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
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
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. |
Disclaimer |
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Foreword |
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Abbreviations |
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Acknowledgments |
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Introduction |
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Respiratory
Protection Program Elements For Health Care Workers Exposed To Tuberculosis |
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Respirator
Program Administration |
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General |
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NIOSH
Recommended Steps for Improving the Knowledge and Skills of the Program
Administrator |
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Duties |
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Step
1 Conduct a TB Risk Assessment |
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Step
2 Select Respirators |
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Respirator
Selection for Protection Against TB |
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Introduction |
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Types of
Respirators for Protection Against TB |
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A. Disposable
Particulate Respirators |
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B. Replaceable
Particulate Respirators |
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C. PAPRs |
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D.
Positive-Pressure Supplied-Air Respirators |
Step
3 Write Standard Operating Procedures |
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Sample
SOP |
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Step
4 Medically Screen All Users |
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Step
5 Provide Training |
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Respirator
Training Program |
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Introduction |
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Who
Should Receive Respirator Training |
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Who
Should Conduct this Training |
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What
Should the Training Include |
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OSHA
Training Requirements Under 29 CFR 1910.139 |
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Tips For
Training |
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Establish
Specific Training Objectives |
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Make the
Objectives Measurable and Observable |
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Make the
Objectives Known to the Trainee |
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Actively
Involve the Trainee in the Training |
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Allow
Time for Adjustment |
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Provide
Feedback |
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Provide
Refresher Training |
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Tips For
Reducing Resistance and Promoting Safety Behaviors |
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Safety
Management |
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Supervisory
Practices |
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Additional
Responsibilities of the Supervisor |
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Environmental
and Organizational Supports |
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Step
6 User Seal Check, Fit-Test, and Issue Respirators |
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Respirator
Face Fitting Procedures |
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Fit-Testing
Procedures |
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User seal
checking Procedures |
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Step
7 Inspect, Clean, Maintain, and Store Respirators |
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Routine
Respirator Inspection |
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Introduction |
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Inspection
Before and After Each Use |
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Inspection
During Cleaning |
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Cleaning,
Repairing, and Storing Respirators Used For Protection Against TB |
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Introduction |
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Cleaning |
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A.
Disassembly |
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B.
Cleaning and Sanitizing |
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C.
Cleaning and Sanitizing Solutions |
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D.
Loose-Fitting PAPRS |
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Repair |
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Storage |
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Sample
SOP |
Step
8 Evaluate the Program |
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Respirator
Program Evaluation |
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Annual
Evaluation |
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Additional
Evaluation |
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References |
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Appendix
A |
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1910.139
Respiratory Protection for M. tuberculosis |
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Appendix
B |
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OSHA
Instruction CPL 2.106 (TB Enforcement) |
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Appendix
C |
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1910.1020
Access to Employee Exposure and Medical Records |
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Appendix
D |
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Names and
Addresses of Respirator Manufacturers and Distributors |
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Appendix
E |
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Respiratory
Protection Checklist |
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Appendix
F |
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CDC
Guidelines (Pages 4-6) |
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Appendix
G |
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Memorandum
for OSHA Regional Administrators |
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Appendix
H |
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Appendix
A to 1910.134: Fit Testing Procedure |
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 |
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
Respiratory Protection
Program Elements For Health Care Workers Exposed To Tuberculosis
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From 1985 to 1992, the
incidence of tuberculosis (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.
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).
* Code of Federal
Regulations. See CFR in references.
** [29 CFR 1910.139] was formerly codified at [29 CFR 1910.134]
This program requires the
following:
NOTE: Each of these
requirements will be addressed in more detail throughout this document.
Respirator Program
Administration
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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.
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N95 Disposable Respirator |
The administrator must be
responsible for the entire program and ensure that the program is written,
reviewed, and implemented. The administrator should:
Remember:
Everything concerning the respirator program must be written.
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:
Obtain the following
additional information:
6. Perform an
observational review of TB infection control practices. 7. Review the most recent
enviromental 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.
Respirator Selection For
Protection Against TB
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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 cough-inducing 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 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 inter
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 µ 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]
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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 half-mask
respirator.
§ See Appendix D for a
list of manufacturers.
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Disposable Particulate Respirator. Photo courtesy of Alpha Pro Tech. |
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|
Disposable Particulate Respirator Photo courtesy of MSA. |
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.
|
Disposable Particulate Respirator
with Photo courtesy of MSA. |
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.
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Half-Mask Replaceable |
|
Photo (left) courtesy of Neoterik |
NOTE: Manufacturer A's
small size is not necessarily the same as Manufacturer B's small size.
Advantages
A. The respirator is lightweight and does not restrict mobility.
B. 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).
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.
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.
|
Full Facepiece Replaceable Photo courtesy of NIOSH. |
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 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.
C. PAPRs
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.
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Tight-Fitting PAPR. Photo courtesy of NIOSH. |
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.
This respirator consists of
a hood or helmet, breathing tube, battery-operated blower, and HEPA filters. It
meets CDC guidelines.
|
Loose-Fitting PAPR. Photo courtesy of Neoterik |
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.
4. The respirator is
durable.
5. Breathing resistance is
lower.
6. Vision may be better.
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.
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.
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.
|
||
Positive-Pressure Supplied-Air
Respirators. Photo courtesy of NIOSH. |
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.
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.
|
Photo courtesy of Racal Health
& Safety, Inc. |
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:
1. |
Administrative
procedures: |
|
A.
Employer responsibilities |
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B.
Employee responsibilities |
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C.
Purchase of certified respirators |
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D.
Inventory control |
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E.
Issuance of respirators |
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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 |
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C. Repair |
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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.
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. |
|
|
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? |
|
____________ |
(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 |
||
____________ |
|
||
____________ |
|
||
____________
|
|
||
____________ |
(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 |
||
____________ |
|
||
____________
|
|
||
____________
|
|
||
____________ |
|
||
____________ |
|
||
|
(6)
Respirator use in the work area |
||
____________ |
|
||
____________
|
|
||
|
(7)
Maintenance of respiratory protective equipment |
||
|
Cleaning
and Disinfecting |
||
____________ |
|
||
____________ |
|
||
|
Storage |
||
____________ |
|
||
____________ |
|
||
____________ |
|
||
|
Inspection |
||
____________ |
|
||
____________ |
|
||
____________ |
|
||
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Repair |
||
____________ |
|
||
____________ |
|
||
|
(8)
Training and Feedback |
||
____________ |
|
||
____________
|
|
||
____________
|
|
||
____________
|
|
1. TYPE________________________________2. NO._______________________
C. DATE:____________________________________________________________
|
|
Medical Evaluation of
Health Care Workers to Determine Fitness to Wear Respirators
|
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:
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.
Respirator Training
Program
|
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.
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 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 respirators). 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, half-mask, 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 tight-fitting 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 pro-gram 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.
The 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.
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 individual 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 face-piece-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. |
Tips For Training
|
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 enhance the effectiveness of the
program. These tips and strategies are discussed in the following subsections.
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.
Objectives 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.
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 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.
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.
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.
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.
Tips For Reducing
Resistance And Promoting Safety Behaviors
|
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. |
7) |
They
produce labored breathing, increased heart 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.
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 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:
|
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.
|
Believe
the illness poses serious consequences to health and well-being |
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 themselves and others. Relate that preventive drug therapy can result in
serious health effects (e.g., liver damage).
|
Believe
that the respirator can control the risk |
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 benefits of respirator use outweigh the barriers |
Wearing a respirator is a
major inconvenience 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.
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:
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.
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:
Respirator Face
Fitting Procedures
|
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 clean-shaven, should not be fit-tested with tight-fitting
respirators because facial hair between the skin and the sealing surfaces of
the respirator will prevent a good seal. Tight-fitting respirators cannot be
assigned to or used by workers with facial hair that interferes with the seal.
|
Saccharin or Bitrex Qualitative
Fit Testing. Photo courtesy of 3M. |
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 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 irritation. A QNFT uses another means of
detecting facepiece leakage and does not require the wearer's subjective
response.
|
Portacount unit. Photo courtesy of 3M. |
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.
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.
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.
|
Negative-pressure user seal check. |
|
Positive-pressure user seal check. Both photos courtesy of NIOSH. |
Routine Respirator Inspection |
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]:
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. |
A. Examine the facepiece of the
disposable 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).
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.
|
Check
straps and buckles. Photo courtesy of
NIOSH |
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, 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.
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.
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.
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
half-masks 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.
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 non-flexibility.
2. Replace defective parts.
3. Thoroughly wash, disinfect, and
reassemble the parts and mask.
Cleaning, Repairing, And
Storing Respirators Used For Protection Against TB
|
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.
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:
A. Disassembly
Respirators cannot simply be immersed in cleaning solutions. Before cleaning
and sanitizing, remove the following parts from the facepiece:
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.
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 sani-tizers (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 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.
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 accomplishing 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:
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 |
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. C. Examine the inhalation
and exhalation valves for cracks, tears, holes, or distortion in the valve
material. 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 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)." |
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 N-95 respirators. |
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 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.
|
Photo
courtesy of NIOSH. |
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 main-tained.
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.
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.
§1910.139*
Respiratory protection for M. tuberculosis.
This section applies only
to respiratory protection against M. tuberculosis and applies in lieu of
§1910.134.
*29 CFR 1910.134 is now
codified for protection against TB at 29 CFR 1910.139.
(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. (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.
(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; orInterim 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.
(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.
|
||||||
|
|
||||||
(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:
Equipment shall be
properly maintained to retain its original effectiveness. (2)
(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
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)
|
||||||
|
|
||||||
(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:
(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
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 |
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 vapors... |
Canister
color for contaminant, as 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. |
CPL 2.106 - Enforcement
Procedures and Scheduling for Occupational Exposure to Tuberculosis.
------------------------------------------------------------------------
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. |
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B. |
Scope. This instruction applies
OSHA-wide. |
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C. |
References. |
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1. |
OSHA
Instruction CPL 2.103, September 26, 1994, Field Inspection Reference Manual
(FIRM). |
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2. |
OSHA
Instruction CPL 2.45B, June 15, 1985, The Revised Field Operations Manual
(FOM). |
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3. |
American
Public Health Association - 1990 or current edition, Control of Communicable
Diseases in Man. |
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4. |
OSHA
Instruction CPL 2-2.20B, CH-3, August 22, 1994. Occupational Safety and
Health Administration Technical Manual Chapter No. 7. |
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5. |
OSHA
Instruction, ADM 1-31, the IMIS Enforcement Data Processing Manual. |
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6. |
OSHA
Instruction ADM 1-32, Enforcement User Skills Manual (for those Area Offices
still using the NCR system). |
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7. |
Centers
for Disease Control and Prevention (CDC), Biosafety in Microbiological and
Biomedical Laboratories, 3rd Edition, or current edition. |
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8. |
Department
of Health and Human Services, Public Health Service, 42 CFR Part 84; Final
Rule. |
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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. |
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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. |
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E. |
Federal
Program Change. This is a federal program change which impacts state programs. |
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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). |
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2. |
The RA
shall explain the content of this change to the state designee as required. |
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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. |
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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. |
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5. |
The RA
shall advise state designees of the following: |
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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. |
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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. |
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|
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. |
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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. |
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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. |
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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 befollowed by employers in carrying out their responsibilities
under the OSH Act. |
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H. |
Inspection
Scheduling and Scope |
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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
|
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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. |
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1. |
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. |
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|
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. |
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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. |
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I. |
Inspection
Procedures. The
procedure given in the FIRM, Chapter II, shall be followed except as modified
in the following sections: |
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|
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. |
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|
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 a hospital, a review of the infection control data. |
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|
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. |
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4. |
CSHOs who
perform smoke-trail visualization tests should review the protocol in
Appendix B of this directive. |
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|
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. |
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J. |
Compliance
Officer Protection |
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|
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. |
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|
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. |
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|
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). |
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|
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. |
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|
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. 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. |
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|
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. |
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K. |
Citation
Policy.
Relevant chapters of the FIRM shall be followed when preparing and issuing
citations for hazards related to TB. |
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|
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 *29 CFR 1910.134 is now
codified for protection against TB at 29 CFR 1910.139. |
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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. |
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|
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." |
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|
|
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. |
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|
|
b. |
Recognition,
for purposes of citing section 5(a)(1), is shown by the CDC Guidelinesfor the
types of exposures detailed below because the CDC is an acknowledged body of
experts familiar with the hazard. |
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|
|
c. |
Citations
shall be issued to employers with employees working in one of the 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: |
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|
|
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]. |
|
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|
|
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). |
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|
3. |
Case
Management of Infected Employees shall include the following: |
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|
|
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). |
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|
b. |
Work
Restrictions for Infectious Employees. See Appendix A, page41. |
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|
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 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) |
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|
5. |
Engineering
Controls.
The use of each control measure must be based on its ability to abate the
hazard. |
|
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|
|
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. |
|
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|
|
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) |
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|
|
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 programto 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. |
|
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|
|
d. |
In order
to avoid leakage, all potentially contaminated air which is 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 |
|
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|
|
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. |
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|
|
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) |
|
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|
g. |
Interim
or supplemental ventilation units equipped with HEPA filters as described in
Appendix A pgs. 70-73 are acceptable. |
|
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|
2. |
Respiratory
Protection - 29 CFR 1910.134 (a) (2) and (b).* "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." *29 CFR 1910.134 is now
codified for protection against TB at 29 CFR 1910.139. |
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a. |
Requirements
for a minimal acceptable program. |
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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:
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3. |
Access to
employee medical and exposure records: 29 CFR 1910.20. |
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a. |
A record
concerning employee exposure to TB is an employee exposure record within the
meaning of 29 CFR 1910.20. |
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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). |
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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. |
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4. |
Accident
prevention signs and tags: 29 CFR 1910.145. |
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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 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. |
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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). |
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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:
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. |
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5. |
OSHA 200 log - 29 CFR 1904: |
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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. |
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b. |
If the
employee's tuberculosis infection which was entered on the OSHA 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. |
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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. |
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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. |
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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:
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2. |
Expert
witnesses may also be necessary in other cases, particularly those involving
29 CFR 1910.134.* |
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*29 CFR 1910.134 is now
codified for protection against TB at 29 CFR 1910.139. |
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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). |
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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:
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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. |
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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. |
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4. |
All IMIS
case file data for TB-related inspections conducted since October 1, 1990,
shall be modified to include the appropriate TB code. |
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O. |
Referrals |
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1. |
When a
complaint or inquiry is received from a source in a state plan regarding
occupational exposure to TB, the Area Office shall refer it to the state plan
designee for action. |
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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. |
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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. |
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Joseph A.
Dear |
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Assistant
Secretary |
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Distribution: |
National,
Regional, and Area Offices |
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. |
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2. |
If there
is an anteroom, release smoke at the inner door undercut, with both anteroom
doors shut. |
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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. |
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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. |
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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. |
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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. |
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7. |
Minimize
momentum imparted to the smoke by squeezing the bulb or bottle slowly. This
will also help minimize the volume of smoke released. |
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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:
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. |
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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). |
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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 thewindow 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 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.
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. |
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(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. |
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(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. (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: |
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|
(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. |
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(6) |
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(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: |
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(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. |
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(ii)
"Employee medical record" does not include medical
information in the form of: |
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(A)
Physical specimens (e.g., blood or urine samples) which are routinely
discarded as apart 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. |
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(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. |
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(12) |
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(i) Specific
written consent means a written authorization containing the following: |
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(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).
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(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: |
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|
(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. |
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(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. |
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(d)
Preservation of records. |
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(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: |
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(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: |
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(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. |
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|
(ii) Employee
exposure records. Each employee exposure record shall be preserved and
maintained for at least thirty (30) years, except that: |
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|
(A)
Background data to environmental (workplace) monitoring or measuring, such as
laboratory 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. 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). |
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(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. |
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(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. |
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(e)
Access to records |
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(1) General. |
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(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. |
||||||
|
|
|
|
||||||
|
|
(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:
(B) Requests by
designated representatives for unconsented access to employee exposure
records shall be in writing and shall specify with reasonable particularity:
|
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|
|
|
|
||||||
|
|
(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:
(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. |
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|
|
|
|
||||||
|
|
(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. |
||||||||
|
|
(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 healthprofessional, employee, or designated representative if: |
||||||||
|
|
(i) The
request is in writing; (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,
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 forcomplying 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
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)
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
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 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).
Names And Addresses Of Respirator
Manufacturers And Distributors |
||||
|
|
|
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 suspected infectious TB
are isolated? |
Y/N/*Sometimes |
2. |
During
cough inducing procedures with known or suspect TB patients? |
Y/N/*Sometimes |
3. |
During
administration of aerosolized medications with known or suspect TB patients? |
Y/N/*Sometimes |
4. |
During
surgical procedures with a known or suspect TB patient? |
Y/N/*Sometimes |
5. |
During
bronchoscopy on a known or suspect TB patient? |
Y/N/*Sometimes |
6. |
During
autopsy of a deceased person suspected or known to have had active TB? |
Y/N/*Sometimes |
7. |
By
visitors of patients with known or suspect TB? Y/N/*Sometimes |
Y/N/*Sometimes |
8. |
On
patients with known or suspect TB while transporting patient within the
hospital? |
Y/N/*Sometimes |
9. |
During
urgent dental treatment on a known or suspect TB patient? |
Y/N/*Sometimes |
10. |
Where
administrative and engineering controls may not provide adequate protection? |
Y/N/*Sometimes |
|
Specify
any such areas:________________________________________________________ |
|
*Clarify all responses
noted as "sometimes" on back of this page; noting the number of the
question with each clarification
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 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) |
Y / N |
|
|
|
3. |
Does the
respirator have the ability to be qualitatively or quantitatively fit 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) |
Y / N |
|
|
|
4. |
Does the
respirator have the ability to fit different facial sizes and characteristics
of HCWs (i.e., is it available in at least three sizes)? (If "yes"
attach any documentation attesting to this) |
Y / N |
|
|
|
5. |
Does the
respirator have 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 respirator? (If "yes"
attach any documentation attesting to this) |
Y / N |
|
|
|
6. |
Are
different levels of respiratory protection (such as powered air purifying or
positive pressure (If "yes"
clarify what respirators are used for high-risk procedures) |
Y / N |
|
|
|
7. |
Are the
respirators selected appropriate for procedures requiring a sterile field? (if
respirators have exhalation valves or are positive pressure they do not
protect the sterile field) |
Y / N |
Respiratory Protection Checklist
III. FIT TESTING OF
RESPIRATORY PROTECTION DEVICES
|
|
All / *Some / *None |
||
|
|
All / *Some / *None |
||
|
|
All / *Some / *None |
||
|
|
All / *Some / *None |
||
|
|
All / *Some / *None |
IV. STORAGE, REUSE
AND DISPOSAL
|
|
All / *Some / *None |
||
|
|
Y / N |
||
|
|
Y / N |
||
|
|
Y / N |
||
|
|
Y / N |
||
|
|
Y / N |
||
|
|
Y / N |
V. RESPIRATORY
PROGRAM
|
* Clarify
"some" and "none" responses by number on the back of this
page. |
Y / N |
||||||
|
Respiratory
Protection Checklist |
|
||||||
|
|
|
||||||
2. |
Who is
responsible for the respiratory protection program? Who is responsible for
the respiratory protection program?
|
|
||||||
|
|
|
||||||
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
|
|
Y / N |
||
|
|
Y / N |
||
|
|
Y / N |
||
|
|
Y / N |
||
|
|
Y / N |
VII. TRAINING
|
|
|
||
|
|
Y / N |
||
|
|
Y / N |
||
|
|
Y / N |
||
|
|
Y / N |
||
|
|
Y / N |
||
|
|
Y / N |
||
|
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Y / N |
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Y / N |
||
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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
MEDICAL QUESTIONNAIRE FOR RESPIRATOR USERS
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: |
|
|
|
Yes No |
|
|
Yes No |
|
|
Yes No |
|
|
Yes No |
|
|
Yes No |
|
|
Yes No |
|
|
Yes No |
|
|
Yes No |
|
|
Yes No |
|
|
Yes No |
|
|
Yes No |
|
|
Yes No |
|
|
Yes No |
|
|
Yes No |
|
|
Yes No |
|
|
Yes No |
|
|
Yes No |
|
Please
explain YES answers (use back of form if
necessary)_________________________________________ |
||
Are you
currently taking any medications? |
Yes No |
|
If YES,
please
list:________________________________________________________________________ |
||
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?_________________________________________ |
||
|
|
____________________ |
____________________ |
REQUEST FOR MEDICAL CLEARANCE FOR RESPIRATOR
USE
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 respirtor(s)_____________
The restrictions for
respirator use by this employee are:______________________________
Examining Physician _________________________________
Date___________________
Section
B of Introduction to CDC Guidelines Pages 4-6 |
B. 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 African-Americans, 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
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 general 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.
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). |
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 multidrug-resistant 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. |
MEMORANDUM
FOR: |
REGIONAL
ADMINISTRATORS |
FROM: |
JOHN B.
MILES, JR., DIRECTOR |
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.
* CFR 1910.134 is now
codified for protection against TB as 29 CFR 1910.139.
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.]
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."
* CFR 1910.134 is now
codified for protection against TB as 29 CFR 1910.139.
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 Bitrex™ 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 Bitrex™ (denatonium benzoate). This test and the
testing protocols are described in:
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 Bitrex™ 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.
* CFR 1910.134 is now
codified for protection against TB as 29 CFR 1910.139.
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):*
* CFR 1910.134 is now
codified for protection against TB as 29 CFR 1910.139.
"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 saccharin-aerosol 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.
* CFR 1910.134 is now
codified for protection against TB as 29 CFR 1910.139.
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).
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 |
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 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 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)
(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 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.
(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 self-sealing 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.
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. Bitrex™
(Denatonium Benzoate) Solution Aerosol Qualitative Fit Test Protocol
The Bitrex™
(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
Centers. 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 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 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 respirator; 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 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 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 + 1/ff4 +
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 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 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.
(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 one-minute 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., Law-rence 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 peer-reviewed 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.
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.
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