[Federal Register: May 6, 2010 (Volume 75, Number 87)][Proposed Rules] [Page 24835-24844]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
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DEPARTMENT OF LABOR
Occupational Safety and Health Administration
29 CFR Part 1910
[Docket No. OSHA-2010-0003]
RIN No. 1218-AC46
Infectious Diseases
AGENCY: Occupational Safety and Health Administration (OSHA),
Department of Labor.
ACTION: Request for information.
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SUMMARY: OSHA requests information and comment on occupational exposure
to infectious agents in settings where healthcare is provided, (e.g.,
hospitals, outpatient clinics, clinics in schools and correctional
facilities), and healthcare-related settings (e.g., laboratories that
handle potentially infectious biological materials, medical examiner
offices and mortuaries). OSHA is interested in strategies that are
being used in such healthcare and other healthcare-related work
settings to mitigate the risk of occupationally-acquired infectious
diseases. As such, OSHA would like to collect information and data on
the facilities and the tasks potentially exposing workers to this risk;
successful employee infection control programs; control methodologies
being utilized (including engineering, work practice, and
administrative controls and personal protective equipment); medical
surveillance programs; and training. OSHA will use the information
received in response to this request to determine what action, if any,
the Agency may take to further limit the spread of occupationally-
acquired infectious diseases in these types of settings.
DATES: Comments must be submitted by the following date:
Hard copy: Your comments must be submitted (postmarked or sent) by
August 4, 2010.
Facsimile and electronic transmission: Your comments must be sent
by August 4, 2010.
ADDRESSES: You may submit comments and additional materials by any of
the following methods:
Electronically: You may submit comments and attachments
electronically at http://www.regulations.gov, which is the Federal
eRulemaking Portal. Follow the instructions online for making
electronic submissions:
Fax: If your submissions, including attachments, are not longer
than 10 pages, you may fax them to the OSHA Docket Office at (202) 693-
1648; or
Mail, hand delivery, express mail, messenger or courier service:
You must submit three copies of your comments and attachments to the
OSHA Docket Office, Docket No. OSHA-2010-0003, U.S. Department of
Labor, Room N-2625, 200 Constitution Avenue, NW., Washington, DC 20210.
Deliveries (hand, express mail, messenger and courier service) are
accepted during the Department of Labor's and Docket Office's normal
business hours, 8:15 a.m.-4:45 p.m., EST.
Instructions: All submissions must include the Agency name and the
OSHA docket number for this rulemaking (OSHA Docket No. OSHA-2010-
0003). Submissions, including any personal information you provide, are
placed in the public docket without change and may be made available
online at http://www.regulations.gov.
Docket: To read or download submissions or other material in the
docket, go to http://www.regulations.gov or the OSHA Docket Office at
the address above. All documents in the docket are listed
in the http://www.regulations.gov index, however, some information
(e.g., copyrighted material) is not publicly available
to read or download through the Web site. All submissions, including
copyrighted material, are available for inspection at the OSHA Docket
Office.
FOR FURTHER INFORMATION CONTACT:
Press Inquiries: Jennifer Ashley, Director, OSHA Office of
Communications, Room N-3647, U.S. Department of Labor, 200 Constitution
Avenue, NW., Washington, DC 20210; telephone: (202) 693-1999.
General and Technical Information: Andrew Levinson, Director,
Office of Biological Hazards, OSHA Directorate of Standards and
Guidance, Room N-3718, U.S. Department of Labor, 200 Constitution
Avenue, NW., Washington, DC, 20210; telephone: (202) 693-2048.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Background
A. Introduction
B. History of Occupational Safety and Health Regulations
Addressing Protection of Workers From Infectious Diseases
C. Summary
II. Request for Data, Information and Comments
A. General
B. Infection Prevention and Control Plan
C. Methods of Control
D. Vaccination and Post-Exposure Prophylaxis
E. Communication of Hazards
F. Recordkeeping
G. Economic Impacts and Benefits
H. Impacts on Small Entities
III. Public Participation
I. Background
A. Introduction
In 2007, the healthcare and social assistance sector as a whole had
16.5 million employees.\1\ Healthcare workplaces can range from small
private practices of physicians to hospitals that employ thousands of
workers. In addition, healthcare is increasingly being provided in
other settings such as nursing homes, free-standing surgical and
outpatient centers, emergency care clinics, patients' homes, and pre-
hospitalization emergency care settings. Over the last 10 years, the
number of healthcare workers (HCWs) (defined as healthcare
professionals, technicians, and healthcare support workers, including
those not directly providing patient care such as maintenance or
laundry workers) has increased from 8.4 million in 1998, to
approximately 11 million in 2008. In 1998, of the 8.4 million HCWs, 3.0
million were employed in hospitals and 5.4 million were employed
outside of hospitals. In 2008, 3.6 million HCWs were employed in
hospitals and 7.3 million outside of hospitals. Of the 7.3 million
workers employed outside of hospitals, 2.1 million were employed by
establishments not defined as part of the healthcare sector.\2\ The
increasing number of HCWs outside of hospital settings who are exposed
to occupational injuries and illnesses likely has implications for risk
management.
Depending on the setting and the job tasks, HCWs may be exposed to
a number of occupational hazards including: Exposure to infectious
agents, radiation and chemicals. The Bureau of Labor Statistics (BLS)
reports that for 2008, the incidence of all occupational injury and
illness (including musculo-skeletal disorders from slips and falls and
lifting patients and equipment) in the healthcare sector as a whole was
5.6 cases per 100 full-time workers, in contrast to an average of 4.2
cases per 100 full-time workers for private industry overall.\3\ Higher
rates have been documented in hospitals, with an incidence rate for all
injuries and illnesses of 7.6 per 100 full-time workers, and nursing
homes, with an incidence rate for all injuries and illnesses of 8.4 per
100 full-time workers.
In addition to settings where healthcare is provided, there are
other work settings where workers might be at increased risk for
occupational exposure to infectious agents. Occupational exposure to
infectious agents may occur in settings where healthcare is provided
(e.g., hospitals, clinics, some emergency response settings; clinics in
schools or correctional facilities); and healthcare-related settings
where there is increased potential for exposure to infectious agents
due to the populations being served or the materials being handled
(e.g., drug treatment programs; laboratories that handle potentially
infectious biological materials; medical examiners' and coroners'
offices; and mortuaries). The purpose of this Request for Information
(RFI) is to gather additional information on occupational exposure to
infectious agents, how occupational exposure is being mitigated, and
other types of work settings where there may be an increased risk of
exposure. It should be noted that bloodborne pathogens (e.g., HIV,
hepatitis B), are already covered by OSHA's Bloodborne Pathogens
standard (Sec. 1910.1030) and are not included in this RFI.
The primary routes of infectious disease transmission in US
healthcare settings are contact, droplet, and airborne. Contact
transmission can be sub-divided into direct and indirect contact.\4\
Direct contact transmission involves physical contact between an
infected person and another person, and the physical transfer of
microorganisms (e.g., direct skin-to-skin contact). Indirect contact
transmission occurs in situations where the physical transfer of
microorganisms to a person comes from contact with a contaminated
surface (e.g., contaminated environmental surfaces, such as a door
knob, inadequately cleaned patient-care instruments or equipment, such
as an examination table or patient bed).
Droplets containing microorganisms are generated when an infected
person coughs, sneezes, or talks, or during certain medical procedures,
such as suctioning or endotracheal intubation. Transmission occurs when
droplets generated in this way come into direct contact with the
mucosal surfaces of the eyes, nose, or mouth of a susceptible
individual.\5\ Droplets are too large to be airborne for long periods
of time, and droplet transmission does not occur through the air over
long distances. However, some of the droplets expelled by the infected
patient will desiccate (dry out) very quickly (less than 1-2 seconds)
and form what are called droplet nuclei (residue from evaporated
droplets). These small particles can remain suspended in air for long
periods of time and travel significantly longer distances.
Airborne transmission occurs when infectious droplet nuclei or
particles containing infectious agents that remain suspended in air,
are inhaled, enter the respiratory tract and cause infection.\6\ Since
air currents can disperse these droplet nuclei or particles over long
distances, airborne transmission does not require face-to-face contact
with an infected individual. Airborne transmission only applies to
those organisms that are capable of surviving and retaining infectivity
for relatively long periods of time in airborne droplet nuclei or
particles. Only a limited number of diseases are transmissible via the
airborne route.
The major goal of infection control (IC) is to prevent transmission
of infectious diseases to patients and HCWs. This fundamental approach
is set forth in the guidelines of the Department of Health and Human
Services (HHS) Centers for Disease Control and Prevention's (CDC)
Healthcare Infection Control Practices Advisory Committee (HICPAC), a
Federal advisory committee to CDC on the practice of health care
infection control in U.S. healthcare facilities. The HICPAC guidelines
include:
Identification and isolation of infectious cases; immunizations for
vaccine-preventable diseases; standard and transmission-based
precautions; training; personal protective equipment (PPE); management
of HCWs' risk of exposure to infected persons, including post-exposure
prophylaxis; and work restrictions for exposed or infected healthcare
personnel.\7\
These recommendations have been endorsed by professional
associations such as the Association for Professionals in Infection
Control and Epidemiology (APIC),\8\ the Society for Healthcare
Epidemiology of America (SHEA),\9\ and the Association of periOperative
Registered Nurses (AORN).\10\ OSHA is soliciting comment through this
RFI on any other strategies that might be applied within healthcare or
healthcare-related work settings to mitigate the risk of occupationally
transmitted infectious diseases.
While the CDC/HICPAC guidelines present the recommended practices
for reducing the risk of infectious disease transmission to patients
and HCWs, the guidelines are non-mandatory. However, Centers for
Medicare and Medicaid Services (CMS) mandates that in order for
hospitals and other providers to receive certification and
reimbursement through Medicare or Medicaid, the "facility must
establish and maintain an Infection Control Program designed to provide
a safe, sanitary and comfortable environment and to help prevent the
development and transmission of disease and infection." \11\
Similarly, the Joint Commission (formerly called the Joint Commission
on Accreditation of Healthcare Organizations), a private not-for-profit
organization that evaluates and accredits more than 17,000 healthcare
organizations and programs in the United States, requires an effective
Infection Prevention and Control Plan for accreditation.\12\
CDC/HICPAC has stated that "adherence to recommended infection
control practices decreases transmission of infectious agents in
healthcare settings." \13\ While the infection control guidelines and
requirements are widely recognized, day-to-day compliance, surveillance
and oversight is left to each individual employer. Due to the continued
prevalence of healthcare-associated infections (HAIs), particularly
among patients,\14\ and the emergence of new infectious diseases that
affect both patients and HCWs [e.g., severe acute respiratory syndrome
(SARS), 2009 H1N1 pandemic influenza], compliance with routine
infection control procedures is an increasingly important issue.
The lack of adherence to voluntary infection control procedures is
of particular interest to OSHA. CDC/HICPAC states that "several
observational studies have shown limited adherence to recommended
practices by healthcare personnel." \15\ It should be noted that these
were small case studies which were not designed to be representative of
healthcare settings in general. CDC/HICPAC has also noted that HCWs
generally reported greater self-adherence to infection control
practices than was actually reported in observational studies. Observed
adherence to universal precautions (now part of standard precautions)
ranged from 43% to 89%, with even greater variability reported for
certain recommended infection control practices (e.g., glove use).\16\
The World Health Organization (WHO) recognized the lack of
compliance with hand hygiene and launched the First Global Patient
Safety Challenge to achieve improvement in hand hygiene worldwide. In
2009, WHO issued hand hygiene guidelines that were based upon a
thorough review of hundreds of manuscripts that dealt with the negative
impact of non-compliance with hand hygiene on the transmission of
infectious diseases in healthcare settings.\17\ A second review that
examined the results of 20 hospital-based studies published between
1977 and 2008, concluded that despite study limitations, most studies
showed a temporal relation between improved hand hygiene practices and
reduced infection and cross-contamination rates.\18\
A study of adherence to CDC recommended respiratory infection
control practices examined 653 healthcare workers in primary care
clinics and emergency departments of five medical centers and found
significant gaps in compliance. There were shortcomings in overall
personal and institutional use of CDC recommended practices, including
deficiencies in posted alerts, patient masking and separation, hand
hygiene, PPE use, staff training, and written procedures.\19\ Another
study, published in 2009, surveyed nurses and doctors from five medical
facilities and documented the lack of compliance with both hand hygiene
and respiratory protection guidelines. Although not necessarily
representative of, or generalizable to, the healthcare industry, it is
of interest that of those doctors that responded to the survey, only 8%
of 177 reported using recommended respiratory protection and only 33%
of 156 reported practicing recommended hand hygiene. In addition, of
those nurses that responded to the survey, only 25% of 249 reported
practicing appropriate respiratory precautions and only 43% of 266
reported practicing recommended hand hygiene measures.\20\
In another recent study 292 HCWs were surveyed about their use of
PPE for protection against influenza. These HCWs consisted of internal
medicine house-staff, pulmonary/critical care fellows, faculty,
respiratory therapists and nurses working in four ICU's in two large
hospitals. The study found that only 63% of the HCWs surveyed were able
to correctly identify appropriate PPE for influenza. The study's
authors stated that of the respondents "nearly 40% of HCWs reported
poor adherence with influenza PPE, and 53% reported that their
colleagues often forget to use appropriate PPE." \21\ The CDC
initiated a similar investigation of possible occupationally-acquired
2009 H1N1 pandemic influenza, which was published in the April-May 2009
MMWR. In response to a solicitation from CDC, State health departments
reported 48 cases of confirmed or probable cases of H1N1 infection in
HCWs. Of the 48 cases, information on PPE use was available for 11 of
the HCWs who were deemed to have probable or possible acquisition from
a patient. Of these 11 HCWs who were infected, only 3 reported always
using either a surgical mask or an N95 respirator when appropriate and
none reported always following standard precautions (e.g., use of
gloves, gown, facemask) and airborne precautions (e.g., use of a
respirator).\22\
In its revised 2007 guidelines, CDC/HICPAC noted that "a recent
review of the literature concluded that variations in organizational
factors (e.g., safety culture, policies and procedures, education and
training) and individual factors (e.g., knowledge, perceptions of risk,
past experience) were determinants of adherence to infection control
guidelines for protection against SARS and other respiratory
pathogens." \23\
Several studies have found organizational factors to be the most
significant predictor of safe work behaviors. A study by Gershon et al.
of 1716 hospital-based HCWs, at three regional hospitals, found that
those who perceived that their institution had a strong commitment to
safety were almost three times more likely to be compliant with
standard precautions than those who did not.\24\ Similar results were
found when a group of 350 HCWs from 28 State correctional facilities
were surveyed.\25\ In addition, a series of studies demonstrated that
interventions targeted at improving organizational support for worker
safety and health, resulted in enhanced compliance with standard
precautions. These studies were: a survey of 789 hospital-based HCWs
at a large regional research medical enter; a survey of 452 nurses
c employed at one large medical center; a review of behavioral
interventions to improve infection control practices;
a survey of 1135 HCWs at one large teaching hospital; and
finally, a survey of 742 nurses at a 900-bed urban teaching
hospital.26 27 28 29 30 A study by Nichol et al sent 400
surveys to nurses in nine nursing units from two urban hospitals. Of
these surveys, 177 were returned with responses. The study found that
nurses used recommended facial protection (e.g., respirators, surgical
masks, and eye/face protection) when they felt that management made
health and safety a high priority, took all reasonable steps to
minimize hazards, encouraged employees' involvement in health and
safety issues, and actively worked to protect employees.\31\ Other
studies in industrial settings have shown that safety culture has an
important influence on implementation of training skills and
knowledge.32 33
The lack of compliance with recommended infection control practices
is also noted by the Institute of Medicine (IOM), a Congressionally-
chartered independent, nonprofit organization that provides unbiased
and authoritative advice to decision makers and the public. In 2009,
the IOM issued a report entitled, Respiratory protection for healthcare
workers in the workplace against novel H1N1 influenza A: A letter
report. The report was requested by both CDC and OSHA, and concluded
that:
* * * although workers are aware of expert guidance and the risk
they face, they often do not wear PPE when faced with conditions
requiring its use. Such noncompliance is also seen in low rates of
hand hygiene and use of gloves, respirators, and eye protection. To
improve the compliance rates and thereby improve worker protection,
a "culture of safety" for workers must be established in all
healthcare organizations evidenced by senior leadership
commitment." \34\
The relationship between safety culture and compliance with
recommended infection control guidance in some portions of the
healthcare sector is not a newly recognized issue. A 1999 IOM report on
medical errors in the healthcare sector emphasized the pivotal role of
system failures and the benefits of a strong safety culture in the
prevention of such errors. The report notes that a safety culture is
created through: (1) The actions management takes to improve both
patient and worker safety; (2) worker participation in safety planning;
(3) the availability of appropriate protective equipment; (4) the
influence of group norms regarding acceptable safety practices; and (5)
the organization's socialization process for new personnel.\35\
Similarly, CDC/HICPAC has noted that "several hospital-based studies
have linked measures of safety culture with both employee adherence to
safe practices and reduced exposures to blood and body fluids." \36\
This evidence was cited by CDC/HICPAC as one of the primary reasons for
updating its guidance in 2007.\37\ CDC/HICPAC noted that organizational
characteristics, including safety culture, influence healthcare
personnel adherence to recommended infection control practices and,
therefore, are important factors in preventing transmission of
infectious agents. CDC/HICPAC further emphasized the need for
administrative involvement in the development and support of IC
programs.
Noncompliance with recommended infection control practices (e.g.,
hand hygiene, and proper use of gloves, facemasks, and respirators)
increases the risk of transmission of infectious diseases among
patients and workers.19 31 38 HHS notes that HAIs are among
the leading causes of death in the United States, accounting for an
estimated 1.7 million infections and 99,000 associated deaths in
2002.\39\ The 2007 CDC/HICPAC guidelines note that infectious agents
are also transmitted from HCWs to patients.\40\
More specifically, poor infection control practices have been
implicated in both acquisition and transmission of methicillin-
resistant Staphylococcus aureus (MRSA) by healthcare personnel.\41\
Other studies have documented the nosocomial (hospital-acquired)
transmission of adenovirus from patients to HCWs 42 43;
invasive Group A Strep (GAS) from a patient to an HCW \44\; Clostridium
difficile infection from a patient to a nurse in an oncology ward \45\;
and a norovirus outbreak in HCWs in a hospital.\46\ Additionally, CDC/
HICPAC has documented the occupational transmission of influenza in
hospitals and nursing homes.\47\ OSHA previously documented
occupational exposure to tuberculosis (TB) in its notice "Occupational
Exposure to Tuberculosis; Proposed Rule" (62 FR 54160-54308; October
17, 1997). Additionally, an investigation of the 2003 SARS outbreak in
Toronto, Canada, described the nosocomial transmission of SARS at a
hospital. The investigation found that 42.5% of the cases occurred
among hospital employees.\48\
Although HCW infections have been documented, published data on the
prevalence of these infections is limited. Recently, the National
Institute for Occupational Safety and Health (NIOSH) noted that a lack
of occupational data in existing healthcare surveillance systems made
tracking illnesses among HCWs difficult.\49\ The healthcare sector puts
forth substantial effort to track patient infections, but does not
appear to match that effort with a systematic means for tracking
occupationally acquired worker infections. A weak culture of worker
safety in this sector may be a contributing factor to this issue.
B. History of Occupational Safety and Health Regulations Addressing
Protection of Workers From Infectious Diseases
OSHA's past efforts to protect workers against occupationally
acquired infectious diseases include the Bloodborne Pathogens standard
(Sec. 1910.1030), promulgated in 1991. That standard requires a
comprehensive programmatic approach to controlling transmission of
bloodborne diseases. Following its promulgation, the incidence of
Hepatitis B in HCWs dropped from more than 100 cases per 100,000 HCWs
in 1991 to only 9.1 cases per 100,000 HCWs in 1995.\50\ The standard
was revised in 2001 in response to the Needlestick Safety and
Prevention Act, Pub. L. 106-430. In general, the revisions require
employers to evaluate and use safer medical devices (e.g., needleless
devices, sharps with engineered sharps injury protections), and to
establish and maintain a sharps injury log for recording percutaneous
injuries from contaminated sharps.
As a result of a marked increase in tuberculosis (TB) during the
early 1990s, which included worker infections, OSHA initiated action to
address occupational exposure to TB. A standard was proposed, but was
later withdrawn. In part, the proposal was withdrawn because of
healthcare facilities' increased adherence to CDC's TB guidelines and
the subsequent decline in TB infection rates.\51\ To assure continued
protection of workers, OSHA addresses occupational exposure to TB
through its TB compliance directive.\52\ The directive utilizes the CDC
guidelines as the recognized means for controlling TB exposure. When
OSHA determines that a TB hazard exists in a facility, exposure control
deficiencies may be cited under existing OSHA standards [e.g., the
Respiratory Protection standard (Sec. 1910.134)] and the General Duty Clause
[Section 5(a)(1) of the Occupational Safety and Health Act of 1970,
Pub. L. 91-596 (OSH Act)]. The General Duty Clause requires employers
to "* * * 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."
California-OSHA (Cal-OSHA) recently promulgated an Aerosol
Transmissible Diseases (ATD) Standard \53\ to protect workers from
exposure to infectious agents transmitted via the droplet or airborne
routes. Following Federal OSHA's withdrawal of the TB proposal, Cal-
OSHA developed its standard in response to concerns about TB, the 2003
SARS epidemic, and a potential influenza pandemic. The standard
significantly expands protection of California workers against aerosol
transmissible diseases (this term, as defined by Cal-OSHA, encompasses
those diseases that can be transmitted by the droplet or airborne
routes). It should be noted that the standard does not deal with
occupational exposure to infectious agents that are transmitted
primarily via the contact route (e.g., MRSA, Group A strep, and
noroviruses).
Existing OSHA standards that may be applicable to controlling
occupational exposure to infectious agents, other than the bloodborne
pathogens standard, include: The Respiratory Protection standard (Sec.
1910.134); the Personal Protective Equipment standard (Sec. 1910.132);
and the Specifications for Accident Prevention Signs and Tags standard
(Sec. 1910.145). OSHA is seeking information through this RFI on
whether or not its existing standards and the voluntary guidelines
issued by other organizations are effectively protecting workers from
occupational exposure to infectious agents. If not, OSHA seeks comment
on what measures might be appropriate for the Agency to take to protect
workers against infectious diseases (e.g., development of a proposed
standard, issuance of guidelines, or other alternatives).
C. Summary
In summary, as a result of several factors raised in the preceding
discussion, OSHA is seeking additional information to more fully
evaluate worker exposures to infectious agents in healthcare and
healthcare-related settings. We are particularly interested in
additional data regarding indications in some studies that transmission
of infectious diseases to both patients and HCWs may be occurring as a
result of incomplete adherence to voluntary infection control measures
in traditional healthcare facilities. Another concern is the movement
of healthcare delivery from the traditional hospital setting, with its
greater infrastructure and resources to effectively implement infection
control measures, into more diverse and smaller workplace settings with
less infrastructure and fewer resources, but with an expanding worker
population.
Consequently, the Agency is seeking information to assist in its
deliberation on these issues. OSHA is interested in more accurately
characterizing the nature and extent of occupationally-acquired
infectious diseases and the strategies that are currently being used to
mitigate the risk of occupational exposure to infectious agents in
healthcare and healthcare-related settings, including patient and non-
patient settings and sites where healthcare is embedded within non-
healthcare settings such as clinics in schools and correctional
facilities. The information being sought includes: the types of
facilities and workers incurring this risk; successful employer
infection control programs; control methodologies being utilized
(including engineering, administrative, and work practice controls, and
the use of appropriate personal protective equipment); medical
surveillance programs; and training programs. The information received
in response to this notice will be carefully reviewed and will assist
OSHA in determining the effectiveness of approaches currently being
used to eliminate and minimize occupational exposure to infectious
agents. Based upon its analysis of this information, OSHA will
determine what action, if any, the Agency may take to address these
issues.
II. Request for Data, Information and Comments
A. General
The following general information will assist OSHA in more fully
understanding each commenter's submissions and the possible differences
in their approaches to infection control. The answers to the questions
will also help OSHA understand the risk of workers contracting various
infectious diseases in different types of workplaces.
Note: Diseases spread through bloodborne pathogens are not
encompassed by this RFI since a specific OSHA standard (Bloodborne
Pathogens, Sec. 1910.1030) addresses those diseases. OSHA
encourages those with experience in non-traditional or non-
healthcare work settings to respond to these questions.
1. Since healthcare is provided in a wide variety of settings (as
previously described), OSHA is interested in being able to sort the
responses received by the characteristics of the workplace about which
each responding entity is providing information. As such, please
describe the characteristics of the workplace to which you are
referring. For example: type of workplace (e.g., hospital, long-term
care, physician/dentist office, emergency medical services); size
(e.g., number of hospital beds, number of residents, average number of
patients/clients); total number of employees (both direct care and
administrative support).
2. While OSHA is primarily concerned about worker exposure to
infectious agents in traditional healthcare settings, the Agency
recognizes that there are other settings where healthcare may be
provided and where occupational exposure to infectious agents may be a
significant concern (e.g., drug treatment facilities, home health
services, prison clinics, school clinics, and laboratories that handle
potentially infectious biological materials). Please describe any other
work settings with an increased risk for occupational exposure to
infectious agents that OSHA should consider, including why they should
be considered. Please describe the nature and extent to which
occupational exposure to infectious agents is a significant concern.
For example, to which infectious agents are workers in these settings
exposed and how often are they exposed? Please describe any infection
control measures that can be or are being used in these settings.
3. One of the most important steps in determining how to
effectively protect workers from infectious diseases is identifying who
is at risk of exposure. What recommendations do you have for how to
determine which employees are potentially exposed to contact, droplet,
and airborne transmissible diseases in the type of workplace about
which you are responding? How many of your total workers have a risk of
exposure to such diseases during the performance of their job duties?
What proportion of your workforce does this represent? What are the job
titles or classification(s) of these workers? What are the job duties
of these workers? To which diseases are they exposed?
4. Workplaces vary in the types of infectious diseases and the
number of infected individuals encountered. OSHA is interested in the
types of diseases that your workplace encounters and how often they are
encountered. Please describe your workplace's experience with
infectious diseases over the past ten years (e.g., which diseases, how often).
5. OSHA is interested in data and information that will further
assist in characterizing workers' occupational exposure to contact,
droplet, and airborne transmissible infectious diseases.
(a) OSHA encourages the submission of your workplace or your
industry's experience with these diseases and the impact of infectious
diseases on your workers (e.g., type and number of exposure incidents,
occupationally-acquired infectious diseases, days of work missed, and
fatalities).
(b) Please provide information about any database that collects and
aggregates data on occupationally-acquired infectious diseases (e.g.,
Federal, State, provider network, or academic).
(c) Please provide any additional information, including peer-
reviewed studies, which addresses occupational exposure to infectious
agents that you think OSHA should consider.
6. Infection control (IC) programs are currently the primary means
of controlling occupational exposure to infectious agents. However,
these programs are largely voluntary. OSHA is particularly interested
in case studies that highlight experience in the implementation and
effectiveness of IC programs in protecting workers against infectious
diseases (e.g., the extent to which employers are fully implementing
and consistently following their written IC programs). For example, has
your workplace had instances where a significant increase in infections
(among either patients or workers) required more rigorous
implementation of your IC program? If so, please describe any factors
that contributed to the increase and what steps your workplace took to
address the situation. Please provide any studies that demonstrate the
difference in infection rates between situations where the IC program
had lapsed and situations where rigorous implementation of control
measures was instituted.
7. While OSHA has a Bloodborne Pathogens standard (Sec.
1910.1030), the Agency does not have a comprehensive standard that
addresses occupational exposure to contact, droplet, and airborne
transmissible diseases. The Agency has other standards [(e.g.,
Respiratory Protection (Sec. 1910.134) and General Personal Protective
Equipment (Sec. 1910.132)] that may apply and, in some situations,
Section 5(a)(1) of the OSH Act (the General Duty Clause) would apply.
OSHA is interested in commenters' insights regarding the adequacy of
existing OSHA requirements to protect workers against occupational
exposure to infectious agents.
8. California OSHA recently issued a standard for occupational
exposure to "Aerosol" Transmissible Diseases that covers infectious
diseases transmitted through the airborne and droplet routes. IC
programs that are established in most healthcare settings address
exposure to contact, droplet, and airborne transmissible diseases.
Please explain whether the Agency's deliberations on occupational
exposure to infectious diseases should focus on only droplet and
airborne transmission or if contact transmissible diseases should also
be included.
9. If the Agency pursues rulemaking and promulgates a standard,
jurisdictions with OSHA-approved State plans will be required to cover
workers who OSHA determines are at occupational risk for exposure to
infectious agents, including public employees. State and local
governments are defined very broadly, and would typically include such
entities as a university hospital associated with a State university as
well as public hospitals and health clinics. What public sector
healthcare or healthcare-related workers are at increased risk for
occupational exposure to infectious agents? Please describe conditions
unique to any of these occupations that are not seen in the private
sector. Please describe any other issues specific to OSHA-approved
State plans that the Agency should consider.
B. Infection Prevention and Control Plan
10. CDC/HICPAC's 2007 Guideline for Isolation Precautions:
Preventing Transmission of Infectious Agents in Healthcare Settings
recommends an IC program for addressing the transmission of airborne
and other infectious diseases. In certain settings, the Center for
Medicare and Medicaid Services (CMS) and the Joint Commission require
that healthcare facilities have such programs.
(a) If you are subject to the CMS or Joint Commission requirements
or otherwise have an IC program, please provide information on the
elements of this program (e.g., early identification of infectious
patients, implementation of transmission-based control measures, HCW
training) and how the program works.
(b) If you are not subject to these requirements and do not have an
IC program, how does your workplace address preventing contact, droplet
and airborne transmissible infectious diseases?
11. In most cases, an IC program is managed by an infection control
preventionist or other designated person. For example, the CDC/HICPAC
guidelines recommend that the IC program be managed by individuals with
training in infection control. Who manages your program? What
percentage of this individual's time is spent managing the IC program?
12. For the IC program(s) established in your workplace, please
describe, in detail, the resource requirements and associated costs, if
available, expended to initiate the program(s) and conduct the
program(s) annually. Please estimate, in percentage terms where
possible, the extent to which the components or elements in your
program(s) are typical of those practiced throughout your industry.
13. In your industry, for the IC programs established in your
workplace or for IC programs in other workplaces of which you are
aware, are there any components or features that may present economic
difficulties to small businesses? Please describe and characterize in
detail these components and why they might present difficulties for
small businesses.
14. Periodic evaluation of IC program effectiveness is recommended
by CDC/HICPAC and required by the Joint Commission and CMS for most
types of facilities under their jurisdiction. Please describe how your
workplace or industry evaluates the effectiveness of its IC program,
including the methods and criteria used. How often does your workplace
evaluate its program? Please describe the results your program has
achieved (e.g., if there has been a decrease in patient and/or worker
infections). Please describe any specific problems and/or successes
that have been encountered in the implementation and operation of the
program.
15. Most peer-reviewed literature evaluating IC programs focuses on
protecting patients from contracting HAIs. While this body of evidence
can be an indicator of worker exposure, OSHA is seeking data that more
specifically address the occupational risk to workers. If your
workplace has a system for tracking worker exposures or infections that
may have been occupationally acquired, please share with us the
following information:
(a) A description of the tracking system and how it works;
(b) The types of infection diseases encountered in your workplace
and the number of exposures and/or infections tracked;
(c) Exposure/infection rates; and
(d) Any trend data.
C. Methods of Control
16. If your workplace has a process for early identification of
patients or clients who may have an infectious disease, please explain
how your workplace conveys information to workers about individuals who
are confirmed or suspected of being infectious, so that proper
precautions can be implemented. Please describe the degree of success
with these procedures and whether you think that such procedures are
likely to be effective in other healthcare or healthcare-related
settings.
17. CDC/HICPAC, CMS, and the Joint Commission provide a variety of
approaches that employers can implement to reduce or eliminate workers'
exposure to infectious agents. For example, a well-structured IC
program can include: immunizations for vaccine-preventable diseases,
isolation precautions to prevent exposures to infectious agents,
training, personal protective equipment, management of workers' risk of
exposure to infected persons, including post exposure prophylaxis, and
work restrictions for exposed or infected personnel. Please describe
the types of problems/obstacles your workplace or industry encountered
with implementing specific control measures. Please include a
discussion of each control measure, the problem/obstacle encountered,
the affected worker group, and any particularly effective solutions
your workplace or industry has implemented to address the obstacle/
problem.
18. When developing and implementing infection control measures in
your workplace, are there any recommended controls that you have found
to be ineffective or unnecessary in controlling infectious diseases? If
so, please explain how you arrived at this conclusion.
19. Airborne infection isolation rooms (AIIRs) are recommended as
one aspect of controlling certain airborne transmitted diseases (e.g.,
TB, SARS). OSHA recognizes that most workplaces outside of hospitals do
not have an AIIR and will transfer persons requiring airborne
precautions to a facility with the necessary capabilities. If your
workplace provides healthcare or other services to individuals
requiring airborne precautions, how many of these patients/individuals
has your workplace encountered in each of the last ten years? If
individuals requiring airborne precautions must be transferred to
another facility, please describe how your workplace identifies and
isolates them while they are awaiting transfer. If your workplace
provides extended care to these individuals (e.g., a hospital), does it
have sufficient AIIRs to isolate the number of infected individuals
your workplace has handled at any one time? If not, how does your
facility provide alternate means of isolation and how many additional
AIIRs would be necessary to fully accommodate your normal patient load?
Please describe how your workplace plans to address surge capacity in
the event of an outbreak, epidemic, or pandemic. Please provide any
additional information, including peer-reviewed studies, which
addresses issues relevant to the use of AIIRs in your workplace or
industry.
20. CDC/HICPAC's 2007 Guideline for Isolation Precautions:
Preventing Transmission of Infectious Agents in Healthcare Settings
addresses the need for a safety culture and its role in improving a
workplace's IC program (e.g., worker adherence to safe work practices).
Please describe the policies and actions undertaken in your workplace
or industry to develop and maintain a culture of worker safety. Please
describe any means that have been particularly effective in fostering a
safety culture and any problems or obstacles that have been encountered
in developing and/or maintaining the safety culture.
21. Poor adherence to infection control measures (e.g., failure to
use necessary PPE or to follow recommended hand hygiene practices) can
be one indicator of the breakdown of an IC program. Please describe
what actions have been undertaken in your workplace or industry to
assess and enforce adherence to infection control measures. What
obstacles has your workplace encountered in maintaining adherence and
are there any particularly successful ways you have found to maintain
adherence (e.g., training initiatives, worker incentives)? Please
discuss any underlying factors that you feel may affect non-compliance
with current infection control guidelines and standards in your
facility.
22. The use of proper PPE is an essential component of an effective
IC program. For example, CDC/HICPAC recommends that facemasks (e.g.,
surgical masks) be worn by workers when droplet precautions are
implemented and respirators be worn under certain circumstances when
airborne precautions are in place. Please describe how your workplace
determines when a facemask (e.g., surgical mask) is used for worker
protection and when a respirator is used for worker protection. How
does your workplace determine which employees use a facemask and which
use a respirator? If your workplace uses different types of
respirators, please describe what types and when they are used.
23. NIOSH regulates the testing and certification of respiratory
protective equipment, has established minimum performance standards,
and conducts independent testing and verification of all respirators
prior to certification. The Food and Drug Administration (FDA) approval
process for facemasks does not have established minimum performance
standards and allows manufacturer submitted data. As noted in a 2009
IOM report,\54\ a 2008 study that examined the filter performance of
nine different types of facemasks using the sodium chloride NIOSH
challenge test, found wide variation in penetration (4 percent to 90
percent) of smaller aerosol particles.\55\ Therefore, the protective
properties of different manufacturers' facemasks may vary. Is there a
need for a more rigorous certification/approval process for facemasks
and additional independent verification of the personal protective
properties of these devices?
24. Some HCWs have medical conditions or are receiving treatments
that impair their ability to resist infection. These HCWs may be unable
to develop protective immune responses after vaccination. What is your
workplace or industry doing to educate its workers about these
conditions? What approaches are being used or should be used to address
the special needs of HCWs with these conditions?
D. Vaccination and Post-Exposure Prophylaxis
25. In the Bloodborne Pathogens standard (Sec. 1910.1030), OSHA
requires that hepatitis B vaccinations be made available to employees
occupationally exposed to blood or other body fluids. It should be
noted that while employers are required to offer the vaccine, employees
are permitted to decline it. CDC/ACIP recommends a number of other
vaccines for various groups of HCWs including: influenza (both seasonal
and the 2009 H1N1); measles, mumps, rubella (MMR); varicella; tetanus,
diphtheria, pertussis (Td/Tdap); and meningococcal vaccines. What
vaccinations, other than hepatitis B, do you consider to be necessary
to protect workers from occupational exposure to infectious agents? Who
should receive these vaccinations, and why? Does your workplace offer
vaccines other than the hepatitis B vaccine to workers and how do you
determine who is offered these vaccines?
26. The Bloodborne Pathogens standard (Sec. 1910.1030) requires
that employers follow certain administrative and recordkeeping
procedures (e.g., signing a declination statement; placing
an employee's vaccination status in his/her medical record). Does your
workplace or industry use similar administrative and recordkeeping
procedures for vaccines other than hepatitis B? If not, please describe
what administrative and recordkeeping procedures are or should be used.
27. Post-exposure prophylaxis (PEP) and evaluation for bloodborne
pathogen exposures, such as hepatitis B and HIV, are addressed in the
Bloodborne Pathogens standard [Sec. 1910.1030(f)]. OSHA is interested
in post-exposure evaluation and PEP for other infectious diseases.
Please describe the current PEP and evaluation practices in your
workplace. For what infectious agent exposures should workers be
provided with PEP and/or evaluation? Please describe the disease, its
associated PEP, and the PEP efficacy.
28. In some instances, a vaccine may be available for a disease but
a worker may decline vaccination. Please describe procedures in your
workplace that ensure workers who have declined vaccination have access
to necessary PEP.
29. In order to appropriately evaluate the health status of a
worker, some basic health information is needed. CDC/HICPAC recommends
a personnel health service program for infection control that includes
a number of components including: pre-placement evaluations, evaluation
and treatment of exposure-related illnesses, and work restriction or
work-exclusion policies for exposed HCWs. OSHA is interested in the
prevalence, content and efficacy of such personnel health service
programs.
(a) What should be included in a pre-placement medical evaluation
for a worker who will be exposed to infectious agents? Please describe
the possible components of the medical history and physical exam and
specific tests (e.g., TB skin test, spirometry, blood tests). How are
pre-placement medical evaluations of workers addressed in your
workplace? What do these evaluations include? If pre-placement medical
evaluations are used in your workplace, have they been effective, and
what metrics are used to evaluate effectiveness? Give the rationale,
including references if available.
(b) What type of ongoing medical surveillance or periodic medical
evaluations should be provided for exposed workers? Please describe the
possible components of such surveillance or evaluations. How often
should periodic medical evaluations be conducted? In what situations
should medical evaluations or surveillance be performed (e.g., return-
to-work, fitness for duty)? How are periodic medical evaluations
addressed in your workplace?
(c) In your State, are there State laws that apply to pre-placement
and periodic medical evaluations of exposed workers? If so, what are
they?
(d) Please describe the administrative procedures used by your
workplace to evaluate and treat workers who have been occupationally
exposed and/or infected (e.g., who do they notify of the exposure/
infection). How are the costs for treatment and follow-up (e.g., visits
to physician, lab tests) handled in your workplace? If a worker is put
on restrictions or excluded from work due to a work-related infectious
exposure or illness, how are the worker's salary, benefits, and
seniority handled by your workplace?
E. Communication of Hazards
30. Training is generally considered a necessary component of an
effective IC program in order to assure that workers understand the
hazards they are exposed to and the proper methods of protection.
Please describe how your workplace assures that workers are adequately
trained in the use of infection control measures, including how your
workplace assesses if a worker has been adequately trained. Please
describe the contribution of training and education to improving
adherence to your IC program. Please describe the format used by your
workplace to conduct training (e.g., computer-based, written material,
interactive classes, hands-on practice, other) and whether you have
found some more effective than others. Please describe what role, if
any, knowledge and/or competency assessment plays in your workplace
training program.
31. Both initial and periodic worker training are recognized as
important components of an effective IC program. Initial training
provides information that workers need to protect themselves against
exposures to hazards while periodic training refreshes worker
knowledge, reinforces the importance of the IC program and provides a
means of introducing new information and procedures.
(a) What information should be included in initial training for
workers who may be exposed to infectious agents? What is the best
format for providing initial training to these workers (e.g.,
specifying a minimum number of hours of training, specifying training
content based on job tasks, specifying that training be adequate to
demonstrate specified competencies, by a combination of these methods
or by some other method)?
(b) How frequently does your workplace provide workers with
refresher training on its IC program? What information should be
included in periodic refresher training for workers who may be exposed
to infectious agents? What is the best format for providing periodic
training to these workers (e.g., specifying a minimum number of hours
of training, specifying training content based on job tasks, specifying
that training be adequate to demonstrate specified competencies, by a
combination of these methods or by some other method)? Should refresher
training be provided based on lack of competency, or be provided at
regular time intervals regardless of demonstrated competency?
F. Recordkeeping
32. Please describe the worker health surveillance system used in
your workplace. Does the system include tracking of occupational
exposures to infectious agents and/or occupationally-acquired
infectious diseases? Please describe the procedures used by your
workplace to determine whether an infectious disease is considered to
have been occupationally-acquired. How is the worker health
surveillance information collected under the system used in your IC
program? Please describe the factors that affect the successful
implementation of such surveillance systems.
33. The OSHA requirements for recording and reporting occupational
injuries and illnesses contain an exemption for the common cold and flu
(Sec. 1904.5(b)(2)(viii)). However, the Agency has determined that, if
certain criteria are met, occupationally-acquired 2009 H1N1 pandemic
influenza is recordable (OSHA Directive CPL-02-02-075). As OSHA more
broadly considers the issue of occupational exposure to infectious
agents, what are the implications, if any, for the Agency's existing
recording and reporting requirements under Sec. 1904?
G. Economic Impacts and Benefits
As part of the Agency's consideration of occupational exposure to
infectious agents, OSHA is interested in the costs, economic impacts,
and benefits of related practices to prevent such exposure. OSHA is
also interested in the benefits of such practices in terms of reduced
deaths, illnesses, and compromised operations (i.e., infirm personnel,
quarantined or disabled units, unexpected reallocation of resources).
The following questions will provide OSHA with needed economic impact
and benefits information.
34. As the Agency considers possible actions to address the
prevention and control of infectious diseases (e.g., prospective
standards or guidelines), what are the potential economic impacts
associated with the promulgation of a standard specific to the hazards
of infectious diseases? Describe these impacts in terms of benefits
from the reduction of incidents and illnesses; effects on revenue and
profit; and any other relevant impact measure. If you have any
estimates of the costs of controlling infectious disease hazards,
please provide them.
35. What changes, if any, in market conditions would reasonably be
expected to result from issuing a comprehensive infectious diseases
standard? Describe any changes in market structure or concentration,
and any effects on services, that would reasonably be expected from
issuing such a standard.
36. What are the potential benefits of more widespread compliance
with infection control guidelines? How can OSHA best assure such
compliance takes place?
H. Impacts on Small Entities
As part of the Agency's consideration of occupational exposure to
infectious agents, OSHA is concerned whether its actions will have a
significant economic impact on a substantial number of small entities.
If the Agency pursues development of a standard and the standard has
such impacts, OSHA is required to develop a regulatory flexibility
analysis and assemble a Small Business Regulatory Enforcement Fairness
Act (SBREFA) Panel prior to publishing a proposal. Regardless of the
significance of the impacts, OSHA seeks ways of minimizing the burdens
on small businesses consistent with OSHA's statutory and regulatory
requirements and objectives.
37. How many, and what type of small firms, or other small
entities, have infectious disease hazards, and what percentage of their
industry (NAICS code) do these entities comprise? Please specify the
types of infectious diseases encountered.
38. How, and to what extent, would small entities in your industry
be affected by a potential comprehensive OSHA infectious diseases
standard regulating occupational exposure to infectious agents? Do
special circumstances exist that make controlling infectious diseases
more difficult or more costly for small entities than for large
entities? Describe these circumstances.
III. Public Participation
You may submit comments in response to this document by (1) hard
copy, (2) fax transmission (facsimile), or (3) electronically through
the Federal Rulemaking Portal. Because of security-related problems,
there may be a significant delay in the receipt of comments by regular
mail. Contact the OSHA Docket Office at (202) 693-2350 for information
about security procedures concerning the delivery of materials by
express delivery, hand delivery and messenger service.
All comments and submissions are available for inspection and
copying at the OSHA Docket Office at the above address. Comments and
submissions are also available at http://www.regulations.gov. OSHA
cautions you about submitting personal information such as social
security numbers and birth dates. Contact the OSHA Docket Office at
(202) 693-2350 for information about accessing materials in the docket.
Electronic copies of this Federal Register notice, as well as news
releases and other relevant documents, are available at OSHA's Web
page: http://www.osha.gov/index.html.
Authority and Signature
This document was prepared under the direction of David Michaels,
Ph.D., MPH, Assistant Secretary of Labor for Occupational Safety and
Health, U.S. Department of Labor. It is issued pursuant to sections 4,
6, and 8 of the Occupational Safety and Health Act of 1970 (29 U.S.C.
653, 655, 657), 29 CFR 1911, and Secretary's Order 5-2007 (72 FR
31160).
Signed at Washington, DC, this 30th day of April, 2010.
David Michaels,
Assistant Secretary of Labor for Occupational Safety and Health.
Footnotes:
\1\ U.S. Bureau of Labor Statistics. Occupational Employment
Statistics. 2007.(http://data.bls.gov/cgi-bin/print.pl/oes/2007/may/naics3_622000.htm).
\2\ U.S. Bureau of Labor Statistics. Occupational Employment
Statistics. 1998.(http://www.bls.gov/oes/oes_dl.htm).
\3\ U.S. Bureau of Labor Statistics. Occupational Employment
Statistics. 2008.(http://www.bls.gov/oes/2008/may/naics3_622000.htm).
\4\ Siegel JD, Rhinehart E, Jackson M, Chiarello L, and the
Healthcare Infection Control Practices Advisory Committee, 2007
Guideline for Isolation Precautions: Preventing Transmission of
Infectious Agents in Healthcare Settings. Page 15.(http://www.cdc.gov/ncidod/dhqp/pdf/isolation2007.pdf).
\5\ Ibid. Page 17.
\6\ Ibid.
\7\ Bolyard EA et al. and the Healthcare Infection Control
Practices Advisory Committee. Guideline for Infection Control in
Health Care Personnel, 1998. Page 292. (http://www.cdc.gov/ncidod/dhqp/pdf/guidelines/InfectControl98.pdf).
\8\ Smith PW, et al. SHEA/APIC Guideline: Infection prevention
and control in the long-term care facility. Am J Infect Control
2008, 36:504-535.
\9\ Ibid.
\10\ Tarrac SE. Application of the updated CDC isolation
guidelines for health care facilities. AORN Journal. 2008. 87:534-542.
\11\ CMS Manual System. State Operations Provider Certification.
Transmittal 51. Department of Health & Human Services (DHHS) Centers
for Medicare & Medicaid Services (CMS) Publication 100-07. July 20,
2009. (http://www.cms.hhs.gov/transmittals/downloads/R51SOMA.pdf).
\12\ The Joint Commission: Infection Control Prevention and
Control. 2009.
\13\ Siegel JD, Rhinehart E, Jackson M, Chiarello L, and the
Healthcare Infection Control Practices Advisory Committee, 2007
Guideline for Isolation Precautions: Preventing Transmission of
Infectious Agents in Healthcare Settings.(http://www.cdc.gov/ncidod/dhqp/pdf/isolation2007.pdf).
\14\ Klevens RM et al, Estimating health care-associated
infections and deaths in U.S. hospitals in 2002. Public Health Rep.
2007, 122:160-166.
\15\ Siegel JD, Rhinehart E, Jackson M, Chiarello L, and the
Healthcare Infection Control Practices Advisory Committee, 2007
Guideline for Isolation Precautions: Preventing Transmission of
Infectious Agents in Healthcare Settings.(http://www.cdc.gov/ncidod/dhqp/pdf/isolation2007.pdf).
\16\ Ibid.
\17\ WHO Guidelines on Hand Hygiene in Health Care: A Summary.
First Global Patient Safety Challenge: Clean Care is Safer Care.
2009. World Health Organization, Switzerland. (http://whqlibdoc.who.int/publications/2009/9789241597906_eng.pdf).
\18\ Allegranzi B and Pittet D. Role of hand hygiene in
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73:305-315.
\19\ Turnberg W, et al. Appraisal of recommended respiratory
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\20\ Turnberg W, et al. Personal healthcare worker (HCW) and
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\21\ Daugherty EL, et al. Use of personal protective equipment
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\23\ Siegel JD, Rhinehart E, Jackson M, Chiarello L, and the
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\24\ Gershon RR, et al. Compliance with universal precautions
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\32\ Ford J, Fisher S. The transfer of safety training in work
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\34\ IOM (Institute of Medicine). 2009. Respiratory protection
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\35\ IOM (Institute of Medicine). 1999. To Err is Human:
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\36\ Siegel JD, Rhinehart E, Jackson M, Chiarello L, and the
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\37\ Pittet D. Infection control and quality health care in the
new millennium. Am J Infect Control. 2005. 33:258-267.
\38\ Allegranzi B, Pittet D. Role of hand hygiene in healthcare-
associated infection prevention. J Hosp Infect. 2009. 73:305-315.
\39\ HHS Action Plan to prevent Healthcare Associated
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\40\ Siegel JD, Rhinehart E, Jackson M, Chiarello L, and the
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\41\ Albrich W, Harbarth S. Health care worker: source, vector
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\42\ Lessa F, et al. Healthcare transmission of a newly emergent
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\43\ Henquell C, et al. Fatal adenovirus infection in a neonate
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\44\ Lacy M, Horn K. Nosocomial transmission of invasive Group A
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\45\ Hell M et al. Clostridium difficle infection in a health
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\47\ Pearson ML, Bridges CB, Harper SA; Healthcare Infection
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\48\ Ofner-Agostini M, et al. Investigation of the second wave
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\49\ NIOSH Statement: Risk of Serious Illness among Healthcare
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\50\ Mahoney FJ, et al. Progress toward the elimination of
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\51\ OSHA. Occupational Exposure to Tuberculosis; Proposed Rule;
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(http://www.gpo.gov/fdsys/pkg/FR-2003-12-31/pdf/03-31845.pdf).
\52\ OSHA. Directive CPL 02-00-106--CPL 2.106--Enforcement
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\53\ California Code of Regulations, Title 8, Section 5199.
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\54\ Institute of Medicine (IOM). 2009. Respiratory Protection
for Healthcare Workers in the Workplace Against Novel H1N1 Influenza
A: A Letter Report. Washington, DC: The National Academies Press.
(http://www.nap.edu/catalog/12748.html).
\55\ Oberg MS and Brosseau LM. Surgical mask filter and fit
performance. Am J Infect Control. 2008. 36:276-282.
[FR Doc. 2010-10694 Filed 5-5-10; 8:45 am]
BILLING CODE 4510-26-P