Tuberculosis Intensive November 17 20, 2015 San Antonio, TX

(1)

EXCELLENCE EXPERTISE INNOVATION

Tuberculosis

Infection Prevention in Health

Care Settings

Jeffrey L. Levin, M.D., M.S.P.H.

November 18, 2015

Tuberculosis Intensive

November 17‐20, 2015

San Antonio, TX

• No conflict of interests

• No relevant financial relationships with any

commercial companies pertaining to this

educational activity

Jeffrey L. Levin, M.D., M.S.P.H. has the

following disclosures to make:

(2)

EXCELLENCE EXPERTISE INNOVATION

Tuberculosis

Infection Prevention in Health Care Settings

Jeffrey L. Levin, M.D., M.S.P.H.*

for Heartland National TB Center *Department of Occupational Health Sciences, The University of Texas Health Science Center at Tyler

Tuberculosis Intensive

• No conflict of interests

• No relevant financial relationships with any

commercial companies pertaining to this

educational activity

Jeffrey L. Levin, M.D., M.S.P.H.

has the

following disclosures to make:

(3)

To describe the components of an effective infection

prevention program including:

 Administrative controls to reduce risk of exposure

 Environmental controls to prevent spread and reduce

concentration of droplet nuclei

 Personal respiratory protection in areas with

increased risk of exposure

 Infection prevention in the operating room

Objectives

 CDC: Tuberculosis Infection Control and Prevention in Health Care Settings last accessed on 06‐29‐2014 at http://www.cdc.gov/tb/topic/infectioncontrol/default.htm#infection.  Centers for Disease Control and Prevention. Guidelines for preventing the transmission of Mycobacterium tuberculosis in Health‐Care Settings, 2005. MMWR Recommendations and Reports, December 30, 2005, Vol. 54, No. RR‐17; last accessed on 06‐29‐2014 at http://www.cdc.gov/mmwr/pdf/rr/rr5417.pdf.  NIOSH Workplace Safety & Health Topics: Tuberculosis web page last accessed on 06‐29‐2014 at http://www.cdc.gov/niosh/topics/tb/.  National Institute for Occupational Safety and Health. NIOSH respiratory protection program in health care facilities. September 1999; DHHS (NIOSH) Publication No. 99‐143.  OSHA: Tuberculosis web page last accessed on 06‐29‐2014 at https://www.osha.gov/SLTC/tuberculosis/index.html.

References & Resource Materials

(4)

 Early identification

 Prompt airborne infection isolation

 Effective treatment of persons with active

TB

 Guidance:

Centers for Disease Control and Prevention. Guidelines for preventing the transmission of Mycobacterium tuberculosis in Health‐Care Settings, 2005. MMWR Recommendations and Reports, December 30, 2005, Vol. 54, No. RR‐ 17; http://www.cdc.gov/mmwr/pdf/rr/rr5417.pdf.

Fundamentals of TB Infection Prevention

The Unsuspected Patient

with TB disease!!

What is the most dangerous type

of TB to Health Care Workers?

(5)

 Aerosol (airborne droplet nuclei) transmits infection  21‐23% of close contacts become infected  Patient factors  Disease in lung, airway, and/or larynx  Coughing or cough inducing procedure  Concentration of droplet nuclei (cavitary>non‐cavitary). Sputum smear – • Positive: transmission occurs • Negative, but culture positive: transmission less often  Environmental factors  Duration of contact  Small enclosed space  Poor ventilation or recirculation of room air  Other factors  Susceptibility of the host  Poorly understood bacteria characteristics  Infection rate drops rapidly with treatment initiation

Transmission of Tuberculosis

How long should

patients be isolated?

(6)

Patients are not considered infectious if they

meet the following criteria:

 Adequate therapy for 2 or 3 weeks

 Favorable clinical response

 Sputum smear negative x 3 (consecutive, 8‐24

hours apart, at least one early morning)

Traditional

CDC Isolation Recommendations

Disconnect:

Recommendation vs. Reality

Amended

CDC Isolation Recommendations

Many patients released from strict

isolation after 2 – 3 weeks

(cough resolved, energy improved,

smear grade↓, pan-susceptible

(7)

 Guiding principle: Minimize transmission risk

 Inpatient

therapy guidelines:



Is it worth putting more people at risk?



Clinical indications (e.g., massive hemoptysis,

concurrent disease complications)



High risk for poor adherence to therapy

Outpatient or Inpatient Therapy?

In general, patients who have suspected or confirmed

TB disease should be considered infectious if they

 have disease in the lungs, airway, or larynx, or

 are coughing, or

 are undergoing cough inducing procedures, or

 have positive AFB sputum smears,

And

 are not on anti‐tuberculosis chemotherapy, or

 have just started chemotherapy, or

 have a poor clinical or bacteriologic response to

chemotherapy.

Recognition of Infectiousness

(8)

 Exposure in small, enclosed spaces

 Inadequate local or general ventilation that results in

insufficient dilution or removal of infectious droplet

nuclei

 Recirculation of air containing infectious droplet nuclei

 Inadequate cleaning of equipment

Environmental Factors that

Enhance Probability of Transmission

 Advisory



CDC 2005 Guidelines



NIOSH and respirators

 Regulatory



Federal OSHA



State OSHA (where applicable)



State public health agency for reporting

 Accreditation



The Joint Commission

Agency “Oversight” for HCWs

(9)

 Applies to entire health care setting rather

than selected areas

 Scope of settings broader: laboratories, more

outpatient & non‐traditional settings

Overview of Scope Difference

2005 versus 1994 CDC Guidelines

(10)

All patients with confirmed drug‐susceptible TB disease should

remain in AII while hospitalized until they:

 have had three consecutive, negative AFB sputum smear results

collected in 8‐24 hour intervals (at least one should be an early

morning specimen as respiratory secretions pool overnight).

Will generally allow patients with negative smear results to be

released from airborne precautions in 2 days;

 demonstrate clinical improvement; and

 are on adequate anti‐TB chemotherapy.

Continued isolation for those with multi‐drug resistant TB

Airborne Infection Isolation (AII)

TB Infection Prevention Program and

Three‐Level Hierarchy of Controls

(11)

Administrative Controls

Primary strategy for

infection prevention

intended to reduce risk of

exposing uninfected

persons to persons who

have infectious TB

 Assigning responsibility for TB infection prevention

 Conducting a TB risk assessment

 Developing and instituting a written TB infection

prevention plan

 Ensuring the timely availability of lab

 Implementing effective work practices and work

assignments

 Ensuring proper cleaning/disinfection of equipment

 Training and education of HCWs

 Screening and evaluating HCWs

 Applying epidemiologic principles

 Coordinating efforts with state/local health departments

Administrative Controls

(12)

 TB infection prevention programs for settings where

patients with suspected or confirmed infectious TB

disease might be encountered (whether or not kept

beyond initial assessment or care)

 TB risk assessment (CDC 2005, Appendix B)

 Community rate of TB disease  Number of patients with TB disease presenting for care  Timeliness of recognition, isolation, and evaluation  Evidence for transmission of MTB in the setting  Types and condition of environmental controls present in facility  Annual risk assessment

Administrative Controls

 Baseline testing for M. tuberculosis infection  Serial testing for M. tuberculosis infection  Serial screening for signs or symptoms of TB disease ‐ exempt HCWs who have a documented history of a positive screening test result or adequate therapy for TB infection or disease, from further testing unless symptomatic  TB training and education  Two step TST versus blood analysis for MTB (BAMT/IGRA) strengths and

TB Screening for HCWs

(CDC 2005 – Appendix C)

(13)

Risk Classification to Determine Need for HCW

TB Screening and Frequency*

*CDC Guidelines, 2005

Environmental Controls

Environmental controls

(the second level of the

hierarchy) prevent the

spread and reduce the

concentration of infectious

droplet nuclei.

Environmental controls

include technologies for

the removal or inactivation

of M. tuberculosis.

(14)

 Primary

 Controlling the source of infection by use of local exhaust ventilation (hoods, tents, or booths)  Diluting and removing contaminated air by use of general ventilation

 Secondary

 Controlling the airflow to prevent contamination of air in areas adjacent to the source (Airborne Infection Isolation rooms or AII)  Cleaning the air by use of high‐efficiency particulate air (HEPA) filtration  CDC guidelines recommend the use of ultraviolet germicidal irradiation (UVGI) only with the simultaneous use of HEPA filters and high rates of purge airflow

Environmental Controls

 Two types of general ventilation system

 Single pass (preferred)  Recirculation (use of air‐cleaning technologies like HEPA filtration)  Constant air volume preferred over variable air volume systems as negative pressure differential easier to maintain

 Negative pressure

 Achieved by exhausting air at higher volumetric rates of 12 air changes per hour (ACH) in new facilities (> 6 ACH for AII in existing facilities)  Move air from less to more contaminated  Ceiling to floor one option to reduce HCW exposure

 Importance of monitoring and regular maintenance

Environmental Controls

General Ventilation‐Special Issues

(15)

 High‐efficiency particulate air filtration

 Minimum removal efficiency of 99.97% of particles >

or = to 0.3 microns in diameter

HEPA

CDC Guidelines, 2005

Room Air Flow Pattern

Designed to Provide Mixing of Air

(16)

An ante room is always recommended, as this provides a

barrier between the TB Room and hallways and limits the

impact of opening doors and traffic. Helps to maintain

Negative Isolation.

Patient

Room Ante room HEPA Filter

From CDC Guidelines, 2005

Monitoring Room Air Flow

Continuous Monitor with Pressure Alarm

(17)

 Normal OR Airflow: OR  Hallway



 Bacterial contamination of surgical field



But… Dissemination of TB from surgical field

 Measures to prevent TB dissemination in OR



Administrative: Schedule patient with TB disease during

low‐use period (few other patients/staff, extended time

after case for air purification)



Environmental: OR w/ ante room; Ante room air flow

pressure negative to OR & hallway; >95% efficiency filter

on expiratory port vent/anesthesia machine



Respiratory Protection: Staff wear N95 mask

Special Situation:

Operating Room (OR)

Personal Respiratory Protection

The third level of the

hierarchy is the use of

personal respiratory

protection in situations

that pose a relatively high

risk for exposure.

(18)

 Implementing a respiratory protection program

 Training HCWs on respiratory protection

 Training patients on respiratory hygiene and cough

etiquette procedures

Respiratory Protection Measures

 1994 – CDC Guidelines  10/17/1997 – OSHA published a proposed standard for occupational exposure to MTB (29 CFR 1910.139)  Respirator usage for TB regulated by OSHA under 29 CFR 1910.139 and compliance policy directive (CPL) 2.106 (Enforcement Procedures and Scheduling for Occupational Exposure to Tuberculosis) and CPL 2‐254A (Respiratory Protection Program Guidelines)  12/31/2003 – OSHA announced termination of rulemaking for a TB standard  Respirator usage for TB now regulated under the general industry standard for respiratory protection (29 CFR 1910.134)  Consolidated Appropriations Act for 2005 and 2006 – none of the funds appropriated to administer or enforce Respirator Standard to require annual fit testing beyond initial testing  Restrictions removed in 2008 – see OSHA at http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=INTERPRETATIONS&p_id

Respirators‐Sequence of Events

(19)

When Should Personal

Respiratory Protection be Used?

 In other settings where administrative

and environmental controls are not

likely to protect them from inhaling

infectious airborne droplet nuclei

 While conducting aerosol‐producing

procedures

 Entering areas in which patients with suspected or

confirmed infectious TB disease are being isolated

 Present during cough inducing or aerosol generating

procedures performed on patients with suspected or

confirmed infectious TB disease

Respirator Program Steps (NIOSH)

 Conduct a TB risk assessment

 Select respirators

 Write Standard Operating Procedures

(SOPs)

 Medically screen all users

 Provide training

 User seal check, fit‐test, and issue

respirators

 Inspect, clean, maintain, and store

respirators

 Evaluate the program

(20)

 At least N‐95 particulate filter respirators certified by

the National Institute for Occupational Safety and

Health (NIOSH) should be used and is adequate in most

situations

 Ability to adequately fit respirator wearers who are

included in a formal respiratory protection program

 Ability to fit the different facial sizes and characteristics

of health care workers. This can usually be met by

making respirators available in different sizes

 In selecting respirator models, give preference to

models shown by their manufacturers to have

inherently well fitting characteristics

Respirator Selection Criteria for MTB

OSHA’s

Respiratory Protection Standard

29 CFR 1910.134

(21)

Filtering Face Piece

A negative pressure particulate respirator with a

filter as an integral part of the face piece or with

the entire face piece composed of the filtering

medium. Meets the CDC/NIOSH criteria for N95.

Also includes other higher efficiency (99 and 100)

models and different (P and R) mask materials.

Nine classes: three levels of filter efficiency, each

with three categories of resistance to filter

efficiency degradation due to the presence of oil

aerosols

Classes of Non‐powered

Air‐Purifying Particulate Filters

N – 95, 99, 100 ; N for Not resistant to oil

R – 95, 99, 100 ; R for Resistant to oil

P – 95, 99, 100 ; P for oil Proof

(22)

An air‐purifying respirator that uses a blower to

force the ambient air through air‐purifying

elements to the inlet covering.

Powered Air‐Purifying Respirator

(PAPR)

Physician or Other Licensed Health

Care Professional (PLHCP)

An individual whose legally permitted scope of

practice (i.e., license, registration, or

certification) allows him/her to independently

provide, or be delegated the responsibility to

provide, some or all of the health care services

required by paragraph (e), Medical evaluation.

(23)

 Must provide a medical evaluation to determine employee’s ability to use a respirator, before fit testing and use  Must identify a PLHCP to perform medical evaluations using a medical questionnaire or an initial medical examination that obtains the same information  Medical evaluation must obtain the information requested by the questionnaire in Sections 1 and 2, Part A of App. C of the OSHA Standard  Follow‐up medical examination is required for an employee who gives a positive response to any question among questions 1 through 8 in Section 2, Part A of App. C or whose initial medical examination demonstrates the need for a follow‐up medical examination

Medical Evaluation: Procedures

 Annual review of medical status is not required

 At a minimum, employer must provide additional medical

evaluations if:

 Employee reports medical signs or symptoms related to the ability to use a respirator  PLHCP, supervisor, or program administrator informs the employer that an employee needs to be reevaluated  Information from the respirator program, including observations made during fit testing and program evaluation, indicates a need  Change occurs in workplace conditions that may substantially increase the physiological burden on an employee

Medical Evaluation

Additional Medical Evaluations

(24)

Fit Testing

Before an employee uses any respirator with a

negative or positive pressure tight-fitting face

piece, the employee must be fit tested with the same

make, model, style, and size of respirator that will be

used – annual testing and training.

Qualitative Fit Test (QLFT)

A pass/fail fit test to assess the adequacy of respirator fit

that relies on the individual’s response to the test agent.

Agents prescribed in Appendix A in OSHA Regulations – •Isoamyl Acetate •Saccharin Sodium