date the report

is released or made available.

101

For

positive

NAA test results, select the option that best describes the

reporting laboratory type

Option

(select one)

Description Comment

Public health

laboratory

Any laboratory associated with a local or

a state health department

Commercial

laboratory

Any laboratory that charges

a fee for each specimen

processed or test performed

Other

Any other laboratory that is

not considered a public health

laboratory or a commercial laboratory

Hospital laboratories (e.g., National

Jewish Health hospital laboratory)

and laboratories associated with

federal public health agencies (e.g.,

Centers for Disease Control and

Prevention, Veterans Administration,

Indian Health Service [IHS], Tribal

Health Department, and Bureau of

Prisons)

Comment: Nucleic Acid Amplification Tests

The MMWR report, “Updated Guidelines for the Use of Nucleic Acid Amplification Tests in the

Diagnosis of Tuberculosis,” provides information on the NAA tests that have been approved by the Food

and Drug Administration for use with AFB smear-positive respiratory specimens. Accessible at

www.cdc.gov/mmwr/preview/mmwrhtml/mm5801a3.htm.

102

Exercise

21.

Nucleic Acid Amplification Test Result

Case Study – Newton

Newton is planning to go to England on vacation in one week. He is feeling sick and

presents at the Newnan County Health Department with symptoms of TB. His doctor

requests a nucleic acid amplification (NAA) test because he is a TB suspect. The test

can determine if Newton has TB disease before he leaves on vacation. The NAA test

result is inconclusive.

21.1 What NAA test result should be selected?

(circle the one best answer)

Positive

Negative

Not done

Unknown

Indeterminate

103

22A.

Initial Chest Radiograph

Primary Purpose: Case management and surveillance. This is part of a diagnostic evaluation used to

determine whether the patient’s disease meets the public health definition of TB.

Select the result of the

initial

chest radiograph(s) performed during the diagnostic evaluation for TB.

Option

(select one)

Description

Normal

Initial chest radiograph(s) showed no abnormalities consistent with TB. This

category includes any other abnormalities that are not consistent with TB.

Abnormal

(consistent with TB)

Any initial chest radiograph showing abnormalities (e.g., hilar adenopathy,

effusion, infiltrate[s], cavity, scarring) consistent with TB.

Not done

It is known that the initial chest radiograph was not done.

Unknown

It is not known whether an initial chest radiograph was done.

Result of initial chest radiograph is not known or result is not known for a

reason other than pending results.

104

For

abnormal

results, select one option for each type of evidence.

Option

(select one)

Description

Yes

Any initial chest radiograph(s) showing evidence of 1 or more lung

cavities

Evidence of

a cavity

Unknown

Option

(select one)

Description

Yes

Any initial chest radiograph(s) showed evidence of miliary disease

(e.g., miliary TB, or miliary or bilateral micronodular pattern)

Evidence of

miliary TB

Unknown

Comment: Miliary TB

Unlike the previous RVCT form, the new form has no place to select miliary TB in

Site of Disease

(item

16). If the report of the initial chest radiograph or the initial chest CT scan indicates “miliary TB or a

miliary or bilateral micronodular pattern,” record this finding under

Initial Chest Radiograph

(item

22A) or

Initial Chest CT Scan or Other Chest Imaging Study

(item 22B), respectively. However,

pulmonary should be selected as

Site of Disease

(item 16) if the chest x-ray or CT scan shows evidence

of nodules consistent with miliary TB.

Miliary TB is a serious type of tuberculosis infection. It is a clinical or radiologic finding, rather than a

site of disease. Miliary TB is the result of a TB lung infection eroding into the bloodstream and from there

disseminating throughout the body to multiple organs. It appears on radiograph as a great number of small

(1- to 2-mm), well-defined nodules that look like millet seeds scattered throughout the lungs, hence the

name “miliary.”

105

Exercise

22 A.

Initial Chest Radiograph

What is the result of the Initial Chest Radiograph for the following patients?

(Choose the one best answer by matching the results of the initial chest radiograph with the

patient. Write in the letter for the result on the line next to the question number.)

Patient Initial Chest Radiograph

___

22 A.1

Emily is a 4-year old whose chest

radiograph shows tiny

(1- to 2-millimeters), well-defined

nodules.

___

22 A.2

Alice has a radiograph that shows no

evidence of TB.

___

22 A.3

Lawrence was evaluated for TB while

living in Arabia and placed on anti-TB

drugs. He remembers getting a chest

radiograph but is not sure of the result.

___

22 A.4

Roy has a chest radiograph that shows

cavities in the left upper lobe of his

lung.

___

22 A.5

Frank’s laboratory results are

consistent with TB disease. On his

way to the clinic to get a chest

radiograph, he dies in an automobile

crash.

Normal

Abnormal with evidence of

cavitary lesion

Abnormal with evidence of

miliary TB

Not Done

Unknown

106

22B.

Initial Chest CT Scan or Other Chest Imaging Study

Primary Purpose: Case management. This is part of a diagnostic evaluation used to determine whether

the patient’s disease meets the public health definition of TB.

Select the result of the

initial

chest computerized tomography (CT) or other chest imaging study such as

magnetic resonance imaging (MRI), performed during the diagnostic evaluation for TB.

Option

(select one)

Description

Normal

Initial chest CT scan or other chest imaging study showed no abnormalities

consistent with TB. This category includes any other abnormalities that are not

consistent with TB.

Abnormal

(consistent

with TB)

Any initial chest CT scan or other chest imaging study showed abnormality

(e.g., hilar adenopathy, effusion, infiltrate[s], cavity, scarring) consistent with TB.

Not done

It is known that the initial chest CT scan or other chest imaging study was not done.

Unknown

It is not known whether an initial chest CT scan or other chest imaging study was

done.

Result of initial chest CT scan or other chest imaging study is not known or result is

not known for a reason other than pending results.

107

For

abnormal

chest CT scan or other chest imaging study results, select one option for each type of

evidence.

Option

(select one)

Description

Yes

Any initial chest CT scan or other chest imaging study showed

evidence of 1 or more cavities.

Evidence of a

cavity

Unknown

Option

(select one)

Description

Yes

Any initial chest CT scan or other chest imaging study showed

evidence of miliary disease (e.g., miliary TB, or miliary or

bilateral micronodular pattern).

Evidence of

miliary TB

Unknown

Comment:

Miliary TB

Unlike the previous RVCT form, the new form has no place to select miliary TB in

Site of Disease

(item

16). If the report of the initial chest radiograph or the initial chest CT scan indicates “miliary TB or a

miliary or bilateral micronodular pattern,” record this finding under

Initial Chest Radiograph

(item

22A) or

Initial Chest CT Scan or Other Chest Imaging Study

(item 22B), respectively. However,

pulmonary should be selected as

Site of Disease

(item 16) if the chest x-ray or CT scan shows evidence

of nodules consistent with miliary TB.

Miliary TB is a serious type of tuberculosis infection. It is a clinical or radiologic finding, rather than a

site of disease. Miliary TB is the result of a TB lung infection eroding into the bloodstream and from there

disseminating throughout the body to multiple organs. It appears on radiograph as a great number of small

(1- to 2-mm), well-defined nodules that look like millet seeds scattered throughout the lungs, hence the

name “miliary.”

108

Exercise

22 B.

Initial Chest CT Scan or Other Chest Imaging Study

Case Study for Items 16, 22A, and 22B – Anna

Anna is a 3-year-old who was diagnosed with miliary TB disease. It appeared in both her

initial chest radiograph and her initial chest CT scan.

22. B. 1 In which item(s) would you record responses indicating that Anna has miliary

TB? (circle the one best answer)

Item 16 – Site of Disease

Item 22 A – Initial Chest Radiograph - Evidence of miliary TB

Item 22 B – Initial Chest CT Scan or Other Chest Imaging Study – Evidence of

miliary TB

A, B, and C are correct

Only B and C are correct

109

23.

Tuberculin (Mantoux) Skin Test at Diagnosis

Primary Purpose: Case management. This result helps guide clinicians in diagnosing TB infection and

is a factor in determining whether the patient’s disease meets the public health definition of TB.

Positive

negative

result of the tuberculin skin test (TST) should be interpreted according to Table 7 of

the currently accepted guidelines (www.cdc.gov/mmwr/PDF/rr/rr4906.pdf).

Guidelines for Entering TST Results

Enter Do Not Enter

Results from a TST performed during the current

diagnostic evaluation

A patient’s

undocumented

self-report of a

previous positive result is

not

acceptable

May enter previous positive test result

•

If patient had tested

positive

to a previous TST

and

•

The previous positive result

is documented

the medical record.

A previous

negative

TST result (reported by the

patient or documented or both) is also

not

acceptable

Option

(select one)

Description

Positive

Meets the criteria for a positive TST result.

Negative

Result of TST did not meet current criteria for a positive test result.

Not done

TST was not performed

Patient reports a positive result of an earlier TST, but it cannot be documented,

and now the patient refuses a TST.

Unknown

It is not known whether a TST was performed

result is not known for a reason other than pending results.

110

For

positive

negative

TST results, enter the following information.

Description Comment

Date TST placed

Month, day, and year the TST was

placed (e.g., 01/17/2009)

If the month or day is unknown, enter

99 as the default value (e.g.,

01/99/2009).

Year must be recorded. Do not use

9999 for the year.

Millimeters (mm)

of induration

Measurement (in millimeters, mm) of

the induration (e.g., 05 mm)

If the millimeters of the induration are

not expressed, enter 99 as the default

value.

111

Interpreting the TST Reaction

5 or more millimeters 10 or more millimeters 15 or more millimeters

An induration of 5 or more

millimeters is considered

positive for

• People living with HIV

• Recent contacts of persons

with infectious TB

• People who have previously

had TB disease

• Patients with organ

transplants and other

immunosuppressed patients

(including patients taking a

prolonged course of oral or

intravenous corticosteriods

or TNF-α antagonists)

An induration of 10 or more

millimeters is considered positive

for

• People who have come to the

U.S. within the last 5 years

from areas of the world where

TB is common (for example,

Asia, Africa, Eastern Europe,

Russia, or Latin America)

• People who inject illegal drugs

• Mycobacteriology lab workers

• People who live or work in

high-risk congregate settings

• People with certain medical

conditions that place them at

high risk for TB (silicosis,

diabetes mellitus, severe kidney

disease, certain types of cancer,

and certain intestinal

conditions)

• Children younger than 4 years

• Infants, children, and

adolescents exposed to adults in

high-risk categories

An induration of 15 or more

millimeters is considered

positive for

• People with no known

risk factors for TB

112

Exercise

23.

Tuberculin (Mantoux) Skin Test at Diagnosis

Case Study – Duc

Duc immigrated from Laos to the United States on May 5, 1995. At that time he was seen

at the health department, where he had a TST. The TST result was read 2 days later as an

induration of 10 millimeters. Since Duc is from Asia, a TST reaction that is 10 or more

millimeters is considered a positive reaction. He completed LTBI treatment in May 1996.

In March 2009 he is diagnosed with extrapulmonary TB of the left tibia.

23.1 What would you select for Tuberculin (Mantoux) Skin Test at Diagnosis?

(circle the one best answer)

Positive

Negative

Not done

Unknown

23.2 What is the date tuberculin skin test (TST) placed?

(circle the one best answer)

A. Month Day Year

0 5 0 5 1 9 9 5

Month Day Year

0 5 9 9 1 9 9 5

C. Month Day Year

0 5 9 9 1 9 9 6

23.3 What would be entered for millimeters (mm) of induration?

(circle the one best answer)

Millimeters (mm) of induration 9 9

Millimeters (mm) of induration 1 0

113

24.

Interferon Gamma Release Assay for

Mycobacterium

tuberculosis

at Diagnosis

Primary Purpose: Case management. This result helps guide clinicians in diagnosing TB infection and

is a factor in determining whether the patient’s disease meets the public health definition of TB.

Interferon gamma release assays (IGRAs) are blood tests for detecting M. tuberculosis infection.

This variable applies to an IGRA performed during the diagnostic evaluation.

Option

(select one)

Description Comment

Positive

Any IGRA result was interpreted as “M.

tuberculosis infection is likely.”

Any positive result supersedes

all other test results (e.g., 1

positive and 2 negatives =

positive; 1 indeterminate and 1

negative and 1 positive =

positive).

Negative

All IGRA results were interpreted as “M.

tuberculosis infection is unlikely.”

A negative result supersedes

indeterminate (e.g., 1 negative

and 1 indeterminate = negative).

Not done

IGRA was not performed.

Unknown

It is not known whether IGRA was

performed.

IGRA results are not known, or result is not

known for a reason other than pending results.

Indeterminate

IGRA results could not be determined to be

positive or negative.

114

For

positive

negative

results of IGRA, enter the following information.

Description Comment

Date collected

Month, day, and year the

blood sample was collected

(e.g., 01/17/2009)

If several blood tests were performed and the

results of one or more tests were positive for M.

tuberculosis complex, enter the date the first blood

test with a positive result was collected.

Test type

(specify)

Specify the blood test

performed [e.g.,

QuantiFERON

-TB Gold test

(QFT-G)]

If more than 1 test was performed, enter the name

of the test used for the specimen for which you

entered the result.

115

Exercise

24.

Interferon Gamma Release Assay for Mycobacterium tuberculosis at

Diagnosis

Case Study – Shepo

Shepo is a recent immigrant from Kenya. He works as a maintenance worker at the

Winston Animal Research Facility. The facility conducts annual employee screening for

TB to prevent exposing the primates to TB. Shepo is tested with a QuantiFERON

-TB

Gold test (QFT-G) because he had BCG vaccination as a child. The QFT-G test result is

positive. Upon further evaluation, Shepo is diagnosed with active TB disease and an

RVCT is initiated for him.

24.1 What would you select for Interferon Gamma Release Assay for Mycobacterium

tuberculosis at Diagnosis?

(circle the one best answer)

Positive

Negative

Not done

Unknown

Indeterminate

24.2 What would you specify as the Test Type?

(circle the one best answer)

Interferon gamma release assay

Tuberculin skin test

Blood test

QuantiFERON

-TB Gold test (QFT-G)

Unknown

116

25.

Primary Reason Evaluated for TB Disease

Primary Purpose: Programmatic function. Data are helpful in assessing how a TB case was found.

Select the

single primary or initial reason

the patient was evaluated for TB disease. The definition of

“primary or initial reason” is the situation or reason that led to the initial suspicion that the patient might

have TB disease. If the patient was referred for evaluation, but the reason for the evaluation is unknown,

try to determine that reason.

Option

(select one)

Description Comment

TB symptoms

Signs and symptoms consistent with TB

(e.g., prolonged persistent cough, fever,

lymphadenopathy, night sweats, weight

loss)

Select if patient seeks medical attention

because of symptoms. Do not select if

symptoms discovered during a

screening program.

Abnormal chest

radiograph

Incidental chest radiograph consistent

with TB disease

Reason for the chest radiograph should

be independent of the other choices

listed and should not have been the

result of suspicion of TB disease.

Contact

investigation

Result of a contact investigation or

source case finding

Targeted testing

Positive result of tuberculin skin test

(TST) or interferon gamma release

assay (IGRA) administered because the

patient was specifically considered as

high risk for TB (e.g., persons from area

of the world with high rate of TB) or as

part of a testing program focused on

specific groups at risk for TB

Do not select if another reason (e.g.,

contact investigation, immigration

medical examination, employment/

administrative testing, or health care

worker status) is more appropriate

(see other choices).

117

Health care

worker

Positive result of TST or IGRA

administered because the patient was a

health care worker

Refers to all paid and unpaid persons

working in health care settings who

have the potential for exposure to M.

tuberculosis.

For health care workers being evaluated

for TB disease, health care worker

supersedes targeted testing and

employment/administrative testing.

Other situations (e.g., TB symptoms,

contact investigation) supersede health

care worker.

Employment/

administrative

testing

Results from routine physical

examination before or periodically

during employment, TST or IGRA

required by employer, or primary or

secondary school program for routine

TST

Reflects an administrative requirement

(e.g., a TST program applied to all 5th

graders in a school or to all job

applicants) rather than testing of a group

considered at high risk. If TST or IGRA

was performed because the person was

considered at high risk, select targeted

testing or a more appropriate category,

such as health care worker. If

employment was health care–related,

select health care worker rather than

employment/administrative testing.

Immigration

medical exam

Findings of a medical examination that

was part of the immigration application

process

A medical examination is mandatory for

specific categories of persons seeking

admission to the United States (e.g.,

immigrants, refugees, asylees). These

medical examinations may be

performed overseas or in the United

States depending on the situation. In

addition, a medical examination may be

required for some persons applying for

nonimmigrant visas or special status

(e.g., parolees) for temporary admission

to the United States.

Incidental lab

result

The clinical evaluation was for

something other than TB (e.g.,

bronchoscopy or autopsy). Specimens

were collected and submitted for

evaluation of TB and other diseases for

diagnostic completeness. TB was not

expected.

Unknown

Reason for evaluating the patient not

known

118

Example: TB Symptoms

If a TB patient seeks medical care because of TB symptoms, select

TB Symptoms

as the primary

reason for the evaluation. If, however, a TB patient was initially encountered via a contact investigation

and during that investigation was also noted to have TB symptoms, select

Contact Investigation

as the

primary reason for the evaluation.

Example: Abnormal Chest Radiograph

If the chest radiograph was performed during a workup for TB disease because of a positive TST result

obtained during targeted testing, select

Targeted Testing

. However, if a chest radiograph was

performed as part of preoperative testing (TB disease was not suspected), select

Abnormal Chest

Radiograph

Examples: Health Care Worker

Includes full time, part-time, temporary, or contract staff. Examples include:

•

Physicians

•

Nurses

•

Health aides

•

Dental workers

•

Health technicians

•

Staff in laboratories and morgues

•

Emergency medical personnel

•

Students enrolled in health care

programs

•

Persons who deliver health care in the community

(e.g., public health nurse, visiting nurse, outreach

worker)

•

Persons not involved directly in patient care, but

potentially at risk for occupational exposure

(e.g., correctional facility staff, volunteers; outreach

workers; dietary/nutritional, housekeeping,

maintenance, clerical, janitorial staff, administrative

staff and supervisors)

119

Exercise

25.

Primary Reason Evaluated for TB Disease

What is the Primary Reason Evaluated for TB for the following patients?

(Choose the one best answer by matching the primary reason evaluated with the patient. Write

the letter for the reason on the line next to the question number.)

Patient Primary Reason

Evaluated for TB

___

25.1

Alan is a nurse at New York City health

department and participated in the annual

workplace TST screening program.

___

25.2

During an autopsy performed on Ben, the

pathologist orders a complete analysis of

various tests to help determine cause of

death. TB is not suspected, but the AFB test

result indicates Ben had TB.

___

25.3

A health care worker is providing DOT to

Carla’s father. During one of the DOT visits

the health care worker evaluates Carla for

TB. Carla is then diagnosed with TB disease.

___

25.4

Drew is in an automobile accident and has a

chest radiograph taken for a possible broken

rib. The chest radiograph also shows a lung

cavity.

___

25.5

Ellen goes to the out patient clinic because

she has been coughing and recently lost

weight.

___

25.6

Tran recently immigrated from Vietnam and

was diagnosed with TB disease.

___

25.7

George is HIV infected. His doctor at the

HIV clinic has him tested for TB infection.

___

25.8

Harry is a new primate keeper at the

Magnolia Zoo where TSTs are routinely

performed on all new employees.

TB symptoms

Abnormal chest

radiograph

Contact investigation

Targeted testing

Health care worker

Employment/

Administrative

testing

Immigration medical

exam

Incidental laboratory

result

120

Case Study – Lanie

Lanie is a nurse at the Canton Health Department in Ohio. She is identified as a contact

during the contact investigation for her brother-in-law, who has TB disease. During the

evaluation, Lanie is diagnosed with TB disease also. She completes therapy on

September 12, 2009.

25.9 What is the Primary Reason Lanie was Evaluated for TB in Ohio?

(circle the one best answer)

Health care worker

Contact investigation

TB symptoms

Targeted testing

Case Study – Lanie (continued)

On October 1, 2009, Lanie accepts a nursing position at the Indianapolis Health

Department in Indiana. On December 14, 2009, Lanie goes to the clinic because she is

coughing up blood and is worried that TB has returned. Her laboratory results indicate

that her sputum is smear and culture positive.

25.10 What is the Primary Reason Lanie was Evaluated for TB in Indiana?

(circle the one best answer)

Health care worker

Contact investigation

TB symptoms

Targeted testing

121

Module

Module Module

Module C

- R

R R

RVCT

VCT VCT

VCT

(page 3

(page 3(page 3

(page 3 of 3

of 3 of 3

of 3)

))

)

Items 26

Items 26 Items 26

Items 26 –

––

– 37

37 37

Module C provides instructions and exercises for completing page 3 of the RVCT report. It includes data

about risks associated with TB, the date that therapy was started, and the initial drug regimen.

122

26.

HIV Status at Time of Diagnosis

Primary Purpose: Case management and surveillance. Data are used to determine TB/HIV co-

morbidity.

Note:

CDC recommends that

all

persons receive HIV testing at the time of TB diagnostic evaluation or

TB diagnosis. Refer to the CDC public health surveillance definition of HIV infection

(http://www.cdc.gov/mmwr/preview/mmwrhtml/rr4813a2.htm).

Note: Documentation of an HIV test result is needed. This documentation from a hospital, clinic, or

private provider, should be written evidence of the test result, or it can be notes in the medical record.

The test result should have been determined within the specified time indicated in the instructions

below.

Option

(select one)

Description Comment

Negative

Documented negative result of HIV test at the time of

TB diagnostic evaluation or at TB diagnosis or earlier,

but not exceeding 1 year

Undocumented report is

not acceptable.

Positive

Laboratory result interpreted as positive according to

published criteria

Documented positive result of an earlier HIV test or

documented earlier diagnosis of HIV infection or AIDS

Undocumented report is

not acceptable.

Indeterminate

Documented indeterminate result of an HIV test at the

time of TB diagnostic evaluation or TB diagnosis

Undocumented report is

not acceptable.

Refused

HIV testing offered but declined at the time of the TB

diagnostic evaluation or TB diagnosis

Not offered

HIV testing not offered at the time of the TB diagnostic

evaluation or TB diagnosis

Test done,

results

unknown

HIV test performed at the time of the TB diagnostic

evaluation or TB diagnosis, but the results not known to

the TB program, or result is not known for a reason

other than pending results.

123

Unknown

Not known whether the patient

• Has had an HIV test

• Was ever offered a test

• Was referred for HIV counseling and testing (e.g.

anonymous testing center, private testing center)

Comments: Negative HIV status

•

Undocumented patient report that an HIV test result was negative is

not

acceptable. Such patients

should be offered the opportunity to be tested for HIV.

•

If a patient has had a negative test result, regardless of when the HIV test was performed, the

patient should be offered HIV testing at the time of TB diagnostic evaluation or TB diagnosis.

•

If the patient had received HIV testing

less than 1 year before the TB diagnostic evaluation or

TB diagnosis

, the documented results were negative for HIV infection, and the patient reports no

risk factor for HIV, check

Negative

for this item.

•

A documented negative HIV test from 1 year ago or longer is

not

valid for checking

Negative

Note:

Update this item if additional information is obtained during the course of treatment.

For

Positive

HIV status at the time of TB diagnosis, enter the following information.

Description

State HIV/AIDS

patient number

Can be obtained from the state or local HIV/AIDS surveillance program

City/county HIV/AIDS

patient number

Can be obtained from the state or local HIV/AIDS surveillance program

124

Exercise

26.

HIV Status at Time of Diagnosis

Case Study – Harvey

Harvey is diagnosed with TB at the County Health Department in May 2009. He is

offered HIV testing. He states that he was tested earlier that year in January 2009 and the

results were negative. Harvey has no other risk factors for HIV. With Harvey’s

permission, the TB program confirms the negative HIV test result by reviewing his HIV

result listed in his medical records.

26.1 What would be selected for Harvey’s HIV Status at Time of Diagnosis?

(circle the one best answer)

Negative

Positive

Indeterminate

Refused

Not offered

Test Done, Results Unknown

Unknown

125

27.

Homeless Within Past Year

Primary Purpose: Surveillance. Data are used to determine the extent to which recent homelessness is

associated with TB disease.

Option

(select one)

Description

Not homeless during the 12 months before the TB diagnostic evaluation was

performed or initiated

Yes

Homeless at any time during the 12 months before the TB diagnostic

evaluation was performed or initiated

Unknown

Not known whether the patient was homeless during the 12 months

before the TB diagnostic evaluation was performed or initiated

Comments: Definitions for Homeless

There are many definitions for homeless (National Coalition for the Homeless). A

homeless

person may be an individual who has

No fixed, regular, and adequate nighttime residence

and

A primary nighttime residence that is

A supervised publicly or privately operated shelter designed to provide temporary living

accommodations, including welfare hotels, congregate shelters, and transitional housing for

the mentally ill

An institution that provides a temporary residence for individuals intended to be

institutionalized

A public or private place not designated for, or ordinarily used as, a regular sleeping

accommodation for human beings.

homeless

person may also be defined as a person who has no home (e.g., is not paying rent, does not

own a home, and is not steadily living with relatives or friends). Persons in unstable housing situations

(e.g., alternating between multiple residences for short stays of uncertain duration) may also be

considered homeless.

126

homeless

person may be a person who lacks customary and regular access to a conventional dwelling

or residence. Included as homeless are persons who live on streets or in nonresidential buildings. Also

included are residents of homeless shelters and shelters for battered women. Residents of welfare hotels

and single room occupancy (SRO) hotels could also be considered homeless. In the rural setting, where

there are usually few shelters, a homeless person may live in non-residential structures, or substandard

housing, or with relatives. Homeless does not refer to a person who is imprisoned or in a correctional

facility.

Note:

The homeless category is limited to living conditions in the United States and does

not

apply to

living in refugee camps outside the United States.

Note:

Update this item if additional information is obtained during the course of treatment.

127

Exercise

27.

Homeless Within Past Year

Case Study – Oscar

Oscar lost his job in December 2008 and subsequently lost his apartment. He had no

place to live except when staying with friends or relatives for a few days at a time

throughout January 2009. Since then he has lived in homeless shelters and had meals at

soup kitchens operated by the American Red Cross. Oscar found a job in July 2009 and

has been living in his current apartment since then. He is diagnosed with TB at the

Carroll County Health Department in November 2009.

27.1 How would you fill out Homeless within the Past Year for Oscar?

(circle the one best answer.)

Yes

Unknown

128

28.

Resident of Correctional Facility at Time of Diagnosis

Primary Purpose: Surveillance. Data are used to determine if residence in a correctional facility is

associated with TB disease.

Note:

Direct the questions regarding classification of a specific correctional facility (federal, state,

local, juvenile, or other) to the Department of Corrections in your state.

Option

(select one)

Description

Not an inmate when the TB diagnostic evaluation was performed or initiated

Yes

An inmate of a correctional facility when the TB diagnostic evaluation was

performed or initiated

Unknown

Not known whether the patient was an inmate when the TB diagnostic evaluation

was performed or initiated

If you selected

Yes,

indicate the type of correctional facility where the patient was an inmate. If the TB

patient was a resident of more than 1 facility during the diagnostic evaluation, select the facility where the

initial TB diagnostic evaluation was performed.

Option

(select one)

Description

Federal prison

Confinement facility administered by a federal agency; includes privately operated

federal correctional facilities

State prison

Confinement facility administered by a state agency; includes privately

operated state correctional facilities

Local jail

Confinement facility usually administered by a local law enforcement agency,

intended for adults but sometimes also containing juveniles; holds persons

detained pending adjudication and/or persons committed after adjudication,

typically for sentences of 1 year or less

Juvenile

correctional

facility

Public or private residential facility; includes juvenile detention centers, reception

and diagnostic centers, ranches, camps, farms, boot camps, residential treatment

centers, and halfway houses or group homes designated specifically for juveniles

129

Other

correctional

facility

Includes Immigration and Customs Enforcement (ICE) detention centers, Indian

reservation facilities (e.g., tribal jails), military stockades and jails, federal park

police facilities, police lockups (temporary holding facilities for persons who have

not been formally charged in court), or other correctional facilities that are not

included in the other specific choices

Unknown

Inmate when the TB diagnostic evaluation was performed, but the type of

correctional facility is not known

Comment: Correctional facility at time of diagnosis

If a patient is an inmate at a correctional facility and goes to a hospital for TB diagnostic evaluation, you

would select

• Yes, an inmate of a correctional facility when the TB diagnostic evaluation was performed

• The type of correctional facility (rather than the hospital) where he/she resided at time of

diagnostic evaluation

Comment: Local Jail

Excludes temporary holding facilities, or lockups, that do not hold persons after they have been formally

charged in court. Includes city and county jails and privately operated local correctional facilities. Report

federal and state prisoners who are boarded at local jails as residents of the local jail.

Comment: Juvenile Correctional Facility

Includes

juveniles charged or adjudicated as delinquents, juveniles who are not delinquents or criminal

offenders (e.g., runaways, truants, incorrigibles, curfew violators), and juveniles committed or detained

for treatment of abuse, dependency, neglect, or other reasons. Report juveniles who are boarded at federal

or state prisons or local jails as residents of the facility at which they are boarded.

If you selected

Yes

, indicate whether this patient was

under custody of Immigration and Customs

Enforcement (ICE)

Option

(select one)

Comment

Yes

Response indicates whether the patient was under the custody of ICE at the

time of diagnosis. Persons in ICE custody can be housed in standalone ICE

detention centers, or other correctional facilities (e.g., federal or state prison,

local jail) when a standalone ICE detention center is not available.

Note:

Update this item if additional information is obtained during the course of treatment.

130

Exercise

28.

Resident of Correctional Facility at Time of Diagnosis

Case Study – Pedro

Pedro has been in the U.S. 6 months. He is incarcerated at the Lanner County Jail. He has

signs and symptoms of TB. He is evaluated by a health care provider at the jail. A sputum

sample is collected on April 25 and sent to the health department. On May 1 he is

transferred to the Immigration and Customs Enforcement (ICE) Detention Center in

Margaritaville, Alabama, where he waits to be deported. The test result is positive for TB

and becomes available on May 5.

28.1 What type of correctional facility should be selected at time of diagnosis

(diagnostic evaluation) for Pedro? (circle the one best answer)

Federal Prison

State Prison

Local Jail

Juvenile Correction Facility

Other Correctional Facility

Unknown

131

29.

Resident of Long-Term Care Facility at Time of

Diagnosis

Primary Purpose: Surveillance. Data are used to determine if residence in a long-term care facility is

associated with TB disease.

Note:

The state licensing agency for long-term care facilities can assist in determining the

category under which a facility is classified.

Option

(select one)

Description

Not a resident of a long-term care facility when the TB diagnostic evaluation was

performed

Yes

Resident of a long-term care facility when the TB diagnostic evaluation was performed

Unknown

Not

known whether the patient was a resident of a long-term care facility when the

TB diagnostic evaluation was performed

If you selected

Yes

, indicate the type of long-term care facility of which the patient was a resident. If the

TB patient was a resident of more than 1 facility during the diagnostic evaluation, select the facility where

most of the TB diagnostic evaluation was performed.

Option

(select one)

Description Comment

Nursing home

Freestanding facility with 3 or more beds

(i.e., is classified as a residential facility

or congregate residential setting) that

provides nursing care services (e.g.,

nursing or medical care and/or

supervision of medications that may be

self-administered)

Facilities may be certified by Medicare

or Medicaid or may be licensed by the

state as a nursing home (e.g., skilled

nursing facility, intermediate care

facility, nursing care unit of a retirement

center)

Hospital-

based facility

Distinct unit with 3 or more beds that is

physically attached to, or managed by, a

hospital

Facilities may be certified by Medicare

or Medicaid or may be licensed by the

state.

132

Residential

facility

Facility with 3 or more beds (i.e., is

classified as a residential facility or

congregate residential setting) and meets both

of the following criteria:

1. Not classified as a nursing home or

hospital-based facility, as described above

and

2. Provides personal care or supervision (not

nursing care services) to its residents, in

addition to room and board (e.g., help with

bathing, dressing, eating, walking, shopping)

This might be an assisted living facility.

Mental health

residential

facility

Facility that provides 24-hour care in a

hospital, residential treatment, or

supportive setting

Include state and local mental hospitals,

private psychiatric hospitals, general

hospitals, the Department of Veterans

Affairs (VA), residential treatment

centers for emotionally disturbed

children, and multiservice mental health

organizations with residential treatment

programs.

For other federal mental health

residential facilities, select “Other

long-term care facility.” Examples

include the Department of Defense,

Bureau of Prisons, Public Health

Service, Indian Health Service, and

Indian reservation facilities that are not

federal.

Alcohol or

drug

treatment

facility

Only long-term rehabilitation or

residential facilities designated for

treatment of 30 days or longer

Exclude all ambulatory or outpatient

facilities, detoxification units, and

facilities designated for fewer than 30

days of treatment. The state agency

responsible for alcohol and drug treatment

can assist in determining whether a

facility is considered residential.

Other long-

term care

facility

A facility not mentioned above that is

designated for treatment of 30 days or

longer and facility type is not Unknown

Unknown

Patient known to be a resident of a long-

term care facility, but the type of facility

is not known

133

Examples:

Residential Facility

•

Assisted living facilities

•

Homes for mentally retarded or developmentally disabled persons

•

Boarding and care homes (e.g., residential care homes, group homes, homes for the aged, family

care homes, adult foster care homes, personal care homes, adult congregate living facilities,

residential community care facilities, domiciliary care homes)

Examples:

Mental Health Residential Facility

•

State and local mental hospitals

•

Private psychiatric hospitals

•

General hospitals (not federal) with separate psychiatric services

•

Department of Veterans Affairs (VA) medical centers

•

Residential treatment centers for emotionally disturbed children

•

Multiservice mental health organizations with residential treatment programs

Note:

Update this item if additional information is obtained during the course of treatment.

134

Exercise

29.

Resident of Long-Term Care Facility at Time of Diagnosis

Case Study – Gladys

Gladys was a resident of the Brittany Nursing Home for 5 months from April 2009 until

September 2009 while she recovered from a stroke. She returned to her home; 2 months

later, in November 2009, she is evaluated and diagnosed with TB.

29.1 Was Gladys a Resident of Long-Term Care Facility at Time of Diagnosis?

(circle the one best answer)

Yes

Unknown

135

30.

Primary Occupation Within the Past Year

Primary Purpose: Surveillance. Data are used to determine if certain primary occupations are

associated with TB disease.

Select one option that best describes the patient’s occupation within the 12 months before the diagnostic TB

evaluation. If the patient held more than 1 occupation during that period, select the longest-held

occupation or the occupation to which the patient devoted more time (i.e., the patient’s

primary

occupation). For example, if the patient was a full-time health care worker and a student (e.g., taking

night classes), the patient’s primary occupation would be

Health Care Worker

Option

(select one)

Description

Health care

worker

Paid or unpaid person working in a health care setting, with potential for

exposure to M. tuberculosis. For health care workers being evaluated for TB

disease, health care worker supersedes correctional facility or other

occupations.

Correctional

facility employee

Person working in a correctional facility; not a health care worker

Migrant/seasonal

worker

Person who is required to be absent from a permanent place of residence for the

purpose of seeking employment, or who may vary their employment for the

purpose of remaining employed while maintaining a permanent place of

residence

Other occupation

Person employed for pay or income in any occupation that is not included in the

options listed above

Retired

Person who was retired during the 12 months before the TB diagnostic

evaluation

Unemployed

Person not employed during the 12 months before the TB diagnostic evaluation

Not seeking

employment

Person not seeking employment, such as infant, child, student, homemaker,

person receiving permanent disability benefits, or person who was

institutionalized

Unknown

Person whose employment status is not known

136

Examples: Health Care Worker

Includes full time, part-time, temporary, or contract staff. Examples include:

•

Physicians

•

Nurses

•

Health Aides

•

Dental workers

•

Health Technicians

•

Staff in laboratories and morgues

•

Emergency medical personnel

•

Students

•

Persons who deliver health care in the community

(e.g., public health nurse, visiting nurse, outreach

worker)

•

Persons not involved directly in patient care, but

potentially at risk for occupational exposure

(e.g., volunteers; outreach workers;

dietary/nutritional, housekeeping, maintenance,

clerical, janitorial, administrative and supervisory

staff)

Examples:

Correctional Facility Employee

•

Federal or state prison

•

Local jail

•

Juvenile correctional facility

•

Immigration and Customs Enforcement (ICE) detention center or other correctional facility

(See

Resident of Correctional Facility

[item 28].)

•

Paid or unpaid persons working in correctional facilities, with potential for exposure to M.

tuberculosis complex (e.g., volunteers; outreach workers; dietary/nutritional, housekeeping,

maintenance, clerical, and janitorial staff)

Examples:

Migrant/Seasonal Worker

•

Migratory agricultural worker

•

Seasonal agricultural worker

•

Migrant factory worker

•

Migrant construction worker

•

Migrant service industry worker

•

Migrant sporting worker (e.g., horse racing, dog racing)

Comment: Unemployed

Select

Unemployed

if a person not included in the preceding list was unemployed for most of the past 12

months. Do not select this option for a person who was unemployed for a short time (e.g., 1 week

during the past 12 months).

Note:

Update this item if additional information is obtained during the course of treatment.

137

Exercise

30.

Primary Occupation Within Past Year

What is the Primary Occupation Within the Past Year?

(Choose the one best answer by matching the Primary Occupation Within the Past Year with

the patient. Write the letter for the occupation on the line next to the question number.)

Patient Primary Occupation within

the Past Year

___

30.1

Vince completed 30 years of service with

the U.S. Army 15 months ago and now

spends all of his time working in his

garden.

___

30.2

Joe, a full time student, does not have a job

and is not looking for work.

___

30.3

Isabella refused to disclose where she

worked.

___

30.4

Roberto picks tomatoes at Lane Produce

Company during the summer season.

___

30.5

Florence is a nurse at the local correctional

jail.

___

30.6

Billy Bob is a truck driver for Texaco.

___

30.7

Marybelle is a cook at the juvenile

detention center.

___

30.8

Andy has been without a job for the past

year.

___

30.9

Debbie is a dietitian at Grady Hospital.

Health care worker

Correctional facility

employee

Migrant/seasonal

worker

Other occupation

Retired

Unemployed

Not seeking

employment

Unknown

138

31.

Injecting Drug Use Within Past Year

Primary Purpose: Surveillance. Data are used to determine the extent to which injecting drug use is

associated with TB.

Option

(select one)

Description

Patient has not injected drugs within the past 12 months.

Yes

Patient is known to have injected drugs within the past 12 months

Unknown

It is not known whether the patient injected drugs within the past 12 months

Comment: Injecting Drug Use

Medical documentation or other indications of enrollment in a drug treatment program (e.g., methadone

detoxification; methadone maintenance; outpatient, residential, or inpatient treatment, halfway house;

prison or jail treatment; Narcotics Anonymous, Cocaine Anonymous, or other self-help program),

medical or laboratory documentation of injection drug use (e.g., urine testing), or physical evidence (e.g.,

needle tracks) may be useful in answering this question. Because many patients respond negatively during

the interview, it may be necessary to ask the patient about drug use at multiple visits.

Comment: Definition of Injecting Drug Use

Injecting drug use involves the use of hypodermic needles and syringes for the injection of drugs not

prescribed by a health care provider. Route of administration may be intravenous, subcutaneous (e.g., skin

popping), or intramuscular.

Note:

Update this item if additional information is obtained during the course of treatment.

Examples: Commonly injected drugs

•

Heroin and other opiates (e.g.,

Demerol, Dilaudid, morphine, opium)

•

Cocaine (e.g., speedball)

•

Methamphetamines

•

Amphetamines

•

Other stimulants

•

Phencyclidine (PCP, also known as angel dust)

•

Other hallucinogens

•

Barbiturates

•

Steroids

•

Other hormones

•

Fentanyl

139

Exercise

31.

Injecting Drug Use Within Past Year

Case Study – Chaz

Chaz has visible needle marks on his arms and appears high, spaced-out, and incoherent.

He denies ever using injectable drugs. However, his medical record shows a previous use

of injectable drugs and that he was in a methadone detoxification program 11 months

ago.

31.1 How would you fill out Injecting Drug Use Within Past Year for Chaz?

(circle the one best answer)

Yes

Unknown

140

32.

Non-Injecting Drug Use Within Past Year

Primary Purpose: Surveillance. Data are used to determine the extent to which non-injecting drug use

is associated with TB.

Option

(select one)

Description

Patient has no history of using non-injecting drugs within the past 12 months

Yes

It is known that the patient has used non-injecting drugs within the past 12 months.

Unknown

It is not known whether the patient used non-injecting drugs within the past 12

months.

Comment: Non-Injecting Drug Use

A history of enrollment in a drug treatment program (e.g., outpatient, residential, or inpatient treatment;

halfway house; prison or jail treatment; Cocaine Anonymous or other self-help program), as well as

medical or laboratory documentation of drug use (e.g., urine testing), may be useful in answering this

question. Because many patients respond negatively during the interview, it may be necessary to ask the

patient about drug use at multiple visits.

Comment: Definition of Non-Injecting Drug Use

Non-injecting drug use involves the use of licensed or prescription drugs or illegal drugs that were not

injected and were not prescribed for the patient by a health care provider. The drugs may be ingested,

inhaled, sniffed, or smoked.

Note:

Update this item if additional information is obtained during the course of treatment.

141

Examples: Non-injecting drugs

•

Heroin or other opiates (e.g., Demerol, Percocet, codeine, Dilaudid, MS Contin, nonprescription

methadone)

•

Cocaine (e.g., snorted) and crack (e.g., smoked)

•

Ingested amphetamines (e.g., speed, uppers, bennies)

•

Xanax, Ativan, Valium, or other benzodiazepams

•

Phencyclidine (PCP), ketamine, LSD, or other hallucinogens

•

Barbiturates

•

Marijuana (e.g., pot, weed, grass, reefers), hashish

•

Inhalants (e.g., nitrous [whippets] oxide, poppers, rush, huff, gasoline, spray paint, butane)

•

Steroids

Note:

Alcohol is

not

included as a non-injecting drug (see

Excess Alcohol Use within Past Year

[item 33]).

142

Exercise

32.

Non-Injecting Drug Use Within Past Year

Case Study – Spider

Spider is interviewed for the RVCT on December 13, 2009. He says he completed a drug

detoxification program about 14 months ago, on October 30, 2008, and has been drug-

free since that time.

32.1 How would you answer Non-Injecting Drug Use Within Past Year for Spider?

(circle the one best answer)

Yes

Unknown

143

33.

Excess Alcohol Use Within Past Year

Primary Purpose: Surveillance. Data are used to determine the extent to which excess alcohol use is

associated with TB.

Option

(select one)

Description

Patient has not used alcohol to excess within the past 12 months.

Yes

Patient has used alcohol to excess within the past 12 months.

Unknown

It is

not

known whether the patient used alcohol to excess within the past

12 months.

Comment:

This information is collected because the patient is in a high risk group for TB. The patient’s response to

this question is sought as an indicator of recent excess alcohol use. Because many patients respond

negatively during the interview, it may be necessary to ask the patient, at multiple visits, about excess use.

Note:

Update this item if additional information is obtained during the course of treatment.

Definition of Excess Alcohol Use:

There is no standard definition. Excess alcohol use can be assessed by

various methods. Examples of reliable indicators of excess alcohol use include:

•

Participation in self-help programs (e.g., Alcoholics Anonymous) or alcohol treatment programs

•

Medical record documentation of excess alcohol use or hospitalization for alcohol-related

medical conditions (e.g., delirium tremens [DTs], pancreatitis, cirrhosis)

•

More than one arrest for intoxication or drunk and disorderly behavior. This can be found by

asking the patient, or contacting the local correctional facility regarding charges.

The National Household Survey on Drug Abuse defines heavy alcohol use as “five or more drinks on the

same occasion on each of 5 or more days in the past 30 days.” Numerous screening instruments (e.g.,

CAGE, AUDIT, MAST) can be helpful in identifying persons who may use alcohol to excess.

A standard drink in the United States is equal to 13.7 grams (0.6 ounces) of pure alcohol or

•

12 ounces of beer

•

8 ounces of malt liquor

•

5 ounces of wine

•

1.5 ounces or a “shot” of 80-proof distilled spirits or liquor (e.g., gin, rum, vodka, or whiskey)

144

Exercise

33.

Excess Alcohol Use Within Past Year

Case Study – Jack Daniel

Jack Daniel comes to the clinic for daily DOT. He often appears intoxicated and smelling

of alcohol. He denies using excess alcohol, but says that he might occasionally have 1 or

2 beers a day. His records indicate that he enrolled in an alcohol treatment program

within the past year, but he never completed the program.

33.1 How would you answer Excess Alcohol Use Within Past Year for Jack Daniel?

(circle the one best answer)

Yes

Unknown

145

34.

Additional TB Risk Factors

Primary Purpose: Surveillance. Data are used to evaluate how these additional risk factors are

associated with TB disease.

Select

all

additional TB risk factors that the TB patient may have. Document additional TB risk factors

from the medical records or a reliable source (e.g., health care provider). Undocumented reporting (e.g.,

oral report from the patient or person other than a medical health care provider) is

not

acceptable.

Note:

Other specific TB risk factors (e.g., occupation, HIV infection) are collected through other items

of the RVCT.

Option

(select all that

apply)

Description

Contact of MDR TB

patient

(2 years or less)

Patient for whom the RVCT form is being completed is a contact of a

patient with multidrug-resistant (MDR) TB, within 2 years or less, regardless

of whether the patient with MDR TB was infectious.

Contact of infectious

TB patient

(2 years or less)

Patient for whom the RVCT form is being completed is a contact of an

infectious TB patient within 2 years or less.

Missed contact

(2 years or less)

Patient for whom the RVCT form is being completed is a contact of a known

TB patient, but was not evaluated or diagnosed with LTBI or TB at that time

(within 2 years or less of current diagnosis).

Incomplete LTBI

treatment

Patient had a previous diagnosis of latent TB infection (LTBI) and did not

complete treatment for LTBI.

Tumor necrosis

factor-alpha

(TNF-α)

antagonist therapy

Patient had recently received, or was receiving, TNF-α antagonist therapy at

the time of TB diagnosis.

Post-organ

transplantation

Patient has received a solid organ transplant (e.g., kidney, heart).

Diabetes mellitus

Patient has a diagnosis of diabetes mellitus (Type I or Type II) either before or

at the time of TB diagnosis.

End-stage renal

disease

Patient had end-stage renal disease or chronic renal failure at the time of

TB diagnosis.

146

Immunosuppression

Patient had immunosuppression due to either a medical condition or

medication, such as hematologic or reticuloendothelial malignancies

(e.g., leukemia, Hodgkin’s lymphoma, carcinoma of the head or neck),

or immunosuppressive therapy, such as prolonged use of high-dose

adrenocorticosteriods (e.g., prednisone).

Other

Patient had a risk factor not included in the preceding choices (e.g.,

undernutrition due to intestinal bypass surgery for obesity, gastrectomy,

jejunoileal bypass, chronic malabsorption syndromes; silicosis; travel to a TB-

endemic country).

None

No TB risk factors could be identified.

Comments: Contact of MDR TB Patient

•

MDR TB is defined as resistance to at least isoniazid and rifampin.

•

If a patient with MDR TB was the only known contact for the patient for whom you are

completing the RVCT, select

Contact of MDR TB Patient

and do

not

select

Contact of

Infectious TB Patient

. The association between the TB patients may have been found through

investigation (e.g., a formal contact investigation) or identified as an incidental finding.

•

The contact with the patient with MDR TB must have been within the last 2 years.

•

If the patient with MDR TB has an RVCT number, enter that number as the

Linking State Case

Number

(item 3), and enter reason 2 - Epidemiologically Linked Case.

Comments:

Contact of Infectious TB Patient

•

If the infectious TB patient is known to have had MDR TB, and the TB patient for whom the

RVCT form is being completed was not a contact of any other infectious TB patient, select only

Contact of MDR TB Patient

(do

not

select

Contact of Infectious TB Patient

•

The association between the TB patients may have been found through investigation (e.g., a

formal contact investigation) or as an incidental finding. The contact with an infectious TB

patient must have been within the last 2 years.

•

If the infectious TB patient has an RVCT number, enter that number as the

Linking State Case

Number

(item 3), and enter reason 2 - Epidemiologically Linked Case

Comment: Missed Contact

The contact must have been within the last 2 years. Do

not

select this option for TB patients identified as

having TB disease during, or as a result of, a contact investigation: such patients are

not

missed contacts.

Here, the intention is to record information about patients whose TB could have been prevented if they

had been identified before developing TB disease.

Comment:

Incomplete LTBI Treatment

The intention is to record information about a patient who started treatment for LTBI. However, the

patient did not complete a full course of treatment.

147

Comment: Tumor Necrosis Factor-alpha (TNF-α) Antagonist Therapy

The Food and Drug Administration (FDA) has approved TNF-α antagonist therapy for treatment of

rheumatoid arthritis and other selected autoimmune diseases. The FDA has also recently determined that

TB disease is a potential adverse reaction to treatment with TNF-α antagonists. The three TNF-α

antagonists currently approved by the FDA are infliximab (Remicade

), etanercept (Enbrel

), and

adalimumab (Humira

Comments: Immunosuppression

•

If the TB patient has diabetes mellitus or end-stage renal disease, check

Diabetes Mellitus

End-Stage Renal Disease

or both (do

not

select

Immunosuppression

unless the patient has

another immunosuppressive condition).

•

If the patient is infected with HIV, complete

HIV Status at Time of Diagnosis

(item 26) (do

not

select

Immunosuppressio

n unless the patient has another immunosuppressive condition).

Comments: Other

not

include risk factors identified in items 27–33:

•

Being homeless within past year

(item 27)

•

Residence status at diagnosis

Correctional facility

(item 28)

Long-term care facility

(item 29)

•

Primary occupation within past year

(item 30)

•

Drug or excess alcohol use within past year

(items 31–33)

On the line labeled

Specify

, write comments regarding

Other

reasons.

148

Exercise

34.

Additional TB Risk Factors

What are the Additional Risk Factors for the following patients?

(Choose the one best answer by matching the additional risk factor with the patient. Write the

letter for the additional risk factor on the line next to the question number.)

Patient Additional Risk Factor

___

34.1

Ralph has rheumatoid arthritis and has

been receiving tumor necrosis factor-

alpha antagonist therapy.

___

34.2

Maddox works at the local market where

he is exposed to a co-worker who has

MDR TB. Two weeks later Maddox is

contacted by the health department, and

they determine that he has active TB.

___

34.3

Rema has a kidney transplant in January

2009 and is diagnosed with TB disease 2

months later in March.

___

34.4

Luella is diagnosed with TB disease in

2010 while being treated for leukemia.

___

34.5

Gloria starts LTBI therapy in November

2008, but stops taking the medication in

late January 2009.

___

34.6

Diego lives with his brother, who is

diagnosed with pulmonary TB disease in

March 2009. Three months later, Diego is

also diagnosed with TB disease.

___

34.7

In July 2009, Debbie, who has diabetes, is

diagnosed with TB disease during a

routine physical.

Contact of MDR TB

patient

Contact of infectious

TB patient

Missed contact

Incomplete LTBI

therapy

TNF-α Antagonist

Therapy

Post-organ

transplantation

Diabetes mellitus

End-stage renal disease

Immunosuppression

(not HIV/AIDS)

Other

None

___

34.8

Marjorie works as a substitute teacher at

Dallas High School during the month of

April 2009. That same month, there is an

outbreak of TB at the high school, but

Marjorie does not know about that

situation, even though some of the

students who have TB are in her class. In

May she moves to Denver and is

diagnosed with TB disease in June.

149

35.

Immigration Status at First Entry to the U.S.

Primary Purpose: Surveillance. Data are used to observe the association between immigration status

and TB.

Option Description

Not applicable Patient was

• “U.S.-born”

o Born in 1 of the 50 states or the District of Columbia

o Born abroad to a parent who was a U.S. citizen (e.g., born on a military

installation)

(See Item 12 for complete instructions on “U.S.-born”)

• Born in 1 of the U.S. Territories, U.S. Island Areas, or U.S. Outlying

Areas

o American Samoa, Federated States of Micronesia, Republic of the

Marshall Islands, Commonwealth of the Northern Mariana Islands,

Republic of Palau, Guam, Puerto Rico, or the U.S. Virgin Islands

If you did

not

select

Not Applicable,

select one option to indicate the patient’s immigration status at first

entry to the United States.

Note:

If the patient had a visa at first entry to the United States, specify the type of visa. Oral

information from a reliable source is acceptable.

There are 2 main types of legal immigration status: permanent (immigrants) and nonimmigrant

(persons with a visa issued for specific purpose and period).

Permanent residents (immigrants) are issued an alien resident card (i.e., green card) and should

carry this card with them.

Nonimmigrants with visas (e.g., student, tourist, employment, V visa, K visa) should be aware of

their visa type, which is stated in their passport (I-94 arrival document stapled in passport).

Refugees are separate from the 2 main categories above: they should have an arrival document

(I-94) showing their status as refugees and they should carry this card with them.

150

Option

(select one)

Description

Immigrant

visa

For foreign-born TB patients who first entered the United States with permanent

resident status (immigrants).

For foreign-born pediatric TB patients who are adopted by U.S. citizens, the patients

enter the U.S. on an immigrant visa.

Student visa

For foreign-born TB patients who first entered the United States with a student visa.

This is a nonimmigrant visa and is obtained by an alien coming to the United States

for a specific period to pursue a full course of study in an approved institution.

Employment

visa

For foreign-born patients who first entered the United States with a nonimmigrant

employment visa (an alien coming to the United States to work for a specific period).

There are many categories of nonimmigrant employment visas (category depends

upon the type of work).

Tourist visa

For foreign-born TB patients who first entered the United States for a specific

period for business or pleasure. This is a nonimmigrant visa.

Family/ fiancé

visa

For foreign-born TB patients who first entered the United States with a V visa or a

K visa.

Refugee

For foreign-born TB patients who first entered the United States as refugees.

Asylee or

parolee

For foreign-born patients who first entered the United States seeking asylum or who

are parolees.

Other

immigration

status

For foreign-born TB patients who first entered the United States with a status that is

not Immigrant, Refugee, Asylee, Parolee, Student, Tourist, Employment, with a V

visa or a K visa, and whose status is not Unknown. This includes foreign-born

persons who were not required to obtain a visa (e.g., foreign-born visitors from

specific countries, such as Canada, that are part of the U.S. visa waiver program and

thus are not required to obtain visas if visiting the United States for short periods

[e.g., <90 days]) or those who entered the United States with no official immigration

status (e.g., they were “undocumented”).

Unknown

For jurisdictions with directives or policies that forbid asking TB patients their

immigration status

• Foreign-born TB patients who

o Do not know their immigration status at first entry to the United States

o May have had a visa at entry to the United States, but the type of visa is

unknown

• Patients who refuse to respond

Note:

For jurisdictions with directives or policies that forbid asking TB patients their immigration

status, please check

Unknown.

151

Comments:

Family/Fiancé Visa

•

The V visa (in the nonimmigrant category) allows the spouse or child of a U.S. legal permanent

resident to live and work in the United States.

•

The K visa (in the nonimmigrant category) allows the fiancé of a U.S. citizen to enter the United

States for a specific period and specifically for the purpose of marriage.

Comment:

Refugee

A refugee is a foreign-born person who is in a country other than his or her country of nationality and

who is unable or unwilling to return to that country because of persecution or a well-founded fear of

persecution.

Comments:

Asylee and Parolee

An asylee is a foreign-born person in the United States who is unable or unwilling to return to his or her

country of nationality because of persecution or a well-founded fear of persecution. An asylee meets the

same criteria as those for a refugee; the only difference is the person’s location at the time of

application—the potential asylee is in the United States or applying for admission at a port of entry, and

the potential refugee is outside the United States.

A parolee is a foreign-born person allowed to enter the United States for urgent humanitarian reasons or

because entry is determined to be of significant public benefit.

Comment: Born in 1 of the U.S. Territories, U.S. Island Areas, or U.S. Outlying Areas (American

Samoa, Federated States of Micronesia, Republic of the Marshall Islands, Commonwealth of the Northern

Mariana Islands, Republic of Palau, Guam, Puerto Rico, or the U.S. Virgin Islands)

Example: For born in 1 of the U.S. Territories, U.S. Island Areas, or U.S. Outlying Areas select

not applicable for

• Entering the United States

• Entering one of the other U.S. Territories, U.S. Island Areas, or U.S. Outlying Areas

152

Exercise

35.

Immigration Status at First Entry to the U.S.

What is the Immigration Status at First Entry to the United States for the following patients?

(Choose the one best answer by matching the Immigration Status at First Entry into the U.S.

with the patient. Write the letter for the Immigration Status on the line next to the question

number.)

Patient Immigration Status

___

35.1

Katrina, a law student from the Ukraine, visited

Disney World and interviewed for a job at the

Thayer Law Firm.

___

35.2

Graciano, a Cuban doctor, escaped to Miami from

Havana and is applying for a U.S. visa. He will be

persecuted if he returns to Cuba.

___

35.3

Pratibha was born in India and is attending a PhD

program in Public Health Surveillance at Harvard.

___

35.4

Wong, a Chinese software designer, is visiting the

United States to work for Microsoft for 3 months.

___

35.5

Ali was born in Saudi Arabia and entered the United

States with permanent resident status.

___

35.6

Anshuman, a bilingual interpreter for the U.S.

military, is a refugee from Pakistan. He cannot

return to his native Pakistan because of fear of

persecution.

___

35.7

Svetlana was born in Moscow. Her father is a U.S.

citizen and her mother is a Russian citizen.

___

35.8

Sabeen, an Iraqi secretary, met her fiancé Jim while

he served in the Gulf War. She is coming to the

United States to meet his parents and marry him.

___

35.9

Boris refuses to define his status.

___

35.10

Jose, a Mexican migrant farmer, illegally entered

the United States through Big Bend, Texas.

Not applicable

(U.S.-born)

Immigrant visa

Student visa

Employment

visa

Tourist visa

Family/fiancé

visa

Refugee

Asylee or

parolee

Other

immigration

status

Unknown

153

36.

Date Therapy Started

Primary Purpose: Programmatic function. Data are used for calculating program management

indicators.

Description Comment

Month, day, and year

(e.g., 01/17/2009)

Date the patient began multidrug

therapy for TB disease or

suspected TB disease

This may be one of several dates,

ideally, when the patient first ingested

medication if documented in a

medical record.

If the month or day is unknown, enter

99 as the default value (e.g.,

01/99/2009).

Date Therapy Started

is the month, day, and year the patient began multidrug therapy for TB disease or

suspected TB disease. Patient history without medical documentation is not acceptable and should be

entered as unknown. Enter a date according to the following chart:

Hierarchy of Determining Date Therapy Started

(Base decision on documented evidence)

Date

Medication was First Dispensed to the Patient

documented

by medical or pharmacy record

Date

Medication was First Prescribed to the Patient

by the Health Care Provider

documented

by medical or pharmacy record

Date

Patient First Ingested Medication

documented

in a medical record, such as hospital,

clinic,

directly observed therapy (DOT) record (preferred)

Preferred

Date Therapy Started

If this date is not known

choose the next alternative

Next Alternative

Date Therapy Started

If this date is not known

choose the last alternative

Last Alternative

Date Therapy Started

154

Exercise

36.

Date Therapy Started

Case Study – Thelma

On February 14, 2010, Thelma is diagnosed with TB. That same day her physician

prescribes the initial standard four-drug regimen of isoniazid, rifampin, pyrazinamide,

and ethambutol. On February 15, Thelma picks up the drugs from the pharmacy. Her

medical records indicate that Thelma is not sure when she started taking the drugs. She

thinks maybe it was on February 17, February 21, or even later.

36.1 Which date is the Date Therapy was Started?

(circle the one best answer)

February 14, 2010

February 15, 2010

February 17, 2010

February 21, 2010

155

37.

Initial Drug Regimen

Primary Purpose: Programmatic function. Data are used for calculating program management

indicators.

Select an option for

each

drug listed.

Option

(select one)

Description Comment

Drug is known to not be part of the initial regimen.

Yes

Drug is known to be part of the initial regimen.

Yes

indicates that the drug was

initially

prescribed

for treatment of TB disease and was taken for at

least 2 weeks. The 2-week requirement should

eliminate most of the record updates necessitated

by changes in regimen after treatment has begun.

If you cannot determine the

initial regimen of at least 2

weeks’ duration, select Yes

for the initial drugs known to

have been prescribed.

Unknown

It is not known whether the drug was part of the

initial regimen.

Comment:

Combination drugs

For combination drugs, select

Yes

for each drug that is a component of the combination drug.

For example

•

Rifamate is a combination of izoniazid and rifampin

•

Rifater is a combination of izoniazid, rifampin, and pyrazinamide

Example: Combination drugs

For Rifamate, select

Yes

for isoniazid and

Yes

for rifampin.

Note:

For

Other

, enter only anti-TB drugs (do

not

include pyridoxine, vitamin B6).

156

Exercise

37.

Initial Drug Regimen

Case Study – Zelda

On March 30, 2010, Zelda is diagnosed with TB. That same day, her physician prescribes

the initial standard four-drug regimen of isoniazid, rifampin, pyrazinamide, and

ethambutol.

What is the Initial Drug Regimen that was prescribed?

(Choose the one best answer by checking the box indicating Initial Drug

Regimen for each drug.)

Yes

Unknown

37.1

Isoniazid

□ □

□

37.2

Rifampin

□

37.3

Pyrazinamide

□

37.4

Ethambutol

□ □ □

37.5

Streptomycin

□ □

□

37.6

Rifabutin

□

157

Modu

ModuModu

Modul

e e

e D

Initial Drug Susceptibility Report (Follow Up Report

Initial Drug Susceptibility Report (Follow Up Report Initial Drug Susceptibility Report (Follow Up Report

Initial Drug Susceptibility Report (Follow Up Report -

- 1)

1) 1)

(page 1 of 1)

(page 1 of 1)(page 1 of 1)

(page 1 of 1)

Items 38

Items 38 Items 38

Items 38 –

––

– 40

40 40

Module D provides instructions and exercises for completing the Initial Drug Susceptibility Report. This

page is a follow-up report to the RVCT and includes data about genotyping, as well as initial drug

susceptibility testing and results.

Complete this report only for cases with positive culture results for M. tuberculosis complex.

Complete and submit this report as soon as initial drug susceptibility results are available. Copy patient

name and address from page 1 of the RVCT. The patient name and address are retained at the local level

for identification purposes; they are not sent to CDC. Enter

Year Counted

State Case Number

, and

City/County Case Number

for data entry purposes.

158

38.

Genotyping Accession Number

Primary Purpose: Surveillance. Data are used to link genotyping results with RVCT data.

Option

(select one)

Description Comment

No isolate was submitted for

genotyping.

No does not indicate that no results were

received or that “untypeable” results were

reported.

Yes

Isolate was submitted for genotyping,

regardless of genotyping results.

If you selected

Yes

, enter the following information.

Description Comment

Genotyping

accession

number

The genotyping accession number for

the current TB episode. This number

is assigned by the genotyping

reference laboratory.

If multiple isolates have been submitted for

one patient, please consult with your

laboratorian or genotyping surveillance

coordinator to determine the correct

genotyping accession number for the current

episode.

Comment:

Genotyping accession number

In 2004, CDC established the National Tuberculosis Genotyping Service (NTGS). The goal was to

genotype one M. tuberculosis isolate from every culture-confirmed TB case in the United States. The

genotyping accession number is the number assigned by the genotyping reference laboratory. Under

current contracts, the numbers are formatted in the following table.

159

Genotyping Accession Number

Sample

Laboratories

Performing

Genotyping Service

Format for

Genotyping Accession Number

Sample

California lab

YY (the 2-digit year), followed by L and 4 digits 05L1234

Michigan lab

YY (the 2-digit year), followed by RF and 4 digits 06RF5678

CDC lab

YY (the 2-digit year), followed by a hyphen and 6 digits

06-012345

When entering the genotyping accession number, begin at the first box and continue to fill to the right.

Include all hyphens and letters. Do not add zeros in the remaining boxes (beyond the number provided by

the reference lab).

160

Exercise

38.

Genotyping Accession Number

Case study - Jenna

Jenna is diagnosed with culture-positive TB in Hawaii in 2009. After the initial

diagnosis, her isolate is sent to the California reference laboratory as part of universal TB

strain genotyping. The Excel spreadsheet that came back from the laboratory looks like

this:

09L9564 09AF0254 777777777760731 222325153325 PCR00208

38.1 What should be entered for the Genotyping Accession Number?

(circle the one best answer)

0 9 L 9 5 6 4

0 9 A F 0 2 5 4

P C R 0 0 2 0 8

161

39.

Initial Drug Susceptibility Testing

Primary Purpose: Programmatic function. Data are used to monitor the rate of susceptibility testing

and calculate indicators.

Option

(select one)

Description

Initial drug susceptibility testing was not performed.

Yes

An initial isolate was obtained, submitted for drug susceptibility testing, and

results are available.

Unknown

It is not known whether initial drug susceptibility testing was performed.

Comments:

If drug susceptibility testing was performed on multiple initial isolates, select one of the following (there is

no hierarchy for selecting these options):

•

The isolate associated with the primary, or major, site of disease

•

The initial isolate from the major site of disease that yields the best or most information concerning

drug susceptibility results

•

The initial culture-positive isolate.

Note:

If the answer is

Unknown

, do

not

complete the remainder of this form (Initial Drug

Susceptibility Report [Follow Up Report–1]).

162

If you selected

Yes

, enter the following information.

Description Comment

Date first specimen

for which drug

susceptibility testing

was done

Month, day, and year the first

specimen was collected

(e.g., 01/17/2009)

If the month or day is unknown, enter

99 as the default value (e.g.,

01/99/2009).

Select the

specimen type

on which initial drug susceptibility testing was performed.

Option

(select one)

Description

Sputum

Not sputum

Enter appropriate anatomic code (e.g., 30 for pericarditis) from the Anatomic

Code list (see Appendix C – Anatomic Codes).

Note: For the purposes of the RVCT training materials, use the codes listed in the appendices. Some

software programs used to enter data on the RVCT may NOT use the codes listed in the appendices.

For example, the Anatomic Codes may be a drop-down item, where you choose the actual site rather

than enter a code. For more information, see instructions for the software you use.

163

Exercise

39.

Initial Drug Susceptibility Testing

Case study – Esmeralda

On July 3, 2009, Esmeralda is suspected of having TB. That same day a urine specimen

is collected and she starts treatment. On July 29 the result of the urine specimen indicates

that it is culture positive for TB. Drug susceptibility results on the urine specimen are

received on August 8.

Three consecutive sputum specimens are collected from Esmeralda on July 5, 6, and 7.

On August 13, the results indicate that all three specimens are smear negative and culture

positive for TB. Drug susceptibility testing performed on the July 5 sputum specimen is

reported on August 21 and is identical to the drug susceptibility testing results from the

urine specimen.

39.1 What is the date of the first specimen on which drug susceptibility testing was

done?

(circle the one best answer)

July 3, 2009

July 5, 2009

August 8, 2009

August 13, 2009

August 21, 2009

39.2 What should be entered for specimen type?

(circle the one best answer)

Sputum

Anatomic Code - Urine (69)

Both A and B are correct

164

40.

Initial Drug Susceptibility Results

Primary Purpose: Programmatic function. Data are used to monitor trends in drug resistance and

calculate indicators.

Record the results of initial drug susceptibility testing on the first specimen on which drug susceptibility

testing was performed. If drug susceptibility testing was performed on multiple initial isolates, select one

of the following (there is no hierarchy for selecting these options):

•

The isolate associated with the primary, or major, site of disease

•

The initial isolate from the major site of disease that yields the best or most information

concerning drug susceptibility results

•

The initial culture-positive isolate.

Note:

Report results from conventional drug susceptibility tests (DST) only. Do

not

report rapid DST

test results (molecular beacon, molecular line probe assays, or other molecular tests).

165

First-line and Second-line Anti-TB Drugs

First-line Drugs Second-line Drugs

•

Isoniazid

•

Rifampin

•

Pyrazinamide

•

Ethambutol

•

Streptomycin

•

Rifabutin

•

Rifapentine

•

Ethionamide

•

Amikacin

•

Kanamycin

•

Capreomycin

•

Ciprofloxacin

•

Levofloxacin

•

Ofloxacin

•

Moxifloxacin

•

Other Quinolones

•

Cycloserine

•

Para-Amino

Salicylic Acid

•

Other

Comments:

•

If drug susceptibility testing for first-line anti-TB drugs was performed on a specific specimen

and resistance to one or more drugs was noted, thus prompting drug susceptibility testing for

second-line anti-TB drugs, this testing should be done on the same specimen. Enter both first- and

second-line testing results for this variable, even if the results are received at different times.

•

If the same specimen is used for drug susceptibility testing for second-line anti-TB drugs after

testing for first-line anti-TB drugs, update these variables when results become available.

•

If a second specimen is needed for drug susceptibility testing for second-line anti-TB drugs, the

second specimen should be collected as soon as possible after the first specimen was collected for

drug susceptibility testing for first-line anti-TB drugs (i.e., interval between specimen collections

should be less than 4 weeks). Update these variables when results become available.

For

each

drug listed, select one of the options listed below.

Option

(select one)

Description

Resistant

Drug has any degree of resistance (even partial resistance, resistance at a low

concentration of the drug, or a result other than completely susceptible).

Susceptible

Select only if completely susceptible.

Not done

Susceptibility testing was not done for this drug.

Unknown

It is not known whether the test was performed.

Results are not available or result is not known for a reason other than pending

results.

Note: Other Quinolones

excludes ciprofloxacin, levofloxacin, moxifloxacin, and ofloxacin

because they are listed on the form.

Use the space at the bottom of the form to write comments (e.g., name of the laboratory that

performed drug susceptibility testing) regarding the case of TB reported on this form (Initial Drug

Susceptibility Report).

If radiometric and conventional results on the same specimen differ (e.g., one is resistant, the other is

susceptible), discuss the results with your state TB laboratory director and complete the item

accordingly.

166

Comment:

Combination drugs

For combination drugs (e.g., Rifamate, Rifater), select

Yes

for each drug that is a component of the

combination drug.

For example

•

Rifamate is a combination of izoniazid and rifampin

•

Rifater is a combination of izoniazid, rifampin and pyrazinamide

Example: Rifamate

For Rifamate, select

Yes

for isoniazid and

Yes

for rifampin.

Note:

For

Other

, enter only anti-TB drugs (do

not

include pyridoxine, [vitamin B6]).

167

Exercise

40.

Initial Drug Susceptibility Results

Case study – Esmeralda (continued from Item 39)

The following first-line drug susceptibility test results for the isolate of M. tuberculosis

complex are received on August 21 from laboratory #1. The second-line laboratory

results are received on September 19 from laboratory #2. The laboratory results are

indicated in the table below.

Results from Laboratory #1 Results from Laboratory #2

• INH – Low-level resistance

• Rifampin – No resistance

• Pyrazinamide – No resistance

• Ethambutol – Resistance

• Streptomycin – Testing not done

• Rifabutin – Resistance

• Rifapentine – Testing not done

• Ethionamide – Not known if test was done

• Amikacin – Susceptible

• Kanamycin – Testing not done

What are the Initial Drug Susceptibility Results entered on the RVCT?

(Choose the one best answer by checking the box indicating Initial Drug

Susceptibility Results from the laboratory for each drug.)

Resistant

Susceptible

Not Done

Unknown

40.1

Isoniazid

□ □

□

40.2

Rifampin

□

40.3

Pyrazinamide

□

40.4

Ethambutol

□ □ □ □

40.5

Streptomycin

□ □

□

40.6

Rifabutin

□

40.7

Rifapentine

□

40.8

Ethionamide

□ □

□

40.9

Amikacin

□

40.10

Kanamycin

□

168

169

Module

Module Module

Module E

Case Completion Report

Case Completion Report Case Completion Report

Case Completion Report (Follow

(Follow(Follow

(Follow U

U U

Up Report

p Report p Report

p Report –

––

–

2)2)

Items 41

Items 41 Items 41

Items 41 –

––

– 49

49 49

Module E provides instructions and exercises for completing the Case Completion Report. This 2 page

report includes data about treatment outcomes, provider status, and if the patient moved during treatment.

Complete this form for all patients who were alive at the time of TB diagnosis. Enter data as soon as

information becomes available during patient follow-up. This report should be completed when the case

is closed to supervision and is due no later than 2 years after the initial RVCT.

Copy patient name and address from page 1 of the RVCT form. Patient name and address are retained at

the local level for identification purposes; they are not sent to CDC. Enter

Year Counted

State Case

Number

, and

City/County Case Number

for data entry purposes.

(page 1 of 2)

(page 1 of 2)(page 1 of 2)

(page 1 of 2)

170

(page 2 of 2)

(page 2 of 2)(page 2 of 2)

(page 2 of 2)

171

41.

Sputum Culture Conversion Documented

Primary Purpose: Programmatic function. Data are used to monitor the rate of sputum culture

conversion.

Provide information on sputum culture conversion only for patients with initially positive sputum

cultures

. Sources for documentation of sputum culture conversion include patient medical records and

laboratory reports.

Note: Do NOT complete this item for patients whose –

•

Sputum culture was

not

indicated as positive in

Sputum Culture

(item 18).

•

Initial sputum specimen did

not

test positive and whose other pulmonary specimens (e.g.,

bronchoscopy fluid) tested positive in

Culture of Tissue and Other Body Fluids

(item 20).

Option

(select one)

Description Comment

Initial sputum specimen was

culture-positive; no later specimens

were culture-negative (e.g., all

follow-up cultures were positive,

patient could not produce sputum

after therapy started, or no follow-

up sputum cultures were obtained).

Yes

Initial sputum specimen was

culture-positive, followed by at

least 1 negative sputum culture.

There should be no positive cultures after the

negative culture(s).

Unknown

Results of all follow-up cultures are

not known.

It is not known whether follow-up

cultures were done.

172

If you selected

Yes

, enter the following information.

Description Comment

Date specimen

collected for

FIRST

consistently

negative sputum

culture

Month, day, and year when the

first of the consistently negative

sputum specimens was

collected (e.g., 01/17/2009).

Complete only for patients who had 1 or more

positive sputum cultures and who

subsequently had at least 1 documented

negative culture.

This date should be at least 1 week after the

last positive culture result. There should be no

positive cultures after this date.

This information may be available from

medical records or laboratory reports.

If the month or day is unknown, enter 99 as

the default value (e.g., 01/99/2009).

If you selected

No,

select one reason for

not documenting sputum culture conversion

Option

(select one)

Description

No follow-up

sputum despite

induction

Repeat sputum collection was attempted (including induced sputum collection),

but because of clinical improvement, patient was not able to produce sputum.

No follow-up

sputum and no

induction

Induction was not attempted (e.g., the health care provider did not order a repeat

specimen, or there were no facilities or equipment for induction).

Died

Patient died before having an opportunity to submit sputum to document whether

the sputum culture had converted.

Patient lost to

follow-up

Patient was lost to follow-up before having an opportunity to submit a sputum to

document whether the sputum culture had converted.

Patient refused

Patient refused to provide a sputum specimen for a repeat culture.

Other

(specify)

A reason not included in the above choices (e.g., treatment failed, or the patient

moved outside the United States).

Unknown

It is not known why a repeat sputum culture was not obtained.

173

Exercise

41.

Sputum Culture Conversion Documented

How would you document Sputum Culture Conversion for the following patients?

(Choose the one best answer by matching the sputum culture conversion with the patient. Write

the letter for the sputum culture conversion on the line next to the question number.)

Patient Sputum Culture

Conversion

___

41.1

Alice has a positive sputum culture in

September. After that she does not allow

any more specimens to be taken because it

hurts when she coughs.

___

41.2

Gene has 3 positive sputum cultures in

May. His physician does not order any

other additional induction to collect

additional sputum samples.

___

41.3

Ivan has a terrible cough. On June 6 he

produces a positive sputum culture. He dies

on July 5 before any other specimen is

collected.

___

41.4

Joyce has a positive sputum culture in July.

Subsequent sputum specimens are

collected on September 21, 22, and 23. Her

medical records indicate that on November

8 all September sputum sample cultures are

negative.

___

41.5

Ollie has a positive sputum culture in

November, and by December his condition

improves. An induction machine is

unsuccessful in collecting additional

sputum specimens.

___

41.6

Roy has a positive sputum culture in July.

He is lost to follow-up and no more sputum

samples are collected.

No, because no follow-

up sputum despite

induction

No, because no follow-

up sputum and no

induction

No, because patient

died

No, because patient

refused

No, because patient

was lost to follow-up

Yes

174

42.

Moved

Primary Purpose: Programmatic function. Data are used to facilitate efficient communication between

TB control programs in providing continuity of care for the patient.

This variable is used to record whether the patient moved during TB therapy. The responsibility for

follow-up reporting generally remains with the reporting area that initially reported the case to CDC and

counted it. (For a detailed description of the responsibility for submitting follow-up reports to CDC, see

the instructions for

Reporting Address for Case Counting

[item 4].)

Definition of Moved:

Relocated, the result of which is a change in local health department jurisdictions.

Option

(select one)

Description

Patient did not move.

Patient moved within the same local health department jurisdiction.

Yes

Patient moved to an area where another jurisdiction must now provide or

coordinate TB care.

175

If you selected

Yes

, select all the options that apply to the area

to which

the patient moved

Option

(select all that apply)

Description

COMMENT

In-state, out-of

jurisdiction

(specify)

Patient moved within the state, but

out of the local heath department

jurisdiction, such as moved to

different county or city.

Enter the city or county health

department jurisdiction to which the

patient moved.

If the patient moved more than

twice, enter the first 2 moves.

Patient moved from 1 of the 50 U.S.

states or the District of Columbia to

• Another state (e.g., moved from

Georgia to Alabama)

• A U.S. Territory, U.S. Island

Area, or U.S. Outlying Area

Out of state

(specify)

Patient moved from a U.S. Territory,

U.S. Island Area, or U.S. Outlying

Area to

• One of the 50 U.S. states or the

District of Columbia

• A U.S. Territory, U.S. Island

Area, or U.S. Outlying Area

Enter the name of the state or

reporting area to which the patient

moved.

If the patient moved more than

twice, enter the first 2 moves.

176

Patient moved from the United States

• Another country (other than a

U.S. Territory, U.S. Island Area,

or U.S. Outlying Area)

Out of the U.S.

(specify)

Moved from a U.S. Territory, U.S.

Island Area, or U.S. Outlying Area to

• Another country (other than the

United States or another U.S.

Territory, U.S. Island Area, or

U.S. Outlying Area)

Enter the name of the country to

which the patient moved.

If the patient moved more than

twice, enter the first 2 moves.

If patient moved

out of the U.S.

, select one option to indicate whether a

transnational referral

was

made.

Option

(select all

that apply)

Description Comment

Referral was not made to

a TB program or

physician outside the

United States.

Yes

Referral was made to a

TB program or physician

outside the United States.

Transnational referral includes participation in

programs such as

• TBNet

• CureTB

• Immigration and Customs Enforcement (ICE)

Communication between programs is important

• To help ensure case management after

deportation

• For completing a case management transfer

and obtaining information from TB programs

and/or physicians outside the United States for

case completion

For more information, visit the CDC/DTBE web

site on the Process for Notification of TB Cases at

www.cdc.gov/tb/pubs/international/default.htm

177

Example: Moved within a county, parish, or within a state

A move could be within a county, parish, or even within a state provided that the same health department

jurisdiction is primarily responsible for providing the TB case management, completing the RVCT, and

ensuring the completion of treatment.

Example: New York City

New York State and New York City (NYC) are separate TB reporting areas that report TB cases directly

to CDC. If a patient moves from New York State to NYC or vice versa, the move is considered “in-state,

out of jurisdiction.” Select In-state, out-of jurisdiction.

Example:

Reporting from one of the U.S. Territories, U.S. Island Areas, or U.S. Outlying Areas

If you are reporting from one of the U.S. Territories, U.S. Island Areas, or U.S. Outlying Areas

(American Samoa, Federated States of Micronesia, Guam, Republic of the Marshall Islands,

Commonwealth of the Northern Mariana Islands, Republic of Palau, Puerto Rico, or U.S. Virgin Islands),

select

Out of state

if a patient moves out of your reporting area to the United States or to another U.S.

Territory, U.S. Island Area, or U.S. Outlying Area.

However, if a patient moves from your jurisdiction to a country other than the United States or another

U.S. Territory, U.S. Island Area, or U.S. Outlying Area, select

Out of the U.S.

Examples of Moved

Moved

From To

Select

Dallas County, Texas Harris County, Texas In-state, out-of jurisdiction

Denali Borough, Alaska Bethel Borough, Alaska In-state, out-of jurisdiction

Orleans Parish, Louisiana Vernon Parish, Louisiana In-state, out-of jurisdiction

Chuuk, Federated States of

Micronesia (FSM)

Yap, FSM In-state, out-of jurisdiction

California Hawaii Out of state

Washington, D.C. Baltimore, Maryland Out of state

California Guam Out of state

Guam Palau Out of state

Guam Hawaii Out of state

Chuuk, FSM Guam Out of state

Chuuk, FSM California Out of state

Puerto Rico Florida Out of state

Guam China Out of the U.S.

California China Out of the U.S.

178

Exercise

42.

Moved

Case Study – Johann

Johann is diagnosed on August 30 with TB disease at the Bogalusa Medical Center in

Washington Parish, Louisiana. He receives DOT and adheres to treatment. On

September 30 his job requires him to relocate from his home in Bogalusa to Opelousas,

Louisiana, 170 miles away. He continues TB treatment at the St. Landry Parish Health

Clinic in Opelousas.

42.1 Which of the following statements is true about whether Johann moved?

(circle the one best answer)

No, did not move during TB therapy

Yes, moved in state, out of jurisdiction

Yes, moved out of state

Yes, moved out of the U.S. and indicate no for U.S. transnational referral

Yes, moved out of the U.S. and indicate yes for U.S. transnational referral

179

43.

Date Therapy Stopped

Primary Purpose: Programmatic function. Data are used to monitor completion of therapy within a

specified time.

Description Comment

Month, day, and

year

(e.g., 01/17/2005)

Date the patient stopped taking

therapy for TB disease or

suspected TB disease

This may be one of several dates, ideally,

when the patient last ingested medication if

documented in a medical record.

If the month or day is unknown, enter 99 as

the default value (e.g., 01/99/2005).

Comment: Date Therapy Stopped

The interval between

Date Therapy Started

(item 36) and

Date Therapy Stopped

(item 43) is meant to

encompass the entire period (including interruptions in therapy) that the patient was receiving medication

to treat TB disease or suspected TB disease.

Patient self-report without medical documentation is not

acceptable.

Although there may be interruptions in anti-TB drug therapy, enter the final documented date

on which the patient last ingested medication for TB disease or suspected TB. For patients being treated

for TB disease or suspected TB disease, enter

Date Therapy Stopped

, according to the following chart:

Hierarchy for Determining Date Therapy Stopped

(for entire treatment period)

Date

Patient Last Ingested Medication

Date

Medication Dispensed to the Patient

Would Have Run Out if the Patient had Taken

All the

Medication

Date

Medication Prescribed to the Patient Would

Have Run Out if the Patient Had Taken All the

Medication from the Date of Prescription

(from the final prescription for the last bottle)

Preferred

Date Therapy Stopped

If this date is not known, choose

the next alternative date stopped

Next Alternative

Date Therapy Stopped

If this date is not known, choose

the last alternative date

Last Alternative

Date Therapy Stopped

180

Comment: Update the date that therapy was stopped

Update the date therapy was stopped only if a patient was lost to follow-up and then returns and

completes therapy.

Comment: Reopened case

If a case is reopened (e.g., patient who has been lost to follow-up is found, restarts therapy, and then

completes therapy), update this form (Case Completion Report [Follow Up – Report 2]) to reflect that the

patient completed therapy.

181

Exercise

43.

Date Therapy Stopped

Case Study – Hannibal

Hannibal, a convicted murderer, was diagnosed on October 31, 2009, with TB disease

while incarcerated at Folsom Prison. He also had HIV and liver disease. He received

DOT. On November 23, 2009, he complained of nausea, fever, and had yellowish skin.

On November 24, Hannibal received DOT in the morning. He became very ill and died

later that evening. The medical examiner determined that Hannibal’s death was likely due

to an adverse reaction to INH.

43.1 What is the Date for Therapy Stopped?

(circle the one best answer)

A. Month Day Year

1 1 2 3 2 0 0 9

B. Month Day Year

1 1 2 4 2 0 0 9

C. Month Day Year

1 1 9 9 2 0 0 9

182

44.

Reason Therapy Stopped or Never Started

Primary Purpose: Programmatic function. Data are used to document treatment outcome.

Complete this item when the patient completes therapy or the case is closed. Select the primary reason

that TB therapy was ended and not resumed, or was never started.

Option

(select one)

Description

Completed

therapy

Patient completed the prescribed course of therapy per the medical record as

recorded by the clinician caring for the patient.

Lost

Patient could not be located before the start or the completion of treatment (e.g., the

patient moved to an unknown location, or the forwarding address is known but the

patient was not found at that address).

Code patients who move outside the United States and cannot be followed up as

Other.

Uncooperative

or refused

Patient refused to complete therapy (e.g., stopped taking drugs).

Adverse

treatment

event

Therapy was permanently stopped because of an adverse event due to anti-TB

medications. Select this option only if the patient lived.

If the patient died because of an adverse TB treatment event, select

• Died as the Reason Therapy Stopped

and then select

• Related to TB Therapy for Cause of Death even if the patient stopped TB

therapy prior to the death due to an adverse treatment event.

This is a determination that has to be made by the clinician.

Not TB

Completed diagnostic evaluation did not substantiate the diagnosis of TB (e.g., M.

avium was isolated from a clinical specimen).

Died

Patient was alive at diagnosis but died before the start or completion of treatment.

This also applies to a patient classified as alive for Status at TB Diagnosis (item 15)

if the patient was taking at least 2 anti-TB drugs before the day of death, even though

the TB case was not verified and counted until after death.

183

Other

Therapy was discontinued for a known reason not included in the above choices and

is not Unknown, (e.g., patient moved outside the United States, or patient moved

from state A to state B, and state A notified state B, but state B never followed up).

Unknown

Reason that therapy was stopped is not known.

Comment: Reopen a case

If a case is reopened (e.g., patient who has been lost to follow-up is found within 12 months of when the

patient was lost, restarts therapy, and then completes therapy), update this form (Case Completion Report

[Follow Up – Report 2]) to reflect that the patient completed therapy.

If you selected

Died

, indicate one

Cause of Death

Option

(select one)

Description Comment

Related to TB

disease

TB was

• The immediate cause

• An underlying cause

• Another significant condition

contributing to death (even if

TB was not the main cause of

death)

Written documentation of the cause of death

(e.g., death certificate, autopsy report, medical

records) is recommended. However, oral

information from a reliable source (e.g., a

health care provider) will be accepted.

A death certificate is not necessarily required

to complete this field. In some cases deaths

may be certified before receipt of results of

• Positive M. tuberculosis culture

• Other findings consistent with TB

Classify as related to TB disease if the patient

died as a result of a surgical procedure for

which

• The primary indication was the diagnosis

of TB

• TB complicated a surgical procedure not

related to TB (e.g., heart surgery)

Criteria for determining the cause of death

related to TB disease should be specified by

the clinician.

Related to TB

therapy

TB therapy (e.g., adverse

treatment event) was related to

the cause of death.

Criteria for determining the cause of death

related to TB therapy should be specified by

the clinician.

184

Unrelated to TB

disease

TB was not

• The immediate cause

• An underlying cause

• Another significant condition

contributing to death

Unknown

Cause of death is not known.

Every effort should be made to determine if

death was related to TB disease before

classifying as unknown.

Note:

Update this item if additional information is obtained.

185

Exercise

44.

Reason Therapy Stopped or Never Started

Case Study – Hannibal (continued from Item 43)

44.1 What is the Reason that Therapy was Stopped for Hannibal?

(circle the one best answer.)

Completed Therapy

Adverse Treatment Event

Died

186

45.

Reason Therapy Extended >12 Months

Primary Purpose: Program function. Data are used to document reason for extended treatment and to

calculate program indicators.

Use the information entered for

Date Therapy Started

(item 36) and

Date Therapy Stopped

(item 43)

to calculate the length of anti-TB therapy. Sources for the reason(s) therapy was extended include patient

medical records, patient interview, and health care provider interview.

Option

(select all that apply)

Description Comment

Rifampin resistance

Patient had drug-resistant TB that

would require a treatment protocol

lasting more than 12 months (e.g.,

resistance to at least rifampin)

according to the ATS/CDC/IDSA

Official Joint Statement on the

Treatment of TB.

Adverse drug reaction

Patient had a significant adverse drug

reaction or experienced an adverse

treatment event due to anti-TB

medications that prolonged therapy.

Non-adherence

There were barriers to the patient’s

adherence to anti-TB therapy (e.g.,

treatment interruption), or the patient’s

lack of adherence resulted in extension

of therapy beyond 12 months.

Failure

A sputum specimen tested positive 4 or

more months after treatment began.

Criteria for determining failure

should be specified by the

clinician.

Clinically indicated―

other reasons

Clinical indications (other than

adverse drug reactions) include

central nervous system TB (e.g.,

meningitis), severe liver disease, or

other criteria as specified by the

clinician.

Other

Reason does not include any of the

choices listed above.

Use additional space at the

bottom of the page to write

comments regarding Other

reasons.

187

Exercise

45.

Reason Therapy Extended >12 months

What is the Reason Therapy was Extended for > 12 Months for the following patients?

(Choose the one best answer by matching the Reason Therapy was Extended for > 12 Months

with the patient. Write the letter for the Reason Therapy was Extended next to the question

number.)

Patient Reason Therapy was

Extended > 12 months

___

45.1

Ralph, a homeless man, begins DOT and

has a sputum culture conversion from

positive to negative by 2 months. But at 4

months his sputum results are positive.

___

45.2

Amy, a 3-year-old, has TB meningitis.

___

45.3

Jose and his brother Raul go on an

extended camping trip to Yosemite

National Park. He loses his medicine and

does not get more medicine until he returns

to the clinic 2 months later.

___

45.4

Bob’s initial drug susceptibility results

indicate that the isolate is resistant to

isoniazid and rifampin.

___

45.5

Nancy experiences severe breathing

difficulties and hives a week into therapy.

Her doctor changes her anti-TB

medications.

Rifampin resistance

Adverse drug reaction

Non-adherence

Failure

Clinical indications –

other reasons

188

46.

Type of Outpatient Health Care Provider

Primary Purpose: Programmatic function. Data are used to guide TB programs in allocating

resources.

Definition for

Type of Outpatient Health Care Provider:

setting or affiliation of the provider who has

primary responsibility for clinical outpatient decision making (excluding diagnostic workup, contact

investigations, anti-TB medications, and directly observed therapy [DOT]).

Note:

•

Outpatient refers to a setting that is not a hospital and that does not provide acute care, such as a

clinic or a physician’s office.

•

Inpatient refers to a hospital or acute-care setting.

Here, these terms refer to the physician, not to the patient. These terms also denote the type of services

that are provided. Some institutions, such as a hospital, correctional facility, or long-term care facility,

may have both outpatient and inpatient settings.

Option

(select all that apply)

Description

Local/state health

department (HD)

Includes a TB program or a health clinic of a health department.

Private outpatient

Includes private physician or health care provider, health maintenance

organization (HMO), and private managed health care provider.

IHS, tribal HD, or tribal

corporation

Primary responsibility for clinical outpatient decision making rests with

the Indian Health Service (IHS); a tribal health department, such as the

American Indian or Alaska Native Tribal Health Department; or a tribal

corporation, such as the Tribal Healthcare Corporation.

Institutional/

correctional

Includes nursing homes and assisted living facilities, and all types of

correctional facilities.

Inpatient care only

Patient did not receive outpatient TB care. Care provided in a hospital.

Other

The provider is not included in the other categories and is not Unknown

(e.g., state TB chest hospital providing outpatient care, city/county/state-

owned hospitals that are not part of the health department providing

outpatient care, private hospital providing outpatient care, Veterans

Administration hospital, federal program, military facility, or community-

based organization [CBO]).

189

Unknown

Type of health care provider is not known. If you select Unknown, do not

select any other option for type of health care provider.

Comment:

Private outpatient

This category includes the private provider who has the primary responsibility for clinical outpatient

decision making for a TB patient, even though the TB control program or local/state health department

may be periodically contacting the private provider for the purpose of completing the RVCT and

ensuring proper TB case management.

Comment:

Inpatient care only

Examples of inpatient care only include

•

TB diagnosed at autopsy

•

Patients who were in the hospital but died before receiving outpatient TB care

•

Patients who received all of their TB care as an inpatient in a hospital

Comment: Multiple options

If a patient first received care from a private health care provider, but after a time (e.g., 3 months) lost his

or her medical insurance and began receiving care from the local or state health department, select both

Private

and

Local/State Health Department.

190

Exercise

46.

Type of Outpatient Health Care Provider

What is the Type of Outpatient Health Care Provider for the following patients?

(Choose the one best answer by matching the Type of outpatient health care provider with the

Patient. Write the letter for the type of provider next to the question number.)

Patient Type of Outpatient Health

Care Provider

___

46.1

Clyde is arrested for armed robbery. He is

diagnosed and treated for TB disease

during the 6 months that he is in the Bonnie

Springs Jail.

___

46.2

Victor, a Vietnam War veteran, comes to a

Virginia Veterans Administration Hospital

to receive DOT.

___

46.3

Howard, an HIV patient, is admitted to

National Jewish Health hospital for

treatment of XDR TB, where he receives

all of his TB treatment.

___

46.4

Nita is treated for TB disease at the

Cherokee Indian Hospital.

___

46.5

Curtis is diagnosed with active TB at the

Dallas County Health Department and

starts DOT.

___

46.6

Joel is diagnosed and treated for TB disease

by his physician at the Kaiser Permanente

Health Center.

Local/

State Health

Department

Private Outpatient

IHS, Tribal HD, or

Tribal Corporation

Institutional/

Correctional

Inpatient Care Only

Other

Unknown

191

47.

Directly Observed Therapy (DOT)

Primary Purpose: Case management. Data are used to document administration of TB medications.

Directly observed therapy (DOT), or supervised therapy, involves the direct visual observation by a health

care provider (e.g., public health nurse, outreach worker, nurse, nurse’s aide) or other reliable trained

person (e.g., worker in a homeless shelter) of a patient’s ingestion of medication. Delivering medication

to a patient without visual confirmation of ingestion does not constitute DOT. However, a live video

camera confirmation of ingestion of medicine of

carefully selected patients

(e.g., stable and compliant)

constitutes DOT.

Anti-TB medication may be

Self-administered (e.g., patient ingests medication dose[s]

without

direct visual observation

by a health care provider or other reliable person)

Given by using DOT

A combination of self-administered and given by using DOT

Option

(select one)

Description

No, totally

self-administered

No doses of medication were given under direct supervision.

Yes, totally directly

observed

Response applies if DOT was used for all doses for a patient who was taking

medication 1–5 times a week. Response also applies if the patient was taking

medication 7 times a week and DOT was used for at least 5 of those doses (i.e.,

patient self-administered the dose[s] during weekends and holidays).

Yes, both directly

observed and

self-administered

Response applies if the patient self-administered any dose while taking

medication 1–5 times a week. Response does not apply if the patient was

taking medication 7 times a week and DOT was used for at least 5 of those

doses (i.e., patient self-administered the dose[s] during weekends and

holidays).

Response also applies if patient took several months of self-administered

therapy and several months of DOT.

Unknown

It is not known whether any doses were given under direct supervision.

192

If you selected any

Yes

option, enter the

Number of weeks of directly observed therapy (DOT).

Option

(select one)

Description Comment

Number of weeks of

directly observed

therapy (DOT)

Based on the total number of

regimen-appropriate weeks and

doses ingested under directly

observed supervision (e.g., 026)

The total number of DOT weeks must

be less than or equal to the time

between Date Therapy Started (item

36) and Date Therapy Stopped (item

43).

To calculate

Number of weeks of directly observed therapy

(DOT weeks), use the following methods:

•

Review the patient’s medication records to determine the number of doses

given by DOT

each week

Review the patient’s medication records to determine the number of doses given by DOT each

week, or 7-day period. The number of days in a week is 7, but the calculation of DOT (or

medication) weeks should be independent of, or not restricted to, calendar weeks (i.e., Sunday

through Saturday).

•

Example: Medication week

A medication week can be, for example, Monday through Sunday or Wednesday through

Tuesday, as long as the week consists of 7 consecutive days.

•

Missed DOT dose

If a patient misses a DOT dose or there is a holiday during a medication week (i.e., DOT cannot

be given that week), as long as DOT is used when the missed dose(s) is made up at the end of

therapy, the dose(s) given at the end of therapy can be combined with the last “partial DOT

week” and counted as a “full DOT week.”

•

Count as a DOT week

Count as a DOT week any week during which DOT was used for every dose for a patient who

was taking medication 1–5 times a week. If the patient was taking medication 7 times a week,

DOT must have been used for at least 5 doses.

Often, the health department or the person completing the RVCT form does not have direct access to the

entire patient medical record or medication log because the TB patient is or was cared for by a provider

other than the health department (e.g., private health care provider). A private health care provider usually

does not provide DOT; rather, a public health care provider (e.g., public health nurse) provides DOT and

maintains the medication log and medication dosage calendar. The health department periodically follows

up with the provider, and when therapy is completed or the case is closed, the health department usually

completes a “close-out” form. In such instances, the health department should request a copy of the

medication log or review the log with the person who provided DOT (e.g., public health nurse) to

determine the amount of medication that was given by DOT.

193

Exercise

47.

Directly Observed Therapy (DOT)

Case study – Maximo

Maximo is diagnosed with TB in June 2009 after being evaluated through a free clinic in

Laredo, Texas. He is provided housing by the health department and starts on a 4-drug

DOT regimen administered by the health department on June 9, 2009. On August 4

(after 8 weeks of daily 4-drug therapy), his DOT regimen changes to twice-weekly INH

and RIF. He misses doses on August 25 and 27, October 8, and November 26

(Thanksgiving day). He successfully completes treatment and adheres to DOT up to

December 17, 2009.

47.1 What would you select for Directly Observed Therapy?

(circle the one best answer)

No, totally self-administered

Yes, totally directly observed

Yes, both directly observed and self-administered

Unknown

Use this calendar to determine weeks of DOT.

May June July August

1 2 1 2 3 4 5 6 1 2 3 4 1

3 4 5 6 7 8 9 7 8 9 10 11 12 13

5 6 7 8 9 10 11

2 3 4 5 6 7 8

10 11 12 13 14 15 16

15 16 17 18 19 20

13 14 15 16 17 18

9 10 11 12 13 14 15

17 18 19 20 21 22 23

22 23 24 25 26 27

20 21 22 23 24 25

17 18 19 20 21 22

24 25 26 27 28 29 30

29 30 26

27 28 29 30 31 23

24 25 26 27 28 29

31 30

September October November December

1 2 3 4 5 1 2 3 1 2 3 4 5 6 7 1 2 3 4 5

6 7 8 9 10 11 12

4 5 6 7 8 9 10

8 9 10 11 12 13 14

6 7 8 9 10 11 12

13 14 15 16 17 18 19

12 13 14 15 16 17

16 17 18 19 20 21

14 15 16 17 18 19

20 21 22 23 24 25 26

19 20 21 22 23 24

23 24 25 26 27 28

21 22 23 24 25 26

27 28 29 30 25

26 27 28 29 30 31

30 27

28 29 30 31

47.2. What would you enter for the number of weeks of DOT?

(circle the one best answer)

0 2 0

0 2 6

0 3 2

194

Case study for Items 43–47 – Maximo (continued)

Now imagine that Maximo self-administers doses on August 25, August 27, and

September 1 because he was out of town visiting his sister that week. He still missed the

October 8 dose and the November 26 dose.

How would you complete items 43–47 on the RVCT?

47.3

Item 43: Date Therapy Stopped

(circle the one best answer)

December 12, 2009

December 17, 2009

47.4

Item 44: Reason Therapy Stopped or Never Started

(circle the one best answer)

Completed Therapy

Unknown

47.5

Item 45: Reason Therapy Extended > 12 Months

(circle the one best answer)

Nonadherence

Not applicable, leave blank

195

47.6

Item 46: Type of Outpatient Health Care Provider

(circle the one best answer)

Local/State Health Department

Private

47.7

Item 47: Directly Observed Therapy (DOT)

(circle the one best answer)

Yes, both directly observed and self-administered

Unknown

47.8 Item 47: Directly Observed Therapy (DOT). How many weeks of DOT were

provided?

(circle the one best answer)

020

025

196

48.

Final Drug Susceptibility Testing

Primary Purpose: Surveillance. Data are used to observe trends in drug-resistant TB and to learn about

its epidemiology.

Option

(select one)

Description

Follow-up drug susceptibility testing was not performed.

Yes

Drug susceptibility testing was performed on a specimen that was collected

30 or more days after the specimen on which initial drug susceptibility testing

was performed.

Unknown

It is not known whether follow-up drug susceptibility testing was performed.

Comment:

This variable will help assess the frequency of acquired drug resistance.

If you selected

Yes

, enter the following information.

Description Comment

Date FINAL

specimen

collected on which

drug

susceptibility

testing was done

Month, day, and year

(e.g., 01/17/2009)

This date should be 30 or more days after the

collection date of the initial specimen on which

drug susceptibility testing was done (item 39).

This information is usually available from medical

records or laboratory reports.

If the month or day is unknown, enter 99 as the

default value (e.g., 01/99/2009).

197

Select the

Specimen Type

on which the final drug susceptibility testing was done.

Option

(select one)

Description

Sputum

Not sputum

Enter appropriate anatomic code (e.g., 30 for pericarditis) from Appendix C –

Anatomic Codes

198

Exercise

48.

Final Drug Susceptibility Testing

48.1 When must the final specimen be collected on which Final Drug Susceptibility

Testing is done?

(circle the one best answer)

The date can be any time after the collection date for the initial specimen on

which drug susceptibility was done.

The date should be less than 30 days after the collection date for the initial

specimen on which drug susceptibility testing was done.

The date should be 30 or more days after the collection date for the initial

specimen on which drug susceptibility testing was done.

199

49.

Final Drug Susceptibility Results

Primary Purpose: Programmatic function. Data are used to monitor trends in drug resistance.

Record results for the

final

specimen on which drug susceptibility testing was performed. Drug

susceptibility testing procedures should comply with approved and accepted guidelines. If drug

susceptibility testing was performed on multiple specimens, select the most appropriate specimen: the one

associated with the primary, or major, site of disease; the final specimen from the major site of disease that

yields the best or most information concerning drug susceptibility results; or the final specimen that tested

positive.

For

each

drug listed, select one option from the following.

Option

(select one)

Description

Resistant

Drug has any degree of resistance (even partial resistance or resistance at a low

concentration of the drug, or other than completely susceptible result).

Susceptible

Select only if completely susceptible.

Not done

Susceptibility testing was not done for this drug.

Unknown

It is not known whether the test was performed.

Results were not available or result is not known for a reason other than pending

results.

200

Note: Other Quinolones

excludes ciprofloxacin, levofloxacin, moxifloxacin, and ofloxacin

because they are listed on the form.

Use the space at the bottom of the form to write comments (e.g., name of the laboratory that

performed drug susceptibility testing) regarding the case of TB reported on this form (Case

Completion Report).

If radiometric and conventional results on the same specimen differ (e.g., one is resistant, the other is

susceptible), discuss the results with your state TB laboratory director and complete the item

accordingly.

201

Exercise

49.

Final Drug Susceptibility Results

Case study for Items 48 and 49 – Lana

Lana is diagnosed with sputum culture-positive TB in October 2009. Initial drug

susceptibility tests showed her TB is sensitive to all of the first-line drugs that are

prescribed. She has a number of treatment interruptions and develops rifampin resistance,

which is discovered upon repeat drug susceptibility testing of sputum collected on

December 13, 2009. The isolate remains susceptible to isoniazid, pyrazinamide, and

ethambutol. The isolate is also found to be susceptible to rifabutin, ciprofloxacin,

moxifloxacin, streptomycin, amikacin, and kanamycin. No other drugs are tested.

What are the Final Drug Susceptibility Results for Lana?

(Choose the one best answer by checking the box indicating Final Drug Susceptibility Results

from the laboratory for each drug.)

Resistant

Susceptible

Not Done

Unknown

Resistant

Susceptible

Not Done

Unknown

49.1

Isoniazid

□ □

□

49.11 Capreomycin

□ □

□

49.2

Rifampin

□

49.12 Ciprofloxacin

□

49.3

Pyrazinamide

□

49.13 Levofloxacin

□

49.4

Ethambutol

□ □

□

49.14 Ofloxacin

□ □

□

49.5

Streptomycin

□

49.15 Moxifloxacin

□

49.6

Rifabutin

□

49.16

Other

Quinolones

□

49.7

Rifapentine

□ □

□

49.17 Cycloserine

□ □

□

49.8

Ethionamide

□

49.9

Amikacin

□

49.18

Para-Amino

Salicylic

Acid

49.10

Kanamycin

□

49.19 Other

□

Specify ____________________________________________

49.20

Other

□

Specify ____________________________________________

202

203

Appendix A

Appendix AAppendix A

Appendix A

Tuberculosis Case Definition for Public Health Surveillance

Tuberculosis Case Definition for Public Health SurveillanceTuberculosis Case Definition for Public Health Surveillance

Tuberculosis Case Definition for Public Health Surveillance

(Revised May 13, 2009)

Clinical description

A chronic bacterial infection caused by Mycobacterium tuberculosis, usually characterized

pathologically by the formation of granulomas. The most common site of infection is the lung,

but other organs may be involved.

Clinical case definition

A case that meets all of the following criteria:

• A positive tuberculin skin test result or positive interferon gamma release assay for M.

tuberculosis

• Other signs and symptoms compatible with tuberculosis (TB) (e.g., abnormal chest

radiograph, abnormal chest computerized tomography scan or other chest imaging study,

or clinical evidence of current disease)

• Treatment with two or more anti-TB medications

• A completed diagnostic evaluation

Laboratory criteria for diagnosis

• Isolation of M. tuberculosis complex from a clinical specimen,

• Demonstration of M. tuberculosis complex from a clinical specimen by nucleic acid

amplification test,

†

• Demonstration of acid-fast bacilli in a clinical specimen when a culture has not been or

cannot be obtained or is falsely negative or contaminated.

Case classification

Confirmed: a case that meets the clinical case definition or is laboratory confirmed

Comment

A case should not be counted twice within any consecutive 12-month period. However, a case

occurring in a patient who had previously had verified TB disease should be reported and

counted again if more than 12 months have elapsed since the patient completed therapy. A case

should also be reported and counted again if the patient was lost to supervision for greater than

12 months and TB disease can be verified again. Mycobacterial diseases other than those caused

by M. tuberculosis complex should not be counted in tuberculosis morbidity statistics unless

there is concurrent tuberculosis.

______________________________

Use of rapid identification techniques for M. tuberculosis (e.g., DNA probes and mycolic acid high-pressure liquid

chromatography performed on a culture from a clinical specimen) are acceptable under this criterion.

†

Nucleic acid amplification (NAA) tests must be accompanied by culture for mycobacteria species for clinical

purposes. A culture isolate of M. tuberculosis complex is required for complete drug susceptibility testing and also

genotyping. However, for surveillance purposes, CDC will accept results obtained from NAA tests approved by the

Food and Drug Administration (FDA) and used according to the approved product labeling on the package insert,

or a test produced and validated in accordance with applicable FDA and Clinical Laboratory Improvement

Amendments (CLIA) regulations.

204

205

Appendix B

Appendix BAppendix B

Appendix B

Recommendations for Reporting and Counting Tuberculosis Cases

Recommendations for Reporting and Counting Tuberculosis CasesRecommendations for Reporting and Counting Tuberculosis Cases

Recommendations for Reporting and Counting Tuberculosis Cases

(Revised May 13, 2009)

Since publication of the “Recommendations for Counting Reported Tuberculosis Cases”

July 1997, numerous changes have occurred, and many issues have been raised within the

field of tuberculosis (TB) surveillance. This current version updates and supersedes the

previous version.

A distinction should be made between reporting TB cases to a health department and

counting TB cases for determining incidence of disease. Throughout each year, TB cases

and suspected cases are reported to public health authorities by sources such as clinics,

hospitals, laboratories, and health care providers. From these reports, the state or local TB

control officer must determine which cases meet the current surveillance definition for TB

disease and whether the case is countable. These countable TB cases are then reported to the

Centers for Disease Control and Prevention (CDC).

Beginning in 2009, state and local TB control officers may also report to CDC those TB

cases that are verified but not countable for morbidity statistics, as a measure of

programmatic and case management burden. The noncountable report can include persons

with TB disease recurring within a consecutive 12-month period after the patient completed

TB therapy.

I. Reporting TB Cases. CDC recommends that health care providers and laboratories

be required to report all TB cases or suspected cases to state and local health

departments based on the current “Tuberculosis Case Definition for Public Health

Surveillance” (Appendix A). This notification is essential in order for TB programs to

• Ensure case supervision

• Ensure completion of appropriate therapy

• Ensure completion of contact investigations

• Evaluate program effectiveness

• Assess trends and characteristics of TB morbidity

II. TB Surveillance. For purposes of surveillance, a case of TB is defined on the basis of

laboratory or clinical evidence of active disease due to M. tuberculosis complex.*

________________________________

* Because most laboratories use tests that do not routinely distinguish Mycobacterium tuberculosis from very

closely related species, these laboratories report culture results as being positive or negative for “Mycobacterium

tuberculosis complex.” Although in almost all cases of human disease, isolates in the M. tuberculosis complex are,

in fact, M. tuberculosis, other species are possible. For example, one study in San Diego found that 6% of human

tuberculosis was caused by Mycobacterium bovis; cultures from these cases would be reported by most laboratories

as being positive for M. tuberculosis complex. Other species in the Mycobacterium tuberculosis complex include M.

africanum, M. microti, M. canetii, M. caprae, and M. pinnipedii. Although M. microti, M. canetii, M. caprae, and

M. pinnipedii are newly described species, their inclusion in M. tuberculosis complex should not impact public

health laboratories or programs, because only a few laboratories identify to the species level. These seven species

are almost identical in DNA homology studies. In terms of their ability to cause clinical disease or be transmissible

from person to person, M. bovis, M. africanum, M. microti, M. canetii, M. caprae, and M. pinnipedii behave like M.

tuberculosis; therefore, disease caused by any of the organisms should be reported as TB, using the Report of

206

Verified Case of Tuberculosis (RVCT). The only exception is the BCG strain of M. bovis, which may be isolated

from persons who have received the vaccine for protection against TB or as cancer immunotherapy; disease caused

by the BCG strain of M. bovis should not be reported as TB.

a. Laboratory Case Definition

• Isolation of M. tuberculosis complex from a clinical specimen. The use of rapid

identification techniques for M. tuberculosis performed on a culture from a clinical

specimen, such as DNA probes and high-pressure liquid chromatography (HPLC), is

acceptable under this criterion.

• Demonstration of M. tuberculosis from a clinical specimen by nucleic acid

amplification (NAA) test. NAA tests must be accompanied by cultures of

mycobacterial species. However, for surveillance purposes, CDC will accept results

obtained from NAA tests approved by the Food and Drug Administration (FDA) and

used according to the approved product labeling on the package insert, or a test

produced and validated in accordance with applicable FDA and Clinical Laboratory

Improvement Amendments (CLIA) regulations.

• Demonstration of acid-fast bacilli (AFB) in a clinical specimen when a culture has

not been or cannot be obtained or is falsely negative or contaminated; historically this

criterion has been most commonly used to diagnose TB in the postmortem setting.

b. Clinical Case Definition. In the absence of laboratory confirmation of M. tuberculosis

complex after a diagnostic process has been completed, persons must have all of the

following criteria for clinical TB:

• Evidence of TB infection based on a positive tuberculin skin test result or positive

interferon gamma release assay for M. tuberculosis

AND

• One of the following:

(1) Signs and symptoms compatible with current TB disease, such as an

abnormal chest radiograph or abnormal chest computerized tomography scan or

other chest imaging study,

(2) Clinical evidence of current disease (e.g., fever, night sweats, cough, weight

loss, hemoptysis)

AND

• Current treatment with two or more anti-TB medications

207

NOTE: The software for TB surveillance developed by CDC includes a calculated variable

called “Vercrit,” for which one of the values is “Provider Diagnosis.” “Provider Diagnosis” is

selected when the user chooses to override a “Suspect” default value in the case verification

screen as “Verified by Provider Diagnosis.” Thus, “Provider Diagnosis” is not a component of

the case definition for TB in the current “Tuberculosis Case Definition for Public Health

Surveillance” (Appendix A). CDC’s national morbidity reports have traditionally included all

TB cases that are considered verified by the reporting areas, without a requirement that cases

meet the published case definition.

III. Counting TB Cases. Cases that meet the current CDC surveillance case

definition for verified TB are counted by 52 reporting areas with count authority

(50 states, District of Columbia, and New York City) to determine annual

incidence for the United States. The remaining 8 reporting areas (American

Samoa, Federated States of Micronesia, Guam, Marshall Islands, Northern

Mariana Islands, Puerto Rico, Republic of Palau, and U.S. Virgin Islands) report

cases to CDC but are not included in the annual incidence for the United States.

The laboratory and clinical case definitions are the two diagnostic categories used

in the CDC “Tuberculosis Case Definition for Public Health Surveillance.”

Most verified TB cases are accepted for counting based on laboratory

confirmation of M. tuberculosis complex from a clinical specimen.

A person may have more than one discrete (separate and distinct) episode of

TB. If disease recurs in a person within any 12-consecutive-month period after

the patient completed therapy, count only one episode as a case. However, if TB

disease recurs in a person, and if more than 12 months have elapsed since the

person completed TB therapy or was lost to supervision, the TB case is

considered a separate episode and should be counted as a new case.

Mycobacterial diseases other than those caused by M. tuberculosis complex

should not be counted in TB morbidity statistics unless there is concurrent TB.

a. Verified TB Cases

COUNT

Count only verified TB cases that meet the laboratory or clinical case

definitions (see Section II). The diagnosis of TB must be verified by the TB

control officer or designee. The current CDC surveillance case definition for

TB describes and defines the criteria to be used in the case definition for TB

disease.

DO NOT COUNT

If diagnostic procedures have not been completed, do not count; wait for

confirmation of disease. Do not count as a case the patient for which two or

more anti-TB medications have been prescribed for preventive therapy for

exposure to multidrug- resistant (MDR) TB, or while the diagnosis is still

pending.

208

b. Nontuberculous Mycobacterial Diseases (NTM)

COUNT

An episode of TB disease diagnosed concurrently with another nontuberculous

mycobacterial disease should be counted as a TB case.

DO NOT COUNT

Disease attributed to or caused by nontuberculous mycobacteria alone should

not be counted as a TB case.

c. TB Cases Reported at Death

COUNT

TB cases first reported to the health department at the time of a person’s death

are counted as incident cases, provided the person had current disease at the

time of death. The TB control officer should verify the diagnosis of TB.

DO NOT COUNT

Do not count as a case of TB if there is no evidence of current disease at the

time of death or at autopsy.

d. Immigrants, Refugees, Permanent Resident Aliens, Border Crossers,* and

Foreign Visitors

COUNT

Immigrants and refugees who are examined after arriving in the United States

and diagnosed with clinically active TB requiring anti-TB medications should

be reported and counted by the locality of their current residence at the time of

diagnosis regardless of citizenship status.

Border crossers* who are diagnosed with TB and plan to receive anti-TB

therapy from a locality in the United States for 90 days or more should be

reported and counted by the locality where they receive anti-TB therapy.

Foreign visitors (e.g., students, commercial representatives, and diplomatic

personnel) who are diagnosed with TB, are receiving anti-TB therapy, and have

been, or plan to remain in, the United States for 90 days or more should be

reported and counted by the locality of current residence.

*Border crosser — defined, by the U.S. Citizenship and Immigration Services

(USCIS)

as “an alien resident of the United States reentering the country after

an absence of less than six months in Canada or Mexico, or a nonresident alien

entering the United States across the Canadian border for stays of no more than

six months, or across the Mexican border for stays of no more than 72 hours.”

Border crossers may go back and forth across the border many times in a short

period.

209

DO NOT COUNT

Any person who was diagnosed and started on anti-TB drugs in another country

should not be counted as a new case but should be reported as a verified

noncountable TB case.

Border crossers* and foreign visitors who are diagnosed with TB and receive

anti-TB therapy from a locality in the United States for less than 90 days but

plan to return to their native country to continue therapy should not be reported

or counted by the locality where they receive anti-TB therapy.

e. Out-of-State or Out-of-Area Residents

COUNT

A person’s TB case should be counted by the locality in which he or she resides

at the time of diagnosis. TB in a person who has no address should be counted

by the locality that diagnosed and is treating the TB. The TB control officer

should notify the appropriate out-of-state or out-of-area TB control officer of

the person’s home locality to (1) determine whether the case has already been

counted to avoid “double counting,” and (2) agree on which TB control office

should count the case if it has not yet been counted.

DO NOT COUNT

Do not count a case in a newly diagnosed TB patient who is an out-of-area

resident and whose TB has already been counted by the out-of-area TB control

office.

f. Migrants and Other Transients

COUNT

Persons without any fixed U.S. residence are considered to be the public health

responsibility of their present locality and their TB case should be reported and

counted where diagnosed.

DO NOT COUNT

Cases in transient TB patients should not be counted when there is evidence that

they have already been counted by another locality.

g. Federal Facilities (e.g., Military and Veterans Administration Facilities)

COUNT

Cases in military personnel, dependents, or veterans should be reported and

counted by the locality where the persons are residing in the United States at the

time of diagnosis and initiation of treatment.

However, if military personnel or dependents are discovered to have TB at a

military base outside the United States but are referred elsewhere for treatment

(e.g., a military base located within the United States), the TB case should be

reported and counted where treated and not where the diagnosis was made.

210

DO NOT COUNT

Do not count if the case was already counted by another locality in the United

States.

h. Indian Health Service

COUNT

TB should be reported to the local health authority (e.g., state or county) and

counted where diagnosed and treatment initiated. However, for a specific group

such as the Navajo Nation, which is geographically located in multiple states,

health departments should discuss each case and determine which locality

should count the case.

DO NOT COUNT

Do not count if the case was already counted by another locality.

i. Correctional Facilities (e.g., Local, State, Federal, and Military)

COUNT

Persons who reside in local, state, federal, or military correctional facilities may

frequently be transferred or relocated within and/or between various

correctional facilities. TB in these persons should be reported to the local health

authority and counted by the locality where the diagnosis was made and

treatment plans were initiated.

DO NOT COUNT

Do not count correctional facility residents’ TB cases that were counted

elsewhere by another locality or correctional facility, even if treatment

continues at another locale or correctional facility.

j. Peace Corps, Missionaries, and Other Citizens Residing Outside the United

States

DO NOT COUNT

TB in persons diagnosed outside the United States should not be counted. TB in

these persons should be counted by the country in which they are residing,

regardless of their plans to return to the United States for further work-up or

treatment.

IV. Suggested Administrative Practices

To promote uniformity in TB case counting, the following administrative

procedures are recommended:

(a) All TB cases verified by the 52 reporting areas with count authority (50 states,

District of Columbia, and New York City) during the calendar year (by

December 31) will be included in the annual U.S. incidence count for that

year. All tuberculosis cases verified during the calendar year by a reporting

area with count authority from one of the remaining 8 reporting areas

(American Samoa, Federated States of Micronesia, Guam, Marshall Islands,

211

Northern Mariana Islands, Puerto Rico, Republic of Palau, and U.S. Virgin

Islands) are also counted but are not included in the annual incidence for the

United States. Cases for which bacteriologic results are pending or for which

confirmation of disease is questionable for any other reason should not be

counted until their status is clearly determined; they should be counted at the

time they meet the criteria for counting. This means that a case reported in one

calendar year could be included in the morbidity count for the following year.

The reporting area with count authority should ensure that there is agreement

between final local and state TB figures reported to CDC. Currently, some

reporting areas may not use this suggested protocol. Some of these areas may

wait until the beginning of the following year when they have received and

processed all of the TB cases for inclusion in the annual case count for the

previous year. If reporting areas decide to revise their protocols, they should

be aware that their TB trends may change.

(b) TB is occasionally reported to health departments over the telephone, by letter

or fax, or on forms other than the Report of Verified Case of Tuberculosis

(RVCT). Such information should be accepted as an official morbidity report

if sufficient details are provided; otherwise, the notification should be used as

an indicator of a possible TB case (suspect) which should be investigated

promptly for confirmation.

V. TB Surveillance Definitions

Case - an episode of TB disease in a person meeting the laboratory or clinical

criteria for TB as defined in the document “Tuberculosis Case Definition for

Public Health Surveillance” (see Section II for criteria).

Suspect - a person for whom there is a high index of suspicion for active TB

(e.g., a known contact to an active TB case or a person with signs or symptoms

consistent with TB) who is currently under evaluation for TB disease.

Verification of a TB case - the process whereby a TB case, after the diagnostic

evaluation is complete, is reviewed at the local level (e.g., state or county) by a

TB control official who is familiar with TB surveillance definitions; if all the

criteria for a TB case are met, the TB case is then verified and eligible for

counting.

Counting of a TB case - the process whereby a reporting area with count

authority evaluates verified TB cases against count criteria (e.g., assesses for

case duplication). These cases are then counted for morbidity in that locality

(e.g., state or county) and reported to CDC for national morbidity counting.

Noncountable, verified cases may also be sent to CDC.

Mycobacterium tuberculosis complex (M. tuberculosis complex) - Because

most laboratories use tests that do not routinely distinguish Mycobacterium

tuberculosis from very closely related species, these laboratories report culture

results as being positive or negative for “Mycobacterium tuberculosis complex.”

Although in almost all cases of human disease, isolates in the M. tuberculosis

complex are, in fact, M. tuberculosis, other species are possible. For example,

212

one study in San Diego found that 6% of human tuberculosis was caused by

Mycobacterium bovis; cultures from these cases would be reported by most

laboratories as being positive for M. tuberculosis complex. Other species in the

Mycobacterium tuberculosis complex include M. africanum, M. microti, M.

canetii, M. caprae, and M. pinnipedii. Although M. microti, M. canetii, M.

caprae, and M. pinnipedii are newly described species, their inclusion in M.

tuberculosis complex should not impact public health laboratories or programs

because only a few laboratories identify to the species level. These seven

species are almost identical in DNA homology studies. In terms of their ability

to cause clinical disease or be transmissible from person to person, M. bovis, M.

africanum, M. microti, M. canetti, M. caprae, and M. pinnipedii behave like M.

tuberculosis; therefore, disease caused by any of the organisms should be

reported as TB, using the Report of Verified Case of Tuberculosis (RVCT). The

only exception is the BCG strain of M. bovis, which may be isolated from

persons who have received the vaccine for protection against TB or as cancer

immunotherapy; disease caused by the BCG strain of M. bovis should not be

reported as TB.

Nontuberculous mycobacteria (NTM) - mycobacteria other than

Mycobacterium tuberculosis complex that can cause human infection or disease.

Common nontuberculous mycobacteria include M. avium complex or MAC (M.

avium, M. intracellulare), M. kansasii, M. marinum, M. scrofulaceum, M.

chelonae, M. fortuitum, and M. simiae. Other terms have been used to represent

NTM, including MOTT (mycobacteria other than TB) and “atypical”

mycobacteria.

Reporting area - areas responsible for counting and reporting verified TB cases

to CDC. Currently there are 60 reporting areas: the 50 states, District of

Columbia, New York City, American Samoa, Federated States of Micronesia,

Guam, Marshall Islands, Northern Mariana Islands, Puerto Rico, Republic of

Palau, and U.S. Virgin Islands. The annual incidence of tuberculosis for the

United States is based on 52 reporting areas (the 50 states, District of Columbia,

and New York City).

Alien - defined by the U.S. Citizenship and Immigration Services (USCIS)

“any person not a citizen or national of the United States.”

Border crosser - defined, by the U.S. Citizenship and Immigration Services

(USCIS)

as “an alien resident of the United States reentering the country after

an absence of less than six months in Canada or Mexico, or a nonresident alien

entering the United States across the Canadian border for stays of no more than

six months, or across the Mexican border for stays of no more than 72 hours.”

Border crossers may go back and forth across the border many times in a short

period.

Class A TB with waiver

All applicants who have tuberculosis disease and have been granted a waiver.

213

Class B1 TB, Pulmonary

No treatment

• Applicants who have medical history, physical exam, HIV, or CXR

findings suggestive of pulmonary TB but have negative AFB sputum

smears and cultures and are not diagnosed with TB or can wait to have

TB treatment started after immigration.

Completed treatment

• Applicants who were diagnosed with pulmonary TB 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 TB. Document the anatomic site of

infection.

Class B2 TB, Latent TB Infection (LTBI) Evaluation

Applicants who have a tuberculin skin test ≥10 mm but otherwise have a

negative evaluation for TB. The size of the TST reaction, 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, whether the applicant

converted the TST should be documented (i.e., initial TST <10 mm but

subsequent TST ≥10 mm).

Class B3 TB, Contact Evaluation

Applicants who are a recent contact of a known tuberculosis case. The size of

the applicant’s TST reaction should be documented. Information about the

source case, name, alien number, relationship to contact, and type of

tuberculosis should also be documented.

Immigrant - defined by the USCIS

as “an alien admitted to the United States

as a lawful permanent resident. Immigrants are those persons lawfully accorded

the privilege of residing permanently in the United States. They may be issued

immigrant visas by the Department of State overseas or adjusted to permanent

resident status by the USCIS of the United States.”

Permanent Resident Alien - see Immigrant.

214

Waivers

- A provision allows applicants undergoing pulmonary or laryngeal

tuberculosis treatment to petition for a Class A TB with waiver. Waivers should

be pursued for any immigrant or refugee who has a complicated clinical course

and would benefit from receiving treatment of their tuberculosis in the United

States. 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.

References

1. Recommendations for Counting Reported TB Cases. Atlanta: CDC, July

1997.

2. U.S. Department of Homeland Security, U.S. Citizenship and Immigration

Services; http://uscis.gov. Accessed March 2009.

3. 2007 Technical Instructions for Tuberculosis Screening and Treatment for

Panel Physicians. Atlanta: CDC, Division of Global Migration and

Quarantine. http://www.cdc.gov/ncidod/dq/panel_2007.htm. Accessed

March 2009.

215

Appendix C

Appendix CAppendix C

Appendix C

Anatomic Codes

Anatomic CodesAnatomic Codes

Anatomic Codes

Anatomic Code Anatomic Code

Dermal System

00 * Skin and skin appendages

01 * Subcutaneous Tissue

02 * Breast

03 Milk

Cardiovascular System

30 * Pericardium

31 * Heart

32 * Cardiac valve

33 Pericardial fluid

34 * Blood vessel

Hematopoietic System

04 * Bone marrow

05 * Spleen

06 * Blood

Lymphatic System

07 Lymph node

Musculoskeletal System

08 Bone, NOS (Not Otherwise Specified)

09 Skeletal system (Bones of head, ribcage,

and vertebral column)

10 Skeletal system (Bones of shoulder,

girdle, pelvis, and extremities)

11 Soft tissue, NOS (Not Otherwise

Specified)

12 Soft tissue (Muscles of head, neck,

mouth, and upper extremity)

13 Soft tissue (Muscles of trunk, perineum,

and lower extremity)

14 Tendon and tendon sheath

15 Ligament and fascia

16 Joints (Synovial tissue)

17 Synovial fluid

Respiratory System

18 * Nose

19 * Accessory Sinus

20 * Nasopharynx

21 * Epiglottis

22 * Trachea

23 Bronchus

24 Bronchiole

25 Lung

26 Pleura

27 Upper respiratory fluids or tracheal fluids

28 Bronchial fluid

29 Pleural fluid

Gastrointestinal System

35 * Mouth

36 * Lip

37 * Tongue

38 * Tooth, gum, and supporting structures

of the tooth

39 * Salivary gland

40 * Liver

41 * Gallbladder

42 * Extrahepatic bile duct

43 * Pancreas

44 Saliva

45 Bile and pancreatic fluid

46 * Pharynx, oropharynx, and hypopharynx

47 * Tonsils and adenoids

48 * Esophagus

49 * Stomach

50 * Small intestine - duodenum

51 * Small intestine - jejunum & ileum

52 * Appendix

53 * Colon

54 * Rectum

55 * Anus

56 Gastric aspirate

57 Gastrointestinal contents (feces)

58 Omentum and peritoneum

59 Peritoneal fluid

* Only codes marked with an asterisk (*) should be used when a Site of Disease (item 16) is Other.

216

Fetal Structures

80 * Placenta, umbilical cord, and

implantation site

81 * Fetus and embryo

Endocrine System

82 * Pituitary gland

83 * Adrenal gland

84 * Thyroid or parathyroid gland(s)

85 * Thymus

Neurological System

86 CSF (Cerebral spinal fluid)

87 Meninges, dural sinus, choroid plexus

88 * Brain

89 * Spinal cord

90 * Cranial, spinal, and peripheral nerve

91 * Eye and ear appendages

92 * Ear and mastoid cells

Urogenital System

60 Kidney

61 Renal pelvis

62 Ureter

63 Urinary bladder

64 Urethra

65 Penis

66 Prostate and seminal vesicle

67 Testis

68 Epididymis, vas deferens, spermatic

cord, and scrotum

69 Urine

70 Male genital fluids

71 Vulva, labia, clitoris, and Bartholin's

gland

72 Vagina

73 Uterus

74 Cervix

75 Endometrium

76 Myometrium

77 Fallopian tube, broad ligament,

parametrium, and parovarian region

78 Ovary

79 Female genital fluids

Other

93 Pus

94 * Other

95 Multiple Sites

99 Unknown

* Only codes marked with an asterisk (*) should be used when a Site of Disease (item 16) is Other.

217

Appendix D

Appendix DAppendix D

Appendix D

Reporting Area Codes

Reporting Area CodesReporting Area Codes

Reporting Area Codes

Name Alpha Code Name Alpha Code

Alabama AL 01 Nebraska NE 31

Alaska AK 02 Nevada NV 32

Arizona AZ 04 New Hampshire NH 33

Arkansas AR 05 New Jersey NJ 34

California CA 06 New Mexico NM 35

Colorado CO 08 New York NY 36

Connecticut CT 09 New York City NO 975772

Delaware DE 10 North Carolina NC 37

Florida FL 12 North Dakota ND 38

Georgia GA 13 Ohio OH 39

Hawaii HI 15 Oklahoma OK 40

Idaho ID 16 Oregon OR 41

Illinois IL 17 Pennsylvania PA 42

Indiana IN 18 Rhode Island RI 44

Iowa IA 19 South Carolina SC 45

Kansas KS 20 South Dakota SD 46

Kentucky KY 21 Tennessee TN 47

Louisiana LA 22 Texas TX 48

Maine ME 23 Utah UT 49

Maryland MD 24 Vermont VT 50

Massachusetts MA 25 Virginia VA 51

Michigan MI 26 Washington WA 53

Minnesota MN 27 Washington D.C. DC 11

Mississippi MS 28 West Virginia WV 54

Missouri MO 29 Wisconsin WI 55

Montana MT 30 Wyoming WY 56

U.S. Island Reporting Area Codes

For information on citizenship and “U.S.-born” for the U.S. Island Areas see Country of Birth (item 12)

Name Alpha

Code Name Alpha

Code

American Samoa AQ 60 Palau PS 70

Federated States of

Micronesia

FM 64 Puerto Rico PR 72

Guam GU 66 Republic of Marshall

Islands

RM 68

Northern Mariana

Islands

CQ 69 Virgin Islands VQ 78

218

219

Appendix E

Appendix EAppendix E

Appendix E

Country Codes

Country CodesCountry Codes

Country Codes

Country Alpha Code

Afghanistan AFG

Albania ALB

Algeria DZA

American Samoa ASM

Andorra AND

Angola AGO

Anguilla AIA

Antarctica ATA

Antigua and Barbuda ATG

Argentina ARG

Armenia ARM

Aruba ABW

Ashmore and Cartier Islands AT

Australia AUS

Austria AUT

Azerbaijan AZE

Bahamas, The BHS

Bahrain BHR

Baker Island FQ

Bangladesh BGD

Barbados BRB

Bassas Da India BS

Belarus BLR

Belgium BEL

Belize BLZ

Benin BEN

Bermuda BMU

Bhutan BTN

Bolivia BOL

Bosnia and Herzegovina BIH

Botswana BWA

Bouvet Island BVT

British Indian Ocean Territory IOT

Brazil BRA

British Virgin Islands VGB

Brunei BRN

Bulgaria BGR

Burkina (Upper Volta) BFA

Burma BUMM

Burundi BDI

Cambodia KHM

Cameroon CMR

Canada CAN

Cape Verde CPV

Cayman Islands CYM

220

Country Alpha Code

Central African Republic CAF

Chad TCD

Chile CHL

China CHN

Christmas Island CXR

Clipperton Island IP

Cocos (Keeling) Islands CCK

Colombia COL

Comoros COM

Congo COG

Cook Islands COK

Coral Sea Islands CR

Costa Rica CRI

Croatia HRV

Cuba CUB

Cyprus CYP

Czech Republic CZE

Czechoslovakia CSHH

Denmark DNK

Djibouti DJI

Dominica DMA

Dominican Republic DOM

Ecuador ECU

Egypt EGY

El Salvador SLV

Equatorial Guinea GNQ

Eritrea ERI

Estonia EST

Ethiopia ETH

Europa Island EU

Falkland Islands (Malvinas) FLK

Faroe Islands FRO

Federated States of Micronesia FSM

Fiji FJI

Finland FIN

French Southern and Antarctic Lands ATF

France FRA

French Guiana GUF

French Polynesia PYF

Gabon GAB

Gambia, The GMB

Gaza Strip GZ

Georgia GEO

Germany DEU

Ghana GHA

Gibraltar GIB

Glorioso Islands GO

Greece GRC

Greenland GRL

Grenada GRD

221

Country Alpha Code

Guadeloupe GLP

Guam GUM

Guatemala GTM

Guernsey GGY

Guinea GIN

Guinea-Bissau GNB

Guyana GUY

Haiti HTI

Heard Island and McDonald Islands HMD

Honduras HND

Hong Kong HKG

Howland Island HQ

Hungary HUN

Iceland ISL

India IND

Indonesia IDN

Iran IRN

Iraq IRQ

Iraq-Saudi Arabia Neutral Zone NTHH

Ireland IRL

Israel ISR

Italy ITA

Ivory Coast CIV

Jamaica JAM

Jan Mayen JN

Japan JPN

Jarvis Island DQ

Jersey JEY

Johnston Atoll JQ

Jordan JOR

Juan De Nova Island JU

Kazakhstan KAZ

Kenya KEN

Kingman Reef KQ

Kiribati KIR

Korea, Republic of KOR

Korea, Democratic People’s Republic PRK

Kuwait KWT

Kyrgyzstan KGZ

Laos LAO

Latvia LVA

Lebanon LBN

Lesotho LSO

Liberia LBR

Libya LBY

Liechtenstein LIE

Lithuania LTU

Luxembourg LUX

Macau MAC

Macedonia MKD

222

Country Alpha Code

Madagascar MDG

Malawi MWI

Malaysia MYS

Maldives MDV

Mali MLI

Malta MLT

Man, Isle of IMN

Marshall Islands MHL

Martinique MTQ

Mauritania MRT

Mauritius MUS

Mayotte MYT

Mexico MEX

Midway Island MIUM

Moldova MDA

Monaco MCO

Mongolia MNG

Montenegro MNE

Montserrat MSR

Morocco MAR

Mozambique MOZ

Myanmar MMR

Namibia NAM

Nauru NRU

Navassa Island BQ

Nepal NPL

Netherlands NLD

Netherlands Antilles ANT

New Caledonia NCL

New Zealand NZL

Nicaragua NIC

Niger NER

Nigeria NGA

Niue NIU

Norfolk Island NFK

Northern Mariana Islands MNP

Norway NOR

Not Specified NI

Oman OMN

Pakistan PAK

Palau PLW

Palmyra Atoll LQ

Panama PAN

Papua New Guinea PNG

Paracel Islands PF

Paraguay PRY

Peru PER

Philippines PHL

Pitcairn Islands PCN

Poland POL

223

Country Alpha Code

Portugal PRT

Portuguese Timor TPTL

Puerto Rico PRI

Qatar QAT

Reunion REU

Romania ROU

Russia RUS

Rwanda RWA

South Georgia/South Sandwich Islands SGS

San Marino SMR

Sao Tome and Principe STP

Saudi Arabia SAU

Senegal SEN

Serbia SRB

Seychelles SYC

Sierra Leone SLE

Singapore SGP

Slovak Republic SVK

Slovenia SVN

Solomon Islands SLB

Somalia SOM

South Africa ZAF

Soviet Union SUHH

Spain ESP

Spratly Islands PG

Sri Lanka LKA

St Lucia LCA

St. Helena SHN

St. Kitts and Nevis KNA

St. Pierre and Miquelon SPM

St. Vincent/Grenadines VCT

Sudan SDN

Suriname SUR

Svalbard SJM

Swaziland SWZ

Sweden SWE

Switzerland CHE

Syria SYR

Taiwan TWN

Tajikistan TJK

Tanzania, United Republic of TZA

Thailand THA

Timor-Leste TLS

Togo TGO

Tokelau TKL

Tonga, Kingdom of TON

Trinidad and Tobago TTO

Tromelin Island TE

Tunisia TUN

Turkey TUR

224

Country Alpha Code

Turkmenistan TKM

Turks and Caicos Islands TCA

Tuvalu TUV

U.S. Minor Outlying Islands UMI

Uganda UGA

Ukraine UKR

United Arab Emirates ARE

United Kingdom GBR

United States USA

Uruguay URY

U.S. Miscellaneous Pacific Islands PUUM

Uzbekistan UZB

Vanuatu (New Hebrides) VUT

Vatican City VAT

Venezuela VEN

Vietnam VNM

Virgin Islands VIR

Wake Island WKUM

Wallis and Futuna WLF

West Bank WE

Western Sahara ESH

Western Samoa WSM

Yemen YEM

Yugoslavia YUCS

Zaire ZRCD

Zambia ZMB

Zimbabwe ZWE

225

Appendix F

Appendix FAppendix F

Appendix F

Glossary

GlossaryGlossary

Glossary

Term Definition

Acid-fast bacilli (AFB)

Microorganisms that when stained, retain color even after they have been

washed in an acid solution; may be detected under a microscope in a stained

smear.

Active case finding

Looking for undiagnosed cases by screening a population.

Active TB disease

An illness, caused by bacteria called Mycobacterium tuberculosis, in which

tuberculosis (TB) bacteria are multiplying and attacking parts of the body,

most commonly the lungs. A person with active TB disease is capable of

spreading the disease to others if the TB bacteria are active in the lungs or

throat. The symptoms of active TB disease include weakness, weight loss,

fever, no appetite, chills, and sweating at night. Other symptoms may

include a bad cough, pain in the chest, and coughing up blood.

Adherence to treatment

Following the recommended course of treatment by taking all the

prescribed medications for the entire length of time necessary.

Adverse effect

Negative side effect resulting from the use of a drug (for example, hepatitis,

nausea, headache).

Bronchoscopy

A procedure used to obtain pulmonary secretions or lung tissue with an

instrument called a bronchoscope.

Case management

A system in which a specific health department employee is assigned

primary responsibility for the patient, systematic regular review of patient

progress is conducted, and plans are made to address any barriers to

adherence.

Case rate

The number of cases that occur during a certain time period, divided by the

size of the population during that time period; the case rate is often

expressed in terms of a population size of 100,000 persons.

Case reporting

Informing the state or local health department when a new case (an

occurrence) of TB disease has been diagnosed or is suspected.

Cavity

A hollow space within the lung, visible on a chest x-ray or CT scan.

Clinical evaluation

An evaluation done to find out whether a patient has symptoms of TB

disease or is responding to treatment; also done to check for adverse

reaction to TB medications.

Clinician

A physician, physician’s assistant, or nurse.

Congregate setting

A setting in which a group of usually unrelated persons reside in close

physical proximity. These settings may include hospitals, long-term care

facilities, assisted living facilities, correctional facilities, or homeless

shelters (see residential facilities).

226

Contact investigation

A procedure for interviewing a person who has TB disease to determine

who may have been exposed to TB. People who have been exposed to TB

are tested for latent TB infection (LTBI) and TB disease.

Contacts

People exposed to someone with infectious TB disease, generally including

family members, roommates or housemates, close friends, coworkers,

classmates, and others.

Country of birth

The country where a person was born.

Culture

To grow organisms on media (substances containing nutrients) so that they

or the product of this process can be identified.

Daily regimen

A treatment schedule in which the patient takes a dose of each prescribed

medication every day.

Diabetes mellitus

A disease in which the body's ability to use sugar is altered.

Diagnostic evaluation

An evaluation used to diagnose TB disease; includes a medical history, a

chest x-ray, the collection of specimens for bacteriologic examination, and

possibly a tuberculin skin test or an interferon-gamma release assay such as

the QuantiFERON

-TB Gold test.

Directly observed

therapy (DOT)

A designated person watches the TB patient swallow each dose of the

prescribed drugs.

Drug susceptibility test

A laboratory method for finding drug resistance in a microorganism.

Drug-resistant TB

TB caused by organisms that are able to grow in the presence of a particular

drug; TB that is resistant to at least one first-line antituberculosis drug.

End-stage renal disease

(ESRD)

A condition when chronic kidney failure has progressed to the point where

kidney function is less than 10% of normal; requires dialysis or

transplantation; also known as stage 5 chronic kidney disease. The most

common cause of ESRD in the United States is diabetes.

Ethambutol (EMB)

A drug used to treat TB disease; may cause vision problems. Ethambutol

should be used cautiously in children who are too young to be monitored for

changes in their vision.

Extrapulmonary TB

TB disease that occurs in places other than the lungs, such as the lymph

nodes, the pleura, the brain, the kidneys, or the bones; most types of

extrapulmonary TB are not infectious.

First-line TB drugs

The initial drugs used for treating TB disease. Include isoniazid (INH),

rifampin (RIF), pyrazinamide (PZA), and either ethambutol (EMB). or

streptomycin (SM).

Foreign-born persons

People born outside of the United States.

HIV

Human immunodeficiency virus, the virus that causes AIDS.

227

Immunosuppressive

therapy

Therapy that suppresses or weakens the immune system.

Interferon-gamma

(IFN-γ)

Protein that is normally produced by the body in response to infection.

Interferon-gamma

release assay (IGRA)

A type of blood test that measures a person’s immune reactivity to M.

tuberculosis by measuring release of IFN-γ. In the U.S., QuantiFERON

TB Gold, QuantiFERON

-TB Gold In-Tube, and T-SPOT

.TB are

currently available IGRAs.

Isolate

A sample from a specimen that was identified as a certain organism such as

M. tuberculosis complex.

Isoniazid (INH)

A drug that is used for treating LTBI and one of the drugs used to treat TB

disease; although relatively safe, it may cause hepatitis and other severe

adverse reaction in some patients.

Latent TB infection

(LTBI)

Refers to the condition when a person is infected with tubercle bacilli, but

TB disease has not developed. Persons with LTBI do not have TB disease

symptoms and they cannot spread TB germs to others. Persons with LTBI

usually have a positive result to the Mantoux tuberculin skin test or an

interferon-gamma release assay.

LTBI treatment

Medication that is given to people who have latent TB infection to prevent

them from developing TB disease.

Mantoux tuberculin skin

test (TST)

A method of testing for TB infection; a needle and syringe are used to inject

0.1 ml of 5 tuberculin units of liquid tuberculin between the layers of the

skin (intradermally), usually on the forearm; the reaction to this test, a

palpable swollen area (induration), is measured 48 to 72 hours after the

injection and is interpreted as positive or negative depending on the size of

the reaction and the patient’s risk factors for TB.

Miliary TB

Miliary TB is a serious type of tuberculosis infection. It is a histological or

radiologic finding, rather than a site of disease. It appears on radiograph as a

great number of small, well-defined nodules that look like millet seeds

scattered throughout the lungs, hence the name “miliary.”

Multidrug-resistant TB

(MDR TB)

Resistant to at least the drugs isoniazid and rifampin; MDR TB is more

difficult to treat than drug-susceptible TB.

Mycobacterium

tuberculosis

One of the organisms causing TB in humans, and sometimes called the

tubercle bacillus; belongs to a group of bacteria called mycobacteria.

Mycobacterium

tuberculosis complex

A group of closely related mycobacteria that can cause active TB (e.g., M.

tuberculosis, M. bovis, and M. africanum). Most TB in the United States is

caused by M. tuberculosis.

Nucleic acid

amplification (NAA)

A technique that amplifies (copies) DNA or RNA segments, in order to

directly identify microorganisms in sputum specimens.

228

Pulmonary TB

TB disease that occurs in the lungs, typically causing a cough and an

abnormal chest x-ray. Pulmonary TB is usually infectious if untreated. Most

TB cases reported in the United States are pulmonary TB.

Pyridoxine

Another name for vitamin B6; it is given to prevent peripheral neuropathy;

should always be given to pregnant and breastfeeding women on isoniazid.

QuantiFERON

-TB

Gold test (QFT-G)

A blood test used for diagnosing infection with M. tuberculosis. The QFT-G

measures a patient’s immune reactivity to M. tuberculosis by measuring the

response to TB proteins when they are mixed with a small amount of blood

(see IGRAs).

Recurrence

A patient who has either a

• Negative culture result while receiving anti-TB therapy, but at some

point after therapy is completed, either the culture result becomes

positive for M. tuberculosis or the patient has clinical or radiologic

deterioration that is consistent with TB disease.

• Negative smear and culture result (e.g., clinical case) at diagnosis

and while receiving anti-TB therapy, but at some point after therapy

is completed, either the patient has a culture result that is positive for

M. tuberculosis or has clinical or radiologic deterioration that is

consistent with TB disease.

Rifabutin

A drug used to treat TB disease; used as a substitute for rifampin (RIF) in

the treatment of all forms of TB.

Rifampin

A drug used to treat TB disease; also used for LTBI treatment. Rifampin

has several possible side effects (for example, hepatitis, turning body fluids

orange, and drug interactions).

Rifapentine

A drug used to treat TB disease; used once weekly with isoniazid during the

continuation phase with selected HIV-negative patients.

Second-line TB drugs

Drugs used to treat TB that is resistant to first-line TB drugs (for example,

capreomycin, kanamycin, ethionamide, cycloserine, ciprofloxacin,

amikacin).

Smear

A specimen that has been smeared onto a glass slide, stained, washed in an

acid solution, and then placed under the microscope for examination; used

to detect acid-fast bacilli in a specimen.

Specimen

A sample collected from a person for testing.

Sputum

Phlegm from deep in the lungs, collected in a sterile container for

processing and examination.

Susceptibility

An organism’s ability to be killed by a particular drug.

Suspect

A person for whom there is a high index of suspicion for active TB (e.g., a

known contact to an active TB case or to a person with signs or symptoms

consistent with TB) who is currently under evaluation for TB disease.

229

XDR TB

The occurrence of TB in persons whose M. tuberculosis isolates are

resistant to isoniazid and rifampin, plus resistant to any fluoroquinolone and

at least one of three injectable second-line drugs (i.e., amikacin, kanamycin,

or capreomycin).

230

231

Appendix

Appendix Appendix

Appendix G

Answer Key for the Exercises

Answer Key for the ExercisesAnswer Key for the Exercises

Answer Key for the Exercises

Module A – RVCT (page 1) Items 1-16

# Correct

Answer

Notes for Answers

1.1 E

1.2 B

1.3 A

For this item, the month and year always need to be entered. But if the exact

day is not known, enter 99.

It is important to read the instructions for entering the dates for each item because

they can vary from item to item. For some items enter “99” for the unknown

month or day, and “9999” for the unknown year. This may vary from what will be

entered into a computer software program.

• 03 99 2009 – for March, unknown day, in 2009

• 99 99 2009 – for unknown month and day in 2009

• 01 02 9999 – for January 2, in a year that is unknown

1.4 A

The Date Reported is the date that a health department first suspects that the

patient might have TB or first receives a report (verbal or written notification)

from a health care provider. In this instance, the Date Reported is January 6.

January 10 is the date that the county health department received laboratory results

confirming TB diagnosis. January 27 is the Date Submitted.

2.1 B

2.2 B

Date Submitted is June 30 because this was the date that the RVCT form is

submitted to the reporting area. June 1 is the date reported and July 10 is the

date counted.

3.1 A

3.2 B

3.3 A

3.4 B

4.1 A

Laverne receives a new diagnosis in Milwaukee, but is an out-of-area resident and

returns home for treatment. The reporting address should be her address in

Chicago.

4.2 B

Eduardo, a migrant worker, receives a new diagnosis, but is an out-of-area

resident. Because of his migrant status, the reporting address for Eduardo should

be the area in which he lives at the time of diagnosis, which is Watsonville. In

addition, he should also be counted in the area in which he lives at the time of

diagnosis (Watsonville), even if he returned to his permanent home in Sacramento

for treatment. For more information on determining the reporting address for

patients, see the Guidelines to Determine Reporting Address in the instructions for

Reporting Address for Case Counting (item 4). For more information about

how cases should be counted, see Count Status (item 5).

5.1 D

232

5.2 C

Because his recurrence of TB disease was within 12 months of completion of

therapy this recurrence is not considered a separate episode of TB. Initial

diagnosis does not factor into this decision. A 2009 RVCT would be completed

and in Count Status (item 5), Verified Case: Recurrent TB within 12 months

would be selected.

5.3 A

It is Yes, because his recurrence of TB disease is more than 12 months after

completion of therapy and is considered a new case of TB. A 2010 RVCT would

be completed and for Count Status (item 5) count as a TB case would be selected.

5.4 B

5.5 A

5.6 A

5.7 A

Raul’s case is counted as a new case of TB in Arizona because his recurrence of

TB is more than 12 months after completion of therapy.

5.8 C

Communication between TB control programs to ensure continuity of care and

submission of reports regarding a patient who is moving from one area to another

should be conducted as securely and efficiently as possible (e.g., telephone, e-mail,

secure fax, express courier).

5.9 A

5.10 A

5.11 C

5.12 B

5.13 B

A 2009 RVCT would be completed by Georgia listing John’s count status in Item

5 as a verified case counted by another area. The 2009 form is completed by

Georgia and the 2009 reporting address should reflect his 2009 Georgia address to

assess level of burden of a noncountable case. However, Georgia cannot count him

in its 2009 case count because he has been counted as a case in Tennessee within

12 months. John never completed therapy in Tennessee, so Georgia should assist

John in completing therapy, and communicate with Tennessee to provide details

for case close-out.

6.1 C

6.2 A

6.3 B

6.4 C

The Date Counted is the date that the responsible count authority verifies the case

as a new case of TB and includes it in the official TB case count.

6.5 B

7.1 C

David is not considered to have a Previous Diagnosis of TB Disease because in

January 2009 he had LTBI and not TB disease.

8.1 C

9.1 A

Health care workers are dependent on the answers that the patients provide,

regardless of how the health care worker thinks the items should be answered.

However, asking the patient probing questions and reviewing the patient’s medical

records and other documentation can provide the most accurate answers for

biological sex at birth.

10.1 A

11.1 E

Joaquin says his mother is American Indian and his father is African American, so

the answer is E because both A and C are correct.

233

11.2 B

Trang is Filipino and Vietnamese, which are both considered Asian race. Even

though the Philippines are islands in the Pacific, Filipinos are considered an Asian

race.

12.1 A

When a patient was born abroad to a parent who is a U.S. citizen, the patient is

considered “U.S.-born.”

12.2 B

Because Wolfgang was actually born in Germany, the correct answer is Germany.

12.3 A

Bernard is considered “U.S.-born” because he was born in 1 of the 50 states or the

District of Columbia. Even though both of his parents were born in a foreign

country, he is still considered “U.S.-born.”

12.4 A

Bernard was born in the United States, so the answer would be United States.

12.5 B

Mayleen is not considered “U.S.-born” because she was not born in 1 of the 50

states or the District of Columbia and neither of her parents were U.S. citizens.

Mayleen is a U.S. citizen but not U.S.-born. Her parents are citizens of Palau.

However, if they had been born in Guam they would be considered U.S. citizens

and Mayleen would be considered “U.S.-born.”

12.6 B

Mayleen was born in Guam, so the answer would be Guam.

12.7 B

Jiguna was born abroad to parents who were not U.S. citizens. Therefore he is not

considered “U.S.-born.”

12.8 B

Because Jiguna was born in Kenya, the correct answer is Kenya.

13.1 A

When a patient is born abroad, the date arrived in the U.S. should be when the

patient entered the U.S. for the first time.

13.2 B

The answer is B. For patients born in another country, enter month and year first

arrived in the U.S. Ken was born in the Republic of the Marshall Islands and

moved to Arkansas. Even though his mother is a U.S. citizen and Ken is

“U.S.-born,” the item is asking when the patient first arrived in the U.S.

14.1 A

Although Pim’s parents are divorced, in this case it is probably best to enter her

mother’s and father’s countries of birth. The guardians are usually the parents.

There are only 2 lines, so it is not possible to indicate 3 people. In another

situation, it might be better to list the stepfather; it just depends on the situation. It

is important to identify not only the guardian who has the most contact with

the child, but also the guardian who may have a possible risk of TB exposure.

In this case, Pim’s father would be a higher priority than the stepfather because he

still has regular and frequent contact with her, and he also has a risk factor because

he immigrated from Thailand. If the biological father was not at risk of TB and

everything else was equal with the stepfather, then the stepfather would probably

be listed as the guardian. It just depends on how the state TB program views

guardianship and factors that put the patient at greatest risk for TB.

14.2 B

14.3 A

Antonio is “U.S.-born” because his father was born in the United States and is a

U.S. citizen.

14.4 A

The answer is El Salvador because Antonio was actually born in El Salvador.

234

14.5 B

The answer might depend on how the state TB program views guardianship.

Antonio’s legal guardians are his uncle and aunt, the Trujillos, both born in El

Salvador. His birth parents’ birth countries are El Salvador (mother) and the

United States (father). Following are 3 options for how this item could be

answered (depending on the state rules regarding parental care):

• If the TB program decided that Antonio still has contact with his father,

the relevant primary guardians might be from El Salvador (Trujillos) and

the United States (father).

• If the TB program decided that Antonio is primarily cared for by the

Trujillos, the relevant primary guardians might be from El Salvador

(Trujillos).

• If the TB program routinely captures data on the country of birth of the

pediatric patients’ mother and father, the relevant answer might be El

Salvador (mother) and United States (father).

14.6 A

Since Antonio was out of the United States for an uninterrupted period of more

than 2 months, select Yes.

14.7 B

Answer No because Regina was out of the United States for an uninterrupted

period less than 2 months. .

14.8 A

Answer Yes because Lisa was out of the United States for more than 2 months

uninterrupted.

15.1 A

15.2 B

Ruth’s status is dead at diagnosis. Even though she clearly had TB when she came

to the emergency room, TB was not suspected until after her death when the

autopsy was performed.

15.3 A

Yes, TB was a cause of death. Regardless of whether pneumonia was

misdiagnosed or was the immediate cause of death, TB was an underlying cause

of death based on the autopsy. Ruth has a verified case of TB based on positive

pathology results on lung tissue, which would be recorded in

Smear/Pathology/Cytology of Tissue and Other Body Fluids (item 19).

16.1 E

TB disease is found in the pulmonary, pleural, and lymphatic intrathoracic sites, so

all three sites should be selected. This item is usually completed by an MD

consultant.

16.2 E

Bone and/or joint is not correct. TB disease is found in both the blood and bone

marrow. Choose “Other: enter anatomic code(s).” The anatomic codes are listed in

Appendix C

– Anatomic Codes.

235

Module B – RVCT (page 2) Items 15-25

# Correct

Answer

Notes for Answers

17.1 A

Select positive if any of the results are positive.

17.2 A

January 13 is the date collected because that was the date when the first positive

sputum was collected.

18.1 A

18.2 B

18.3 B

January 16 was date that the first positive culture specimen was collected.

February 16 is the date that the first positive culture was reported.

18.4 B

Forbes Diagnostics Incorporated is a commercial laboratory because fees are

charged for each specimen processed or test performed.

18.5 C

National Jewish Health hospital laboratory is not considered a public health

laboratory or a commercial laboratory. This laboratory sometimes charges for

services, but for the purposes of the RVCT it is categorized as “Other.”

19.1 B

19.2 B

19.3 A

19.4 A

19.5 B

Any positive result supersedes a negative result in reporting TB diagnostic

criteria. Since the results are discrepant (smear negative, pathology positive),

Type of Exam should correspond to the result captured as positive. If both smear

and pathology are positive, both smear and pathology/cytology should be checked

under Type of Exam.

20.1 A

20.2 C

The date collected is the date for the specimen that came back positive. The initial

specimen collected on October 13 is contaminated. The second specimen

collected on October 25 has a positive result, so that is the date used for date

collected.

20.3 C

20.4 A

Public health laboratory was selected because the specimen was sent to the state

health laboratory.

21.1 E

The result was reported as indeterminate. Although the test was done, it was

inconclusive rather than positive or negative.

22.A 1 C

Emily’s result is C – Abnormal because her radiograph shows tiny, well-defined

nodules, indicating evidence of miliary TB.

22.A 2 A

Alice’s result is A – Normal because her chest radiograph shows no evidence of

22.A 3 E

Lawrence’s result is E – Unknown because he remembers getting a chest

radiograph but the result is not known.

22.A 4 B

Roy’s result is B – Abnormal with evidence of cavitary lesion because he has

an abnormal chest radiograph with a cavitary lesion.

22.A 5 D

Frank’s result is D – Not Done because the radiograph was not done.

236

22.B 1 E

Site of Disease (item 16) does not include miliary TB. On the old RVCT, miliary

TB could be selected as a Site of Disease. However, in this version of the RVCT,

items 22A and 22B are the only items that indicate military TB. Since miliary TB

appeared in both the initial chest radiograph and the CT scan, the answer is “E.”

23.1 A

23.2 A

The documented TST was May 1995.

23.3 B

24.1 A

24.2 D

25.1 E

Health care worker is the answer because that reason supersedes

Employment/Administrative testing.

25.2 H

25.3 C

25.4 B

25.5 A

25.6 G

25.7 D

25.8 F

25.9 B

25.10 C

237

Module C – RVCT (page 3) Items 26-37

# Correct

Answer

Notes for Answers

26.1 A

27.1 B

Yes, because he was homeless at some time during the past year.

28.1 C

Local jail is the answer because he was at Lanner County Jail when the diagnostic

evaluation was performed, even though the result did not come back until he was in

the ICE Detention Center.

29.1 A

At the time of diagnosis, Gladys is living at home, not at the nursing facility. She

may have acquired TB while she lived at the nursing home, but that is not where she

was diagnosed. In addition, Gladys was not evaluated for TB when she was at the

nursing facility.

30.1 E

30.2 G

30.3 H

30.4 C

30.5 A

30.6 D

30.7 B

30.8 F

30.9 A

31.1 B

Even though Chaz denies that he injects drugs, his record shows that he was in an

injecting drug detoxification program within the past year.

32.1 A

According to Spider, he used non-injecting drugs in the past, but not within the past

12 months. You have to take his word for this because there is no proof that he did

use drugs within the past 12 months, and you do not suspect or see any evidence of

drug use.

33.1 B

Based on your observations of Jack Daniel, you have seen evidence that he has used

alcohol excessively during the past 12 months. In addition, he was in an alcohol

treatment program within the past year.

34.1 E

34.2 A

34.3 F

34.4 I

34.5 D

34.6 B

34.7 G

34.8 C

35.1 E

35.2 H

35.3 C

35.4 D

35.5 B

35.6 G

238

35.7 A

35.8 F

35.9 J

35.10

36.1 B

The documented date that the patient first ingests the drugs is the date that is

preferred. But, in this case study, Thelma was not sure about the date she started

taking the drugs, so the next documented date would be the date that the pharmacy

dispensed the drug, which in this case was February 15.

37.1 B

37.2 B

37.3 B

37.4 B

37.5 A

37.6 A

239

Module D – Initial Drug Susceptibility Report (Follow Up Report – 1) Items 38–40

# Correct

Answer

Notes for Answers

38.1 A

There are 12 spaces for genotyping accession number. Instructions are to complete

the number beginning at the left-most box. Do not add zeros to finish filling the

boxes. This genotyping accession number is from the California laboratory because

it has the 2-digit year (09) followed by L, then 4 digits. If the genotyping accession

number is from the CDC laboratory, it will have a hyphen after the 2-digit year; this

hyphen should also be entered into a box as part of the genotyping accession

number. If the genotyping accession number is from the Michigan laboratory, it will

have RF after the 2-digit year.

The last three columns above are the spoligotype, MIRU, and PCR type,

respectively. The second column is not a genotyping accession number because it

does not fit the numbering format of any of the three reference laboratories. RVCT

users should be aware that there may be additional local, state, submitter, cluster, or

other identification numbers listed on a genotyping report. RVCT users should be

able to identify the genotyping accession number by becoming familiar with the

format used by the NTGS laboratory serving their reporting area.

39.1 A

39.2 B

Item 39 refers to the first culture positive specimen on which drug susceptibility

testing was performed , regardless of which site it was taken from (e.g., it does not

have to be the major site of disease). Because the urine culture grew before the sputum

cultures, drug susceptibility testing was performed on the urine specimen. Therefore

the urine is the first specimen on which drug susceptibility testing was performed.

That is why July 3 is the answer for 39.1, and the specimen type is urine for 39.2. If

the July 5 sputum culture had grown first, drug susceptibility testing would have been

performed on that specimen; July 5 would have been the answer for 39.1, and sputum

would have been the answer for 39.2. Even though the major site of disease may be

pulmonary, this question is asking for the first specimen on which drug susceptibility

testing was performed.

40.1 A

Isoniazid: Any resistance is resistance, even if it is low.

40.2 B

40.3 B

40.4 A

40.5 C

40.6 A

40.7 C

40.8 D

Ethionamide: It is not known if the test was done, so Unknown should be selected.

Some laboratories report no resistance, which means susceptible.

40.9 B

40.10 C

240

Module E – Case Completion Report (Follow Up Report – 2) Items 41–49

# Correct

Answer

Notes for Answers

41.1 D

41.2 B

41.3 C

41.4 F

41.5 A

41.6 E

42.1 B

Moved is defined as a relocation of a patient’s residence, resulting in a change in

local health department jurisdiction. Therefore Johann moved in state, but out of

jurisdiction.

43.1 B

44.1 C

This question is asking what is the reason that therapy was stopped, not what is

the cause of death. The autopsy indicated that his death was likely due to an

adverse treatment event to INH. However, the reason that therapy was stopped was

that Hannibal died, and then it was determined the cause of death was related to TB

therapy.

If his therapy had been stopped before he died, the answer would still be the same

because he died. You would answer adverse treatment event for therapy stopped

only for a patient who had not died and his/her treatment was permanently stopped.

45.1 D

45.2 E

45.3 C

45.4 A

45.5 B

46.1 D

46.2 F

46.3 E

46.4 C

46.5 A

46.6 B

47.1 B

241

47.2 B

There always need to be 3 numbers entered into the boxes provided. In this case

there needs to be a leading 0 in the first box as opposed to entering “2” in the left-

most box. If the number of weeks of DOT is a single digit such as 8 weeks, this

would be entered as 008. If the patient has 2 full years of DOT, this would be

entered as 104 weeks.

Count the following weeks of DOT for Maximo:

• 8 weeks of daily 4-drug regimen

• 18 weeks of 2-drug regimen

This equals a total of 26 weeks of DOT.

Do not count the following doses of DOT for Maximo:

• The missed doses on August 25 and 27 when no drugs were given. (The

missed doses in August were “made up” on December 8 and 10 by adding

an extra week of therapy.)

• The week when only 1 dose of a twice-weekly regimen was given on

October 6 and missed on October 8. (The missed dose on October 8

was

“made up” on December 15. October 6 and December 15 contribute 0.5 of a

twice-weekly regimen each, adding up to 1 week.)

• The week when only 1 dose of a twice-weekly regimen was given on

November 24 and missed on November 26. (The missed dose on November

26 was “made up” on December 17. November 24 and December 17

contribute 0.5 of a twice-weekly regimen each, adding up to 1 week.)

47.3 B

Item 43: Date Therapy Stopped is December 17, 2009 (12/17/2009).

47.4 A

Item 44: Reason Therapy Stopped or Never Started is completed therapy.

47.5 B

Item 45: Reason Therapy Extended > 12 Months is not applicable, leave

blank.

47.6 A

Item 46: Type of Outpatient Health Care Provider is Local/state health

department.

47.7 A

Item 47: Directly Observed Therapy (DOT) is Yes, both directly observed and

self-administered.

47.8 B

Item 47: Directly Observed Therapy (DOT) Use the above calendar to count the

number of weeks of DOT. The total number of DOT weeks from initiation of

therapy to completion is entered as 025. There were 8 weeks of 4-drug regimen and

17 weeks of 2-drug regimen. Do not count the last week of August, when no DOT

doses were given. Then begin counting 7-day periods on September 7. The dose

on October 10 (whether missed or self-administered) is skipped, and October 5 and

12 administration forms a DOT week (2 doses appropriately given). Begin

counting whole weeks again the week of October 16. The December 12 dose

counts as 0.5 dose, but there is no dose to match it with, so it does not form a DOT

week.

48.1 C

49.1 B

49.2 A

49.3 B

49.4 B

49.5 B

49.6 B

49.7 C

242

49.8 C

49.9 B

49.10

49.11

49.12

49.13

49.14

49.15

49.16

49.17

49.18

49.19

All items have to be checked as either resistant, susceptible, not done, or unknown.

You can’t leave any of them blank unless the item is pending.

49.20

All items have to be checked as either resistant, susceptible, not done, or unknown.

You can’t leave any of them blank unless the item is pending.

243

244

For more information, contact

U.S. Department of Health and Human Services

Centers for Disease Control and Prevention

National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention

Division of Tuberculosis Elimination

1600 Clifton Road N.E.

MS E-10

Atlanta, GA 30333

Phone (404) 639-8120

Fax: (404) 639-8959