iii

TB

Respiratory Protection Program

In Health Care Facilities

Administrator's Guide

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service

Centers for Disease Control and Prevention

National Institute for Occupational Safety and Health

September 1999
iv

Discla imer

Mention of any company name or product does not constitute

endorsement by the National Institute for Occupational Safety and Health.

Copies of this and other NIOSH documents are available from

National Institute for Occupational Safety and Health

Publications Dissemination

4676 Columbia Parkway

Cincinnati, OH 45226-1998

1-800-35-NIOSH (1-800-356-4674)

Fax number: (513) 533-8573

To receive other information about

occupational safety and health problems, call

1-800-35-NIOSH (1-800-356-4674), or

visit the NIOSH Web site at:

www.cdc.gov/niosh

DHHS (NIOSH) Publication No. 99-143
v

For ew or d

The use of respirators in the health care setting is a relatively new but important step forward in the efforts to prevent the transmission of

tuberculosis (TB). Air purifying respirators provide a barrier to prevent

health care workers from inhaling Mycobacterium tuberculosis. The level of

protection a respirator provides is determined by the efficiency of the filter material and how well the facepiece fits or seals to the health care

worker’s face. A number of studies have shown that surgical masks will

not provide adequate protection in filtering out the TB organism. Additionally, surgical masks are not respirators and therefore, are not NIOSH

certified and do not satisfy OSHA requirements for respiratory protection.

The proper use of respirators represents a significant improvement in employee protection against TB. NIOSH realizes that the use of respirators

involves a number of new and perhaps confusing practices for the health

care community. This manual is designed to serve as a practical guide for

those individuals responsible for initiating and running a TB respiratory

protection program in health care facilities.

Other areas of the hospital may also require the use of respirators but the

program and respirators used may be different. If such a program exists in

your facility and has an experienced program administrator, it would be effective to administer the TB respirator program under the existing program

and use existing facilities for fit-testing, cleaning, maintenance, storage, etc.

This document is not designed to provide information on ventilation systems, negative pressure isolation rooms, and risk assessment methodologies,

which should be included in a total TB prevention program. The TB respirator program described in this document does not supplant the

respirator protection program necessary for other regulated hazards (e.g.,

formaldehyde or ethylene oxide) that may be found in health care facilities.

Sincerely yours,

Linda Rosenstock, M.D., M.P.H.

Director
vi

Ta ble of Conten of Conten t s

Disclaimer

Foreword

Abbreviations

Acknowledgments

Introduction

Respiratory Protection Program Elements For Health Care Workers

 Exposed To Tuberculosis

Respiratory Program Administration

General

NIOSH Recommended Steps for Improving the Knowledge and

 Skills of the Program Administrator

Duties

Step 1 Conduct a TB Risk Assessment

Step 2 Select Respirators

Respirator Selection for Protection Against TB

Introduction

Types of Respirators for Protection Against TB

A. Disposable Particulate Respirators

B. Replaceable Particulate Respirators

C. PAPRs

D. Positive-Pressure Supplied-Air Respirators

Step 3 Write Standard Operating Procedures

Sample SOP

Step 4 Medically Screen All Users

iv

v

ix

x

1

1

2

2

2

3

4

5

5

5

7

7

8

9

10

11

12

18
vii

Step 5 Provide Training

Respirator Training Program

Introduction

Who Should Receive Respirator Training

Who Should Conduct this Training

What Should the Training Include

OSHA Training Requirements Under 29 CFR 1910.139

Tips For Training

Establish Specific Training Objectives

Make the Objectives Measurable and Observable

Make the Objectives Known to the Trainee

Actively Involve the Trainee in the Training

Allow Time for Adjustment

Provide Feedback

Provide Refresher Training

Tips For Reducing Resistance and Promoting Safety Behaviors

Safety Management

Supervisory Practices

Additional Responsibilities of the Supervisor

Environmental and Organizational Supports

Step 6 User Seal Check, Fit-Test, and Issue Respirators

Respirator Face Fitting Procedures

Fit-Testing Procedures

User seal checking Procedures

Step 7 Inspect, Clean, Maintain, and Store Respirators

Routine Respirator Inspection

Introduction

Inspection Before and After Each Use

Inspection During Cleaning

19

19

19

19

19

19

20

21

21

21

21

21

22

22

22

22

23

23

24

24

26

26

26

27

28

28

28

28

30
viii

Cleaning, Repairing, and Storing Respirators Used For Protection Against TB

Introduction

Cleaning

A. Disassembly

B. Cleaning and Sanitizing

C. Cleaning and Sanitizing Solutions

D. Loose-Fitting PAPRS

Repair

Storage

Sample SOP

Step 8 Evaluate the Program

Respirator Program Evaluation

Annual Evaluation

Additional Evaluation

References

Appendix A 1910.139 Respiratory Protection for M. tuberculosis

Appendix B OSHA Instruction CPL 2.106 (TB Enforcement)

Appendix C 1910.1020 Access to Employee Exposure and Medical Records

Appendix D Names and Addresses of Respirator Manufacturers and Distributors

Appendix E Respiratory Protection Checklist

Appendix F CDC Guidelines (Pages 4-6)

Appendix G Memorandum for OSHA Regional Administrators

Appendix H Appendix A to 1910.134: Fit Testing Procedure

30

30

30

31

31

31

31

31

32

33

36

36

36

36

37

38

45

62

76

82

90

93

97
ix

ACGIH American Conference of Governmental Industrial Hygienists

AFB Acid-fast bacilli

AIHA American Industrial Hygiene Association

ANSI American National Standards Institute

APF Assigned Protection Factor

ATS American Thoracic Society

cc Cubic centimeter(s)

CDC Centers for Disease Control and Prevention

CFR Code of Federal Regulations

CNC Condensation nuclei counter

CNP Controlled negative pressure

DHHS Department of Health and Human Services

FF Fit-factor

g Gram(s)

HCWs Health Care Workers

HEPA filter High-efficiency particulate air filter

hr Hour(s)

in. Inch(es)

L Liter(s)

L/min Liter(s) per minute

M. tuberculosis Mycobacterium tuberculosis

mg Milligram(s)

min Minute(s)

ml Milliliter(s)

NIOSH National Institute for Occupational Safety and Health

OSHA Occupational Safety and Health Administration

QLFT Qualitative fit-testing

QNFT Quantitative fit-testing

PAPR Powered air-purifying respirator

PEL Permissible exposure limit

PPD Purified protein derivative

RPA Respirator Program Administrator

sec Second(s)

SOPs Standard operating procedures

TB Tuberculosis

USP United States Pharmacopeia

μm Micrometer

Abbreviations
x

Acknowledgments

This document was developed by Nancy Bollinger, Jeff Bryant, Walter

Ruch, Jerry Flesch, Edward Petsonk, Thomas Hodous, Brian Day, Teri

Palermo, Michael Colligan, Linda Martin, and Robert Mullan.

Technical review and assistance were provided by Larry Reed, Roland

Berry Ann, and Larry Murphy. Kim Clough, Brian Day, and Dorothy

Tan-Wilhelm produced the poster. We thank Anne Hamilton and

Chris Ellison for editing and Kim Clough for the cover design,

photography, and formatting of the document.

Cover photographs courtesy of MSA, Alpha Pro Tech, and NIOSH.

NIOSH thanks the many reviewers who helped in completing this

document, particularly the following agencies and their representatives:

CDC Hospital Infections Program, Elizabeth Bolyard

CDC Division of TB Elimination, Patricia Simone

CDC National Center for Infections Disease, Walter Bond

OSHA Demetra Collia and John Steelnack

Ruby Memorial Hospital Staff
1

Introduction

Written Standard Operating Procedures (SOPs)

describing the selection and use of respirators

must be developed. Information and guidance

needed for the proper selection, use, and care of

these devices must be included.

Respirator selection must be based on the

hazard to which the worker is exposed. More

protective respirators may be needed for certain high-risk procedures [CDC 1994, p. 99].

The respirator user must be trained in the

correct use of the respirator as well as its

limitations. This training must include instructions for wearing and adjusting the respirator

and for checking the fit.

Respirators must be regularly cleaned and

disinfected. Disposable respirators (cannot be

used by more than one person) must be discarded if they are soiled or physically damaged (e.g., creased or torn). If the replaceable

filter respirator is used by more than one

person (that is, not assigned to one person

permanently), it must be cleaned and disinfected after each use.

Respirators must be stored in a convenient,

clean, sanitary location. They must be stored so

they are protected from dust, harmful chemicals, sunlight, moisture, and excessive heat or

cold.

Respirators that are used routinely must be

inspected during cleaning, and damaged or

deteriorated parts must be replaced.

Appropriate surveillance must be maintained

for work area conditions and the degree of

worker exposure or stress. Any changes from

the last evaluation must be identified and

evaluated.

A regular inspection and evaluation (e.g.,

yearly) must be conducted to determine the

continued effectiveness of the program.

A determination must be made that a worker

Respiratory Protection

Program Elements For Health

Care Workers Exposed To

Tuberculosis

From 1985 to 1992, the incidence of turberculosis (TB)

in the general U.S. population increased approximately 14 percent, reversing a 30-year downward

trend. In 1993, 25,313 new cases of TB were reported

in the U.S. [CDC 1994]. Associated with this resurgence were hospital outbreaks of TB, and the emergence of multiple-drug-resistant TB. In response to

these public health threats, extensive efforts were

taken across the nation to improve TB-prevention and

TB-control programs. As a result of these measures,

since 1992, there has been a consistent decline in the

number and incidence of TB (i.e., 7.4 cases per 100,000

population and 19,855 total cases in 1997) and a

decline in multiple-drug-resistant TB [CDC 1998b].

The public health and the occupational risks of TB

thus appear to be once again decreasing, but they

remain very significant.

* Code of Federal Regulations. See CFR in references.

+ [29 CFR 1910.139] was formerly codified at [29 CFR 1910.134].

Health care workers exposed to patients with infectious TB require protection from that disease. Because the use of engineering controls (such as isolation rooms and ventilation) may not completely

control the TB hazard, respiratory protection is

needed.

When respirators are used, the Occupational Safety

and Health Administration (OSHA) standard for

respiratory protection for M. tuberculosis [29 CFR*

1910.139]+ must be followed. OSHA has stated that

it will promulgate a separate standard for TB; but

until then, the use of respirators for TB exposures

will be enforced under the original respiratory

protection program prescribed by OSHA in 29 CFR

1910.139 (see Appendix A). This program requires

the following:
2

NIOSH Recommended Steps for

Improving the Knowledge and Skills

of the Program Administrator

Become completely familiar with and understand the OSHA respirator standard.

Also understand standards, interpretation letters, and field manuals which

provide interpretation and inspection

methods used by OSHA inspectors (see

Appendix B).

Attend a respirator course given by commercial vendors and NIOSH Educational

Resource Centers.

Obtain materials from respirator manufacturers. These include VCR tapes, slide

shows, publications, etc.

Read and understand the NIOSH Guide to

Industrial Respiratory Protection [Bollinger

and Schutz 1987], the American National

Standard for Respiratory Protection [ANSI

Z88.2-1992], the American Industrial Hygiene Association Respiratory Protection

Manual [AIHA 1993], and the Centers for

Disease Control and Prevention (CDC) Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care

Facilities [CDC 1994].

Read respirator articles in the American

Industrial Hygiene Association Journal, Applied Occupational and Environmental Hygiene, and other journals. The Internet may

also be a source of information.

Read books on respiratory protection

available from The American Industrial

Hygiene Association (AIHA), The American Conference of Governmental Industrial Hygienists (ACGIH), and others.

Visit installations (health care and others)

that have ongoing respiratory protection

programs.

For a respirator program to be properly established and effective on a continuing basis,

written SOPs must be established. One person

(the program administrator) must be in charge

of the program and be given the authority and

responsibility to manage all aspects of the

program. The administrator must have sufficient knowledge (obtained by training or

experience) to develop and implement a respiratory protection program. Preferably, he or

she should have a background in industrial

hygiene, safety, health care, or engineering.

The program administrator should report to

the highest official possible (manager of the

safety department, supervisor of nurses,

worker health manager, infection control

manager, etc.) and should be given sufficient

time to administer the respirator program in

addition to any other duties assigned.

General

Respirator Program Administration

NOTE: Each of these requirements will be addressed in

more detail throughout this document.

is physically able to safely do the work while

using the respiratory protection equipment.

The physician must determine what health and

physical conditions are pertinent. The

respirator user's medical status should be

reviewed periodically (e.g., annually).

Respirators must be selected from those

approved by the National Institute for Occupational Safety and Health (NIOSH) under the

provisions of 42 CFR 84 or 30 CFR 11 (highefficiency particulate air [HEPA] filter only).

If a health care facility uses respirators for

worker protection against other regulated hazards (e.g., formaldehyde, ethylene oxide, etc.),

then a respirator program must be implemented for these hazards that incorporate all

the requirements of OSHA standard 1910.134.
3

Remember: Everything concerning the respirator program must be written.

N95 Disposable Respirator N95 Disposable Respirator

Photo courtesy of Geiss. Photo courtesy of Geiss.

Duties

The administrator must be responsible for the

entire program and ensure that the program is

written, reviewed, and implemented. The administrator should:

Develop a written policy statement showing that the employer is responsible for

providing a safe and healthful workplace.

For example: The management of this facility is responsible for providing a safe

workplace for its workers and for supplying respirators and any other materials

necessary to provide such an environment.

Develop a policy detailing the workers' responsibility to follow all written policies and

the consequences of not following them. For

example, the workers are responsible for

following all procedures and written policies

developed by the program manager; workers violating these policies may need to be

retrained and provided with positive feedback to improve adherence to the policies.

Provide a written program showing responsibility, accountability, and authority for conducting the program and indicate the person delegated to conduct

parts of the program.

Review the TB risk assessment regularly

to determine whether conditions have

changed. CDC recommends that this

review be conducted at least yearly in

minimal-, very low-, and low-risk categories; every 6-12 months for intermediate-risk categories; and every 3 months

in high-risk categories [CDC 1994, pp. 8-

23].

Determine what types and brands of respirators to purchase.

Designate an area or areas staffed to maintain, issue, and fit-test respiratory protective equipment.

Develop administrative procedures for the

purchase of approved respirators and for

inventory control of spare parts, if needed.

Ensure that only NIOSH-certified respirators are purchased and used.

Determine what records need to be kept,

where to keep them, and how long to keep

them. Consider the type of records that

need to be maintained to demonstrate

compliance with OSHA standards and to

satisfy any legal considerations. The administrator should follow the provisions of

29 CFR 1910.1020--OSHA's rule on Access

to Employee Exposure and Medical Records

(See Appendix C).

Write and/or approve all SOPs (SOPs

will be addressed later in more detail).
4

Step 1 Conduct a TB Risk Assessment

Conduct a risk assessment for the entire facility

and for specific areas within the facility. The

elements of the risk assessment are included

below for complete information on how to conduct the assessment. Perform a follow-up risk

assessment at the intervals indicated by the most

recent risk assessment [CDC 1994, Figure 1,

Table 2]. Determine who must wear a respirator

and be included in the program.

1. Review the community TB profile

(from public health department data).

2. Review the number of TB patients

who were treated in each area of the

facility (both inpatient and outpatient).

(This information can be obtained by

analyzing laboratory surveillance data

and by reviewing discharge diagnoses or

medical and infection-control records.)

3. Review the drug-susceptibility patterns of TB isolates of patients who were

treated at the facility.

4. Analyze purified protein derivative

(PPD)-tuberculin skin-test results of

health care workers (HCWs), by area or

by occupational group for HCWs not

assigned to a specific area (e.g., respiratory therapists).

5. To evaluate infection-control parameters, review medical records of a sample

of TB patients seen at the facility.

Calculate intervals from:

admission until TB suspected;

admission until TB evaluation

performed;

admission until acid-fast bacilli (AFB)

specimens ordered;

AFB specimens ordered until AFB

specimens collected;

AFB specimens collected until AFB

smears performed and reported;

AFB specimens collected until cultures

performed and reported;

AFB specimens collected until species

identification conducted and reported;

AFB specimens collected until drugsusceptibility tests performed and

reported;

admission until TB isolation initiated;

admission until TB treatment initiated;

and duration of TB isolation.

 Obtain the following additional information:

Were appropriate criteria used for discontinuing isolation?

Did the patient have a history of prior

admission to the facility?

Was the TB treatment regiment

adequate?

Were follow-up sputum specimens

collected properly?

Was appropriate discharge planning

conducted?

 6. Perform an observational review of TB

 infection control practices.

 7. Review the most recent environmental

 evaluation and maintenance procedures.

Copies of the Morbidity and Mortality Weekly

Report (October 28, 1994/Vol. 43/No. RR-13)

entitled "Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health Care

Facilities, 1994" may be obtained by calling

1-800-843-6356 or is available through the CDC

homepage at http://www.cdc.gov.

TABLE 1. Elements of a risk assessment

for tuberculosis (TB) in health care facilities (Reprinted from [CDC 1994, page 8])
5

collected, the precise level of effectiveness

in protecting HCWs [health care workers]

from M. tuberculosis transmission in health

care settings has not been determined. Information concerning the transmission of

M. tuberculosis is incomplete. Neither the

smallest infectious dose of M. tuberculosis

nor the highest level of exposure to M. tuberculosis at which transmission will not occur has been defined conclusively (59, 151,

152). Furthermore, the size distribution of

droplet nuclei and the number of particles

containing viable M. tuberculosis that are expelled by infectious TB patients have not

been defined adequately, and accurate

methods of measuring the concentration of

infectious droplet nuclei in a room have not

been developed.

Nevertheless, in certain settings the administrative and engineering controls may not

adequately protect HCWs from airborne

droplet nuclei (e.g., in TB isolation rooms,

treatment rooms in which cough-inducing

or aerosol-generating procedures are performed, and ambulances during the transport of infectious TB patients). Respiratory

protective devices used in these settings

should have characteristics that are suitable

for the organism they are protecting against

and the settings in which they are used.

A. Performance Criteria for Personal

Respirators for Protection Against

Transmission of M. tuberculosis

Respiratory protective devices used in

health care settings for protection against

M. tuberculosis should meet the following

standard criteria. These criteria are based

on currently available information, including a) data on the effectiveness of respiratory protection against noninfectious

hazardous materials in workplaces other

than health care settings and on an interStep 2 Select Respirators

Introduction

Surgical masks are not respirators and are not certified as such; they do not protect the user adequately

from exposure to TB. Disposable respirators (e.g.,

N-95s) are commonly used in TB isolation rooms,

in transport of TB cases, or in other areas of the

health care facility. However, when high-risk procedures such as bronchoscopy or autopsy are conducted, respiratory protection exceeding the CDC

standard performance criteria may be needed.

This protection includes full facepiece negative-pressure respirators, powered air-purifying respirators

(PAPRs), or positive-pressure airline respirators

equipped with a half-mask or full facepiece.

In addition, individual medical conditions such as

latex allergy, can influence respirator selections. Latex-free respirators are available.

Additional information is provided below.

I. Consideration for Selection of Respirators

Personal respiratory protection should be used

by a) persons entering rooms where patients

with known or suspected infectious TB are being isolated, b) persons present during coughinducing or aerosol-generating procedures performed on such patients, and c) persons in other

settings where administrative and engineering

controls are not likely to protect them from inhaling infectious airborne droplet nuclei. These

other settings should be identified on the basis

of the facility’s risk assessment.

Although data regarding the effectiveness

of respiratory protection from many hazardous airborne materials have been

Supplement 4: Respiratory Protection

(Reprinted from [CDC 1994, Page 97])

Respirator Selection For Protection

Against TB
6

pretation of how these data can be applied to respiratory protection against M.

tuberculosis; b) data on the efficiency of

respirator filters in filtering biological

aerosols; c) data on face-seal leakage; and

d) data on the characteristics of respirators that were used in conjunction with

administrative and engineering controls

in outbreak settings where transmission to

HCWs and patients was terminated.

1. The ability to filter particles 1 μm in size

in the unloaded state with a filter efficiency

of > 95% (i.e., filter leakage < of 5%), given

flow rates of up to 50 L per minute.

Available data suggest that infectious

droplet nuclei range in size from 1 mm to 5

mm; therefore, respirators used in health

care settings should be able to efficiently

filter the smallest particles in this range.

Fifty liters per minute is a reasonable

estimate of the highest airflow rate an

HCW is likely to achieve during breathing,

even while performing strenuous work

activities.

2. The ability to be qualitatively or quantitatively fit tested in a reliable way to

obtain a face-seal leakage of < 10% (54,

55).

3. The ability to fit the different facial sizes

and characteristics of HCWs, which can

usually be met by making the respirators

available in at least three sizes.

4. The ability to be checked for facepiece

fit, in accordance with OSHA standards

and good industrial hygiene practice, by

HCWs each time they put on their

respirators (54, 55).

In some settings, HCWs may be at risk for

two types of exposure: a) inhalation of M.

tuberculosis and b) mucous membrane

exposure to fluids that may contain

bloodborne pathogens. In these settings,

protection against both types of exposure

should be used.

When operative procedures (or other procedures requiring a sterile field) are performed on patients who may have infectious TB, respiratory protection worn by the

HCW should serve two functions: a) it

should protect the surgical field from the

respiratory secretions of the HCW and b) it

should protect the HCW from infectious

droplet nuclei that may be expelled by the

patient or generated by the procedure. Respirators with expiration valves and positive-pressure respirators do not protect the

sterile field; therefore, a respirator that does

not have a valve and that meets the criteria

in Supplement 4, Section I.A, should be

used.

References reprinted from supplement

4 [CDC 1994, page 108 & page 112]

54. American National Standards

Institute. American national standard practices for respiratory protection. New York: American

National Standards Institute, 1992.

55. NIOSH. Guide to industrial respiratory protection. Morgantown,

WV: US Department of Health and

Human Services, Public Health Service, CDC, 1987; DHHS publication no. (NIOSH)87-116.

59. CDC/National Institutes of Health.

Agent: Mycobacterium tuberculosis,

M. bovis. In: Biosafety in microbiological and biomedical laboratories.

Atlanta: US Department of Health

and Human Services, Public Health

Service, 1993:95; DHHS publication no. (CDC)93-8395.
7

NOTE: Allow users to choose from a variety of

respirators (several manufacturers and sizes) to

obtain the best and most comfortable fit possible.§

The minimum level of respiratory protection for

TB recommended by NIOSH is the N-95 halfmask respirator.

A. Disposable Particulate Respirators

The NIOSH-certified disposable respirators

labeled N, R, or P meet CDC criteria and may

be obtained with or without exhalation valves.

Most manufacturers also produce them in

different sizes. A face shield may also be used

in conjunction with a half-mask disposable

respirator for protection against body fluids.

Advantages

1. The respirator is disposable and most models require no cleaning or maintenance

(See page 28).

2. The respirator is light weight and fairly

comfortable to wear.

Disadvantages

1. The respirator is a negative-pressure device

using the suction produced by inhalation to

draw air through the filter. The inhalation

process, even under the best of circumstances,

will allow some contaminated air to leak into

the facepiece.

2. A respirator with exhalation valves cannot

be used when working in a sterile field such

as an operating room. The exhalation valve

allows droplets and particles exhaled by the

user to escape and potentially contaminate

the surgical field. These respirators are also

available without exhalation valves.

151. Bloom BR, Murray CJL. Tuberculosis: commentary on a reemergent

killer. Science 1992;257:1055-64.

152. Nardell EA. Dodging droplet nuclei:

reducing the probability of nosocomial tuberculosis transmission in the

AIDS era. Am Rev Respir Dis

1990;142:501-3.

Disposable

Particulate

Respirator with

adjustable straps

and exhalation

valve.

Photo courtesy

of MSA.

Disposable

Particulate

Respirator.

Photo courtesy of

Alpha Pro Tech.

Disposable

Particulate

Respirator with

fixed straps and no

exhalation valve.

Photo courtesy of

MSA.

Types of Respirators for Protection

Against TB

§See Appendix D for a list of manufacturers.

References from supplement 4 continued
8

The full facepiece respirator also meets CDC

requirements for respiratory protection against

exposure to TB. The respirator can be equipped

with the N, R, or P filters (HEPA filters can

also be used). It is also manufactured in more

than one size.

B. Replaceable Particulate Filter

 Respirators

The half-mask respirator also meets CDC

requirements. This respirator has single or dual

filters made of the same material as the N, R, and P

disposable respirators (HEPA filters can also be

used). Most manufacturers produce more than one

size. A face shield may also be used in conjunction

with a half-mask particulate filter respirator for

protection against body fluids.

Full Facepiece Replaceable Particulate

Filter Respirator

 Half-Mask Replaceable Particulate

 Filter Respirator

Advantages

1. The respirator provides a better seal than

the half-mask and with HEPA or 100 series

filter is more protective.

2. The respirator is durable.

3. The respirator provides eye protection.

Disadvantages

1. The respirator cannot be used in areas

where a sterile field is required.

2. The respirator must be inspected, cleaned,

and repaired.

3. The respirator is a negative-pressure device

using the suction produced by inhalation to draw

air through the filter. The inhalation process, even

NOTE: Manufacturer A’s small size is not

necessarily the same as Manufacturer B’s small size.

Advantages

1. The respirator is lightweight and does not

restrict mobility.

2. The respirator is made of rubber or elastomer

and is durable. Only the filters need to be

replaced when necessary.

Disadvantages

1. The respirator must be routinely inspected,

cleaned, disinfected, and repaired (See Step 7).

2. The respirator is a negative-pressure device

using the suction produced by inhalation to

draw air through the filter. The inhalation

process, even under the best of circumstances,

will allow some contaminated air to leak into the

facepiece.

3. Communication may be difficult.

4. The respirator cannot be used in areas where a

sterile field is required (surgical suite).

Half-Mask Replaceable Particulate Filter Respirator.

Photo (left) courtesy of Neoterik Health Technologies

Inc. Photo (right) courtesy of NIOSH.

Full Facepiece

Replaceable

Particulate Filter

Respirator.

Photo courtesy of

NIOSH.
9

C. PAPRs

Tight-Fitting PAPR

These respirators also meet CDC guidelines for

protection against TB exposure. The equipment

is battery operated, consists of a half or full

facepiece, breathing tube, battery-operated

blower, and particulate filters (HEPA only). A

PAPR uses a blower to pass contaminated air

through a HEPA filter, which removes the contaminant and supplies purified air to a facepiece.

A PAPR is not a true positive-pressure device because it can be over-breathed when inhaling. A

face shield may also be used in conjunction with

a half-mask PAPR respirator for protection

against body fluids.

Advantages

1. The respirator is more protective than a

half-mask respirator.

2. The respirator is usually more comfortable

because air is forced into the mask by the

blower, producing a cooling effect.

3. The respirator is durable.

4. Breathing resistance is lower.

Disadvantages

1. The respirator cannot be used where a

sterile field is required because it has an

exhalation valve and in some cases air can exit

around the face seal.

2. Batteries must be recharged and maintained

to assure proper flow rates into the mask.

3. The respirator must be inspected, cleaned,

and repaired.

4. Communication may be a problem.

5. A PAPR may be bulky and noisy.

Loose Fitting PAPR

This respirator consists of a hood or helmet,

breathing tube, battery-operated blower, and

HEPA filters. It meets CDC guidelines.

Advantages

1. More protective than a half-mask respirator.

2. The respirator is more comfortable because

it is loose-fitting.

3. Provides a cooling effect in the hood or

helmet.

Tight-Fitting PAPR.

Photo courtesy

of NIOSH.

Loose-Fitting PAPR.

Photo courtesy of

Neoterik Health

Technologies Inc.

under the best of circumstances, will allow some

contaminated air to leak into the facepiece.

4. Communication may be difficult.

5. Special lens kits are required for those

respirator users who wear glasses.

4. The respirator is durable.

5. Breathing resistance

is lower.

6. Vision may be better.
10

Advantages

1. The respirator is much more protective because it provides positive pressure in the

facepiece and almost all leakage is outward.

A positive-pressure supplied-air respirator

should be used when disposable respirators,

replaceable respirators, or PAPRs do not provide adequate protection.

2. Breathing resistance is minimal.

3. The respirator is relatively comfortable to

wear.

D. Positive-Pressure Supplied-Air

Respirators

Supplied-air respirators use compressed air

from a stationary source delivered through a

hose under pressure to a half-mask or a full

facepiece. A face shield may also be used in

conjunction with a half-mask airline respirator

for protection against body fluids.

Positive-Pressure

Supplied-Air

Respirators.

Photo courtesy of

NIOSH.

7. Can be worn with facial hair as long as facial

hair does not interfere with valve or function of

the respirator.

Disadvantages

1. The equipment cannot be used where a sterile field must be maintained because air exits

around the hood or helmet.

2. Batteries must be charged and maintained.

3. The respirator must be inspected, cleaned,

and repaired.

4. Communication may be difficult.

5. A PAPR may be bulky and noisy.

Disadvantages

1. The airline hose restricts the user’s mobility.

2. This respirator exhausts air contaminated

by the user and should not be worn during

sterile procedures.

3. The respirator must be inspected, cleaned,

and repaired.

4. Communication may be difficult.

5. Requires installation and maintenance of a

regulated compressed air supply for Grade D

breathing air.

6. Maintenance requires highly skilled, technically trained personnel.

7. Length of hose and connection point must

be adequate to prevent exposure to TB when

removing the respirator.
11

1. Administrative procedures:

A. Employer responsibilities

B. Employee responsibilities

C. Purchase of certified respirators

D. Inventory control

E. Issuance of respirators

F. Special problems (beards, etc.)

2. Respirator selection

3. Medical surveillance

4. Respirator training program

5. Respirator face-fitting procedures

6. Maintenance procedures:

A. Cleaning and sanitizing

B. Inspection

C. Repair

D. Storage

7. Program evaluation

Guidance for an SOP follows on the next

page. Additional information on SOPs may

also be available from the manufacturer of

the respirator.

Step 3 Write Standard Operating Procedures

The importance of written Standard Operating

Procedures (SOPs) is emphasized by OSHA in

29 CFR Part 1910.139 which specifies the first

requirement for a “minimal acceptable (respirator) program” as establishment of written SOPs

governing the selection and use of respirators.

Part 1910.139 does not provide any guidance

for preparing these procedures and does not

differentiate between large and small users.

An SOP is a detailed written procedure that describes an operation so thoroughly that it can be

accomplished repeatedly and can consistently

arrive at the same end point. No room for interpretation exists. The SOPs should contain all

information needed to maintain an effective respirator program to meet the user’s individual

requirements. SOPs should be written to be

useful to those directly involved in the respirator program, the program administrator, those

fitting the respirators and training the workers,

respirator maintenance workers, and the supervisors responsible for overseeing respirator use

on the job. Generally, the procedures should

cover the following topics:

Photo courtesy of Racal Health & Safety, Inc.
12

Purpose:

The purpose of this standard operating procedure is to ensure the protection of all employees from

respiratory hazards caused by exposure to TB, through the proper use of respirators.

Responsibility:

The Respirator Program Administrator (RPA) is _________________________________. She/he is

solely responsible for all aspects of this program and has full authority to make the necessary decisions to

ensure its success. This authority includes (but is not limited to) hiring personnel, purchasing the

necessary equipment to implement the program, and operate the respiratory protection program. The RPA

(or designee) will develop written detailed instructions covering each of the basic elements in this

program, and is the only person authorized to amend these instructions.

The ABC health care facility has expressly authorized the RPA to audit and change respirator usage

procedures whenever there is a chance of exposure to TB. This includes designating mandatory respirator

usage areas.

Program Elements:

1. The RPA (or designee) will develop detailed written standard operating procedures governing the

selection and use of respirators, using the OSHA regulations and the NIOSH Respirator Decision Logic

as guidelines. Outside consultation, manufacturers assistance, and other recognized authorities will be

consulted if there is any doubt regarding proper selection and use of respirators. These detailed

procedures will be included as appendices to this respirator program. Only the RPA may amend these

procedures.

2. Respirators will be selected on the basis of CDC guidelines. All selections will be made by the RPA

(or designee). Only NIOSH certified respirators will be selected and used.

3. The user will be instructed and trained in the proper use of respirators and their limitations. Both

supervisors and workers will be trained by the RPA (or designee). The training should provide the

employee an opportunity to handle the respirator, have it fitted properly, test its facepiece-to-face seal,

wear it in normal air for a long familiarity period, and finally to wear it in a test atmosphere. Every

respirator wearer will receive fitting instructions, including demonstrations and practice in how the

respirator should be worn, how to adjust it, and how to determine if it fits properly.

Respirators should not be worn when conditions prevent a good face seal. Such conditions may be a

growth of beard, sideburns, a skull cap that projects under the facepiece, or temple pieces on glasses.

No employees of this facility, who are required to wear tight fitting respirators may wear beards. Also

the absence of one or both dentures can seriously affect the fit of a facepiece. The workers diligence in

observing these factors will be evaluated by periodic checks. To assure proper protection, the user seal

check will be done by the wearer each time she/he puts on the respirator. The manufactures instructions

will be followed.

ABC Health Care Facility

Respiratory Protection Program
13

4. Where practicable, the respirators will be assigned to individual workers for their exclusive use.

5. Nondisposable respirators will be regularly cleaned and disinfected. Those issued for the

exclusive use of one worker will be cleaned after each days use, or more often if necessary. Those

used by more than one worker will be thoroughly cleaned and disinfected after each use. The RPA

will establish a respirator cleaning and maintenance facility and develop detailed written cleaning

instructions.

Disposable respirators will be discarded if they are soiled or are no longer functional. See the

manufacturers instructions.

6. The central respirator cleaning and maintenance facility will store respirators in a clean and

sanitary location.

7. Respirators used routinely will be inspected during cleaning. Worn or deteriorated parts will be

replaced.

8. Appropriate (e.g., quarterly) surveillance of work area conditions and degree of employee exposure

will be maintained.

9. There will be regular (e.g., annually) inspections and evaluations to determine the continued

effectiveness of the program. The RPA will make frequent inspections of all areas where

respirators are used to ensure compliance with the respiratory protection programs.

10. Persons will not be assigned to tasks requiring use of respirators unless it has been determined that

they are physically able to perform the work and use the equipment. The ABC health care facility

physician will determine what health and physical conditions are pertinent. The respirator users

medical status will be reviewed annually.

11. NIOSH certified respirators will be used.

Respirator Program Evaluation Checklist

In general, the respiratory protection program should be evaluated for each job or at least annually, with

program adjustments, as appropriate, made to reflect the evaluation results. Program function can be

separated into administration and operation.

A. Program Administration

____________ (1) Is there a written policy which acknowledges employer responsibility for

providing a safe and healthful workplace, and assigns program responsibility,

accountability, and authority?

____________ (2) Is program responsibility vested in one individual who is knowledgeable and

who can coordinate all aspects of the program at the health care facility?
14

____________ (3) Can administrative and engineering controls eliminate the need for respirators?

____________ (4) Are there written procedures/statements covering the various aspects of the

respirator program, including:

____________ (a) designation of an administrator;

____________ (b) respirator selection;

____________ (c) purchase of NIOSH certified respirators;

____________ (d) medical aspects of respirator usage;

____________ (e) issuance of equipment;

____________ (f) fitting;

____________ (g) training;

____________ (h) maintenance, storage, and repair;

____________ (i) inspection;

____________ (j) use under special conditions; and

____________ (k) work area surveillance?

B. Program Operation

(1) Respiratory protective equipment selection

____________ (a) Are work area conditions and worker exposures properly surveyed?

____________ (b) Are respirators selected on the basis of the hazard to which the worker

is exposed?

____________ (c) Are selections made by individuals knowledgeable in proper selection

procedures?

____________ (2) Are only NIOSH certified respirators purchased and used; do they provide

adequate protection for the specific hazard?

____________ (3) Has a medical evaluation of the prospective user been made to determine

physical and psychological ability to wear the selected respiratory protective

equipment?

____________ (4) Where practical, have respirators been issued to the users for their exclusive

use, and are there records covering issuance?

(5) Respiratory protective equipment fitting

____________ (a) Are the users given the opportunity to try on several respirators to

determine whether the respirator they will be subsequently wearing is the

best fitting one?

____________ (b) Is the fit tested at appropriate intervals?
15

____________ (c) Are those users who require corrective lenses properly fitted?

____________ (d) Is the facepiece-to-faceseal tested in a test atmosphere?

____________ (e) Are workers prohibited from wearing respirators in contaminated

work areas when they have facial hair or other characteristics which

may cause faceseal leakage?

(6) Respirator use in the work area

____________ (a) Are respirators being worn correctly (i.e., head covering over respirator

straps)?

____________ (b) Are workers keeping respirators on all the time while in the designated

areas?

(7) Maintenance of respiratory protective equipment

Cleaning and Disinfecting

____________ (a) Are nondisposable respirators cleaned and disinfected after each use

when different people use the same device, or as frequently as necessary for

devices issued to individual users?

____________ (b) Are proper methods of cleaning and disinfecting utilized?

Storage

____________ (a) Are respirators stored in a manner so as to protect them from dust,

sunlight, heat, damaging chemicals, or excessive cold or moisture?

____________ (b) Are respirators stored in a storage facility so as to prevent them from

deforming?

____________ (c) Is storage in lockers permitted only if the respirator is in a carrying case

or carton?

Inspection

____________ (a) Are respirators inspected before and after each use and during cleaning?

____________ (b) Are qualified individuals/users instructed in inspection techniques?
16

____________ (c) Are records kept of the inspection of respiratory protective equipment?

Repair

____________ (a) Are replacement parts used in repair those of the manufacturer of the

respirator?

____________ (b) Are repairs made by trained individuals?

(8) Training and Feedback

____________ (a) Are users trained in proper respirator use, cleaning, and inspection?

____________ (b) Are users trained in the basis for selection of respirators?

____________ (c) Are users evaluated, using competency-based evaluation, before and

after training?

____________ (d) Are users periodically consulted about program issues (e.g., discomfort,

fatigue, etc.)
17

SAMPLE RESPIRATOR INSPECTION RECORD

1. TYPE_________________________________________ 2. NO._______________________

3. DATE:_____________________________________________________________________

A. Facepiece

B. Inhalation Valve

C. Exhalation Valve Assembly

D. Headbands / Straps

E. Filter Cartridge

F. Cartridge/Canister

G. Harness Assembly

H. Hose Assembly

I. Speaking Diaphragm

J. Gaskets

K. Connections

L. Other Defects

DEFECTS FOUND CORRECTIVE ACTION
18

Respirators place several physiological stresses

on wearers—stresses that particularly involve

the pulmonary and cardiac systems. However, respirators typically used by health care

workers are generally lightweight, and the

physiological stresses they create are usually

small. Therefore, most workers can safely

wear respirators.

OSHA has exempted the respirator requirements of the current 1910.134 for prevention of

occupational transmission of TB in health care

settings. Current OSHA regulations (29 CFR

1910.139) state that workers should not be assigned tasks requiring respirators unless they

have been determined to be physically able to

perform the work while using the equipment.

The regulations also note that a physician

should determine the criteria on which to base

this determination.

No general consensus exists about what elements to include in medical evaluations for

respirator use in general industry. Some institutions use only a questionnaire as a screening

tool; others routinely include a physical examination and spirometry; and some include a

chest X-ray. No generally accepted criteria exist

for excluding workers from wearing respirators.

Specifically, no spirometric criteria exist for exclusion. However, several studies have shown

that most workers with mild pulmonary function impairment can safely wear respirators.

Thus, some journal articles and organizations

recommend the following:

Medical clearance for those with

normal or mild pulmonary function

impairment.

Step 4 Medically Screen All Users

Medical Evaluation of Health Care

Workers to Determine Fitness to

Wear Respirators

Some restrictions (e.g., type of respirator or

workload) for those with moderate

impairment.

No respirator wear for individuals

with severe impairment.

NOTE: Some respirators have a latex component

and should not be worn by those who are allergic

to latex.

Because most health care workers wear the very

light, disposable half-mask respirator, CDC

Guidelines [CDC 1994] recommend that a health

questionnaire be the initial step in the evaluation.

If results from this evaluation are essentially normal, the employee can be cleared for respirator

wear. Further evaluation, possibly including a

directed physical examination and/or spirometry, should be considered in cases in which potential problems are suggested on the basis of the

questionnaire results.

Medical reviews of this issue including practical

recommendations from several groups, including

the American National Standards Institute (ANSI),

AIHA, and the American Thoracic Society (ATS)

are included in the references [ANSI 1992; AIHA

1993; American Thoracic Society 1996]. Sample

questionnaires that have been used in health care

settings are in Appendix E.

OSHA has issued a compliance memorandum

(see Appendix B) and is developing a separate

standard which will address the medical

evaluation issue. Health care administrators

should be alert to developments in this area.

If a health care facility uses respirators for

worker protection against other regulated

hazards (e.g., formaldehyde, ethylene oxide,

etc.), then a respirator program must be

implemented for these hazards under 1910.134

including medical evaluations by a physician

or other licensed health care professional.
19

Step 5 Provide Training

Respirator Training Program

Introduction

Equally important to selecting the appropriate

respirator is using the selected device properly.

Proper use can be achieved by carefully training

both supervisors and workers in selection, use,

and maintenance of respirators.

Provide the supervisor, the person issuing the respirators, and the respirator user with adequate training

by qualified persons to ensure that the respirator is

used correctly (see Respirator Program Administration

in the Introduction).

The supervisor is defined as the person who oversees one or more workers who need to wear respirators. The supervisors must be in close contact

with the workers to ensure that the workers are

wearing respirators when necessary and that they

are being worn properly. The training provided

should emphasize that health and safety is an important part of the management function. It is recommended that the proper use of respirators should

also be included in the supervisor's and worker's

annual evaluation.

Who Should Receive Respirator Training

Who Should Conduct This Training

The training must be given by a qualified person—

usually the Respirator Program Administrator. As an

alternative, the Administrator can have someone

trained to do the job or hire a consultant. See Respirator Program Administration in the Introduction for

more information about respiratory protection

training.

1. Describe the nature, extent, and specific hazards

of TB in your health care facility (See Appendix F).

2. Explain the risk assessment and its relationship

What Should the Training Include

to the respirator program. The risk assessment

should define facility areas requiring the use of respirators and the level of protection required. For example: normal operations might require only

disposable N95 respirators. Higher-risk areas, such

as autopsy rooms, could require a higher level of

protection such as full facepiece negative-pressure

respirators, PAPRs, or half-mask positive-pressure

airline respirators.

Also, advise the trainees that risk assessment will

be done periodically. CDC recommends that risk

assessment be conducted at least yearly in the minimal-risk, very-low-risk, and low-risk areas; every

6-12 months for intermediate-risk areas; and every

3 months in high risk areas. The workers should

also be trained to recognize signs and symbols used

to show that respirators are required in an area.

3. Explain the reason for using respirators. For

example, the respirator needs to be used to

minimize exposure to the hazards in the workplace

(in this case, TB).

Some individuals (e.g., those that are immunocompromised are at higher risk for TB (see

appendix F). These individuals need to understand

the risk and the need to wear their respirator.

4. Describe existing engineering controls. Engineering controls are methods used to prevent the spread

and reduce the concentration of infectious droplet

nuclei. Examples are ventilation controls (e.g.,

negative-pressure isolation rooms) and laboratory

hoods. Because engineering controls may not entirely eliminate the TB hazard, the respirator

wearer must be trained to know when to wear a

respirator.

5. Explain the reason for selecting a particular respirator for a given hazard (see Step 2). In most cases,

the N95 disposable respirator will be selected. This

NIOSH-certified respirator meets minimum CDC

criteria for respiratory protection in TB areas.

For high-risk areas, more protective respirators

may be needed (e.g., full facepiece respirators

with PAPRs and positive-pressure airline respi-
20

1910.139 (a)(3) The employee shall

use the provided respiratory protection in

accordance with instructions and training

received.

1910.139 (b)(3) The user shall be instructed and trained in the proper use of

respirators and their limitations.

1910.139 (e)(2) The correct respirator

shall be specified for each job. The respirator

type is usually specified in the work procedures by a qualified individual supervising

the respiratory protective program. The indiThe training recommendations listed in the

preceding section should provide the basis for

an adequate training program and summarize

methods for satisfying the OSHA requirements

listed in 29 CFR 1910.139. These requirements are reprinted as a summary below and

reproduced fully in Appendix A.

OSHA Training Requirements Under 29

CFR 1910.139

rators). The respirator chosen depends on the severity of exposure.

6. Explain how the respirator works, its

capabilities, and limitations. Negative-pressure

air-purifying respirators (e.g., disposable, halfmask, and full facepiece respirators) work by

drawing ambient air through the filter element

during inhalation. Inhalation causes a negative

pressure to develop in the tight-fitting facepiece

and allows air to enter while the particles are

captured on the filter. Air leaves the facepiece

during exhalation because a positive pressure

develops in the facepiece and forces air out of the

mask through the filter (disposable) or through an

exhalation valve (replaceable and some

disposable). PAPRs are equipped with a blower

that draws air through the filters into the

facepiece. PAPRs can be equipped with a tightfitting facepiece or loose-fitting helmet or hood.

Airline (supplied-air) respirators are provided

with air from a stationary source (compressor)

or a bottle. (See Step 2 for a discussion about

the advantages and disadvantages of different

respirator classes).

7. During the training session, give the user

the chance to handle and wear the respirator

until the user is proficient. Also teach the user

how to perform the user seal check and wear

the respirator in an uncontaminated environment for a period of time. Instruct the user to

follow the manufacturer’s instructions provided with the respirator. Give workers a copy

of the manufacturers instructions.

8. Teach the user the importance of and how to

properly store disposable respirators. Teach the

user the importance of and how to clean, maintain, and store replaceable filter respirators (unless there is a central maintenance facility that

provides this service for cleaning, see Step 7).

9. Explain that facial hair between the wearer’s

skin and the sealing surfaces of the tight-fitting

respirator will prevent a good seal. A respirator

that permits negative-air pressure inside the

facepiece during inhalation may allow leakage

and, in the case of positive pressure devices,

will either reduce service time or waste breathing air.

10. Provide the trainees with the lecture materials (or a summary) developed by the program

administrator to use as quick reference materials.

11. Instruct trainees to refer all respirator

problems immediately to the respirator program administrator.

12. Discuss the OSHA standard [29 CFR 1910.

139] (see Appendix A) in detail with the

trainee. Everyone must know the mandatory

regulations.

Training may need to be repeated yearly to

maintain the respirator skills of the users.
21

Make sure that the trainer has a definite

understanding of exactly what the trainee

should know or be able to do as a result of the

training. If this objective is not clear to the

trainer, it will never be clear to the trainee.

Also, state the objectives in such a way that

the trainer can measure whether they have

been achieved.

The OSHA training requirements under 29 CFR

1910.139 (see preceding section and Appendix

A) consist of the “bare bones” training responsibilities of the respiratory protection program

manager. A trainer can use various tips and

strategies to meet these obligations and to enObjectives such as “the trainee will be made

aware of the need for respiratory protection” or

“the trainee will know how to inspect a respirator” cannot be measured directly. Instead, state

the objectives using action terms or tasks the

trainee should be able to do. For example: (1)

“the trainee will be able to name the areas of

the facility where respirators are required,” or

(2) “the trainee will be able to inspect a respirator and identify a defective valve.” Measurable training objectives allows the trainer to

determine whether people are learning what

they need to know.

Inform trainees about the objectives of the

training. This knowledge provides them with

a framework for understanding the information that will follow and motivates them to

keep their attention focused on the important

points.

Establish Specific Training Objectives

Make the Objectives Measurable and

Observable

Make the Objectives Known to the

Trainee

Tips For Training

Actively Involve the Trainee in the

Training

People generally learn better by doing than by

watching or listening. Ask the trainees to put on

and remove respirators, inspect respirators, replace

filters, discuss respiratory protection issues, etc.

Such activities are much more effective than

hance the effectiveness of the program. These

tips and strategies are discussed in the following

subsections.

vidual issuing them shall be adequately instructed to insure that the correct respirator is

issued.

1910.139 (e)(5) For safe use of any

respirator, it is essential that the user be

properly instructed in its selection, use,

and maintenance. Both supervisors and

workers shall be so instructed by competent persons. Training shall provide the

workers an opportunity to handle the respirator, have it fitted properly, test its facepiece-to-face seal, wear it in normal air for

a long familiarity period, and, finally, to

wear it in a test atmosphere.

1910.139 (e)(5)(i) Every respirator

wearer shall receive fitting instructions including demonstrations and practice in

how the respirator should be worn, how to

adjust it, and how to determine if it fits

properly. Respirators shall not be worn

when conditions prevent a good face seal.

Such conditions may be a growth of beard,

sideburns, a skull cap that projects under

the facepiece, or temple pieces on glasses.

Also, the absence of one or both dentures

can seriously affect the fit of a facepiece.

The worker’s diligence in observing these

factors shall be evaluated by periodic

check. To assure proper protection, the

facepiece fit shall be checked by the

wearer each time he puts on the respirator.

This may be done by following the

manufacturer’s facepiece fitting instructions.
22

No matter how much time and effort are put

into developing a respiratory protection

program, it is doomed to fail if workers do not

wear the equipment properly under the

prescribed conditions. Workers fail to wear

respirators for a number of reasons, and it is

important to understand the nature of this

resistance to overcome it. The following are

the most frequently cited reasons for not

wearing respirators:

1) They are hot and uncomfortable.

2) They produce “pain spots” if poorly

fitted.

3) They interfere with communication

and performance.

4) They are not easily accessible when

you need them.

5) They put the burden of safety on the

wearer rather than the company.

6) They make the wearer look “funny,”

alarmist, not macho, or unattractive.

Give feedback to workers during the initial

training and in the workplace to tell them what

they are doing right or wrong. The feedback

should always be positive, constructive, and

specific. Thus comments such as “keep up the

good work” or “good job” (although complimentary) provide little information. Instead say

“good job in replacing your filter” or “John, you

need to remember to check your seal every time

you put on your respirator.” The point is not to

criticize or punish the individual but to provide

corrective instruction.

Provide Feedback

Provide Refresher Training

Tips For Reducing Resistance And

Promoting Safety Behaviors

Wearing a respirator for the first time can be

a strange and even traumatic experience for

the new user, particularly if the user is given

a respirator and immediately put to work.

The barriers of respirator usage noted earlier

(such as labored breathing and impaired

vision) coupled with the demands of the job

may be too great for many first-time users,

increasing their intolerance to the respirator

and reducing the likelihood of future

compliance.

Allow the user to gradually adjust to the

respirator by wearing it for short periods in a

relaxed, non-work setting. Tell new users

that it is normal to feel a little strange and

frightened the first time they wear a

respirator. This information lets them know

that their initial adverse reaction does not

indicate a chronic personal intolerance to

respirators and that their tolerance will

improve. Once users become accustomed to

the physical and psychological effects of

wearing a respirator, it will be easier for them

to perform their normal work routine.

Allow Time for Adjustment

having trainees read about these procedures or

merely listen to a description. Films and

demonstrations are useful in modeling the

desired behavior, but it is important to have

the trainee actively replicate what was just

witnessed.

Establish a schedule for periodically evaluating

on-the-job performance and providing refresher training when indicated. Such training

is needed because unfortunately, the effects of

training do not last forever. Forgetting or relapse occurs over time—especially if the behaviors are not frequently practiced or rehearsed

(that is, respirators are worn only occasionally),

if the behavior is costly and complex (for example, inspection and maintenance), and if

continuous monitoring and corrective feedback

are not provided.
23

In addition to feeling susceptible to TB, workers

must also understand its consequences to health

and well-being. Training programs often describe the illness in abstract medical terms or

use scare tactics to exaggerate the symptoms.

Instead, describe the disease in a realistic and

imaginable fashion. Describe the impact of the

illness on life-style factors such as family interactions, hobbies, and recreational activities.

Use case histories, testimonies from illness victims, and illness simulations to help workers

identify with the impact of the disease on

7) They produce labored breathing,

increasedheart rate, and perspiration.

8) They impair vision and can actually

be a safety hazard.

9) They produce feelings of claustrophobia and anxiety.

In addition to these numerous barriers to

working while wearing a respirator, the

benefits (that is, the avoidance of disease) may

seem remote. Furthermore, since air contaminated with infectious droplet nuclei have no

over-whelming noxious properties or physical

effects, there is no immediate consequence for

not wearing a respirator except that the user

feels better without it. Therefore, the program

manager must work hard to overcome worker

resistance to wearing respirators and promote

full compliance with the respiratory protection

program.

For a worker to behave safely, three conditions

must be met: (1) the worker must have the necessary knowledge, skills, and ability; (2) the

worker must be properly motivated; and (3)

the worker must receive the necessary environmental and organizational supports.

The first condition is addressed by the training program, the second by supervisory

practice, and the third by organizational climate and policy. The first factor is addressed

in the preceding section (Tips for Training)

and the latter two factors are considered

briefly as follows.

Safety Management

Supervisory Practices

Motivating workers to behave safely is a major

responsibility of the supervisor or program administrator. Workers must not only know how

to maintain and wear respirators, they must

actually wear them when working in a hazardous environment. To convince a worker to

Believe the illness poses serious

consequences to health and well-being

Feel susceptible to the disease or

condition related to the hazard

The worker must understand that the disease is

related to exposure, and that symptom onset

may be delayed. In explaining TB, tell the

worker how the inhaled droplet nuclei from an

infectious person’s cough or sneeze lodge

themselves in the alveoli of the lungs, where

infection begins. No immediate symptoms will

occur as the infection spreads to other areas in

which TB is most likely to develop. The immune

system usually intervenes within 2 to 10 weeks

after infection and halts the multiplication of

tubercle bacilli. Approximately 10% of those

infected will develop the disease. The other 90%

will remain infected but free of disease for the

rest of their lives. Many workers do not feel

susceptible because they have no firsthand

experience with TB and do not understand how

it develops. Cause and effect must be established

in a straightforward, concrete fashion.

wear a respirator, the worker must see that the benefits of respirator use outweigh the barriers. The

first step in this direction is the training program,

which describes workplace hazards, their consequences, and the role of respirators in reducing

these hazards. Although different models exist for

presenting this information, one of the most popular

is the Health Belief Model developed by Becker

[1974]. To use this model to foster respirator use, a

worker must:
24

Correcting improper use through

immediate constructive feedback

Acting as a role model by properly

following respiratory use procedures

Consistently enforcing respirator policy

for employees

Actively monitoring respirator use

Periodically complementing workers for

proper respirator use

In addition to providing workers with the kind

of information described above, the immediate

supervisor must take steps to assure that workers’ intentions to wear respirators are carried

over and sustained in the workplace. This is a

continuing responsibility of the supervisor—

much like work scheduling and production

oversight. The supervisor must convey to the

worker his or her commitment to the respirator

program through actions as well as words. Examples of what this requires from the supervisor are as follows:

Additional Responsibilities of the

Supervisor

A safety management program cannot succeed

without the sincere support and commitment of

the highest levels of the organization. A token

or superficial endorsement of the safety program is quickly perceived by members of the organization as manipulative and hypocritical; it

is likely to produce resentment and resistance.

Steps an organization can take to demonstrate

its level of commitment to the respiratory protection program might include the following:

Developing and distributing a written

respiratory protection policy

Establishing a visible and formal training

program documenting worker training

Including safety as a topic on the agenda

at all meetings

Tracking and documenting worker

training

Environmental and Organizational

Wearing a respirator is a major inconvenience Supports

to most workers. A training program that

ignores this point lacks credibility. Instead,

emphasize that despite the drawbacks, wearing

a respirator and protecting one’s health are

worth the inconvenience.

The worker must understand that the use of a

respirator can effectively reduce the risk of

exposure. To convey this information, explain

the way respirators work and the importance of

proper use, fit-testing, and maintenance. Use

the fit-testing exercise to simulate leakage, and

give the worker a sense of how a toxic agent can

be inhaled if the seal is not sufficient. Workers

need to know the basic principles of respirator

operation in order to accept them and believe they

can provide protection if used properly.

Believe that the respirator can control

the risk

Believe that the benefits of respirator

use outweigh the barriers

themselves and others. Relate that preventive

drug therapy can result in serious health effects

(e.g., liver damage).

Make workers aware of their own role in

motivating others to wear respirators. Peer

influences are often effective in encouraging

self-protective behavior. Inform physicians that

they often serve as role models for other

hospital workers, and that by the simple act of

wearing a respirator, they may be encouraging

many other workers to wear respirators.

Unfortunately, the opposite may also be true.
25

Consulting users about respirator

program issues

Writing safety compliance criteria into

the job descriptions and performance

evaluations of workers and supervisors

Using engineering controls (e.g., ventilation) and administrative controls (for

example, minimizing the number of

times employees enter isolation rooms)

wherever feasible to minimize workplace hazards

Investing resources in purchasing and

maintaining proper equipment

Reviewing (formally and openly) respirator policy at regular intervals and

making respirators easily accessible

to workers

Requiring respirator use only when

necessary
26

when the respirator fits properly. Such knowledge is important because TB aerosol can leak

around the facepiece into the respirator and be

inhaled if the respirator does not fit the user’s

face. In the December 11, 1998, MMWR article,

NIOSH found that fit testing " N95 respirators is

essential in programs employing these respirators and can eliminate poorly fitting respirators,

ensuring at least the expected level of protection.

Without surrogate fit testing, average exposure

for the 25-person panel was reduced to 33% of

the ambient level, which is much less protection

than expected of this class of respirators (i.e., exposure reduced to <10% of ambient levels) However, when fit tested first, the panel received

substantially greater protection than normally

expected (the average exposure was reduced to

4% of the ambient level). Without fit testing, persons unknowingly may have poor face seals, resulting in excessive leakage and exposure" [CDC

1998a]. Fit-testing is also required by OSHA [29

CFR 1910.139(e)(5)]. Determining facepiece fit

involves qualitative fit-testing (QLFT) or quantitative fit-testing (QNFT). A QLFT test relies on

the wearer’s subjective response to taste, odor, or

Fit-Testing

A fit-test must be conducted to determine which

brand, model, and size of respirator fits the user

adequately and to ensure that the user knows

Step 6 User Seal Check, Fit-Test, & Issue Respirators

The following step presents procedures for user

seal checking and fit-testing respirators used by

health care workers exposed to TB. All respirators (excluding loose-fitting models) must be

fit-tested and user seal checked. A user seal

check is a method for determining whether a

respirator has been put on and adjusted to fit

properly and is performed every time a respirator is worn. A fit-test is a method used to select

the respirator that provides an adequate and

comfortable fit. Fit tests should be completed at

regular, periodic intervals (e.g., annually) to ensure continued adequate fit.

Note: Respirator users who are not cleanshaven, should not be fit-tested with tightfitting respirators because facial hair between

the skin and the sealing surfaces of the

respirator will prevent a good seal. Tightfitting respirators cannot be assigned to or used

by workers with facial hair that interferes with

the seal.

Respirator Face Fitting Procedures

Saccharin or

Bitrex Qualitative

Fit Testing.

Photo courtesy of

3M.

Portacount unit.

Photo courtesy of 3M.

Procedures
27

NOTE: For facilities conducting QNFTs on

disposable and replaceable half-masks, OSHA

requires a minimum fit-factor (FF) of 100. When an

individual passes a QLFT, a minimum FF of 100

will be assumed to have been achieved. (See

Appendix G, OSHA Memorandum For Regional

Administrators Regarding Fit-Testing and User

Seal Checking Procedures).

NIOSH does not recommend qualitative fit testing

using irritant smoke because of the health risk

associated with exposure to the irritant fume.

Fit-checking procedures that have been accepted

by OSHA in 1910.134 can be found in Appendix

H. When the TB standard is promulgated,

specific guidance will be included.

User Seal Checking Procedures

Positive-pressure

user seal check.

Negative-pressure user seal check.

Both photos courtesy of NIOSH.

To ensure adequate protection, the user of a respirator equipped with a tight-fitting facepiece

must check the seal of the facepiece routinely before each entry into areas with potential TB exposures. This check may be accomplished by

using the seal-check procedures recommended

by the manufacturer or by using those described

in Appendix H.

irritation. A QNFT uses another means of detecting facepiece leakage and does not require the

wearer’s subjective response.

Respirator models have inherently different fitting characteristics. Moreover, each of the several brands that are marketed has slightly

different fitting characteristics. Although every

manufacturer designs facepieces to fit the broadest possible section of the working population,

no single respirator fits everyone. Therefore,

more than one brand or model, and various

sizes of a given type of respirator should be purchased to take advantage of the different fitting

characteristics of each and to increase the chances

of properly fitting all workers. Having more

than one facepiece from which to choose also

gives the worker a better chance of finding a respirator that provides reasonable comfort and

good protection.

The respirator program administrator must decide whether to use QLFT or QNFT procedures.

After fit-testing, a wallet-sized card should be

provided to the respirator user showing worker's

name, date, type, brand, model, and size of respirator.
28

A. Examine the facepiece of the disposStep 7 Inspect, Clean, Maintain, & Store Respirators

Routine Respirator Inspection

Introduction

Scrupulous respirator inspection and maintenance

must be an integral part of the overall respirator

program. Follow the manufacturer’s instructions

for inspection, cleaning, and maintenance to ensure

that the respirator continues to function properly.

Wearing poorly maintained or malfunctioning respirators may be more dangerous than not wearing

a respirator at all. The worker who wears a defective device may falsely assume that protection is being provided.

The OSHA respirator regulations require the following [29 CFR 1910.139]:

Inspection Before And After

Each Use

able respirator to determine whether it is functional and has structural integrity. If the filter

material is physically damaged or soiled, discard the respirator. Also discard the respirator if

there are nicks, abrasions, cuts, or creases in the

facepiece-to-face sealing material.

B. Check the respirator straps to be sure

they are not cut or otherwise damaged. The

straps should be attached at all connection

points.

C. Make sure that the metal nose clip (if

applicable) is in place and functions correctly.

D. Make sure that the respirator is

NIOSH approved (NIOSH approval will be

marked on the filter, filter package, or respirator

box).

Inspect replaceable filter half-mask

respirators as follows:

A. Check the integrity of the facepiece to be

sure it is not cut, torn, modified, deteriorated, or

dirty. The elastomer should not be abraded, and

the sealing surface should be smooth and undamaged.

B. Check to see that the straps on the respirator are elastic, pliable, and have not been knotted

to shorten them. The buckles and any attachment

must be present and working correctly.

C. Inspect the inhalation and exhalation

valves to see that they are in place and pliable,

Check

straps and

buckles.

Photo

courtesy of

NIOSH.

1. [b] (7) Respirators used routinely shall be inspected during cleaning. Worn or deteriorated

parts shall be replaced. Respirators for emergency

use such as self-contained devices shall be thoroughly inspected at least once a month after each

use.

2. (f) (2) (i) All respirators shall be inspected routinely before and after each use. A respirator that is

not routinely used but is kept ready for emergency

use shall be inspected after each use and at least

monthly to assure that it is in satisfactory working

conditions.

3. (f) (2) (iii) Respirator inspection shall include a

check of the tightness of connections and the condition of the facepiece, headbands, valves, connecting

tube, and canisters. Rubber or elastomer parts shall

be inspected for pliability and signs of deterioration.

Stretching and manipulating rubber or elastomer

parts with a massaging action will keep them pliable and flexible and prevent them from taking a

“set” during storage.

Inspect disposable half-mask respirators

as follows:
29

functioning properly, and lying flat on the surface of the valve seat. The sealing surfaces

must be clean and not chipped, scratched, or

broken.

D. Make sure that the exhalation valve

covers are present and attached to the respirator.

E. An approved half-mask respirator

includes the facepiece and filters. Check the

respirator to be sure the correct filters for the

hazard are in place. The filter and filter holder

threads should not be scratched, chipped, or

otherwise damaged. If gaskets are required

between the filter and filter holder be sure

they are in place and in good condition. Remove the gaskets to check for dirt under them.

F. Make sure that the gaskets fit properly in the filter holders.

G. If the filters seal directly against the

facepiece, be sure that the sealing surface is not

torn, chipped, cut, or otherwise damaged.

H. Inspect the filters to be sure that the

threads are not scratched, chipped, dented, or

otherwise damaged.

I. The strap assembly will usually

have corrugations in the rubber that holds the

strap tightly once it is placed on the head and

tightened. Be sure that the corrugations are

not worn off, all clips are present, and the

straps are attached to the mask.

Inspect replaceable filter full

facepiece respirators as follows:

A. Check to see that the lens in a full

facepiece respirator is not scratched, cracked,

broken, or otherwise damaged. The lens should

be completely sealed around the facepiece.

B. If the respirator has a speaking diaphragm, make sure that it is in place, not punctured, and that the gasket is in place.

C. Check the integrity of the facepiece

to be sure it is not cut, torn, modified, deteriorated, or dirty. The elastomer should not be

abraded and the sealing surface should be

smooth and undamaged.

D. Make sure that all the required

clamps are in place and are specific for the respirator being inspected.

E. Inspect the inhalation and exhalation valves to see that they are in place and

pliable, functioning properly, and lying flat

on the surface of the valve seat. The sealing

surfaces must be clean and not chipped,

scratched, or broken.

F. An approved full facepiece respirator includes the facepiece and the filters. Check

the respirator to be sure the correct filters for

the hazard are in place. The filter and filter

holder threads should not be scratched,

chipped, or otherwise damaged. If gaskets are

required between the filter and filter holder

be sure they are in place and in good condition. Remove the gaskets to check for dirt under them.

G. The strap assembly will usually have

corrugations in the rubber that holds the strap

tightly once it is placed on the head and tightened. Be sure that the corrugations are not

worn off, all clips are present, and the straps

are attached to the mask.

H. Check to see that the straps on the

respirator are elastic, pliable, and have not been

knotted to shorten them. The buckles and any

attachment must be present and working correctly.

I. Make sure that the exhalation valve

covers are present and attached to the respirator.
30

Generally, disposable respirators do not need to

be cleaned or maintained. If they are soiled or

otherwise damaged they are discarded. However, some manufacturers make disposable respirators that look like replaceable respirators

(filters cannot be removed or replacement parts

are not available) and the facepiece may require

some cleaning.

Replaceable filter respirators must be carefully

maintained. The manufacturer’s recommendations should be followed to ensure proper functioning of the respirator. The following discussion of maintenance procedures should help

users understand the overall process:

The OSHA respirator regulation (see Appendix

A) requires that respirators be properly cleaned,

repaired, and stored. A proper maintenance program ensures that the worker’s respirator remains

as effective as when it was new.

Cleaning, Repairing, And Storing

Respirators Used For Protection

Against TB

Introduction

Cleaning

J. Make sure that the gaskets fit properly in the filter holders.

K. If the filters seal directly against the

facepiece, be sure that the sealing surface is not

torn, chipped, cut, or otherwise damaged.

L. Inspect the filters to be sure that the

threads are not scratched, chipped, dented, or

otherwise damaged.

Inspect PAPRs as follows:

A. Stretch out the corrugated breathing

tube to inspect it for cuts, abrasions, and pinholes.

B. Inspect the blower assembly and

batteries as described by the manufacturer.

C. The inspection procedures for halfmasks and full facepieces used with PAPRs are

the same as those described above.

D. If the PAPR is equipped with a hood

or helmet, inspect according to the manufacturer’s instructions.

Inspect supplied-air respirators as

follows:

A. The inspection procedures for

half-masks and full facepieces used with

supplied-air devices are the same as those

described for air-purifying respirators (excluding filter cartridges). If the respirator

is equipped with a corrugated hose, stretch

it out and inspect for cuts, abrasions, and

pinholes.

B. Check the condition of the air

supply hose, including attachments and

end fittings.

C. Check the regulator as described by

the manufacturer.

The respirator must also be inspected during

cleaning:

1. Use the same inspection procedures followed

before and after each use, but remove all parts

of the respirator from the mask and check for

dirt, damage, and nonflexibility.

2. Replace defective parts.

3. Thoroughly wash, disinfect, and reassemble

the parts and mask.

Inspection During Cleaning
31

B. Cleaning and Sanitizing

Follow the manufacturer’s instructions for

cleaning and sanitizing respirators, especially

with regard to maximum temperatures. These

steps are generally as follows:

1. Wash the respirator in warm water containing a mild detergent at the temperature recommended by the manufacturer. A combination

cleaner/sanitizer solution can also be used (see

the following subsection, Cleaning and Sanitizing

Solutions). NEVER use an organic solvent to

clean a respirator.

2. The elastic straps are cleaned by using a

bristle brush and mild detergent.

3. If a cleaner/sanitizer solution has not been

used, sanitize and rinse the respirator in clean

water. Use the manufacturers’ recommended

temperature.

4. Drain water from the respirator and allow it

to air-dry in a clean and sanitary location.

A. Disassembly

Respirators cannot simply be immersed in

cleaning solutions. Before cleaning and sanitizing, remove the following parts from the

facepiece:

1. Filters

2. Speaking diaphragms

3. Valve assemblies

4. Elastic straps

5. Corrugated breathing tube

6. Gaskets

7. Any other parts recommended

 by the manufacturer

5. Clean and sanitize all the parts previously

removed from the respirator.

6. Wipe the respirator and all its components

with a cloth to remove any remaining water.

When a large number of respirators must be

cleaned, a commercial clothes washer and dryer

can be used if they have been modified to hold

the facepieces in a fixed position.

 C. Cleaning and Sanitizing Solutions

Use cleaning and sanitizing solutions as

follows:

1. Use any good detergent to clean a respirator

or use specifically designed cleaners or sanitizers (a class of liquid chemical germicides

having surfactant action). A sanitizer is often a

quaternary ammonium compound.

2. Follow the instructions on the sanitizer

label for immersion times.

3. Rinse the cleaned and disinfected respirators

thoroughly in clean water at the manufacturer’s

recommended temperature to remove all traces

of detergent and sanitizer. This step is very important to prevent dermatitis in respirator users.

 D. Loose-Fitting PAPRS

To clean loose-fitting PAPRs, remove the

hood or helmet from the respirator and clean

with a detergent solution. Clean the suspension inside the head gear in a similar fashion.

Clean and sanitize the protective face shield.

Repair respirators as follows:

1. Inspect the respirator and all its parts.

2. Replace defective parts with parts designed

Repair
32

Store respirators as follows:

1. Fulfill OSHA requirements by packing or

storing the respirators so that the facepieces

and exhalation valves rest in normal positions

[29 CFR 1910.139(f)(5)(ii)]. Impaired function

will result if the elastomer sets in an abnormal

position.

2. Store disposable respirators at the entrance

to designated TB areas so that users can pick

them up when entering. One method for acStorage

for that particular respirator. Use only replacement parts from the respirator manufacturer.

3. Reassemble the respirator and its parts.

4. Attach new filters to the respirator.

5. Inspect the entire respirator for completeness and tightness of parts.

complishing this is to install a box with sufficient compartments for storing all the respirators required in that area. The storage bin

would look like a mail box with slots for each

user’s respirator. Each slot would be labeled

with the user’s name.

3. Never store disposable respirators in pockets,

plastic bags, or other confined areas.

4. Store replaceable filter half-mask and full

facepiece respirators in plastic bags after

drying and keep them in storage cabinets.

Store them in a single layer with the

facepieces and exhalation valves in normal

positions to prevent the elastomer from taking a permanent “set.”

NOTE: Always read and follow the manufacturer's

instructions for cleaning, sanitizing, repairing,

inspecting, and storing the respirator.

Two example SOPs for maintenance, cleaning, and storage follow:
33

Standard Operating Procedure # ____

Maintenance Of Brand ___________ Replaceable Filter Half-Mask Respirator

Hospital name: ________________________________

Address: ______________________________________

 ______________________________________

Program administrator (or other designated author) _________________________

Date SOP written _______________

Date signed by program administrator _______________

Date to be reviewed ________________

Disassembly:

1. Have central supply personnel collect used respirators at the designated collection points located

in the hallway of each TB isolation room.

2. Take used respirators to the respirator maintenance area in central supply.

3. Remove all parts from the respirator as recommended by the manufacturer:

A. Filters and gaskets

B. Exhalation valve cover

C. Inhalation and exhalation valves

D. Speaking diaphragm

E. Elastic straps (headbands)

F. Facepiece

4. Inspect the respirator for damaged and defective parts; discard them if found. Replacement parts

must be identical to the original parts, or NIOSH-accepted alternatives obtained from the

respirator manufacturer.

A. Check the filters for damage (dents or cracks), filter soiling, and damaged threads

(scratched, chipped, or dented). Inspect the gaskets for pliability and wear.

B. Check the exhalation valve cover for defects.
34

C. Examine the inhalation and exhalation valves for cracks, tears, holes, or distortion in the

valve material.

D. Examine the speaking diaphragm for structural defects.

E. Examine the headbands for breaks, loss of elasticity, and malfunctioning buckles and

attachments.

F. Check the facepiece for cracks, tears, holes, lack of flexibility, or distortion from improper

storage.

Cleaning and Sanitizing:

1. Clean and sanitize the respirator and parts using __________ at the following temperature:

________. Immerse respirator components for ______ minutes. Always follow the

manufacturer’s instructions.

2. Rinse the cleaned and disinfected respirators thoroughly in clean water at ______ temperature to

remove all traces of detergent and sanitizer. This step is important in the prevention of dermatitis.

3. Allow the respirator and parts to air-dry in a clean, sanitary location.

4. The respirator and all component parts are wiped with cloth to remove any remaining water.

Reassembly and Repair:

1. Reassemble and inspect the clean, dry facepiece and parts. Replace filter.

Storage:

1. Place the freshly cleaned and dried respirator in a reusable plastic bag until reissue. Store it in a

clean, dry location away from direct sunlight and with the facepiece in a normal position to prevent

the rubber or plastic from taking a permanent “set (deforming).”
35

Standard Operating Procedure # _____

Maintenance Of Brand ___________ Disposable N95 Half-Mask Respirator

Hospital Name: ___________________________________

Address: _________________________________________

 _________________________________________

Program Administrator (Or Other Designated Official) ____________________________

Date SOP Written _____________________________

Date Signed By Program Administrator _____________________________

Date To Be Reviewed __________________________________

1. Determine whether the respirator straps hold the respirator tightly against the face. If not, discard

the respirator. Do not attempt to tighten the respirator by knotting the straps.

Note: Some manufacturer’s disposable respirators may have adjustable straps.

2. Inspect the respirator to determine if it is soiled or damaged. If so, discard the respirator.

3. Store the respirator in a clean and dry location. Respirators should be labeled for each worker.

Storing the respirator in a plastic sealable bag after use is not considered a good practice. The

respirator may be damp after use and sealing prevents drying and encourages microbial growth. If

plastic bags are used, respirators should be allowed to dry before storage.

Note: Always read the manufacturer’s recommendations on maintenance procedures for these N95 respirators.
36

Take the following steps at least once each year:

A. Review the program using the respiratory protection checklist in Appendix E and

make necessary changes to reflect current operations and procedures.

B. Using CDC protocol, conduct a risk

assessment in all potential TB exposure areas

to determine whether the level of exposure has

changed.

C. Review the medical surveillance of

respirator users.

D. Follow up evidence of excessive

exposure to hazards (e.g., TB skin test conversion

rates) to determine why inadequate protection

was provided and what action should be taken

to remedy the problem.

Step 8 Evaluate the Program

Respirator Program Evaluation

The respirator program needs to be evaluated

periodically to ensure that it continues to be

effective. Review the entire program at least

annually and modify the written operating

procedures to reflect the evaluation results if

necessary.

Take the following steps more frequently:

A. Use frequent inspections to determine

whether the correct respirators are being used

and worn properly.

B. Examine respirators in use and in

storage to determine how well they are maintained.

C. Consult users about their acceptance

of respirators, including the discomfort, resistance to breathing, fatigue, interference with vision and communication, restriction of movement, interference with job performance, and

their confidence in the respirator’s effectiveness.

Annual Evaluation

Additional Evaluations

Photo courtesy of NIOSH.
37

References

AIHA [1993]. Respiratory protection: a manual and guideline. 2nd ed. Fairfax, VA: American

Industrial Hygiene Association.

American Thoracic Society [1996]. Respiratory protection guidelines. Am J Respir Crit Care

Med 154:1153-1165.

ANSI [1980]. American national standard: respiratory protection. New York, NY: American

National Standards Institute, ANSI Z88.2–1980.

ANSI [1992]. American national standard: respiratory protection. New York, NY: American

National Standards Institute, ANSI Z88.2–1992.

Becker MH [1974]. The health belief model and personal health behavior. Thorofare, NJ:

Charles B. Slack, Inc.

Bollinger NJ, Schutz RH [1987]. NIOSH guide to industrial respiratory protection. Cincinnati,

OH: U.S. Department of Health and Human Services, Public Health Service, Centers for

Disease Control, National Institute for Occupational Safety and Health, DHHS (NIOSH)

Publication No. 87-116.

CDC (Centers for Disease Control and Prevention) [1994]. Guidelines for preventing the

transmission of Mycobacterium tuberculosis in health care facilities, 1994. MMWR 43:RR–13.

CDC (Centers for Disease Control and Prevention) [1998a]. Laboratory performance

evaluation of N95 filtering facepiece respirators, 1996. MMWR, 47(48):1045-1049.

CDC (Centers for Disease Control and Prevention) [1998b]. Tuberculosis morbidity--United

States, 1997. MMWR 47:253-257.

CFR. Code of Federal Regulations. Washington, DC: U.S. Government Printing Office, Office of

the Federal Register.
38

§1910.139* Respiratory protection for M. tuberculosis.

This section applies only to respiratory protection against M. tuberculosis and applies in lieu of

§1910.134.

 (a) Permissible practice.

(1) In the control of those occupational diseases caused by breathing air contaminated with harmful

dusts, fogs, fumes, mists, gases, smokes, sprays, or vapors, the primary objective shall be to prevent

atmospheric contamination. This shall be accomplished as far as feasible by accepted engineering

control measures (for example, enclosure or confinement of the operation, general and local

ventilation, and substitution of less toxic materials). When effective engineering controls are not

feasible, or while they are being instituted, appropriate respirators shall be used pursuant to the

following requirements.

(2) Respirators shall be provided by the employer when such equipment is necessary to protect the

health of the employee. The employer shall provide the respirators which are applicable and suitable

for the purpose intended. The employer shall be responsible for the establishment and maintenance

of a respiratory protective program which shall include the requirements outlined in paragraph (b) of

this section.

(3) The employee shall use the provided respiratory protection in accordance with instructions and

training received.

(b) Requirements for a minimal acceptable program.

(1) Written standard operating procedures governing the selection and use of respirators shall be

established.

(2) Respirators shall be selected on the basis of hazards to which the worker is exposed.

(3) The user shall be instructed and trained in the proper use of respirators and their limitations.

(4) [Reserved]

(5) Respirators shall be regularly cleaned and disinfected. Those used by more than one worker shall

be thoroughly cleaned and disinfected after each use.

(6) Respirators shall be stored in a convenient, clean, and sanitary location.

(7) Respirators used routinely shall be inspected during cleaning. Worn or deteriorated parts shall be

replaced. Respirators for emergency use such as self-contained devices shall be thoroughly inspected

at least once a month and after each use.

(8) Appropriate surveillance of work area conditions and degree of employee exposure or stress shall

be maintained.

APPENDIX A

* 29 CFR 1910.134 is now codified for protection against TB as 29 CFR 1910.139.
39

(9) There shall be regular inspection and evaluation to determine the continued effectiveness of the

program.

(10) Persons should not be assigned to tasks requiring use of respirators unless it has been determined

that they are physically able to perform the work and use the equipment. The local physician shall

determine what health and physical conditions are pertinent. The respirator user’s medical status

should be reviewed periodically (for instance, annually).

(11) Respirators shall be selected from among those jointly approved by the Mine Safety and Health

Administration and the National Institute for Occupational Safety and Health under the provisions

of 30 CFR part 11.

(c) Selection of respirators. Proper selection of respirators shall be made according to the guidance of

American National Standard Practices for Respiratory Protection Z88.2-1969.

(d) Air quality.

(1) Compressed air, compressed oxygen, liquid air, and liquid oxygen used for respiration shall be of

high purity. Oxygen shall meet the requirements of the United States Pharmacopoeia for medical or

breathing oxygen. Breathing air shall meet at least the requirements of the specification for Grade D

breathing air as described in Compressed Gas Association Commodity Specification G-7.1-1966.

Compressed oxygen shall not be used in supplied-air respirators or in open circuit self-contained

breathing apparatus that have previously used compressed air. Oxygen must never be used with air

line respirators.

(2) Breathing air may be supplied to respirators from cylinders or air compressors.

(i) Cylinders shall be tested and maintained as prescribed in the Shipping Container Specification

Regulations of the Department of Transportation (49 CFR Part 178).

(ii) The compressor for supplying air shall be equipped with necessary safety and standby devices.

A breathing air-type compressor shall be used. Compressors shall be constructed and situated so

as to avoid entry of contaminated air into the system and suitable in-line air purifying sorbent

beds and filters installed to further assure breathing air quality. A receiver of sufficient capacity to

enable the respirator wearer to escape from a contaminated atmosphere in event of compressor

failure, and alarms to indicate compressor failure and overheating shall be installed in the system.

If an oil-lubricated compressor is used, it shall have a high-temperature or carbon monoxide

alarm, or both. If only a high-temperature alarm is used, the air from the compressor shall be

frequently tested for carbon monoxide to insure that it meets the specifications in paragraph (d)

(1) of this section.

(3) Air line couplings shall be incompatible with outlets for other gas systems to prevent inadvertent

servicing of air line respirators with nonrespirable gases or oxygen.

(4) Breathing gas containers shall be marked in accordance with American National Standard

Method of Marking Portable Compressed Gas Containers to Identify the Material Contained, Z48.1-

1954; Federal Specification BB-A-1034a, June 21, 1968. Air, Compressed for Breathing Purposes; or
40

Interim Federal Specification GG-B-00675b, April 27, 1965, Breathing Apparatus, Self-Contained.

(e) Use of respirators.

(1) Standard procedures shall be developed for respirator use. These should include all information

and guidance necessary for their proper selection, use, and care. Possible emergency and routine

uses of respirators should be anticipated and planned for.

(2) The correct respirator shall be specified for each job. The respirator type is usually specified in the

work procedures by a qualified individual supervising the respiratory protective program. The

individual issuing them shall be adequately instructed to insure that the correct respirator is issued.

(3) Written procedures shall be prepared covering safe use of respirators in dangerous atmospheres

that might be encountered in normal operations or in emergencies. Personnel shall be familiar with

these procedures and the available respirators.

(i) In areas where the wearer, with failure of the respirator, could be overcome by a toxic or

oxygen-deficient atmosphere, at least one additional man shall be present. Communications

(visual, voice, or signal line) shall be maintained between both or all individuals present.

Planning shall be such that one individual will be unaffected by any likely incident and have the

proper rescue equipment to be able to assist the other(s) in case of an emergency.

(ii) When self-contained breathing apparatus or hose masks with blowers are used in

atmospheres immediately dangerous to life or health, standby men must be present with suitable

rescue equipment.

(iii) Persons using air line respirators in atmospheres immediately hazardous to life or health shall

be equipped with safety harnesses and safety lines for lifting or removing persons from hazardous

atmospheres or other and equivalent provisions for the rescue of persons from hazardous

atmospheres shall be used. A standby man or men with suitable self-contained breathing

apparatus shall be at the nearest fresh air base for emergency rescue.

(4) Respiratory protection is no better than the respirator in use, even though it is worn

conscientiously. Frequent random inspections shall be conducted by a qualified individual to assure

that respirators are properly selected, used, cleaned, and maintained.

(5) For safe use of any respirator, it is essential that the user be properly instructed in its selection, use

and maintenance. Both supervisors and workers shall be so instructed by competent persons.

Training shall provide the workers an opportunity to handle the respirator, have it fitted properly, test

its face-piece-to-face seal, wear it in normal air for a long familiarity period, and, finally, to wear it in a

test atmosphere.

(i) Every respirator wearer shall receive fitting instructions including demonstrations and practice

in how the respirator should be worn, how to adjust it, and how to determine if it fits properly.

Respirators shall not be worn when conditions prevent a good face seal. Such conditions may be

a growth of beard, sideburns, a skull cap that projects under the face piece, or temple pieces on

glasses. Also, the absence of one or both dentures can seriously affect the fit of a face piece. The

worker’s diligence in observing these factors shall be evaluated by periodic check. To assure

proper protection, the facepiece fit shall be checked by the wearer each time he puts on the

respirator. This may be done by following the manufacturer’s face piece fitting instructions.
41

(ii) Providing respiratory protection for individuals wearing corrective glasses is a serious problem.

A proper seal cannot be established if the temple bars of eye glasses extend through the sealing edge

of the full face piece. As a temporary measure, glasses with short temple bars or without temple

bars may be taped to the wearer’s head. Wearing of contact lenses in contaminated atmospheres

with a respirator shall not be allowed. Systems have been developed for mounting corrective lenses

inside full facepieces. When a workman must wear corrective lenses as part of the face piece, the

face piece and lenses shall be fitted by qualified individuals to provide good vision, comfort, and a

gas-tight seal.

(iii) If corrective spectacles or goggles are required, they shall be worn so as not to affect the fit of the

face piece. Proper selection of equipment will minimize or avoid this problem.

(f) Maintenance and care of respirators.

(1) A program for maintenance and care of respirators shall be adjusted to the type of plant, working

conditions, and hazards involved, and shall include the following basic services:

(i) Inspection for defects (including a leak check),

(ii) Cleaning and disinfecting,

(iii) Repair,

(iv) Storage.

Equipment shall be properly maintained to retain its original effectiveness.

(2)

(i) All respirators shall be inspected routinely before and after each use. A respirator that is

not routinely used but is kept ready for emergency use shall be inspected after each use and at

least monthly to assure that it is in satisfactory working condition.

(ii) Self-contained breathing apparatus shall be inspected monthly. Air and oxygen cylinders shall be

fully charged according to the manufacturer’s instructions. It shall be determined that the regulator

and warning devices function properly.

(iii) Respirator inspection shall include a check of the tightness of connections and the condition of

the face piece, headbands, valves, connecting tube, and canisters. Rubber or elastomer parts shall be

inspected for pliability and signs of deterioration. Stretching and manipulating rubber or elastomer

parts shall be inspected for pliability and signs of deterioration. Stretching and manipulating rubber

or elastomer parts with a massaging action will keep them pliable and flexible and prevent them

from taking a set during storage.

(iv) A record shall be kept of inspection dates and findings for respirators maintained for emergency use.

(3) Routinely used respirators shall be collected, cleaned, and disinfected as frequently as necessary to

insure that proper protection is provided for the wearer. Respirators maintained for emergency use

shall be cleaned and disinfected after each use.

(4) Replacement or repairs shall be done only by experienced persons with parts designed for the
42

respirator. No attempt shall be made to replace components or to make adjustment or repairs beyond

the manufacturer’s recommendations. Reducing or admission valves or regulators shall be returned to

the manufacturer or to a trained technician for adjustment or repair.

(5)

(i) After inspection, cleaning, and necessary repair, respirators shall be stored to protect against dust,

sunlight, heat, extreme cold, excessive moisture, or damaging chemicals. Respirators placed at

stations and work areas for emergency use should be quickly accessible at all times and should be

stored in compartments built for the purpose. The compartments should be clearly marked.

Routinely used respirators, such as dust respirators may be placed in plastic bags. Respirators

should not be stored in such places as lockers or tool boxes unless they are in carrying cases or

cartons.

(ii) Respirators should be packed or stored so that the face piece and exhalation valve will rest in a

normal position and function will not be impaired by the elastomer setting in an abnormal

position.

(iii) Instructions for proper storage of emergency respirators, such as gas masks and self-contained

breathing apparatus, are found in “use and care” instructions usually mounted inside the

carrying case lid.

(g) Identification of gas mask canisters.

(1) The primary means of identifying a gas mask canister shall be by means of properly worded

labels. The secondary means of identifying a gas mask canister shall be by a color code.

(2) All who issue or use gas masks falling within the scope of this section shall see that all gas mask

canisters purchased or used by them are properly labeled and colored in accordance with these

requirements before they are placed in service and that the labels and colors are properly maintained

at all times thereafter until the canisters have completely served their purpose.

(3) On each canister shall appear in bold letters the following:

(i)—

Canister for ___________________________________

(Name for atmospheric contaminant)

or

Type N Gas Mask Canister

(ii) In addition, essentially the following wording shall appear beneath the appropriate phrase on

the canister label:

“For respiratory protection in atmospheres containing not more than __________ percent by volume

of ______________________________.“

(Name of atmospheric contaminant)

(4) Canisters having a special high-efficiency filter for protection against radio nuclides and other highly

toxic particulates shall be labeled with a statement of the type and degree of protection afforded by the

filter. The label shall be affixed to the neck end of, or to the gray stripe which is around and near the top
43

of, the canister. The degree of protection shall be marked as the percent of penetration of the canister

by a 0.3-micron-diameter dioctyl phthalate (DOP) smoke at a flow rate of 85 liters per minute.

(5) Each canister shall have a label warning that gas masks should be used only in atmospheres

containing sufficient oxygen to support life (at least 16 percent by volume), since gas mask canisters are

only designed to neutralize or remove contaminants from the air.

(6) Each gas mask canister shall be painted a distinctive color or combination of colors indicated in

Table I-1. All colors used shall be such that they are clearly identifiable by the user and clearly

distinguishable from one another. The color coating used shall offer a high degree of resistance to

chipping, scaling, peeling, blistering, fading, and the effects of the ordinary atmospheres to which

they may be exposed under normal conditions of storage and use. Appropriately colored pressure

sensitive tape may be used or the stripes.
44

Table I-1

Atmospheric contaminants to be protected against Colors assigned*

Acid gases ... White.

Hydrocyanic acid gas ... White with 1⁄2-inch green strip completely

around the canister near the bottom.

Chlorine gas ... White with 1⁄2- inch yellow stripe

completely around the canister near the

bottom.

Organic vapors ... Black.

Ammonia gas ... Green.

Acid gases and ammonia gas ... Green with 1⁄2-inch white stripe completely

around the canister near the bottom.

Carbon monoxide ... Blue.

Acid gases and organic vapors ... Yellow.

Hydrocyanic acid gas and chloropicrin vapor ... Yellow with 1⁄2-inch blue stripe completely

around the canister near the bottom.

Acid gases, organic vapors, and ammonia gases ... Brown.

Radioactive materials, excepting tritium and...

noble gases ... Purple (Magenta).

Particulates (dusts, fumes, mists, fogs, or smokes)

in combination with any of the above gases or Canister color for contaminant, as

vapors ... designated above, with 1⁄2-inch gray stripe

completely around the canister near the

top.

All of the above atmospheric contaminants ... Red with 1⁄2-inch gray stripe completely

around the canister near the top.

*Gray shall not be assigned as the main color for a canister designed to remove acids or vapors.

NOTE: Orange shall be used as a complete body, or stripe color to represent gases not included in this table. The

user will need to refer to the canister label to determine the degree of protection the canister will afford.
45

CPL 2.106 - Enforcement Procedures and Scheduling for Occupational Exposure to Tuberculosis.

•Record Type: Instruction

•Directive Number: CPL 2.106

•Subject: Enforcement Procedures and Scheduling for Occupational Exposure to Tuberculosis (TB).

•Information Date: February 9, 1996

------------------------------------------------------------------------

OSHA Instruction CPL 2.106

February 9, 1996

Office of Health Compliance Assistance

SUBJECT: Enforcement Procedures and Scheduling for Occupational Exposure to Tuberculosis

(TB)

A. Purpose. This instruction provides uniform inspection procedures and guidelines to be followed

when conducting inspections and issuing citations under Section 5(a)(1) of the OSHA Act and

pertinent standards for employees who are occupationally exposed to tuberculosis.

B. Scope. This instruction applies OSHA-wide.

C. References.

1. OSHA Instruction CPL 2.103, September 26, 1994, Field Inspection Reference Manual

(FIRM).

2. OSHA Instruction CPL 2.45B, June 15, 1985, The Revised Field Operations Manual

(FOM).

3. American Public Health Association - 1990 or current edition, Control of

Communicable Diseases in Man.

4. OSHA Instruction CPL 2-2.20B, CH-3, August 22, 1994. Occupational Safety and

Health Administration Technical Manual Chapter No. 7.

5. OSHA Instruction, ADM 1-31, the IMIS Enforcement Data Processing Manual.

6. OSHA Instruction ADM 1-32, Enforcement User Skills Manual (for those Area Offices

still using the NCR system).

7. Centers for Disease Control and Prevention (CDC), Biosafety in Microbiological and

Biomedical Laboratories, 3rd Edition, or current edition.

8. Department of Health and Human Services, Public Health Service, 42 CFR Part 84;

Final Rule.

APPENDIX B
46

9. Centers for Disease Control and Prevention (CDC); Guidelines for Preventing the

transmission of mycobacterium tuberculosis in Health Care Facilities, 1994; MMWR

October 26, 1994 Vol. 43, No. RR-13.

D. Action. OSHA Regional Administrators and Area Directors will use this instruction to ensure

uniformity when performing inspections for occupational exposures to tuberculosis (TB). The

Directorate of Compliance Programs will provide support as necessary to assist the Regional

Administrators and Area Directors in enforcing this directive. Issuance of this directive cancels

the Memorandum to Regional Administers dated October 8, 1993, and entitled Enforcement

Policy and Procedures for Occupational Exposure to Tuberculosis.

E. Federal Program Change. This is a federal program change which impacts state programs.

1. The Regional Administrator (RA) will ensure that this change is promptly forwarded to

each state designee using a format consistent with the Plan Change Two-way

Memorandum in Appendix A, State Plan Policies and Procedures Manual (SPM).

2. The RA shall explain the content of this change to the state designee as required.

3. The state shall respond to this change within 70 days in accordance with paragraph

I.1.a.(2).(a). and (b)., Part I, Chapter III of the SPM.

4. The state’s acknowledgment shall include (a) the state’s plan to adopt and implement an

identical change, (b) the state’s plan to develop an alternative, which is as effective, or the

reasons why no change is necessary to maintain a program which is as effective. The

state shall submit a plan supplement within six months in accordance with I.1.a.(3).(c).,

Part I, Chapter III of the SPM.

5. The RA shall advise state designees of the following:

a. In order to ensure a sound and consistent national enforcement and litigation

strategy in relation to complex issues addressed by this instruction, state

implementation of the procedures in this instruction, or comparable state

procedures, must be carefully coordinated with OSHA.

b. The state is also responsible for extending coverage under its procedures for

addressing occupational exposure to tuberculosis to the public sector employees in

workplaces covered by this instruction.

c. The Directorate of Technical Support is available to assist the states in locating

expert witnesses (see paragraph M., expert witnesses). Also, the Directorate of

Compliance Programs will provide support to the states through the RA to assist

in the enforcement of this directive.

6. The RA shall review policies, instructions, and guidelines issued by the state to determine

that this change has been communicated to state compliance personnel.

F. Definitions. For a complete list of definitions applicable to tuberculosis please refer to the list of

definitions in the 1994 CDC guidelines found in Appendix A beginning on page 113.
47

G. Background. Since 1985, the incidence of tuberculosis (TB) in the general U.S. population has

increased approximately 14 percent, reversing a 30-year downward trend. In 1993, 25,313 new cases

of TB were reported in the United States. Increases in the incidence of TB have been observed in

some geographic areas; these increases are related partially to the high risk for TB among

immunosuppressed persons, particularly those infected with human immunodeficiency virus (HIV).

Other factors (e.g., socioeconomic) have also contributed to these increases. Outbreaks have

occurred in hospitals, correctional institutions, homeless shelters, nursing homes, and residential care

facilities for AIDS patients. During 1994 and 1995 there has been a decrease in the number of TB

cases in the United States that is likely been due to increased awareness and efforts in the prevention

and control of TB, including the implementation of TB control measures recommended by the CDC

and required by OSHA.

Recently, drug resistant strains of M. tuberculosis have become a serious concern and cases of

multi-drug-resistant (MDR) TB have occurred in forty states. In a recent New York City study,

33% of cases had organisms resistant to the two most effective drugs available for treating the

disease. When organisms are resistant to both drugs, the course of the treatment increases from

six months to 18-24 months, and the cure rate decreases from 100% to 60% or less.

In a 1992 American Hospital Association survey/CDC survey, 90 of 729 (13%) respondents

reported nosocomial TB transmission to health care workers. More than 80% of those facilities

experienced TB skin test conversions among workers. More than 100 cases of active TB disease

in health care workers were known to CDC and reported to Congress by Dr. William Roper in

the Spring of 1993. Twelve (12) health care workers have died. Nationwide, at least several

hundred employees have become infected and required medical treatment after workplace

exposure to TB. In general, persons who become infected with TB have approximately a 10% risk

for developing active TB in their lifetimes. M. tuberculosis is carried through the air in tiny infectious

droplet nuclei of 1 to 5 microns in diameter. These droplets may be generated when a person with

pulmonary and laryngeal TB disease coughs, speaks, sings, sneezes, or spits. When inhaled by

susceptible persons, the mycobacteria in these droplets may become established in the lungs and, in

some cases, spread throughout the body. After an interval of months, years, or even decades, the

initial infection may then progress to clinical illness (i.e., tuberculosis disease). Transmission of TB is

most likely to occur from persons with pulmonary or laryngeal TB that are not on effective anti-TB

therapy and who have not been placed in respiratory isolation.

In occupational health care settings, where patients with TB are seen, workers exposed to

tuberculosis droplet nuclei are at increased risk of infection with exposure to TB. Certain

high-risk medical procedures that are cough-inducing or aerosol generating can further increase

the risk of infection in health care workers.

The employer’s obligations are those set forth in the Occupational Safety and Health Act (OSH

Act) of 1970. Recommendations for preventing the transmission of TB for health care settings

were originally established with the 1990 CDC Guidelines. In October, of 1994, those guidelines

were revised and published (Appendix A). The new guidelines emphasize the control of TB

through an effective TB infection control program. Under these guidelines the control of TB is to

be accomplished through the early identification, isolation, and treatment of persons with TB, use

of engineering and administrative procedures to reduce the risk of exposure, and through the use

of respiratory protection. OSHA believes these guidelines reflect an industry recognition of the

hazard as well as appropriate, widely recognized, and accepted standards of practice to be

followed by employers in carrying out their responsibilities under the OSH Act.
48

H. Inspection Scheduling and Scope

1. The evaluation of occupational exposure to TB shall be conducted in response to employee

complaints, related fatality/catastrophes, or as part of all industrial hygiene inspections

conducted in workplaces where the CDC has identified workers as having a greater

incidence of TB infection than in the general population. The degree of risk of

occupational exposure of a worker to TB will vary based on a number of factors discussed

in detail by the CDC (Appendix A, pg. 4-5). These workplaces have been the subject of

reports issued by the CDC which provide recommendations for the control of

tuberculosis. Specifically, these workplaces are as follows:

a. health care facilities

b. correctional institutions

c. long-term care facilities for the elderly

d. homeless shelters

e. drug treatment centers

Note: Health care facilities include hospitals where patients with confirmed or suspect TB are treated or to

which they are transported. Coverage of non-hospital health care settings (i.e., doctors’ offices, clinics, etc.)

includes only personnel present during the performance of high hazard procedures on suspect or active TB

patients. Dental health care personnel are covered by the directive only if they treat suspect or active

patients in a hospital or correctional facility.

Homeless shelters - due to a variety of circumstances, the control of TB in homeless

shelters presents unique problems for the protection of workers. Shelters must establish

protocols that provide for rapid early identification followed by immediate transfer of

suspect cases if the shelters have elected not to treat these patients.

2. All inspections in these workplaces shall include a review of the employer’s plans for

employee TB protection, if any. Such plans may include the infection control program,

respiratory protection and skin testing. Employee interviews and site observations are an

integral part of the process evaluation.

3. Complaints received from state and local government employees who are outside federal

jurisdiction in federal enforcement states shall be referred to the appropriate agency by the

Area Office.

I. Inspection Procedures. The procedure given in the FIRM, Chapter II, shall be followed except as

modified in the following sections:

1. Health care facilities generally have internal infection control and employee health

programs. This function may be performed by a team or individual. Upon entry, the

CSHO shall request the presence of the infection control director and employee

occupational health professional responsible for occupational health hazard control.

Other individuals who will be responsible for providing records pertinent to the inspection

may include: training director, facilities engineer, director of nursing, etc.

2. The CSHO shall establish whether or not the facility has had a suspect or confirmed TB

case within the previous six (6) months from the opening conference to determine

coverage under the OSH Act. This determination may be based upon interviews and, in

1.
49

a hospital, a review of the infection control data.

3. If the facility has had a suspect or confirmed TB case within the previous six months, the

CSHO shall proceed with the TB portion of the inspection. The CSHO shall verify

implementation of the employer’s plans for TB protection through employee interviews

and direct observation where feasible. Professional judgment shall be used to identify

which areas of a facility must be inspected during the walk through (e.g., emergency rooms,

respiratory therapy areas, bronchoscopy suites, and morgue). After review of the facility

plans for worker TB protection, employee interviews combined with an inspection of

appropriate areas of the facility, shall be used to determine compliance.

4. CSHOs who perform smoke-trail visualization tests should review the protocol in

Appendix B of this directive.

5. CSHOs should be prepared to present to the employer the material safety data sheet

(MSDS) for the smoke that is released on a smoke-trail visualization.

J. Compliance Officer Protection

1. Area Directors or Assistant Area Directors shall ensure that CSHOs performing TB related

inspections are familiar with the CDC Guidelines, terminology, and are adequately

trained through either course work or field/work experience in health care settings.

Consultation with the regional TB coordinators is encouraged prior to beginning such

inspections.

2. CSHOs shall not enter occupied respiratory isolation [AFB (acid fast bacilli)] rooms to

evaluate compliance unless, in their determination entry is required to document a

violation. Prior to entry CSHOs will discuss the need for entry with the Area Director.

Photographs or video taping where practical shall be used for case documentation.

Under no circumstances shall photographing or videotaping of patients be done. CSHO’s

must take all necessary precautions to assure and protect patient confidentiality.

3. CSHOs shall exercise professional judgement and extreme caution when engaging in

activities that may involve potential exposure to TB. CSHOs normally shall establish the

existence of hazards and adequacy of work practices through employee interviews and

shall observe them in a manner which prevents exposure (e.g., through an observation

window where available).

4. On rare occasions when entry into potentially hazardous areas is judged necessary (e.g.,

where the CSHO determines that direct observation of a high hazard procedure is

necessary), the CSHO shall be properly equipped as required by the facility, this directive,

and following consultation with the CSHO’s supervisor. Since CSHOs’ respiratory

protection is used in more than one type of industry they shall use their negative pressure

elastomeric face piece respirators equipped with HEPA filters as the minimum level of

respiratory protection.

5. CSHOs who conduct TB inspections shall have been offered the TB skin tests. CSHOs

exposed to an individual(s) with active infectious TB shall receive a follow-up

examination and follow Sections J. and K. of Appendix A beginning on page 37.
50

Note: A “TB Skin Test” means the intradermal injection (Mantoux Method) of

tuberculin antigen (usually PPD) with subsequent measurement of the induration by

designated, trained personnel.

6. If an isolation room is occupied by a patient with confirmed or suspect TB or has not been

adequately purged when a smoke-trail test is performed, then the CSHO should assume

that the isolation room is not under negative pressure. Under such circumstances CSHOs

shall wear a negative pressure HEPA respirator when performing air tests as described in

Appendix B or if entry into the room is determined to be necessary.

K. Citation Policy. Relevant chapters of the FIRM shall be followed when preparing and issuing

citations for hazards related to TB.

1. The following requirements apply when citing hazards found in target workplaces.

Employers must comply with the provisions of these requirements whenever an employee

may be occupationally exposed to TB:

Section 5(a)(1) -- General Duty Clause and Executive Order 12196, Section 1-201(a)

for Federal facilities.

29 CFR 1910.134* -- Respiratory Protection

29 CFR 1910.145 -- Accident Prevention Signs and Tags

29 CFR 1910.20 -- Access to Employee Exposure and Medical Records

29 CFR 1904 -- Recording and Reporting Occupational Injuries & Illness

L. Violations. All elements in this section must be addressed to ensure adequate protection of

employees from TB hazards. Violations of these OSHA requirements will normally be classified as

serious.

1. General Duty Clause - Section 5(a) (1). Section 5(a)(1) provides: “Each employer shall

furnish to each of his employees employment and a place of employment which are free

from recognized hazards that are causing or are likely to cause death or serious physical

harm to his employees.”

a. Section 5(a)(1) citations must meet the requirements outlined in the FIRM, and

shall be issued only when there is no standard that applies to the particular

hazard. The hazard, not the absence of a particular means of abatement, is the

basis for a general duty clause citation. All applicable abatement methods

identified as correcting the same hazard shall be issued under a single 5(a)(1)

citation.

b. Recognition, for purposes of citing section 5(a)(1), is shown by the CDC Guidelines

for the types of exposures detailed below because the CDC is an acknowledged

body of experts familiar with the hazard.

c. Citations shall be issued to employers with employees working in one of the

* 29 CFR 1910.134 is now codified for protection against TB as 29 CFR 1910.139.
51

workplaces where the CDC has identified workers as having a higher incidence of

TB infection than the general population, when the employees are not provided

appropriate protection and who have exposure as defined below:

1. Exposure to the exhaled air of an individual with suspected or confirmed

pulmonary TB disease, or

Note: A suspected case is one in which the facility has identified an

individual as having symptoms consistent with TB. The CDC has

identified the symptoms to be:

productive cough, coughing up blood, weight loss, loss of appetite,

lethargy/weakness, night sweats, or fever.

2. Employee exposure without appropriate protection to a high hazard

procedure performed on an individual with suspected or confirmed

infectious TB disease and which has the potential to generate infectious

airborne droplet nuclei. Examples of high hazard procedures include

aerosolized medication treatment, bronchoscopy, sputum induction,

endotracheal intubation and suctioning procedures, emergency dental,

endoscopic procedures, and autopsies conducted in hospitals.

d. If a citation under 5(a)(1) is justified, the citation, after setting forth the SAVE for

section 5(a)(1), shall state:

Section 5(a)(1) of the Occupational Safety and Health Act of 1970: The employer

did not furnish employment and a place of employment which were free from

recognized hazards that were causing or likely to cause death or serious physical

harm to employees exposed to the hazard of being infected with Mycobacterium

tuberculosis through unprotected contact with [specify group such as patients,

inmates, clients, etc.] who was/were infectious or suspected to be infectious with

tuberculosis in that: [list deficiencies]

Feasible and useful abatement methods for reducing this hazard, as recommended

by the CDC, include, but are not limited to: [list abatement methods].

e. The following are examples of feasible and useful abatement methods, which must

be implemented to abate the hazard. Deficiencies found in any category can result

in the continued existence of a serious hazard and may, therefore, allow citation

under 5(a)(1).

1. Early Identification of Patient/Client. The employer shall implement a

protocol for the early identification of individuals with active TB. See

Appendix A pages 19 - 30.

2. Medical Surveillance:

a. Initial Exams. The employer, in covered workplaces, shall offer TB

skin tests (at no cost to the employees) to all current potentially

exposed employees and to all new employees prior to exposure. A

two-step baseline shall be used for new employees who have an
52

initially negative PPD test result and who have not had a

documented negative TB skin test result during the preceding 12

months (See Appendix A, pg. 63). TB skin tests shall be offered at a

time and location convenient to workers. Follow-up and treatment

evaluations are also to be offered at no cost to the workers.

Note: The reading and interpretation of the TB skin tests shall be

performed by a qualified individual as described in the CDC

Guidelines.

b. Periodic Evaluations. TB skin testing shall be conducted every three

(3) months for workers in high risk categories, every six (6) months

for workers in intermediate risk categories, and annually for low

risk personnel (The CDC has defined the criteria for high,

intermediate, and low risk categories, see Appendix A, pg. 8-17).

Workers with a documented positive TB skin test who have

received treatment for disease or preventive therapy for infection

are exempt from the TB skin test but must be informed periodically

about the symptoms of TB and the need for immediate evaluation

of any pulmonary symptoms suggestive of TB by a physician or

trained health care provider to determine if symptoms of TB

disease have developed.

Note: If the facility has not completed a risk assessment the CSHO

shall review the TB related records to establish required testing

frequencies for the facility and areas of the facility.

c. Reassessment following exposure or change in health. Workers

who experience exposure to an individual with suspect or

confirmed infectious TB for whom infection control precautions

have not been taken shall be managed according to CDC

recommendations (Appendix A). An employee who develops

symptoms of TB disease shall be immediately evaluated according

to the CDC Guidelines.

3. Case Management of Infected Employees shall include the following:

a. Protocol for New Converters. Conversion to a positive TB skin test

shall be followed as soon as possible, by appropriate physical,

laboratory, and radiographic evaluations to determine whether the

employee has infectious TB disease. (see Appendix A, pg. 65).

b. Work Restrictions for Infectious Employees. See Appendix A, page

41.

4. Worker Education and Training. Training and information to ensure

employee knowledge of such issues as the mode of TB transmission, its

signs and symptoms, medical surveillance and therapy, and site specific

protocols including the purpose and proper use of controls shall be

provided to all current employees and to new workers upon hiring. (See
53

Appendix A, pgs. 36-37) Training should be repeated as needed.

Workers shall be trained to recognize, and report to a designated person,

any patients or clients with symptoms suggestive of infectious TB and

instructed on the post exposure protocols to be followed in the event of an

exposure incident. (see Appendix A, pg. 23)

5. Engineering Controls. The use of each control measure must be based on

its ability to abate the hazard.

a. Individuals with suspected or confirmed infectious TB disease must

be placed in a respiratory acid-fast bacilli (AFB) isolation room.

High hazard procedures on individuals with suspected or

confirmed infectious TB disease must be performed in AFB

treatment rooms, AFB isolation rooms, booths, and/or hoods. AFB

isolation refers to a negative pressure room or an area that exhausts

room air directly outside or through HEPA filters if recirculation is

unavoidable.

b. Isolation and treatment rooms in use by individuals with suspected

or confirmed infectious TB disease shall be kept under negative

pressure to induce airflow into the room from all surrounding

areas (e.g., corridors, ceiling plenums, plumbing chases, etc.). (See

Appendix A, Supplement No. 3, page 76)

Note: The employer must assure that AFB isolation rooms are

maintained under negative pressure. At a minimum, the employer

must use nonirritating smoke trails or some other indicator to

demonstrate that direction of airflow is from the corridor into the

isolation/treatment room with the door closed. If an anteroom

exists, direction of airflow must be demonstrated at the inner door

between the isolation/treatment room and the anteroom. (See

Appendix B)

c. Air exhausted from AFB isolation or treatment rooms must be

safely exhausted directly outside and not recirculated into the

general ventilation system. (See Appendix A, Supplement No. 3,

page 87).

In circumstances where recirculation is unavoidable, HEPA filters

must be installed in the duct system from the room to the general

ventilation system. (See Appendix A, Supplement No. 3, page 82).

For these HEPA filters, a regularly scheduled monitoring program

to demonstrate as-installed effectiveness should include; 1)

recognized field test method, 2) acceptance criteria, and 3) testing

frequencies (see Appendix A, Supplement No. 3, page 85). The air

handling system should be appropriately marked with a TB

warning where maintenance personnel would have access to the

duct work, fans, or filters for maintenance or repair activities.

d. In order to avoid leakage, all potentially contaminated air which is
54

ducted through the facility must be kept under negative pressure

until it is discharged safely outside (i.e., away from occupied

areas and air intakes), or

e. The air from isolation and treatment rooms must be

decontaminated by a recognized process (e.g., HEPA filter)

before being recirculated back to the isolation/treatment room.

The use of UV radiation as the sole means of decontamination

shall not be used. The CDC Guidelines allow the use of UV in

waiting rooms, emergency rooms, corridors, and the like where

patients with undiagnosed TB could potentially contaminate the

air. (See appendix A, pg 90)

Note: The opening and closing of doors in an isolation or

treatment room which is not equipped with an anteroom

compromises the ability to maintain negative pressure in the

room. For these rooms, the employer should utilize a

combination of controls and practices to minimize spillage of

contaminated air into the corridor. Recognized controls and

practices include, but are not limited to: minimizing entry to the

room; adjusting the hydraulic closer to slow the door movement

and reduce displacement effects; adjusting doors to swing into

the room where fire codes permit; avoiding placement of room

exhaust intake near the door; etc.

f. If high-hazard procedures are performed within AFB isolation or

treatment rooms without benefit of source control ventilation or

local exhaust ventilation (e.g., hood, booth, tent, etc.), and

droplets are released into the environment (e.g., coughing), then

a purge time interval must be imposed during which personnel

must use a respirator when entering the room. (See Appendix

A, pg. 35 and Suppl. 3, Table S3-1)

g. Interim or supplemental ventilation units equipped with HEPA

filters as described in Appendix A pgs. 70-73 are acceptable.

2. Respiratory Protection - 29 CFR 1910.134 (a) (2) and (b).*

The standard provides in part:

“Respirators shall be provided by the employer when such equipment is

necessary to protect the health of the employee. The employer shall provide

the respirators which are applicable and suitable for the purpose intended.

The employer shall be responsible for the establishment and maintenance of a

respiratory protective program which shall include the requirement outlined in

paragraph (b) of this section.”

a. Requirements for a minimal acceptable program.

The 1994 CDC Guidelines specify standard performance criteria for

* 29 CFR 1910.134 is now codified for protection against TB as 29 CFR 1910.139.
55

respirators for exposure to TB. These criteria include (see appendix A

pg 97):

1. The ability to filter particles 1 μm in size in the unloaded state

with a filter efficiency of > 95% (i.e., filter leakage of < 5%), given

flow rates of up to 50 L per minute.

2. The ability to be qualitatively or quantitatively fit tested in a

reliable way to obtain a face-seal leakage of < 10%.

3. The ability to fit the different facial sizes and characteristics of

health care workers which can usually be met by making the

respirators available in at least three sizes.

4. The ability to be checked for face piece fit, in accordance with

OSHA standards and good industrial hygiene practice, by

health care workers each time they put on their respirator.

b. Under the new NIOSH criteria, filter materials would be tested at a flow

rate of 85 L/minute for penetration by particles with a median

aerodynamic diameter of 0.3 uμ and, if certified would be placed in one of

the following categories: Type 100 (99.7% efficient), Type 99 (99%

efficient), and Type 95 (95% efficient). NIOSH has determined that

these categories of respirators are effective against TB. Based upon

these criteria, the minimally acceptable level of respiratory protection

for TB is the Type 95 Respirator. The classes of these air-purifying,

particulate respirators to be certified are described under 42 CFR Part

84 Subpart K. See Volume 60 of the Federal Register, page 30338 (June

8, 1995). Until these classes of respirators are commercially available

the minimal acceptable respiratory protection meeting the criteria will

remain the HEPA respirator (see Appendix A, pg 98). The following

respiratory protection measures must be addressed:

1. Employees wear HEPA or respirators certified under 42 CFR

Part 84 Subpart K in the following circumstances:

a. When workers enter rooms housing individuals with

suspected or confirmed infectious TB.

b. When workers are present during the performance of

high hazard procedures on individuals who have

suspected or confirmed infectious TB.

c. When emergency-medical-response personnel or others

transport, in a closed vehicle, an individual with

suspected or confirmed infectious TB.

Note: If a facility chooses to use disposable respirators as part of their
56

respiratory protection program, their reuse by the same health care

worker is permitted as long as the respirator maintains its structural

and functional integrity and the filter material is not physically

damaged or soiled. The facility must address the circumstances in

which a disposable respirator will be considered to be contaminated

and not available for reuse.

2. The following sample language is provided for citations which are

warranted under 1910.134(a)(2):*

“The employer did not provide respirators which were applicable and

suitable for the purpose intended, nor was a respiratory protection

program established which included the requirements outlined in 29

CFR 1910.134(b):*

(a) Employees were given a [surgical mask or list manufacturer/model

number] respirator for protection against airborne Mycobacterium

tuberculosis when entering isolation rooms or performing high hazard

procedures [including vehicular transporting if applicable]. They shall use

NIOSH approved respirators (HEPA or those certified under 42 CFR

Part 84 Subpart K).

NIOSH approved respirators providing greater protection would also be

acceptable.*

3. When respiratory protection (including disposable respirators) is

required, a complete respiratory protection program must be in place in

accordance with 29 CFR1910.134(b).

3. Access to employee medical and exposure records: 29 CFR 1910.20.

a. A record concerning employee exposure to TB is an employee exposure

record within the meaning of 29 CFR 1910.20.

b. A record of TB skin test results and medical evaluations and treatment

are employee medical records within the meaning of 29 CFR 1910.20.

Where known, the workers exposure record should contain a notation

of the type of TB, to which the employee was exposed to (e.g.,

multidrug resistant TB).

c. These records shall be handled according to 29 CFR 1913.10 in order for

the CSHO to determine compliance with 29 CFR 1910.20.

4. Accident prevention signs and tags: 29 CFR 1910.145.

a. In accordance with 1910.145(f)(8), a warning shall be posted outside

the Respiratory isolation or treatment room. 1910.145(f)(4) requires that

a signal word (i.e.; "STOP," "HALT," or "NO ADMITTANCE") or

* 29 CFR 1910.134 is now codified for protection against TB as 29 CFR 1910.139.
57

biological hazard symbol be presented as well as a major message (e.g.;

“special respiratory isolation,“ “Respiratory isolation,” or AFB isolation).

A description of the necessary precautions, e.g., respirators must be

donned before entering. Respiratory isolation rooms in an emergency

department or a message referring one to the nursing station for

instruction must also be posted.

b. The employer shall also use biological hazard tags on air transport

components (e.g., fans, ducts, filters) which identify TB hazards to

employees associated with working on air systems that transport

contaminated air (See Appendix A, page 85).

c. The standard provides in part:

29 CFR 1910.145(e)(4): Biological hazard warning signs were not used

to signify the actual or potential presence of a biohazard and to identify

equipment, containers, rooms, materials, experimental animals, or

combinations thereof, which contain, or are contaminated with viable

hazardous agents:

Sample violation language:

a. On or about [date], warning signs posted outside respiratory

(Respiratory) isolation or treatment rooms did not state the entry

requirement of wearing HEPA filtered respirators.

Abatement Note: Warning signs must be posted on respiratory

isolation or treatment rooms stating “pulmonary isolation,” “respiratory

isolation,” or “AFB isolation.” The sign must state specifically the

precautions required to interact with those patients. Indicators on

patient records or tags on corpses, printed in language or symbols easily

recognized by employees are additional methods to achieve this

purpose.

5. OSHA 200 log - 29 CFR 1904:

a. For OSHA Form 200 record keeping purposes, both tuberculosis

infections (positive TB skin test) and tuberculosis disease are recordable

in the high risk setting referenced in section H.1. A positive skin test for

tuberculosis, even on initial testing (except pre-assignment screening) is

recordable on the OSHA 200 log because there is a presumption of

work-relatedness in these settings unless there is clear documentation

that an outside exposure occurred.

Note: In this case pre-assignment means the same as pre employment

and initial testing is the same as baseline testing.

b. If the employee’s tuberculosis infection which was entered on the OSHA
58

200 log progresses to tuberculosis disease during the five-year maintenance

period, the original entry for the infection shall be updated to reflect the

new information. Because it is difficult to determine if tuberculosis disease

resulted from the source indicated by the skin test conversion or from

subsequent exposures, only one case should be entered to avoid double

counting.

c. A positive TB skin test provided within two weeks of employment does not

have to be recorded on the OSHA 200 forms. However, the initial test

must be performed prior to any potential workplace exposure within the

initial two weeks of employment.

M. Expert Witness. The Directorate of Technical Support will assist Regional Offices and the States

in locating expert witnesses. Expert witnesses must be contacted before issuance of citations.

1. In the event that a 5(a)(1) citation is contested, proper expert witness support will be

required. Issues which the expert must be prepared to address include:

a. The risk to workers associated with the exposure circumstances.

b. Existence, feasibility and utility of abatement measures.

c. Recognition of the hazard in the industry.

2. Expert witnesses may also be necessary in other cases, particularly those involving 29 CFR

1910.134.*

N. Recording in the IMIS. A TB-related inspection is any health inspection conducted to investigate

the presence or alleged presence of TB disease (i.e., a referral or complaint inspection).

1. When a TB-related inspection is conducted, complete the OSHA-1 as for any inspection

and enter the code “N 02 TB” in Item 42, Optional Information. EXAMPLE:

Type ID Value

N 2 TB

2. When an OSHA-7 is completed and the complaint alleges the presence of TB hazards,

enter the code “N 02 TB” in Item 46, Optional Information.

3. When an OSHA-90 is completed and the referral alleges the presence of TB hazards, enter

the code “N 02 TB” in Item, 26, Optional Information.

4. All IMIS case file data for TB-related inspections conducted since October 1, 1990, shall be

modified to include the appropriate TB code.

O. Referrals

1. When a complaint or inquiry is received from a source in a state plan regarding

* 29 CFR 1910.134 is now codified for protection against TB as 29 CFR 1910.139.
59

occupational exposure to TB, the Area Office shall refer it to the state plan designee for

action.

2. When a complaint or inquiry regarding occupational exposure to TB in a state or local

government health care facility is received in a state without an OSHA-approved state

plan, the Regional Administrator shall refer it to the appropriate State public health

agency or local health agency.

P. Pre-citation Review. Citations proposed pursuant to this program shall be reviewed prior to

issuance, by the Regional Administrator and Regional Office Solicitor for consistency with these

procedures. The Directorate of Technical Support shall be contacted to establish expert witness

support. The Office of Health Compliance Assistance shall be provided with a copy of all

citations issued related to TB during the first 6 months of this directive.

Joseph A. Dear

Assistant Secretary

Distribution: National, Regional, and Area Offices

All Compliance Officers

State Designees

NIOSH Regional Program Directors

7(c)(1) Consultation Project Managers

Appendix A

“Guidelines for preventing the Transmission of Mycobacterium Tuberculosis in Health care Facilities, 1994”

Appendix B

Smoke-Trail Testing Method for Negative pressure Isolation Room

Test Method Description:

One of the purposes of a negative pressure TB isolation room is to prevent TB droplet nuclei from

escaping the isolation room and entering the corridor or other surrounding uncontaminated spaces. To

check for negative room pressure, use smoke-trails to demonstrate that the pressure differential is

inducing airflow from the corridor, through the crack at the bottom of the door (undercut) and into the

isolation room. When performing a smoke-trail test follow these recommendations where applicable:

1. Test only with the isolation room door shut. If not equipped with an anteroom, it is assumed that

there will be a loss of space pressure control when the isolation door is opened and closed. It is

not necessary to demonstrate direction of airflow when the door is open.

2. If there is an anteroom, release smoke at the inner door undercut, with both anteroom doors shut.

3. In addition to a pedestrian entry, some isolation rooms are also accessed through a wider

wheeled-bed stretcher door. Release smoke at all door entrances to isolation rooms.

4. So that the smoke is not blown into the isolation room, hold the smoke bottle/tube parallel to the

door so the smoke is released perpendicular to the direction of airflow through the door undercut.

5. Position the smoke bottle/tube tight to the floor, centered in the middle of the door jamb and

approximately two inches out in front of the door.
60

6. Release a puff of smoke and observe the resulting direction of airflow. Repeat the test at least

once or until consistent results are obtained.

7. Minimize momentum imparted to the smoke by squeezing the bulb or bottle slowly. This will

also help minimize the volume of smoke released.

8. Depending on the velocity of the air through the door undercut, the smoke plume will either

stay disorganized or it will form a distinct streamline. In either case, the smoke will

directionally behave in one of three ways. It will:

a. go through the door undercut into the isolation room,

b. remain motionless, or

c. be blown back into the corridor.

Compliance with the intent of the CDC Guidelines for negative pressure requires that the

smoke be drawn into the isolation room through the door undercut.

9. Release smoke from the corridor side of the door only for occupied TB isolation rooms. If the

room is unoccupied, also release smoke inside the isolation room (same position as in Step No.

5) to verify that released smoke remains contained in the isolation room (i.e., smoke as a

surrogate for TB droplet nuclei).

10. If photography is performed or videotaping, it is recommended that a dark surface be placed

on the floor to maximize contrast. Be aware that most auto focusing cameras cannot focus on

smoke.

Testing “As Used” Conditions:

Testing of negative pressure isolation rooms requires that the test reflect “as-used” conditions.

Consider the following use variables which may affect space pressurization and the performance of

the negative pressure isolation room:

1. Patient toilet rooms are mechanically exhausted to control odors. The position of the toilet

room door may affect the pressure differential between the isolation room and the corridor.

Smoke-trail tests should be performed with the toilet room door open and the toilet room door

closed. This will not be necessary if the toilet room door is normally closed and controlled to

that position by a mechanical door closer.

2. An open window will adversely affect the performance of a negative pressure isolation room.

If the isolation room is equipped with an operable window, perform smoke-trail tests with the

window open and the window closed.

3. There may be corridor doors that isolate the respiratory ward or wing from the rest of the

facility. These corridor doors are provided in the initial design to facilitate space

pressurization schemes and/or building life safety codes. Direct communication with the rest

of the facility may cause pressure transients in the corridor (e.g., proximity to an elevator

lobby) and affect the performance of the isolation room. Perform isolation room smoke-trail
61

testing with these corridor doors in their “as-used” position which is either normally open or

normally closed.

4. Isolation rooms may be equipped with auxiliary, fan-powered, recirculating, stand alone

HEPA filtration or UV units. These units must be running when smoke-trail tests are

performed.

5. Do not restrict corridor foot traffic while performing smoke-trail tests.

6. Negative pressure is accomplished by exhausting more air than is supplied to the isolation

room. Some HVAC systems employ variable air volume (VAV) supply air and sometimes

VAV exhaust air. By varying the supply air delivered to the space to satisfy thermal

requirements, these VAV systems can adversely impact the performance of a negative

pressure isolation room. If the isolation room or the corridor is served by a VAV system you

should perform the smoke test twice. Perform the smoke test with the zone thermostat

thermally satisfied and again with the zone thermostat thermally unsatisfied thus stimulating

the full volumetric flow rate range of the VAV system serving the area being tested.

Smoke:

Most smoke tubes, bottles and sticks use titanium chloride (TiCl4) to produce a visible fume. There is

no OSHA PEL or ACGIH TLV for this chemical although it is a recognized inhalation irritant.

Health care professionals are concerned about releasing TiCl4 around pulmonary patients. The

smoke released at the door undercut makes only one pass through the isolation room and is

exhausted directly outside. Isolation room air is typically not “recirculated.”

The CDC in the supplementary information to the 1994 TB Guidelines has indicated that “The

concern over the use of smoke is unfounded.” Controlled tests by NIOSH have shown that the

quantity of smoke that is released is so minute that it is not measurable in the air. Nonirritating

smoke tubes are available and should be utilized whenever possible.
62

1910.1020 - Access To Employee Exposure And Medical Records.

(a) Purpose.

The purpose of this section is to provide employees and their designated representatives a right of

access to relevant exposure and medical records; and to provide representatives of the Assistant

Secretary a right of access to these records in order to fulfill responsibilities under the

Occupational Safety and Health Act. Access by employees, their representatives, and the

Assistant Secretary is necessary to yield both direct and indirect improvements in the detection,

treatment, and prevention of occupational disease. Each employer is responsible for assuring

compliance with this section, but the activities involved in complying with the access to medical

records provisions can be carried out, on behalf of the employer, by the physician or other health

care personnel in charge of employee medical records. Except as expressly provided, nothing in

this section is intended to affect existing legal and ethical obligations concerning the maintenance

and confidentiality of employee medical information, the duty to disclose information to a

patient/employee or any other aspect of the medical-care relationship, or affect existing legal

obligations concerning the protection of trade secret information.

(b) Scope and application.

(1) This section applies to each general industry, maritime, and construction employer who

makes, maintains, contracts for, or has access to employee exposure or medical records, or

analyses thereof, pertaining to employees exposed to toxic substances or harmful physical agents.

(2) This section applies to all employee exposure and medical records, and analyses thereof, of

such employees, whether or not the records are mandated by specific occupational safety and

health standards.

(3) This section applies to all employee exposure and medical records, and analyses thereof, made

or maintained in any manner, including on an in-house or contractual (e.g., fee-for-service) basis.

Each employer shall assure that the preservation and access requirements of this section are

complied with regardless of the manner in which records are made or maintained.

(c) Definitions.

(1) Access means the right and opportunity to examine and copy.

(2) Analysis using exposure or medical records means any compilation of data or any statistical

study based at least in part on information collected from individual employee exposure or

medical records or information collected from health insurance claims records, provided that

either the analysis has been reported to the employer or no further work is currently being done

by the person responsible for preparing the analysis.

(3) Designated representative means any individual or organization to whom an employee gives

written authorization to exercise a right of access. For the purposes of access to employee

exposure records and analyses using exposure or medical records, a recognized or certified

collective bargaining agent shall be treated automatically as a designated representative without

regard to written employee authorization.

APPENDIX C
63

(4) Employee means a current employee, a former employee, or an employee being assigned or

transferred to work where there will be exposure to toxic substances or harmful physical agents.

In the case of a deceased or legally incapacitated employee, the employee’s legal representative

may directly exercise all the employee’s rights under this section.

(5) Employee exposure record means a record containing any of the following kinds of information:

(i) Environmental (workplace) monitoring or measuring of a toxic substance or harmful

physical agent, including personal, area, grab, wipe, or other form of sampling, as well as

related collection and analytical methodologies, calculations, and other background data

relevant to interpretation of the results obtained;

(ii) Biological monitoring results which directly assess the absorption of a toxic substance or

harmful physical agent by body systems (e.g., the level of a chemical in the blood, urine,

breath, hair, fingernails, etc.) but not including results which assess the biological effect of a

substance or agent or which assess an employee’s use of alcohol or drugs;

(iii) Material safety data sheets indicating that the material may pose a hazard to human

health; or

(iv) In the absence of the above, a chemical inventory or any other record which reveals

where and when used and the identity (e.g., chemical, common, or trade name) of a toxic

substance or harmful physical agent.

(6)

(i) Employee medical record means a record concerning the health status of an employee which

is made or maintained by a physician, nurse, or other health care personnel, or technician,

including:

(A) Medical and employment questionnaires or histories (including job description and

occupational exposures),

(B) The results of medical examinations (pre-employment, pre-assignment, periodic, or

episodic) and laboratory tests (including chest and other X-ray examinations taken for the

purpose of establishing a base-line or detecting occupational illnesses and all biological

monitoring not defined as an “employee exposure record”),

(C) Medical opinions, diagnoses, progress notes, and recommendations,

(D) First aid records,

(E) Descriptions of treatments and prescriptions, and

(F) Employee medical complaints.

(ii) “Employee medical record” does not include medical information in the form of:

(A) Physical specimens (e.g., blood or urine samples) which are routinely discarded as a
64

part of normal medical practice,; or

(B) Records concerning health insurance claims if maintained separately from the employer’s

medical program and its records, and not accessible to the employer by employee name or

other direct personal identifier (e.g., social security number, payroll number, etc.); or

(C) Records created solely in preparation for litigation which are privileged from discovery

under the applicable rules of procedure or evidence; or

(D) Records concerning voluntary employee assistance programs (alcohol, drug abuse, or

personal counseling programs) if maintained separately from the employer’s medical program

and its records.

(7) Employer means a current employer, a former employer, or a successor employer.

(8) Exposure or exposed means that an employee is subjected to a toxic substance or harmful physical

agent in the course of employment through any route of entry (inhalation, ingestion, skin contact or

absorption, etc.), and includes past exposure and potential (e.g., accidental or possible) exposure, but

does not include situations where the employer can demonstrate that the toxic substance or harmful

physical agent is not used, handled, stored, generated, or present in the workplace in any manner

different from typical non-occupational situations.

(9) Health Professional means a physician, occupational health nurse, industrial hygienist, toxicologist,

or epidemiologist, providing medical or other occupational health services to exposed employees.

(10) Record means any item, collection, or grouping of information regardless of the form or process

by which it is maintained (e.g., paper document, microfiche, microfilm, X-ray film, or automated data

processing).

(11) Specific chemical identity means a chemical name, Chemical Abstracts Service (CAS) Registry

Number, or any other information that reveals the precise chemical designation of the substance.

(12)

(i) Specific written consent means a written authorization containing the following:

(A) The name and signature of the employee authorizing the release of medical information,

(B) The date of the written authorization,

(C) The name of the individual or organization that is authorized to release the medical

information,

(D) The name of the designated representative (individual or organization) that is authorized to receive

the released information,

(E) A general description of the medical information that is authorized to be released,

(F) A general description of the purpose for the release of the medical information, and

(G) A date or condition upon which the written authorization will expire (if less than one year).
65

(ii) A written authorization does not operate to authorize the release of medical information not in

existence on the date of written authorization, unless the release of future information is expressly

authorized, and does not operate for more than one year from the date of written authorization.

(iii) A written authorization may be revoked in writing prospectively at any time.

(13) Toxic substance or harmful physical agent means any chemical substance, biological agent (bacteria,

virus, fungus, etc.), or physical stress (noise, heat, cold, vibration, repetitive motion, ionizing and

non-ionizing radiation, hypo - or hyperbaric pressure, etc.) which:

(i) Is listed in the latest printed edition of the National Institute for Occupational Safety and

Health (NIOSH) Registry of Toxic Effects of Chemical Substances (RTECS) which is incorporated

by reference as specified in Sec. 1910.6; or

(ii) Has yielded positive evidence of an acute or chronic health hazard in testing conducted by, or

known to, the employer; or

(iii) Is the subject of a material safety data sheet kept by or known to the employer indicating that

the material may pose a hazard to human health.

(14) Trade secret means any confidential formula, pattern, process, device, or information or

compilation of information that is used in an employer’s business and that gives the employer an

opportunity to obtain an advantage over competitors who do not know or use it.

(d) Preservation of records.

 (1) Unless a specific occupational safety and health standard provides a different period of time,

each employer shall assure the preservation and retention of records as follows:

(i) Employee medical records. The medical record for each employee shall be preserved and

maintained for at least the duration of employment plus thirty (30) years, except that the

following types of records need not be retained for any specified period:

(A) Health insurance claims records maintained separately from the employer’s medical

program and its records,

(B) First aid records (not including medical histories) of one-time treatment and subsequent

observation of minor scratches, cuts, burns, splinters, and the like which do not involve

medical treatment, loss of consciousness, restriction of work or motion, or transfer to another

job, if made on-site by a non-physician and if maintained separately from the employer’s

medical program and its records, and

(C) The medical records of employees who have worked for less than (1) year for the

employer need not be retained beyond the term of employment if they are provided to the

employee upon the termination of employment.

(ii) Employee exposure records. Each employee exposure record shall be preserved and maintained

for at least thirty (30) years, except that:

(A) Background data to environmental (workplace) monitoring or measuring, such as laboratory
66

reports and worksheets, need only be retained for one (1) year so long as the sampling results,

the collection methodology (sampling plan), a description of the analytical and mathematical

methods used, and a summary of other background data relevant to interpretation of the results

obtained, are retained for at least thirty (30) years1; and

(B) Material safety data sheets and paragraph (c)(5)(iv) records concerning the identity of a

substance or agent need not be retained for any specified period as long as some record of the

identity (chemical name if known) of the substance or agent, where it was used, and when it

was used is retained for at least thirty (30) years1 ; and

(C) Biological monitoring results designated as exposure records by specific occupational

safety and health standards shall be preserved and maintained as required by the specific

standard.

(iii) Analyses using exposure or medical records. Each analysis using exposure or medical records

shall be preserved and maintained for at least thirty (30) years.

(2) Nothing in this section is intended to mandate the form, manner, or process by which an

employer preserves a record so long as the information contained in the record is preserved and

retrievable, except that chest X-ray films shall be preserved in their original state.

(e) Access to records

 (1) General.

(i) Whenever an employee or designated representative requests access to a record, the employer

shall assure that access is provided in a reasonable time, place, and manner. If the employer

cannot reasonably provide access to the record within fifteen (15) working days, the employer

shall within the fifteen (15) working days apprise the employee or designated representative

requesting the record of the reason for the delay and the earliest date when the record can be

made available.

(ii) The employer may require of the requester only such information as should be readily known

to the requester and which may be necessary to locate or identify the records being requested (e.g.

dates and locations where the employee worked during the time period in question).

(iii) Whenever an employee or designated representative requests a copy of a record, the employer

shall assure that either:

(A) A copy of the record is provided without cost to the employee or representative,

(B) The necessary mechanical copying facilities (e.g., photocopying) are made available

without cost to the employee or representative for copying the record, or

(C) The record is loaned to the employee or representative for a reasonable time to enable a

copy to be made.

1 Material safety data sheets must be kept for those chemicals currently in use that are effected by

the Hazard Communication Standard in accordance with 29 CFR 1910.1200(g).
67

(iv) In the case of an original X-ray, the employer may restrict access to on-site examination or make

other suitable arrangements for the temporary loan of the X-ray.

(v) Whenever a record has been previously provided without cost to an employee or designated

representative, the employer may charge reasonable, non-discriminatory administrative costs (i.e.,

search and copying expenses but not including overhead expenses) for a request by the employee

or designated representative for additional copies of the record, except that

(A) An employer shall not charge for an initial request for a copy of new information that has

been added to a record which was previously provided; and

(B) An employer shall not charge for an initial request by a recognized or certified collective

bargaining agent for a copy of an employee exposure record or an analysis using exposure or

medical records.

(vi) Nothing in this section is intended to preclude employees and collective bargaining agents

from collectively bargaining to obtain access to information in addition to that available under

this section.

(2) Employee and designated representative access

(i) Employee exposure records.

(A) Except as limited by paragraph (f) of this section, each employer shall, upon request,

assure the access to each employee and designated representative to employee exposure

records relevant to the employee. For the purpose of this section, an exposure record relevant

to the employee consists of:

(1)A record which measures or monitors the amount of a toxic substance or harmful physical

agent to which the employee is or has been exposed;

(2) In the absence of such directly relevant records, such records of other employees with

past or present job duties or working conditions related to or similar to those of the

employee to the extent necessary to reasonably indicate the amount and nature of the

toxic substances or harmful physical agents to which the employee is or has been

subjected,; and

(3) Exposure records to the extent necessary to reasonably indicate the amount and nature of

the toxic substances or harmful physical agents at workplaces or under working conditions

to which the employee is being assigned or transferred.

(B) Requests by designated representatives for unconsented access to employee exposure

records shall be in writing and shall specify with reasonable particularity:

(1) The record requested to be disclosed; and

(2) The occupational health need for gaining access to these records.
68

(ii) Employee medical records.

(A) Each employer shall, upon request, assure the access of each employee to employee medical

records of which the employee is the subject, except as provided in paragraph (e)(2)(ii)(D) of this

section.

(B) Each employer shall, upon request, assure the access of each designated representative to the

employee medical records of any employee who has given the designated representative specific

written consent. Appendix A to this section contains a sample form which may be used to establish

specific written consent for access to employee medical records.

(C) Whenever access to employee medical records is requested, a physician representing the

employer may recommend that the employee or designated representative:

(1) Consult with the physician for the purposes of reviewing and discussing the records requested,

(2) Accept a summary of material facts and opinions in lieu of the records requested, or

(3) Accept release of the requested records only to a physician or other designated representative.

(D) Whenever an employee requests access to his or her employee medical records, and a physician

representing the employer believes that direct employee access to information contained in the

records regarding a specific diagnosis of a terminal illness or a psychiatric condition could be

detrimental to the employee’s health, the employer may inform the employee that access will only

be provided to a designated representative of the employee having specific written consent, and

deny the employee’s request for direct access to this information only. Where a designated

representative with specific written consent requests access to information so withheld, the

employer shall assure the access of the designated representative to this information, even when it is

known that the designated representative will give the information to the employee.

(E) A physician, nurse, or other responsible health care personnel maintaining employee medical

records may delete from requested medical records the identity of a family member, personal friend,

or fellow employee who has provided confidential information concerning an employee’s health

status.

(iii) Analyses using exposure or medical records.

(A) Each employer shall, upon request, assure the access of each employee and designated

representative to each analysis using exposure or medical records concerning the employee’s

working conditions or workplace.

(B) Whenever access is requested to an analysis which reports the contents of employee medical

records by either direct identifier (name, address, social security number, payroll number, etc.) or by

information which could reasonably be used under the circumstances indirectly to identify specific

employees (exact age, height, weight, race, sex, date of initial employment, job title, etc.), the

employer shall assure that personal identifiers are removed before access is provided. If the

employer can demonstrate that removal of personal identifiers from an analysis is not feasible,

access to the personally identifiable portions of the analysis need not be provided.

(3) OSHA access.
69

(i) Each employer shall, upon request, and without derogation of any rights under the Constitution

or the Occupational Safety and Health Act of 1970, 29 U.S.C. 651 et seq., that the employer chooses to

exercise, assure the prompt access of representatives of the Assistant Secretary of Labor for

Occupational Safety and Health to employee exposure and medical records and to analyses using

exposure or medical records. Rules of agency practice and procedure governing OSHA access to

employee medical records are contained in 29 CFR 1913.10.

(ii) Whenever OSHA seeks access to personally identifiable employee medical information by

presenting to the employer a written access order pursuant to 29 CFR 1913.10(d), the employer

shall prominently post a copy of the written access order and its accompanying cover letter for at

least fifteen (15) working days.

(f) Trade secrets.

(1) Except as provided in paragraph (f)(2) of this section, nothing in this section precludes an

employer from deleting from records requested by a health professional, employee, or designated

representative any trade secret data which discloses manufacturing processes, or discloses the

percentage of a chemical substance in mixture, as long as the health professional, employee, or

designated representative is notified that information has been deleted. Whenever deletion of trade

secret information substantially impairs evaluation of the place where or the time when exposure to a

toxic substance or harmful physical agent occurred, the employer shall provide alternative

information which is sufficient to permit the requesting party to identify where and when exposure

occurred.

(2) The employer may withhold the specific chemical identity, including the chemical name and

other specific identification of a toxic substance from a disclosable record provided that:

(i) The claim that the information withheld is a trade secret can be supported;

(ii) All other available information on the properties and effects of the toxic substance is disclosed;

(iii) The employer informs the requesting party that the specific chemical identity is being

withheld as a trade secret; and

(iv) The specific chemical identity is made available to health professionals, employees and

designated representatives in accordance with the specific applicable provisions of this

paragraph.

(3) Where a treating physician or nurse determines that a medical emergency exists and the specific

chemical identity of a toxic substance is necessary for emergency or first-aid treatment, the employer

shall immediately disclose the specific chemical identity of a trade secret chemical to the treating

physician or nurse, regardless of the existence of a written statement of need or a confidentiality

agreement. The employer may require a written statement of need and confidentiality agreement, in

accordance with the provisions of paragraphs (f)(4) and (f)(5), as soon as circumstances permit.

(4) In non-emergency situations, an employer shall, upon request, disclose a specific chemical

identity, otherwise permitted to be withheld under paragraph (f)(2) of this section, to a health

professional, employee, or designated representative if:

(i) The request is in writing;
70

(ii) The request describes with reasonable detail one or more of the following occupational health

needs for the information:

(A) To assess the hazards of the chemicals to which employees will be exposed;

(B) To conduct or assess sampling of the workplace atmosphere to determine employee

exposure levels;

(C) To conduct pre-assignment or periodic medical surveillance of exposed employees;

(D) To provide medical treatment to exposed employees;

(E) To select or assess appropriate personal protective equipment for exposed employees;

(F) To design or assess engineering controls or other protective measures for exposed

employees; and

(G) To conduct studies to determine the health effects of exposure.

(iii) The request explains in detail why the disclosure of the specific chemical identity is essential

and that, in lieu thereof, the disclosure of the following information would not enable the health

professional, employee or designated representative to provide the occupational health services

described in paragraph (f)(4)(ii) of this section:

(A) The properties and effects of the chemical;

(B) Measures for controlling workers’ exposure to the chemical;

(C) Methods of monitoring and analyzing worker exposure to the chemical; and

(D) Methods of diagnosing and treating harmful exposures to the chemical;

(iv) The request includes a description of the procedures to be used to maintain the confidentiality of

the disclosed information; and

(v) The health professional, employee, or designated representative and the employer or

contractor of the services of the health professional or designated representative agree in a written

confidentiality agreement that the health professional, employee or designated representative will

not use the trade secret information for any purpose other than the health need(s) asserted and

agree not to release the information under any circumstances other than to OSHA, as provided in

paragraph (f)(9) of this section, except as authorized by the terms of the agreement or by the

employer.

(5) The confidentiality agreement authorized by paragraph (f)(4)(iv) of this section:

(i) May restrict the use of the information to the health purposes indicated in the written

statement of need;

(ii) May provide for appropriate legal remedies in the event of a breach of the agreement,
71

including stipulation of a reasonable pre-estimate of likely damages; and,

(iii) May not include requirements for the posting of a penalty bond.

(6) Nothing in this section is meant to preclude the parties from pursuing non-contractual remedies to

the extent permitted by law.

(7) If the health professional, employee or designated representative receiving the trade secret

information decides that there is a need to disclose it to OSHA, the employer who provided the

information shall be informed by the health professional prior to, or at the same time as, such

disclosure.

(8) If the employer denies a written request for disclosure of a specific chemical identity, the denial

must:

(i) Be provided to the health professional, employee, or designated representative within thirty

days of the request;

(ii) Be in writing;

(iii) Include evidence to support the claim that the specific chemical identity is a trade secret;

(iv) State the specific reasons why the request is being denied; and

(v) Explain in detail how alternative information may satisfy the specific medical or occupational

health need without revealing the specific chemical identity.

(9) The health professional, employee, or designated representative whose request for information is

denied under paragraph (f)(4) of this section may refer the request and the written denial of the

request to OSHA for consideration.

(10) When a health professional, employee, or designated representative refers a denial to OSHA

under paragraph (f)(9) of this section, OSHA shall consider the evidence to determine if:

(i) The employer has supported the claim that the specific chemical identity is a trade secret;

(ii) The health professional employee, or designated representative has supported the claim that

there is a medical or occupational health need for the information; and

(iii) The health professional, employee, or designated representative has demonstrated adequate

means to protect the confidentiality.

(11)

(i) If OSHA determines that the specific chemical identity requested under paragraph (f)(4) of this

section is not a bona fide trade secret, or that it is a trade secret but the requesting health professional,

employee, or designated representatives has a legitimate medical or occupational health need for the

information, has executed a written confidentiality agreement, and has shown adequate means for

complying with the terms of such agreement, the employer will be subject to citation by OSHA.

(ii) If an employer demonstrates to OSHA that the execution of a confidentiality agreement would
72

not provide sufficient protection against the potential harm from the unauthorized disclosure of a

trade secret specific chemical identity, the Assistant Secretary may issue such orders or impose such

additional limitations or conditions upon the disclosure of the requested chemical information as

may be appropriate to assure that the occupational health needs are met without an undue risk of

harm to the employer.

(12) Notwithstanding the existence of a trade secret claim, an employer shall, upon request, disclose

to the Assistant Secretary any information which this section requires the employer to make

available. Where there is a trade secret claim, such claim shall be made no later than at the time the

information is provided to the Assistant Secretary so that suitable determinations of trade secret

status can be made and the necessary protections can be implemented.

(13) Nothing in this paragraph shall be construed as requiring the disclosure under any

circumstances of process or percentage of mixture information which is a trade secret.

(g) Employee information.

(1) Upon an employee’s first entering into employment, and at least annually thereafter, each

employer shall inform current employees covered by this section of the following:

(i) The existence, location, and availability of any records covered by this section;

(ii) The person responsible for maintaining and providing access to records; and

(iii) Each employee’s rights of access to these records.

(2) Each employer shall keep a copy of this section and its appendices, and make copies readily

available, upon request, to employees. The employer shall also distribute to current employees any

informational materials concerning this section which are made available to the employer by the

Assistant Secretary of Labor for Occupational Safety and Health.

(h) Transfer of records.

(1) Whenever an employer is ceasing to do business, the employer shall transfer all records subject to

this section to the successor employer. The successor employer shall receive and maintain these

records.

(2) Whenever an employer is ceasing to do business and there is no successor employer to receive and

maintain the records subject to this standard, the employer shall notify affected current employees of

their rights of access to records at least three (3) months prior to the cessation of the employer’s

business.

(3) Whenever an employer either is ceasing to do business and there is no successor employer to

receive and maintain the records, or intends to dispose of any records required to be preserved for at

least thirty (30) years, the employer shall:

(i) Transfer the records to the Director of the National Institute for Occupational Safety and

Health (NIOSH) if so required by a specific occupational safety and health standard; or

(ii) Notify the Director of NIOSH in writing of the impending disposal of records at least three (3)
73

months prior to the disposal of the records.

(4) Where an employer regularly disposes of records required to be preserved for at least thirty (30)

years, the employer may, with at least (3) months notice, notify the Director of NIOSH on an annual

basis of the records intended to be disposed of in the coming year.

(i) Appendices.

The information contained in appendices A and B to this section is not intended, by itself, to create

any additional obligations not otherwise imposed by this section nor detract from any existing obligation.

APPENDIX A TO 1910.1020 - SAMPLE AUTHORIZATION LETTER FOR THE RELEASE OF

EMPLOYEE MEDICAL RECORD INFORMATION TO A DESIGNATED REPRESENTATIVE

(NON-MANDATORY)

I, _______, (full name of worker/patient) hereby authorize __________ (individual or

organization holding the medical records) to release to _________ (individual or organization

authorized to receive the medical information), the following medical information from my

personal medical records:

(Describe generally the information desired to be released).

I give my permission for this medical information to be used for the following purpose:

but I do not give permission for any other use or re-disclosure of this information.

(Note: Several extra lines are provided below so that you can place additional restrictions on this

authorization letter if you want to. You may, however, leave these lines blank. On the other

hand, you may want to (1) specify a particular expiration date for this letter (if less than one

year); (2) describe medical information to be created in the future that you intend to be covered

by this authorization letter; or (3) describe portions of the medical information in your records

which you do not intend to be released as a result of this letter.)

Full name of Employee or Legal Representative

Signature of Employee or Legal Representative

Date of Signature
74

APPENDIX B TO §1910.1020 - AVAILABILITY OF NIOSH REGISTRY OF TOXIC EFFECTS OF

CHEMICAL SUBSTANCES (RTECS)(NON-MANDATORY)

The final regulation, 29 CFR 1910.1020, applies to all employee exposure and medical records,

and analyses thereof, of employees exposed to toxic substances or harmful physical agents

(paragraph (b)(2)). The term toxic substance or harmful physical agent is defined by paragraph

(c)(13) to encompass chemical substances, biological agents, and physical stresses for which there

is evidence of harmful health effects. The regulation uses the latest printed edition of the

National Institute for Occupational Safety and Health (NIOSH) Registry of Toxic Effects of

Chemical Substances (RTECS) as one of the chief sources of information as to whether evidence

of harmful health effects exists. If a substance is listed in the latest printed RTECS, the regulation

applies to exposure and medical records (and analyses of these records) relevant to employees

exposed to the substance.

It is appropriate to note that the final regulation does not require that employers purchase a copy

of RTECS, and many employers need not consult RTECS to ascertain whether their employee

exposure or medical records are subject to the rule. Employers who do not currently have the

latest printed edition of the NIOSH RTECS, however, may desire to obtain a copy. The RTECS is

issued in an annual printed edition as mandated by section 20(a)(6) of the Occupational Safety

and Health Act (29 U.S.C. 669(a)(6)).

The introduction to the 1980 printed edition describes the RTECS as follows:

“The 1980 edition of the Registry of Toxic Effects of Chemical Substances, formerly known as the

Toxic Substances list, is the ninth revision prepared in compliance with the requirements of

Section 20(a)(6) of the Occupational Safety and Health Act of 1970 (Public Law 91-596). The

original list was completed on June 28, 1971, and has been updated annually in book format.

Beginning in October 1977, quarterly revisions have been provided in microfiche. This edition of

the Registry contains 168,096 listings of chemical substances; 45,156 are names of different

chemicals with their associated toxicity data and 122,940 are synonyms. This edition includes

approximately 5,900 new chemical compounds that did not appear in the 1979 Registry.(p. xi)

“The Registry’s purposes are many, and it serves a variety of users. It is a single source document

for basic toxicity information and for other data, such as chemical identifiers and information

necessary for the preparation of safety directives and hazard evaluations for chemical

substances. The various types of toxic effects linked to literature citations provide researchers and

occupational health scientists with an introduction to the toxicological literature, making their

own review of the toxic hazards of a given substance easier. By presenting data on the lowest

reported doses that produce effects by several routes of entry in various species, the Registry

furnishes valuable information to those responsible for preparing safety data sheets for chemical

substances in the workplace. Chemical and production engineers can use the Registry to identify

the hazards which may be associated with chemical intermediates in the development of final

products, and thus can more readily select substitutes or alternate processes which may be less

hazardous. Some organizations, including health agencies and chemical companies, have

included the NIOSH Registry accession numbers with the listing of chemicals in their files to

reference toxicity information associated with those chemicals. By including foreign language

chemical names, a start has been made toward providing rapid identification of substances
75

produced in other countries. (p xi)

“In this edition of the Registry, the editors intend to identify “all known toxic substances” which

may exist in the environment and to provide pertinent data on the toxic effects from known

doses entering an organism by any route described. (p xi)

“It must be reemphasized that the entry of a substance in the Registry does not automatically

mean that it must be avoided. A listing does mean, however, that the substance has the

documented potential of being harmful if misused, and care must be exercised to prevent tragic

consequences. Thus the Registry lists many substances that are common in everyday life and are

in nearly every household in the United States. One can name a variety of such dangerous

substances: prescription and non-prescription drugs; food additives; pesticide concentrates,

sprays, and dusts; fungicides; herbicides, paints; glazes, dyes; bleaches and other household

cleaning agents; alkalis; and various solvents and diluents. The list is extensive because chemicals

have become an integral part of our existence.”

The RTECS printed edition may be purchased from the Superintendent of Documents, U.S.

Government Printing Office (GPO), Washington, DC 20402 (202-783-3238).

Some employers may desire to subscribe to the quarterly update to the RTECS which is published

in a microfiche edition. An annual subscription to the quarterly microfiche may be purchased

from the GPO (Order the “Microfiche Edition, Registry of Toxic Effects of Chemical Substances”).

Both the printed edition and the microfiche edition of RTECS are available for review at many

university and public libraries throughout the country. The latest RTECS editions may also be

examined at the OSHA Technical Data Center, Room N2439 - Rear, United States Department of

Labor, 200 Constitution Avenue, N.W., Washington, DC 20210 (202-523-9700), or at any OSHA

Regional or Area Office (See, major city telephone directories under United States Government -

Labor Department).
76

Names And Addresses Of Respirator

Manufacturers And Distributors

3M Company

OH & ES Division, Bldg. 260-3A-07

St. Paul, Minnesota 55144

Aearo Company

90 Mechanic Street

Southbridge, Massachusetts 01550

Air-Ace OY

Palokankaantie 6

FIN-40320 Jyvaskyla

FINLAND

Air Ace OY

Palokankaantie 6

SF-40320 Jyvaskyla, FINLAND

Allegro Industries

7221 Orangewood Avenue

Garden Grove, California 92841

Alpha Pro-Tech

903 West Center Street

North Salt Lake, Utah 84054

Avon Polymer Products Ltd

Bath Road, Melksham

Wiltshire, SN12 8AA

ENGLAND

U.S. CONTACT

Avon (Safety Systems Corp.)

25 W. 626 St Charles Road

Carol Stream, Illinois 60188

Aswan International

2156 Majestic Woods Blvd

Apopka, Florida 32712

Better Breathing, Inc.

15 Union Street

Lawrence, Massachusetts 01840

APPENDIX D

Biomarine, Inc.

456 Creamery Way

Exton, Pennsylvania 19341

Mr. Gene Ardoin

Breathing Systems, Inc.

(Delaware Corporation)

7292 Highway 190 West

Livingston, Texas 77351

Breathing Systems, Inc.

(Florida Corporation)

8800 Grow Drive

Pensacola, Florida 32514

E.D. Bullard Company

1898 Safety Way

Cynthiana, Kentucky 41031

CairnsAIR

11 Parkway Circle

New Castle, Delaware 19720

CairnsAIR, L.L.C.

11 Parkway Circle

New Castle, Delaware 19720

Canadian Technical Tape

455 Cote Vertu Road

St. Laurent, Quebec H4N 1E8

CANADA

Clemco

1 Cable Car Drive

Washington, Missouri 63090

CSE Corporation

600 Seco Road

Monroeville, Pennsylvania 15146-1428

Dan Am (SATA)

1 SATA Drive

P.O. Box 46

Spring Valley, Minnesota 55975

Defense Apparel

247 Addison Road

Windsor, Connecticut 06095
77

Essex PB&R

14 Conlin Road

Oxford, Massachusetts 01540

Fastech, Corp.

24 Center Drive

Gilberts, Illinois 60136

Glendale Protective Technologies Inc.

5300 Region Court

Lakeland, Florida 33801

Louis M. Gerson, Co.

15 Sproat Street

Middleboro, Massachusetts 02346

Hamernik-Harrod, Inc.

980 Osbourne Road

Road North East

Fridley, Minnesota 55432

Hornell Speedglas, Inc.

2374 Edison Blvd.

Twinsburg, Ohio 44087-2340

Interspiro Inc.

31 Business Park Drive

Branford, Connecticut 06405

International Certification Services, Inc.

9337 Ravenna Road, Unit M, Suite B-14

Twinsburg, Ohio 44087

International Safety Devices

16717 Smoketree Street

Hesperia, California 92345

International Safety Instruments, Inc.

922 Hurricane Shoals Road

Lawrenceville, Georgia 30243

Jackson Products, Inc.

5801 Safety Drive N.E.

Belmont, Michigan 49306

Johnson & Johnson Medical Inc.

2500 Arbrook Blvd

Arlington, Texas 76014

Depuy Inc.

P.O. Box 988

700 Orthopaedic Drive

Warsaw, Indiana 46581

Devilbiss

1724 Indian Wood Circle, Suite G

Maumee, Ohio 43537

Draeger Limited

Ullswater Close

Kitty Breuster

Blyth, Northumberland

NE24 4RG

United Kingdom

National Draeger, Inc.

P.O. Box 120

101 Technology Drive

Pittsburgh, Pennsylvania 15230

Draegerwerk Aglubreck

Postfache 13 39

D-23542 Lubeck

WEST GERMANY

Dual Safe Life Support Systems, Inc.

2315 West Main Street

Baytown, Texas 77520

Elephant Prince Co., LTD.

P.O. Box 9-017

Keelung Taiwan

REPUBLIC OF CHINA

The ESAB Group, Inc.

P.O. Box 100545

411 S. Ebenezer Road

Florence, South Carolina 29501

Ekonic Company, Inc.

25/11 Sukhapiban #3 Road

Buengkum, Bangkok 10240

THAILAND

US CONTACT

P.O. Box 1208

Carver, Massachusetts 02330
78

Kappler USA

P.O. Box 218

Guntersville, Alabama 35976

Kasco

Via Romania 12

42100 Reggio Emilia

ITALY

FLORIDA BRANCH:

Kasco Safety Products, Inc.

742 Clay Street

Winter Park, Florida 32789

Koken Limited

7, Yonbancho, Chiyoda-Ku

Tokyo, 102

JAPAN

Lancs Industries

12704 Northeast 124th Street

Kirkland, Washington 98034-8397

Litton Instruments & Life Support

2734 Hickory Grove Road

P.O. Box 4508

Davenport, Iowa 52808-4508

Makrite Industries, Inc.,

11F-5, No. 79 Sec. 1, Hsin Tai Wu Road

His-Chih, Taipei

Hsein, Taiwan, ROC

U.S. CONTACT:

(Makrite Industries, Inc.,)

Sanex Protective Products, Inc.

236 Upland Ave

Newton Highlands, Massachusetts 02161

Masprot S.C., eI. LTDA.

Walker Martinez, No. 5558 (Parod. 13G. Av.)

San Miguel-Santiago

CHILE

U.S. CONTACT:

Masprot S.C., eI. LTDA

755 Greenville Ave.

Glendale, Ohio 45246

Miller de Mexico, S.A. de C.V.

Felix Guzman no. 16, 4o. PISO, Col. El Parque

Naucalpan, Edo. De Mexico C.P. 53390

Mine Safety Appliances Company

P.O. Box 439

Pittsburgh, Pennsylvania 15230

Moldex/Metrics, Inc.

10111 W. Jefferson Blvd.

Culver City, California 90232

Neoterik Health Technologies, Inc.

P.O. Box 128

Woodsboro, Maryland 21798

North Safety Products

Safety Equipment Division

2000 Plainfield Pike

Cranston, Rhode Island 02921

Northstar Manufacturing Company, Inc.

322 Powell Road

Suite 5

Spring, Texas 77373

Nuclear Power Outfitters

P.O. Box 737

Crystal Lake, Illinois 60039

Ocenco Incorporated

Lakeview Corporate Center

10225 82nd Avenue

Kenosha, Wisconsin 53142-7737

O-Two Systems International

7575 Kimbel Street

Mississauga Ontario

CANADA L55 1C8

Essex

PB&R Corporation

5071 Springfield Dr

Edwardsville, Illinois 62025

U.S. CONTACT:

P.O. Box 510

Ilion, New York 13357-0510
79

Racal Health and Safety, Inc.

7305 Executive Way

Frederick, Maryland 21704-8368

Rayphil Blastmaster

P.O. Box 29-021

Fendalton

Christchurch

NEW ZEALAND

Respiratory Systems, Inc.

1040 East Howell Ave

Anaheim, California 92805

Respirex Safety & Protection

Prochem House

23/27 Endsleigh Road

South Merstham

Surrey RH1 3LX

ENGLAND

Rummil Ltd.

Hambledon House Wks.

Vann Lane, Hambledon

Surrey, England GU8 4HW

U.S. CONTACT:

UNIBRI International Co., Ltd.

PO Box 6012

Rock Island, Illinois 61204-6012

Sam Gong Industrial Co., Ltd.

17350 Sunset Blvd.

Pacific Palasades, Suite C406

Los Angeles, California 90272

Sanex Protective

255 North Road #15

Chelmesford, Massachusetts 01824

San Huei United Company Ltd.

120 Chi Pei Road, Pan Chiao City

Taipei, Taiwan

REPUBLIC OF CHINA

U.S. CONTACT:

Maytex Corp.

25029 Viking Street

Hayward, California 94545

P & J Safety LTD T/A

Europa Safety Products

66 Edison Road

Rabans Lane Industrial Estate

Aylesbury Bucks

HP19 3TE England

U.S. CONTACT:

801 Third Street

Findlay, Ohio 45840

Primatec, Inc.

P.O. Box 1208

Carver, Massachusetts 02330

Protector Technologies Europe

Matterson House

Ash Road

Aldershot, Hampshire

GU12 4DE

ENGLAND

Protector Technologies

Pimbo Road

West Pimbo

Skelmersdale, Lancashire

WN8 9RA

England

Protector Technologies

14 Conlin Road

Oxford, Massachusetts 05140-1401

Pro-Tech Respirators, Inc.

P.O. Drawer 339

107 E. Alexander Street

Buchanan, Michigan 49107

Pulsafe/Safety Products, Ltd.

Holmethorpe Avenue

Redhill Surrey RH1 2PA

UNITED KINGDOM

Racal Health & Safety Limited

12-16 Bristol Road

Greenford

Middlesex

UB6 8XT

ENGLAND
80

SATA-Farbspritztechnik GmbH & Co.

Domertalstrasse 20

Postfach 1828

D-70799 Kornwestheim

GERMANY

U.S. CONTACT:

Dan Am (SATA)

1 SATA Drive

P.O. Box 46

Spring Valley, Minnesota 55975

Scott Aviation

A Figgie International Company

225 Erie Street

Lancaster, New York 14086-9502

SEL Corporation

One Sellstrom Drive

Palatine, Illinois 60078-0355

Shigematsu Works Co. , Ltd.

3-13-8, Sotokanda

Chiyoda-Ku, Tokyo

JAPAN

Shigematsu Works Co., Ltd.

13-8, Sotokanda 3-Chome

Chiyoda-Ku, Tokyo 101

JAPAN

Siebe Gorman, Ltd

Abondale Way, Cwmbran

Gwent, Wales NP4 1YR

UNITED KINGDOM

Spring Protezione S.R.L.

41058 Vignola (Modena)

Via Maremagna, 5

Modena

ITALY

Stackhouse Inc.

1100 Bird Center Drive

Palm Springs, California 92262

Standard Safety Equipment

1407 Ridgeview Drive

McHenry , Illinois 60050

Sundstrom Safety AB

Vaster gaten no. 2

Box 76

S-340 14 Lagan

SWEDEN

U.S. CONTACT:

Sundstrom Safety AB

28501 Botorrita Street

Mission Veijo, California 92692-2232

Supplied Air Monitoring Systems, Inc.

P.O. Box 1367

Alvin, Texas 77512

Plant Address:

205 Dixie Farm Road

Pearland, Texas 77581

Survivair, Inc.

3001 S. Susan Street

Santa Ana, California 92704

Tecnol Inc./Safety & Supply

7201 Industrial Park Boulevard

Fort Worth, Texas 76180

UNIBRI International Co., LTD

P.O. Box 6012

Rock Island, Illinois 61204-6012

Trusafe, Inc.

5685 South Utah Street

Seattle, Washington 98134

U.S. Safety

8101 Lenexa Drive

P.O. Box 15965

Lenexa, Kansas 66285-5965

Vinyl Technology Inc.

200 Railroad Avenue

Monrovia, California 91016-4643

ITW Vortec Corporation

10125 Carver Road

Cincinnati, Ohio 45242-4798
81

Wen Mask Industrial Co. LTD

12F-1 No219 Chang Chun Road

Taipei, Taiwan

Republic of China

US CONTACT:

Wen Mask Canada

16865 Caledon-King Town Line North

RR4 Tottenham, Ontario

CANADA L0G 1W0

Willson Safety

A Division of WGM Safety Corporation

205 Washington Street

P.O. Box 622

Reading, Pennsylvania 19603-0622
82

Respiratory Protection Checklist

Modified from the New Jersey Department of Health

Public Employees Occupational Safety and Health Program

Facility_________________________ Contact Person___________________________

Date___________________________ Phone___________________________________

(month/day/year) (area code)

Data Collected By____________________________

1. ASSESSMENT OF RESPIRATORY PROTECTION USE

A. Is respiratory protection used:

1. By persons entering rooms where patients with known or Y/N/*Sometimes

suspected infectious TB are isolated?

2. During cough inducing procedures with known or suspect Y/N/*Sometimes

TB patients?

3. During administration of aerosolized medications with Y/N/*Sometimes

known or suspect TB patients?

4. During surgical procedures with a known or suspect Y/N/*Sometimes

TB patient?

5. During bronchoscopy on a known or suspect TB patient? Y/N/*Sometimes

6. During autopsy of a deceased person suspected or known Y/N/*Sometimes

to have had active TB?

7. By visitors of patients with known or suspect TB? Y/N/*Sometimes

8. On patients with known or suspect TB while transporting Y/N/*Sometimes

patient within the hospital?

9. During urgent dental treatment on a known or suspect TB Y/N/*Sometimes

patient?

10. Where administrative and engineering controls may not Y/N/*Sometimes

provide adequate protection?

Specify any such areas:________________________________________________________

APPENDIX E

*Clarify all responses noted as “sometimes” on back of this page; noting the number of

the question with each clarification
83

Respiratory Protection Checklist

II. SELECTION OF RESPIRATORY PROTECTION

A. Do respirators issued to HCWs meet the following performance for protection against

Mycobacterium tuberculosis:

1. Are all respirators used approved by NIOSH? Y / N

2. Does the respirator have the ability to filter particles 1 micrometer in size in Y / N

the unloaded state with a filter efficiency greater than or equal to 95% (i.e.,

filter leakage of less than or equal to 5%), given flow rates of up to 50 liters

(L) per minute?

(If “yes” attach any documentation attesting to this)

3. Does the respirator have the ability to be qualitatively or quantitatively fit Y / N

tested in a reliable way to obtain face-seal leakage of less than or equal to

10%?

(If “yes” attach any documentation attesting to this)

4. Does the respirator have the ability to fit different facial sizes and Y / N

characteristics of HCWs (i.e., is it available in at least three sizes)?

(If “yes” attach any documentation attesting to this)

5. Does the respirator have the ability to be checked for facepiece fit, Y / N

in accordance with OSHA standards and good industrial hygiene

practice, by HCWs each time they put on their respirator?

(If “yes” attach any documentation attesting to this)

6. Are different levels of respiratory protection (such as powered air purifying Y / N

or positive pressure airline respirators), which exceed the above performance

criteria, available for selected high-risk procedures on patients known or

suspected to have TB (e.g., bronchoscopy, autopsy).

(If “yes” clarify what respirators are used for high-risk procedures)

7. Are the respirators selected appropriate for procedures requiring a sterile field? Y / N

(if respirators have exhalation valves or are positive pressure they do not

protect the sterile field)
84

Respiratory Protection Checklist

III. FIT TESTING OF RESPIRATORY PROTECTION DEVICES

1. Are employees fit-tested? All / *Some / *None

(document when and how often)

2. Are employees quantitatively fit-tested? All / *Some / *None

(attach protocol)

3. Are employees qualitatively fit-tested? All / *Some / *None

(attach protocol)

4. Who performs the respirator fit-testing?

__________________________________________

5. Are employees trained to perform a fit check with the respirator All / *Some / *None

before each use? (Explain employee user seal check procedure)

___________________________________________

IV. STORAGE, REUSE AND DISPOSAL

1. Are respirators reused? All / *Some / *None

2. If respirators are reused are there procedures in place for:

Cleaning/disinfecting:___________________________ Y / N

____________________________________________

Storage:______________________________________ Y / N

____________________________________________

Reuse:_______________________________________ Y / N

____________________________________________

Disposal:_____________________________________ Y / N

____________________________________________

3. Is there a procedure for obtaining new respirators? Y / N

4. If respirators are not reused, are there procedures for disposal? Y / N

V. RESPIRATORY PROGRAM

1. Is there a written respiratory protection program? Y / N

(attach copy of written program)

* Clarify “some” and “none” responses by number on the back of this page.
85

Respiratory Protection Checklist

2. Who is responsible for the respiratory protection program?

_____________________________________ _____________________________________

Name Title

_____________________________________ _____________________________________

Name Title

3. Does the written program provide written procedures for:

Respirator selection? Y / N

Assessing the need for respirators (i.e., exposure monitoring data)? Y / N

Employee training? Y / N

Cleaning, inspection and disinfecting? Y / N

Storage? Y / N

Medical surveillance? Y / N

Prohibiting facial hair which prevents adequate facepiece-to-face seal? Y / N

Accommodating employees who must wear corrective lenses? Y / N

Program evaluation on a yearly basis? (Inclusive of employee input) Y / N

VI. MEDICAL SURVEILLANCE

A. Does the Medical Surveillance Program include:

1. A general screening process (e.g., a questionnaire) for pertinent medical Y / N

conditions?

2. Further evaluation of employees who have medical conditions which may Y / N

preclude the use of negative-pressure respirators (e.g., employees with

mild to severe pulmonary or cardiac conditions)?

3. Are employees rescreened (at least every 5 years)? Y / N

4. What percentage of employees, who are assigned respirators, are Y / N

medically evaluated? _________________________________
86

VII. TRAINING

A. Does the Respiratory Training Program provide the following

information to employees:

1. The necessity for wearing respirators and the potential risks associated Y / N

with not wearing respiratory protection?

2. The nature, extent, and specific hazards of M. tuberculosis transmission Y / N

in their health care facility?

3. A description of specific risks for TB infection among persons exposed Y / N

to M. tuberculosis, of any subsequent treatment with INH or other

chemoprophylactic agents, and of the possibility of active TB disease?

4. A description of engineering controls and work practices and the reasons Y / N

why they do not eliminate the need for personal respiratory protection?

5. An explanation for selecting a particular type of respirator, how the Y / N

respirator is properly maintained and stored, and the operation,

capabilities, and limitations of the respirator provided?

6. Instructions, including demonstration and practice, in how the Y / N

respirator should be worn, how it should be adjusted, and how

to determine if it fits properly?

7. Instruction to employees regarding how to check the facepiece fit Y / N

before each use?

8. The manufacturers’ instructions for inspecting, cleaning, and Y / N

maintaining respirators?

B. What percentage of employees are trained?

___________________________________________________

___________________________________________________

C. What is the frequency of training?

___________________________________________________

___________________________________________________

D. How much time (in hours) is spent on respiratory protection training

for each employee?

____________________________________________________

____________________________________________________

____________________________________________________
87

FIT TESTING RECORD FOR RESPIRATOR USERS

Employee:______________________________________Job Title:_______________________________

SS#:_____________________Date of Birth:___________Employer:_______________________________

Employer Phone Number: ______________________________

Age:______________________________Height:_____________________Weight:___________________

Description of condition requiring RPE use: ___________________________________________________

____________________________________________________________________________________

FIT TESTING RECORD

PE Manufacturer__________________________________Model Number_________________________

Facepiece Type and Size_________________________________________________________________

NIOSH Approval Number ______________________________________

Cartridge Type________________________________________________

NIOSH Approval Number _______________________________________

Medical Restriction Noted By Physician? Yes No

Odor Detection Adequate? Yes No

Date Fit Tested_______________________________Test Atmosphere___________________________

Pass/Fail______________________Comments:______________________________________________

___________________________________________________________________________________

_____________________________

 SIGNATURE OF FIT TESTER

____________________________

 DATE
88

Employee:_______________________________________Job Title:________________________________

SS#: Date of Birth: Employer:__________________________________

Employer Phone Number: ____________________________________

Age: Height: Weight: _____________

Have you worn a respirator before? Yes No

If Yes, describe any difficulties noted with respirator use:____________________________________________

______________________________________________________________________________________

Will you be wearing any other personal protective equipment? Yes No

If Yes, please describe:____________________________________________________________________

Have you had or do you currently have any of the following:

1. Lung Disease Yes No

2. Persistent Cough Yes No

3. Heart Trouble Yes No

4. Shortness of Breath Yes No

5. History of Fainting/Seizures Yes No

6. High Blood Pressure Yes No

7. Diabetes Yes No

8. Feelings of Claustrophobia Yes No

9. Skin Problems/Abnormalities Yes No

10. Heat Exhaustion/Heat Stroke Yes No

11. Defective Vision Yes No

12. Defective Hearing Yes No

13. Asthma Yes No

14. Anemia Yes No

15. Epilepsy Yes No

16. Back Problems Yes No

17. Any other conditions which might interfere with respirator use Yes No

Please explain YES answers (use back of form if necessary)_________________________________________

______________________________________________________________________________________

Are you currently taking any medications? Yes No

If YES, please list:________________________________________________________________________

______________________________________________________________________________________

Do you now or have you ever smoked? Yes No

At what age did you start smoking?________________________________________

How long ago did you quit smoking?________________________________________

How many packs per day did or do you smoke? _______________________________

PHYSICIAN SIGNATURE EMPLOYEE SIGNATURE

DATE DATE

MEDICAL QUESTIONNAIRE FOR RESPIRATOR USERS
89

Employee:____________________________________________________________________________

Job Title:____________________________________________________________________________

SS#: __________________Date of Birth:______________________Employer:______________________

Employer Phone Number:________________________________________________________________

Age: ______________________Height: ________________________Weight: ______________________

Describe the job or work assignment for which respiratory protection will be used:______________________

____________________________________________________________________________________

What hazardous material will respiratory protection be used for? ___________________________________

____________________________________________________________________________________

Circle Type or Types of Respirator(s) to be used?

Powered-air purifying

Supplied-air (pressure demand) Air-purifying (non-powered)

Other

Circle extent of use:

Full Shift (Daily) Task Dependent (Occasionally)Rarely Emergency Use Only

Length of time respiratory protection will be required (hours per day):________________________________

Will there be elevated temperatures? Yes No

Supervisor______________________________________Date__________________________________

PHYSICIAN’S EVALUATION

Employee Name_______________________________________________________________________

May ____________________May not ______________Wear the above noted respirator(s)____________

The restrictions for respirator use by this employee are:__________________________________________

Examining Physician ___________________________________________ Date_____________________

REQUEST FOR MEDICAL CLEARANCE FOR RESPIRATOR USE
90

APPENDIX F

mouth or nasal passages, upper respiratory tract,

and bronchi to reach the alveoli of the lungs. Once

in the alveoli, the organisms are taken up by alveolar macrophages and spread throughout the body.

Usually within 2-10 weeks after initial infection

with M. tuberculosis, the immune response limits further multiplication and spread of the tubercle bacilli; however, some of the bacilli remain dormant

and viable for many years. This condition is referred to as latent TB infection. Persons with latent

TB infection usually have positive purified protein

derivative (PPD)-tuberculin skin-test results, but

they do not have symptoms of active TB, and they

are not infectious.

In general, persons who become infected with M. tuberculosis have approximately a 10% risk for developing active TB during their lifetimes. This risk is

greatest during the first 2 years after infection.

Immunocompromised persons have a greater risk

for the progression of latent TB infection to active TB

disease; HIV infection is the strongest known risk

factor for this progression. Persons with latent TB

infection who become coinfected with HIV have approximately an 8%-10% risk per year for developing active TB (8). HIV- infected persons who are already severely immunosuppressed and who become

newly infected with M. tuberculosis have an even

greater risk for developing active TB (9-12).

The probability that a person who is exposed to M.

tuberculosis will become infected depends primarily

on the concentration of infectious droplet nuclei in

the air and the duration of exposure. Characteristics

of the TB patient that enhance transmission include

a) disease in the lungs, airways, or larynx; b) presence of cough or other forceful expiratory measures;

c) presence of acid-fast bacilli (AFB) in the sputum;

d) failure of the patient to cover the mouth and nose

when coughing or sneezing ; e) presence of cavitation on chest radiograph; f) inappropriate or short

duration of chemotherapy; and g) administration of

procedures that can induce coughing or cause aerosolization of M. tuberculosis (e.g., sputum induction).

Environmental factors that enhance the likelihood

of transmission include a) exposure in relatively

small, enclosed spaces; b) inadequate local or genB. Epidemiology, Transmission, and Pathogenesis of TB

The prevalence of TB is not distributed evenly

throughout all segments of the U.S. population.

Some subgroups or persons have a higher risk for

TB either because they are more likely than other

persons in the general population to have been exposed to and infected with M. tuberculosis or because their infection is more likely to progress to active TB after they have been infected (5). In some

cases, both of these factors may be present. Groups

of persons known to have a higher prevalence of TB

infection include contacts of persons who have active TB, foreign-born persons from areas of the

world with a high prevalence of TB (e.g., Asia, Africa, the Caribbean, and Latin America), medically

underserved populations (e.g., some AfricanAmericans, Hispanics, Asians and Pacific Islanders,

American Indians, and Alaskan Natives), homeless

persons, current or former correctional-facility inmates, alcoholics, injecting-drug users, and the elderly. Groups with a higher risk for progression

from latent TB infection to active disease include

persons who have been infected recently (i.e.,

within the previous 2 years), children less than 4

years of age, persons with fibrotic lesions on chest

radiographs, and persons with certain medical conditions (i.e., human immunodeficiency virus {HIV}

infection, silicosis, gastrectomy or jejuno-ileal bypass, being greater than or equal to 10% below

ideal body weight, chronic renal failure with renal

dialysis, diabetes mellitus, immunosuppression resulting fro receipt of high-dose corticosteroid or

other immunosuppressive therapy, and some malignancies) (5). M. tuberculosis is carried in airborne particles, or droplet nuclei, that can be generated when persons who have pulmonary or

laryngeal TB sneeze, cough, speak, or sing (6). The

particles are an estimated 1-5 mm in size, and normal air currents can keep them airborne for prolonged time periods and spread them throughout a

room or building (7). Infection occurs when a susceptible person inhales droplet nuclei containing M.

tuberculosis, and these droplet nuclei traverse the

Section B of Introduction to

CDC Guidelines Pages 4-6
91

References

2. CDC. Guidelines for preventing the transmission of

tuberculosis in health care settings, with special focus

on HIV-related issues. MMWR 1990;39(No. RR-17).

5. CDC. Screening for tuberculosis and tuberculous infection in high-risk populations, and the use of preventive therapy for tuberculous infection in the

United States: recommendations of the Advisory

Committee for Elimination of Tuberculosis. MMWR

1990;39(No. RR-8).

eral ventilation that results in insufficient dilution

and/or removal of infectious droplet nuclei; and c)

recirculation of air containing infectious droplet nuclei. Characteristics of the persons exposed to M. tuberculosis that may affect the risk for becoming infected are not as well defined. In general, persons

who have been infected previously with M. tuberculosis may be less susceptible to subsequent infection.

However, reinfection can occur among previously

infected persons, especially if they are severely

immunocompromised. Vaccination with Bacille of

Calmette and Guérin (BCG) probably does not affect the risk for infection; rather, it decreases the risk

for progressing from latent TB infection to active TB

(13). Finally, although it is well established that

HIV infection increases the likelihood of progressing from latent TB infection to active TB, it is unknown whether HIV infection increases the risk for

becoming infected if exposed to M. tuberculosis.

C. Risk for Nosocomial Transmission of M. tuberculosis

Transmission of M. tuberculosis is a recognized risk

in health care facilities (14-22). The magnitude of

the risk varies considerably by the type of health

care facility, the prevalence of TB in the community,

the patient population served, the HCW’s occupational group, the area of the health care facility in

which the HCW works, and the effectiveness of TB

infection-control interventions. The risk may be

higher in areas where patients with TB are provided care before diagnosis and initiation of TB

treatment and isolation precautions (e.g., in clinic

waiting areas and emergency departments) or

where diagnostic or treatment procedures that

stimulate coughing are performed. Nosocomial

transmission of M. tuberculosis has been associated

with close contact with persons who have infectious

TB and with the performance of certain procedures

(e.g., bronchoscopy [17], endotracheal intubation

and suctioning [18], open abscess irrigation [20],

and autopsy [21,22]). Sputum induction and aerosol treatments that induce coughing may also increase the potential for transmission of M. tuberculosis (23,24). Personnel of health care facilities should

be particularly alert to the need for preventing

transmission of M. tuberculosis in those facilities in

which immunocompromised persons (e.g., HIV-infected persons) work or receive care—especially if

cough-inducing procedures, such as sputum induction and aerosolized pentamidine treatments, are

being performed.

Several TB outbreaks among persons in health care

facilities have been reported recently (11,24-28;

CDC unpublished data). Many of these outbreaks

involved transmission of multidrug-resistant strains

of M. tuberculosis to both patients and HCWs. Most

of the patients and some of the HCWs were HIV-infected persons in whom new infection progressed

rapidly to active disease. Mortality associated with

those outbreaks was high (range: 43%-93%). Furthermore, the interval between diagnosis and death

was brief (range of median intervals: 4-16 weeks).

Factors contributing to these outbreaks included delayed diagnosis of TB, delayed recognition of drug

resistance, and delayed initiation of effective

therapy—all of which resulted in prolonged infectiousness, delayed initiation and inadequate duration of TB isolation, inadequate ventilation in TB

isolation rooms, lapses in TB isolation practices and

inadequate precautions for cough-inducing procedures, and lack of adequate respiratory protection.

Analysis of data collected from three of the health

care facilities involved in the outbreaks indicates

that transmission of M. tuberculosis decreased significantly or ceased entirely in areas where measures

similar to those in the 1990 TB Guidelines were

implemented (2,29-32). However, several interventions were implemented simultaneously, and the effectiveness of the separate interventions could not be

determined.
92

6. American Thoracic Society/CDC. Diagnostic

standards and classification of tuberculosis. Am Rev

Respir Dis 1990;142:725-35.

7. Wells WF. Aerodynamics of droplet nuclei. In: Airborne contagion and air hygiene. Cambridge:

Harvard University Press, 1955:13-9.

8. Selwyn PA, Hartel D, Lewis VA, et al. A prospective

study of the risk of tuberculosis among intravenous

drug users with human immunodeficiency virus infection. N Engl J Med 1989;320:545-50.

9. Di Perri G, Cruciani M, Danzi MC, et al. Nosocomial

epidemic of active tuberculosis among HIV-infected

patients. Lancet 1989;2:1502-4.

10. Daley CL, Small PM, Schecter GF, et al. An outbreak

of tuberculosis with accelerated progression among

persons infected with the human immunodeficiency

virus: an analysis using restriction-fragment-length

polymorphisms. N Engl J Med 1992;326:231-5.

11. Edlin BR, Tokars JI, Grieco MH, et al. An outbreak of

multidrug-resistant tuberculosis among hospitalized

patients with the acquired immunodeficiency syndrome. N Engl J Med 1992;326:1514-21.

12. Dooley SW, Villarino E, Lawrence M, et al. Nosocomial transmission of tuberculosis in a hospital unit for

HIV-infected patients. JAMA 1992;267:2632-4.

13. Ten Dam HG. Research on BCG vaccination. Adv

Tuberc Res 1984;21:79-106.

14. Barrett-Connor E. The epidemiology of tuberculosis in

physicians. JAMA 1979;241:33-8.

15. Brennen C, Muder RR, Muraca PW. Occult endemic

tuberculosis in a chronic care facility. Infect Control

Hosp Epidemiol 1988;9:548-52.

16. Goldman KP. Tuberculosis in hospital doctors. Tubercle 1988;69:237-40.

17. Catanzaro A. Nosocomial tuberculosis. Am Rev

Respir Dis 1982;125:559-62.

18. Ehrenkranz NJ, Kicklighter JL. Tuberculosis outbreak

in a general hospital: evidence of air-borne spread of

infection. Ann Intern Med 1972;77:377-82.

19. Haley CE, McDonald RC, Rossi L, et al. Tuberculosis

epidemic among hospital personnel. Infect Control

Hosp Epidemiol 1989;10:204-10.

20. Hutton MD, Stead WW, Cauthen GM, et al. Nosocomial Transmission of tuberculosis associated with a

draining tuberculosis abscess. J Infect Dis

1990;161:286-95.

21. Kantor HS, Poblete R, Pusateri SL. Nosocomial transmission of tuberculosis from unsuspected disease. Am

J Med 1988;84:833-8.

22. Lundgren R, Norrman E, Asberg I. Tuberculosis infection transmitted at autopsy. Tubercle 1987;68:147-50.

23. CDC, Mycobacterium tuberculosis transmission in a

health clinic—Florida, 1988. MMWR 1989;38:256-

8,263-4.

24. Beck-Sagué C, Dooley SW, Hutton MD, et al. Outbreak of multidrug-resistant Mycobacterium tuberculosis infections in a hospital: transmission to patients

with HIV infection and staff. JAMA 1992;268:1280-6.

25. CDC. Nosocomial transmission of multidrug-resistant tuberculosis to health care workers and HIV-infected patients in an urban hospital—Florida.

MMWR 1990;39:718-22.

26. CDC. Nosocomial transmission of multidrug-resistant tuberculosis among HIV-infected persons—

Florida and New York, 1988-1991. MMWR

1991;40:585-91.

27. Pearson ML, Jereb JA, Frieden TR, et al. Nosocomial

transmission of multidrug-resistant Mycobacterium

tuberculosis: a risk to patients and health care workers. Ann Intern Med 1992;117:191-6.

28. Dooley SW, Jarvis WR, Martone WJ, Snider DE Jr.

Multidrug-resistant tuberculosis [Editorial]. Ann Intern Med 1992;117:257-8.

29. Wenger P, Beck-Sagué C, Otten J, et al. Efficacy of

control measures in preventing nosocomial transmission of multidrug-resistant tuberculosis among patient and health care workers [Abstract 53A]. In: Program and abstracts of the World Congress on Tuberculosis. Bethesda, MD: National Institutes of Health,

Fogarty International Center, 1992.

30. Otten J, Chen J, Cleary T. Successful control of an outbreak of multidrug-resistant tuberculosis in an urban

teaching hospital [Abstract 51D]. In: Program and

abstracts of the World Congress on Tuberculosis.

Bethesda, MD: National Institutes of Health, Fogarty

International Center, 1992.

31. Maloney S, Pearson M, Gordon M, et al. The efficacy

of recommended infection control measures in preventing nosocomial transmission of multidrug-resistant TB [Abstract 51C]. In: Program and abstracts of

the World Congress on Tuberculosis. Bethesda, MD:

National Institutes of Health, Fogarty International

Center, 1992.

32. Stroud L, Tokars J, Grieco M, Gilligan M, Jarvis W. Interruption of nosocomial transmission of multidrugresistant Mycobacterium tuberculosis (MDR-TB)

among AIDS patients in a New York City Hospital

[Abstract A1-3]. In: Third Annual Meeting of the Society for Hospital Epidemiologists of America. Chicago: Society for Hospital Epidemiologists of

America, 1993.
93

Respirator Fit-Testing and User seal

checking Requirements:

The procedures and requirements for fit-testing the new classes of particulate respirators

have not changed from those OSHA currently

requires. While the respirator standard (29

CFR 1910.134)* does not specify what fit tests

and fit-testing protocols to be used, OSHA

would accept either a quantitative fit test

(QNFT) or qualitative fit test (QLFT) as meeting the fit test requirement.

A QNFT consists of wearing the respirator in

a stable test atmosphere that contains a suitable challenge agent (e.g., corn oil). The adequacy of the fit is determined by measuring

and establishing a ratio of the actual levels of

the challenge agent both inside and outside of

the respirator. Among QNFT methods, OSHA

allows the use of ambient-particulate measurement technology (Portacount) and the controlled-negative pressure technology (Dynatech

Fit-Tester 3000). [Note: the controlled negative-pressure technology is only applicable to

respirators with replaceable filters. It is not

applicable to filtration facepiece respirators.]

APPENDIX G

MEMORANDUM FOR: REGIONAL ADMINISTRATORS

FROM: JOHN B. MILES, JR., DIRECTOR

DIRECTORATE OF COMPLIANCE PROGRAMS

SUBJECT: RESPIRATORY FIT TESTING AND FIT CHECKING PROCEDURES

This memorandum replaces the February 26 memorandum on the same subject. As you are

aware, OSHA and NIOSH during the last year have been involved in a number respirator

related issues. OSHA is in the process of issuing a final respiratory protection standard that

revises 29 CFR 1910.134,* while NIOSH issued new certification guidelines (42 CFR Part 84) last

summer for particulate respirators. The new NIOSH certification procedures directly affected

our requirements for respiratory protection for exposure to tuberculosis and particulates. The

new NIOSH certification procedures coupled with OSHA’s proposed respiratory protection

standard has generated numerous questions to the Office of Health Compliance Assistance.

Respirator related questions have centered around OSHA requirements for fit-testing, fit

checking, and reuse of the new respirators certified under 42 CFR Part 84. The most commonly

asked questions include:

1. What does OSHA expect for a fit-test?

2. What is the difference between a fit-test and user seal check?

3. What does OSHA expect for an acceptable fit-test and user seal check?

In response to these questions, this memorandum is being distributed to provide information

and guidance on current Agency respirator requirements.

* 29 CFR 1910.134 is now codified for protection against TB as 29 CFR 1910.139.
94

A QLFT involves the introduction of an aerosol challenge agent into the area around the

face of the respirator wearer. OSHA requirements for fit-testing of respiratory protection

are spelled out under the third sentence of 29

CFR 1910.134(e)(5):*

“Training shall provide... an opportunity

to handle the respirator, have it fitted

properly, test its face-piece-to-face seal,

wear it in normal air for a long familiarity

period, and, finally, to wear it in a test

atmosphere.”

Protection Factors and QNFT/QLFT:

Half-mask respirators (including disposable

or filtering facepiece and replaceable filters)

have typically received an assigned protection

factor (APF) of 10 by ANSI and NIOSH. For

a QNFT, one uses the APF plus an assigned

minimum safety factor of 10 to establish the

“fit factor (FF).” The FF is what the wearer of

that respirator is assigned for the respirator

with which he/she was tested. For a disposable respirator or half-mask respirator, based

upon the APF times the safety factor, one

must achieve a minimum FF of 100 in a

QNFT. [Note: the safety factor of 10 was chosen based upon standard practice to help ensure adequate protection during field use;

ANSI Z88.2-1992 also recommends a safety

factor of 10]. OSHA has not formally assigned an APF to the Type 95, 99, or 100 respirators certified under 42 CFR Part 84. As

you know, OSHA issued a proposed respiratory protection standard in the Federal Register on November 15th, 1994 (Vol. 59, No.

219). When the final respiratory protection

standard is issued, the Agency will take a formal position on the APFs. In the interim,

when the Type 95, 99, or 100 respirators are

quantitatively fit tested, OSHA will continue

to require a minimum FF of 100 in order for

the employer to conclude that they fit the

worker well enough to satisfy the respiratory protection standard.

In the 1994 CDC Tuberculosis Guidelines

where respiratory protection for occupational

exposure to Tuberculosis is addressed, the

CDC spelled out standard performance criteria for half mask respirators. One point under the criteria stated the following:

“The ability to be qualitatively or quantitatively fit tested in a reliable way to obtain a face-seal leakage of < 10%.”

This statement apparently has been misinterpreted by some to imply that the new classes

of half mask respirators must only meet an individual FF of 10 rather than a FF of 100.

Until assigned protection factors are determined for these respirators, for those facilities

conducting QNFT, OSHA continues to require minimum fit factors of 100 to be obtained.

Qualitative Fit-Testing Procedures:

For facilities electing to conduct QLFTs, a determination of adequate fit is based upon

whether or not the individual can smell, taste

or detect the challenge agent. OSHA will accept those tests using the following challenge

agents currently available: irritant fume, saccharin or BitrexTM aerosol. When an individual passes a QLFT, a minimum FF of 100

will be assumed to have been achieved.

A number of queries to OSHA have involved

concerns regarding the use of irritant smoke

or saccharin aerosol QLFT protocols. Recently, a peer reviewed article discussed the

validation of an alternative qualitative fit testing media. That test media used is a substance called BitrexTM (denatonium benzoate).

This test and the testing protocols are described in:

* 29 CFR 1910.134 is now codified for protection against TB as 29 CFR 1910.139.
95

Mullins, H.E.; Danisch, S.G.; and

Johnston, A.R.: Development of a New

Qualitative Test for Fit Testing Respirators. American Industrial Hygiene

Journal. Vol. 56: 1068-1073 (November

1995).

Based upon the information presented in this

peer-reviewed article, OSHA will accept for

an interim period the common BitrexTM aerosol QLFT procedure when performed using

the protocol described in the article, as a valid

alternative to the other QLFT protocols. All

of the QLFT protocols will be reviewed as

part of the 29 CFR 1910.134* revision.

User seal checking Procedures:

In contrast to a QNFT or QLFT fit-test, a fit

check is a quick determination of respirator

fit by the wearer each time a respirator is

donned to assure that a proper face-to-respirator seal has been achieved. The requirements for fit checking are spelled out under

the last two sentences of 29 CFR

1910.134(5)(I):*

“To assure proper protection, the

facepiece fit shall be checked by the

wearer each time he puts on the respirator. This may be done by following the

manufacturer’s facepiece fitting instruction.”

Concerns have been raised from the field

about user seal checking procedures and

whether or not there is a valid procedure for

user seal checking disposable respirators. The

user seal check on a disposable respirator is

difficult and often less reliable than fit checks

done on an elastomeric half mask respirator.

However, a recently published article does

provide valid information on how to conduct

a user seal check with a disposable respirator. The article also provides a validation

and comparison data with the saccharinaerosol protocol. The reference for the article

is:

Myers, W.A.; Jaraiedi, M; and

Hendricks, L.: Effectiveness of Fit

Check Methods on Half Mask Respirators. Applied Occupational and Environmental Hygiene Journal. Vol. 10

(11): 934-942 (November 1995).

One of the main conclusions of the article

was that when employees donned a respirator and followed the manufacturers’ recommended fit check procedures, the wearer was

better able to detect and thus prevent a

poorer-quality fit of the respirator. Hence,

the fit check provided an added assurance

that the respirator was correctly being worn.

This is currently under review by OSHA as

part of the 29 CFR 1910.134* revision.

Reuse of Disposable Respirators:

According to NIOSH, the reuse of the Part 84

particulate respirators is permitted for tuberculosis provided the respirators have not

been damaged, soiled, or the breathing resistance becomes great enough to cause discomfort to the wearer (overloaded) or the

integrity of the mask has not been compromised. OSHA accepts this view. Apparently

some suppliers of the new disposable respirators are informing clients that the respirators

can only be used one time and then must be

replaced.

We suggest individuals who have any additional questions or require any further assistance should contact either Richard Fairfax of

my staff at (202) 219-8036 or the local OSHA

Regional Office (see attachment).

* 29 CFR 1910.134 is now codified for protection against TB as 29 CFR 1910.139.
96

Attachment

OSHA Regional Offices

Region I - Boston: 617-565-7164

Region II - New York: 212-337-2326

Region III - Philadelphia: 215-596-1201

Region IV - Atlanta: 404-347-3573

Region V - Chicago: 312-353-2220

Region VI - Dallas: 214-767-4731

Region VII - Kansas City: 816-426-5861

Region VIII - Denver: 303-391-5858

Region IX - San Francisco: 415-975-4310

Region X - Seattle: 206-553-5930
97

subject is not familiar with using a particular

respirator, the test subject shall be directed to

don the mask several times and to adjust the

straps each time to become adept at setting

proper tension on the straps.

6. Assessment of comfort shall include a review

of the following points with the test subject and

allowing the test subject adequate time to determine the comfort of the respirator:

(a) Position of the mask on the nose

(b) Room for eye protection

(c) Room to talk

(d) Position of mask on face and cheeks

7. The following criteria shall be used to help

determine the adequacy of the respirator fit:

(a) Chin properly placed;

(b) Adequate strap tension, not overly tightened;

(c) Fit across nose bridge;

(d) Respirator of proper size to span distance

from nose to chin;

(e) Tendency of respirator to slip;

(f) Self-observation in mirror to evaluate fit and

respirator position.

8. The test subject shall conduct a user seal

check, either the negative and positive pressure

seal checks described in Appendix B-1 of this

section or those recommended by the respirator manufacturer which provide equivalent

protection to the procedures in Appendix B- 1.

Before conducting the negative and positive

pressure checks, the subject shall be told to seat

the mask on the face by moving the head from

side-to-side and up and down slowly while

Appendix A to 1910.134: Fit Testing Procedure

Part I. OSHA-Accepted Fit Test Protocols

A. Fit Testing Procedures—General Requirements

The employer shall conduct fit testing using the

following procedures. The requirements in this

appendix apply to all OSHA-accepted fit test

methods, both QLFT and QNFT.

1. The test subject shall be allowed to pick the

most acceptable respirator from a sufficient

number of respirator models and sizes so that

the respirator is acceptable to, and correctly fits,

the user.

2. Prior to the selection process, the test subject

shall be shown how to put on a respirator, how

it should be positioned on the face, how to set

strap tension and how to determine an acceptable fit. A mirror shall be available to assist the

subject in evaluating the fit and positioning of

the respirator. This instruction may not constitute the subject’s formal training on respirator

use, because it is only a review.

3. The test subject shall be informed that he/

she is being asked to select the respirator that

provides the most acceptable fit. Each respirator represents a different size and shape, and if

fitted and used properly, will provide adequate

protection.

4. The test subject shall be instructed to hold

each chosen facepiece up to the face and eliminate those that obviously do not give an acceptable fit.

5. The more acceptable facepieces are noted in

case the one selected proves unacceptable; the

most comfortable mask is donned and worn at

least five minutes to assess comfort. Assistance

in assessing comfort can be given by discussing

the points in the following item A.6. If the test

APPENDIX H
98

taking in a few slow deep breaths. Another

facepiece shall be selected and retested if the

test subject fails the user seal check tests.

9. The test shall not be conducted if there is

any hair growth between the skin and the

facepiece sealing surface, such as stubble beard

growth, beard, mustache or sideburns which

cross the respirator sealing surface. Any type

of apparel which interferes with a satisfactory

fit shall be altered or removed.

10. If a test subject exhibits difficulty in breathing during the tests, she or he shall be referred

to a physician or other licensed health care

professional, as appropriate, to determine

whether the test subject can wear a respirator

while performing her or his duties.

11. If the employee finds the fit of the respirator unacceptable, the test subject shall be given

the opportunity to select a different respirator

and to be retested.

12. Exercise regimen. Prior to the commencement of the fit test, the test subject shall be

given a description of the fit test and the test

subject’s responsibilities during the test procedure. The description of the process shall include a description of the test exercises that the

subject will be performing. The respirator to be

tested shall be worn for at least 5 minutes before the start of the fit test.

13. The fit test shall be performed while the

test subject is wearing any applicable safety

equipment that may be worn during actual

respirator use which could interfere with respirator fit.

14. Test Exercises. (a) The following test exercises are to be performed for all fit testing

methods prescribed in this appendix, except

for the CNP method. A separate fit testing exercise regimen is contained in the CNP protocol. The test subject shall perform exercises, in

the test environment, in the following manner:

(1) Normal breathing. In a normal standing

position, without talking, the subject shall

breathe normally.

(2) Deep breathing. In a normal standing position, the subject shall breathe slowly and

deeply, taking caution so as not to hyperventilate.

(3) Turning head side to side. Standing in

place, the subject shall slowly turn his/her

head from side to side between the extreme

positions on each side. The head shall be held

at each extreme momentarily so the subject

can inhale at each side.

(4) Moving head up and down. Standing in

place, the subject shall slowly move his/her

head up and down. The subject shall be instructed to inhale in the up position (i.e., when

looking toward the ceiling).

(5) Talking. The subject shall talk out loud

slowly and loud enough so as to be heard

clearly by the test conductor. The subject can

read from a prepared text such as the Rainbow Passage, count backward from 100, or recite a memorized poem or song.

Rainbow Passage

When the sunlight strikes raindrops in the

air, they act like a prism and form a rainbow.

The rainbow is a division of white light into

many beautiful colors. These take the shape

of a long round arch, with its path high

above, and its two ends apparently beyond

the horizon. There is, according to legend, a

boiling pot of gold at one end. People look,

but no one ever finds it. When a man looks

for something beyond reach, his friends say

he is looking for the pot of gold at the end of

the rainbow.

(6) Grimace. The test subject shall grimace by

smiling or frowning. (This applies only to

QNFT testing; it is not performed for QLFT)
99

(7) Bending over. The test subject shall bend

at the waist as if he/she were to touch his/

her toes. Jogging in place shall be substituted

for this exercise in those test environments

such as shroud type QNFT or QLFT units

that do not permit bending over at the waist.

 (8) Normal breathing. Same as exercise (1).

(b) Each test exercise shall be performed for

one minute except for the grimace exercise

which shall be performed for 15 seconds. The

test subject shall be questioned by the test

conductor regarding the comfort of the respirator upon completion of the protocol. If it

has become unacceptable, another model of

respirator shall be tried. The respirator shall

not be adjusted once the fit test exercises begin. Any adjustment voids the test, and the

fit test must be repeated.

B. Qualitative Fit Test (QLFT) Protocols

1. General

(a) The employer shall ensure that persons administering QLFT are able to prepare test solutions, calibrate equipment and perform tests

properly, recognize invalid tests, and ensure

that test equipment is in proper working order.

(b) The employer shall ensure that QLFT

equipment is kept clean and well maintained

so as to operate within the parameters for

which it was designed.

2. Isoamyl Acetate Protocol

Note: This protocol is not appropriate to use

for the fit testing of particulate respirators. If

used to fit test particulate respirators, the respirator must be equipped with an organic vapor

filter.

(a) Odor Threshold Screening

Odor threshold screening, performed without

wearing a respirator, is intended to determine if

the individual tested can detect the odor of

isoamyl acetate at low levels.

(1) Three 1 liter glass jars with metal lids are required.

(2) Odor-free water (e.g., distilled or spring water) at approximately 25 deg. C (77 deg. F) shall

be used for the solutions.

(3) The isoamyl acetate (IAA) (also known at isopentyl acetate) stock solution is prepared by adding 1 ml of pure IAA to 800 ml of odor-free water

in a 1 liter jar, closing the lid and shaking for 30

seconds. A new solution shall be prepared at

least weekly.

(4) The screening test shall be conducted in a

room separate from the room used for actual fit

testing. The two rooms shall be well-ventilated to

prevent the odor of IAA from becoming evident

in the general room air where testing takes place.

(5) The odor test solution is prepared in a second jar by placing 0.4 ml of the stock solution

into 500 ml of odor-free water using a clean

dropper or pipette. The solution shall be

shaken for 30 seconds and allowed to stand for

two to three minutes so that the IAA concentration above the liquid may reach equilibrium.

This solution shall be used for only one day.

(6) A test blank shall be prepared in a third jar

by adding 500 cc of odor-free water.

(7) The odor test and test blank jar lids shall be

labeled (e.g., 1 and 2) for jar identification. Labels shall be placed on the lids so that they can

be peeled off periodically and switched to

maintain the integrity of the test.

(8) The following instruction shall be typed on

a card and placed on the table in front of the

two test jars (i.e., 1 and 2): “The purpose of this

test is to determine if you can smell banana oil

at a low concentration. The two bottles in front
100

of you contain water. One of these bottles also

contains a small amount of banana oil. Be sure

the covers are on tight, then shake each bottle

for two seconds. Unscrew the lid of each bottle,

one at a time, and sniff at the mouth of the

bottle. Indicate to the test conductor which

bottle contains banana oil.”

(9) The mixtures used in the IAA odor detection test shall be prepared in an area separate

from where the test is performed, in order to

prevent olfactory fatigue in the subject.

(10) If the test subject is unable to correctly

identify the jar containing the odor test solution, the IAA qualitative fit test shall not be

performed.

(11) If the test subject correctly identifies the jar

containing the odor test solution, the test subject may proceed to respirator selection and fit

testing.

(b) Isoamyl Acetate Fit Test

(1) The fit test chamber shall be a clear 55-gallon drum liner suspended inverted over a 2-

foot diameter frame so that the top of the

chamber is about 6 inches above the test

subject’s head. If no drum liner is available, a

similar chamber shall be constructed using

plastic sheeting. The inside top center of the

chamber shall have a small hook attached.

(2) Each respirator used for the fitting and fit

testing shall be equipped with organic vapor

cartridges or offer protection against organic

vapors.

(3) After selecting, donning, and properly adjusting a respirator, the test subject shall wear it

to the fit testing room. This room shall be separate from the room used for odor threshold

screening and respirator selection, and shall be

well-ventilated, as by an exhaust fan or lab

hood, to prevent general room contamination.

(4) A copy of the test exercises and any prepared text from which the subject is to read

shall be taped to the inside of the test chamber.

(5) Upon entering the test chamber, the test

subject shall be given a 6-inch by 5-inch piece

of paper towel, or other porous, absorbent,

single-ply material, folded in half and wetted

with 0.75 ml of pure IAA. The test subject shall

hang the wet towel on the hook at the top of the

chamber. An IAA test swab or ampule may be

substituted for the IAA wetted paper towel

provided it has been demonstrated that the alternative IAA source will generate an IAA test

atmosphere with a concentration equivalent to

that generated by the paper towel method.

(6) Allow two minutes for the IAA test concentration to stabilize before starting the fit test exercises. This would be an appropriate time to

talk with the test subject; to explain the fit test,

the importance of his/her cooperation, and the

purpose for the test exercises; or to demonstrate

some of the exercises.

(7) If at any time during the test, the subject detects the banana-like odor of IAA, the test is

failed. The subject shall quickly exit from the

test chamber and leave the test area to avoid

olfactory fatigue.

(8) If the test is failed, the subject shall return

to the selection room and remove the respirator. The test subject shall repeat the odor sensitivity test, select and put on another

respirator, return to the test area and again

begin the fit test procedure described in (b) (1)

through (7) above. The process continues until

a respirator that fits well has been found.

Should the odor sensitivity test be failed, the

subject shall wait at least 5 minutes before retesting. Odor sensitivity will usually have returned by this time.

(9) If the subject passes the test, the efficiency

of the test procedure shall be demonstrated by

having the subject break the respirator face

seal and take a breath before exiting the

chamber.
101

(10) When the test subject leaves the chamber,

the subject shall remove the saturated towel

and return it to the person conducting the test,

so that there is no significant IAA concentration

buildup in the chamber during subsequent

tests. The used towels shall be kept in a selfsealing plastic bag to keep the test area from

being contaminated.

3. Saccharin Solution Aerosol Protocol

The entire screening and testing procedure

shall be explained to the test subject prior to the

conduct of the screening test.

(a) Taste threshold screening. The saccharin

taste threshold screening, performed without

wearing a respirator, is intended to determine

whether the individual being tested can detect

the taste of saccharin.

(1) During threshold screening as well as during fit testing, subjects shall wear an enclosure

about the head and shoulders that is approximately 12 inches in diameter by 14 inches tall

with at least the front portion clear and that allows free movements of the head when a respirator is worn. An enclosure substantially similar

to the 3M hood assembly, parts # FT 14 and #

FT 15 combined, is adequate.

(2) The test enclosure shall have a 3/4-inch (1.9

cm) hole in front of the test subject’s nose and

mouth area to accommodate the nebulizer

nozzle.

(3) The test subject shall don the test enclosure.

Throughout the threshold screening test, the

test subject shall breathe through his/her

slightly open mouth with tongue extended. The

subject is instructed to report when he/she detects a sweet taste.

(4) Using a DeVilbiss Model 40 Inhalation

Medication Nebulizer or equivalent, the test

conductor shall spray the threshold check solution into the enclosure. The nozzle is directed

away from the nose and mouth of the person.

This nebulizer shall be clearly marked to distinguish it from the fit test solution nebulizer.

(5) The threshold check solution is prepared by

dissolving 0.83 gram of sodium saccharin USP

in 100 ml of warm water. It can be prepared by

putting 1 ml of the fit test solution (see (b)(5)

below) in 100 ml of distilled water.

(6) To produce the aerosol, the nebulizer bulb

is firmly squeezed so that it collapses completely, then released and allowed to fully expand.

(7) Ten squeezes are repeated rapidly and then

the test subject is asked whether the saccharin

can be tasted. If the test subject reports tasting

the sweet taste during the ten squeezes, the

screening test is completed. The taste threshold

is noted as ten regardless of the number of

squeezes actually completed.

(8) If the first response is negative, ten more

squeezes are repeated rapidly and the test subject is again asked whether the saccharin is

tasted. If the test subject reports tasting the

sweet taste during the second ten squeezes, the

screening test is completed. The taste threshold

is noted as twenty regardless of the number of

squeezes actually completed.

(9) If the second response is negative, ten more

squeezes are repeated rapidly and the test subject is again asked whether the saccharin is

tasted. If the test subject reports tasting the

sweet taste during the third set of ten squeezes,

the screening test is completed. The taste

threshold is noted as thirty regardless of the

number of squeezes actually completed.

(10) The test conductor will take note of the

number of squeezes required to solicit a taste

response.

(11) If the saccharin is not tasted after 30

squeezes (step 10), the test subject is unable to

taste saccharin and may not perform the saccharin fit test.
102

Note to paragraph 3. (a): If the test subject eats

or drinks something sweet before the screening

test, he/she may be unable to taste the weak

saccharin solution.

(12) If a taste response is elicited, the test subject shall be asked to take note of the taste for

 reference in the fit test.

(13) Correct use of the nebulizer means that approximately 1 ml of liquid is used at a time in

the nebulizer body.

(14) The nebulizer shall be thoroughly rinsed

in water, shaken dry, and refilled at least each

morning and afternoon or at least every four

hours.

(b) Saccharin solution aerosol fit test procedure.

(1) The test subject may not eat, drink (except

plain water), smoke, or chew gum for 15 minutes before the test.

(2) The fit test uses the same enclosure described in 3. (a) above.

(3) The test subject shall don the enclosure

while wearing the respirator selected in section

I. A. of this appendix. The respirator shall be

properly adjusted and equipped with a particulate filter(s).

(4) A second DeVilbiss Model 40 Inhalation

Medication Nebulizer or equivalent is used to

spray the fit test solution into the enclosure.

This nebulizer shall be clearly marked to distinguish it from the screening test solution

nebulizer.

(5) The fit test solution is prepared by adding

83 grams of sodium saccharin to 100 ml of

warm water.

(6) As before, the test subject shall breathe

through the slightly open mouth with tongue

extended, and report if he/she tastes the sweet

taste of saccharin.

(7) The nebulizer is inserted into the hole in

the front of the enclosure and an initial concentration of saccharin fit test solution is sprayed

into the enclosure using the same number of

squeezes (either 10, 20 or 30 squeezes) based

on the number of squeezes required to elicit a

taste response as noted during the screening

test. A minimum of 10 squeezes is required.

(8) After generating the aerosol, the test subject

shall be instructed to perform the exercises in

 section I. A. 14. of this appendix.

(9) Every 30 seconds the aerosol concentration

shall be replenished using one half the original

number of squeezes used initially (e.g., 5, 10 or

15).

(10) The test subject shall indicate to the test

conductor if at any time during the fit test the

taste of saccharin is detected. If the test subject

does not report tasting the saccharin, the test is

passed.

(11) If the taste of saccharin is detected, the fit

is deemed unsatisfactory and the test is failed.

A different respirator shall be tried and the entire test procedure is repeated (taste threshold

screening and fit testing).

(12) Since the nebulizer has a tendency to clog

during use, the test operator must make periodic checks of the nebulizer to ensure that it is

not clogged. If clogging is found at the end of

the test session, the test is invalid.

4. BitrexTM (Denatonium Benzoate) Solution

Aerosol Qualitative Fit Test Protocol

The BitrexTM (Denatonium benzoate) solution

aerosol QLFT protocol uses the published saccharin test protocol because that protocol is

widely accepted. Bitrex is routinely used as a

taste aversion agent in household liquids

which children should not be drinking and is

endorsed by the American Medical Association, the National Safety Council, and the

American Association of Poison Control Cen-
103

ters. The entire screening and testing procedure

shall be explained to the test subject prior to the

conduct of the screening test.

(a) Taste Threshold Screening.

The Bitrex taste threshold screening, performed without wearing a respirator, is intended to determine whether the individual

being tested can detect the taste of Bitrex.

(1) During threshold screening as well as during fit testing, subjects shall wear an enclosure

about the head and shoulders that is approximately 12 inches (30.5 cm) in diameter by 14

inches (35.6 cm) tall. The front portion of the

enclosure shall be clear from the respirator and

allow free movement of the head when a respirator is worn. An enclosure substantially similar to the 3M hood assembly, parts # FT 14

and # FT 15 combined, is adequate.

(2) The test enclosure shall have a 3/4 inch (1.9

cm) hole in front of the test subject’s nose and

mouth area to accommodate the nebulizer

nozzle.

(3) The test subject shall don the test enclosure.

Throughout the threshold screening test, the

test subject shall breathe through his or her

slightly open mouth with tongue extended.

The subject is instructed to report when he/she

detects a bitter taste.

(4) Using a DeVilbiss Model 40 Inhalation

Medication Nebulizer or equivalent, the test

conductor shall spray the Threshold Check Solution into the enclosure. This Nebulizer shall

be clearly marked to distinguish it from the fit

test solution nebulizer.

(5) The Threshold Check Solution is prepared

by adding 13.5 milligrams of Bitrex to 100 ml

of 5% salt (NaCl) solution in distilled water.

(6) To produce the aerosol, the nebulizer bulb

is firmly squeezed so that the bulb collapses

completely, and is then released and allowed

to fully expand.

(7) An initial ten squeezes are repeated rapidly and then the test subject is asked

whether the Bitrex can be tasted. If the test

subject reports tasting the bitter taste during

the ten squeezes, the screening test is completed. The taste threshold is noted as ten regardless of the number of squeezes actually

completed.

(8) If the first response is negative, ten more

squeezes are repeated rapidly and the test

subject is again asked whether the Bitrex is

tasted. If the test subject reports tasting the

bitter taste during the second ten squeezes,

the screening test is completed. The taste

threshold is noted as twenty regardless of

the number of squeezes actually completed.

(9) If the second response is negative, ten

more squeezes are repeated rapidly and the

test subject is again asked whether the Bitrex

is tasted. If the test subject reports tasting the

bitter taste during the third set of ten

squeezes, the screening test is completed.

The taste threshold is noted as thirty regardless of the number of squeezes actually completed.

(10) The test conductor will take note of the

number of squeezes required to solicit a

taste response.

(11) If the Bitrex is not tasted after 30

squeezes (step 10), the test subject is unable

to taste Bitrex and may not perform the

Bitrex fit test.

(12) If a taste response is elicited, the test

subject shall be asked to take note of the

taste for reference in the fit test.

(13) Correct use of the nebulizer means that

approximately 1 ml of liquid is used at a

time in the nebulizer body.

(14) The nebulizer shall be thoroughly
104

rinsed in water, shaken to dry, and refilled at

least each morning and afternoon or at least

every four hours.

(b) Bitrex Solution Aerosol Fit Test Procedure.

(1) The test subject may not eat, drink (except

plain water), smoke, or chew gum for 15 minutes before the test.

(2) The fit test uses the same enclosure as that

described in 4. (a) above.

(3) The test subject shall don the enclosure

while wearing the respirator selected according

to section I. A. of this appendix. The respirator

shall be properly adjusted and equipped with

any type particulate filter(s).

(4) A second DeVilbiss Model 40 Inhalation

Medication Nebulizer or equivalent is used to

spray the fit test solution into the enclosure.

This nebulizer shall be clearly marked to distinguish it from the screening test solution

nebulizer.

(5) The fit test solution is prepared by adding

337.5 mg of Bitrex to 200 ml of a 5% salt

(NaCl) solution in warm water.

(6) As before, the test subject shall breathe

through his or her slightly open mouth with

tongue extended, and be instructed to report if

he/she tastes the bitter taste of Bitrex.

(7) The nebulizer is inserted into the hole in the

front of the enclosure and an initial concentration of the fit test solution is sprayed into the

enclosure using the same number of squeezes

(either 10, 20 or 30 squeezes) based on the

number of squeezes required to elicit a taste response as noted during the screening test.

(8) After generating the aerosol, the test subject

shall be instructed to perform the exercises in

section I. A. 14. of this appendix.

(9) Every 30 seconds the aerosol concentration

shall be replenished using one half the number

of squeezes used initially (e.g., 5, 10 or 15).

(10) The test subject shall indicate to the test

conductor if at any time during the fit test the

taste of Bitrex is detected. If the test subject

does not report tasting the Bitrex, the test is

passed.

(11) If the taste of Bitrex is detected, the fit is

deemed unsatisfactory and the test is failed. A

different respirator shall be tried and the entire

test procedure is repeated (taste threshold

screening and fit testing).

5. Irritant Smoke (Stannic Chloride) Protocol

This qualitative fit test uses a person’s response

to the irritating chemicals released in the

“smoke” produced by a stannic chloride ventilation smoke tube to detect leakage into the

respirator.

(a) General Requirements and Precautions

(1) The respirator to be tested shall be

equipped with high efficiency particulate air

(HEPA) or P100 series filter(s).

(2) Only stannic chloride smoke tubes shall be

used for this protocol.

(3) No form of test enclosure or hood for the

test subject shall be used.

(4) The smoke can be irritating to the eyes,

lungs, and nasal passages. The test conductor

shall take precautions to minimize the test

subject’s exposure to irritant smoke. Sensitivity

varies, and certain individuals may respond to a

greater degree to irritant smoke. Care shall be

taken when performing the sensitivity screening

checks that determine whether the test subject can

detect irritant smoke to use only the minimum

amount of smoke necessary to elicit a response

from the test subject.

(5) The fit test shall be performed in an area with
105

adequate ventilation to prevent exposure of the

person conducting the fit test or the buildup of irritant smoke in the general atmosphere.

(b) Sensitivity Screening Check

The person to be tested must demonstrate his

or her ability to detect a weak concentration of

the irritant smoke.

(1) The test operator shall break both ends of a

ventilation smoke tube containing stannic

chloride, and attach one end of the smoke tube

to a low flow air pump set to deliver 200 milliliters per minute, or an aspirator squeeze bulb.

The test operator shall cover the other end of

the smoke tube with a short piece of tubing to

prevent potential injury from the jagged end of

the smoke tube.

(2) The test operator shall advise the test subject that the smoke can be irritating to the eyes,

lungs, and nasal passages and instruct the

subject to keep his/her eyes closed while the

test is performed.

(3) The test subject shall be allowed to smell a

weak concentration of the irritant smoke before the respirator is donned to become familiar with its irritating properties and to

determine if he/she can detect the irritating

properties of the smoke. The test operator shall

carefully direct a small amount of the irritant

smoke in the test subject’s direction to determine that he/she can detect it.

(c) Irritant Smoke Fit Test Procedure

(1) The person being fit tested shall don the

respirator without assistance, and perform the

required user seal check(s).

(2) The test subject shall be instructed to keep

his/her eyes closed.

(3) The test operator shall direct the stream of

irritant smoke from the smoke tube toward the

faceseal area of the test subject, using the low

flow pump or the squeeze bulb. The test operator shall begin at least 12 inches from the

facepiece and move the smoke stream around

the whole perimeter of the mask. The operator

shall gradually make two more passes around

the perimeter of the mask, moving to within

six inches of the respirator.

(4) If the person being tested has not had an involuntary response and/or detected the irritant smoke, proceed with the test exercises.

(5) The exercises identified in section I.A. 14. of

this appendix shall be performed by the test

subject while the respirator seal is being continually challenged by the smoke, directed

around the perimeter of the respirator at a distance of six inches.

(6) If the person being fit tested reports detecting the irritant smoke at any time, the test is

failed. The person being retested must repeat

the entire sensitivity check and fit test procedure.

(7) Each test subject passing the irritant smoke

test without evidence of a response (involuntary cough, irritation) shall be given a second

sensitivity screening check, with the smoke

from the same smoke tube used during the fit

test, once the respirator has been removed, to

determine whether he/she still reacts to the

smoke. Failure to evoke a response shall void

the fit test.

(8) If a response is produced during this second sensitivity check, then the fit test is passed.

C. Quantitative Fit Test (QNFT) Protocols

The following quantitative fit testing procedures have been demonstrated to be acceptable: Quantitative fit testing using a

non-hazardous test aerosol (such as corn oil,

polyethylene glycol 400 [PEG 400], di-2-ethyl

hexyl sebacate [DEHS], or sodium chloride)

generated in a test chamber, and employing

instrumentation to quantify the fit of the respi-
106

rator; Quantitative fit testing using ambient

aerosol as the test agent and appropriate instrumentation (condensation nuclei counter) to

quantify the respirator fit; Quantitative fit testing using controlled negative pressure and appropriate instrumentation to measure the

volumetric leak rate of a facepiece to quantify

the respirator fit.

 1. General

(a) The employer shall ensure that persons administering QNFT are able to calibrate equipment and perform tests properly, recognize

invalid tests, calculate fit factors properly and

ensure that test equipment is in proper working order.

(b) The employer shall ensure that QNFT

equipment is kept clean, and is maintained

and calibrated according to the manufacturer’s

instructions so as to operate at the parameters

for which it was designed.

2. Generated Aerosol Quantitative Fit Testing

Protocol

(a) Apparatus.

(1) Instrumentation. Aerosol generation, dilution, and measurement systems using particulates (corn oil, polyethylene glycol 400 [PEG

400], di-2-ethyl hexyl sebacate [DEHS] or sodium chloride) as test aerosols shall be used

for quantitative fit testing.

(2) Test chamber. The test chamber shall be

large enough to permit all test subjects to perform freely all required exercises without disturbing the test agent concentration or the

measurement apparatus. The test chamber

shall be equipped and constructed so that the

test agent is effectively isolated from the ambient air, yet uniform in concentration throughout the chamber.

(3) When testing air-purifying respirators, the

normal filter or cartridge element shall be replaced with a high efficiency particulate air

(HEPA) or P100 series filter supplied by the

same manufacturer.

(4) The sampling instrument shall be selected

so that a computer record or strip chart record

may be made of the test showing the rise and

fall of the test agent concentration with each

inspiration and expiration at fit factors of at

least 2,000. Integrators or computers that integrate the amount of test agent penetration

leakage into the respirator for each exercise

may be used provided a record of the readings is made.

(5) The combination of substitute air-purifying

elements, test agent and test agent concentration shall be such that the test subject is not exposed in excess of an established exposure

limit for the test agent at any time during the

testing process, based upon the length of the

exposure and the exposure limit duration.

(6) The sampling port on the test specimen respirator shall be placed and constructed so that

no leakage occurs around the port (e.g., where

the respirator is probed), a free air flow is allowed into the sampling line at all times, and

there is no interference with the fit or performance of the respirator. The in-mask sampling

device (probe) shall be designed and used so

that the air sample is drawn from the breathing zone of the test subject, midway between

the nose and mouth and with the probe extending into the facepiece cavity at least 1/4

inch.

(7) The test setup shall permit the person administering the test to observe the test subject

inside the chamber during the test.

(8) The equipment generating the test atmosphere shall maintain the concentration of test

agent constant to within a 10 percent variation

for the duration of the test.

(9) The time lag (interval between an event

and the recording of the event on the strip
107

chart or computer or integrator) shall be kept to

a minimum. There shall be a clear association

between the occurrence of an event and its being recorded.

(10) The sampling line tubing for the test

chamber atmosphere and for the respirator

sampling port shall be of equal diameter and

of the same material. The length of the two

lines shall be equal.

(11) The exhaust flow from the test chamber

shall pass through an appropriate filter (i.e.,

high efficiency particulate filter) before release.

(12) When sodium chloride aerosol is used, the

relative humidity inside the test chamber shall

not exceed 50 percent.

13) The limitations of instrument detection

shall be taken into account when determining

the fit factor.

(14) Test respirators shall be maintained in

proper working order and be inspected regularly for deficiencies such as cracks or missing

valves and gaskets.

(b) Procedural Requirements.

(1) When performing the initial user seal check

using a positive or negative pressure check, the

sampling line shall be crimped closed in order

to avoid air pressure leakage during either of

these pressure checks.

(2) The use of an abbreviated screening QLFT

test is optional. Such a test may be utilized in

order to quickly identify poor fitting respirators that passed the positive and/or negative

pressure test and reduce the amount of QNFT

time. The use of the CNC QNFT instrument in

the count mode is another optional method to

obtain a quick estimate of fit and eliminate

poor fitting respirators before going on to perform a full QNFT.

(3) A reasonably stable test agent concentration

shall be measured in the test chamber prior to

testing. For canopy or shower curtain types of

test units, the determination of the test agent’s

stability may be established after the test subject has entered the test environment.

(4) Immediately after the subject enters the test

chamber, the test agent concentration inside

the respirator shall be measured to ensure that

the peak penetration does not exceed 5 percent

for a half mask or 1 percent for a full facepiece

respirator.

(5) A stable test agent concentration shall be

obtained prior to the actual start of testing.

(6) Respirator restraining straps shall not be

over-tightened for testing. The straps shall be

adjusted by the wearer without assistance

from other persons to give a reasonably

comfortable fit typical of normal use. The

respirator shall not be adjusted once the fit test

exercises begin.

(7) The test shall be terminated whenever any

single peak penetration exceeds 5 percent for

half masks and 1 percent for full facepiece respirators. The test subject shall be refitted and

retested.

(8) Calculation of fit factors.

(i) The fit factor shall be determined for the

quantitative fit test by taking the ratio of the

average chamber concentration to the concentration measured inside the respirator for each

test exercise except the grimace exercise.

(ii) The average test chamber concentration

shall be calculated as the arithmetic average of

the concentration measured before and after

each test (i.e., 7 exercises) or the arithmetic average of the concentration measured before

and after each exercise or the true average

measured continuously during the respirator

sample.

(iii) The concentration of the challenge agent

inside the respirator shall be determined by
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one of the following methods:

(A) Average peak penetration method means

the method of determining test agent penetration into the respirator utilizing a strip chart

recorder, integrator, or computer. The agent

penetration is determined by an average of the

peak heights on the graph or by computer integration, for each exercise except the grimace

exercise. Integrators or computers that calculate the actual test agent penetration into the

respirator for each exercise will also be considered to meet the requirements of the average

peak penetration method.

(B) Maximum peak penetration method means

the method of determining test agent penetration in the respirator as determined by strip

chart recordings of the test. The highest peak

penetration for a given exercise is taken to be

representative of average penetration into the

respirator for that exercise.

(C) Integration by calculation of the area under

the individual peak for each exercise except the

grimace exercise. This includes computerized

integration.

(D) The calculation of the overall fit factor using individual exercise fit factors involves first

converting the exercise fit factors to penetration

values, determining the average, and then converting that result back to a fit factor. This procedure is described in the following equation:

Overall Fit Factor =

_ Number of exercises _

1/ff1 + 1/ff2 + 1/ff3 + 1ff/4 + 1/ff5 + 1/ff6 + 1/ff7 + 1/ff8

Where ff1, ff2, ff3, etc. are the fit factors for exercises 1, 2, 3, etc.

(9) The test subject shall not be permitted to

wear a half mask or quarter facepiece respirator unless a minimum fit factor of 100 is obtained, or a full facepiece respirator unless a

minimum fit factor of 500 is obtained.

(10) Filters used for quantitative fit testing

shall be replaced whenever increased breathing resistance is encountered, or when the test

agent has altered the integrity of the filter media.

3. Ambient aerosol condensation nuclei counter

(CNC) quantitative fit testing protocol.

The ambient aerosol condensation nuclei

counter (CNC) quantitative fit testing

(PortacountTM ) protocol quantitatively fit tests

respirators with the use of a probe. The probed

respirator is only used for quantitative fit tests.

A probed respirator has a special sampling device, installed on the respirator, that allows the

probe to sample the air from inside the mask.

A probed respirator is required for each make,

style, model, and size that the employer uses

and can be obtained from the respirator manufacturer or distributor. The CNC instrument

manufacturer, TSI Inc., also provides probe attachments (TSI sampling adapters) that permit

fit testing in an employee’s own respirator. A

minimum fit factor pass level of at least 100 is

necessary for a half-mask respirator and a

minimum fit factor pass level of at least 500 is

required for a full facepiece negative pressure

respirator. The entire screening and testing

procedure shall be explained to the test subject

prior to the conduct of the screening test.

(a) Portacount Fit Test Requirements.

(1) Check the respirator to make sure the sampling probe and line are properly attached to the

facepiece and that the respirator is fitted with a

particulate filter capable of preventing significant

penetration by the ambient particles used for the

fit test (e.g., NIOSH 42 CFR 84 series 100, series

99, or series 95 particulate filter) per

manufacturer’s instruction.

 (2) Instruct the person to be tested to don the respirator for five minutes before the fit test starts.

This purges the ambient particles trapped inside
109

the respirator and permits the wearer to make

certain the respirator is comfortable. This individual shall already have been trained on how

to wear the respirator properly.

(3) Check the following conditions for the adequacy of the respirator fit: Chin properly

placed; Adequate strap tension, not overly

tightened; Fit across nose bridge; Respirator of

proper size to span distance from nose to chin;

Tendency of the respirator to slip; Self-observation in a mirror to evaluate fit and respirator

position.

(4) Have the person wearing the respirator do

a user seal check. If leakage is detected, determine the cause. If leakage is from a poorly fitting facepiece, try another size of the same

model respirator, or another model of respirator.

(5) Follow the manufacturer’s instructions for

operating the Portacount and proceed with the

test.

(6) The test subject shall be instructed to perform the exercises in section I. A. 14. of this appendix.

(7) After the test exercises, the test subject shall

be questioned by the test conductor regarding

the comfort of the respirator upon completion

of the protocol. If it has become unacceptable,

another model of respirator shall be tried.

(b) Portacount Test Instrument.

(1) The Portacount will automatically stop and

calculate the overall fit factor for the entire set

of exercises. The overall fit factor is what

counts. The Pass or Fail message will indicate

whether or not the test was successful. If the

test was a Pass, the fit test is over.

(2) Since the pass or fail criterion of the

Portacount is user programmable, the test operator shall ensure that the pass or fail criterion meet the requirements for minimum

respirator performance in this Appendix.

(3) A record of the test needs to be kept on file,

assuming the fit test was successful. The

record must contain the test subject’s name;

overall fit factor; make, model, style, and size

of respirator used; and date tested.

4. Controlled negative pressure (CNP) quantitative fit testing protocol.

The CNP protocol provides an alternative to

aerosol fit test methods. The CNP fit test

method technology is based on exhausting air

from a temporarily sealed respirator facepiece

to generate and then maintain a constant

negative pressure inside the facepiece. The

rate of air exhaust is controlled so that a constant negative pressure is maintained in the

respirator during the fit test. The level of pressure is selected to replicate the mean inspiratory pressure that causes leakage into the

respirator under normal use conditions. With

pressure held constant, air flow out of the respirator is equal to air flow into the respirator.

Therefore, measurement of the exhaust stream

that is required to hold the pressure in the

temporarily sealed respirator constant yields a

direct measure of leakage air flow into the respirator. The CNP fit test method measures

leak rates through the facepiece as a method

for determining the facepiece fit for negative

pressure respirators. The CNP instrument

manufacturer Dynatech Nevada also provides

attachments (sampling manifolds) that replace

the filter cartridges to permit fit testing in an

employee’s own respirator. To perform the

test, the test subject closes his or her mouth

and holds his/her breath, after which an air

pump removes air from the respirator

facepiece at a pre-selected constant pressure.

The facepiece fit is expressed as the leak rate

through the facepiece, expressed as milliliters

per minute. The quality and validity of the

CNP fit tests are determined by the degree to

which the in-mask pressure tracks the test

pressure during the system measurement time

of approximately five seconds. Instantaneous
110

feedback in the form of a real-time pressure

trace of the in-mask pressure is provided and

used to determine test validity and quality. A

minimum fit factor pass level of 100 is necessary for a half-mask respirator and a minimum fit factor of at least 500 is required for a

full facepiece respirator. The entire screening

and testing procedure shall be explained to the

test subject prior to the conduct of the screening

test.

(a) CNP Fit Test Requirements.

(1) The instrument shall have a non-adjustable

test pressure of 15.0 mm water pressure.

(2) The CNP system defaults selected for test

pressure shall be set at — 15 mm of water (-

0.58 inches of water) and the modeled inspiratory flow rate shall be 53.8 liters per minute

for performing fit tests.

(Note: CNP systems have built-in capability to

conduct fit testing that is specific to unique

work rate, mask, and gender situations that

might apply in a specific workplace. Use of

system default values, which were selected to

represent respirator wear with medium cartridge resistance at a low-moderate work rate,

will allow inter- test comparison of the respirator fit.)

(3) The individual who conducts the CNP fit

testing shall be thoroughly trained to perform

the test.

(4) The respirator filter or cartridge needs to be

replaced with the CNP test manifold. The inhalation valve downstream from the manifold either needs to be temporarily removed or

propped open.

(5) The test subject shall be trained to hold his

or her breath for at least 20 seconds.

(6) The test subject shall don the test respirator

without any assistance from the individual

who conducts the CNP fit test.

(7) The QNFT protocol shall be followed according to section I. C. 1. of this appendix with

an exception for the CNP test exercises.

(b) CNP Test Exercises.

(1) Normal breathing. In a normal standing

position, without talking, the subject shall

breathe normally for 1 minute. After the normal breathing exercise, the subject needs to

hold head straight ahead and hold his or her

breath for 10 seconds during the test measurement.

(2) Deep breathing. In a normal standing position, the subject shall breathe slowly and

deeply for 1 minute, being careful not to hyperventilate. After the deep breathing exercise,

the subject shall hold his or her head straight

ahead and hold his or her breath for 10 seconds during test measurement.

(3) Turning head side to side. Standing in

place, the subject shall slowly turn his or

her head from side to side between the extreme positions on each side for 1 minute.

The head shall be held at each extreme momentarily so the subject can inhale at each

side. After the turning head side to side exercise, the subject needs to hold head full

left and hold his or her breath for 10 seconds during test measurement. Next, the

subject needs to hold head full right and

hold his or her breath for 10 seconds during

test measurement.

(4) Moving head up and down. Standing in

place, the subject shall slowly move his or

her head up and down for 1 minute. The

subject shall be instructed to inhale in the

up position (i.e., when looking toward the

ceiling). After the moving head up and

down exercise, the subject shall hold his or

her head full up and hold his or her breath

for 10 seconds during test measurement.

Next, the subject shall hold his or her head

full down and hold his or her breath for 10

seconds during test measurement.
111

(5) Talking. The subject shall talk out loud

slowly and loud enough so as to be heard

clearly by the test conductor. The subject can

read from a prepared text such as the Rainbow Passage, count backward from 100, or recite a memorized poem or song for 1 minute.

After the talking exercise, the subject shall

hold his or her head straight ahead and hold

his or her breath for 10 seconds during the test

measurement.

(6) Grimace. The test subject shall grimace by

smiling or frowning for 15 seconds.

(7) Bending Over. The test subject shall bend

at the waist as if he or she were to touch his or

her toes for 1 minute. Jogging in place shall be

substituted for this exercise in those test environments such as shroud-type QNFT units

that prohibit bending at the waist. After the

bending over exercise, the subject shall hold

his or her head straight ahead and hold his or

her breath for 10 seconds during the test measurement.

(8) Normal Breathing. The test subject shall remove and re-don the respirator within a oneminute period. Then, in a normal standing

position, without talking, the subject shall

breathe normally for 1 minute. After the normal breathing exercise, the subject shall hold

his or her head straight ahead and hold his or

her breath for 10 seconds during the test measurement. After the test exercises, the test subject shall be questioned by the test conductor

regarding the comfort of the respirator upon

completion of the protocol. If it has become unacceptable, another model of a respirator shall

be tried.

(c) CNP Test Instrument.

(1) The test instrument shall have an effective

audio warning device when the test subject

fails to hold his or her breath during the test.

The test shall be terminated whenever the test

subject failed to hold his or her breath. The test

subject may be refitted and retested.

(2) A record of the test shall be kept on file, assuming the fit test was successful. The record

must contain the test subject’s name; overall fit

factor; make, model, style and size of respirator used; and date tested.

Part II. New Fit Test Protocols

A. Any person may submit to OSHA an application for approval of a new fit test protocol. If

the application meets the following criteria,

OSHA will initiate a rulemaking proceeding

under section 6(b)(7) of the OSH Act to determine whether to list the new protocol as an approved protocol in this Appendix A.

B. The application must include a detailed description of the proposed new fit test protocol.

This application must be supported by either:

1. A test report prepared by an independent

government research laboratory (e.g., Lawrence Livermore National Laboratory, Los

Alamos National Laboratory, the National Institute for Standards and Technology) stating

that the laboratory has tested the protocol and

had found it to be accurate and reliable; or

2. An article that has been published in a peerreviewed industrial hygiene journal describing the protocol and explaining how test data

support the protocol’s accuracy and reliability.

C. If OSHA determines that additional information is required before the Agency commences a rulemaking proceeding under this

section, OSHA will so notify the applicant and

afford the applicant the opportunity to submit

the supplemental information. Initiation of a

rulemaking proceeding will be deferred until

OSHA has received and evaluated the supplemental information.
112

 Appendix B-1 to 1910.134 user seal check

procedures

I. Facepiece Positive and/or Negative Pressure

Checks

A. Positive pressure check. Close off the

exhalation valve and exhale gently into the

facepiece. The face fit is considered satisfactory

if a slight positive pressure can be built up

inside the facepiece without any evidence of

outward leakage of air at the seal. For most

respirators this method of leak testing requires

the wearer to first remove the exhalation valve

cover before closing off the exhalation valve

and then carefully replacing it after the test.

B. Negative pressure check. Close off the inlet

opening of the canister or cartridge(s) by

covering with the palm of the hand(s) or by

replacing the filter seal(s), inhale gently so that

the facepiece collapses slightly, and hold the

breath for ten seconds. The design of the inlet

opening of some cartridges cannot be

effectively covered with the palm of the hand.

The test can be performed by covering the inlet

opening of the cartridge with a thin latex or

nitrile glove. If the facepiece remains in its

slightly collapsed condition and no inward

leakage of air is detected, the tightness of the

respirator is considered satisfactory.

II. Manufacturer’s Recommended User Seal Check

Procedures

The respirator manufacturer’s recommended

procedures for performing a user seal check

may be used instead of the positive and/or

negative pressure check procedures provided

that the employer demonstrates that the

manufacturer’s procedures are equally

effective.