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## Complete Summary

#### GUIDELINE TITLE

Guidelines for preventing the transmission of *Mycobacterium
tuberculosis* in health-care settings, 2005.

#### BIBLIOGRAPHIC SOURCE(S)

Jensen PA, Lambert LA, Iademarco MF, Ridzon R. Guidelines for preventing
the transmission of Mycobacterium tuberculosis in health-care settings,
2005. MMWR Recomm Rep 2005 Dec 30;54(17):1-141. \[487 references\]
[PubMed](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16382216)

#### GUIDELINE STATUS

This is the current release of the guideline.

### COMPLETE SUMMARY CONTENT

 SCOPE\
 METHODOLOGY - including Rating Scheme and Cost Analysis\
 RECOMMENDATIONS\
 EVIDENCE SUPPORTING THE RECOMMENDATIONS\
 BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS\
 CONTRAINDICATIONS\
 IMPLEMENTATION OF THE GUIDELINE\
 INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT
CATEGORIES\
 IDENTIFYING INFORMATION AND AVAILABILITY\
 DISCLAIMER

### SCOPE

#### DISEASE/CONDITION(S)

Tuberculosis (TB)

#### GUIDELINE CATEGORY

Diagnosis\
Evaluation\
Management\
Prevention\
Risk Assessment\
Screening

#### CLINICAL SPECIALTY

Family Practice\
Infectious Diseases\
Internal Medicine\
Pediatrics\
Preventive Medicine\
Pulmonary Medicine

#### INTENDED USERS

Advanced Practice Nurses\
Clinical Laboratory Personnel\
Health Care Providers\
Hospitals\
Nurses\
Physician Assistants\
Physicians\
Public Health Departments\
Respiratory Care Practitioners\
Utilization Management

#### GUIDELINE OBJECTIVE(S)

To reassess and update tuberculosis (TB) control recommendations to
reflect shifts in the epidemiology of TB, advances in scientific
understanding, and changes in health-care practice that have occurred in
the United States during the preceding decade

#### TARGET POPULATION

-   Patients and health-care workers with suspected or confirmed
    tuberculosis (TB) or latent TB infection (LTBI)

-   People in health-care settings who are at risk for TB

#### INTERVENTIONS AND PRACTICES CONSIDERED

1.  Tuberculosis (TB) risk assessment and classification depending on
    the type of setting

    -   TB screening (tuberculin skin test \[TST\], blood assay for
        *Mycobacterium tuberculosis* \[BAMT), chest radiograph, symptom
        screen, laboratory tests, bronchoscopy)

2.  Identification of problems in the TB infection-control procedures

3.  Management of patients who have suspected or confirmed disease
    including considerations for special circumstances and settings

    -   Triage

    -   TB airborne precautions

    -   Airborne infection isolation (AII) room practices

    -   Diagnostic procedures

    -   Treatment (isoniazid, rifampin, rifampin/pyrazinamide) using
        directly observed therapy

    -   Management in inpatient settings

    -   Management in outpatient settings

4.  Training and educating health-care workers (HCWs)

5.  TB infection-control surveillance

6.  Collaboration with the local or state health department

7.  Environmental controls

8.  Respiratory protection

#### MAJOR OUTCOMES CONSIDERED

-   Infectiousness of a TB patient

-   Effectiveness of environmental controls and respiratory protection

### METHODOLOGY

#### METHODS USED TO COLLECT/SELECT EVIDENCE

Searches of Electronic Databases

#### DESCRIPTION OF METHODS USED TO COLLECT/SELECT THE EVIDENCE

Not stated

#### NUMBER OF SOURCE DOCUMENTS

Not stated

#### METHODS USED TO ASSESS THE QUALITY AND STRENGTH OF THE EVIDENCE

Not stated

#### RATING SCHEME FOR THE STRENGTH OF THE EVIDENCE

Not applicable

#### METHODS USED TO ANALYZE THE EVIDENCE

Review\
Review of Published Meta-Analyses

#### DESCRIPTION OF THE METHODS USED TO ANALYZE THE EVIDENCE

Not stated

#### METHODS USED TO FORMULATE THE RECOMMENDATIONS

Not stated

#### RATING SCHEME FOR THE STRENGTH OF THE RECOMMENDATIONS

Not applicable

#### COST ANALYSIS

A formal cost analysis was not performed and published cost analyses
were not reviewed.

#### METHOD OF GUIDELINE VALIDATION

Peer Review

#### DESCRIPTION OF METHOD OF GUIDELINE VALIDATION

Not stated

### RECOMMENDATIONS

#### MAJOR RECOMMENDATIONS

**Note from the National Guideline Clearinghouse (NGC)**: The
recommendations in this report update tuberculosis (TB) control
recommendations reflecting shifts in the epidemiology of TB, advances in
scientific understanding, and changes in health-care practice that have
occurred in the United States during the preceding decade. This report
replaces all previous Centers for Disease Control and Prevention (CDC)
guidelines on TB infection control in health-care settings. For a
description of all changes that differentiate this report from previous
guidelines, refer to the original guideline document.

**[Recommendations for Preventing Transmission of]{.underline}
*Mycobacterium tuberculosis* [in Health-Care Settings]{.underline}**

**TB Infection-Control Program**

Every health-care setting should have a TB infection-control plan that
is part of an overall infection-control program. The specific details of
the TB infection-control program will differ, depending on whether
patients with suspected or confirmed TB disease might be encountered in
the setting or whether patients with suspected or confirmed TB disease
will be transferred to another health-care setting. Administrators
making this distinction should obtain medical and epidemiologic
consultation from state and local health departments.

*TB Infection-Control Program for Settings in Which Patients with
Suspected or Confirmed TB Disease Are Expected To Be Encountered*

The TB infection-control program should consist of administrative
controls, environmental controls, and a respiratory-protection program.
Every setting in which services are provided to persons who have
suspected or confirmed infectious TB disease, including laboratories and
nontraditional facility-based settings, should have a TB
infection-control plan. The following steps should be taken to establish
a TB infection-control program in these settings:

1.  Assign supervisory responsibility for the TB infection-control
    program to a designated person or group with expertise in latent TB
    infection (LTBI) and TB disease, infection control, occupational
    health, environmental controls, and respiratory protection. Give the
    supervisor or supervisory body the support and authority to conduct
    a TB risk assessment, implement and enforce TB infection-control
    policies, and ensure recommended training and education of
    health-care workers (HCWs).

    -   Train the persons responsible for implementing and enforcing the
        TB infection-control program.

    -   Designate one person with a back-up as the TB resource person to
        whom questions and problems should be addressed, if supervisory
        responsibility is assigned to a committee.

2.  Develop a written TB infection-control plan that outlines a protocol
    for the prompt recognition and initiation of airborne precautions of
    persons with suspected or confirmed TB disease, and update it
    annually.

3.  Conduct a problem evaluation (see \"Problem Evaluation\" below) if a
    case of suspected or confirmed TB disease is not promptly recognized
    and appropriate airborne precautions not initiated, or if
    administrative, environmental, or respiratory-protection controls
    fail.

4.  Perform a contact investigation in collaboration with the local or
    state health department if health-care-associated transmission of
    *M. tuberculosis* is suspected (Centers for Disease Control and
    Prevention \[CDC\], \"Effective TB interviewing,\" 2004). Implement
    and monitor corrective action.

5.  Collaborate with the local or state health department to develop
    administrative controls consisting of the risk assessment, the
    written TB infection-control plan, management of patients with
    suspected or confirmed TB disease, training and education of HCWs,
    screening and evaluation of HCWs, problem evaluation, and
    coordination.

6.  Implement and maintain environmental controls, including airborne
    infection isolation (AII) room(s) (see Supplement, \"Environmental
    Controls\" in the original guideline document).

7.  Implement a respiratory-protection program.

8.  Perform ongoing training and education of HCWs (see \"Suggested
    Components of an Initial TB Training and Education Program for
    HCWs\" in the original guideline document).

9.  Create a plan for accepting patients who have suspected or confirmed
    TB disease if they are transferred from another setting.

*TB Infection-Control Program for Settings in Which Patients with
Suspected or Confirmed TB Disease Are Not Expected To Be Encountered*

Settings in which TB patients might stay before transfer should still
have a TB infection-control program in place consisting of
administrative, environmental, and respiratory-protection controls. The
following steps should be taken to establish a TB infection-control
program in these settings:

1.  Assign responsibility for the TB infection-control program to
    appropriate personnel.

2.  Develop a written TB infection-control plan that outlines a protocol
    for the prompt recognition and transfer of persons who have
    suspected or confirmed TB disease to another health-care setting.
    The plan should indicate procedures to follow to separate persons
    with suspected or confirmed infectious TB disease from other persons
    in the setting until the time of transfer. Evaluate the plan
    annually, if possible, to ensure that the setting remains one in
    which persons who have suspected or confirmed TB disease are not
    encountered and that they are promptly transferred.

3.  Conduct a problem evaluation (see \"Problem Evaluation\" below) if a
    case of suspected or confirmed TB disease is not promptly
    recognized, separated from others, and transferred.

4.  Perform an investigation in collaboration with the local or state
    health department if health-care-associated transmission of
    *Mycobacterium tuberculosis* (*M. tuberculosis*) is suspected.

5.  Collaborate with the local or state health department to develop
    administrative controls consisting of the risk assessment and the
    written TB infection-control plan.

**TB Risk Assessment**

Every health-care setting should conduct initial and ongoing evaluations
of the risk for transmission of *M. tuberculosis*, regardless of whether
or not patients with suspected or confirmed TB disease are expected to
be encountered in the setting. The TB risk assessment determines the
types of administrative, environmental, and respiratory-protection
controls needed for a setting and serves as an ongoing evaluation tool
of the quality of TB infection control and for the identification of
needed improvements in infection-control measures. Part of the risk
assessment is similar to a program review that is conducted by the local
TB-control program (CDC, \"Core curriculum,\" 2000). The TB Risk
Assessment Worksheet (refer to Appendix B in the original guideline
document) can be used as a guide for conducting a risk assessment. This
worksheet frequently does not specify values for acceptable performance
indicators because of the lack of scientific data.

*TB Risk Assessment for Settings in Which Patients with Suspected or
Confirmed TB Disease Are Expected To Be Encountered*

The initial and ongoing risk assessment for these settings should
consist of the following steps:

1.  Review the community profile of TB disease in collaboration with the
    state or local health department.

2.  Consult the local or state TB-control program to obtain
    epidemiologic surveillance data necessary to conduct a TB risk
    assessment for the health-care setting.

3.  Review the number of patients with suspected or confirmed TB disease
    who have been encountered in the setting during at least the
    previous 5 years.

4.  Determine if persons with unrecognized TB disease have been admitted
    to or were encountered in the setting during the previous 5 years.

5.  Determine which HCWs need to be included in a TB screening program
    and the frequency of screening (based on risk classification) (see
    Appendix C in the original guideline document).

6.  Ensure the prompt recognition and evaluation of suspected episodes
    of health-care-associated transmission of *M. tuberculosis*.

7.  Identify areas in the setting with an increased risk for
    health-care-associated transmission of *M. tuberculosis*, and target
    them for improved TB infection controls.

8.  Assess the number of AII rooms needed for the setting. The risk
    classification for the setting should help to make this
    determination, depending on the number of TB patients examined. At
    least one AII room is needed for settings in which TB patients stay
    while they are being treated, and additional AII rooms might be
    needed, depending on the magnitude of patient-days of cases of
    suspected or confirmed TB disease. Additional AII rooms might be
    considered if options are limited for transferring patients with
    suspected or confirmed TB disease to other settings with AII rooms.

9.  Determine the types of environmental controls needed other than AII
    rooms (see \"TB Airborne Precautions\" below).

10. Determine which HCWs need to be included in the
    respiratory-protection program.

11. Conduct periodic reassessments (annually, if possible) to ensure

    -   proper implementation of the TB infection-control plan

    -   prompt detection and evaluation of suspected TB cases

    -   prompt initiation of airborne precautions of suspected
        infectious TB cases

    -   recommended medical management of patients with suspected or
        confirmed TB disease (\"Treatment of tuberculosis,\" 2003)

    -   functional environmental controls

    -   implementation of the respiratory-protection program, and

    -   ongoing HCW training and education regarding TB

12. Recognize and correct lapses in infection control.

*TB Risk Assessment for Settings in Which Patients with Suspected or
Confirmed TB Disease Are Not Expected To Be Encountered*

The initial and ongoing risk assessment for these settings should
consist of the following steps:

1.  Review the community profile of TB disease in collaboration with the
    local or state health department.

2.  Consult the local or state TB-control program to obtain
    epidemiologic surveillance data necessary to conduct a TB risk
    assessment for the health-care setting.

3.  Determine if persons with unrecognized TB disease were encountered
    in the setting during the previous 5 years.

4.  Determine if any HCWs need to be included in the TB screening
    program.

5.  Determine the types of environmental controls that are currently in
    place, and determine if any are needed in the setting (see
    \"Environmental Controls\"; Appendices A and D in the original
    guideline document).

6.  Document procedures that ensure the prompt recognition and
    evaluation of suspected episodes of health-care-associated
    transmission of *M. tuberculosis*.

7.  Conduct periodic reassessments (annually, if possible) to ensure 1)
    proper implementation of the TB infection-control plan; 2) prompt
    detection and evaluation of suspected TB cases; 3) prompt initiation
    of airborne precautions of suspected infectious TB cases before
    transfer; 4) prompt transfer of suspected infectious TB cases; 5)
    proper functioning of environmental controls, as applicable; and 6)
    ongoing TB training and education for HCWs.

8.  Recognize and correct lapses in infection control.

*Use of Risk Classification to Determine Need for TB Screening and
Frequency of Screening HCWs*

Risk classification should be used as part of the risk assessment to
determine the need for a TB screening program for HCWs and the frequency
of screening (see Appendix C in the original guideline document). A risk
classification usually should be determined for the entire setting.
However, in certain settings (e.g., health-care organizations that
encompass multiple sites or types of services), specific areas defined
by geography, functional units, patient population, job type, or
location within the setting might have separate risk classifications.
Examples of assigning risk classifications have been provided in the
original guideline document.

*TB Screening Risk Classifications*

The three TB screening risk classifications are low risk, medium risk,
and potential ongoing transmission. The classification of low risk
should be applied to settings in which persons with TB disease are not
expected to be encountered, and, therefore, exposure to *M.
tuberculosis* is unlikely. This classification should also be applied to
HCWs who will never be exposed to persons with TB disease or to clinical
specimens that might contain *M. tuberculosis*.

The classification of medium risk should be applied to settings in which
the risk assessment has determined that HCWs will or will possibly be
exposed to persons with TB disease or to clinical specimens that might
contain *M. tuberculosis*.

The classification of potential ongoing transmission should be
temporarily applied to any setting (or group of HCWs) if evidence
suggestive of person-to-person (e.g., patient-to-patient,
patient-to-HCW, HCW-to-patient, or HCW-to-HCW) transmission of *M.
tuberculosis* has occurred in the setting during the preceding year.
Evidence of person-to-person transmission of *M. tuberculosis*
includes 1) clusters of tuberculin skin test (TST) or blood assay for
*M. tuberculosis* (BAMT) conversions, 2) HCW with confirmed TB disease,
3) increased rates of TST or BAMT conversions, 4) unrecognized TB
disease in patients or HCWs, or 5) recognition of an identical strain of
*M. tuberculosis* in patients or HCWs with TB disease identified by
deoxyribonucleic acid (DNA) fingerprinting.

If uncertainty exists regarding whether to classify a setting as low
risk or medium risk, the setting typically should be classified as
medium risk.

*TB Screening Procedures for Settings (or HCWs) Classified as Low Risk*

-   All HCWs should receive baseline TB screening upon hire, using
    two-step TST or a single BAMT to test for infection with *M.
    tuberculosis*.

-   After baseline testing for infection with *M. tuberculosis*,
    additional TB screening is not necessary unless an exposure to *M.
    tuberculosis* occurs.

-   HCWs with a baseline positive or newly positive test result for *M.
    tuberculosis* infection (i.e., TST or BAMT) or documentation of
    treatment for LTBI or TB disease should receive one chest radiograph
    result to exclude TB disease (or an interpretable copy within a
    reasonable time frame, such as 6 months). Repeat radiographs are not
    needed unless symptoms or signs of TB disease develop or unless
    recommended by a clinician (\"Targeted tuberculin testing,\" 2000;
    Food and Drug Administration, 1983).

*TB Screening Procedures for Settings (or HCWs) Classified as Medium
Risk*

-   All HCWs should receive baseline TB screening upon hire, using
    two-step TST or a single BAMT to test for infection with *M.
    tuberculosis*.

-   After baseline testing for infection with *M. tuberculosis*, HCWs
    should receive TB screening annually (i.e., symptom screen for all
    HCWs and testing for infection with *M. tuberculosis* for HCWs with
    baseline negative test results).

-   HCWs with a baseline positive or newly positive test result for *M.
    tuberculosis* infection or documentation of previous treatment for
    LTBI or TB disease should receive one chest radiograph result to
    exclude TB disease. Instead of participating in serial testing, HCWs
    should receive a symptom screen annually. This screen should be
    accomplished by educating the HCW about symptoms of TB disease and
    instructing the HCW to report any such symptoms immediately to the
    occupational health unit. Treatment for LTBI should be considered in
    accordance with CDC guidelines (\"Targeted tuberculin testing,\"
    2000).

*TB Screening Procedures for Settings (or HCWs) Classified as Potential
Ongoing Transmission*

-   Testing for infection with *M. tuberculosis* might need to be
    performed every 8 to 10 weeks until lapses in infection control have
    been corrected, and no additional evidence of ongoing transmission
    is apparent.

-   The classification of potential ongoing transmission should be used
    as a temporary classification only. It warrants immediate
    investigation and corrective steps. After a determination that
    ongoing transmission has ceased, the setting should be reclassified
    as medium risk. Maintaining the classification of medium risk for at
    least 1 year is recommended.

*Settings Adopting BAMT for Use in TB Screening*

Settings that use TST as part of TB screening and want to adopt BAMT can
do so directly (without any overlapping TST) or in conjunction with a
period of evaluation (e.g., 1 or 2 years) during which time both TST and
BAMT are used. Baseline testing for BAMT would be established as a
single step test. As with the TST, BAMT results should be recorded in
detail. The details should include date of blood draw, result in
specific units, and the laboratory interpretation (positive, negative,
or indeterminate - and the concentration of cytokine measured, for
example, interferon-gamma).

Refer to the original guideline document for examples of risk
classification.

*Screening HCWs Who Transfer to Other Health-Care Settings*

All HCWs should receive baseline TB screening, even in settings
considered to be low risk. Infection-control plans should address HCWs
who transfer from one health-care setting to another and consider that
the transferring HCWs might be at an equivalent or higher risk for
exposure in different settings. Infection-control plans might need to be
customized to balance the assessed risks and the efficacy of the plan
based on consideration of various logistical factors. Guidance is
provided based on different scenarios.

Because some institutions might adopt BAMT for the purposes of testing
for *M. tuberculosis* infection, infection-control programs might be
confronted with interpreting historic and current TST and BAMT results
when HCWs transfer to a different setting. On a case-by-case basis,
expert medical opinion might be needed to interpret results and refer
patients with discordant BAMT and TST baseline results. Therefore,
infection-control programs should keep all records when documenting
previous test results. For example, an infection-control program using a
BAMT strategy should request and keep historic TST results of a HCW
transferring from a previous setting. Even if the HCW is transferring
from a setting that used BAMT to a setting that uses BAMT, historic TST
results might be needed when in the future the HCW transfers to a
setting that uses TST. Similarly, historic BAMT results might be needed
when the HCW transfers from a setting that used TST to a setting that
uses BAMT.

**HCWs transferring from low-risk to low-risk settings**. After a
baseline result for infection with *M. tuberculosis* is established and
documented, serial testing for *M. tuberculosis* infection is not
necessary.

**HCWs transferring from low-risk to medium-risk settings**. After a
baseline result for infection with *M. tuberculosis* is established and
documented, annual TB screening (including a symptom screen and TST or
BAMT for persons with previously negative test results) should be
performed.

**HCWs transferring from low- or medium-risk settings to settings with a
temporary classification of potential ongoing transmission**. After a
baseline result for infection with *M. tuberculosis* is established, a
decision should be made regarding follow-up screening on an individual
basis. If transmission seems to be ongoing, consider including the HCW
in the screenings every 8 to 10 weeks until a determination has been
made that ongoing transmission has ceased. When the setting is
reclassified back to medium-risk, annual TB screening should be resumed.

Refer to the original guideline document for calculation and use of
conversion rates for *M. tuberculosis* infection, use of conversion test
data for *M. tuberculosis* infection to identify lapses in infection
control, and example calculations of conversion rates.

*Evaluation of Tuberculosis (TB) Infection-Control Procedures and
Identification of Problems*

Annual evaluations of the TB infection-control plan are needed to ensure
the proper implementation of the plan and to recognize and correct
lapses in infection control. Previous hospital admissions and outpatient
visits of patients with TB disease should be noted before the onset of
TB symptoms. Medical records of a sample of patients with suspected and
confirmed TB disease who were treated or examined at the setting should
be reviewed to identify possible problems in TB infection control. The
review should be based on the factors listed on the TB Risk Assessment
Worksheet (see Appendix B in the original guideline).

-   Time interval from suspicion of TB until initiation of airborne
    precautions and antituberculosis treatment

    -   suspicion of TB disease and patient triage to proper AII room or
        referral center for settings that do not provide care for
        patients with suspected or confirmed TB disease

    -   admission until TB disease was suspected

    -   admission until medical evaluation for TB disease was performed

    -   admission until specimens for acid-fast bacilli (AFB) smears and
        polymerase chain reaction (PCR)-based nucleic acid amplification
        (NAA) tests for *M. tuberculosis* were ordered

    -   admission until specimens for mycobacterial culture were ordered

    -   ordering of AFB smears, nucleic acid amplification (NAA) tests,
        and mycobacterial culture until specimens were collected

    -   collection of specimens until performance and AFB smear results
        were reported

    -   collection of specimens until performance and culture results
        were reported

    -   collection of specimens until species identification was
        reported

    -   collection of specimens until drug-susceptibility test results
        were reported

    -   admission until airborne precautions were initiated

    -   admission until antituberculosis treatment was initiated

-   Duration of airborne precautions

-   Measurement of meeting criteria for discontinuing airborne
    precautions. Certain patients might be correctly discharged from an
    AII room to home

-   Patient history of previous admission

-   Adequacy of antituberculosis treatment regimens

-   Adequacy of procedures for collection of follow-up sputum specimens

-   Adequacy of discharge planning

-   Number of visits to outpatient setting from the start of symptoms
    until TB disease was suspected (for outpatient settings)

Work practices related to airborne precautions should be observed to
determine if employers are enforcing all practices, if health-care
workers (HCWs) are adhering to infection-control policies, and if
patient adherence to airborne precautions is being enforced. Data from
the case reviews and observations in the annual risk assessment should
be used to determine the need to modify 1) protocols for identifying and
initiating prompt airborne precautions for patients with suspected or
confirmed infectious TB disease, 2) protocols for patient management, 3)
laboratory procedures, or 4) TB training and education programs for
HCWs.

*Environmental Assessment*

-   Data from the most recent environmental evaluation should be
    reviewed to determine if recommended environmental controls are in
    place (see \"Suggested Components of an Initial TB Training and
    Education Program for HCWs\" in the original guideline document).

-   Environmental control maintenance procedures and logs should not be
    reviewed to determine if maintenance is conducted properly and
    regularly.

-   Environmental control design specifications should be compared with
    guidelines from the American Institute of Architects (AIA) and other
    ventilation guidelines (American Society for Heating, Refrigerating
    and Air-Conditioning Engineers, 2003; AIA, 2001) (see \"Risk
    Classification Examples\" in the original guideline document) and
    the installed system performance.

-   Environmental data should be used to assist building managers and
    engineers in evaluating the performance of the installed system.

-   The number and types of aerosol-generating or aerosol-producing
    procedures (e.g., specimen processing and manipulation,
    bronchoscopy, sputum induction, and administration of aerosolized
    medications) performed in the setting should be assessed.

-   The number of AII rooms should be suitable for the setting based on
    AIA Guidelines and the setting risk assessment. The Joint Commission
    on Accreditation of Healthcare Organizations (JCAHO) has adapted the
    AIA guidelines when accrediting facilities (AIA, 2001).

Refer to the original guideline document for information regarding
suggested components of an initial TB training and education programs
for HCWs.

**Managing Patients Who Have Suspected or Confirmed TB Disease: General
Recommendations**

The primary TB risk to HCWs is the undiagnosed or unsuspected patient
with infectious TB disease. A high index of suspicion for TB disease and
rapid implementation of precautions are essential to prevent and
interrupt transmission. Specific precautions will vary depending on the
setting.

*Prompt Triage*

Within health-care settings, protocols should be implemented and
enforced to promptly identify, separate from others, and either transfer
or manage persons who have suspected or confirmed infectious TB disease.
When patients\' medical histories are taken, all patients should be
routinely asked about 1) a history of TB exposure, infection, or
disease; 2) symptoms or signs of TB disease; and 3) medical conditions
that increase their risk for TB disease (see Supplements, \"Diagnostic
Procedures for Latent tuberculosis infection (LTBI) and TB Disease;\"
and \"Treatment Procedures for LTBI and TB Disease\" in the original
guideline document). The medical evaluation should include an interview
conducted in the patient\'s primary language, with the assistance of a
qualified medical interpreter, if necessary. HCWs who are the first
point of contact should be trained to ask questions that will facilitate
detection of persons who have suspected or confirmed infectious TB
disease. For assistance with language interpretation, contact the local
and state health department. Interpretation resources are also available
(Francis J. Curry National Tuberculosis Center, 2003) at
[http://www.atanet.org](http://www.atanet.org/);
[http://www.languageline.com](http://www.languageline.com/); and
[http://www.ncihc.org](http://www.ncihc.org/).

A diagnosis of respiratory TB disease should be considered for any
patient with symptoms or signs of infection in the lung, pleura, or
airways (including larynx), including coughing for \>3 weeks, loss of
appetite, unexplained weight loss, night sweats, bloody sputum or
hemoptysis, hoarseness, fever, fatigue, or chest pain. The index of
suspicion for TB disease will vary by geographic area and will depend on
the population served by the setting. The index of suspicion should be
substantially high for geographic areas and groups of patients
characterized by high TB incidence (CDC, \"Reported tuberculosis,\"
2005).

Special steps should be taken in settings other than TB clinics.
Patients with symptoms suggestive of undiagnosed or inadequately treated
TB disease should be promptly referred so that they can receive a
medical evaluation. These patients should not be kept in the setting any
longer than required to arrange a referral or transfer to an AII room.
While in the setting, symptomatic patients should wear a surgical or
procedure mask, if possible, and should be instructed to observe strict
respiratory hygiene and cough etiquette procedures (see Glossary in the
original guideline document) (Lenehan, 2004; Piotrowski, 2003; CDC,
\"Key facts,\" 2004).

Immunocompromised persons, including those who are HIV-infected, with
infectious TB disease should be physically separated from other persons
to protect both themselves and others. To avoid exposing HIV-infected or
otherwise severely immunocompromised persons to *M. tuberculosis*,
consider location and scheduling issues to avoid exposure.

*TB Airborne Precautions*

Within health-care settings, TB airborne precautions should be initiated
for any patient who has symptoms or signs of TB disease, or who has
documented infectious TB disease and has not completed antituberculosis
treatment. For patients placed in AII rooms because of suspected
infectious TB disease of the lungs, airway, or larynx, airborne
precautions may be discontinued when infectious TB disease is considered
unlikely and either 1) another diagnosis is made that explains the
clinical syndrome or 2) the patient has three consecutive, negative
acid-fast bacilli (AFB) sputum smear results (Al Zahrani et al., 2001;
Conde et al., 2000; Bell, Leckie, & McKendrick, 2003; Merrick et al.,
1997; Leonard et al., 2005). Each of the three sputum specimens should
be collected in 8 to 24-hour intervals (Toman, 2004), and at least one
specimen should be an early morning specimen because respiratory
secretions pool overnight. Generally, this method will allow patients
with negative sputum smear results to be released from airborne
precautions in 2 days.

The classification of the risk assessment of the health-care setting is
used to determine how many AII rooms each setting needs, depending on
the number of TB patients examined.

At least one AII room is needed for settings in which TB patients stay
while they are being treated, and additional AII rooms might be needed
depending on the magnitude of patient-days of persons with suspected or
confirmed TB disease (AIA, 2001). Additional rooms might be considered
if options are limited for transferring patients with suspected or
confirmed TB disease to other settings with AII rooms. For example, for
a hospital with 120 beds, a minimum of one AII room is needed, possibly
more, depending on how many TB patients are examined in 1 year.

*TB Airborne Precautions for Settings in Which Patients with Suspected
or Confirmed TB Disease Are Expected To Be Encountered*

Settings that plan to evaluate and manage patients with TB disease
should have at least one AII room or enclosure that meets AII
requirements (see \"Environmental Controls below;\" and the Supplement,
\"Environmental Controls\" in the original guideline document). These
settings should develop written policies that specify 1) indications for
airborne precautions, 2) persons authorized to initiate and discontinue
airborne precautions, 3) specific airborne precautions, 4) AII
room-monitoring procedures, 5) procedures for managing patients who do
not adhere to airborne precautions, and 6) criteria for discontinuing
airborne precautions.

A high index of suspicion should be maintained for TB disease. If a
patient has suspected or confirmed TB disease, airborne precautions
should be promptly initiated. Persons with suspected or confirmed TB
disease who are inpatients should remain in AII rooms until they are
determined to be noninfectious and have demonstrated a clinical response
to a standard multidrug antituberculosis treatment regimen or until an
alternative diagnosis is made. If the alternative diagnosis cannot be
clearly established, even with three negative sputum smear results,
empiric treatment of TB disease should strongly be considered (see
Supplement, \"Estimating the Infectiousness of a TB Patient\" in the
original guideline document). Outpatients with suspected or confirmed
infectious TB disease should remain in AII rooms until they are
transferred or until their visit is complete.

*TB Airborne Precautions for Settings in Which Patients with Suspected
or Confirmed TB Disease Are Not Expected To Be Encountered*

Settings in which patients with suspected or confirmed TB disease are
not expected to be encountered do not need an AII room or a
respiratory-protection program for the prevention of transmission of *M.
tuberculosis*. However, follow the following steps in these settings.

A written protocol should be developed for referring patients with
suspected or confirmed TB disease to a collaborating referral setting in
which the patient can be evaluated and managed properly. The referral
setting should provide documentation of intent to collaborate. The
protocol should be reviewed routinely and revised as needed.

Patients with suspected or confirmed TB disease should be placed in an
AII room, if available, or in a room that meets the requirements for an
AII room, or in a separate room with the door closed, apart from other
patients and not in an open waiting area. Adequate time should elapse to
ensure removal of *M. tuberculosis*-contaminated room air before
allowing entry by staff or another patient (see Supplement,
\"Environmental Controls;\" Tables 1 and 2 in the original guideline
document).

If an AII room is not available, persons with suspected or confirmed
infectious TB disease should wear a surgical or procedure mask, if
possible. Patients should be instructed to keep the mask on and to
change the mask if it becomes wet. If patients cannot tolerate a mask,
they should observe strict respiratory hygiene and cough etiquette
procedures.

*AII Room Practices*

AII rooms should be single-patient rooms in which environmental factors
and entry of visitors and HCWs are controlled to minimize the
transmission of *M. tuberculosis*. All HCWs who enter an AII room should
wear at least N95 disposable respirators (see Supplement, \"Respiratory
Protection\" in the original guideline document). Visitors may be
offered respiratory protection (i.e., N95) and should be instructed by
HCWs on the use of the respirator before entering an AII room. AII rooms
have specific requirements for controlled ventilation, negative
pressure, and air filtration (AIA, 2001) (see Supplement,
\"Environmental Controls\" in the original guideline document). Each
inpatient AII room should have a private bathroom.

Refer to the original guideline document for information on settings
with AII rooms.

*Diagnostic Procedures*

Diagnostic procedures should be performed in settings with appropriate
infection-control capabilities. The following recommendations should be
applied for diagnosing TB disease and for evaluating patients for
potential infectiousness.

[Clinical Diagnosis]{.underline}

A complete medical history should be obtained, including symptoms of TB
disease, previous TB disease and treatment, previous history of
infection with *M. tuberculosis*, and previous treatment of LTBI or
exposure to persons with TB disease. A physical examination should be
performed, including chest radiograph, microscopic examination, culture,
and, when indicated, nucleic acid amplification (NAA) testing of sputum
(\"Targeted tuberculin testing,\" 2000; CDC, 1998; \"Update: nucleic
acid,\" 2000; Willcox et al., 1986). If possible, sputum induction with
aerosol inhalation is preferred, particularly when the patient cannot
produce sputum. Gastric aspiration might be necessary for those
patients, particularly children, who cannot produce sputum, even with
aerosol inhalation (Abadco & Steiner, 1992; Abadco et al., 1992; Chan,
Abadco, & Steiner, 1994; Lillehei, 1961). Bronchoscopy might be needed
for specimen collection, especially if sputum specimens have been
nondiagnostic and doubt exists as to the diagnosis (Pizzichini et al.,
2002; Bell, Leckie, & McKendrick, 2003; Abadco & Steiner, 1992; Abadco
et al., 1992; Willcox, Benatar, & Portgieter, 1982; Djukanovic et al.,
2002; Paggiaro et al., 2002; Gibson et al., 2002).

All patients with suspected or confirmed infectious TB disease should be
placed under airborne precautions until they have been determined to be
noninfectious (see Supplement, \"Estimating the Infectiousness of a TB
Patient\" in the original guideline document). Adult and adolescent
patients who might be infectious include persons who are coughing; have
cavitation on chest radiograph; have positive AFB sputum smear results;
have respiratory tract disease with involvement of the lung, pleura or
airways, including larynx, who fail to cover the mouth and nose when
coughing; are not on antituberculosis treatment or are on incorrect
antituberculosis treatment; or are undergoing cough-inducing or
aerosol-generating procedures (e.g., sputum induction, bronchoscopy, and
airway suction) (\"Diagnostic standards,\" 2000; Curtis et al., 1999).

Persons diagnosed with extrapulmonary TB disease should be evaluated for
the presence of concurrent pulmonary TB disease. An additional concern
in infection control with children relates to adult household members
and visitors who might be the source case (American Academy of
Pediatrics \[AAP\], 2003). Pediatric patients, including adolescents,
who might be infectious include those who have extensive pulmonary or
laryngeal involvement, prolonged cough, positive sputum AFB smears
results, cavitary TB on chest radiograph (as is typically observed in
immunocompetent adults with TB disease), or those for whom
cough-inducing or aerosol-generating procedures are performed (AAP,
2003; Rabalais, Adams, & Stover, 1991).

Although children are uncommonly infectious, pediatric patients should
be evaluated for infectiousness by using the same criteria as for adults
(i.e., on the basis of pulmonary or laryngeal involvement). Patients
with suspected or confirmed TB disease should be immediately reported to
the local public health authorities so that arrangements can be made for
tracking their treatment to completion, preferably through a case
management system, so that directly observed therapy (DOT) can be
arranged and standard procedures for identifying and evaluating TB
contacts can be initiated. Coordinate efforts with the local or state
health department to arrange treatment and long-term follow-up and
evaluation of contacts.

[Laboratory Diagnosis]{.underline}

To produce the highest quality laboratory results, laboratories
performing mycobacteriologic tests should be skilled in both the
laboratory and the administrative aspects of specimen processing.
Laboratories should use or have prompt access to the most rapid methods
available: 1) fluorescent microscopy and concentration for AFB smears;
2) rapid NAA testing for direct detection of *M. tuberculosis* in
patient specimens (\"Update: nucleic acid,\" 2000); 3) solid and rapid
broth culture methods for isolation of mycobacteria; 4) nucleic acid
probes or high pressure liquid chromatography (HPLC) for species
identification; and 5) rapid broth culture methods for drug
susceptibility testing. Laboratories should incorporate other more rapid
or sensitive tests as they become available, practical, and affordable
(see Supplement, \"Diagnostic Procedures for LTBI and TB Disease\" in
the original guideline document) (CDC & National Institutes of Health
\[NIH\], \"Agent: *Mycobacterium tuberculosis*,\" 1999; Association of
State and Territorial Public Health Laboratory Directors \[ASTPHLD\] &
CDC, 1995).

In accordance with local and state laws and regulations, a system should
be in place to ensure that laboratories report any positive results from
any specimens to clinicians within 24 hours of obtaining the result
(ASTPHLD & CDC, 1995; Tenover et al., 1993). Certain settings perform
AFB smears on-site for rapid results (and results should be reported to
clinicians within 24 hours) and then send specimens or cultures to a
referral laboratory for identification and drug-susceptibility testing.
This referral practice can speed the receipt of smear results but delay
culture identification and drug-susceptibility results. Settings that
cannot provide the full range of mycobacteriologic testing services
should contract with their referral laboratories to ensure rapid results
while maintaining proficiency for on-site testing. In addition, referral
laboratories should be instructed to store isolates in case additional
testing is necessary.

All drug susceptibility results on *M. tuberculosis* isolates should be
reported to the local or state health department as soon as these
results are available. Laboratories that rarely receive specimens for
mycobacteriologic analysis should refer specimens to a laboratory that
performs these tests routinely. The reference laboratory should provide
rapid testing and reporting. Out-of-state reference laboratories should
provide all results to the local or state health department from which
the specimen originated.

*Special Considerations for Persons Who Are at High Risk for TB Disease
or in Whom TB Disease Might Be Difficult to Diagnose*

The probability of TB disease is higher among patients who 1) previously
had TB disease or were exposed to *M. tuberculosis*, 2) belong to a
group at high risk for TB disease or, 3) have a positive TST or BAMT
result. TB disease is strongly suggested if the diagnostic evaluation
reveals symptoms or signs of TB disease, a chest radiograph consistent
with TB disease, or AFB in sputum or from any other specimen. TB disease
can occur simultaneously in immunocompromised persons who have pulmonary
infections caused by other organisms (e.g., *Pneumocystis jiroveci*
\[formerly *P. carinii*\] and *M. avium* complex) and should be
considered in the diagnostic evaluation of all such patients with
symptoms or signs of TB disease (CDC, 1998).

TB disease can be difficult to diagnose in persons who have HIV
infection (Benson et al., 2004) (or other conditions associated with
severe suppression of cell mediated immunity) because of nonclassical or
normal radiographic presentation or the simultaneous occurrence of other
pulmonary infections (e.g., *P. jiroveci or M. avium* complex) (Bennett
et al., 2000). Patients who are HIV-infected are also at greater risk
for having extrapulmonary TB (Bennett et al., 2000). The difficulty in
diagnosing TB disease in HIV-infected can be compounded by the possible
lower sensitivity and specificity of sputum smear results for detecting
AFB (CDC, 1998; Klein et al., 1989) and the overgrowth of cultures with
*M. avium* complex in specimens from patients infected with both *M.
tuberculosis* and *M. avium* complex. The TST in patients with advanced
HIV infection is unreliable and cannot be used in clinical decision
making (CDC, \"Guidelines for using the QuantiFERON®-TB,\" 2005; CDC,
1998; Pitchenik & Rubinson, 1985).

For immunocompromised patients who have respiratory symptoms or signs
that are attributed initially to infections or conditions other than TB
disease, conduct an evaluation for coexisting TB disease. If the patient
does not respond to recommended treatment for the presumed cause of the
pulmonary abnormalities, repeat the evaluation (see Supplement,
\"Diagnostic Procedures for LTBI and TB Disease\" in the original
guideline document). In certain settings in which immunocompromised
patients and patients with TB disease are examined, implementing
airborne precautions might be prudent for all persons at high risk.
These persons include those infected with HIV who have an abnormal chest
radiograph or respiratory symptoms, symptomatic foreign-born persons who
have immigrated within the previous 5 years from TB-endemic countries,
and persons with pulmonary infiltrates on chest radiograph, or symptoms
or signs of TB disease.

*Initiation of Treatment*

For patients who have confirmed TB disease or who are considered highly
probable to have TB disease, promptly start antituberculosis treatment
in accordance with current guidelines (see Supplements, \"Diagnostic
Procedures for LTBI and TB Disease;\" and \"Treatment Procedures for
LTBI and TB Disease\" in the original guideline document) (\"Treatment
of tuberculosis,\" 2003). In accordance with local and state
regulations, local health departments should be notified of all cases of
suspected TB.

DOT is the standard of care for all patients with TB disease and should
be used for all doses during the course of therapy for treatment of TB
disease. All inpatient medication should be administered by DOT and
reported to the state or local health department. Rates of relapse and
development of drug-resistance are decreased when DOT is used (Chaulk &
Kazandjian, 1998; Frieden et al., 1995; Weis et al., 1994). All patients
on intermittent (i.e., once or twice per week) treatment for TB disease
or LTBI should receive DOT. Settings should collaborate with the local
or state health department on decisions concerning inpatient DOT and
arrangements for outpatient DOT (\"Treatment of tuberculosis,\" 2003).

**Managing Patients Who Have Suspected or Confirmed TB Disease:
Considerations for Special Circumstances and Settings**

The recommendations for preventing transmission of *M. tuberculosis* are
applicable to all health-care settings, including those that have been
described (see Appendix A in the original guideline document). These
settings should each have independent risk assessments if they are
stand-alone settings, or each setting should have a detailed section
written as part of the risk assessment for the overall setting.

*Minimum Requirements*

The specific precautions for the settings included in this section vary,
depending on the setting.

[Inpatient Settings]{.underline}

Emergency Departments (EDs)

The symptoms of TB disease are usually symptoms for which patients might
seek treatment in EDs. Because TB symptoms are common and nonspecific,
infectious TB disease could be encountered in these settings. The use of
ED-based TB screening has not been demonstrated to be consistently
effective (Sokolove et al., 2000).

The amount of time patients with suspected or confirmed infectious TB
disease spend in EDs and urgent-care settings should be minimized.
Patients with suspected or confirmed infectious TB disease should be
promptly identified, evaluated, and separated from other patients.
Ideally, such patients should be placed in an AII room. When an AII room
is not available, use a room with effective general ventilation, and use
air cleaning technologies (e.g., a portable high-efficiency particulate
air \[HEPA\] filtration system), if available, or transfer the patient
to a setting or area with recommended infection-control capacity.
Facility engineering personnel with expertise in heating, ventilation,
and air conditioning (HVAC) and air handlers have evaluated how this
option is applied to ensure no over pressurization of return air or
unwanted alternations exists in design of air flow in the zone.

EDs with a high volume of patients with suspected or confirmed TB
disease should have at least one AII room (see \"TB risk assessment
worksheet\" \[Appendix B\] in the original guideline document).
Air-cleaning technologies (e.g., HEPA filtration and ultraviolet
germicidal irradiation \[UVGI\]) can be used to increase equivalent air
changes per hour (ACH) in waiting areas (see Table 1 in the original
guideline document). HCWs entering an AII room or any room with a
patient with infectious TB disease should wear at least an N95
disposable respirator. After a patient with suspected or confirmed TB
disease exits a room, allow adequate time to elapse to ensure removal of
*M. tuberculosis*-contaminated room air before allowing entry by staff
or another patient (see Supplement, \"Environmental Controls\" and
Tables 1 and 2 in the original guideline document).

Before a patient leaves an AII room, perform an assessment of 1) the
patient\'s need to discontinue airborne precautions, 2) the risk for
transmission and the patient\'s ability to observe strict respiratory
hygiene, and 3) cough etiquette procedures. Patients with suspected or
confirmed infectious TB who are outside an AII room should wear a
surgical or procedure mask, if possible. Patients who cannot tolerate
masks because of medical conditions should observe strict respiratory
hygiene and cough etiquette procedures.

Intensive Care Units (ICUs)

Patients with infectious TB disease might become sick enough to require
admission to an ICU. Place ICU patients with suspected or confirmed
infectious TB disease in an AII room, if possible. ICUs with a high
volume of patients with suspected or confirmed TB disease should have at
least one AII room (see \"TB risk assessment worksheet,\" \[Appendix B\]
in the original guideline document). Air-cleaning technologies (e.g.,
HEPA filtration and UVGI) can be used to increase equivalent air changes
per hour (ACH) in waiting areas (see Supplement, \"Environmental
Controls\" in the original guideline document).

HCWs entering an AII room or any room with a patient with infectious TB
disease should wear at least an N95 disposable respirator. To help
reduce the risk for contaminating a ventilator or discharging *M.
tuberculosis* into the ambient air when mechanically ventilating (i.e.,
with a ventilator or manual resuscitator) a patient with suspected or
confirmed TB disease, place a bacterial filter on the patient\'s
endotracheal tube (or at the expiratory side of the breathing circuit of
a ventilator) (Aranha-Creado et al., 1997; Berry & Nolte, 1991; Demers,
2001; Langevin, Rand, & Layon, 1999; Tait, 1997). In selecting a
bacterial filter, give preference to models specified by the
manufacturer to filter particles 0.3 micron in size in both the unloaded
and loaded states with a filter efficiency of \>95% (i.e., filter
penetration of \<5%) at the maximum design flow rates of the ventilator
for the service life of the filter, as specified by the manufacturer.

Surgical Suites

Surgical suites require special infection-control considerations for
preventing transmission of *M. tuberculosis*. Normally, the direction of
airflow should be from the operating room (OR) to the hallway (positive
pressure) to minimize contamination of the surgical field. Certain
hospitals have procedure rooms with reversible airflow or pressure,
whereas others have positive-pressure rooms with a negative pressure
anteroom. Surgical staff, particularly those close to the surgical
field, should use respiratory protection (e.g., a valveless N95
disposable respirator) to protect themselves and the patient undergoing
surgery.

When possible, postpone non-urgent surgical procedures on patients with
suspected or confirmed TB disease until the patient is determined to be
noninfectious or determined to not have TB disease. When surgery cannot
be postponed, procedures should be performed in a surgical suite with
recommended ventilation controls. Procedures should be scheduled for
patients with suspected or confirmed TB disease when a minimum number of
HCWs and other patients are present in the surgical suite, and at the
end of the day to maximize the time available for removal of airborne
contamination (see Supplement, \"Environmental Controls\" and Tables 1
and 2 in the original guideline document).

If a surgical suite or an OR has an anteroom, the anteroom should be
either 1) positive pressure compared with both the corridor and the
suite or OR (with filtered supply air) or 2) negative pressure compared
with both the corridor and the suite or OR. In the usual design in which
an OR has no anteroom, keep the doors to the OR closed, and minimize
traffic into and out of the room and in the corridor. Using additional
air-cleaning technologies (e.g., UVGI) should be considered to increase
the equivalent ACH. Air-cleaning systems can be placed in the room or in
surrounding areas to minimize contamination of the surroundings after
the procedure (Sehulster & Chinn, 2003) (see Supplement, \"Environmental
Controls\" in the original guideline document).

Ventilation in the OR should be designed to provide a sterile
environment in the surgical field while preventing contaminated air from
flowing to other areas in the health-care setting. Personnel steps
should be taken to reduce the risk for contaminating ventilator or
anesthesia equipment or discharging tubercle bacilli into the ambient
air when operating on a patient with suspected or confirmed TB disease
(Teo & Lim, 2004). A bacterial filter should be placed on the patient\'s
endotracheal tube (or at the expiratory side of the breathing circuit of
a ventilator or anesthesia machine, if used) (Aranha-Creado et al.,
1997; Berry & Nolte, 1991; Demers, 2001; Langevin, Rand, & Layon, 1999;
Tait, 1997). When selecting a bacterial filter, give preference to
models specified by the manufacturer to filter particles 0.3 micron in
size in both the unloaded and loaded states with a filter efficiency of
[\>]{.underline}95% (i.e., filter penetration of \<5%) at the maximum
design flow rates of the ventilator for the service life of the filter,
as specified by the manufacturer.

When surgical procedures (or other procedures that require a sterile
field) are performed on patients with suspected or confirmed infectious
TB, respiratory protection should be worn by HCWs to protect the sterile
field from the respiratory secretions of HCWs and to protect HCWs from
the infectious droplet nuclei generated from the patient. When selecting
respiratory protection, do not use valved or positive-pressure
respirators, because they do not protect the sterile field. A respirator
with a valveless filtering facepiece (e.g., N95 disposable respirator)
should be used.

Postoperative recovery of a patient with suspected or confirmed TB
disease should be in an AII room in any location where the patient is
recovering (AIA, 2001). If an AII or comparable room is not available
for surgery or postoperative recovery, air-cleaning technologies (e.g.,
HEPA filtration and UVGI) can be used to increase the number of
equivalent ACH (see Supplement, \"Environmental Controls\" in the
original guideline document); however, the infection-control committee
should be involved in the selection and placement of these supplemental
controls.

Laboratories

Staff who work in laboratories that handle clinical specimens encounter
risks not typically present in other areas of a health-care setting (Kao
et al., 1997; Peerbooms et al., 1995; Garber et al., 2003). Laboratories
that handle TB specimens include 1) pass-through facilities that forward
specimens to reference laboratories for analysis; 2) diagnostic
laboratories that process specimens and perform acid-fast staining and
primary culture for *M. tuberculosis*; and 3) facilities that perform
extensive identification, subtyping, and susceptibility studies.

Procedures involving the manipulation of specimens or cultures
containing *M. tuberculosis* introduce additional substantial risks that
must be addressed in an effective TB infection-control program.
Personnel who work with mycobacteriology specimens should be thoroughly
trained in methods that minimize the production of aerosols and undergo
periodic competency testing to include direct observation of their work
practices. Risks for transmission of *M. tuberculosis* in laboratories
include aerosol formation during any specimen or isolate manipulation
and percutaneous inoculation from accidental exposures. Biosafety
recommendations for laboratories performing diagnostic testing for TB
have been published (Menzies et al., 1995; Menzies et al., 2003; CDC &
NIH, \"Agent; *Mycobacterium tuberculosis*,\" 1999; Metchok, Nolte, &
Wallace, 1999; Richmond, 2001).

In laboratories affiliated with a health-care setting (e.g., a hospital)
and in free-standing laboratories, the laboratory director, in
collaboration with the infection-control staff for the setting, and in
consultation with the state TB laboratory, should develop a risk-based
infection-control plan for the laboratory that minimizes the risk for
exposure to *M. tuberculosis*. Consider factors including 1) incidence
of TB disease (including drug-resistant TB) in the community and in
patients served by settings that submit specimens to the laboratory, 2)
design of the laboratory, 3) level of TB diagnostic service offered, 4)
number of specimens processed, and 5) whether or not aerosol-generating
or aerosol-producing procedures are performed and the frequency at which
they are performed. Referral laboratories should store isolates in case
additional testing is necessary.

Biosafety level (BSL)-2 practices and procedures, containment equipment,
and facilities are required for nonaerosol-producing manipulations of
clinical specimens (e.g., preparing direct smears for acid-fast staining
when done in conjunction with training and periodic checking of
competency) (CDC & NIH, \"Agent: *Mycobacterium tuberculosis*,\" 1999).
All specimens suspected of containing *M. tuberculosis* (including
specimens processed for other microorganisms) should be handled in a
Class I or II biological safety cabinet (BSC) (CDC & NIH, 2000; CDC &
NIH, \"Biosafety,\" 1999). Conduct all aerosol-generating activities
(e.g., inoculating culture media, setting up biochemical and
antimicrobic susceptibility tests, opening centrifuge cups, and
performing sonication) in a Class I or II BSC (CDC & NIH, 2000).

For laboratories that are considered at least medium risk (see Appendix
C in the original guideline document), conduct testing for *M.
tuberculosis* infection at least annually among laboratorians who
perform TB diagnostics or manipulate specimens from which *M.
tuberculosis* is commonly isolated (e.g., sputum, lower respiratory
secretions, or tissues) (see Appendix D in the original guideline
document). More frequent testing for *M. tuberculosis* is recommended in
the event of a documented conversion among laboratory staff or a
laboratory accident that poses a risk for exposure to *M. tuberculosis*
(e.g., malfunction of a centrifuge leading to aerosolization of a
sample).

Based on the risk assessment for the laboratory, employees should use
personal protective equipment (including respiratory protection)
recommended by local regulations for each activity. For activities that
have a low risk for generating aerosols, standard personal protective
equipment consists of protective laboratory coats, gowns, or smocks
designed specifically for use in the laboratory. Protective garments
should be left in the laboratory before going to nonlaboratory areas.

For all laboratory procedures, disposable gloves should be worn. Gloves
should be disposed of when work is completed, the gloves are overtly
contaminated, or the integrity of the glove is compromised. Local or
state regulations should determine procedures for the disposal of
gloves. Face protection (e.g., goggles, full-facepiece respirator, face
shield, or other splatter guard) should also be used when manipulating
specimens inside or outside a BSC. Use respiratory protection when
performing procedures that can result in aerosolization outside a BSC.
The minimum level of respiratory protection is an N95 filtering
facepiece respirator. Laboratory workers who use respiratory protection
should be provided with the same training on respirator use and care and
the same fit testing as other HCWs.

After documented laboratory accidents, conduct an investigation of
exposed laboratory workers. Laboratories in which specimens for
mycobacteriologic studies (e.g., AFB smears and cultures) are processed
should follow the AIA and CDC/National Institute of Health guidelines
(AIA, 2001; CDC & NIH, \"Biosafety,\" 1999) (see Supplement,
\"Environmental Controls\" in the original guideline). BSL-3 practices,
containment equipment, and facilities are recommended for the
propagation and manipulation of cultures of *M. tuberculosis* complex
(including *M. bovis*) and for animal studies in which primates that are
experimentally or naturally infected with *M. tuberculosis* or *M.
bovis* are used. Animal studies in which guinea pigs or mice are used
can be conducted at animal BSL-2. Aerosol infection methods are
recommended to be conducted at BSL-3 (CDC & NIH, \"Biosafety,\" 1999).

Refer to the original guideline document for information on managing TB
patients in bronchoscopy suites, sputum induction and inhalation therapy
rooms, autopsy suites, and embalming rooms.

[Outpatient Settings]{.underline}

Outpatient settings might include TB treatment facilities, dental-care
settings, medical offices, ambulatory-care settings, and dialysis units.
Environmental controls should be implemented based on the types of
activities that are performed in the setting.

TB Treatment Facilities

TB treatment facilities might include TB clinics, infectious disease
clinics, or pulmonary clinics. TB clinics and other settings in which
patients with TB disease and LTBI are examined on a regular basis
require special attention. The same principles of triage used in EDs and
ambulatory-care settings (See Minimum Requirements) should be applied to
TB treatment facilities. These principles include prompt identification,
evaluation, and airborne precautions of patients with suspected or
confirmed infectious TB disease.

All TB clinic staff, including outreach workers, should be screened for
*M. tuberculosis* infection (see Appendix C in the original guideline
document). Patients with suspected or confirmed infectious TB disease
should be physically separated from all patients, but especially from
those with HIV infection and other immunocompromising conditions that
increase the likelihood of development of TB disease if infected.
Immunosuppressed patients with suspected or confirmed infectious TB
disease need to be physically separated from others to protect both the
patient and others. Appointments should be scheduled to avoid exposing
HIV-infected or otherwise severely immunocompromised persons to *M.
tuberculosis*. Certain times of the day should be designated for
appointments for patients with infectious TB disease or treat them in
locations in areas in which immunocompromised persons are not treated.

Persons with suspected or confirmed infectious TB disease should be
promptly placed in an AII room to minimize exposure in the waiting room
and other areas of the clinic, and they should be instructed to observe
strict respiratory hygiene and cough etiquette procedures. Clinics that
provide care for patients with suspected or confirmed infectious TB
disease should have at least one AII room. The need for additional AII
rooms should be based on the risk assessment for the setting.

All cough-inducing and aerosol-generating procedures should be performed
using environmental controls (e.g., in a booth or an AII room) (see
Supplement, \"Environmental Controls\" in the original guideline
document). Patients should be left in the booth or AII room until
coughing subsides. Another patient or HCW should not be allowed to enter
the booth or AII room until sufficient time has elapsed for adequate
removal of *M. tuberculosis-*contaminated air (see Supplement,
\"Environmental Controls\" in the original guideline document). A
respiratory-protection program should be implemented for all HCWs who
work in the TB clinic and who enter AII rooms, visit areas in which
persons with suspected or confirmed TB disease are located, or transport
patients with suspected or confirmed TB disease in vehicles. When
persons with suspected or confirmed infectious TB disease are in the TB
clinic and not in an AII room, they should wear a surgical or procedure
mask, if possible.

Medical Offices and Ambulatory-Care Settings

The symptoms of TB disease are usually symptoms for which patients might
seek treatment in a medical office. Therefore, infectious TB disease
could possibly be encountered in certain medical offices and
ambulatory-care settings.

Because of the potential for *M. tuberculosis* transmission in medical
offices and ambulatory-care settings, follow the general recommendations
for management of patients with suspected or confirmed TB disease and
the specific recommendations for EDs (see \"Intensive Care Units
\[ICUs\]\" above). The risk assessment may be used to determine the need
for or selection of environmental controls and the frequency of testing
HCWs for *M. tuberculosis* infection.

Dialysis Units

Patients with ESRD who need chronic dialysis should have at least one
test for *M. tuberculosis* infection to determine the need for treatment
of LTBI. Annual re-screening is indicated if ongoing exposure of ESRD
patients to *M. tuberculosis* is probable.

Hemodialysis procedures should be performed on hospitalized patients
with suspected or confirmed TB disease in an AII room. Dialysis staff
should use recommended respiratory protection, at least an N95
disposable respirator. Patients with suspected or confirmed TB disease
who need chronic hemodialysis might need referral to a hospital or other
setting with the ability to perform dialysis procedures in an AII room
until the patient is no longer infectious or another diagnosis is made.
Certain antituberculosis medications are prescribed differently for
hemodialysis patients (\"Targeted tuberculin testing,\" 2000).

Dental-Care Settings

To prevent the transmission of *M. tuberculosis* in dental-care
settings, certain recommendations should be followed (Kohn et al., 2004;
Kohn et al., 2003). Infection-control policies for each dental
healthcare setting should be developed, based on the community TB risk
assessment (see \"TB risk assessment worksheet\" \[Appendix B\] in the
original guideline document), and should be reviewed annually, if
possible. The policies should include appropriate screening for LTBI and
TB disease for dental HCWs, education on the risk for transmission to
the dental HCWs, and provisions for detection and management of patients
who have suspected or confirmed TB disease.

When taking a patient\'s initial medical history and at periodic
updates, dental HCWs should routinely document whether the patient has
symptoms or signs of TB disease. If urgent dental care must be provided
for a patient who has suspected or confirmed infectious TB disease,
dental care should be provided in a setting that meets the requirements
for an AII room (see Supplement, \"Environmental Controls\" in the
original guideline document). Respiratory protection (at least N95
disposable respirator) should be used while performing procedures on
such patients.

In dental health-care settings that routinely provide care to
populations at high risk for TB disease, using engineering controls
(e.g., portable HEPA units) similar to those used in waiting rooms or
clinic areas of health-care settings with a comparable community-risk
profile might be beneficial.

During clinical assessment and evaluation, a patient with suspected or
confirmed TB disease should be instructed to observe strict respiratory
hygiene and cough etiquette procedures (CDC, \"Key facts,\" 2004). The
patient should also wear a surgical or procedure mask, if possible.
Non-urgent dental treatment should be postponed, and these patients
should be promptly referred to an appropriate medical setting for
evaluation of possible infectiousness. In addition, these patients
should be kept in the dental health-care setting no longer than required
to arrange a referral.

[Nontraditional Facility-Based Settings]{.underline}

Nontraditional facility-based settings include emergency medical
services (EMS), medical settings in correctional facilities, home-based
health-care and outreach settings, long-term-care settings (e.g.,
hospices and skilled nursing facilities), and homeless shelters.
Environmental controls should be implemented based on the types of
activities that are performed in the setting.

Because persons who visit homeless shelters frequently share exposure
and risk characteristics of TB patients who are treated in outpatient
clinics, homeless shelters with clinics should observe the same TB
infection-control measures as outpatient clinics. Advisory Council for
the Elimination of Tuberculosis (ACET) has developed recommendations to
assist health-care providers, health departments, shelter operators and
workers, social service agencies, and homeless persons to prevent and
control TB in this population (\"Prevention and control,\" 1992).

Emergency Medical Services (EMS)

EMS personnel should be included in a comprehensive screening program to
test for *M. tuberculosis* infection and provide baseline screening and
follow-up testing as indicated by the risk classification of the
setting. Persons with suspected or confirmed infectious TB disease who
are transported in an ambulance should wear a surgical or procedure
mask, if possible, and drivers, HCWs, and other staff who are
transporting the patient might consider wearing an N95 respirator.

The ambulance ventilation system should be operated in the
nonrecirculating mode, and the maximum amount of outdoor air should be
provided to facilitate dilution. If the vehicle has a rear exhaust fan,
use this fan during transport. If the vehicle is equipped with a
supplemental recirculating ventilation unit that passes air through HEPA
filters before returning it to the vehicle, use this unit to increase
the number of ACH (CDC, \"Guidelines for infection control,\" 2003). Air
should flow from the cab (front of vehicle), over the patient, and out
the rear exhaust fan. If an ambulance is not used, the ventilation
system for the vehicle should bring in as much outdoor air as possible,
and the system should be set to nonrecirculating. If possible,
physically isolate the cab from the rest of the vehicle, and place the
patient in the rear seat (Seitz, Decker, & Jensen, 1996).

EMS personnel should be included in the follow-up contact investigations
of patients with infectious TB disease. The Ryan White Comprehensive
AIDS Resource Emergency Act of 1990 (Public law 101-381) mandates
notification of EMS personnel after they have been exposed to a patient
with suspected or confirmed infectious TB disease (Title 42 U.S. Code
1994) (<http://hab.hrsa.gov/data2/adap/introduction.htm>).

Refer to the original guideline document for information regarding
medical settings in:

-   Correctional facilities

-   Home-based health-care and outreach settings

-   Long-term-care facilities (LTCFs)

**Training and Educating HCWs**

HCW training and education regarding infection with *M. tuberculosis*
and TB disease is an essential part of administrative controls in a TB
surveillance or infection-control program. Training physicians and nurse
managers is especially essential because of the leadership role they
frequently fulfill in infection control. HCW training and education can
increase adherence to TB infection-control measures. Training and
education should emphasize the increased risks posed by an undiagnosed
person with TB disease in a health-care setting and the specific
measures to reduce this risk. HCWs receive various types of training;
therefore, combining training for TB infection control with other
related trainings might be preferable.

*Initial TB Training and Education*

The setting should document that all HCWs, including physicians, have
received initial TB training relevant to their work setting and
additional occupation-specific education. The level and detail of
baseline training will vary according to the responsibilities of the HCW
and the risk classification of the setting.

Educational materials on TB training are available from various sources
at no cost in printed copy, on videotape (CDC, \"Mantoux,\" 2003), on
compact discs, and the Internet. The local or state health department
should have access to additional materials and resources and might be
able to help develop a setting-specific TB education program. Suggested
components of a baseline TB training program for HCWs have been
described previously (see the original guideline document). CDC\'s TB
website provides information regarding training and education materials
(<http://www.cdc.gov/tb>). Additional training and education materials
are available on CDC\'s TB Education and Training Resources website
(http://www.findtbresources.org) and on other TB-related websites and
resources (see Appendix E in the original guideline document).

Physicians, trainees, students, and other HCWs who work in a health-care
setting but do not receive payment from that setting should receive
baseline training in TB infection-control policies and practices, the TB
screening program, and procedures for reporting an *M. tuberculosis*
infection test conversion or diagnosis of TB disease. Initial TB
training should be provided before the HCW starts working.

*Follow-Up TB Training and Education*

All settings should conduct an annual evaluation of the need for
follow-up training and education for HCWs based on the number of
untrained and new HCWs, changes in the organization and services of the
setting, and availability of new TB infection-control information.

If a potential or known exposure to *M. tuberculosis* occurs in the
setting, prevention and control measures should include retraining HCWs
in the infection-control procedures established to prevent the
recurrence of exposure. If a potential or known exposure results in a
newly recognized positive TST or BAMT result, test conversion, or
diagnosis of TB disease, education should include information on 1)
transmission of *M. tuberculosis*, 2) noninfectiousness of HCWs with
LTBI, and 3) potential infectiousness of HCWs with TB disease.

Occupational Safety and Health Administration (OSHA) requires annual
respiratory-protection training for HCWs who use respiratory devices
(see Supplement, \"Respiratory Protection\"). HCWs in settings with a
classification of potential ongoing transmission should receive
additional training and education on 1) symptoms and signs of TB
disease, 2) *M. tuberculosis* transmission, 3) infection-control
policies, 4) importance of TB screening for HCWs, and 5)
responsibilities of employers and employees regarding *M. tuberculosis*
infection test conversion and diagnosis of TB disease.

**TB Infection-Control Surveillance**

*HCW Screening Programs for TB Support Surveillance and Clinical Care*

TB screening programs provide critical information for caring for
individual HCWs and information that facilitates detection of *M.
tuberculosis* transmission. The screening program consists of four major
components: 1) baseline testing for *M. tuberculosis* infection, 2)
serial testing for *M. tuberculosis* infection, 3) serial screening for
symptoms or signs of TB disease, and 4) TB training and education.

Surveillance data from HCWs can protect both HCWs and patients.
Screening can prevent future transmission by identifying lapses in
infection control and expediting treatment for persons with LTBI or TB
disease. Tests to screen for *M. tuberculosis* infection should be
administered, interpreted, and recorded according to procedures in this
report (see Supplement, \"Diagnostic Procedures for LTBI and TB
Disease\" in the original guideline document). Protection of privacy and
maintenance of confidentiality of HCW test results should be ensured.
Methods to screen for infection with *M. tuberculosis* are available
(\"Diagnostic standards,\" 2000; \"Treatment of tuberculosis,\" 2003;
\"Targeted tuberculin testing,\" 2000).

*Baseline Testing for M. tuberculosis Infection*

Baseline testing for *M. tuberculosis* infection is recommended for all
newly hired HCWs, regardless of the risk classification of the setting
and can be conducted with the TST or BAMT. Baseline testing is also
recommended for persons who will receive serial TB screening (e.g.,
residents or staff of correctional facilities or LTCFs) (\"Targeted
tuberculin testing,\" 2000; Snider & Cauthen, 1984). Certain settings,
with the support of the infection-control committee, might choose not to
perform baseline or serial TB screening for HCWs who will never be in
contact with or have shared air space with patients who have TB disease
(e.g., telephone operators who work in a separate building from
patients) or who will never be in contact with clinical specimens that
might contain *M. tuberculosis*.

Baseline test results 1) provide a basis for comparison in the event of
a potential or known exposure to *M. tuberculosis* and 2) facilitate the
detection and treatment of LTBI or TB disease in an HCW before
employment begins and reduces the risk to patients and other HCWs. If
TST is used for baseline testing, two-step testing is recommended for
HCWs whose initial TST results are negative (\"Targeted tuberculin
testing,\" 2000; Snider & Cauthen, 1984). If the first-step TST result
is negative, the second-step TST should be administered 1 to 3 weeks
after the first TST result was read. If either 1) the baseline
first-step TST result is positive or 2) the first-step TST result is
negative but the second-step TST result is positive, TB disease should
be excluded, and if it is excluded, then the HCW should be evaluated for
treatment of LTBI. If the first and second-step TST results are both
negative, the person is classified as not infected with *M.
tuberculosis*.

If the second test result of a two-step TST is not read within 48 to 72
hours, administer a TST as soon as possible (even if several months have
elapsed) and ensure that the result is read within 48 to 72 hours
(\"Targeted tuberculin testing,\" 2000). Certain studies indicate that
positive TST reactions might still be measurable from 4 to 7 days after
testing (Duboczy &  Brown, 1961; Cobelens et al., 2003). However, if a
patient fails to return within 72 hours and has a negative test result,
the TST should be repeated (CDC, \"Core Curriculum,\" 2000).

A positive result to the second step of a baseline two-step TST is
probably caused by boosting as opposed to recent infection with *M.
tuberculosis*. These responses might result from remote infections with
*M. tuberculosis*, infection with an nontuberculosis mycobacteria (NTM)
(also known as mycobacterium other than tuberculosis \[MOTT\]), or
previous bacille Calmette-Guerin (BCG) vaccination. Two-step testing
will minimize the possibility that boosting will lead to an unwarranted
suspicion of transmission of *M. tuberculosis* with subsequent testing.
A second TST is not needed if the HCW has a documented TST result from
any time during the previous 12 months (see \"Baseline Testing for *M.
tuberculosis* Infection After TST Within the Previous 12 Months\"
below).

A positive TST reaction as a result of BCG wanes after 5 years.
Therefore, HCWs with previous BCG vaccination will frequently have a
negative TST result (Menzies et al., 1995; CDC, 1996; Huebner, Schein, &
Bass, 1993; Karalliedde, Katugaha, & Uragoda, 1987; Mazurek et al.,
2001; Menzies & Vissandjee, 1992; Snider, 1985). Because HCWs with a
history of BCG are frequently from high TB-prevalence countries,
positive test results for *M. tuberculosis* infection in HCWs with
previous BCG vaccination should be interpreted as representing infection
with *M. tuberculosis* (Menzies et al., 1995; CDC, 1996; Huebner,
Schein, & Bass, 1993; Karalliedde, Katugaha, & Uragoda, 1987; Mazurek et
al., 2001; Menzies & Vissandjee, 1992; Snider, 1985; Bugiani et al.,
2003). Although BCG reduces the occurrence of severe forms of TB disease
in children and overall might reduce the risk for progression from LTBI
to TB disease (Aronson et al., 2004; Dye, 2004), BCG is not thought to
prevent *M. tuberculosis* infection (Fine et al., 1999). Test results
for *M. tuberculosis* infection for HCWs with a history of BCG should be
interpreted by using the same diagnostic cut points used for HCWs
without a history of BCG vaccination.

BAMT does not require two-step testing and is more specific than skin
testing. BAMT that uses *M. tuberculosis* specific antigens (e.g.,
QuantiFERON-TB Gold test \[QFT-G\]) are not expected to result in
false-positive results in persons vaccinated with BCG. Baseline test
results should be documented, preferably within 10 days of HCWs starting
employment.

*Baseline Testing for M. tuberculosis Infection After TST Within the
Previous 12 Months*

A second TST is not needed if the HCW has a documented TST result from
any time during the previous 12 months. If a newly employed HCW has had
a documented negative TST result within the previous 12 months, a single
TST can be administered in the new setting (see Box 1 \"Indications for
two-step tuberculin skin tests (TSTs)\" in the original guideline
document). This additional TST represents the second stage of two-step
testing. The second test decreases the possibility that boosting on
later testing will lead to incorrect suspicion of transmission of *M.
tuberculosis* in the setting.

A recent TST (performed in [\<]{.underline}12 months) is not a
contraindication to a subsequent TST unless the test was associated with
severe ulceration or anaphylactic shock, which are substantially rare
adverse events (\"Diagnostic standards,\" 2000; Aventis Pasteur, 2001;
Parkdale Pharmaceuticals, 2002; Froeschle, Ruben, & Bloh, 2002).
Multiple TSTs are safe and do not increase the risk for a false-positive
result or a TST conversion in persons without infection with
mycobacteria (\"Targeted tuberculin testing,\" 2000).

*Baseline Documentation of a History of TB Disease, a Previously
Positive Test Result for M. tuberculosis Infection, or Completion of
Treatment for LTBI or TB Disease*

Additional tests for *M. tuberculosis* infection do not need to be
performed for HCWs with a documented history of TB disease, documented
previously positive test result for *M. tuberculosis* infection, or
documented completion of treatment for LTBI or TB disease. Documentation
of a previously positive test result for *M. tuberculosis* infection can
be substituted for a baseline test result if the documentation includes
a recorded TST result in millimeters (or BAMT result), including the
concentration of cytokine measured (e.g., IFN-gamma). All other HCWs
should undergo baseline testing for *M. tuberculosis* infection to
ensure that the test result on record in the setting has been performed
and measured using the recommended diagnostic procedures (see
Supplement, \"Diagnostic Procedures for LTBI and TB Disease\" in the
original guideline document).

A recent TST (performed in [\<]{.underline}12 months) is not a
contraindication to the administration of an additional test unless the
TST was associated with severe ulceration or anaphylactic shock, which
are substantially rare adverse events (\"Diagnostic standards,\" 2000;
Aventis Pasteur, 2001; Parkdale Pharmaceuticals, 2002). However, the
recent test might complicate interpretation of subsequent test results
because of the possibility of boosting.

*Serial Follow-Up of TB Screening and Testing for M. tuberculosis
Infection*

The need for serial follow-up screening for groups of HCWs with negative
test results for *M. tuberculosis* infection is an institutional
decision that is based on the setting\'s risk classification. This
decision and changes over time based on updated risk assessments should
be official and documented. If a serial follow-up screening program is
required, the risk assessment for the setting (see \"TB risk assessment
worksheet\" \[Appendix B\] in the original guideline document) will
determine which HCWs should be included in the program and the frequency
of screening. Two-step TST testing should not be performed for follow-up
testing.

If possible, stagger follow-up screening (rather than testing all HCWs
at the same time each year) so that all HCWs who work in the same area
or profession are not tested in the same month. Staggered screening of
HCWs (e.g., on the anniversary of their employment or on their
birthdays) increases opportunities for early recognition of
infection-control problems that can lead to conversions in test results
for *M. tuberculosis* infection. Processing aggregate analysis of TB
screening data on a periodic regular basis is important for detecting
problems.

*HCWs with a Newly Recognized Positive Test Result for M. tuberculosis
Infection or Symptoms or Signs of TB Disease*

[Clinical Evaluation]{.underline}

Any HCW with a newly recognized positive test result for *M.
tuberculosis* infection, test conversion, or symptoms or signs of TB
disease should be promptly evaluated. The evaluation should be arranged
with employee health, the local or state health department, or a
personal physician. Any physicians who evaluate HCWs with suspected TB
disease should be familiar with current diagnostic and therapeutic
guidelines for LTBI and TB disease (\"Treatment of tuberculosis,\" 2003;
\"Targeted tuberculin testing,\" 2000).

The definitions for positive test results for *M. tuberculosis*
infection and test conversion in HCWs are included in this report (see
Supplement, \"Diagnostic Procedures for LTBI and TB Disease\" in the
original guideline document). Symptoms of disease in the lung, pleura,
or airways, and the larynx include coughing for \>3 weeks, loss of
appetite, unexplained weight loss, night sweats, bloody sputum or
hemoptysis, hoarseness, fever, fatigue, or chest pain. The evaluation
should include a clinical examination and symptom screen (a procedure
used during a clinical evaluation in which patients are asked if they
have experienced any symptoms or signs of TB disease), chest radiograph,
and collection of sputum specimens.

If TB disease is diagnosed, begin antituberculosis treatment
immediately, according to published guidelines (\"Treatment of
tuberculosis,\" 2003). The diagnosing clinician (who might not be a
physician with the institution\'s infection-control program) should
notify the local or state health department in accordance with disease
reporting laws, which generally specify a 24-hour time limit.

If TB disease is excluded, offer the HCW treatment for LTBI in
accordance with published guidelines (see Supplements, \"Diagnostic
Procedures for LTBI and TB Disease\" in the original guideline document;
and \"Treatment Procedures for LTBI and TB Disease\" \[\"Targeted
tuberculin testing,\" 2000; CDC & ATS, 2003\]). If the HCW has already
completed treatment for LTBI and is part of a TB screening program,
instead of participating in serial skin testing, the HCW should be
monitored for symptoms of TB disease and should receive any available
training, which should include information on the symptoms of TB disease
and instructing the HCW to report any such symptoms immediately to
occupational health. In addition, annual symptom screens should be
performed, which can be administered as part of other HCW screening and
education efforts. Treatment for LTBI should be offered to HCWs who are
eligible (\"Targeted tuberculin testing,\" 2000).

HCWs with a previously negative test result who have an increase of
[\>]{.underline}10 mm induration when examined on follow-up testing
probably have acquired *M. tuberculosis* infection and should be
evaluated for TB disease. When disease is excluded, HCWs should be
treated for LTBI unless medically contraindicated (\"Targeted tuberculin
testing,\" 2000; CDC & ATS, 2003).

[Chest Radiography]{.underline}

HCWs with a baseline positive or newly positive TST or BAMT result
should receive one chest radiograph to exclude a diagnosis of TB disease
(or an interpretable copy within a reasonable time frame, such as 6
months). After this baseline chest radiograph is performed and the
result is documented, repeat radiographs are not needed unless symptoms
or signs of TB disease develop or a clinician recommends a repeat chest
radiograph (\"Targeted tuberculin testing,\" 2000; Food and Drug
Administration, 1983). Instead of participating in serial testing for
*M. tuberculosis* infection, HCWs with a positive test result for *M.
tuberculosis* infection should receive a symptom screen. The frequency
of this symptom screen should be determined by the risk classification
for the setting.

Serial follow-up chest radiographs are not recommended for HCWs with
documentation of a previously positive test result for *M. tuberculosis*
infection, treatment for LTBI or TB disease, or for asymptomatic HCWs
with negative test results for *M. tuberculosis* infection. HCWs who
have a previously positive test result for *M. tuberculosis* infection
and who change jobs should carry documentation of a baseline chest
radiograph result (and the positive test result for *M. tuberculosis*
infection) to their new employers.

[Workplace Restrictions]{.underline}

HCWs with a baseline positive or newly positive test result for *M.
tuberculosis* infection should receive one chest radiograph result to
exclude TB disease (or an interpretable copy within a reasonable time
frame, such as 6 months).

HCWs with confirmed infectious pulmonary, laryngeal, endobroncheal, or
tracheal TB disease, or a draining TB skin lesion pose a risk to
patients, HCWs, and others. Such HCWs should be excluded from the
workplace and should be allowed to return to work when the following
criteria have been met: 1) three consecutive sputum samples (Al Zahrani,
et al., 2001; Conde et al., 2000; Bell, Leckie, & McKendrick, 2003;
Merrick et al., 1997) collected in 8- to 24-hour intervals that are
negative, with at least one sample from an early morning specimen
(because respiratory secretions pool overnight); 2) the person has
responded to antituberculosis treatment that will probably be effective
(can be based on susceptibility results); and 3) the person is
determined to be noninfectious by a physician knowledgeable and
experienced in managing TB disease (see Supplements, \"Estimating the
Infectiousness of a TB Patient;\" \"Diagnostic Procedures for LTBI and
TB Disease;\" and \"Treatment Procedures for LTBI and TB Disease\" in
the original guideline document).

HCWs with extrapulmonary TB disease usually do not need to be excluded
from the workplace as long as no involvement of the respiratory track
has occurred. They can be confirmed as noninfectious and can continue to
work if documented evidence is available that indicates that concurrent
pulmonary TB disease has been excluded.

HCWs receiving treatment for LTBI can return to work immediately. HCWs
with LTBI who cannot take or do not accept or complete a full course of
treatment for LTBI should not be excluded from the workplace. They
should be counseled regarding the risk for developing TB disease and
instructed to report any TB symptoms immediately to the occupational
health unit.

HCWs who have a documented positive TST or BAMT result and who leave
employment should be counseled again, if possible, regarding the risk
for developing TB disease and instructed to seek prompt evaluation with
the local health department or their primary care physician if symptoms
of TB disease develop. Consider mailing letters to former HCWs who have
LTBI. This information should be recorded in the HCWs\' employee health
record when they leave employment.

Asymptomatic HCWs with a baseline positive or newly positive TST or BAMT
result do not need to be excluded from the workplace. Treatment for LTBI
should be considered in accordance with CDC guidelines (\"Targeted
tuberculin testing,\" 2000).

[Identification of Source Cases and Recording of Drug-Susceptibility
Patterns]{.underline}

If an HCW experiences a conversion in a test result for *M.
tuberculosis* infection, evaluate the HCW for a history of suspected or
known exposure to *M. tuberculosis* to determine the potential source.
When the source case is identified, also identify the drug
susceptibility pattern of the *M. tuberculosis* isolate from the source.
The drug-susceptibility pattern should be recorded in the HCW\'s medical
or employee health record to guide the treatment of LTBI or TB disease,
if indicated.

*HCWs with Medical Conditions Associated with Increased Risk for
Progression to TB Disease*

In settings in which HCWs are severely immunocompromised additional
precautions must be taken. Refer to the original guideline document for
additional information on HCWs with medical conditions associated with
increased risk for progression to TB disease.

**Problem Evaluation**

Contact investigations might be initiated in response to 1) conversions
in test results in HCWs for *M. tuberculosis* infection, 2) diagnosis of
TB disease in an HCW, 3) suspected person-to-person transmission of *M.
tuberculosis*, 4) lapses in TB infection-control practices that expose
HCWs and patients to *M. tuberculosis*, or 5) possible TB outbreaks
identified using automated laboratory systems (Widdowson et al., 2003).
In these situations, the objectives of a contact investigation might be
to 1) determine the likelihood that transmission of *M. tuberculosis*
has occurred; 2) determine the extent of *M. tuberculosis* transmission;
3) identify persons who were exposed, and, if possible, the sources of
potential transmission; 4) identify factors that could have contributed
to transmission, including failure of environmental infection-control
measures, failure to follow infection-control procedures, or inadequacy
of current measures or procedures; 5) implement recommended
interventions; 6) evaluate the effectiveness of the interventions; and
7) ensure that exposure to *M. tuberculosis* has been terminated and
that the conditions leading to exposure have been eliminated.

Earlier recognition of a setting in which *M. tuberculosis* transmission
has occurred could be facilitated through innovative approaches to TB
contact investigations (e.g., network analysis and genetic typing of
isolates). Network analysis makes use of information (e.g., shared
locations within a setting that might not be collected in traditional TB
contact investigations) (McElroy et al., \"A network informed,\" 2003).
This type of information might be useful during contact investigations
involving hospitals or correctional settings to identify any shared
wards, hospital rooms, or cells. Genotyping of isolates is universally
available in the United States and is a useful adjunct in the
investigation of *M. tuberculosis* transmission (McElroy et al.,
\"Outbreak of tuberculosis among homeless persons coinfected with human
immunodeficiency virus\", 2003; Nivin et al., 2002; Malakmadze et al.,
2005; Nardell et al., 1986). Because the situations prompting an
investigation are likely to vary, investigations should be tailored to
the individual circumstances. Recommendations provide general guidance
for conducting contact investigations (CDC, \"Guidelines for the
investigation\", 2005; CDC,\" Effective TB,\" 2004).

*General Recommendations for Investigating Conversions in Test Results
for M. tuberculosis Infection in HCWs*

A test conversion might need to be reported to the health department,
depending on state and local regulations. Problem evaluation during
contact investigations should be accomplished through cooperation
between infection-control personnel, occupational health, and the local
or state TB-control program. If a test conversion in an HCW is detected
as a result of serial screening and the source is not apparent, conduct
a source case investigation to determine the probable source and the
likelihood that transmission occurred in the health-care setting (CDC,
\"Effective TB,\" 2004).

Lapses in TB infection control that might have contributed to the
transmission of *M. tuberculosis* should be corrected. Test conversions
and TB disease among HCWs should be recorded and reported, according to
OSHA requirements (<http://www.osha.gov/recordkeeping>). Consult
*Recording and Reporting Occupational Injuries and Illness* (OSHA
standard 29 Code of Federal Regulations \[CFR\], 1904) to determine
recording and reporting requirements (Occupational Safety and Health
Administration, 2003).

Refer to the original guideline document for further details on the
following topics:

-   Investigating conversions in test results for *M. tuberculosis*
    Infection in HCWs: Probable source outside the health-care setting

-   Investigating conversions in test results for *M. tuberculosis*
    infection in HCWs: Known source in the health-care setting

-   Investigating a conversion of a test result for M. tuberculosis
    infection in an HCW with an unknown exposure

-   Investigations that do not identify a probable source

-   Conversions in test results for *M. tuberculosis* infection detected
    in follow-up testing

-   Investigating a case of TB disease in an HCW

-   Investigating possible patient-to-patient transmission of *M.
    tuberculosis*

-   Surveillance of TB cases in patients indicates possible
    patient-to-patient transmission of *M. tuberculosis*

-   Contact investigations

**Collaboration with the Local or State Health Department**

For assistance with the planning and implementation of TB-control
activities in the health-care setting and for names of experts to help
with policies, procedures, and program evaluation, settings should
coordinate with the local or state TB-control program. By law, the local
or state health department must be notified when TB disease is suspected
or confirmed in a patient or HCW so that follow up can be arranged and a
community contact investigation can be conducted. The local or state
health department should be notified as early as possible before the
patient is discharged to facilitate follow-up and continuation of
therapy by DOT (\"Treatment of tuberculosis,\" 2003). For inpatient
settings, coordinate a discharge plan with the patient (including a
patient who is an HCW with TB disease) and the TB-control program of the
local or state health department.

*Environmental Controls*

Environmental controls are the second line of defense in the TB
infection-control program, after administrative controls. Environmental
controls include technologies for the removal or inactivation of
airborne *M. tuberculosis*. These technologies include local exhaust
ventilation, general ventilation, HEPA filtration, and UVGI. These
controls help to prevent the spread and reduce the concentration of
infectious droplet nuclei in the air. A summary of environmental
controls and their use in prevention of transmission of *M.
tuberculosis* is provided in the Supplement section of the original
guideline document, including detailed information concerning the
application of environmental controls.

Refer to the original guideline document for more detailed information
on the following environmental control topics:

-   Local exhaust ventilation

-   General ventilation

-   Hepa filters

-   UVGI

*Program Issues*

Personnel from engineering, maintenance, safety and infection control,
and environmental health should collaborate to ensure the optimal
selection, installation, operation, and maintenance of environmental
controls. A written maintenance plan should be developed that outlines
the responsibility and authority for maintenance of the environmental
controls and addresses HCW training needs. Standard operating procedures
should include the notification of infection-control personnel before
performing maintenance on ventilation systems servicing TB patient-care
areas.

Personnel should schedule routine preventive maintenance for all
components of the ventilation systems (e.g., fans, filters, ducts,
supply diffusers, and exhaust grills) and air-cleaning devices. Quality
control (QC) checks should be conducted to verify that environmental
controls are operating as designed and that records are current.
Provisions for emergency electrical power should be made so that the
performance of essential environmental controls is not interrupted
during a power failure.

**Respiratory Protection**

The first two levels of the infection-control hierarchy, administrative
and environmental controls, minimize the number of areas in which
exposure to *M. tuberculosis* might occur. In addition, these
administrative and environmental controls also reduce, but do not
eliminate, the risk in the few areas in which exposures can still occur
(e.g., AII rooms and rooms where cough-inducing or aerosol-generating
procedures are performed). Because persons entering these areas might be
exposed to airborne *M. tuberculosis*, the third level of the hierarchy
is the use of respiratory protective equipment in situations that pose a
high risk for exposure (see Supplement, \"Respiratory Protection\" in
the original guideline document).

Refer to the original guideline for information regarding indications
for respiratory protection use.

*Respiratory-Protection Program*

OSHA requires health-care settings in which HCWs use respiratory
protection to develop, implement, and maintain a respiratory-protection
program. All HCWs who use respiratory protection should be included in
the program (see Supplement, \"Respiratory Protection\" in the original
guideline document).

Refer to the original guideline document for information regarding:

-   Training HCWS

-   Selection of respirators

-   Fit testing

*Respirator Options: General Recommendations*

In situations that require respiratory protection, the minimum
respiratory protection device is a filtering facepiece (nonpowered,
air-purifying, half-facepiece) respirator (e.g., an N95 disposable
respirator). This CDC/NIOSH-certified respirator meets the minimum
filtration performance for respiratory protection in areas in which
patients with suspected or confirmed TB disease might be encountered.
For situations in which the risk for exposure to *M. tuberculosis* is
especially high because of cough-inducing and aerosol-generating
procedures, more protective respirators might be needed (see
\"Respirator Options: Special Circumstances\" in the original guideline
document).

**Cough-Inducing and Aerosol-Generating Procedures**

*General Recommendations*

Procedures that involve instrumentation of the lower respiratory tract
or induction of sputum can increase the likelihood that droplet nuclei
will be expelled into the air. These cough-inducing procedures include
endotracheal intubation, suctioning, diagnostic sputum induction,
aerosol treatments (e.g., pentamidine therapy and nebulized treatments),
bronchoscopy, and laryngoscopy; gastric aspiration and nasogastric tube
placement can also induce cough in certain patients. Other procedures
that can generate aerosols include irrigating TB abscesses, homogenizing
or lyophilizing tissue, performing autopsies on cadavers with untreated
TB disease, and other processing of tissue that might contain tubercle
bacilli and TB laboratory procedures.

If possible, postpone cough-inducing or aerosol-generating procedures on
patients with suspected or confirmed infectious TB disease unless the
procedure can be performed with recommended precautions. When a
cough-inducing or aerosol-generating procedure must be performed on a
patient with suspected or confirmed infectious TB disease, use a local
exhaust ventilation device (e.g., booth or special enclosure). If using
this device is not feasible, perform the procedure in a room that meets
the ventilation requirements for an AII room.

After completion of cough-inducing procedures, keep patients in the AII
room or enclosure until coughing subsides. Patients should be given
tissues and instructed to cover the mouth and nose with tissues when
coughing. Tissues should be disposed of in accordance with the
infection-control plan.

Before the booth, enclosure, or room is used for another patient, allow
enough time for the removal of [\>]{.underline}99% of airborne
contaminants. This interval will vary based on the efficiency of the
ventilation or filtration system (see Supplement, \"Environmental
Controls\" and Table 2 in the original guideline document).

For postoperative recovery, do not place the patient in a recovery room
with other patients; place the patient in a room that meets the
ventilation requirements for an AII room. If the room does not meet the
ventilation requirements for an AII room, air-cleaning technologies
(e.g., HEPA filtration and UVGI) can be used to increase the number of
equivalent ACH (see Supplement, \"Environmental Controls\" in the
original guideline document).

Perform all manipulations of suspected or confirmed *M. tuberculosis*
specimens that might generate aerosols in a BSC. When in rooms or
enclosures in which cough-inducing or aerosol-generating procedures are
being performed, respiratory protection should be worn.

Refer to the original guideline document for the following:

-   Special considerations for bronchoscopy

-   Special considerations for administration of aerosolized pentamidine
    and other medications

Refer to the Supplement section in the original guideline document for
more information on the following topics:

-   Estimating the infectiousness of a TB patient

-   Diagnostic procedures for LTBI and TB disease

-   Treatment procedures for LTBI and TB disease

-   Surveillance and detection of *M. tuberculosis* infections in
    health-care settings

-   Environmental controls

-   Respiratory protection

-   Cleaning, disinfecting, and sterilizing patient-care equipment and
    rooms

#### CLINICAL ALGORITHM(S)

None provided

### EVIDENCE SUPPORTING THE RECOMMENDATIONS

#### REFERENCES SUPPORTING THE RECOMMENDATIONS

[References open in a new
window](http://www.guideline.gov/summary/select_ref.aspx?doc_id=8532)

#### TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The Centers for Disease Control and Prevention (CDC) prepared the
guidelines in this report in consultation with experts in tuberculosis
(TB), infection control, environmental control, respiratory protection,
and occupational health. Primary references citing evidence-based
science are used in this report to support explanatory material and
recommendations. Review articles, which include primary references, are
used for editorial style and brevity.

### BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS

#### POTENTIAL BENEFITS

Prevention of another tuberculosis (TB) resurgence and elimination of
the lingering threat to health-care workers (HCWs), which is primarily
from patients or other persons with unsuspected and undiagnosed
infectious TB disease

**Subgroups Most Likely to Benefit**

In addition to close contacts, the following persons are also at higher
risk for exposure to and infection with *M. tuberculosis*. Persons
listed who are also close contacts should be top priority.

-   Foreign-born persons, including children, especially those who have
    arrived to the United States within 5 years after moving from
    geographic areas with a high incidence of TB disease (e.g., Africa,
    Asia, Eastern Europe, Latin America, and Russia) or who frequently
    travel to countries with a high prevalence of TB disease.

-   Residents and employees of congregate settings that are high risk
    (e.g., correctional facilities, long-term-care facilities \[LTCFs\],
    and homeless shelters).

-   Health-care workers (HCWs) who serve patients who are at high risk.

-   HCWs with unprotected exposure to a patient with TB disease before
    the identification and correct airborne precautions of the patient.

-   Certain populations who are medically underserved and who have low
    income, as defined locally.

-   Populations at high risk who are defined locally as having an
    increased incidence of TB disease.

-   Infants, children, and adolescents exposed to adults in high-risk
    categories.

**Persons Whose Condition is at High Risk for Progression From LTBI to
TB Disease**

The following persons are at high risk for progressing from Latent
Tuberculosis Infection (LTB)I to TB disease:

-   Persons infected with human immunodeficiency virus (HIV)

-   Persons infected with *M. tuberculosis* within the previous 2 years

-   Infants and children aged \<4 years

-   Persons with any of the following clinical conditions or other
    immunocompromising conditions

    -   Silicosis

    -   Diabetes mellitus

    -   Chronic renal failure

    -   Certain hematologic disorders (leukemias and lymphomas)

    -   Other specific malignancies (e.g., carcinoma of the head, neck,
        or lung)

    -   Body weight [\>]{.underline}10% below ideal body weight

    -   Prolonged corticosteroid use

    -   Other immunosuppressive treatments (including tumor necrosis
        factor-alpha \[TNFa\] antagonists)

    -   Organ transplant

    -   End-stage renal disease (ESRD)

    -   Intestinal bypass or gastrectomy

-   Persons with a history of untreated or inadequately treated TB
    disease, including persons with chest radiograph findings consistent
    with previous TB disease.

Persons who use tobacco or alcohol, illegal drugs, including injection
drugs and crack cocaine, might also be at increased risk for infection
and disease. However, because of multiple other potential risk factors
that commonly occur among such persons, use of these substances has been
difficult to identify as separate risk factors.

#### POTENTIAL HARMS

-   False-positive and false-negative tuberculin skin tests for
    *Mycobacterium tuberculosis*

-   Adverse effect of therapy for tuberculosis

### CONTRAINDICATIONS

#### CONTRAINDICATIONS

-   A previous tuberculin skin test (TST) is not a contraindication to a
    subsequent TST unless the test was associated with severe ulceration
    or anaphylactic shock, which are substantially rare adverse events.

-   Persons who might not be good candidates for treatment of latent
    tuberculosis infection (LTBI) include those with a previous history
    of liver injury or a history of excessive alcohol consumption.
    Active hepatitis and end-stage liver disease are relative
    contraindications to the use of isoniazid (INH) for treatment of
    LTBI. If the decision is made to treat such patients, baseline and
    follow-up monitoring of serum aminotransaminases should be
    considered.

-   Reports of severe liver injury and death associated with the
    combination of rifampin and pyrazinamide (RZ) for treatment of LTBI
    prompted the American Thoracic Society and the Centers for Disease
    Control and Prevention (CDC) to revise previous recommendations to
    indicate that RZ generally should not be offered for the treatment
    of LTBI. If the potential benefits substantially outweigh the
    demonstrated risk for severe liver injury and death associated with
    this regimen and the patient has no contraindications, a physician
    with experience treating LTBI and TB disease should be consulted
    before using this regimen. Clinicians should continue the
    appropriate use of rifampin and pyrazinamide in standard multidrug
    antituberculosis treatment regimens for the treatment of TB disease.

-   Latex allergy can be a contraindication to skin testing if the
    allergy is severe and the products used to perform the test (e.g.,
    syringe plungers, PPD antigen bottle stopper, and gloves) contain
    latex.

### IMPLEMENTATION OF THE GUIDELINE

#### DESCRIPTION OF IMPLEMENTATION STRATEGY

Refer to the Major Recommendations field and the Supplement section in
the original guideline document for detailed information regarding
implementation strategy.

#### IMPLEMENTATION TOOLS

Chart Documentation/Checklists/Forms\
Staff Training/Competency Material

For information about
[availability](#identifying-information-and-availability), see the
\"Availability of Companion Documents\" and \"Patient Resources\" fields
below.

### INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES

#### IOM CARE NEED

Getting Better\
Staying Healthy

#### IOM DOMAIN

Effectiveness\
Patient-centeredness

### IDENTIFYING INFORMATION AND AVAILABILITY

#### BIBLIOGRAPHIC SOURCE(S)

Jensen PA, Lambert LA, Iademarco MF, Ridzon R. Guidelines for preventing
the transmission of Mycobacterium tuberculosis in health-care settings,
2005. MMWR Recomm Rep 2005 Dec 30;54(17):1-141. \[487 references\]
[PubMed](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16382216)

#### ADAPTATION

Not applicable: The guideline was not adapted from another source.

#### DATE RELEASED

2005 Dec 30

#### GUIDELINE DEVELOPER(S)

Centers for Disease Control and Prevention - Federal Government Agency
\[U.S.\]

#### SOURCE(S) OF FUNDING

United States Government

#### GUIDELINE COMMITTEE

TB Infection-Control Guidelines Work Group

#### COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

*Prepared by*: Paul A. Jensen, PhD, Division of Tuberculosis
Elimination, National Center for HIV, STD, and TB Prevention; Lauren A.
Lambert, MPH, Division of Tuberculosis Elimination, National Center for
HIV, STD, and TB Prevention; Michael F. Iademarco, MD, Division of
Tuberculosis Elimination, National Center for HIV, STD, and TB
Prevention; Renee Ridzon, MD, Division of Tuberculosis Elimination,
National Center for HIV, STD, and TB Prevention

*TB Infection-Control Guidelines Work Group Members*: Diane I. Bennett,
MD; Michael F. Iademarco, MD; Paul A. Jensen, PhD; Lauren A. Lambert,
MPH; Beverly Metchock, DrPH; Renee Ridzon, MD, Division of Tuberculosis
Elimination, National Center for HIV, STD and TB Prevention, CDC
(Currently with the Bill and Melinda Gates Foundation); Paul M. Arguin,
MD; Denise M. Cardo, MD; Amy B. Curtis, PhD; Adelisa L. Panlilio, MD;
Patricia M. Simone, MD, Division of Global Migration and Quarantine,
National Center for Infectious Diseases, CDC; Jennifer L. Cleveland,
DMD; Amy S. Collins, MPH, Division of Oral Health, National Center for
Chronic Disease Prevention and Health Promotion, CDC; G. Scott Earnest,
PhD, Division of Applied Research and Technology, National Institute for
Occupational Safety and Health, CDC; Teri Palermo, Division of
Respiratory Disease Studies, National Institute for Occupational Safety
and Health, CDC; Teresa A. Seitz, MPH, Division of Surveillance, Hazard
Evaluations, and Field Studies, National Institute for Occupational
Safety and Health; Yona Hackl, MS, Occupational Health and Safety,
Office of the Director, CDC; Jonathan Y. Richmond, PhD (Retired), Office
of Health and Safety, Office of the Director, CDC; John C. Ridderhof,
DrPH, Division of Public Health Partnerships, National Center for Health
Marketing, CDC; Allison Greenspan, Office of the Director, National
Center for Infectious Diseases, CDC

*External Contributors*: James August, MPH, American Federation of
State, County and Municipal Employees, Washington, DC; Scott Barnhart,
MD, Harborview Medical Center, Seattle, Washington; Joe Bick, MD,
University of California, Davis, California; Henry Blumberg, MD, Emory
University, Atlanta, Georgia; Dorothy Dougherty, Occupational Safety and
Health Administration, Washington, DC; Charles E. Dunn, Sr, Commercial
Lighting Design, Inc. (Lumalier), Memphis, Tennessee; Amanda L. Edens,
MPH, Occupational Safety and Health Administration, Washington, DC, New
Jersey Medical School, Newark, New Jersey; Kevin Fennelly, MD, New
Jersey Medical School, Newark, New Jersey; Victoria Fraser, MD,
Washington University School of Medicine, St. Louis, Missouri; Mary
Gilchrist, PhD, University Hygienic Laboratory, Iowa City, Iowa; Robert
J. Harrison, MD, California Department of Health Services, Oakland,
California; Denise Ingman, U.S. Department of Health and Human Services,
Helena, Montana; Pam Kellner, MPH, New York City Department of Health,
New York, New York; James McAuley, MD, Rush-Presbyterian-St. Luke\'s
Medical Center, Chicago, Illinois; Roy McKay, PhD, University of
Cincinnati, Cincinnati, Ohio; Dick Menzies, MD, McGill University,
Montreal, Canada; Shelly L. Miller, PhD, University of Colorado,
Boulder, Colorado; Jose Montero, MD, New Hampshire Department of Health
and Human Services, Concord, New Hampshire; Edward Nardell, MD, Harvard
Medical School, Boston, Massachusetts; Mark Nicas, PhD, University of
California at Berkeley, Berkeley, California; Paul S. Ninomura, Health
Resources and Services Administration, Seattle, Washington; Tholief
O\'Flaherty, PhD, New York City Department of Health, New York, New
York; Nicholas Pavelchak, New York State Department of Health, Troy, New
York; Jean Pottinger, MA, University of Iowa, Iowa City, Iowa; Gina
Pugliese, MS, Premier Safety Institute, Chicago, Illinois; Randall
Reves, MD, Denver Public Health Department, Denver, Colorado; Jane
Siegel, MD, University of Texas, Dallas, Texas; Kent Sepkowitz, MD,
Memorial Sloan-Kettering Cancer Center, New York, New York; Andrew J.
Streifel, MS, University of Minnesota, Minneapolis, Minnesota; Rachel L.
Stricof, MPH, New York State Department of Health, Albany, New York;
Michael L. Tapper, MD, Lenox Hill Hospital, New York, New York; Robert
Weinstein, MD, Healthcare Infection Control Practices Advisory
Committee; Sharon Welbel, MD, Cook County Hospital, Chicago, Illinois;
Karen Worthington, MS, Occupational Safety and Health Administration,
Lambertville, New Jersey

*CDC Contributors*: Heinz William Ahlers, JD, National Institute for
Occupational Safety and Health, CDC, Pittsburgh, Pennsylvania; Gabrielle
Benenson, MPH, National Center for HIV, STD, and TB Prevention, CDC,
Atlanta, Georgia; Roland BerryAnn, National Institute for Occupational
Safety and Health, CDC, Pittsburgh, Pennsylvania; Regina Bess, National
Center for HIV, STD, and TB Prevention, CDC, Atlanta, Georgia; Yvonne
Boudreau, MD, National Institute for Occupational Safety and Health,
CDC, Denver, Colorado; Kenneth G. Castro, MD, National Center for HIV,
STD, and TB Prevention, CDC, Atlanta, Georgia; L. Casey Chosewood, MD,
Office of Health and Safety, CDC, Atlanta, Georgia; Christopher C.
Coffey, PhD, National Institute for Occupational Safety and Health, CDC,
Morgantown, West Virginia; Janet L. Collins, PhD, National Center for
HIV, STD, and TB Prevention, CDC, Atlanta, Georgia; Maria Fraire, MPH,
National Center for HIV, STD, and TB Prevention, CDC, Atlanta, Georgia;
Judy Gibson, MSN, National Center for HIV, STD, and TB Prevention, CDC,
Atlanta, Georgia; Robert C. Good, PhD (Retired), National Center for
Infectious Diseases, CDC, Atlanta, Georgia; Maryam Haddad, MSN, National
Center for HIV, STD, and TB Prevention, CDC, Atlanta, Georgia; Connie
Henderson, National Center for HIV, STD, and TB Prevention, CDC,
Atlanta, Georgia; Kashef Ijaz, MD, National Center for HIV, STD, and TB
Prevention, CDC, Atlanta, Georgia; William R. Jarvis, MD (Retired),
National Center for Infectious Diseases, CDC, Atlanta, Georgia; John A.
Jereb, MD, National Center for HIV, STD, and TB Prevention, CDC,
Atlanta, Georgia; Margaret Kitt, MD, National Institute for Occupational
Safety and Health, CDC, Morgantown, West Virginia; Mark Lobato, MD,
National Center for HIV, STD, and TB Prevention, CDC, Atlanta, Georgia;
Suzanne Marks, MPH, National Center for HIV, STD, and TB Prevention,
CDC, Atlanta, Georgia; Stephen B. Martin, Jr., National Institute for
Occupational Safety and Health, CDC, Morgantown, West Virginia; Kenneth
F. Martinez, MSEE, National Institute for Occupational Safety and
Health, CDC, Cincinnati, Ohio; Jerry Mazurek, MD, National Center for
HIV, STD, and TB Prevention, CDC, Atlanta, Georgia; R. Leroy Mickelsen,
MS, National Institute for Occupational Safety and Health, CDC,
Cincinnati, Ohio; Vincent Mortimer, MS (Retired), National Institute for
Occupational Safety and Health, CDC, Cincinnati, Ohio; Glenda Newell,
National Center for HIV, STD, and TB Prevention, CDC, Atlanta, Georgia;
Tanja Popovic, MD, Office of the Director, CDC, Atlanta, Georgia;
Laurence D. Reed, MS, National Institute for Occupational Safety and
Health, CDC, Cincinnati, Ohio; Apavoo Rengasamy, PhD, National Institute
for Occupational Safety and Health, CDC, Pittsburgh, Pennsylvania;
Millie P. Schafer, PhD, National Institute for Occupational Safety and
Health, CDC, Cincinnati, Ohio; Philip Spradling, MD, National Center for
HIV, STD, and TB Prevention, CDC, Atlanta, Georgia; James W. Stephens,
PhD, National Institute for Occupational Safety and Health, CDC,
Atlanta, GA; Carol M. Stephenson, PhD, National Institute for
Occupational Safety and Health, CDC, Cincinnati, Ohio; Zachary Taylor,
MD, National Center for HIV, STD, and TB Prevention, CDC, Atlanta,
Georgia; Tonya Thrash, National Center for HIV, STD, and TB Prevention,
CDC, Atlanta, Georgia; Douglas B. Trout, MD, National Institute for
Occupational Safety and Health, CDC, Cincinnati, Ohio; Andrew Vernon,
MD, National Center for HIV, STD, and TB Prevention, CDC, Atlanta,
Georgia; Gregory R. Wagner, MD, National Institute for Occupational
Safety and Health, CDC, Washington, DC; Wanda Walton, PhD, National
Center for HIV, STD, and TB Prevention, CDC, Atlanta, Georgia; Angela M.
Weber, MS, National Center for Environmental Health, CDC, Atlanta,
Georgia; Robbin S. Weyant, PhD, Office of Health and Safety, CDC,
Atlanta, Georgia; John J. Whalen, MS (Retired), National Institute for
Occupational Safety and Health, CDC, Cincinnati, Ohio

#### FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Centers for Disease Control and Prevention (CDC), their planners, and
content experts wish to disclose they have no financial interests or
other relationships with the manufacturers of commercial products,
suppliers of commercial services, or commercial supporters.
Presentations will not include any discussion of the unlabeled use of a
product or a product under investigational use.

#### GUIDELINE STATUS

This is the current release of the guideline.

#### GUIDELINE AVAILABILITY

Electronic copies: Available from the Centers for Disease Control and
Prevention (CDC) Web site:

-   [HTML Format](http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5417a1.htm)

-   [Portable Document Format
    (PDF)](http://www.cdc.gov/mmwr/PDF/rr/rr5417.pdf)

Print copies: Available from the Centers for Disease Control and
Prevention, MMWR, Atlanta, GA 30333.  Additional copies can be purchased
from the Superintendent of Documents, U.S. Government Printing Office,
Washington, DC 20402-9325; (202) 783-3238.

#### AVAILABILITY OF COMPANION DOCUMENTS

A variety of implementation tools, including a risk assessment
worksheet, procedural observation checklist, medical evaluation request,
and a questionnaire for users of N95 respirators are available in the
appendices to the [original guideline
document](http://www.cdc.gov/mmwr/PDF/rr/rr5417.pdf).

A Continuing Education activity is also available at [CDC
Website](http://www2a.cdc.gov/ce/availableactivities.asp).

#### PATIENT RESOURCES

None available

#### NGC STATUS

This NGC summary was completed by ECRI on February 21, 2005.

#### COPYRIGHT STATEMENT

No copyright restrictions apply.

### DISCLAIMER

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Date Modified: 11/3/2008