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pdfCDC Tuberculosis Surveillance Data Training
Mycobacterium tuberculosis
Report of Verified Case
of Tuberculosis (RVCT)
Instruction Manual
This manual includes the instructions for how to complete each item on the RVCT. It
can be used as a reference guide when completing the RVCT. The exercises from the
RVCT Self-Study Modules that are used to practice completing the RVCT are not
included in this manual.
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
1
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 Health
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
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RVCT Revision Work Group
Members, 2001-2007
Janice Boutotte, PhD, RN
N. Alex Bowler, MPH, FACHE
James Cobb
Theresa Crisp, MPH
Mayleen Jack Ekiek, MD
Kimberly Field, RN, PHN, MSN
Michael E Fleenor, MD, MPH
Lorena Jeske, RN, MN
Stephen E. Hughes, PhD
Scott Jones
Yvonne Luster-Harvey, MPH
Debbie Merz, MS
Masahiro Narita, MD
Mary Naughton, MD, MPH
Lynelle Phillips, RN, MPH
Shameer Poonja, MPH
Carol Pozsik, RN, MPH
Randall Reves, MD, MSc
Maria G. Rodriguez
Diana Schneider, DrPH, MA
Barbara Seaworth, MD
Sharon Sharnprapai, MS
Muriel Silin, MPH
Wendy Mills Sutherland, MPH
Jacinthe Thomas, MPH
Janice Westenhouse, MPH
RVCT
Reviewers
Cecilia Teresa T. Arciaga
Sherri Austin
Angelito Bravo, MD
Gayle L. Canfield, RN
Smita G. Chatterjee, MS
Christine A. Feaster, M(ASCP)CM, M(NRM)
Kitty B. Herrin, MA, PHD
Pat F. Infield, RN
Harvey L. Marx, Jr.
Sandra A. Morris, MPH
Kathleen Moser, MD, MPH
Ellen Murray, RN, BSN
Rebbie M. Ortega
Lillian T. Pirog, RN, BS, PNP
Vicki Randle, MPH, RN
Paul Regan, PHA
Kristina Schaller
Gladys Simon
Barbara Simpkins
Mary K. Sisk, RN, CIC
Sarah Macinski Sperry, MS
Richard A. Stevens, DrPH, MPH, MSHSA, MS
Barbara L. Stone, MSPH
Jason Stout, MD
Sharon J. Thompson, RN
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.
3
Contents
Highlighted items = more complicated
Introduction
Page
Background
Overview of the RVCT Form
What Is New in the RVCT
8
10
15
Overview of the RVCT Instructions
RVCT Training Materials
16
17
* Status of Item
New
Revised
RVCT (page 1)
20
1 – Date Reported
2 – Date Submitted
3 – Case Numbers
R
R
R
4 – Reporting Address for Case Counting
5 – Count Status
6 – Date Counted
7 – Previous Diagnosis of TB Disease
8 – Date of Birth
9 – Sex at Birth
21
24
25
NC
N
R
NC
NC
NC
10 – Ethnicity
11 – Race
12 – Country of Birth
13 – Month-Year Arrived in U.S.
14 – Pediatric TB Patients (<15 years old)
15 – Status at TB Diagnosis
Page
No Change
NC
NC
R
43
44
46
49
50
52
R
54
R
NC
N
16 – Site of TB Disease
30
35
38
39
41
42
RVCT (page 2)
56
17 – Sputum Smear
18 – Sputum Culture
R
R
57
59
19 – Smear/Pathology/Cytology of Tissue and Other Body Fluids
20 – Culture of Tissue and Other Body Fluids
21 – Nucleic Acid Amplification Test Result
22A – Initial Chest Radiograph
22B – Initial Chest CT Scan or Other Chest Imaging Study
23 – Tuberculin (Mantoux) Skin Test at Diagnosis
R
R
61
64
67
70
72
74
N
R
N
R
24 – Interferon Gamma Release Assay for Mycobacterium
tuberculosis at Diagnosis
N
77
25 – Primary Reason Evaluated for TB Disease
N
79
* Status of item refers to whether the items in the revised 2009 RVCT form are new, revised, or have no change.
4
Status of Item
New
Revised
Page
No Change
RVCT (page 3)
82
26 – HIV Status at Time of Diagnosis
27 – Homeless Within Past Year
28 – Resident of Correctional Facility at Time of Diagnosis
29 – Resident of Long-Term Care Facility at Time of Diagnosis
30 – Primary Occupation Within Past Year
31 – Injecting Drug Use Within Past Year
32 – Non-Injecting Drug Use Within Past Year
33 – Excess Alcohol Use Within Past Year
34 – Additional TB Risk Factors
35 – Immigration Status at First Entry to the U.S.
R
NC
R
NC
R
NC
NC
NC
N
N
36 – Date Therapy Started
37 – Initial Drug Regimen
NC
R
Initial Drug Susceptibility Report
Follow Up Report–
Report–1
38 – Genotyping Accession Number
39 – Initial Drug Susceptibility Testing
40 – Initial Drug Susceptibility Results
89
92
94
95
97
98
101
104
105
106
N
107
109
111
R
R
Case Completion Report
Follow Up Report–
Report–2
114
41 – Sputum Culture Conversion Documented
R
42 – Moved
43 – Date Therapy Stopped
44 – Reason Therapy Stopped or Never Started
45 – Reason Therapy Extended > 12 Months
46 – Type of Outpatient Health Care Provider
47 – Directly Observed Therapy (DOT)
48 – Final Drug Susceptibility Testing
83
85
87
116
N
R
R
R
118
122
124
127
128
130
132
R
134
NC
R
N
49 – Final Drug Susceptibility Results
Appendices
136
Appendix A – Tuberculosis Case Definition for Public Health Surveillance
Appendix B – Recommendations for Reporting and Counting Tuberculosis Cases
137
138
Appendix C – Anatomic Codes
Appendix D – Reporting Area Codes
Appendix E – Country Codes
Appendix F – Glossary
148
150
151
157
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.
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Introduction
This section provides an introduction to the Report of Verified Case of Tuberculosis and an overview of
the form, the instructions, as well as information on continuing education, and additional materials.
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Introduction Contents
Section
Page
Introduction
Background
Tuberculosis Surveillance Data
Impact of RVCT Data
Quality Assurance
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
RVCT Training Materials
RVCT Self-Study Modules
Continuing Education
How to View or Order Materials
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8
8
8
8
9
10
10
11
13
13
13
13
14
14
14
15
15
16
16
17
17
18
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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.
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Impact of Revised RVCT Data
Benefits of 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)
Consequences of Inaccurate,
Incomplete, or Unknown RVCT Data
• 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.
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Overview of the RVCT 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
The RVCT must be
completed for all
verified cases of TB
that are to be included
in the reporting area’s
annual morbidity
count.
Additional Recommended Uses
of the RVCT
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
Possible Use of the RVCT for
a Suspected Case of TB
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 to
patients with latent TB infection (LTBI).
10
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.
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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
Page 2
Page 3
(Items 1 – 16)
(Items 17 – 25)
(Items 26 – 37)
Initial Drug Susceptibility Report
(Follow Up Report - 1)
•
•
•
•
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
Page 1
(Items 38 – 40)
Case Completion Report
(Follow Up Report - 2)
•
•
•
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 41 – 46)
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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.
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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.
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What Is New in the RVCT
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.
15
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
Recurrence is considered the same episode (count
only 1 episode as a case for that year; within a 12month period, not calendar year).
TB Disease Recurs
More Than 12 Months
After the Patient Completed Therapy
Recurrence is considered a separate episode.
Do 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 Instructions
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 Instruction Manual (this 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 RVCT Instruction Manual from the internet, see the section below on “Additional RVCT
Materials.”
•
The Report of Verified Case of Tuberculosis Self-Study 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. For more
information, see the section below on “Additional RVCT Materials.”
16
RVCT Training Materials
To help health care staff learn how to accurately complete the RVCT the following training materials
have been developed:
• RVCT Self-Study Modules Participant Manual
• RVCT Self-Study Modules Facilitator Manual
• RVCT Instruction Manual (this manual, it includes instructions only)
• RVCT Self-Study Modules Exercises (exercises only)
• RVCT Materials Description
• RVCT Materials CD ROM
RVCT Self-Study Modules
The Report of Verified Case of Tuberculosis Self-Study Modules are described below.
•
RVCT Self-Study Modules
The modules consist of the following components:
o Instructions for how to complete each item on the RVCT (the same instructions as are in
this manual)
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.
The modules can be used in the following ways:
1. For individuals to learn in a 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 the modules as a reference
2. As part of a 2-day 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 the RVCT
training course to others.
17
Continuing Education
Continuing education units are available free of charge for the RVCT Self-Study Modules. For more
information, see the Introduction section in the modules or visit the CDC web site, www.cdc.gov/tb.
How to View or Order RVCT Materials
The chart on the next page describes the RVCT 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.
18
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
Materials
RVCT Self-Study
Modules
Participant Manual
(with CD ROM)
RVCT Self-Study
Modules
Facilitator Manual
(with CD ROM)
RVCT Instruction
Manual
RVCT Self-Study
Modules Exercises
RVCT Materials
Description
RVCT Materials Order
Form
RVCT Materials
CD ROM
File Formats Available
On
On
FTP site and CDC/DTBE
CD ROM
web site
Description
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.
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
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.)
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.
Description of the RVCT materials
PDF
PDF of manual.
Various formats
for other
training
documents
PDF
PDF
Microsoft Word
For those who want to order the CD ROM only. Includes the electronic files of
the following documents:
• RVCT Participant Manual
• RVCT Self-Study Module
Exercises
• RVCT Facilitator Manual and
• RVCT Materials Description
training materials
• RVCT Instruction Manual
• RVCT Materials Order Form
Various formats
E-mail or Fax RVCT Materials
Order Form (see form for
instructions)
E-mail or Fax RVCT Materials
Order Form (see form for
instructions)
PDF
Microsoft Word
Form used to order the RVCT materials from CDC.
19
PDF
How to Order
(Available only on the FTP site or
CD ROM)
HTML
E-mail or Fax RVCT Materials
Order Form (see form for
instructions)
E-mail or Fax RVCT Materials
Order Form (see form for
instructions)
RVCT
(page 1 of 3)
Items 1 – 16
The RVCT report includes the first three pages of the RVCT data collection form. Complete this report
for all patients with a verified case of TB disease. Page 1 of the RVCT report provides instructions for
completing items 1 – 16. This first page of the report includes data about patient demographics and site of
disease.
20
1.
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.
Month, day, and year
(e.g., 01/17/2009)
Description
Date that a health department (e.g.,
local, county, state) first suspected
that the patient may have TB.
or
Date the health department received
notification (verbal or written) from
a health care provider that a patient
was suspected of having TB.
Comment
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.
21
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
Date Reported
(Item(it1)1), Date Submitted (item 2), and Date
Counted (item 6). The following information describes the differences in these three items.
• Date the health department (local, county, or state) first suspected that a patient has TB
or
•
Summary of Events for
Item 1. Date Reported, Item 2. Date Submitted, and Item 6. Date Counted
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 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.
Date Counted (Item 6)
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)
22
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.
23
2.
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.
Month, day, and year
(e.g., 01/17/2009)
Description
Comment
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.
24
3.
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.
25
Assigning case numbers
Both the State Case Number and the City/County Case Number have 15 alphanumeric characters.
Year Reported (YYYY)
2
•
•
0
1
0
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
G
A
Locally Assigned Identification
Number
0 0 0 1 2 3
4
5
6
State Code indicates the 2letter 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.
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.
26
Rationale for Linking RVCT Forms
Reason Code
Reason for Linking Case
1
Recurrence
or
Previous diagnosis of TB
2
Epidemiologically linked case, source case, or contact with another case
3
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
o TB disease was verified in the past
or
o The patient completed therapy (even if the case-to-case interval is within 12 months)*
or
o 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 of
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.
27
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.
28
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.
Do 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)
Complete 2 RVCT Forms
(Both TB episodes are 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.
1) For the initial countable TB episode:
a.) 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 so
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.
2) For the second countable TB episode:
a.) Enter a new RVCT State Case Number (item
3), different from the State Case Number on
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 so
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.
29
4.
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
No
Patient does not live within the city limits
30
Guidelines to Determine Reporting Address
Specific Populations
Specific Locations
(these groups supersede Specific Locations,
but not Other People Entering the United States)
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
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
Count in the morbidity count for that
Receives a new TB
diagnosis in the community area
that he/she considers home
Enter city, county,
and ZIP Code of
residence
Receives a new TB
diagnosis, but is an out-ofarea 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-ofarea 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
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.
Enter city, county,
and ZIP Code of
his/her home area
Communication between health
departments may be necessary to decide
which jurisdiction will count the case.
31
Other People Entering the United States
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
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).
32
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 followup 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)
33
Comments: Definitions for Homeless
There are many definitions for homeless (National Coalition for the Homeless). A homeless
person may be an individual who has
1. No fixed, regular, and adequate nighttime residence
and
2. A primary nighttime residence that is
a. 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
or
b. An institution that provides a temporary residence for individuals intended to be
institutionalized
or
c. A public or private place not designated for, or ordinarily used as, a regular sleeping
accommodation for human beings.
A 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.
A 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.
34
5.
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
Count as a TB case
Description
Officially counted as a TB case, by the jurisdiction with count authority
(usually state health department).
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).
35
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)
Counted by another
area (e.g., county,
state, or counting
authority)
Description
TB case counted by another U.S. area
such as a state or other counting
authority (e.g., transfer in)
Comment
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.
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)
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.
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.
36
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
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).
TB Disease Recurs
More Than 12 Months
After the Patient Completed Therapy
Recurrence is considered a separate TB episode.
Do 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.
37
6.
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
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
Comment
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.
38
7.
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)
Yes
No
Description
Comment
Patient has received a previous
diagnosis of TB disease.
Do not enter a previous diagnosis of latent
TB infection (LTBI).
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
or
• The patient completed therapy for TB disease (even if the case-to-case interval is within 12
months)
or
• 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.
39
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.
1st Priority
Written Documentation
If written documentation is
not available use the 2nd
priority
2nd Priority
Oral Report
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.
Oral Report
When 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).
40
8.
Date of Birth
Primary Purpose: Surveillance. Data are used to document patient demographic information.
Description
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).
Comment
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.
41
9.
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.
42
10.
Ethnicity
Primary Purpose: Surveillance. Data are used to detect high-risk groups for TB by ethnicity.
Option
(select one)
Description
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.
Not Hispanic or
Latino
Patient does not consider himself or
herself Hispanic or Latino.
Comment
Some patients prefer the term
“Spanish origin” to 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.”
43
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 or 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.
44
National Electronic Disease Surveillance System (NEDSS)
Person Race Categories for Asian and for
Native Hawaiian or Other Pacific Islander*
Asian
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
Native Hawaiian or
Other Pacific Islander
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)
45
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)
Yes
No
Description
Comment
If the person was born
• In 1 of the 50 U.S. states or
the District of Columbia,
or
• 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.
If the person was born
• Abroad
and
• Neither parent was a U.S.
citizen.
Select for any country other than the United
States.
Not all U.S. citizens (e.g., naturalized citizens) are
“U.S.-born.”
46
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
U.S.-born
Yes
Yes
Patient
Description
No
Born in 1 of the 50 states or the District of
Columbia
Father
U.S. citizen
Mother
U.S. citizen
Yes
Yes
Yes
Yes
No
Yes
Born in 1 of the 50 states or the District of
Columbia
Yes
Born in another country
Yes
Yes
Born in another country
Yes
Yes
Born in another country
No
Born in another country
No
No
No
No
No
Yes
No
Yes
No
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
47
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
48
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
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).
Comment
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.
49
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.
No
Pediatric patient did not live outside the
United States for an uninterrupted period
of more than 2 months.
50
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).
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
Countries
(specify)
Comment
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
51
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
or
• 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
•
•
•
•
52
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
Date of death
(e.g., 01/17/2005)
Comment
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)
Yes
(related to TB
disease)
Description
Comment
TB was
• The immediate cause
or
• An underlying cause
or
• 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
or
• 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.
No
(unrelated to TB
disease)
TB was not
• The immediate cause
or
• An underlying cause
or
• 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.
53
16.
Site of TB Disease
Primary Purpose: Surveillance. Data are used to document site of TB disease.
Option
(select all that apply)
Description
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.
Comment
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.
If you selected Site not stated, do not
check any other box.
Site not stated
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.
54
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.”
55
RVCT
(page 2 of 3)
Items 17 – 25
Page 2 of the RVCT report includes instructions for completing items 17 – 25. It includes data about
laboratory results and primary reason the patient was evaluated for TB disease.
56
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
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.
or
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).
Comment
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.
57
For Positive or Negative results of sputum smear examinations, enter the following information.
Description
Date
collected
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.
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.
58
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)
Positive
Negative
Description
Comment
The result of any (or the only) sputum
culture was positive for M. tuberculosis
complex.
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.
or
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.
59
For positive or negative results of sputum cultures, enter the following information.
Description
Date
collected
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.
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
Date result
reported
Comment
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.”
60
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)
Positive
Description
Any tissue or body fluid other than sputum that (see
Note above)
• Tested positive by smear examination
or
•
Negative
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.)
All specimens of tissue or fluid that
• Tested negative by smear examination
or
•
Not done
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.)
Examinations of tissue or fluids are known not to have
been done.
61
Comment
Any positive result
supersedes a negative
result.
Unknown
It is not known whether tissue or fluids
• Were examined
or
•
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 or negative results of an examination for a smear or, pathology, or cytology of tissue and/or
other body fluids, enter the following information.
Description
Date
collected
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.
Month, day, and year the first negative If several specimen examinations were done
specimen was collected (e.g.,
and all results were negative, enter the date
01/17/2009) if all results were negative 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.
62
For Type of Exam, select both of the following if applicable.
Option
(select all that apply)
Smear
Comment
Select the type(s) of exam that correspond(s) to the result selected in
item 19.
Pathology/cytology
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 Diagnosis
(Any TB Test Result Is Positive)
Negative Diagnosis
(All TB Test Results Are Negative)
1st Test
2nd Test
1st Test
2nd Test
Positive
Positive
Negative
Negative
Positive
Negative
Negative
Positive
63
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)
Positive
Description
The culture results for any tissue or fluid culture
other than sputum (see Note above) was positive
for M. tuberculosis complex.
Comment
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
or
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).
64
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 or negative result of tissue or fluid culture, enter the following information.
Date
collected
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.
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.
65
For the first tissue or fluid culture reported to be positive for M. tuberculosis complex, enter the
following information.
Date result
reported
Description
Comment
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
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
Comment
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.”
66
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.
or
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.
67
For positive or negative results of NAA testing, enter the following information.
Description
Date
collected
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.
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
Date result
reported
Comment
Month, day, and year the result was
reported by the laboratory (e.g.,
01/17/2009)
68
This date can be found on the
laboratory report as the date the report
is released or made available.
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.
69
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.
or
Result of initial chest radiograph is not known or result is not known for a
reason other than pending results.
70
For abnormal results, select one option for each type of evidence.
Option
(select one)
Evidence of
a cavity
Yes
Description
Any initial chest radiograph(s) showing evidence of 1 or more lung
cavities
No
Unknown
Option
(select one)
Evidence of
miliary TB
Yes
Description
Any initial chest radiograph(s) showed evidence of miliary disease
(e.g., miliary TB, or miliary or bilateral micronodular pattern)
No
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.”
71
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)
Not done
Any initial chest CT scan or other chest imaging study showed abnormality
(e.g., hilar adenopathy, effusion, infiltrate[s], cavity, scarring) consistent with TB.
Unknown
It is not known whether an initial chest CT scan or other chest imaging study was
done.
or
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.
It is known that the initial chest CT scan or other chest imaging study was not done.
72
For abnormal chest CT scan or other chest imaging study results, select one option for each type of
evidence.
Option
(select one)
Evidence of a
cavity
Yes
Description
Any initial chest CT scan or other chest imaging study showed
evidence of 1 or more cavities.
No
Unknown
Option
(select one)
Evidence of
miliary TB
Yes
Description
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).
No
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.”
73
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 or 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 in
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
or
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
or
result is not known for a reason other than pending results.
74
For positive or negative TST results, enter the following information.
Description
Date TST placed
Comment
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)
75
If the millimeters of the induration are
not expressed, enter 99 as the default
value.
Interpreting the TST Reaction
5 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)
10 or more millimeters
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
76
15 or more millimeters
An induration of 15 or more
millimeters is considered
positive for
• People with no known
risk factors for TB
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.
or
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.
77
For positive or 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.
78
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
79
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).
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
80
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)
81
RVCT
(page 3 of 3)
Items 26 – 37
Page 3 of the RVCT report provides instructions for completing items 26 – 37. It includes data about risks
associated with TB, the date that therapy was started, and the initial drug regimen.
82
26.
HIV Status at Time of Diagnosis
Primary Purpose: Case management and surveillance. Data are used to determine TB/HIV comorbidity.
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
or
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.
83
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
84
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
No
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
1. No fixed, regular, and adequate nighttime residence
and
2. A primary nighttime residence that is
a. 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
or
b. An institution that provides a temporary residence for individuals intended to be
institutionalized
or
c. A public or private place not designated for, or ordinarily used as, a regular sleeping
accommodation for human beings.
A 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.
85
A 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.
86
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
No
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
87
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)
No
Yes
Comment
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.
88
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
No
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)
Hospitalbased 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.
89
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:
This might be an assisted living facility.
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)
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
Other longterm 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 longterm care facility, but the type of facility
is not known
90
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.
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.
91
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
92
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.
93
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
No
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
•
•
•
•
•
•
94
Phencyclidine (PCP, also known as angel dust)
Other hallucinogens
Barbiturates
Steroids
Other hormones
Fentanyl
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
No
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.
95
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]).
96
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
No
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)
97
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)
Missed contact
(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.
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.
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).
98
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 TBendemic 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.
99
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 or
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 Immunosuppression unless the patient has another immunosuppressive condition).
Comments: Other
Do not include risk factors identified in items 27–33:
• Being homeless within past year (item 27)
• Residence status at diagnosis
o Correctional facility (item 28)
o 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.
100
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
Not applicable
Description
Patient was
• “U.S.-born”
o Born in 1 of the 50 states or the District of Columbia
or
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).
1. Permanent residents (immigrants) are issued an alien resident card (i.e., green card) and should
carry this card with them.
2. 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.
101
Option
(select one)
Immigrant
visa
Description
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.
102
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
or
• Entering one of the other U.S. Territories, U.S. Island Areas, or U.S. Outlying Areas
103
36.
Date Therapy Started
Primary Purpose: Programmatic function. Data are used for calculating program management
indicators.
Description
Month, day, and year
(e.g., 01/17/2009)
Date the patient began multidrug
therapy for TB disease or
suspected TB disease
Comment
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)
Preferred
Date Therapy Started
Patient First Ingested Medication
If this date is not known
choose the next alternative
if documented in a medical record, such as hospital, or
clinic, or directly observed therapy (DOT) record (preferred)
Next Alternative
Date Therapy Started
Medication was First Dispensed to the Patient
If this date is not known
choose the last alternative
Last Alternative
Date Therapy Started
Date
Date
as documented by medical or pharmacy record
Date
Medication was First Prescribed to the Patient
by the Health Care Provider
as documented by medical or pharmacy record
104
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
No
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.
Unknown
Comment
If you cannot determine the
initial regimen of at least 2
weeks’ duration, select Yes
for the initial drugs known to
have been prescribed.
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).
105
Initial
Initial Drug Susceptibility Report (Follow Up Report – 1)
(page 1 of 1)
Items 38 – 40
Page 1 of the Initial Drug Susceptibility Report (Follow Up Report – 1) provides instructions for
completing items 38 – 40. 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.
106
38.
Genotyping Accession Number
Primary Purpose: Surveillance. Data are used to link genotyping results with RVCT data.
Option
(select one)
Description
Comment
No
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
Genotyping
accession
number
Comment
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.
107
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).
108
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
No
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
or
• The initial isolate from the major site of disease that yields the best or most information concerning
drug susceptibility results
or
• The initial culture-positive isolate.
Note: If the answer is No or Unknown, do not complete the remainder of this form (Initial Drug
Susceptibility Report [Follow Up Report–1]).
109
If you selected Yes, enter the following information.
Description
Date first specimen
for which drug
susceptibility testing
was done
Month, day, and year the first
specimen was collected
(e.g., 01/17/2009)
Comment
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.
110
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
or
• The initial isolate from the major site of disease that yields the best or most information
concerning drug susceptibility results
or
• 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).
111
First-line and Second-line Anti-TB Drugs
First-line Drugs
•
•
•
•
Isoniazid
Rifampin
Pyrazinamide
Ethambutol
Second-line Drugs
•
•
•
•
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.
or
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.
112
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]).
113
Case Completion Report (Follow Up Report – 2)
Items 41 – 49
Pages 1 and 2 of the Case Completion Report (Follow Up Report – 2) provide instructions for completing
items 41 – 49. 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)
114
(page 2 of 2)
115
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
No
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 followup sputum cultures were obtained).
Yes
Initial sputum specimen was
culture-positive, followed by at
least 1 negative sputum culture.
Unknown
Results of all follow-up cultures are
not known.
or
It is not known whether follow-up
cultures were done.
116
There should be no positive cultures after the
negative culture(s).
If you selected Yes, enter the following information.
Date specimen
collected for
FIRST
consistently
negative sputum
culture
Description
Comment
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)
No follow-up
sputum despite
induction
No follow-up
sputum and no
induction
Died
Description
Repeat sputum collection was attempted (including induced sputum collection),
but because of clinical improvement, patient was not able to produce sputum.
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).
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.
117
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)
No
Description
Patient did not move.
or
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.
118
If you selected Yes, select all the options that apply to the area to which the patient moved.
Option
(select all that apply)
In-state, out-of
jurisdiction
(specify)
Description
Patient moved within the state, but
out of the local heath department
jurisdiction, such as moved to
different county or city.
COMMENT
If the patient moved more than
twice, enter the first 2 moves.
Enter the city or county health
department jurisdiction to which the
patient moved.
Out of state
(specify)
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)
or
• A U.S. Territory, U.S. Island
Area, or U.S. Outlying Area
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
or
• 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.
119
If the patient moved more than
twice, enter the first 2 moves.
Out of the U.S.
(specify)
Patient moved from the United States
to
• Another country (other than a
U.S. Territory, U.S. Island Area,
or U.S. Outlying Area)
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)
If the patient moved more than
twice, enter the first 2 moves.
Enter the name of the country to
which the patient moved.
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
No
Referral was not 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)
Yes
Referral was made to a
TB program or physician Communication between programs is important
outside the United States. • 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
120
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
Select
From
Dallas County, Texas
Denali Borough, Alaska
Orleans Parish, Louisiana
Chuuk, Federated States of
Micronesia (FSM)
California
Washington, D.C.
California
Guam
Guam
Chuuk, FSM
Chuuk, FSM
Puerto Rico
Guam
California
To
Harris County, Texas
Bethel Borough, Alaska
Vernon Parish, Louisiana
Yap, FSM
In-state, out-of jurisdiction
In-state, out-of jurisdiction
In-state, out-of jurisdiction
In-state, out-of jurisdiction
Hawaii
Baltimore, Maryland
Guam
Palau
Hawaii
Guam
California
Florida
China
China
Out of state
Out of state
Out of state
Out of state
Out of state
Out of state
Out of state
Out of state
Out of the U.S.
Out of the U.S.
121
43.
Date Therapy Stopped
Primary Purpose: Programmatic function. Data are used to monitor completion of therapy within a
specified time.
Description
Month, day, and
year
(e.g., 01/17/2005)
Comment
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)
Preferred
Date
Date Therapy Stopped
Patient
Last
Ingested
Medication
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
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)
122
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.
123
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).
Uncooperative
or refused
Adverse
treatment
event
Code patients who move outside the United States and cannot be followed up as
Other.
Patient refused to complete therapy (e.g., stopped taking drugs).
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.
124
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)
Related to TB
disease
Description
Comment
TB was
• The immediate cause
or
• An underlying cause
or
• 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
or
• 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
or
• 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.
125
Criteria for determining the cause of death
related to TB therapy should be specified by
the clinician.
Unrelated to TB
disease
TB was not
• The immediate cause
or
• An underlying cause
or
• 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.
126
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
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.
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.
127
Comment
Criteria for determining failure
should be specified by the
clinician.
Use additional space at the
bottom of the page to write
comments regarding Other
reasons.
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/stateowned 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 communitybased organization [CBO]).
128
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.
129
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
1) Self-administered (e.g., patient ingests medication dose[s] without direct visual observation
by a health care provider or other reliable person)
or
2) Given by using DOT
or
3) 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.
130
If you selected any Yes option, enter the Number of weeks of directly observed therapy (DOT).
Option
(select one)
Number of weeks of
directly observed
therapy (DOT)
Description
Based on the total number of
regimen-appropriate weeks and
doses ingested under directly
observed supervision (e.g., 026)
Comment
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.
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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
No
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
Date FINAL
specimen
collected on which
drug
susceptibility
testing was done
Month, day, and year
(e.g., 01/17/2009)
Comment
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).
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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
133
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.
or
Results were not available or result is not known for a reason other than pending
results.
134
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.
135
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
136
Appendix A
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,*
or
• Demonstration of M. tuberculosis complex from a clinical specimen by nucleic acid
amplification test,†
or
• 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.
137
Appendix B
Recommendations for Reporting and Counting Tuberculosis Cases
(Revised May 13, 2009)
Since publication of the “Recommendations for Counting Reported Tuberculosis Cases”1 in
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
138
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.
OR
•
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.
OR
•
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,
OR
(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
139
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.
140
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 Visitors2
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)2 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.
141
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.
142
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,
143
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,
144
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)2 as
“any person not a citizen or national of the United States.”
Border crosser - defined, by the U.S. Citizenship and Immigration Services
(USCIS)2 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 waiver3
All applicants who have tuberculosis disease and have been granted a waiver.
145
Class B1 TB, Pulmonary3
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, Extrapulmonary3
Applicants with evidence of extrapulmonary TB. Document the anatomic site of
infection.
Class B2 TB, Latent TB Infection (LTBI) Evaluation3
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 Evaluation3
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 USCIS2 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.
146
Waivers3 - 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.
147
Appendix C
Anatomic Codes
Anatomic Code
Dermal System
00 * Skin and skin appendages
01 * Subcutaneous Tissue
02 * Breast
03 Milk
Anatomic Code
Cardiovascular System
30 * Pericardium
31 * Heart
32 * Cardiac valve
33 Pericardial fluid
34 * Blood vessel
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
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
* Only codes marked with an asterisk (*) should be used when a Site of Disease (item 16) is Other.
148
Urogenital System
Fetal Structures
60 Kidney
80 * Placenta, umbilical cord, and
implantation site
61 Renal pelvis
81 * Fetus and embryo
62 Ureter
63 Urinary bladder
Endocrine System
64 Urethra
82 * Pituitary gland
65 Penis
83 * Adrenal gland
84 * Thyroid or parathyroid gland(s)
66 Prostate and seminal vesicle
85 * Thymus
67 Testis
68 Epididymis, vas deferens, spermatic
Neurological System
cord, and scrotum
86 CSF (Cerebral spinal fluid)
69 Urine
87 Meninges, dural sinus, choroid plexus
70 Male genital fluids
88 * Brain
71 Vulva, labia, clitoris, and Bartholin's
89 * Spinal cord
gland
90 * Cranial, spinal, and peripheral nerve
72 Vagina
91 * Eye and ear appendages
73 Uterus
92 * Ear and mastoid cells
74 Cervix
Other
75 Endometrium
93 Pus
76 Myometrium
94 * Other
77 Fallopian tube, broad ligament,
95 Multiple Sites
parametrium, and parovarian region
99 Unknown
78 Ovary
79 Female genital fluids
* Only codes marked with an asterisk (*) should be used when a Site of Disease (item 16) is Other.
149
Appendix D
Reporting Area Codes
Reporting Area Codes
Name
Alabama
Alaska
Arizona
Arkansas
California
Colorado
Connecticut
Delaware
Florida
Georgia
Hawaii
Idaho
Illinois
Indiana
Iowa
Kansas
Kentucky
Louisiana
Maine
Maryland
Massachusetts
Michigan
Minnesota
Mississippi
Missouri
Montana
Alpha
Code
AL
AK
AZ
AR
CA
CO
CT
DE
FL
GA
HI
ID
IL
IN
IA
KS
KY
LA
ME
MD
MA
MI
MN
MS
MO
MT
01
02
04
05
06
08
09
10
12
13
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
Name
Nebraska
Nevada
New Hampshire
New Jersey
New Mexico
New York
New York City
North Carolina
North Dakota
Ohio
Oklahoma
Oregon
Pennsylvania
Rhode Island
South Carolina
South Dakota
Tennessee
Texas
Utah
Vermont
Virginia
Washington
Washington D.C.
West Virginia
Wisconsin
Wyoming
Alpha
Code
NE
NV
NH
NJ
NM
NY
NO
NC
ND
OH
OK
OR
PA
RI
SC
SD
TN
TX
UT
VT
VA
WA
DC
WV
WI
WY
31
32
33
34
35
36
975772
37
38
39
40
41
42
44
45
46
47
48
49
50
51
53
11
54
55
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
American Samoa
Federated States of
Micronesia
Guam
AQ
FM
60
64
GU
66
Northern Mariana
Islands
CQ
69
Name
150
Alpha
Code
Palau
Puerto Rico
PS
PR
70
72
Republic of Marshall
Islands
Virgin Islands
RM
68
VQ
78
Appendix E
Country Codes
Country
Alpha Code
Afghanistan
Albania
Algeria
American Samoa
Andorra
Angola
Anguilla
Antarctica
Antigua and Barbuda
Argentina
Armenia
Aruba
Ashmore and Cartier Islands
Australia
Austria
Azerbaijan
Bahamas, The
Bahrain
Baker Island
Bangladesh
Barbados
Bassas Da India
Belarus
Belgium
Belize
Benin
Bermuda
Bhutan
Bolivia
Bosnia and Herzegovina
Botswana
Bouvet Island
British Indian Ocean Territory
Brazil
British Virgin Islands
Brunei
Bulgaria
Burkina (Upper Volta)
Burma
Burundi
Cambodia
Cameroon
Canada
Cape Verde
Cayman Islands
151
AFG
ALB
DZA
ASM
AND
AGO
AIA
ATA
ATG
ARG
ARM
ABW
AT
AUS
AUT
AZE
BHS
BHR
FQ
BGD
BRB
BS
BLR
BEL
BLZ
BEN
BMU
BTN
BOL
BIH
BWA
BVT
IOT
BRA
VGB
BRN
BGR
BFA
BUMM
BDI
KHM
CMR
CAN
CPV
CYM
Country
Alpha Code
Central African Republic
Chad
Chile
China
Christmas Island
Clipperton Island
Cocos (Keeling) Islands
Colombia
Comoros
Congo
Cook Islands
Coral Sea Islands
Costa Rica
Croatia
Cuba
Cyprus
Czech Republic
Czechoslovakia
Denmark
Djibouti
Dominica
Dominican Republic
Ecuador
Egypt
El Salvador
Equatorial Guinea
Eritrea
Estonia
Ethiopia
Europa Island
Falkland Islands (Malvinas)
Faroe Islands
Federated States of Micronesia
Fiji
Finland
French Southern and Antarctic Lands
France
French Guiana
French Polynesia
Gabon
Gambia, The
Gaza Strip
Georgia
Germany
Ghana
Gibraltar
Glorioso Islands
Greece
Greenland
Grenada
152
CAF
TCD
CHL
CHN
CXR
IP
CCK
COL
COM
COG
COK
CR
CRI
HRV
CUB
CYP
CZE
CSHH
DNK
DJI
DMA
DOM
ECU
EGY
SLV
GNQ
ERI
EST
ETH
EU
FLK
FRO
FSM
FJI
FIN
ATF
FRA
GUF
PYF
GAB
GMB
GZ
GEO
DEU
GHA
GIB
GO
GRC
GRL
GRD
Country
Alpha Code
Guadeloupe
Guam
Guatemala
Guernsey
Guinea
Guinea-Bissau
Guyana
Haiti
Heard Island and McDonald Islands
Honduras
Hong Kong
Howland Island
Hungary
Iceland
India
Indonesia
Iran
Iraq
Iraq-Saudi Arabia Neutral Zone
Ireland
Israel
Italy
Ivory Coast
Jamaica
Jan Mayen
Japan
Jarvis Island
Jersey
Johnston Atoll
Jordan
Juan De Nova Island
Kazakhstan
Kenya
Kingman Reef
Kiribati
Korea, Republic of
Korea, Democratic People’s Republic
Kuwait
Kyrgyzstan
Laos
Latvia
Lebanon
Lesotho
Liberia
Libya
Liechtenstein
Lithuania
Luxembourg
Macau
Macedonia
153
GLP
GUM
GTM
GGY
GIN
GNB
GUY
HTI
HMD
HND
HKG
HQ
HUN
ISL
IND
IDN
IRN
IRQ
NTHH
IRL
ISR
ITA
CIV
JAM
JN
JPN
DQ
JEY
JQ
JOR
JU
KAZ
KEN
KQ
KIR
KOR
PRK
KWT
KGZ
LAO
LVA
LBN
LSO
LBR
LBY
LIE
LTU
LUX
MAC
MKD
Country
Alpha Code
Madagascar
Malawi
Malaysia
Maldives
Mali
Malta
Man, Isle of
Marshall Islands
Martinique
Mauritania
Mauritius
Mayotte
Mexico
Midway Island
Moldova
Monaco
Mongolia
Montenegro
Montserrat
Morocco
Mozambique
Myanmar
Namibia
Nauru
Navassa Island
Nepal
Netherlands
Netherlands Antilles
New Caledonia
New Zealand
Nicaragua
Niger
Nigeria
Niue
Norfolk Island
Northern Mariana Islands
Norway
Not Specified
Oman
Pakistan
Palau
Palmyra Atoll
Panama
Papua New Guinea
Paracel Islands
Paraguay
Peru
Philippines
Pitcairn Islands
Poland
MDG
MWI
MYS
MDV
MLI
MLT
IMN
MHL
MTQ
MRT
MUS
MYT
MEX
MIUM
MDA
MCO
MNG
MNE
MSR
MAR
MOZ
MMR
NAM
NRU
BQ
NPL
NLD
ANT
NCL
NZL
NIC
NER
NGA
NIU
NFK
MNP
NOR
NI
OMN
PAK
PLW
LQ
PAN
PNG
PF
PRY
PER
PHL
PCN
POL
154
Country
Alpha Code
Portugal
Portuguese Timor
Puerto Rico
Qatar
Reunion
Romania
Russia
Rwanda
South Georgia/South Sandwich Islands
San Marino
Sao Tome and Principe
Saudi Arabia
Senegal
Serbia
Seychelles
Sierra Leone
Singapore
Slovak Republic
Slovenia
Solomon Islands
Somalia
South Africa
Soviet Union
Spain
Spratly Islands
Sri Lanka
St Lucia
St. Helena
St. Kitts and Nevis
St. Pierre and Miquelon
St. Vincent/Grenadines
Sudan
Suriname
Svalbard
Swaziland
Sweden
Switzerland
Syria
Taiwan
Tajikistan
Tanzania, United Republic of
Thailand
Timor-Leste
Togo
Tokelau
Tonga, Kingdom of
Trinidad and Tobago
Tromelin Island
Tunisia
Turkey
155
PRT
TPTL
PRI
QAT
REU
ROU
RUS
RWA
SGS
SMR
STP
SAU
SEN
SRB
SYC
SLE
SGP
SVK
SVN
SLB
SOM
ZAF
SUHH
ESP
PG
LKA
LCA
SHN
KNA
SPM
VCT
SDN
SUR
SJM
SWZ
SWE
CHE
SYR
TWN
TJK
TZA
THA
TLS
TGO
TKL
TON
TTO
TE
TUN
TUR
Country
Alpha Code
Turkmenistan
Turks and Caicos Islands
Tuvalu
U.S. Minor Outlying Islands
Uganda
Ukraine
United Arab Emirates
United Kingdom
United States
Uruguay
U.S. Miscellaneous Pacific Islands
Uzbekistan
Vanuatu (New Hebrides)
Vatican City
Venezuela
Vietnam
Virgin Islands
Wake Island
Wallis and Futuna
West Bank
Western Sahara
Western Samoa
Yemen
Yugoslavia
Zaire
Zambia
Zimbabwe
156
TKM
TCA
TUV
UMI
UGA
UKR
ARE
GBR
USA
URY
PUUM
UZB
VUT
VAT
VEN
VNM
VIR
WKUM
WLF
WE
ESH
WSM
YEM
YUCS
ZRCD
ZMB
ZWE
Appendix F
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).
157
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.
158
Immunosuppressive
therapy
Interferon-gamma
(IFN-γ)
Interferon-gamma
release assay (IGRA)
Therapy that suppresses or weakens the immune system.
Protein that is normally produced by the body in response to infection.
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.
159
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.
or
• 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.
160
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).
161
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
162
| File Type | application/pdf |
| File Title | Microsoft Word - RVCT Instruction Manual FINAL.doc |
| Author | ctt1 |
| File Modified | 2009-08-12 |
| File Created | 2009-08-12 |