GUIDE TO MANAGING AN EMERGENCY SERVICE INFECTION CONTROL PROGRAM

**2002**

**UNITED STATES FIRE ADMINISTRATION**

As an entity of the Federal Emergency Management Agency, the

mission of the U.S. Fire Administration is to reduce life and

economic losses due to fire and related emergencies through

leadership, advocacy, coordination, and support. We serve the

Nation independently, in coordination with other Federal agencies

and in partnership with fire protection and emergency service

communities. With a commitment to excellence, we provide public

education, training, technology, and data initiatives.

# PREFACE

In 1992, the United States Fire Administration (USFA) developed the
*Guide to Developing an Emergency Service Infection Control Program* in
conjunction with the National Fire Academy (NFA) field course,
*Infection Control for Emergency Response Personnel: The Supervisor's
Role*. These two major Federal initiatives were designed to provide
accurate information and guidance to the emergency services regarding
communicable disease infection control. Both were developed with the
support and assistance of the Centers for Disease Control and Prevention
(CDC) and the Occupational Safety and Health Administration (OSHA), to
coincide with the promulgation of 29 CFR Part 1910.1030, *Occupational
Exposure to Bloodborne Pathogens, Final Rule*.

Since the original publication, many advances have occurred in the field
of infection control, and all emergency services should have some form
of infection control program. The initial guide focused on the
development of an infection control program. The new *Guide to Managing
an Emergency Service Infection Control Program* updates relevant
information from the original 1992 guide and focuses on the management
of an infection control program. The guide is designed to meet or exceed
all applicable Federal/national laws, regulations, standards, and
guidelines in effect at the time of publication. Many of these are
included in their entirety in Appendix B of the guide. The guide also
contains Internet Web addresses for accessing those guidelines not
included in their entirety.

The principal development team for the guide included: Judy Janing,
Ph.D., R.N., EMT-P, Emergency Program Specialist, IOCAD Emergency
Services Group, Omaha, NE; Murrey Loflin, M.S., EMT-B, Battalion Chief,
Virginia Beach Fire Department, Virginia Beach, VA.; Gordon Sachs, MPA,
Director, IOCAD Emergency Services Group; Mike Grill, Captain, Sierra
Vista Fire Department, Sierra Vista, AZ; David Barillo, M.D., Associate
Professor of Surgery, Medical University of South Carolina, Charleston,
SC. Sandy Bodgucki, M.D., Ph.D., Assistant Professor, Yale University
School of Medicine, Department of Surgery, Section of Emergency
Medicine, New Haven, CT.

Members of the Technical Review Panel for the development of this guide
were: Jonathan M. Lieske, M.D., M.P.H., International Association of
Fire Fighters (IAFF); Richard Knopf, International Association of Fire
Chiefs (IAFC), Health and Safety Committee; Philip Stittleburg, National
Volunteer Fire Council; Decker Williams, Phoenix Fire Department;
Richard Patrick, VFIS, Inc.; Scott Deitchman, M.D., Centers for Disease
Control and Prevention (CDC); Ron Thackery, American Ambulance
Association; and Susan McHenry, National Highway Transportation and
Safety Administration (NHTSA).

TABLE OF CONTENTS

Preface 3

Table of Contents 5

# INTRODUCTION 7

# SECTION 1: OVERVIEW OF INFECTION CONTROL 11

Chapter One: Technical Background 13

Introduction to Infection Control 15

Basic Concepts 16

Assessing Risk Potential 17

Bloodborne Diseases 18

Airborne Diseases 21

Infection Control Techniques 22

Summary 23

Chapter Two: Laws, Regulations, and Standards 29

Public Law 32

OSHA Regulations 34

National Fire Protection Association (NFPA) 37

Centers for Disease Control and Prevention 40

Summary 46

# SECTION 2: COMPONENTS OF AN INFECTION CONTROL PROGRAM 47

Risk Management 49

Risk Management Model 50

Training and Education 53

Members 54

Health Maintenance 55

Roles and Responsibilities 56

Policies and Procedures 62

Exposure Control Plan 64

Standard Operating Procedures 65

Interactions with Other Departments 65

# SECTION 3: VEHICLES, EQUIPMENT, AND SUPPLY CONSIDERATIONS 69

Vehicles 71

Personal Protective Equipment 76

Equipment and Supplies 81

Equipment Advances 82

Other Considerations 85

Summary 87

**SECTION 4: FACILITIES CONSIDERATIONS 89**

The Need for Facility Safety 91

Facility Issues 93

Summary 98

**SECTION 5: ASSESSING EFFECTIVENESS: THE EVALUATION PROCESS 99**

Overview 101

Assessing Effectiveness 102

Information Management 104

Program Revision 113

Action Plan 114

Summary 115

**SECTION 6: SPECIAL SITUATIONS 117**

Overview 119

The Training Environment 119

Protecting the Patient 121

Summary 122

# BIBLIOGRAPHY 123

**APPENDICES 129**

**Appendix A: Glossary of Common Terms 131**

#  Appendix B: Laws, Regulations, and Standards 143

*Health Care Worker Needlestick Prevention Act* (PL 106-430) 145

*Occupational Exposure to Bloodborne Pathogens: Final Rule.*

(29 CFR Part 1910.1030) 149

> *Occupational Exposure to Bloodborne Pathogens: NeedlesticksAnd Other
> Sharps Injuries: Final Rule.* (29 CFR Part 1910.1030) 173
>
> *Updated U.S. Public Health Service Guidelines for the Management of
> Occupational Exposures to HBV, HCV,And HIV and Recommendations for
> Postexposure Prophylaxis*(June 29, 2001/MMWR 50 (RR11); 1-42.) 197

**Appendix C: Sources of Additional Information 241**

**INTRODUCTION**

**SCOPE AND PURPOSE**

Since infection control requirements vary by agency type, local
regulations, department size, etc., emergency response organizations
cannot simply adopt a generic infection control program as their
program. Therefore, this *Guide* is designed as a resource to help
emergency response organizations tailor the requirements identified in
regulations and standards to their own unique situations.

The structure of the *Guide* facilitates its use for different purposes.
The first section, **Overview of Infection Control** contains two
chapters.

-   Chapter 1: **Technical Background** summarizes basic terms and
    concepts, and describes the risks associated with various
    communicable diseases particularly relevant to emergency services.

-   Chapter 2: **Laws and Regulations** summarizes applicable laws,
    regulations, and standards.

The second section, **Components of an Infection Control Program**,
covers the aspects of an infection control program that organizations
need to address. These components include risk management, training and
education, health maintenance, roles and responsibilities of department
personnel, policies and procedures, standard operating procedures, and
interactions with other departments.

The third section, **Vehicles, Equipment, and Supply Considerations**,
addresses issues related to vehicle design, decontamination of
disposable and non-disposable equipment, equipment advances (including
needleless systems), and considerations related to clothing/linen and
volunteers responding from and returning to home or the primary
workplace.

The fourth section, **Facilities Considerations**, discusses infection
control in relation to the various functioning areas of emergency
services facilities.

The fifth section, **Assessing Effectiveness**, provides a description
of the evaluation process. A step-by-step approach for developing
performance standards and compliance (evaluation criteria) for measuring
effectiveness is described. Other aspects addressed include information
management and program revision.

The final section, **Special Situations**, provides a brief overview of
infection control practices in the training environment and as they
relate to protecting the patient.

In addition, the *Guide* also contains a bibliography of useful
reference documents and several appendices:

-   **Glossary of Common Terms** used in infection control.

-   Text of major **Laws, Standards, and Guidelines** of interest to
    managers of infection control programs.

-   **Sources of Additional Information** for special needs in infection
    control.

The USFA *Guide* incorporates all requirements specified by applicable
regulations and standards at the time of publication. However, users are
encouraged to go beyond the information contained in the *Guide* to
address specific needs.

Managers also should remember that infection control is a rapidly
evolving field. OSHA's *Occupational Exposure to Bloodborne Pathogens*,
29 CFR Part 1910.1030 requires that the department's exposure control
plan be reviewed and updated at least annually, and that the
consideration and implementation of safer medical devices be documented.
It is imperative to review new medical developments, consensus
standards, and regulations. This will ensure that mechanisms exist to
integrate that new information into a department\'s existing program.
The goal of the infection control program is to provide the best
protection available for members.

**SECTION 1**

**OVERVIEW OF INFECTION CONTROL**

**CHAPTER 1**

**TECHNICAL BACKGROUND**

**OVERVIEW**

This chapter provides an introduction to the basic principles of
infection control in the emergency service environment. Technical terms
are defined. The risk of occupational exposure to communicable disease
is discussed.

**INTRODUCTION TO INFECTION CONTROL**

In the mid-1800's in Vienna, Austria, a physician named Ignaz Semmelweis
demonstrated the importance of hand washing in decreasing the incidence
of infection in women following childbirth. He observed that medical
students were conducting cadaver dissections in the morning and then
delivering babies in the afternoon without wearing gloves or washing
their hands. When the medical students were on vacation, the incidence
of infection was reduced. Semmelweis traveled to other European cities
to demonstrate that hand washing could reduce deaths related to
infection. Even though he had reduced infection from 18 percent to 1
percent in the Vienna hospital, at the time the medical community did
not take him seriously.

Although hand washing remains the most fundamental measure for
controlling infection, it is still not taken as seriously as it should
be. Infection rates in patients, hospital personnel, and emergency
responders continue to be a national problem, despite continuing
improvements in medical technology.

Infection control procedures have been developed and refined
continuously over the years. Unfortunately, research on the incidence of
infection, the spread of infection from patient to care provider, and
the incidence of infection related to contaminated medical equipment
continues to be limited almost exclusively to hospital-based studies. To
date, there are few studies related to the incidence of disease in the
emergency response environment. As a result, recommended practice and/or
procedures for emergency responders are generally modifications of those
established for in-hospital personnel.

Without definitive data, it is difficult to demonstrate the need for
infection control procedures specifically for emergency services.
However, the U.S. Centers for Disease Control and Prevention (CDC) has
classified emergency response personnel as being at high risk for
exposure. They face the same potential for exposure as hospital
personnel. In many instances, the volatility and unpredictability of the
emergency scene increases the level of risk. The *Guidelines for
Prevention of Transmission of Human Immunodeficiency Virus and Hepatitis
B Virus to Health Care and Public Safety Workers* (MMWR Vol. 38, No.
2-6, 1989) states

The unpredictable and emergent nature of exposures

> encountered by emergency and public-safety workers may make
> differentiation between hazardous body fluids and those which are not
> hazardous very difficult and often impossible. For example, poor
> lighting may limit the worker's ability to detect visible blood in
> vomitus or feces. Therefore, **when emergency medical and
> public-safety workers encounter body fluids under uncontrolled,
> emergency circumstances in which differentiation between fluid types
> is difficult, if not impossible, they should treat all body fluids as
> potentially hazardous.**

**BASIC CONCEPTS**

An effective infection control program requires a basic understanding of
key infection control concepts.

**Disease-Producing Organisms**

Viruses and bacteria are the organisms commonly responsible for the
spread of disease. Viruses normally reside in a living host and cannot
multiply outside of a living cell. However, viruses can spread disease
through contact with inanimate surfaces that are contaminated with
fluids/blood containing the virus. Bacteria can multiply outside the
body, i.e., on surfaces or objects. Therefore, proper cleaning of
equipment is critical.

**Infectious Versus Communicable Disease**

An **infectious** disease results from invasion of a host by
disease-producing organisms, such as bacteria, viruses, fungi, or
parasites. A **communicable** (contagious) disease is one that can be
transmitted from one person to another.

Not all infectious diseases are communicable. For example, there are
many cases involving people getting salmonella "food poisoning" from
poorly prepared food containing salmonella bacteria. Salmonella is
highly infectious, but it is not **contagious**. Chickenpox is an
infectious disease that also is communicable. It can be transmitted
easily from one person to another by airborne droplets. Infection
control for emergency services is primarily, but not solely, concerned
with communicable disease.

**Modes of Transmission**

A communicable disease can be spread directly or indirectly. **Direct
transmission** occurs through direct contact with the blood or other
body substances of an infected individual. **Indirect transmission**
occurs without person-to-person contact; the disease-producing organism
passes from the infected individual to an inanimate object. Another
person comes in contact with the contaminated object and contracts the
disease.

Although a communicable disease may be transmitted by body fluids other
than blood (e.g., cytomegalovirus), those of primary concern to
emergency responders are those communicable diseases that are bloodborne
or airborne. **Bloodborne** diseases are spread by direct contact with
the blood or other body substances of an infected person. Bloodborne
diseases of most concern to emergency responders include Human
Immunodeficiency Virus (HIV), Hepatitis B, and Hepatitis C.

**Airborne diseases** are spread by droplets of the disease-producing
organism being expelled into the air by a productive cough or sneeze or
by direct contact with infected bodily secretions. Airborne diseases
include tuberculosis, meningitis, mumps, rubella, and chickenpox.

**ASSESSING RISK POTENTIAL**

Any exposure to a communicable disease carries a certain amount of risk.
For bloodborne pathogens, an exposure occurs whenever there is contact
with blood or other body fluids through open wounds, mucous membranes,
or parenteral (by injection) routes. The degree of risk depends on the
degree of exposure. Five factors are critical in assessing potential
risk in any exposure situation:

-   **Communicability** -- Identification of the causative agent is
    critical. As noted previously, some disease-producing organisms are
    more readily communicable than others; some are capable of causing
    more serious effects.

-   **Dosage of the Disease-Producing Organism** -- Dosage refers to the
    number of viable (live) organisms received during an exposure. Each
    illness requires that a certain number of infectious agents be
    present in order to cause disease. For example, one Hepatitis B
    virus in 1 milliliter of blood may be all that is needed to spread
    the infection, while 100,000 HIV viral particles may be needed.

-   **Virulence of the Disease-Producing Organism** -- Virulence is the
    disease-evoking power of the organism, in other words, the strength
    or ability of the organism to infect or overcome bodily defenses.

-   **Hardiness of the Organism** -- Hardiness is the organism's ability
    to survive in the environment. This varies from one situation to
    another. In most cases, the organism must be one that survives
    outside the body. For example, the hepatitis B virus has been shown
    to live on a surface for days to weeks and still be infectious.

-   **Host Resistance** -- Host resistance is the ability of the host to
    fight infection. Infection occurs as a result of an interruption in
    the body's normal defense mechanisms, which allows the organism to
    enter the body. Typically, the healthier you are, the less likely
    you are to become ill.

    **BLOODBORNE DISEASES**

**HIV/AIDS**

The number of new HIV cases reported in the United States has decreased
slightly over the past decade. CDC reported 47,915 new cases of HIV
(17.4 cases/100,000 population) in 1998 and 46,400 new cases (16.7
cases/100,000 population) in 1999. As of the 1999 report, there were
113,000 persons living with HIV and 290,542 persons living with AIDS in
the United States. CDC reported twelve potential and no documented cases
of HIV in emergency services personnel in 1999. This low number can
probably be attributed to the use of personal protective equipment, but
it must be remembered that emergency services personnel remain in a
high-risk group.

**Hepatitis B**

Hepatitis B virus (HBV) infection is the major infectious hazard for
health-care personnel. The risk of HBV infection after percutaneous
exposure varies from 2 percent if the patient is negative for the
Hepatitis B early antigen (HBeAg) to 40 percent if HBeAg antigen is
present. Overall, the estimated risk of HBV infection after an
occupational exposure ranges from 20 to 30 percent.[^1] During 1993, an
estimated 1,450 workers became infected through exposure to blood and
serum-derived body fluids, a 90 percent decrease from the number
estimated to have been thus infected during 1985.[^2] This decline is
partly due to widespread adoption of preventive immunization, increased
adherence to universal precautions, and use of personal protective
equipment by health- care workers. Hepatitis B immunization is a
critical preventative factor of an Emergency Medical Service infection
control program.

**Hepatitis C**

Hepatitis C (HCV) is a leading cause of cirrhosis of the liver, liver
cancer, and one of the major causes of the need for liver transplants.
CDC estimates that the annual number of newly acquired HCV infections
ranged from 180,000 in 1984 to 28,000 in 1995. Of these, an estimated
2-4 percent occurred among health-care personnel who were occupationally
exposed to blood. After an unintentional needlestick from an
HCV-positive source, the average risk for HCV infection is 1.8 percent.
Transmission rarely occurs from mucous membrane exposures to blood, and
no transmission has been documented from intact or non-intact skin
exposures to blood.[^3] At least 50-80 percent of persons who contract
HCV infection become chronically infected, and half of those chronically
infected develop cirrhosis or liver cancer. Up to 10 percent of
parenterally transmitted hepatitis may be caused by other bloodborne
viral agents not yet characterized.

**Hepatitis A**

Occupational exposure generally does not increase health-care workers'
risk for Hepatitis A virus (HAV) infection.[^4] When proper infection
control practices are followed, nosocomial HAV transmission is rare.
Transmission of HAV from adult patients to health-care workers usually
is associated with fecal incontinence in the patients. There is a
vaccine for Hepatitis A. Currently it is recommended only for travelers
and the military.

**Other Hepatitis Viruses**

There have been three additional Hepatitis viruses (E, F, and G)
identified in addition to Hepatitis A, B, and C. Knowledge regarding
these viruses is limited; however it is known that the mode of
transmission for E is the fecal-oral route, for G is bloodborne, and F
may be bloodborne.

**Risk of Infection**

Risk of infection from bloodborne diseases varies according to the type
of exposure. The following list was published by the CDC to help
evaluate risk levels. Risk decreases from top to bottom.

-   Contaminated needle stick injury (large-bore, hollow needle carries
    more risk than small bore solid needle).

-   Cuts with sharp objects covered with blood/body fluid.

-   Blood/Body fluid contact with an open area of the skin.

-   Blood/Body fluid contact to the mucous membrane surface of the eyes,
    nose, or mouth.

-   Blood/Body fluid contact to intact skin.

Although incidence of the major bloodborne diseases have decreased over
the past several years, emergency service personnel remain at risk for
contracting these diseases. If these declines are to be sustained,
emergency service personnel must continue to adhere to protection
strategies.

**AIRBORNE DISEASES**

**Tuberculosis (pulmonary)**

The airborne disease of greatest concern to emergency services providers
is tuberculosis (TB). Nationally, the number of reported cases of TB
increased by 14 percent from 1985 to 1993. Consequently, concern about
this disease increased, and more attention was focused on control
measures. At the same time drug-resistant tuberculosis also increased,
creating a serious concern. From 1982 to 1986, only 0.5 percent of new
cases were resistant to both isoniazid and rifampin. By 1991, this
proportion had increased to about 3.1 percent. Among recurrent cases,
3.0 percent were resistant to both drugs during the 1982 to 1986 period,
but in 1991 this proportion had more than doubled, to 6.9 percent.

The reported cases of TB began a decline in the years following this
increase. There were 26,673 cases (10.5/100,000 population) in 1992.
This decreased to 17,531 cases (6.4/100,000 population) in 1999. Of the
cases reported in 1999, 2.5 percent occurred in health-care workers.
Statistics specific to emergency services are not available, since CDC
does not break out emergency services workers as a separate category in
their TB surveillance program.

Drug-resistant cases also have decreased. In 1999, 12.2 percent of new
cases and 8.4 percent of recurrent cases were resistant to isoniazid
alone and 3.8 percent of new cases and 1.1 percent of recurrent cases
were resistant to both isoniazid and rifampin.

It is well known that the organism that causes TB dies when exposed to
light and air, however there are factors that can affect the potential
for infection from TB as well as other airborne diseases. These factors
are duration of exposure and ventilation. Some diseases require
prolonged exposure in order to contract the disease. Therefore shorter
transport times can reduce risk potential. Risk potential also can be
reduced by maximum ventilation. Ventilation systems for vehicles are
addressed in depth in Section 3 of this *Guide*. On older vehicles
without modern ventilation systems, personnel should open windows
whenever possible.

**INFECTION CONTROL TECHNIQUES**

**Hand washing** is the most effective overall infection control
measure, yet it is frequently ignored. Hands should be washed whenever
gloves are removed, after all patient contacts, and after disinfecting
equipment, as well as before eating and after using the bathroom. Hands
should be well lathered with regular soap and scrubbed for at least 15
seconds before rinsing and drying. The towel should be used to turn off
the faucet.

**Universal precautions** is an infection control strategy developed by
the CDC for **hospital workers**. Specific precautionary procedures are
recommended for reducing potential exposure to bloodborne pathogens.
Universal precautions are based on the concept that blood and
**certain** body fluids (any body fluids containing visible blood,
semen, vaginal secretions, tissues, cerebrospinal fluid (CSF), synovial
fluid, pleural fluid, peritoneal fluid, pericardial fluid, and amniotic
fluid) of all patients should be considered potentially infectious for
HIV, HBV, HCV, and other bloodborne pathogens.

In 1996, CDC published **standard precautions**. Standard precautions
synthesize the major features of body substance isolation and universal
precautions and apply to isolation precautions in **the hospital
setting**.

**Body substance isolation** (BSI) goes beyond universal precautions and
considers **all** body substances potentially infectious. Thus, in
addition to those listed under universal precautions, feces, nasal
secretions, sputum, sweat, tears, urine, and vomitus also are considered
potentially infectious. Such an approach obviously is safer in the
emergency response environment, where medical histories are often
incomplete or not known at all and differentiation between body fluids
may be impossible. In effect, each emergency incident has exposure
potential.

BSI is generally accomplished through the barrier technique, using
personal protective equipment (gloves, masks, protective eyewear, gowns,
and resuscitation devices) to prevent personal contact with blood or
other potentially infectious materials. Other infection control
techniques include proactive preventive measures such as health
maintenance, immunization programs, decontamination procedures, proper
waste handling and disposal practices, and both initial and ongoing
training.

**SUMMARY**

The intent of this chapter was to provide a brief overview of
communicable disease and infection control principles, as background
information for the rest of the *Guide*. Table 1-1-1, on the following
pages, summarizes the most common communicable diseases encountered by
emergency services personnel.

It must be emphasized that a crucial component of an effective infection
control program is learning as much as possible about various types of
communicable disease and updating the infection control program as new
knowledge becomes available. Organizations should capitalize on all
available expertise by enlisting the help of local health and medical
practitioners and/or infection control experts. Additional sources of
information are provided in the References and Bibliography, and in
Appendix C.

**Table 1-1-1**

#  DISEASE INFORMATION FOR EMERGENCY RESPONSE PERSONNEL

+---------------+---------------+---------+---------------+-----------+
| **Diseas      | **Mode of     | **      | **Sig         | **Post    |
| e/Infection** | T             | Vaccine | ns/Symptoms** | -Exposure |
|               | ransmission** | Avai    |               | Tr        |
|               |               | lable** |               | eatment** |
+---------------+---------------+---------+---------------+-----------+
| **AIDS/HIV**  | Needlestick,  | NO      | Fever, cough, | Antir     |
|               | blood splash  |         | night sweats, | etroviral |
| **(Human      | into mucous   |         | weight loss,  | Regimen   |
| Imm           | membranes     |         |               |           |
| unodeficiency | (e.g., eyes,  |         |               | (see      |
| Virus)**      | mouth), or    |         |               | complete  |
|               | blood contact |         |               | g         |
|               | with open     |         |               | uidelines |
|               | wound         |         |               | in        |
|               |               |         |               | Appendix  |
|               |               |         |               | B)        |
+---------------+---------------+---------+---------------+-----------+
| **Chickenpox  | Respiratory   | YES     | Fever, rash,  | # Vaccine |
| (Varicella)** | secretions    |         | cutaneous     |           |
|               | and contact   |         | vesicles      |           |
|               | with moist    |         | (blisters)    |           |
|               | vesicles      |         |               |           |
+---------------+---------------+---------+---------------+-----------+
| **Diarrhea:** | Fecal/Oral    | NO      | Loose, watery | # None    |
|               |               |         | stools        |           |
| **            |               |         |               |           |
| Campylobactor |               |         |               |           |
| Cr            |               |         |               |           |
| yptosporidium |               |         |               |           |
| Giardia       |               |         |               |           |
| Salmonella    |               |         |               |           |
| Shigella      |               |         |               |           |
| Viral         |               |         |               |           |
| Yersinia**    |               |         |               |           |
+---------------+---------------+---------+---------------+-----------+
| **German      | Respiratory   | YES     | Fever, rash   | Vaccine   |
| Measles       | droplets and  |         |               | in 72     |
| (Rubella)**   | contact with  |         |               | hours,    |
|               | respiratory   |         |               | immune    |
|               | secretions    |         |               | globulin  |
+---------------+---------------+---------+---------------+-----------+
| **Hepatitis A | Fecal/Oral    | YES     | Fever, loss   | Immune    |
| (HAV)**       |               |         | of appetite,  | globulin, |
|               |               |         | jaundice,     |           |
|               |               |         | fatigue       | vaccine   |
+---------------+---------------+---------+---------------+-----------+
| **Hepatitis B | Needlestick,  | YES     | Fever,        | Booster   |
| (HBV)**       | blood splash  |         | fatigue, loss | and/or    |
|               | into mucous   |         | of appetite,  | immune    |
|               | membranes     |         | nausea,       | globulin  |
|               | (e.g., eye or |         | headache,     |           |
|               | mouth), or    |         | jaundice      |           |
|               | blood contact |         |               |           |
|               | with open     |         |               |           |
|               | wound.        |         |               |           |
|               | Possible      |         |               |           |
|               | exposure      |         |               |           |
|               | during        |         |               |           |
|               | mouth-to-     |         |               |           |
|               | mouth         |         |               |           |
|               | resuscitation |         |               |           |
+---------------+---------------+---------+---------------+-----------+
| ###           |               |         |               |           |
| #  DISEASE IN |               |         |               |           |
| FORMATION FOR |               |         |               |           |
|  EMERGENCY RE |               |         |               |           |
| SPONSE PERSON |               |         |               |           |
| NEL (cont\'d) |               |         |               |           |
+---------------+---------------+---------+---------------+-----------+
| **Diseas      | **Mode of     | **      | **Sig         | **Post    |
| e/Infection** | T             | Vaccine | ns/Symptoms** | -Exposure |
|               | ransmission** | Avai    |               | Tr        |
|               |               | lable** |               | eatment** |
+---------------+---------------+---------+---------------+-----------+
| **Hepatitis C | Same as       | NO      | Same as       | # None    |
| (HCV)**       | Hepatitis B   |         | Hepatitis B   |           |
+---------------+---------------+---------+---------------+-----------+
| **Hepatitis D | Same as       | NO      | Same as       | # None    |
| (HDV)**       | Hepatitis B   |         | Hepatitis B   |           |
|               | dependent on  |         |               |           |
|               | HBV (past or  |         |               |           |
|               | present) to   |         |               |           |
|               | cause         |         |               |           |
|               | infection     |         |               |           |
+---------------+---------------+---------+---------------+-----------+
| **Hepatitis   | Several       | NO      | Fever,        | # None    |
| E,F, & G**    | viruses with  |         | headache,     |           |
|               | different     |         | fatigue,      |           |
|               | modes of      |         | jaundice      |           |
|               | transmission  |         |               |           |
+---------------+---------------+---------+---------------+-----------+
| **Herpes      | Contact of    | NO      | Skin lesions  |           |
| Simplex**     | mucous        |         | located       |           |
|               | membrane with |         | around the    |           |
| **(Cold       | moist         |         | mouth         |           |
| Sores)**      | lesions.      |         |               |           |
|               | Fingers are   |         |               |           |
|               | at particular |         |               |           |
|               | risk for      |         |               |           |
|               | becoming      |         |               |           |
|               | infected.     |         |               |           |
+---------------+---------------+---------+---------------+-----------+
| **Herpes      | Contact with  | Va      | Skin lesions, |           |
| Zoster        | moist lesions | ricella | regional      |           |
| (Shingles)    |               | vaccine | associated    |           |
| localized     |               | may be  | pain          |           |
| d             |               | ef      |               |           |
| isseminated** |               | fective |               |           |
|               |               | even if |               |           |
| **(See        |               | person  |               |           |
| Varicella)**  |               | has     |               |           |
|               |               | already |               |           |
|               |               | had     |               |           |
|               |               | va      |               |           |
|               |               | ricella |               |           |
+---------------+---------------+---------+---------------+-----------+
| **Influenza** | Airborne      | YES     | Fever,        | A         |
|               |               |         | fatigue, loss | ntivirals |
|               |               | (       | of appetite,  |           |
|               |               | changes | nausea,       | (am       |
|               |               | yearly  | headache      | antadine, |
|               |               | based   |               | rim       |
|               |               | on      |               | antadine, |
|               |               | strains |               | z         |
|               |               | e       |               | anamivir, |
|               |               | xpected |               | and       |
|               |               | to      |               | ose       |
|               |               | cause   |               | ltamivir) |
|               |               | inf     |               |           |
|               |               | ection) |               |           |
+---------------+---------------+---------+---------------+-----------+

+---------------+---------------+---------+---------------+-----------+
| ####          |               |         |               |           |
|   DISEASE INF |               |         |               |           |
| ORMATION FOR  |               |         |               |           |
| EMERGENCY RES |               |         |               |           |
| PONSE PERSONN |               |         |               |           |
| E L (cont\'d) |               |         |               |           |
+---------------+---------------+---------+---------------+-----------+
| **Diseas      | **Mode of     | **      | **Sig         | **Post    |
| e/Infection** | T             | Vaccine | ns/Symptoms** | -Exposure |
|               | ransmission** | Avai    |               | Tr        |
|               |               | lable** |               | eatment** |
+---------------+---------------+---------+---------------+-----------+
| **Lice: Head, | Close head to | NO      | Severe        | Wash      |
| Body, Pubic** | head contact. |         | itching and   | clothes,  |
|               | Both body and |         | scratching,   | personal  |
|               | pubic lice    |         | often with    | articles  |
|               | require       |         | secondary     | in hot    |
|               | intimate      |         | infection.    | water.    |
|               | contact       |         | Scalp and     |           |
|               | (usually      |         | hairy         | Gamma     |
|               | sexual) or    |         | portions of   | benzene   |
|               | sharing of    |         | body may be   | hex       |
|               | intimate      |         | affected.     | achloride |
|               | clothing.     |         | Eggs of head  | shampoo   |
|               |               |         | lice (nits)   | (Kwell,   |
|               |               |         | attach to     | Rid,      |
|               |               |         | hairs as      | etc.) if  |
|               |               |         | small round,  | crawling  |
|               |               |         | gray lumps.   | lice or   |
|               |               |         |               | nits are  |
|               |               |         |               | noted     |
|               |               |         |               | close to  |
|               |               |         |               | the       |
|               |               |         |               | scalp.    |
+---------------+---------------+---------+---------------+-----------+
| **Measles**   | Respiratory   | YES     | Fever, rash,  | See       |
|               | droplets and  |         | cough         | German    |
|               | contact with  |         |               | Measles   |
|               | nasal or      |         |               |           |
|               | throat        |         |               |           |
|               | secretions    |         |               |           |
+---------------+---------------+---------+---------------+-----------+
| **            | Respiratory   | YES     | Fever, severe | Rifampin, |
| Meningitis:** | secretions    |         | headache,     |           |
|               | contact       | YES     | stiff neck,   | Cep       |
| **Me          |               |         | sore throat,  | hlosporin |
| ningoccocal** | Respiratory   | NO      | may have      |           |
|               | secretions    |         | distinctive   |           |
| **Haemophilus | contact       |         | rash          |           |
| influenza     |               |         |               |           |
| (usually seen | Fecal/Oral    |         | (Same)        |           |
| in very young |               |         |               |           |
| children)**   |               |         | (Same)        |           |
|               |               |         |               |           |
| **Viral**     |               |         |               |           |
+---------------+---------------+---------+---------------+-----------+
| **Mo          | Contact with  | NO      | Fever, sore   |           |
| nonucleosis** | respiratory   |         | throat,       |           |
|               | secretions or |         | fatigue,      |           |
|               | saliva, such  |         | swollen lymph |           |
|               | as with       |         | nodes/spleen  |           |
|               | m             |         |               |           |
|               | outh-to-mouth |         |               |           |
|               | resuscitation |         |               |           |
+---------------+---------------+---------+---------------+-----------+

+---------------+---------------+---------+---------------+-----------+
| ###           |               |         |               |           |
| #  DISEASE IN |               |         |               |           |
| FORMATION FOR |               |         |               |           |
|  EMERGENCY RE |               |         |               |           |
| SPONSE PERSON |               |         |               |           |
| NEL (cont\'d) |               |         |               |           |
+---------------+---------------+---------+---------------+-----------+
| **Diseas      | **Mode of     | **      | **Sig         | **Post    |
| e/Infection** | T             | Vaccine | ns/Symptoms** | -Exposure |
|               | ransmission** | Avai    |               | Tr        |
|               |               | lable** |               | eatment** |
+---------------+---------------+---------+---------------+-----------+
| **Mumps**     | Respiratory   | YES     | Fever,        | See       |
|               | droplets and  |         | swollen       | German    |
| **            | contact with  |         | salivary      | Measles   |
| (Parotitis)** | saliva        |         | (parotid)     |           |
|               |               |         | glands        |           |
+---------------+---------------+---------+---------------+-----------+
| **Sa          | Foodborne     | NO      | Sudden onset  |           |
| lmonellosis** |               |         | of fever,     |           |
|               |               |         | abdominal     |           |
|               |               |         | pain,         |           |
|               |               |         | diarrhea,     |           |
|               |               |         | nausea, and   |           |
|               |               |         | frequent      |           |
|               |               |         | vomiting      |           |
+---------------+---------------+---------+---------------+-----------+
| **Scabies**   | Close body    | NO      | Itching, tiny |           |
|               | contact       |         | linear        |           |
|               |               |         | burrows or    |           |
|               |               |         | "tracks,"     |           |
|               |               |         | vesicles -    |           |
|               |               |         | particularly  |           |
|               |               |         | around        |           |
|               |               |         | fingers,      |           |
|               |               |         | wrists,       |           |
|               |               |         | elbows, and   |           |
|               |               |         | skin folds    |           |
+---------------+---------------+---------+---------------+-----------+
| **Syphilis**  | Primarily     | NO      | Genital and   |           |
|               | sexual        |         | cutaneous     |           |
|               | contact;      |         | lesions,      |           |
|               | rarely        |         | nerve         |           |
|               | through blood |         | degeneration  |           |
|               | transfusion   |         | (late)        |           |
+---------------+---------------+---------+---------------+-----------+
| **            | Airborne      | NO      | Fever, night  | ##        |
| Tuberculosis, |               |         | sweats,       |           |
| pulmonary**   |               |         | weight loss,  | ##        |
|               |               |         | cough         | Isoniazid |
|               |               |         |               |           |
|               |               |         |               | Rifampin, |
|               |               |         |               | pyr       |
|               |               |         |               | azinamide |
+---------------+---------------+---------+---------------+-----------+
| **Whooping    | Airborne,     | YES     | Violent cough |           |
| Cough         | direct        |         | at night,     |           |
| (Pertussis)** | contact with  |         | whooping      |           |
|               | oral          |         | sound when    |           |
|               | secretions    |         | cough         |           |
|               |               |         | subsides      |           |
+---------------+---------------+---------+---------------+-----------+

**Note:** Post-exposure protocols change frequently based on new
information. The Centers for Disease Control and Prevention (CDC) and
the *Morbidity Mortality Weekly Report* should be checked regularly for
the most up-to-date information.

### CHAPTER 2

**LAWS, REGULATIONS, AND REGULATIONS**

**OVERVIEW**

A formal infection control program has two basic goals: (1) to provide
all members with the best possible protection from communicable disease;
and (2) to protect patients from potential infection. A resultant third
goal is to protect the department or jurisdiction from potential
liability. A properly designed infection control program will help
reduce the risk of members contracting a communicable disease, manage
civil liability, lower health insurance costs, minimize "sick time," and
ensure compliance with all applicable statutes. Knowledge of applicable
laws, regulations, and standards is a prerequisite to meeting these
goals. This chapter summarizes current national laws, regulations, and
standards that relate to emergency service infection control.

**LAWS, REGULATIONS, AND STANDARDS**

Many Federal and national organizations play a critical role in
establishing requirements and recommendations for infection control in
the work environment. These organizations include:

-   Public Law (U.S. Congress)

-   The Occupational Safety and Heath Administration (OSHA), U.S.
    Department of Labor

-   The National Fire Protection Association (NFPA)

-   The U.S. Department of Health and Human Services, Centers for
    Disease Control and Prevention (CDC).

Ensuring compliance with the standards described in this *Guide* is
crucial in managing an effective infection control program. However,
additional research will be needed to identify State and/or local
regulations that also apply.

While State/local regulations vary from jurisdiction to jurisdiction,
some of the more common ones include

-   **Duty-to-act laws** that require emergency response personnel to
    provide a "reasonable level of care" to all patients.

-   **Patient abandonment laws** that specify that patient care may be
    relinquished only to someone having an equal or higher level of
    medical expertise.

-   **Biohazard waste laws** that govern the storage, handling, and
    disposal of medical waste.

**PUBLIC LAW**

**Ryan White Comprehensive AIDS Resources Emergency Act of 1990**

**(PL 101-381)**

This act delineates specific notification requirements that allow
emergency response personnel to find out if they have been exposed to an
"infectious disease" while providing patient care. Diseases covered
include Hepatitis B, tuberculosis, meningococcal (bacterial) meningitis,
and HIV.

Each employer of emergency response personnel is required to name a
"designated officer" to coordinate communication between the treating
facility (hospital) and the emergency response organization.
Notification of exposure may be "routine" or "by request."

**Routine notification -** Notification must be provided by the treating
facility to the designated officer when it is determined that a patient
transported by emergency response personnel has an airborne communicable
disease. This includes patients that expire in transit, or shortly
after. Notification must be made no later than 48 hours after the
diagnosis is made. Routine notification only pertains to transportation
crews. It does not cover responders who provide on-scene care but not
transportation.

**Notification by request -** Any member who "attended, treated,
assisted, or transported" a victim of an emergency where exposure to
infectious disease may have occurred can request notification. The
request is made through the designated officer, who reviews the case and
notifies the treating facility. The treating facility reviews the case
and notifies the designated officer that: a) an exposure took place; b)
an exposure did not take place; or c) insufficient information exists to
determine exposure risk. In disputed cases, or cases of insufficient
information, the designated officer may use the services of the local
public health officer in resolution. This Act does not authorize
mandatory patient testing for infectious diseases.

**Americans with Disabilities Act (ADA) (PL 101-336)**

This Act provides a national mandate for the elimination of
discrimination against individuals with disabilities. The ADA prohibits
discrimination against disabled individuals in the areas of hiring,
firing, promotion, benefits, and management of staff. The ADA obligates
employers to make **reasonable accommodation** to the disabilities of
otherwise qualified people, in order to guarantee equal employment
opportunities.

"Contagious diseases," such as tuberculosis and HIV infection, are
considered disabilities under the ADA. People with contagious
(communicable) diseases are protected against discrimination, as long as
they can perform the essential functions of a job and do not pose a
threat to the health and safety of others in the workplace. Cases must
be considered individually; one individual who has a communicable
disease and poses a serious health threat does not justify excluding all
persons with actual or perceived communicable diseases.

Fear expressed by other employees of being infected by an "otherwise
qualified" employee with a communicable disease must be supported by
objective evidence of risk. If a person poses a significant risk of
transmission of infection that cannot be eliminated by reasonable
accommodation, the person may be found to constitute a direct threat to
the health or safety of others.

The ADA poses a substantial potential liability to any employer who
fails to heed the requirements of the Act. Lawsuits and/or fines may be
a result of discriminatory acts in hiring, firing, promotion, benefits,
and/or management of staff. Compliance may be costly, and must be
considered in budgetary planning. This includes training of employees,
supervisors, and managers if necessary.

#### Health Care Worker Needlestick Safety and Prevention Act (PL 106-430)

Passed unanimously by Congress, the Needlestick Safety and Prevention
Act became effective in November 2000. This Act directed OSHA to make
specific revisions to the *Occupational Exposure to Bloodborne
Pathogens* (29 CFR Part 1910.1030) within 6 months. These revisions went
into effect January 18, 2001 with the release of *Occupational Exposure
to Bloodborne Pathogens; Needlesticks and Other Sharps Injuries; Final
Rule* (29 CFR Part 1910.1030). The text of the law can be found in
Appendix B1.

**OSHA REGULATIONS**

The Occupational Safety and Health Administration (OSHA), U.S.
Department of Labor, is the branch of the Federal government responsible
for safety in the workplace. OHSA publishes Federal regulations that
establish minimum standards for workplace safety and health. Each State,
territory, or possession has the option of adopting OSHA regulations as
published, or enacting "State" OSHA plans that are at least as stringent
as the Federal standards. Table 1-2-1 lists the States that have their
own OSHA plans.

+--------------------------+--------------------------+----------------+
| **Table 1-2-1**          |                          |                |
|                          |                          |                |
| **STATES/TERRITORIES     |                          |                |
| WITH OSHA PLANS**        |                          |                |
+--------------------------+--------------------------+----------------+
| **Alaska**               | **Michigan**             | **South        |
|                          |                          | Carolina**     |
+--------------------------+--------------------------+----------------+
| **Arizona**              | **Minnesota**            | **Tennessee**  |
+--------------------------+--------------------------+----------------+
| **California**           | **Nevada**               | **Utah**       |
+--------------------------+--------------------------+----------------+
| **Connecticut**          | **New Jersey**           | **Vermont**    |
+--------------------------+--------------------------+----------------+
| **Hawaii**               | **New Mexico**           | **Virginia**   |
+--------------------------+--------------------------+----------------+
| **Indiana**              | **New York**             | **Virgin       |
|                          |                          | Islands**      |
+--------------------------+--------------------------+----------------+
| **Iowa**                 | **North Carolina**       | **Washington** |
+--------------------------+--------------------------+----------------+
| **Kentucky**             | **Oregon**               | **Wyoming**    |
+--------------------------+--------------------------+----------------+
| **Maryland**             | **Puerto Rico**          |                |
+--------------------------+--------------------------+----------------+

**Applicability**

Emergency service personnel are not always covered by OSHA regulations.
Determining whether or not a particular agency is required to comply
with OSHA regulations requires research. However, the following general
guidelines apply.

Federal OSHA regulations generally apply only to Federal, military, and
private employers. Thus, in States that have simply adopted the Federal
OSHA regulations, most emergency service personnel (whether paid or
volunteer) are not covered.

If a State opts to develop its own OSHA plan, all paid State and local
government employees (including emergency response personnel) **must**
be covered. (In some States, only State and local employees are
covered.) However, each specific State decides whether or not to include
volunteer emergency response personnel. At present, 24 States, the
Virgin Islands, and Puerto Rico have "State" OSHA plans. OSHA maintains
a list of States with their own plans and contact information on their
Web site at http://www.osha.gov/as/opa/worker/.

Emergency response personnel involved in hazardous material response in
States and territories having a State OSHA plan are covered under OSHA
29 CFR Part 1910.120. For workers not covered by a State OSHA plan, the
Environmental Protection Agency (EPA) issued a regulation (40 CFR Part
311) in 1989. This regulation is functionally similar to OSHA's
Hazardous Waste Operations and Emergency Response (HAZWOPER) regulation,
specifically citing that the requirements in the OSHA 29 CFR Part
1910.120 will be applicable in all States, regardless of OSHA status.
Communicable disease risks and hazards are the same in each State,
regardless of local compliance requirements. Thus, adherence to OSHA
regulations is recommended for **all** emergency service agencies.

**Occupational Exposure to Bloodborne Pathogens (29 CFR Part
1910.1030)**

This regulation establishes standards for workplace protection from
bloodborne diseases. The primary diseases of concern are Hepatitis B
(HBV), Hepatitis C (HCV), and Human Immunodeficiency Virus (HIV). The
primary methods of protection are training, engineering and work
practice controls, immunization against HBV, and the use of universal
precautions. Recognizing that the tasks performed by emergency
responders often are undertaken during uncontrolled situations, the
regulation states that **all body fluids are considered infectious when
differentiation between fluid types is difficult.**

Each employer must establish an "exposure control plan." The plan must

-   Identify and categorize all job classifications and tasks that
    reasonably can be anticipated to have a potential for exposure to
    blood or body fluids.

-   Delineate the implementation plan and schedule for the infection
    control program.

-   Identify the procedures for evaluating/investigating exposure
    incidents.

This regulation prohibits eating, drinking, smoking, applying cosmetics,
or handling contact lenses in work areas where there is potential for
occupational exposure to bloodborne pathogens. Hands must be washed as
soon as feasible after removal of gloves or other personal protective
equipment. If hand-washing facilities are not available (e.g., at the
scene), alternative hand-washing provisions must be provided by the
employer.

Personal protective equipment (PPE) is covered in detail. Employers are
required to supply, repair, and replace PPE including gloves, gowns,
face shields or masks and eye protection, and resuscitation equipment.
Exemptions to the use of PPE are allowed where "its use would have
prevented the delivery of health-care of public safety services or would
have posed an increased hazard to the safety of the worker or
co-workers." These exemptions are meant to apply to unexpected, "rare
and extraordinary circumstances." The decision not to use PPE rests with
the employee, and not the employer.

A general framework for post-exposure care that follows Public Health
Service guidelines is presented, including the need for medical
recordkeeping. Each employee must receive a copy of the regulation and,
to assure understanding, must receive training in communicable
disease/infection control. Written training records must be maintained,
including attendance. Training must be provided annually in each of the
following subjects:

-   Epidemiology, modes of transmission, and symptoms of bloodborne
    diseases.

-   The employer's exposure control plan.

-   Recognition of tasks that may result in exposure to bloodborne
    diseases.

-   Use and limitations of practices that will reduce or prevent
    exposures.

-   Proper selections, use, location, removal, handling,
    decontamination, and disposal of PPE.

-   Information on Hepatitis B vaccine.

-   Emergency procedures, including post-exposure requirements.

-   Recognition of standard biohazard markings, color-coding, and
    labeling.

#### Subpart Z of *Occupational Exposure to Bloodborne Pathogens; Final Rule.* (OSHA 29 CFR Part 1910.1030) are included in Appendix B2. The entire regulation is available on the Web at http://www.osha-slc.gov/OshStd_data/1910_1030.html.

**Occupational Exposure to Bloodborne Pathogens; Needlesticks and Other
Sharps Injuries; Final Rule (29 CFR Part 1910.1030, January 18, 2001)**

This regulation updates the original *Occupational Exposure to
Bloodborne Pathogens* (29 CFR Part 1910.1030) to include the
requirements of the Health Care Worker Needlestick Safety and Prevention
Act (PL 106-430). This adds new requirements for exposure control
programs and requires the use of a sharps/needlestick injury log. The
revision clearly specifies engineering controls necessary for
minimization of employee exposure. It clarifies the need to involve
employees in identifying and choosing the devices and includes
provisions designed to maintain the privacy of employees who have
experienced needlesticks. The text of this regulation can be found in
Appendix B3 of this manual and also is available on the Web at
http://www.osha-slc.gov/needlesticks/index.html.

**Access to Employee Exposure and Medical Records (29 CFR Part
1910.20)**

This section provides for employee access to their own medical and
exposure records and regulates the storage of such records. Employers
must make medical and relevant exposure records available within fifteen
days of any formal request. A physician representing the employer may
recommend that the records be released as a summary rather than the
complete chart, or that the records be released only to a physician.
This section also allows OSHA access to medical and exposure records.

Employee medical/exposure records must be maintained for the duration of
employment plus thirty years. Instruction on transfer of records is
provided for businesses that close before the thirty-year limit is
reached.

**NATIONAL FIRE PROTECTION ASOCIATION (NFPA)**

Standards and codes published by the NFPA represent the consensus
opinions of a committee of experts representing different interests
relating to the subject matter involved. NFPA standards are not
mandatory until official adoption by the authority having jurisdiction.
Nor does NFPA enforce or monitor compliance. However, since NFPA
standards reflect the national "industry standard" or "standard of
care", a department not meeting these standards could face possible
liability in the event of litigation.

NFPA 1500 (1997 Edition)

NFPA 1500, *Standard on Fire Department Occupational Safety and Health
Program*, is an umbrella document intended to establish a framework for
a comprehensive safety and health program. It requires an official
written department occupational safety and health policy, and the
appointment of an occupational safety and health officer, an
occupational safety and health committee, and a fire department
physician. Health maintenance issues addressed include pre-entry health
examinations and periodic health reassessment as specified in NFPA 1582,
*Standard on Medical Requirements for Fire Fighters and Information for
Fire Department Physicians*, and after "debilitating illnesses or
injuries."

Infection control recommendations include active attempts to identify
and limit member exposure to contagious diseases and making available
"inoculations, vaccinations, and other treatment." It requires
departments to operate an infection control program as specified in NFPA
1581, *Standard on Fire Department Infection Control Program*, and to
maintain a confidential health database that documents occupational
injuries, illnesses, and exposures to hazardous materials, toxic
products, or contagious diseases.

Preventive health measures recommended include a member assistance and
wellness program and a critical incident stress program. Recordkeeping
requirements and confidentiality safeguards for member assistance
programs are listed.

NFPA 1521 (1997 Edition)

NFPA 1521, *Standard on Fire Department Safety Officer*, differentiates
between the roles of Incident Safety Officer (ISO) and Health and Safety
Officer (HSO). The Health and Safety Officer must "have and maintain a
knowledge of the current health and physical fitness factors" that
affect the work environment. The Health and Safety Officer has the
authority to "cause immediate correction of situations that create an
imminent hazard to members." The Incident Safety Officer must "have and
maintain a knowledge of safety and health hazards involved in emergency
operations" and has the authority to "alter, suspend, or terminate"
activities at an emergency incident that are judged to be "unsafe or to
involve an imminent hazard."

The standard also requires the establishment of a department database to
maintain records of all "accidents, occupational deaths, injuries,
illnesses, and exposures." The Health and Safety Officer is responsible
for management and analysis of this information.

**NFPA 1581** **(2000 Edition)**

NFPA 1581, *Standard on Fire Department Infection Control Program*,
establishes minimum requirements for an infection control program in
emergency service organizations. Specific areas addressed include

-   Program components, including the designation of an Infection
    Control Officer.

-   Station facilities and apparatus requirements.

-   Personal Protective Equipment.

-   Cleaning, disinfection, and disposal procedures.

-   Post-exposure procedures.

-   Immunization requirements.

Immunization requirements vary somewhat from CDC recommendations. CDC
currently recommends immunizations for Hepatitis B, measles, mumps,
rubella, influenza, and chickenpox. NFPA recommends immunization for
Hepatitis B and influenza, and "where specific or local conditions
dictate": Hepatitis A, measles, mumps, rubella, tetanus and diptheria
(Td) booster every 10 years, and meningococcal disease.

NFPA 1582 (2000 Edition)

NFPA 1582, *Standard on Medical Requirements for Fire Fighters and
Information for Fire Department Physicians*, addresses the medical
requirements necessary for persons who perform firefighting tasks. Two
categories of medical conditions are identified. Category A identifies
the medical conditions that "would not allow a person to perform
firefighting operations." Category B identifies medical conditions that
must be evaluated "on a case-by-case basis" to determine if the
condition would prevent a person from performing firefighting
operations.

The standard specifically requires "a tuberculosis monitoring program
that will test members at least annually and as indicated by CDC
guidelines." Medical evaluations, medical examinations, recordkeeping,
and confidentiality also are addressed.

#### CENTERS FOR DISEASE CONTROL AND PREVENTION 

The Centers for Disease Control and Prevention (CDC) publishes the
*Morbidity Mortality Weekly Report* (MMWR), a weekly update of
information on communicable diseases. The infection control officer
should review periodically MMWR for new information. A subscription is
expensive; however, the contents are available for both the latest and
past issues of MMWR online at http://www2.cdc.gov/mmwr/mmwr_wk.html.
Liaison with a local infection control practitioner is another possible
source of current information. The most current issues dealing with
worker protection from HIV, HBV, HCV, tuberculosis, and immunization
recommendations are summarized on the following pages. All of the MMWR
publications discussed in this *Guide* can be viewed and downloaded in
Adobe format in their entirety by accessing the "Search" at
http://www2.cdc.gov/mmwr/mmwr_wk.html and typing in the Volume, Number,
and Date.

Recommendations for Prevention of HIV Transmission in Health-Care
Settings (MMWR Vol. 36, No. 2, August 21, 1987)

This document established the concept of "universal precautions." Under
universal precautions, the blood and certain body fluids of all patients
are considered potentially infectious. Although saliva still has not
been implicated as a mode of transmission for HIV, the use of
mouthpieces or resuscitation bags to minimize the need for
mouth-to-mouth resuscitation was recommended.

Additional information is available from CDC regarding respiratory
protection against tuberculosis. *CDC Recommendations from Respiratory
Protection* updates the 1994 recommendations to account for subsequent
national Institute for Occupational Safety and Health (NIOSH)
respiratory classifications and contains the recommendation for
respirators meeting Class N95 or better. This document is available at
http://www.cdc.gov/niosh/tb.html. NIOSH also has produced several
reference documents on this subject, including *Protect Yourself Against
Tuberculosis* (http://www.cdc.gov/niosh/tb.html) and *Respiratory
Protection Program In Health Care Facilities -- Administrator's Guide*
(http://www.cdc.gov/niosh/99-143.html).

Universal Precautions for Prevention of Transmission of Human
Immunodeficiency Virus, Hepatitis B Virus, and Other Bloodborne
Pathogens in Health Care Settings (MMWR Vol. 37, No. 24, June 24, 1988)

This document extended universal precautions to include body tissues and
cerebrospinal, synovial, pleural, pericardial, and amniotic fluids.
Universal precautions are not required for feces, nasal secretions,
sputum, saliva, urine, tears, or vomitus, unless they contain visible
blood.

Blood was cited as the most important source of HIV/HBV infection in
occupational settings. Semen and vaginal secretions also can transmit
HIV/HBV as sexual diseases.

Guidelines for Prevention of Transmission of Human Immunodeficiency
Virus and Hepatitis B Virus to Health Care and Public Safety Workers
(MMWR Vol. 38, No. 2-6, 1989)

This document was published in response to the Health Omnibus Programs
Extension Act of 1988 (PL 100-607). Universal precautions were expanded
to the extent that "when emergency medical and public-safety workers
encounter body fluids under uncontrolled, emergency circumstances in
which differentiation between fluid types is difficult, if not
impossible, they should treat all body fluids as potentially hazardous."
This document is often considered the "Bible" of emergency service
infection control. However, much of the information contained in these
guidelines was taken from other MMWR's.

# 

#  

# Recommendations for Preventing Transmission of Human Immunodeficiency Virus and Hepatitis B Virus to Patients During Exposure-Prone Invasive Procedures (MMWR Vol. 40, No. RR-08, July 12, 1991)

This document addresses the status of health-care workers who have HIV
or HBV. Although directed at hospital personnel, this document
identifies exposure-prone procedures as those that include digital
palpation of a needle tip in a body cavity or the simultaneous presence
of the health-care worker's fingers and a needle or other sharp
instrument or object in a poorly visualized or highly confined anatomic
site.

The document also outlines the scope of practice for infected
health-care workers as follows. Health-care workers who are infected
with HIV or HBV (and are positive for the HbeAg antigen) should not
perform exposure-prone procedures unless they have sought counsel from
an expert review panel and been advised under what circumstances, if
any, they may continue to perform these procedures. Such circumstances
would include notifying prospective patients of the health-care worker's
seropositivity before they undergo exposure-prone invasive procedures.

Health-care workers whose practices are modified because of their HIV or
HBV infection status should, whenever possible, be provided
opportunities to continue appropriate patient-care activities. Career
counseling and job retraining should be encouraged to promote the
continued use of the worker's talents, knowledge, and skills.
Health-care workers whose practices are modified because of HBV
infection should be reevaluated periodically to determine whether their
seropositive status changes due to resolution of infection or as a
result of treatment

**Guidelines for Preventing the Transmission of Mycobacterium
Tuberculosis in Health-Care Facilities, 1994 (MMWR Vol. 43, No. RR-13,
October 28, 1994)**

This document updates the 1990 guidelines and focuses on the importance
of a) the hierarchy of control measures, including administrative and
engineering controls and personal respiratory protection; b) the use of
risk assessments for developing a written tuberculosis (TB) control
plan; c) early identification and management of persons who have TB; d)
TB screening programs for health-care workers; e) health-care worker
training and education; and f) the evaluation of TB infection control
programs. The following criteria are identified for respiratory
protective devices:

-   "The ability to filter particles 1 um in size in the unloaded state
    with a filter efficiency of greater than or equal to 95percent
    (i.e., filter leakage of less than or equal to 5 percent), given
    flow rates of up to 50 L per minute.

-   The ability to be qualitatively or quantitatively fit tested in a
    reliable way to obtain a face-seal leakage of less than or equal to
    10 percent.

-   The ability to fit the different facial sizes and characteristics of
    health care workers, which can usually be met by making the
    respirators available in at least three sizes.

-   The ability to be checked for face piece fit, in accordance with
    standards established by the Occupational Safety and Health
    Administration (OSHA) and good industrial hygiene practice, ... each
    time they put on their respirators."

Two recommendations specific to emergency medical services are

-   "When EMS personnel or others must transport patients who have
    confirmed or suspected active TB, a surgical mask should be placed,
    if possible, over the patient\'s mouth and nose. Because
    administrative and engineering controls during emergency transport
    situations cannot be ensured, EMS personnel should wear respiratory
    protection when transporting such patients. If feasible, the windows
    of the vehicle should be kept open. The heating and air-conditioning
    system should be set on a nonrecirculating cycle.

-   EMS personnel should be included in a comprehensive PPD screening
    program and should receive a baseline PPD test and follow-up testing
    as indicated by the risk assessment. They should also be included in
    the follow-up of contacts of a patient with infectious TB."

Immunization of Health-Care Workers: Recommendations of the Advisory
Committee on Immunization Practices (ACIP) and the Hospital Infection
Control Practices Advisory Committee (HICPAC) (MMWR Vol. 46, No. RR-18,
December 26, 1997)

This report discusses all the immunizations recommended for health-care
workers and provides the regime for those immunizations. ACIP strongly
recommends that all health-care workers be vaccinated against (or have
documented immunity to) Hepatitis B, influenza, measles, mumps, rubella,
and varicella.

The report identifies Hepatitis B virus (HBV) infection as the major
infectious hazard for health-care personnel. Prevaccination serologic
screening for prior infection is not indicated. Postvaccination testing
for antibody to Hepatitis B surface antigen (anti-HB's) response is
indicated for health-care workers who have blood or patient contact and
are at ongoing risk for injuries with sharp instruments or needlesticks.
Studies among adults have demonstrated that, despite declining serum
levels of antibody, vaccine-induced immunity continues to prevent
clinical disease or detectable viremic HBV infection. Therefore, booster
doses are not considered necessary. This is a change from the 1990
recommendations. Table 1-2-2 summarizes these recommendations.

+-----------------------+------------------+---------------------------+
| Table 1-2-2           |                  |                           |
|                       |                  |                           |
| **Immunization of     |                  |                           |
| Health-Care Workers:  |                  |                           |
| Recommendations of    |                  |                           |
| the Advisory          |                  |                           |
| Committee on          |                  |                           |
| Immunization          |                  |                           |
| Practices (ACIP) and  |                  |                           |
| the Hospital          |                  |                           |
| Infection Control     |                  |                           |
| Practices Advisory    |                  |                           |
| Committee (HICPAC)**  |                  |                           |
+-----------------------+------------------+---------------------------+
| **Disease**           | **Immunization** | **Notes**                 |
+-----------------------+------------------+---------------------------+
| Hepatitis B           | Series of three  | Mandated by OSHA that it  |
|                       | doses            | is offered to employees   |
|                       |                  | at employer\'s expense.   |
+-----------------------+------------------+---------------------------+
| Influenza             | Yearly in the    | Each year influenza       |
|                       | fall             | vaccine recommendations   |
|                       |                  | are reviewed and amended  |
|                       |                  | to reflect updated        |
|                       |                  | information concerning    |
|                       |                  | influenza activity in the |
|                       |                  | United States for the     |
|                       |                  | preceding season. These   |
|                       |                  | recommendations are       |
|                       |                  | published annually in the |
|                       |                  | MMWR, usually during May  |
|                       |                  | or June.                  |
+-----------------------+------------------+---------------------------+
| Measles, Mumps,       | Series of two    | MMR is the vaccine of     |
| Rubella               | doses            | choice.                   |
+-----------------------+------------------+---------------------------+
| Varicella             | Series of two    | Recommended for all       |
|                       | doses            | health-care workers       |
+-----------------------+------------------+---------------------------+
| Tetanus, Diptheria    | Primary          | Booster is recommended    |
|                       | vaccination of   | every 10 years.           |
|                       | previously       |                           |
|                       | unvaccinated     | When wound is incurred,   |
|                       | adults consists  | booster should be         |
|                       | of three doses   | administered if last      |
|                       | of adult         | booster was more than 5   |
|                       | te               | years prior.              |
|                       | tanus-diphtheria |                           |
|                       | toxoid.          |                           |
+-----------------------+------------------+---------------------------+

ACIP does not recommend routine immunization of health-care workers
against tuberculosis, Hepatitis A, pertussis, meningococcal disease,
typhoid fever, or vaccinia. However, immunoprophylaxis for these
diseases may be indicated in certain circumstances.

**Catch-Up Vaccination Programs**

Managers of health-care facilities should consider implementing catch-up
vaccination programs for those already employed, in addition to policies
to ensure those newly hired receive necessary vaccinations. This
strategy will help prevent outbreaks of vaccine-preventable diseases.
Because education enhances the success of many immunization programs,
reference materials should be available to assist in answering questions
regarding the diseases, vaccines, and toxoids, and the program or policy
being implemented.

**Updated U.S. Public Health Service Guidelines for the Management of
Occupational Exposures to HBV, HCV, and HIV and Recommendations for
Postexposure Prophylaxis** (**MMWR***,* **Vol. 50, No. RR-11, June 29,
2001**)

This report updates and consolidates all previous U.S. Public Health
Service recommendations for the management of health-care workers who
have occupational exposure to blood or other body fluids that might
contain Hepatitis B (HBV), Hepatitis C (HCV), or HIV.

Recommendations for HBV postexposure management include initiation of
Hepatitis B vaccine series to susceptible unvaccinated persons and
Hepatitis B immune globulin and/or Hepatitis B vaccine series after
evaluation of the Hepatitis B surface antigen status.

Immune globulin or antiviral drugs are not recommended for HCV. However,
the HCV status of the source person and the exposed person should be
determined. If the source person is positive, follow-up testing should
be conducted to determine if an infection develops.

Recommendations for HIV include a basic 4-week course of two drugs
(zidovudine \[ZDV\] and lamivudine \[3TC\]; 3TC and stavudine \[d4T\];
or didanosine \[ddI\] and d4T). For exposures that pose an increased
risk of transmission, an expanded regimen includes the addition of a
third drug. The complete text of this guideline is included in Appendix
B4.

#####  SUMMARY

The department infection control program is designed to protect both the
health of the members and the department against related liability. For
these reasons, it is important to review and remain current on Federal,
State, and local statutes affecting infection control/environmental
issues.

Infection control is a rapidly expanding field. As new knowledge is
gained, the laws, standards, and regulations based on this knowledge
will change. The department Infection Control Officer needs to stay
up-to-date on both medical and legal changes. The department plan must
be reviewed and revised to incorporate these changes at appropriate
intervals.

### SECTION 2

**COMPONENTS OF AN INFECTION CONTROL PROGRAM**

**INTRODUCTION**

Developing, implementing, and managing an effective and efficient
infection control program is a process that involves several key
components. After it is developed, changes continually take place that
require the program be updated and revised to provide the best
protection possible for members.

#### RISK MANAGEMENT

Risk management is comprised of many elements including liability,
insurance, safety, health, security, financial impact, and several
others. The risks encountered by emergency services personnel are many,
such as traffic, response hazards, blood and body fluids, and violence.
To control these risks effectively, a fire or EMS department must use a
risk management program. **The primary focus of the internal
(organizational) risk management plan is firefighter safety and
health.**

Occupational exposure to blood, body fluids, or communicable or
infectious disease is a very real hazard for department members on a
daily basis. A written infection control policy or program is one
essential component that must be incorporated into the risk management
plan. Regardless of the type of service delivery (first responder, Basic
Life Support (BLS), or Advanced Life Support (ALS)), departments need to
have an infection control program and a risk management plan.

The safety and health component of risk management was incorporated into
NFPA 1500, *Standard on Fire Department Occupational Safety and Health*,
during the 1992 revision process. Simply stated, the requirements of the
risk management program are

-   The fire department shall adopt an official written risk management
    plan which addresses organizational policies and procedures.

-   The risk management plan shall be developed to address the following
    areas: administration, facilities, training, vehicle operations,
    protective clothing and equipment, operations at emergency
    incidents, operations at non-emergency incidents, and other related
    activities.

-   The risk management plan shall include the following components:

    -   risk identification

    -   risk evaluation

    -   risk control techniques

    -   risk monitoring

There is an additional step that can be added or incorporated into this
process, which is typically inserted between the risk identification and
risk control techniques. This step is called **prioritization of
risks**.

#### RISK MANAGEMENT MODEL 

There is no single method or solution for managing risk effectively.
Determining how to manage risk is a decision each department should make
based on the risk management model. In order for the risk management
plan to be effective, the following components must be included

**Risk Identification:** Actual or potential hazards for all job
functions.

Compile a list of all emergency and non-emergency operations provided by
the department. There are many sources to assist with this
identification process. The first, and possibly the most effective, is
the department's loss prevention data.

**Risk Evaluation:** The potential of occurrence of a given hazard and
the severity of its consequences.

Once the risks are identified, they can be evaluated from the standpoint
of both frequency and severity. Frequency addresses the likelihood of
occurrence. Typically, if a particular type of incident, such as back
injuries have occurred repeatedly, they will continue to occur until
effective control measures are implemented.

Severity addresses the degree of seriousness of the incident. This can
be measured in a variety of ways such as time away from work, cost of
damage, cost of and time for repair or replacement, disruption of
service, or legal costs. Using the information gathered in the
identification step, the risks then can be classified based on severity.

**Prioritizing Risk:** The degree of a hazard based upon the frequency
and severity of occurrence.

Taken in combination, the results of the frequency and severity
determinations will help to establish priorities for determining action.
Any risk that has a high probability of occurrence combined with serious
consequences, deserves immediate action, and would be considered a high
priority item. On the other end of the scale, non-serious incidents with
a low likelihood of occurrence are a lower priority, and can be placed
near the bottom of the \"action required\" list.

**Risk Control Measures:** Solutions for elimination or reduction of
real or potential hazards by implementing an effective control measure.

There are several approaches for controlling risk, including risk
avoidance, implementation of control measures, and risk transfer.

In any situation, the best choice is **risk avoidance.** Simply put,
this means avoid the activity that creates the risk. Frequently in an
emergency services organization this is not a practical choice. Lifting
a patient onto a stretcher presents a serious back injury risk, but you
cannot avoid this risk and still provide effective service!

An example of where avoidance has been very practical is the widespread
use of sharps containers. The risks associated with recapping needles
are well documented, so recapping is no longer an accepted practice.
This risky behavior can be avoided through the proper use of a sharps
container.

The most common method used for the management of risk is the adoption
of effective **control measures.** While control measures will not
eliminate the risk, they can reduce the likelihood of occurrence or
mitigate the severity. Safety programs, ongoing training and education
programs, and well-defined standard operating procedures (SOP's) are all
effective control measures.

Some typical measures instituted for infection control include
appropriate use of personal protective equipment (PPE) (gloves, masks,
goggles, etc.) during patient contact, training and education, and
competent SOP's. The combined use of these control measures results in
an effective program that reduces the risk of exposure to infectious
disease. **Risk transfer** can be accomplished in two primary ways -
physically transferring the risk to somebody else, or through the
purchase of insurance. For a fire or EMS organization, the transfer of
risk may be difficult, if not impossible. However, examples of risk
transfer would be 1) scheduling a routine transfer patient in protective
isolation in a newer vehicle with circulating air rather than an older
vehicle, and 2) contracting out the laundering of contaminated
linen/clothing to a commercial laundry. The risks associated with
example two have been transferred to a private contractor.

The purchase of insurance transfers financial risk only. It does nothing
to affect the likelihood of occurrence. Buying fire insurance on the
station, while highly recommended to protect the assets of the
department, does nothing to prevent the station from burning down.
Therefore, insurance is no substitute for effective control measures.

**Risk Monitoring:** Evaluation of effectiveness of risk control

measures.

The last step in the process is risk management monitoring. Once control
measures have been implemented, they need to be evaluated to measure
their effectiveness. Any problems that occur in the process have to be
revised or modified. This final step ensures that the system is dynamic,
and will facilitate periodic reviews of the entire program.

The intent of the risk management plan is to develop a strategy for
reducing the inherent risks associated with fire department operations.
Regardless of the size or type of fire department, every organization
should operate within the parameters of a risk management plan. This is
a dynamic and aggressive process that must be monitored and revised
annually by the health and safety officer.

The risk to members providing care to a patient with a communicable
disease poses a real hazard and should be properly addressed through a
written infection control program. The infection control program should
include, at a minimum, the following issues:

-   Training and education

```{=html}
<!-- -->
```
-   PPE

```{=html}
<!-- -->
```
-   Health maintenance

-   Immunizations

-   Exposure management

-   Fire department facilities

-   Fire department vehicles

-   Cleaning, disinfecting, and disposal

Infection control is a preventive means of controlling risks associated
with patient care. By incorporating infection control into the risk
management process, frequency and severity of risks associated with
communicable diseases are adequately controlled. The health and safety
officer, designated infection control officer, incident safety officer,
and the department's Occupational Safety and Health Committee should
ensure that evaluations and revisions to the risk management plan occur
at least annually.

Safety is a major component of risk management. Most of the emphasis
placed on risk management from a fire service perspective is from a
safety approach. The safety component affects other risk management
components in areas such as liability and finance. An aggressive,
proactive occupational safety and health program will reduce accidents,
injuries, occupational illnesses, and health exposures. This, in turn,
reduces the department's liability claims and payments and also provides
a positive effect on the financial well being of the organization. Many
fire departments are self-insured, which means that the entity,
jurisdiction, or the fire department generates funding for various types
of insurance such as workers' compensation, vehicle and general
liability.

##### TRAINING AND EDUCATION

Training and education is a vital component to ensure a successful
program, and is a crucial element of the risk management process. The
department shall conduct initial and annual training and education
programs for all members in accordance with Federal or State
regulations. Members will receive bloodborne pathogen training at the
time of initial assignment of job functions (recruit training or company
in-service) whenever exposure potential exists. Additional training
shall be provided whenever there are changes in work assignments, job
functions, or new protective clothing and equipment is placed in
service. Training will include an opportunity for members to have their
questions answered by the instructor.

Topics for the infection control training program include

-   Epidemiology

-   Proper use of PPE

-   SOP's for safe work practices relating to infection control

-   Proper methods of disposal of contaminated medical waste

-   Cleaning and decontamination

-   Reporting process of exposures

-   Exposure management.

-   Medical followup care and treatment.

All training and education programs for infection control will be
properly documented in writing. The training report needs to include

-   Dates of training session

-   Contents and/or summary of the training session

-   Names and qualifications of instructor(s)

-   Names and job titles of members attending.

##### 

##### MEMBERS

Each member of the fire department has the right to be protected by an
effective occupational safety and health program and shall participate
and comply with the requirements of the occupational safety and health
program. Each member can also participate or be represented in the
research, development, implementation, evaluation, and enforcement of
this program.

The infection control program has the goal of identifying the risks of
exposures to members and the means to prevent those exposures. All
members have the individual responsibility for their own health, safety,
and welfare. Each member is responsible for complying with all
departmental SOP's, including occupational safety and health. Each
member must ensure his or her own safety and health against occupational
exposures by:

-   Participating in available health maintenance programs (annual
    medical examinations, immunizations, medical screenings, etc.)

-   Practicing good personal hygiene

-   Reporting any personal medical conditions which could require work
    restrictions

-   Following infection control procedures at emergency incidents or
    while conducting patient care at any time

-   Properly using all infection control protective clothing and
    equipment

-   Reporting and documenting all exposures

-   Complying with medical followup treatment

-   Assuring proper decontamination of equipment after each incident

-   Proper storage/disposal of contaminated waste

```{=html}
<!-- -->
```
-   Attending annual retraining of all members as required by
    *Occupational Exposure to Bloodborne Pathogens* (29 CFR Part
    1910.1030).

##### 

##### HEALTH MAINTENANCE

All members of fire departments and emergency medical services
organizations must participate in a health maintenance process. The
health maintenance program is a significant part of the infection
control process. The health maintenance process as it relates to
infection control includes

-   Access to an appropriate immunization program which includes
    immunization against influenza and Hepatitis B;

```{=html}
<!-- -->
```
-   Members shall be offered immunizations for the following:

    -   Hepatitis A

    -   Measles, Mumps, and Rubella

    -   Tetanus/Diptheria

    -   Meningococcal disease

    -   Other diseases as required by specific incidents or local
        conditions

```{=html}
<!-- -->
```
-   Access to tuberculosis screening on an annual basis.

-   Health maintenance program which complies with NFPA 1582*, Standard
    on Medical Requirements for Fire Fighters and Information for Fire
    Department Physicians*.

-   The development of a confidential health database is established and
    maintained for each member in accordance with NFPA 1582*, Standard
    on Medical Requirements for Fire Fighters and Information for Fire
    Department Physicians* and 29 CFR Part 1910.20*, Access to Employee
    Exposure and Medical Records*.

-   In the event of an exposure, the member shall receive a confidential
    medical evaluation, post-exposure prophylaxis, counseling, and
    evaluation.

-   Return-to-work policy.

##### ROLES AND RESPONSIBILITIES

Many different individuals within a department or organization have a
valuable role to ensure that the infection control program is developed,
implemented, and properly and effectively managed. Each individual must
understand his/her role and responsibility in this process for the
safety, health, and welfare of the members. Role definition must spell
out specific areas of responsibility and accountability throughout the
organization. Specific role definitions will vary in each department,
depending on organizational structure, available resources, and program
requirements. The most vital issue is assigning and managing the
necessary components of the infection control program.

##### 

##### Chief of the Department

Although the chief of the department may have little direct involvement
in daily operations, he/she has the ultimate responsibility for the
health and welfare of department members. The chief of the department is
responsible for ensuring that an infection control program has been
developed and implemented, adequate funding is available for the
training, resources, procurement of equipment, supplies, and health
maintenance requirements. The chief must ensure that adequate staffing
is available to accomplish program goals and objectives and must define
authority and responsibility for each position identified in the
infection control program. In addition, he/she has the ultimate
responsibility of holding each member accountable for assigned
functions.

##### 

##### Safety Officer

The Safety Officer is defined by two distinct functions - Health and
Safety Officer (HSO) and Incident Safety Officer (ISO). Each of these
job functions has a defined responsibility relating to infection
control. In larger departments, the HSO serves as the manager of the
department's occupational safety and health program, while the ISO is
assigned to particular shifts or at emergency incidents to manage the
operational issues relating to firefighter health and safety. In smaller
departments, the Safety Officer may have both titles, as well as the
additional title of infection control officer.

##### 

##### Health and Safety Officer

The HSO has the responsibility of ensuring that the department has an
effective occupational safety and health program. As the manager of this
program, the HSO is responsible for ensuring that the fire department's
infection control program meets the requirements of 29 CFR Part
1910.1030, *Occupational Exposure to Bloodborne Pathogens,* 29 CFS Part
1910 *Occupational Exposure to Bloodborne Pathogens; Needlesticks and
Other Sharps Injuries; Final Rule, Guidelines for the Management of
Occupational Exposures to HBV, HCV and HIV and Recommendations for
Postexposure Prophylaxis* (MMWR, May 15, 2001), and NFPA 1581*, Standard
on Fire Department Infection Control Program*.

If the department does not have an infection control officer, the HSO
fills this void. If the department does have an infection control
officer, the HSO maintains a liaison with this individual to assist in
achieving the objectives of the infection control program as required by
NFPA 1581*, Standard on Fire Department Infection Control Program*.

##### 

##### Incident Safety Officer

As an operational function, the ISO monitors for compliance at an
emergency incident. The ISO can monitor emergency operations relating to
infection control. The ISO must ensure compliance with NFPA 1581*,
Standard on Fire Department Infection Control Program* during EMS
operations. Any problems that are encountered relating to infection
control can be channeled through the HSO for changes in appropriate
areas such as SOP's, training and education, and PPE.

##### Infection Control Officer

The Ryan White Comprehensive AIDS Resource Emergency Act of 1990
requires each department to name a designated infection control officer.
One of the primary responsibilities of the infection control officer is
to serve as a liaison between the department and the treating facility
in a potential or actual exposure.

The infection control officer should be a member of the department's
occupational safety and health committee. The infection control officer
works closely with the HSO and the ISO to ensure compliance with program
goals. The infection control officer is responsible for ensuring the
availability of PPE, monitoring compliance, and quality assurance
throughout the department, as well as maintaining required documentation
and recordkeeping.

##### 

##### Chief of Training

The chief of training is responsible for ensuring that all members have
met their initial and annual training requirements as required by 29 CFR
Part 1910.1030*, Occupational Exposure to Bloodborne Pathogens,* 29 CFS
Part 1910 *Occupational Exposure to Bloodborne Pathogens; Needlesticks
and Other Sharps Injuries; Final Rule,* and NFPA 1581*, Standard on Fire
Department Infection Control Program*. Each member must demonstrate the
necessary knowledge, skills, and abilities required to perform his/her
assigned tasks safely and to meet the mandated laws and standards.

The chief of training must work with the HSO and the infection control
officer to ensure a competent training program. Program managers must be
provided with an overview of the entire program. Officers must receive
training in SOP's, compliance, monitoring, recordkeeping requirements,
and proper use of protective clothing and equipment.

##### 

##### Occupational Safety and Health Committee

Each department should establish an occupational safety and health
committee. This committee provides an avenue for department members to
voice their concerns regarding safety and health issues, provide
guidance to the HSO, participate in research and development projects,
and suggest development of policies and procedures related to
occupational safety and health. The primary purpose of the committee is
to study, review, and make recommendations pertaining to occupational
health and safety within a department. Objectives of this committee
should include

-   Review department health and safety issues related to SOP's

-   Research and make recommendations concerning all fire department
    related equipment

-   Review causes of accidents and injuries within the department and
    develop means of reducing these incidents

-   Develop and implement an infection control program which meets the
    applicable laws, codes, and standards

-   Effect a reciprocal flow of information to all department members as
    it pertains to health and safety.

The occupational safety and health committee will be involved with
policy development, research of proper PPE, make recommendations for
facility safety issues, and participate in training programs. The
participation and involvement by members of this committee brings
expertise that improves the safety and health within the department.

##### 

##### Field Supervisors/Company Officers/Battalion Chiefs

All supervisors in the department are responsible for supporting,
promoting, and ensuring that each member comply with the infection
control program. Leading by example is a key component of the leadership
and management required for a compliant infection control program.
First-line supervisors play a critical role in this process by serving
as a positive role model. The supervisor's attitude and behavior
relating to infection control have a profound influence on actions or
inactions of subordinates.

Supervisors must ensure that all components of the infection control
plan are properly followed, particularly:

-   Health maintenance (assuring members are fit for duty)

-   Notification and documentation of exposures

-   Storage, maintenance, and availability of all necessary supplies,
    protective clothing, and equipment

-   Training

-   Decontamination and waste disposal

-   Proper use of protective clothing and equipment.

Supervisors also have the responsibility for managing an incident scene,
including ensuring effective customer service when dealing with
citizens, maintaining patient confidentiality, and being sensitive to
the needs of the patient.

##### 

##### Fire Department Physician 

The fire department physician is responsible for developing,
implementing, and managing a health maintenance program that is
compliant with the requirements of NFPA 1582*, Standard on Medical
Requirements for Fire Fighters and Information for Fire Department
Physicians*. This process involves a comprehensive health maintenance
program for all members, which includes 1) pre-entry and ongoing health
assessments, 2) immunizations, 3) postexposure procedures, 4)
recordkeeping, 5) medical treatment and followup care, and 6) member
assistance program.

The size and needs of the organization will dictate whether the fire
department needs a full-time physician. Fire departments of all sizes
and types, including those that do not provide EMS, should have a
working relationship with at least one designated physician who can
serve as the primary medical contact with other physicians and
specialists. Alternately, a department can designate several physicians,
use the services of a group practice, or have multiple providers \--
whichever best meets the needs of the organization and its members. The
most important aspect is to have a physician who is aware of the medical
needs of the department members and who is available on an immediate
basis.

The fire department physician is responsible for guiding, directing, and
advising members regarding their health and fitness to perform assigned
duties and responsibilities. He/She oversees the health components of
the department's occupational safety and health program and serves as a
resource for the infection control officer, particularly in assessing
potential exposure incidents.

Another key requirement is to be available for consultation and
counseling following members' exposures. The physician should provide
objective information regarding risk of disease based on specific type
of exposure, potential risk to members' families, recommended followup
treatment, possible long-term effects of the disease, and prophylactic
therapy. Maintaining confidentiality is an important responsibility of
the fire department physician.

The fire department physician should have specific expertise and
experience relating to the needs of firefighters and emergency medical
personnel and a thorough knowledge of the physical demands involved in
emergency operations. If possible, he/she should be a specialist in the
field of occupational medicine.

##### 

##### Local Medical Facility

The local medical facilities (hospitals) must have procedures in place
which provide adequate feedback to the department regarding exposures to
a communicable disease. The medical facility's infection control officer
must work jointly with the department's infection control officer so
feedback in either direction will ensure the health and welfare of the
members. The process must enable members to report a potential or actual
exposure to the department's infection control officer. This individual
forwards the information to the medical facility's infection control
officer for proper action. If the medical facility determines a patient
has a communicable disease (e.g. tuberculosis), this information must be
passed onto the responders who treated and transported the patient.
Immediate notification must be made by the medical facility's infection
control officer to the department's infection control officer. Exposures
occur at various times, and the notification process must be functional
24 hours a day/7 days a week in order to meet the medical requirements
specified for testing, prophalyxsis, and reporting.

# 

# Municipal/County Risk Manager

Those fire and EMS departments that are self-insured must provide the
funding for workers' compensation, medical care and treatment, medical
followup, and other components of the infection control process funded
by the government entity. A funding process must be established to
ensure the program is financially capable of maintaining this program.
If fire and EMS departments carry private insurance, these costs are
covered by the insurance policy. Prevention is a key to the success of
the infection control program. A risk manager prefers to fund a
preventive program rather than the financial impact of long-term or
chronic health problems or conditions.

##### 

##### POLICIES AND PROCEDURES

NFPA 1581, *Standard on Fire Department Infection Control Program*,
requires that a fire department develop and implement a written
infection control plan and *Occupational Exposure to Bloodborne
Pathogens* (29 CFR Part 1910.1030) requires the department to have a
written exposure control plan. For members to practice effective control
procedures and practices, the department must have a written infection
policy statement and procedures. Simply stated, the goal of the
infection control plan is to identify and limit the exposure of members
to communicable or infectious disease during the course of their
assigned duties and while in fire department facilities.

# 

# Policy Statement

The policy statement discusses purpose, scope, and content and sends a
safety and health message regarding the severity of the issue to all
members. Figure 2-1 is an example of an infection control policy
statement.

##### Exposure Control Plan

An exposure control plan is designed to minimize and prevent the
exposure of department members to infectious diseases transmitted
through human blood, body fluids, and other potentially infectious
materials. The *Occupational Exposure to Bloodborne Pathogens*, 29 CFR
Part 1910.1030 requires an exposure control plan. The exposure control
plan encompasses all members who must comply with the requirements of an
infection control program. The exposure control plan compliments the
specific procedures of individual departments. All members with a
reasonable potential for exposure to blood, body fluids, and other
potentially infectious materials as part of their assigned job tasks are
included in the exposure control plan.

The basic components of the exposure control plan include

-   Exposure Determination

-   Methods of Compliance

-   Hepatitis B Vaccination Policy

-   Procedures for Evaluation and Followup

-   Exposure Incidents

-   Member Training

-   Recordkeeping Procedures

The exposure control plan mandates that the employer identify those
tasks and procedures with the potential for an occupational exposure.
The employer also must identify the positions in the department with
duties and responsibilities that may result in an occupational exposure.
Lastly, the exposure control plan requires the employer to identify the
members who will receive training, protective clothing and equipment,
vaccination, and other benefits of the OSHA *Occupational Exposure to
Bloodborne Pathogens* regulation.

The exposure control plan will be designed to include an implementation
schedule and methods of compliance with the OSHA *Occupational Exposure
to Bloodborne Pathogens* regulation. Once the written program is in
place, the employer is charged with providing copies to all members.
Initial and annual update training must be conducted. Training also must
be conducted as needed to educate members about new or modified changes
to procedures which affect infection control practices or changes in
member duties and responsibilities.

##### 

##### Standard Operating Procedures

A SOP is defined as an organizational directive that establishes a
course of action. A fire department uses a SOP to provide the necessary
control measures to prevent an occupational exposure to a communicable
disease.

Topics that should be covered in an infection control SOP are training
and education, health maintenance, PPE, respiratory protection, eye
protection, operational procedures, handling sharps, skin washing,
facility disinfecting and cleaning areas, disinfecting and cleaning of
equipment, disinfecting and cleaning vehicles, biohazard waste, exposure
incidents and medical follow-up, and the infection control officer. The
U.S. Fire Administration's *Developing Effective Standard Operating
Procedures for Fire and EMS Departments* (1999) is an additional
resource for information regarding SOP's. It can be downloaded from
http://www.usfa.fema.gov/usfapubs/.

##### INTERACTION WITH OTHER DEPARTMENTS

With the implementation of an infection control program, the fire
department should have interaction with other city or county public
safety agencies. These agencies face similar problems and issues
relating to compliance with infection control standards and regulations.
Combining resources and efforts will improve this process for all
members involved. As a city or county entity develops a comprehensive
infection control program, an exposure control plan can incorporate all
applicable departments.

## 

## **Law Enforcement**

Law enforcement agencies face a variety of issues relating to infection
control. Police, sheriffs, and other law enforcement departments must
consider the same infection control factors as a fire and EMS
department. Compliance may be more difficult due to work schedules,
station and precinct locations, proper cleaning, disinfecting and
disposal facilities, and type of services provided.

By combining and/or sharing resources with fire and EMS departments, law
enforcement agencies may be able to develop and implement more effective
infection control programs. Law enforcement can use resources related to

-   training and education issues

-   cleaning and disinfecting facilities

-   disposal facilities

-   laundry areas

-   protective clothing and equipment

-   health maintenance

-   joint infection control officer

-   notification and verification of exposures relating an infectious
    disease

Fire and EMS departments can also provided guidance during the
development and implementation of an infection control program, while
tailoring the program to law enforcement needs.

Other Municipal/County Departments

#  Other municipal or county departments have the potential for possible exposure to airborne or bloodborne pathogens. Examples of departments or divisions that might be affected include, but are not limited to, medical examiner/coroner's office, social services, community mental health, general services (housekeeping), and sanitation. These departments also need an infection control program tailored to meet the needs of their specific duties and responsibilities relating to an exposure to a communicable disease. These departments may not have the expertise to develop a comprehensive infection control program and may need assistance from fire and EMS. Fire and EMS can provide direction, support, and share resources to ensure that members are adequately protected.

Vital issues for these departments can include

-   training and education

-   protective clothing and equipment

-   health maintenance

-   design of cleaning and disinfecting areas

-   disposal areas

The most important factor is to ensure that proper control measures are
in place in the event of an exposure. When providing medical care,
regardless of the frequency and severity, the risk is still very real
for any department\'s members.

**SECTION 3**

**VEHICLES, EQUIPMENT, AND SUPPLY CONSIDERATIONS**

# VEHICLES

All department vehicles involved in providing emergency medical services
should comply with applicable and appropriate health and infection
control laws, regulations, and standards. In addition, there are several
factors that must be taken into consideration.

Vehicle operations pose many risks for a fire department and the
firefighters that drive and ride on these vehicles. The operation of
fire apparatus and vehicles during emergency and non-emergency response
creates a liability for any fire department.

Another safety and health issue regarding vehicle safety relates to
infection control procedures. As departments design new vehicles,
consideration must be given to the ability to decontaminate the patient
compartment and equipment. Other considerations, regarding infection
control include ventilation, air filtration, and interior surfaces.

##### 

##### Emergency Vehicle Safety

An important component of the fire department's occupational safety and
health program is vehicle operations. Vehicle operations encompass a
wide spectrum of issues such as specifications, design, construction,
purchase, operation, inspection, maintenance, response procedures, and
repair of apparatus. In terms of member safety, a fully enclosed cab,
seatbelts for all passengers, noise, warning lights and sirens, braking
capacity, gross vehicle weight, infection control, and tool and
equipment storage must be addressed during the initial specification
phase.

Vehicles currently in use must be evaluated for risks and an action plan
established to address and correct any safety issues. The HSO, the
infection control officer, and the department's occupational safety and
health committee must take a leading role to ensure the development and
implementation of the action plan.

##### 

##### Ergonomics

The field of ergonomics studies methods used to perform a job task with
the necessary tools and equipment and the physical skills used by an
employee to perform that task. Any occupational task may be studied, but
the focus is on repetitive tasks, particularly those that have resulted
in numerous occupational injuries.

The fire service must incorporate ergonomics into the design of fire
department vehicles and the use of tools and equipment. Before placing
tools and equipment on vehicles, accessibility and the number of members
needed to use them should be considered. Examples of ergonomics for tool
and equipment placement include: backboards stored in compartments that
allow removal without twisting or stretching, soft sleeves preconnected
or stored near the inlet, traffic cones, and EMS equipment stored in a
location for easy, frequent access.

When designing new vehicles, the placement and accessibility of tools
and equipment are essential safety and ergonomics issues. As the design
and use of enclosed fire apparatus continues, more and more tools and
equipment are finding their way into the riding compartment. EMS
equipment is being relocated to the interior for convenience, safety,
and security. It is important to address the ability to remove equipment
easily and safely without causing injury to firefighters (Figures 3-1
and 3-2).

##### ![](media/image1.jpeg){width="2.7645833333333334in" height="4.125in"}  {#section-21 .unnumbered}

##### Fire Apparatus

Emergency medical services (EMS) equipment assigned to engine companies,
truck companies, and rescue companies must be located in a designated
compartment(s) on the apparatus. The compartments may need to be secured
if Advanced Life Support medications are carried. Another safety and
health consideration is the ability to clean and disinfect this
compartment in the event of contamination from blood and body fluids.
Although not as great an issue as on an ambulance, procedures must be in
place in the event contaminated equipment is accidentally placed in the
compartment.

In the event of an exposure to a member, procedures must be in place to
decontaminate the member before he/she gets in or on the apparatus. An
affected member may be placed in a disposable garment and transported
back to quarters for proper cleaning. The personal protective equipment
(PPE) must be placed in a biohazard bag and taken to quarters for
evaluation for decontamination or disposal.

##### Ambulances

To ensure the safety of members operating and riding in an ambulance,
the design and construction of the vehicle must meet appropriate design
criteria such as those specified in the U.S. General Services
Administration (GSA) Federal Specifications for the Star-of-Life
Ambulance or KKK-A-1822 Specifications. This ensures that the steering,
braking, seating capacity, patient care compartment, warning lights,
electrical system, emergency medical care equipment, infection control,
and other components are incorporated into the construction of the
vehicle. The fire department must ensure that the vehicle is inspected
prior to use and that regular preventive maintenance is performed per
the manufacturer's guidelines.

NFPA 1500, *Standard on Fire Department Occupational Safety and Health
Program*, requires that members performing emergency medical care must
be secured to the vehicle by a seat belt or a safety harness while in an
ambulance or rescue. The harness or belt is for the protection of the
member providing medical care in the event of an accident, sudden stop,
or start.

##### Design Considerations

As a fire department designs new vehicles used for patient care, strong
consideration must be given to infection control. This is a prevention
issue. Many problems can be avoided by effective planning and design of
the interior of vehicles. The vehicle must be designed to meet the
criteria established by applicable health and infection control laws,
regulations, and standards - specifically criteria established by
Occupational Safety and Health Administration (OSHA), Centers for
Disease Control and Prevention (CDC), and the National Fire Protection
Association (NFPA).

Vehicles that are used as rescue vehicles, ambulances, and non-emergency
vehicles must comply with the guidelines, standards, and regulations
established by these agencies. Engineering controls will enhance the
infection control process when used with training, effective infection
control practices, appropriate personal protective clothing and
equipment, and disinfecting and cleaning procedures.

The ventilation of an ambulance is critical for the safety and health of
members operating inside the vehicle. NFPA 1581 includes the following
criteria for adequate and effective ventilation. The ventilation system
must provide complete ambient air exchange in both the driver and
patient compartments on a regular basis. Control of the ventilation
system should be possible from both compartments. Fresh air intakes
should be located towards the front of the vehicle to afford maximum
intake of fresh air. Exhaust vents should be located in the upper rear
of the vehicle. To reduce the risk of tuberculosis, high efficiency
particulate arresting (HEPA) filters should be integrated in the patient
compartment ventilation system. All seats, mounted cushions, cots,
floors, counters, shelves, bulkheads, and container linings must be made
of or covered by non-absorbent, washable material. These surface
materials should be inert to detergents, solutions, and solvents, for
disinfecting and cleaning as described by OSHA or CDC. Some simple
design considerations for an ambulance regarding ventilation are

-   When a vehicle is stationary, the ventilation systems shall provide
    complete exchange of ambient air in both the driver and patient
    compartment every 2 minutes.

-   Fresh air intakes for the ventilation shall be located towards the
    front of the vehicle.

-   ![](media/image3.gif){width="2.125in"
    height="1.7965277777777777in"}Exhaust systems should be located on
    the upper rear of the vehicle.

```{=html}
<!-- -->
```
-   Ventilation for the patient compartment shall be separate from the
    power intake or exhaust ventilation system.

-   Interior surfaces must be covered by or comprised of nonabsorbent,
    washable material.

There are now transport units available with self-contained purification
units that exchange patient compartment air in less than 90 seconds and
remove particles 0.3 microns and larger at 99.97 percent efficiency.
(See Figure 3-3.)

##### Decontamination and Disinfection of Vehicles

The fire department must consider engineering controls for proper
decontamination and disinfecting when designing new vehicles and
apparatus. EMS compartments on fire apparatus and other vehicles should
be designed to facilitate easy decontamination and disinfecting in the
event contaminated materials are placed in these compartments.

All disinfectants used should be approved and registered with the
Environmental Protection Agency (EPA) as tuberculocidal. If a
disinfectant is tuberculocidal, it is strong enough to kill all other
bacteria and virus of concern. Members using disinfectants must be aware
of safety and health precautions such as ventilation, use of appropriate
PPE, and flammability and reactivity of the disinfectants. A chlorine
bleach solution also can be used to disinfect compartments, hard
surfaces, or other areas of a vehicle or apparatus. The CDC's
*Recommendations for Prevention of HIV Transmission in Health-Care
Settings* (MMWR, 39:RR17) states that effective concentrations range
from 500 ppm (1:100) to 5,000 ppm (1:10) depending on the amount of
organic material present on the surface. Surfaces first should be washed
with hot soapy water and then rinsed with clean water so all visible
material has been removed. If organic material has been removed by
cleaning, the lower concentration of bleach (1:100) appears to be
effective. A 1:100 dilution can be attained by mixing approximately 2
cups of chlorine bleach per gallon of water. The lower concentration is
preferable whenever possible since stronger concentrations may corrode
or destroy vulnerable metal with continued use. The bleach solution
should be prepared daily. Use of commercial disinfectants should follow
manufacturers' instructions.

PERSONAL PROTECTIVE EQUIPMENT

Hand washing and effective personal hygiene are key factors in reducing
the risk of contracting a communicable disease. If hand washing is not
feasible, antiseptic soap (waterless) or wipes should be used. Hands
should be washed immediately after PPE is removed. Hands, mucous
membranes, or exposed skin should be washed after an exposure to blood
or body fluids.

![](media/image4.jpeg){width="2.0in" height="3.011111111111111in"}PPE
serves as a control measure to reduce the risk of an exposure. The
purpose of PPE is to provide a barrier to prevent personal contact with
blood or other potentially infectious materials. PPE includes gloves,
masks, protective eyewear, and gowns; it must be provided at no cost to
the employee. Some departments issue waist or \"fanny\" packs for
carrying PPE (Figure 3-4).

The potential risk of an exposure determines the type of PPE used. The
minimum PPE used should be examination gloves. The greater the risk of
an exposure to blood or body fluids, the more protective clothing should
be used. Due to health problems resulting from latex examination gloves,
the employer must provide a variety of hypoallergenic gloves in a
variety of sizes. Structural firefighting protective clothing serves as
an excellent barrier against blood and body fluids. When firefighters
are performing vehicle extrication, turnout gear (helmet, coat, pants,
boots, and gloves) is the optimum choice of PPE to prevent
injuries/exposures from sharp surfaces or obstructions.

# Gloves

Members providing emergency medical care must don emergency medical
gloves. Medical gloves are single-use, designed to provide barrier
protection against body fluids while examining and caring for patients.
Medical gloves are a standard component of emergency medical response
equipment. Latex-free gloves must be provided for members with a latex
allergy or for use when providing medical care to patients with a latex
allergy.

Emergency medical gloves should be removed as soon as possible after the
completion of patient care. Care must be taken to prevent skin contact
with the gloves' surface, and they should be properly disposed of per
the department's SOP.

Vinyl or latex gloves specifically recommended for patient care should
be used on all responses where there is any potential for exposure to
blood or body fluids. Providers should put on gloves **before** contact
with the patient. It is not an uncommon practice for providers to don
gloves enroute, based on dispatch information.

Gloves that become grossly contaminated, punctured, or torn at the scene
should be changed as soon as it can be done safely. Hands should be
washed before donning new gloves. A waterless hand cleaner should be
used if normal hand washing facilities are not available at the scene.
Double gloving may also be considered when providers are in situations
with a large amount of blood/body fluids, when there is a potential for
gloves being torn or punctured by the surrounding environment, or when
dealing with multiple patients.

Heavy gloves, such as structural firefighting gloves, should be used for
extricating a patient and where broken glass or jagged metal is present.
Since these gloves do not provide a moisture barrier, vinyl or latex
gloves should be worn under them. Structural firefighting gloves, if
available, should be worn where sharp or rough surfaces or potentially
high heat exposure may be encountered, such as vehicle extrication.
Medical gloves should not be worn under structural firefighting gloves
when there is potential for exposure to heat. Heat can cause the
emergency medical glove to burn, melt, or drip. Structural firefighting
gloves that become contaminated should be disinfected and cleaned per
manufacturer's instructions. The vinyl or latex gloves used for patient
contact also are not adequate for cleaning soiled equipment or vehicles.
These tasks require a more durable glove.

About 10 percent of health-care workers are allergic to latex.^5^ The
infection control officer should work with the department medical
director to determine appropriate gloves made of other materials for use
by any provider who is allergic to latex.

##### 

##### Masks

Masks (and protective eyewear) should be used during situations
involving excessive exposure to blood, trauma, childbirth, and other
situations where gross contamination is anticipated or encountered.
Masks are designed to limit exposure of the nasal, oral, respiratory, or
mucosal membranes to bloodborne and airborne pathogens.

Surgical masks (Figure 3-5) are designed to prevent **blood** or **body
fluids** from coming in contact with the mouth and nose. These are
disposable, single-use masks. Some surgical masks are designed with a
face shield attached. They do not protect against airborne pathogens
such as tuberculosis.

A NIOSH-approved, N-95 or HEPA respirator (Figure 3-6) should be worn
the entire time a provider is in contact with a patient suspected of
having tuberculosis. If the patient is not suffering any respiratory
distress, placing a surgical mask on the patient will reduce the release
of droplets from coughing.

![](media/image5.jpeg){width="2.75in" height="2.115972222222222in"}
![](media/image6.jpeg){width="2.779861111111111in" height="2.125in"}

#  

# Eye Protection

Protective eyewear should be donned in any situation with the potential
for blood or

  -----------------------------------------------------------------------
  body fluids to come in contact with the eyes. Acceptable eye protection
  includes goggles or glasses with side protectors. Providers who
  normally wear glasses can have them modified with clip-on side
  protectors or use goggles designed to be worn over the glasses.
  Providers should remember that touching the eyes while wearing
  potentially contaminated gloves should be avoided. Figure 3-7 shows
  protective eyewear with side
  protectors.![](media/image7.jpeg){width="2.3465277777777778in"
  height="1.9097222222222223in"}

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

# 

# Gowns

Gowns should be worn to provide a barrier to blood/body fluid in
situations where heavy bleeding may contaminate clothing, including
childbirth. Gowns should also be worn while cleaning the vehicle after a
response if it is heavily contaminated by blood. Table 3-1 summarizes
which type of PPE is indicated in specific situations.

+-----------------------------------+-------+--------+-------+--------+
| # Ta                              |       |        |       |        |
| ble 3-1 When and Which Types of P |       |        |       |        |
| erson Protective Equipment to Use |       |        |       |        |
+-----------------------------------+-------+--------+-------+--------+
| # Activity                        | **Glo | **Eye  | **M   | **     |
|                                   | ves** | wear** | ask** | Gown** |
+-----------------------------------+-------+--------+-------+--------+
| Uncontrolled bleeding             | Yes   | Yes    | Yes   | Yes    |
+-----------------------------------+-------+--------+-------+--------+
| Controlled bleeding               | Yes   | No     | No    | No     |
+-----------------------------------+-------+--------+-------+--------+
| Childbirth                        | Yes   | Yes    | Yes   | Yes    |
+-----------------------------------+-------+--------+-------+--------+
| Endotracheal intubation           | Yes   | Yes    | Yes   | No     |
+-----------------------------------+-------+--------+-------+--------+
| Oral/Nasal suctioning, manually   | Yes   | Yes    | Yes   | Yes    |
| cleaning airway                   |       |        |       |        |
+-----------------------------------+-------+--------+-------+--------+
| Handling/Cleaning possibly        | Yes   | Yes    | Yes   | Yes    |
| contaminated instruments          |       |        |       |        |
+-----------------------------------+-------+--------+-------+--------+
| Measuring blood pressure          | No\*  | No     | No    | No     |
+-----------------------------------+-------+--------+-------+--------+
| Giving an injection/Starting an   | Yes   | No     | No    | No     |
| IV                                |       |        |       |        |
+-----------------------------------+-------+--------+-------+--------+
| Measuring temperature             | Yes   | No     | No    | No     |
+-----------------------------------+-------+--------+-------+--------+
| Cleaning patient compartment      | Yes   | No\*\* | N     | No\*\* |
| after a call                      |       |        | o\*\* |        |
+-----------------------------------+-------+--------+-------+--------+

\* Unless the patient's arm is contaminated with blood or body fluids or
unless required by department policy.

\*\* Unless heavily contaminated by blood or body fluids or unless
required by department policy.

Dickinson, E. (1999). *Fire Service Emergency Care*. Upper Saddle River,
NJ; Prentice-Hall, Inc. Reprinted with permission.

######## Sleeves

Sleeves provide protection of exposed skin of the arms. Sleeves are
valuable personal protective equipment for services operating in warm
climates and when long-sleeved apparel is not worn. Figure 3-8 shows the
use of protective sleeves.

![](media/image8.jpeg){width="3.375in" height="3.3618055555555557in"}

PPE should be cleaned, washed/laundered, or disposed of appropriately by
the employer at no cost to the worker. All PPE should remain at the
worksite. If at all possible, nothing should be taken home in order to
prevent cross-contamination of family clothing. Contaminated PPE that
can be decontaminated and cleaned can be reused. If cleaning and
decontamination is not possible, the equipment must be disposed of
properly in an approved method. Laundering provisions located in fire
stations need to be separate from the laundering equipment used for
normal cleaning such as linens, uniforms, and towels. The hot water must
be above 130 degrees, and waste water must empty into a sanitary sewer
system.

# EQUIPMENT AND SUPPLIES

# Biohazardous Waste Disposal

![](media/image9.png){width="1.7in" height="1.6097222222222223in"}Many
of the items used for patient care, such as bag-valve-masks (BVM),
suction catheters, etc., are single-use, disposable and should be
properly disposed of after use. Some items, such as bag-valve-masks
(BVM), may be left with the patient at the hospital for continued use,
unless they are grossly contaminated.

Grossly contaminated BVM's and other single-use items, with the
exception of needles, must be placed in a red bag or container marked
with a biohazard seal (Figure 3-9). Needles and other sharp objects
should be placed in a puncture-proof container that is designated for
biohazard waste disposal. Disposal of biohazardous waste should follow
the department's written procedure.

# Non-Disposable Equipment

Surfaces of non-disposable equipment that may have come in contact with
a patient's blood or body fluids must be cleaned, disinfected, or
sterilized. Non-disposable equipment includes blood pressure cuffs,
splints, backboards, cervical immobilization devices, laryngoscope
blades, etc. Cleaning means washing the item with soap and water.
Disinfecting involves the use of a disinfectant that kills some
microorganisms. Sterilization, either chemical or superheated steam in
an autoclave, kills all microorganisms.

###### Equipment in Contact with Intact Skin

In the majority of patient contacts, the blood pressure cuff and
stethoscope are in contact with intact skin. In many instances, splints,
backboards, and cervical immobilization devices contact only intact
skin. For equipment that contacts only intact skin, cleaning and
disinfecting with a 1:100 bleach solution or EPA-registered
tuberculocidal disinfectant is adequate. These disinfectants will
destroy mycobacterium tuberculosis, most viruses, vegetative bacteria,
and most fungi.

# Equipment in Contact with Mucous Membranes

Equipment such as laryngoscopes, blades, and handles that come in
contact with mucous membranes should be either chemically sterilized
with an EPA-registered chemical sterilant for 10 to 45 minutes after
cleaning, or autoclaved. The chemical sterilant will destroy
mycobacterium tuberculosis, most viruses, vegetative bacteria, and most
fungi. Many services leave the used equipment at the hospital for
sterilization and replace it with new equipment from hospital stock.

# 

# Equipment Contaminated with Blood/Body Fluids

Any equipment contaminated with blood or body fluids first should be
cleaned of all visible material since disinfectants are less effective
when they must penetrate dirt and other debris. Gloves that are heavy
enough to resist puncture from sharp edges should be worn while cleaning
the equipment. If there is a potential for splashing, face protection,
eyewear, and fluid- impervious gown or apron also should be used.
Disposable towels should be used if available. If disposable towels are
not available, use towels that can be placed in a plastic bag for
contaminated laundry after the cleaning is complete.

Following cleaning, the equipment should be decontaminated with a
germicide following manufacturer's instructions or a 1:100 bleach
solution using clean towels. All equipment should be allowed to air dry.
After decontamination is complete, place gloves in a sealed plastic bag
for disposal and wash hands.

![](media/image10.png)

######### EQUIPMENT ADVANCES

**Backboards**

Backboards are now available made of material that is resistant to
penetration by body fluids and chemicals, thus are easier to clean and
disinfect. Figure 3-10 is an example of one of these plastic backboards.

#####   {#section-26 .unnumbered}

##### Cervical Immobilization Devices 

Cervical Immobilization Devices (CID) are available in both disposable
and non- disposable forms (Figures 3-11 and 3-12). Most disposable CID's
are corrugated material that is treated to be water-resistant. The
disposable CID's have some limitations, but may be an option for mass
casualties. Non-disposable CID's also are water-proofed with smooth
surfaces that make cleaning easier.

Although this new construction assists in the ease of cleaning and
decontaminating, care must be taken to assure that the Velcro straps
used to immobilize patients to the backboard and to assure placement of
CID's are also cleaned and decontaminated appropriately.

![](media/image12.jpeg){width="2.6in" height="1.9861111111111112in"}

#### Needleless Systems

The most common bloodborne pathogen exposure is the needlestick that
results while recapping a needle. This particular cause of needlesticks
should be totally preventable. As a result of changes in technology,
there is a renewed strong focus on reducing needlestick injuries. In
1999, several legislative initiatives and regulatory agencies began the
process of addressing changes to decrease the potential for infectious
diseases as the result of needlesticks. The Health Care Worker
Needlestick Safety and Prevention Act was signed into law in November
2000. Sixteen States have already passed needle safety legislation and
it is pending in one other State. Table 3-2 summarizes the States that
have passed needle safety legislation to date.

+-----------------------+-----------------------+-----------------------+
| ## **Table 3          |                       |                       |
| -2 States with Needle |                       |                       |
|  Safety Legislation** |                       |                       |
+-----------------------+-----------------------+-----------------------+
| ## **California**     | **Maryland**          | **Oklahoma**          |
+-----------------------+-----------------------+-----------------------+
| ## **Alaska**         | **Massachusetts**     | **Tennessee**         |
+-----------------------+-----------------------+-----------------------+
| **Connecticut**       | **Minnesota**         | **Texas**             |
+-----------------------+-----------------------+-----------------------+
| **Georgia**           | **New Hampshire**     | **West Virginia**     |
+-----------------------+-----------------------+-----------------------+
| **Iowa**              | **New Jersey**        | **Pennsylvania**      |
|                       |                       | (pending)             |
+-----------------------+-----------------------+-----------------------+
| **Maine**             | **Ohio**              |                       |
+-----------------------+-----------------------+-----------------------+

# 

# Revisions to the *Occupational Exposure to Bloodborne Pathogens* (29 CFR Part 1910.1030) obligate employers to consider safer needle devices when they conduct their annual review of their exposure control plan and requires that a log of injuries from contaminated sharps be maintained. 

# An increasing number and variety of needle devices with safety features are now available. Figure 3-13 is an example of one of these devices. This needleless system has a built-in flow valve that helps prevent blood exposure.

![](media/image13.png){width="5.063194444444444in"
height="1.542361111111111in"}

# 

# 

# 

# 

# Because of the proliferation of needle devices with safety features, many of these devices have had only limited use in the workplace. As a result, NIOSH released its Alert: Preventing Needlestick Injuries in Health Care Settings, which states that needle devices with safety features should be evaluated to ensure that: 

-   the safety feature works effectively and reliably

-   the device is acceptable to the health care worker

-   the device does not adversely affect patient care

As EMS services evaluate needleless systems, consider cost of the
devices and resupply issues. If the service resupplies these items on an
exchange system with the local hospital(s), it would be in the best
interest of the EMS service program to work with the hospitals in the
evaluation process to determine which needle device will be used. Even
if the service does not obtain resupply from area hospitals, those
hospitals should be contacted to gather information from their
evaluations of, and experience with, different types of devices.

# Waterless Hand Cleaners

As stated earlier in this manual, hand washing with regular soap and
water is the most important method of preventing the spread of
infectious diseases. Hands should be washed after each patient
encounter, after all cleaning and decontamination of equipment, and
immediately after each contact with a potentially contaminated patient
or item. There are several occasions when hand washing is desirable, but
there is no water available. Examples include a patient refusal when the
provider removes his/her gloves, or when patient care requires a glove
change due to a tear. When water is unavailable, there are several
commercial waterless hand cleaners available for use. Waterless cleaners
come in both gel or wipe form. The main ingredient in the waterless
cleansers is alcohol. Several brands also contain PCMX, a manmade
phenolic active (antiseptic compound).

### 

### OTHER CONSIDERATIONS

# Clothing and Linen

Although the risk of disease transmission from soiled clothing or linen
is minimal, the risk should not be ignored. There are several steps that
the provider should take to reduce the risk.

Dirty clothes should be changed as soon as possible and the provider
should shower before donning clean clothes. Providers should keep at
least one extra uniform at the station while on duty. Volunteers who
respond from home should keep an extra change of clothes at the station
for use if needed when returning from a call, or carry an extra set in
their vehicle.

Dirty linen and clothing should be handled as little as possible. Soiled
items should be bagged, with blood-contaminated clothing/linen placed in
a separate, leak-proof bag marked with a biohazard label. Soiled
clothing/linen should be washed in the normal laundry cycles with
regular detergent following label instructions. Gloves should be used
when handling, bagging, and placing dirty items in the washing machine.

If a volunteer provider's clothes are contaminated with blood or body
fluid, it should be a policy that he/she return to the station to
shower, change, and bag the soiled clothing in a controlled environment
rather than driving home directly following a call. It is preferable
that the contaminated clothing be washed at the station. If laundry
facilities are not available at the station, the department must make
alternative arrangements for laundering so contaminated items are not
taken home. This may include arrangements with other departments,
hospitals, or commercial laundry facilities.

# 

# Responding From/Returning to Home or Work

Volunteers who respond from and return to home or the primary work site
have an obligation to protect patients and the public from the potential
of infectious disease as well as protecting themselves. The issue of
contaminated clothing for volunteers returning home from a call has been
addressed above. What must also be considered is the workplace
environment and conditions when the volunteer responds. If the work
environment (e.g., working around animals, food handling of raw meat,
construction work, etc.) carries the possibility of disease-causing
germs to be present, the provider must take the time to wash hands
thoroughly and be sure clothes are not soiled before responding and
coming in contact with the patient. The same holds true if the potential
exists to transmit disease from the patient to co-workers on return to
the primary job.

Since volunteers may respond to the scene in a private vehicle to render
care while waiting for the ambulance, it is important to be careful that
blood or body fluids are not carried back to the interior of the
personal vehicle. It also may be a reasonable policy to supply personnel
who do not accompany the patient during transport with waterless hand
cleaner to use before re-entering their private vehicle to return to
work.

**Resource Management**

Although a rare occurrence, service programs should have a plan in place
to access additional infection control supplies on short notice in
situations such as mass casualty incidents that may deplete the normal
supply level rapidly. Access to other service programs' supplies through
mutual-aid agreements may handle the extra demand. Other options include
having an emergency number for a local vendor or developing an agreement
with the local hospital(s) to get an emergency stock if needed.

**SUMMARY**

OSHA regulations, CDC guidelines, and NFPA standards have affected the
operations and management of emergency service agencies. The intent of
these regulations and standards is to provide protection for employees
at risk for an exposure to blood or body fluids.

Occupationally, an exposure to a communicable disease can have
devastating results for members. Contracting a communicable disease
could lead to death, long-term disability, early retirement, significant
health concerns, and reduced life expectancy. It is critical that
following an exposure, the member be seen for medical follow-up as soon
as possible. Optimal use of post exposure prophylaxis (PEP) for HIV
requires treatment within hours.

Infection control must become a significant part of the daily operations
of emergency responders. The delivery of emergency medical services
continues to be a major part of service delivery for fire departments.
The potential for an exposure is an occupational risk that emergency
service personnel face every day.

This chapter discussed many ways to reduce and eliminate exposures to
airborne and bloodborne diseases. Members must realize that this is a
real occupational threat. The cost of treating an exposure is momentous,
and can have a major financial impact on the department. Moreover, the
human side has more cataclysmic results that affect the individual,
family, department, and community. The exposure to blood or body fluids
is truly an occupational hazard that must be addressed properly as part
of a department's occupational safety and health program. As a
department develops or revises its mission statement, infection control
should become a vital part of the process.

**SECTION 4**

**FACILITY CONSIDERATIONS**

## **THE NEED FOR FACILITY SAFETY**

A successful occupational safety and health program must address
facility safety, which encompasses fire stations, offices, shop areas,
and any other area where personnel work while on duty. NFPA 1500,
*Standard on Fire Department Occupational Safety and Health Program*,
defines a fire department facility as

> Any building or area owned, operated, occupied, or used by a fire
> department on a routine basis. This does not include locations where a
> fire department can be summoned to perform emergency operations or
> other duties, unless such premises are normally under the control of
> the fire department.

Most firefighters' duties and activities focus around the fire station.
The majority of on-duty time is spent in fire stations, training
centers, administrative offices, and department shop areas. The facility
environment must be routinely examined to ensure the safety of the
personnel. Hazards and unsafe conditions that exist in the fire station
or in other fire department facilities can endanger both personnel and
visitors who enter these facilities.

The design, construction, maintenance, and general upkeep of fire
department facilities are a major financial expense. Depending on the
funding, operation, and composition of a fire department, the facilities
may be used for a variety of functions. One building may house multiple
functions including an assembly area for meetings or other social
functions, administrative offices, apparatus repair/shop, training
center, dispatch center, and fire station.

NFPA 1500 requires the Health and Safety Officer (HSO) to ensure that
all facilities are inspected at least annually to assure the safest
working environment possible. Personnel assigned to these facilities
must take responsibility to correct any unsafe condition by conducting
at least a monthly inspection. If unsafe conditions are found,
procedures must be in place to correct any hazards or code violations
and to prevent an accident or possible injury.

## **Infection Control**

Fire department facilities are not exempt from regulations and standards
that address a safe and healthy work environment. Facilities must be
designed to provide the proper working conditions and conform to
infection control standards. Proper equipment, protective clothing, and
disposal of infectious waste must be provided to ensure compliance with
*Occupational Exposure to Bloodborne Pathogens* (29 CFR Part
1910.1030)*.* If emergency medical care is provided by the department,
the facility will need to be equipped with a decontamination area to
clean and disinfect personnel, protective clothing, and equipment
properly. An excellent resource for guidance in developing a fire
department infection control program is NFPA 1581*, Standard on Fire
Department Infection Control Program.*

Facility safety and health is just one part of the infection control
process. Infection control procedures should address issues such as:

-   Hand washing

-   Need for protective clothing and equipment while disinfecting and
    cleaning

-   How to properly and effectively disinfect medical equipment,
    protective clothing, and protective equipment

-   Disinfecting and cleaning areas once finished

-   Proper disposal of contaminated materials in a container marked
    infectious waste

-   Proper storage and disposal of sharps in a sharps container

Adherence to all State and local laws governing infection control and
compliance is required. Failure to comply with these regulations can
cause an occupational exposure and create added liability for the fire
department. Alan Brunacini, Fire Chief of the Phoenix Fire Department,
summarized the importance of complying with regulations when he said,
"Safety prevents meetings."[^5] Compliance is a less expensive method.

### Decontamination Areas

Decontamination needs to be carried out in separate areas that are
properly marked and secured. Appropriate disinfecting supplies must be
available. A nonporous sink, such as stainless steel, with hot and cold
running water, should be available. Nonporous materials are safer than
traditional porous materials such as wood, plastic, and porcelain.
Porous materials have a tendency to allow foreign matter to permeate the
surface, which makes disinfecting the sink difficult. Other equipment
needed for the decontamination area includes

-   Racks or shelves for air-drying of equipment

-   ![](media/image14.jpeg){width="2.004861111111111in"
    height="2.50625in"}Two sinks

-   Sprayer attachment

-   Drains attached to sanitary sewer system or septic system

-   Faucets that are turned on by elbow, foot, or sensor (Figure 4-1)

-   Continuous molded counter tops/splash panels

-   Proper lighting

-   Proper ventilation

-   Floor drains attached to the sanitary sewer system

Most fire stations were not initially designed to incorporate
decontamination of infectious waste. This need surfaced in the early
1990's. Fire stations that do not have a separate or available room for
decontamination may have to add a room or a separate building.
Decontamination of personnel and cleaning and disinfecting equipment
must never be done in the kitchen, living, sleeping, or personal hygiene
areas.

### 

### FACILITY ISSUES

Each area of a fire station or fire department facility has particular
safety and health issues and features that need to be identified,
evaluated, implemented, and monitored.

### Kitchen

The kitchen is the central location of activities in most fire stations.
Activities routinely occurring in the kitchen include food preparation,
eating, discussions/meetings, and watching television. With so many
activities occurring in this area, safety and health procedures are
paramount. **Medical equipment should never be cleaned, disinfected, or
stored in the kitchen area.** All equipment cleaning should be done in a
designated area to prevent chemical or biological agents from coming in
contact with food and food preparation utensils and equipment.

Double sinks and a dishwasher should be provided to clean dishes and
utensils properly. The refrigerator/freezer should maintain foods at
proper temperatures \-- cold storage 38º F (3º C) or less, and freezer
temperatures at 0º F (-18º C) or less. In addition to regular
inspections, a thermometer should be placed in a conspicuous place in
both the refrigerator and the freezer.

Countertops and shelving should be constructed of nonporous materials.
Food should be properly heated to kill the parasites or bacteria and
leftovers should be covered for storage. In the event of an alarm, food
should be stored properly to prevent food poisoning.

All members working in the kitchen must use good safety practices.

Common safety practices include

-   Cleaning up after spills

-   Storing sharp objects, especially knives, in a safe manner

-   Discouraging horseplay

-   Watching food on the stove at all times

-   Promptly turning off all burners and ovens when not in use

-   Using all appliances in accordance with manufacturer's instructions

```{=html}
<!-- -->
```
-   Exercising extreme caution when using knives, graters, slicers, or
    can openers

### 

### Sleeping Quarters

According to NFPA 1581, there should be a minimum of 60 square feet of
floor space for each bed space in sleeping areas. This provides rapid
and easy access during alarms. The required floor space per bed also is
designed to reduce the chances of spreading colds or other airborne
diseases among members, and to make sleep easier.

Separate bedding and clothing lockers should be provided for each member
who requires a bed. Proper ventilation, heating, and cooling are
essential to the health of personnel living in the fire station.
Sleeping quarters should be separated by a 1-hour fire-resistive wall
and be equipped with a smoke detector(s), a carbon monoxide detector,
and a sprinkler system.

### 

### Bathrooms

Personal hygiene is a fundamental defense against preventing illness and
communicable diseases. All fire department facilities should have the
proper facilities for washing and cleaning. Hand washing should be done
only in restrooms or bathrooms, not in the kitchen.

![](media/image15.jpeg){width="1.875in" height="2.625in"}

Showers should be cleaned regularly to prevent the growth of mold and
mildew. Showers should have curtains or doors to minimize the amount of
water that reaches the floor (Figure 4-2). Safety glass or plastic
panels should be used in the shower doors. Drying racks for towels
should be available, as well as good ventilation to prevent mold and
mildew. The flush valves on toilets and urinals should be foot-operated
or use an electric eye so hands are not required to operate it. Most
importantly, a clear and visible sign should be mounted prominently in
each bathroom to remind members to wash their hands.

### 

### Storage

Clean equipment and unused supplies should have a separate storage area.
This ensures that contaminants are isolated. The storage area needs to
be conspicuously marked and secured. In the event a separate area is not
available, a secure locker or cabinet can be used as a suitable
substitute.

General storage areas have a tendency to become disorganized and
cluttered, which can cause slips, falls, fire, or injury from a falling
object. Some general safety considerations should be

-   Limiting storage in utility rooms

-   Assuring storage is well organized and maintained

-   Storing heavy items near the floor

-   Assuring no items block utility boxes or escapes

-   Storing flammable liquids in safety containers

-   Storing containers for flammable liquids away from heat sources,
    preferably in a storage container or outside the facility

-   Properly marking containers' contents

### 

### Laundry Areas

The fire department should provide a designated area equipped with a
washer and dryer in each fire station for cleaning station work
uniforms, protective clothing, and linens (Figure 4-3). All necessary
detergents and prescrub, proper water temperature, and laundering
instructions should be available. This eliminates the need for members
to take contaminated uniforms or clothing home, which might
cross-contaminate the family laundry.

![](media/image16.jpeg){width="3.875in" height="2.591666666666667in"}

To comply with these requirements, most fire departments have provided
the following:

-   At least one washer and dryer in the station for laundering station
    work uniforms

-   A laundry service for station work uniforms and protective clothing

-   A centrally located commercial washer and dryer for laundering
    protective clothing

The laundry area should also provide a means for cleaning and other
laundry items in a washer and dryer that is used only for
non-contaminated items. For contaminated items, a commercial washer and
dryer must be provided, or a laundry service contracted for proper
cleaning and decontamination.

**Cleaning Areas**

Similar to the laundry area, a designated cleaning area must be provided
for cleaning personal protective equipment (PPE), portable equipment,
and any other contaminated clothing and equipment. The cleaning areas
must have proper ventilation, lighting, and drainage connected to a
sanitary sewer or a septic system. This area must be separate from the
areas used for food preparation, eating, sleeping, living areas, and
personal hygiene. This area must also be separate from the disinfecting
area.

**Disinfecting Areas/Facilities**

A fire station should have an area that is designated for disinfecting
contaminated clothing and equipment. This area should be accessible from
the outside of the facility as well as through the apparatus bay. The
area must meet the requirements established by the local and State
health departments. It must be equipped with proper lighting and
ventilation, have floor drains that are connected to a sanitary sewer or
septic system, and be properly maintained in terms of general
housekeeping requirements.

**Disposal Areas**

Effective cleaning and disinfecting areas include a method for proper
disposal of contaminated waste. Disposal shall take place in a properly
marked and secured area separate from the kitchen, living, personal
hygiene, and sleeping areas. Disposal of infectious waste must meet
State and local laws and regulations pertaining to the handling,
storage, transportation, and disposal of medical or infectious waste.
Proper containers must be marked and used for disposal purposes, and not
used for the disposal of regular waste or trash.

**SUMMARY**

Whether a department is designing a new facility or renovating a current
facility, the most important factor is infection control. Financial
obligations from the governing entity will need to be considered in
order to bring a facility into compliance with the applicable and
appropriate health and infection control laws, codes, and standards for
fire department or EMS facilities. Prevention is much more cost
effective than having to pay workers' compensation claims resulting from
exposures to an infectious disease. The U.S. Fire Administration's
*Safety and Health Considerations for the Design of Fire and Emergency
Medical Services Stations* (1997) provides a comprehensive resource for
other facility design considerations.

# SECTION 5

**ASSESSING EFFECTIVENESS:**

**THE EVALUATION PROCESS**

**OVERVIEW**

Any program is incomplete without a formal evaluation process. Managing
any program is best described as an ongoing cyclical process (Figure
5-1).

Figure 5-1

Thus, although evaluation is the "final" step, it actually leads to a
repetition of the development cycle.

Evaluation is a systematic analysis of program activities and results
for the purpose of determining the program's overall effectiveness. The
evaluation process should address two specific aspects: 1) compliance
with the performance indicators of the existing program, and 2) the
attainment of the program goal. Quality monitoring is used to determine
whether individuals in the organization are complying with established
protocols/performance standards. In other words, quality monitoring
answers the question: Are we doing things right? Program evaluation
answers the question: Are we doing the right things?

Program analysis relies on a systematic analysis of various types of
data collected over a predetermined period of time. The focus is on
identifying measurable **changes** that have occurred as a result of the
program. Data collected from quality monitoring is one source of
information used to determine if the program is meeting the overall
program goal. Review of changes in laws and standards and changes in
technology also should be used to determine if the program is
accomplishing what it should. Analysis of these data should be used to
identify what needs to be done to improve program effectiveness. In
effect, this leads back to the planning component.

### 

### ASSESSING EFFECTIVENESS

In very simple terms, the evaluation phase focuses on measuring the
difference between what was happening before and what is happening now.
In order to compare the differences, evaluation criteria/performance
indicators must be written in measurable terms with an expected outcome
stated (compliance level). Performance indicators should be reviewed and
revised on a regular basis. By analyzing data on a regular basis, the
organization will be able to revise performance indicators based on
compliance, new technology, or changing laws/regulations. Performance
indicators should be based on governmental regulations, such as
Occupational Safety and Health Administration (OSHA), and national
standards, such as National Fire Protection Association (NFPA) 1500 and
NFPA 1581.

### 

### Developing Objectives and Performance Indicators

##### Objectives

Performance indicators are developed from the objectives identified for
the program. The objectives should be defined during the planning (or
revision) phase of the program management cycle and should be consistent
with the goal of the organization \-- injury prevention and preventive
health care. Objectives should be

-   S -- specific

-   M -- measurable

-   A -- attainable

-   R -- realistic

-   T -- timely

Some objectives, when well-defined, also can be used as performance
indicators. However, other objectives may be too broad to use as
performance indicators. For example: an organization has documented 40
accidental needlesticks during IV initiation (4% of all IV initiations)
over the past year. Although the ultimate goal is to reduce accidental
needlesticks to zero, the organization might begin with an initial goal
to reduce accidental needlesticks during IV initiations to less than 2%
in the next 6 months. Because this is a broad objective, additional
indicators must be identified to measure the attainment of this
objective and analyze the cause.

#### Performance Indicators

Performance indicators are the actions that measure the attainment of
the objective. They must also be specific, attainable, and realistic.
Using the objective of reducing needlesticks, some performance
indicators might include

-   Does not recap needles.

-   Disposes of needles in a sharps container with the needle down
    immediately after use.

As stated above, objectives must be timely. Taking this example one step
further, based on technological advancements, the organization might
implement a needleless system for IV administration. In order to
evaluate the effectiveness of the new system, new performance
indicator(s) will need to be developed. One performance indicator might
be: Uses a needless system for IV initiation/administration.

##### 

##### Compliance

Compliance with objective/performance indicators involves using
available sources of data and information to measure how often personnel
comply with the performance indicator. In our example, the compliance
level for the objective of decreasing accidental needlesticks during IV
initiation is less than 2 percent. In order to determine effectiveness,
performance indicators are normally written with the expected compliance
level identified. Going back to the original examples:

-   Does not recap needles *100 percent of the time*.

-   Disposes of needles in a sharps container with the needle down
    immediately after use *98 percent of the time*.

-   Uses a needleless system for IV initiation/administration *100
    percent of the time*.

Careful consideration must be given to setting compliance levels. Since
the analysis of compliance levels is used to determine the extent to
which the objectives have been met, if all objective compliance levels
are set at 100 percent, effectiveness of the program is doomed to
failure.

There are two primary methods for determining appropriate compliance
levels. The first is **benchmarking**. Benchmarking uses comparisons
based on data from other organizations, States, or regions.
Benchmarking, in some instances, uses national standards. This includes
OSHA regulations, NFPA standards, and State law. For example, using
personal protective equipment (PPE) and following body substance
isolation techniques 100 percent of the time when there is potential
exposure to any body fluid is a national standard. This may be another
objective of the organization's infection control program. Again this is
broad, so performance indicators should be developed that address
situations requiring just gloves, situations requiring personal
respiratory protection, situations requiring protective eyewear, etc.
When there is no standard or accepted compliance level for an
objective/performance indicator, the organization must determine the
compliance level through data collection and analysis.

### INFORMATION MANAGEMENT

When compliance of performance indicator(s) is not met, an analysis must
be completed to determine the cause of the problem. Relevant data must
be available to complete this analysis. The efficient collection and
management of data and their transformation into useful information are
fundamental to successful **quality monitoring**. Local, State, and
Federal agencies all have specific requirements and/or guidelines that
must be included in the infection control program. Therefore, each
department will have individual forms and checklists to record the
required data.

###  Data collection also plays a critical role in program evaluation. Baseline data collected before implementing a change to the existing program can be compared to later data collected at established intervals. This will provide a clear picture of the progress in attaining program objectives. The data also can be used to identify training needs.

Finally, data collection permits effective **program management** on a
day-to-day basis by facilitating various administrative requirements.
These include equipment/supplies inventory management, expenditure
monitoring, maintenance of employee records, incident analysis,
establishing training schedules, etc.

### Selection of Data Elements

The elements of data collected should meet the needs of those who will
use the information. The data elements must be linked to the program
objectives/performance indicators. Determining what data need to be
collected should be part of the planning process as program objectives
are developed, reviewed, and revised. This may involve modifying
existing data elements. Data and information also must be standardized,
reliable, rapidly accessible, and timely.

Data should be **standardized**. This means that data sets (what is
collected), data definitions, codes, classifications, and terminology
are uniform across departments as well as compatible with external
databases.

**Reliability** refers to data being entered consistently. For example,
the element of "appropriate protective eye wear worn," could be
interpreted as only face shields by some, while others include safety
glasses. Reliability hinges on standard definitions of the data
elements, and is affected by the motivation of the data collector and
the integrity of the storage of the data. Data collection should be
automated whenever possible and integrated into work processes. There
should be ongoing assessment of data quality. In addition, all those
involved in collecting and entering data should be trained so they are
knowledgeable about the data being collected and understand how the data
are used and the benefits to the organization.

The data also must be **timely** and **rapidly accessible**. Data
collection systems vary from simple paper-based records to complex
multicomputer systems. For data to be timely and rapidly accessible, the
organization must computerize the information collected by other means
and integrate other computer data into a central database. This means
the organization must have a person whose primary functions are to keep
data up-to-date and accurate, conduct analyses, and submit data to
State/regional databases.

Regardless of how relevant the data elements are, performance cannot be
measured if the analysis program cannot retrieve the needed information.
Many commercial software databases are available, but organizations must
work with vendors to customize the software to meet their needs.
Software also may be developed at the organizational level, if the
computer expertise is present.

### Types of Infection Control Data

The specific types of data maintained will vary from jurisdiction to
jurisdiction, depending on applicable laws, standards, and
organizational needs. The following are the most common types of
infection control data maintained by emergency response services.

### 

### Training

Infection control training (initial and refresher) is necessary to
ensure the protection of each emergency responder. Documentation of
training reduces potential departmental liability and may be a legal
requirement. Training records should document

-   Date(s) of the training session

-   Subjects covered

-   Name(s) and qualifications of instructor(s)

-   Names and titles of all individuals attending

-   Duration of training

-   Test scores or other indications of satisfactory performance

It is helpful if the information system also includes the responders'
certifications and the expiration dates of those certifications so
qualifications can be tracked and training records can be compared with
established training requirements. In this way, individual training
needs can be identified, and organizational trends and priorities can be
analyzed. OSHA requires that training records on infection control be
maintained for 3 years from the date the training occurred.

### 

### Exposures

All exposures to communicable disease must be documented. Exposure
documentation ensures compliance with jurisdictional regulations and
protection of members and their families. It also can be used to
identify trends that may indicate the need for new training requirements
and/or modification of existing protocols. Exposure records should
include

-   Date of incident

-   Location of incident

-   Incident number

-   Route of exposure

-   PPE used

-   Type of exposure, if known

-   Member's name

-   Description of member's duties as they relate to this exposure

-   Social Security Number (required by OSHA)

-   Description of incident and circumstances under which the exposure
    occurred

-   Notifications made

-   Treatment and follow-up provided

Figure 5-2 is an example of an exposure form.

![](media/image17.png){width="6.375in" height="8.0in"}

It is important to remember that all exposure records are
**confidential**. It will be necessary to establish passwords in
computerized systems to prevent unauthorized access to records.
Analytical report formats should not include individual names or other
identifying information unless necessary. Similarly, information from
the system should not be distributed to persons without a need to know.

OSHA requires exposure records be retained for the duration of
employment plus 30 years. This may require transfer of the records to a
separate system: Microfilm may be used. It also should be considered
that the programs currently being used to store exposure records will be
outdated in 30 years, so original records may not be retrievable.

### 

### Personal Health Data

The department must establish and maintain an accurate personal medical
health record for each member. The medical record should be up-to-date
and include

-   Name of member

-   Results of all medical examinations (pre-entry, pre-assignment,
    annual/ongoing, and post-exposure)

-   Medical diagnoses and recommendations

-   Treatment and prescriptions

-   Immunization record, including hepatitis B

-   Follow-up procedures and post-exposure evaluations

-   Member medical complaints and symptoms

-   Record of medically caused work restrictions

Like exposure records, medical records are confidential, and can be
released only to authorized individuals with the written consent of the
member. Medical records should not be kept with other personnel records.
Protection of member/employee medical records and the requirement that
medical records be retained for the duration of employment plus 30 years
is covered in 29 CFR Part 1910.20.

### 

### Work Practices

The department must record data on work practices at the scene and in
the station to be able to evaluate whether safety is being maintained.
Collection of these data will fulfill applicable legal compliance and
quality monitoring requirements. Regular observation of employee
behavior at emergency incidents and in the station is necessary to
evaluate compliance with established protocols and work practices. Areas
that require monitoring include

-   Compliance with infection control protocols (i.e., appropriate use
    of PPE)

-   Storage facilities (conspicuously marked and secured)

-   Disinfecting areas (marked, contaminants isolated)

-   Disposal areas (marked, containers secured, waste disposal logs
    up-to-date)

-   Compliance with applicable laws/regulations

Compliance monitoring can be accomplished by using specific audit forms
based on jurisdictional requirements. Analysis results should be
documented and maintained. All deficiencies noted should include
recommendations for improvement and follow-up re-inspections.

#### Equipment and Supplies Inventory

All infection control equipment and supplies must be available. This can
be accomplished only through an accurate and efficient inventory system.
The inventory list must identify all items necessary for the program.
For each item, the inventory should document

-   Cost

-   Minimum on-hand requirement

-   Expiration date

-   Current stock balance

-   Date/Amount ordered

-   Date received

-   Date/Amount issued

-   Organization/Individual receiving the supplies

### Additional Data Types

Several additional types of data may contribute to information regarding
the effectiveness of the infection control program. **Employee
interviews** can be used to determine individual knowledge and
acceptance of infection control protocols. Post-incident analyses or
individual debriefing after an emergency response can also help identify
areas of confusion that can be addressed in counseling and/or training
sessions.

**Incident run sheets** can help identify unexpected trends within the
system. For example, an increase in response volume will require
increased supplies and equipment. This affects inventory supply and the
need to re-order. It may also require increases in future budget
requests.

Monitoring **compensation claims** will help identify trends in injuries
and exposures. Analysis of these claims can provide direction for
possible training, behavior modification needs, and/or protocol changes.

The department also should monitor **community health trends** to stay
current on prevalent communicable diseases, potentially dangerous
situations, etc. Monitoring community trends facilitates a proactive
infection control response to unexpected threats. For example, if there
is an outbreak of meningitis within the community, the department could
take immediate early action to notify all members and implement more
stringent infection control procedures.

### 

### Confidentiality 

Maintaining the confidentiality of certain records is necessary for the
protection of both employees and patients. Each individual's right to
privacy is guaranteed by law and each State/municipality has enacted
"privacy laws" that regulate information release and record retention.

All **patient-related information** is confidential. Each department
should have standard operating procedures (SOP's) covering the release
of patient information, since inadvertent release of confidential
information can result in civil liability. Patient information should be
released only to authorized individuals, and in accordance with current
guidelines and regulations regarding patient privacy, need for consent,
and (if a research study) approval of appropriate supervisory bodies.
All inquiries and the release of patient information should be
documented and stored. The records should include a copy of the
authorization for release, the name of the individual receiving the
information, the name of the individual releasing the information, and
the dates involved.

**Members' medical records** also are confidential. While exposure
records may be used to evaluate the effectiveness of the program, the
confidentiality of the members involved must be maintained. The types
and numbers of exposures can be audited, but names must not be used.
Written procedures should specify who has access to medical records and
under what circumstances. The process by which medical information is
collected, stored, retrieved, and released must be thought out
carefully. Release of medical information should occur only with the
written consent of the member. The consent form should include

-   Date of written authorization

-   Name and signature of member authorizing release of information

-   Name of individual authorized to receive medical information

-   Description of medical information to be released

-   General description of the purpose for release of medical
    information

-   Date the written authorization expires

It is critical that members' medical records are not disclosed or
reported to any person within or outside the department except as
required by law. The original medical records should stay in the
department medical file. Only copies of this information should be
released with proper authorization.

**Computer security** must be designed to protect the confidentiality of
patient and member medical records. This may require the use of
passwords to limit access to a minimum of individuals. Logs should be
maintained to document the release of information. Access to the
computer or computer terminals must be secured. (This also applies to
written records in a filing system.) Only authorized personnel should
have access to the password or secure areas that contain medical
records. The issuance of authorization, keys, etc., should be recorded
and monitored. The department should take full advantage of legal
resources available for guidance on statutory requirements related to
confidentiality.

### PROGRAM REVISION

Program revision occurs as the result of three primary causes. Changes
in laws/regulations or technology may require revisions in protocols or
equipment related to infection control. Program revision may also be
necessary when information analysis reveals lack of compliance of
performance indicators.

### 

### Laws/Regulations

As stated earlier in this manual, it is critical that the infection
control officer stay current on the laws/regulations governing infection
control practices. Reviewing *Morbidity Mortality Weekly* on a regular
basis is an excellent resource for finding changes in suggested
practices and updating knowledge of infectious/communicable diseases.
Establishing a relationship with local infection control specialists in
hospitals is also a resource that should be helpful in maintaining
up-to-date information.

### 

### Non-compliance

When compliance set for a performance indicator is not met, an analysis
must be completed to determine the cause of the problem. For example, an
infection control performance objective is that personnel will use body
substance isolation techniques 100 percent of the time when there is
potential exposure to any body fluid. Compliance is determined to be
only 85 percent. A careful analysis might identify one or more of the
following reasons for the non-compliance, each of which may require
action steps at different levels of the system.

[Possible reason]{.underline}: Personnel are not following protocol.

a.  Personnel are not familiar with specific infection control
    protocols.

b.  Personnel do not know which situations require specific PPE (e.g.,
    eyewear during intubation)

c.  PPE interferes, or is perceived to interfere with task performance.

[Possible reason]{.underline}: Inadequate supplies of PPE.

a.  Increased call volume depleted supplies.

b.  There is a distribution problem

c.  There is a supplier problem.

[Possible reason]{.underline}: Personnel respond directly to the scene
without adequate PPE.

a.  Protocols are inadequate or unclear.

b.  There is an inadequate supply of PPE.

c.  Personnel do not maintain appropriate PPE in personal vehicles.

From this limited example, it is obvious that analyzing causes of
non-compliance involves the entire organization and system, including
policymakers, line personnel, health and safety personnel, and others.

### 

### Action Plan

### Developing the Plan

Once the analysis is completed, an action plan needs to be developed to
correct the cause(s) of the problem. The action plan should be specific,
with exact steps necessary to assure compliance. The first decision that
management must make is who will be on the team that develops the action
plan. In addition to the infection control officer, the team should
include representatives directly affected by the performance indicator,
including line personnel. A timeframe for both the completion of the
action plan and the accomplishment of the actions should be identified.
Providing the team with a schedule and checkpoints for completion of the
plan helps keep them on-task to reach a solution in an acceptable
timeframe.

In addition to identifying the specific steps necessary to correct the
problem, two additional areas should be addressed when developing the
action plan. First, obstacles that might impede the implementation of
the plan should be identified. Examples of obstacles include lack of
resources or lack of funding. Second, resources needed to carry out the
plan should be identified. These resources might include equipment,
funding, and/or training programs.

### 

### Implementing the Plan

In addition to the obvious necessity of allocating resources, the
biggest challenge during project implementation will be to maintain
credibility and focus, and to maintain momentum among team members.

-   **Follow the schedule** \-- This may seem rather obvious, but often
    it is not done. Efficient use of the schedule will help concentrate
    efforts and attention where they are most needed. It also will help
    anticipate the next steps. Schedules enhance coordination and
    communication within a team. Everyone should be able to identify
    where they are at any given point, and know others\'
    responsibilities.

-   **Empower team members** \-- Provide the resources and authority to
    accomplish the task, and **allow** the team members to do what they
    do best.

-   **[Keep others informed]{.underline}** \-- This is an obvious
    component, but one that is often neglected or ignored during
    critical periods. Schedule communication opportunities, and carry
    through.

### 

### Monitor the Plan

Once the plan is implemented, it is critical that the results of the
implementation be monitored and evaluated to determine results or
problems that arise. Monitoring and evaluation may take a variety of
forms, depending on the actions specified in the plan. Methods to
collect data to monitor results should be developed during the planning
stage. It is important that the monitoring methods allow for timely
feedback, so any problems will be detected early. If problems with the
plan are detected during the monitoring phase, or if the action plan did
not make a difference, it must be revised. Based on the problem
identified, revision may require re-entering the process cycle at any
point.

### SUMMARY

Infection control principles and practices are being updated constantly.
Therefore, the department's infection control program must be evaluated
regularly and revised to ensure continuing effectiveness. Periodic
evaluations ensure continued compliance with current standards and
practices.

Infection control data collection and analysis are critical for
effective program evaluation, compliance/quality monitoring, and ongoing
program management. Detailed records must be maintained in the areas of
training, exposure, incidents, health, work practices, and
equipment/supplies inventories. The confidentiality of patient-related
information and members' medical/exposure records must be assured. The
department should seek a legal review of all program changes prior to
implementation, since infection control programs deal with medical and
legal issues and member safety.

# SECTION 6

**SPECIAL SITUATIONS**

#### OVERVIEW

This chapter will cover infection control considerations for two special
situations: the training environment and practices for protecting the
patient.

### THE TRAINING ENVIRONMENT

Two aspects of training are addressed: training in context and the
cleaning and disinfecting of equipment.

#### Training in Context

For many years training has reinforced the use of personal protective
equipment (PPE) when dealing with the potential for exposure to blood or
body fluids. There are few services left where providers do not don
protective gloves when dealing with patients. However, the same cannot
be said about the use of eyewear, masks, and gowns.

Training programs should consistently stress the use of **appropriate**
PPE in lectures and discussions. Training programs also should reinforce
using the appropriate PPE needed in "hands on" practice stations.
Testing stations for the National Registry Examination (both basic and
advanced levels) require the provider to use body substance isolation
(BSI). Although this concept usually is reinforced verbally, frequently
it is accepted as being met when the student demonstrates the donning of
gloves only.

It is a well-known educational fact that the way we learn a
process/skill in the training environment is the way we tend to carry
that process out in real life. A second educational fact is that it is
very difficult to change the steps of a work process/skill from the way
it was initially learned. When the training environment allows students
to don only gloves as a demonstration of the use of PPE, this practice
frequently is carried into the real world of patient care.

Training programs can increase compliance with the use of appropriate
BSI by developing a variety of "hands on" scenarios that require
providers to don PPE in addition to gloves. Such scenarios might include
an airway management case that requires protective eyewear and a mask,
or the assessment of a potential tuberculosis patient that requires the
use of respiratory protection that meets Occupational Safety and Health
Administration (OSHA) standards. If providers practice skills using
**all** the PPE dictated by the situation, they are far more likely to
use all the equipment in the job environment.

Those responsible for planning and conducting training should assess the
need for training in context, provide supplies of PPE adequate to allow
all attendees to complete the training exercises using the appropriate
PPE, and notify attendees to bring any personally fitted PPE needed with
them to training sessions.

#### Cleaning Equipment 

Risk of disease transmission using manikins is extremely low. According
to the American Heart Association, as of March 2000 there were no
reports of infection associated with direct contact with manikins during
CPR training.[^6]

Since there is some risk of disease transmission, manikin surfaces
should be cleaned and disinfected after each use. Cleaning means washing
the equipment with soap and water. Disinfecting involves the use of a
disinfectant to kill many of the microorganisms that may be on the
object. There are many types of manikins, so cleaning and disinfecting
should follow the specific manufacturer's guidelines. Internal parts
such as artificial lungs and valve mechanisms should be cleaned
thoroughly between users.

The human immunodeficiency virus (HIV) is inactivated in less than 10
minutes at room temperature by a number of commercial disinfectants. An
equally effective and less expensive alternative to commercial
disinfectants is a bleach solution. One part bleach to 100 parts water
(1:100, approximately 2 cups/gallon) should be effective for training
equipment, as long as the equipment is first washed with warm, soapy
water and rinsed with clean water. Follow manufacturers' instructions
for commercial disinfectants.

#### PROTECTING THE PATIENT

# Guidelines for job functions for health-care workers infected with HIV or Hepatitis B virus (HBV) are addressed in *Recommendations for Preventing Transmission of Human Immunodeficiency Virus and Hepatitis B Virus to Patients During Exposure-Prone Invasive Procedures* (MMWR Vol. 40, No. RR-08, July 12, 1991) and *Guidelines for the Management of Occupational Exposures to HBV, HCV and HIV and Recommendations for Postexposure Prophylaxis* (MMWR, May 15, 2001). These recommendations are summarized in Chapter 2 of this Guide. The major focus of infected workers providing care revolves around invasive procedures that might result in exposing the patient to the virus. Although the recommendations are made for hospital workers, intravenous initiation often occurs in confined spaces or under conditions of poor visibility in the out-of-hospital area. Therefore, this is a legitimate concern in emergency services.

The work status of an infected worker also may be a legal issue under
the Americans with Disability Act (ADA). Some contagious diseases,
including HIV infection and tuberculosis (TB), are considered
disabilities under the ADA. Relieving an "otherwise qualified" employee
with a communicable disease must be supported by objective evidence of
risk, and reasonable accommodation to eliminate that risk must have been
attempted.

Health-care workers who are infected with HIV or HBV should receive
counseling from an expert review panel, including the department
physician and the employee's personal physician and receive advice
regarding under what circumstances, if any, they may perform invasive
procedures. If these workers are allowed to continue to perform invasive
procedures, there may be an obligation to notify patients of their
positive HIV/HBV status before the procedure is initiated.

If counseling results in the prohibition of invasive procedures, the
worker should be provided opportunities to continue appropriate patient
care activities whenever possible. If the worker is removed from patient
care due to strong risk, career counseling and job retraining should be
available to allow continued employment in another appropriate area. If
the worker's practices are modified because of HBV infection, he/she
should be reevaluated periodically to determine whether the seropositive
status changes due to resolution of infection or as a result of
treatment

#### SUMMARY

The training environment and the infected worker are two special
situations that must be considered in the department's overall infection
control program. Infection control practices in the training environment
should reflect the infection control practices required in the field. To
reinforce appropriate infection control practices, training programs
should develop a variety of scenarios that require the use of all PPE.
Practicing with appropriate PPE will increase the compliance of using
that equipment when needed in the actual job environment. Although there
has been no documented transmission of infection from manikins, training
programs must remain vigilant in cleaning and disinfecting the equipment
used in an educational setting by following the manufacturer's suggested
guidelines.

Workers with HIV and tuberculosis are protected under ADA. The scope of
practice for workers with HIV and HBV relative to invasive procedures is
addressed in the Center for Disease Control and Prevention's (CDC)
*Recommendations for Preventing Transmission of Human Immunodeficiency
Virus and Hepatitis B Virus to Patients During Exposure-Prone Invasive
Procedures* and *Guidelines for the Management of Occupational Exposures
to HBV, HCV and HIV and Recommendations for Postexposure Prophylaxis*
(MMWR, May 15, 2001). Restricting the scope of practice of an infected
worker should be preceded by counsel from an expert panel that includes
the fire department physician and the member's personal physician. If
practice is restricted, the worker should be allowed to continue
appropriate patient care activities whenever possible or provided job
retraining to allow continued employment in another appropriate area. If
the worker is HBV positive, he/she should be reevaluated periodically to
determine whether the positive status changes due to resolution of
infection or as a result of treatment

**BIBLIOGRAPHY**

# BIBLIOGRAPHY

# 

# Barillo, D. (1997). Infection control In Pons, P. & Cason, D. (Eds.). *Paramedic Field Care* (131-144). American College of Emergency Physicians St. Louis: Mosby YearBook.

# 

Bolyard, E.A., Tablan, O.C., Williams W.W., Pearson, M., Shapiro, C.N.,
Deitchman, S.D. & Hospital Infection Control Practices Advisory
Committee. (1998). Guidelines for infection control in health care
personnel. *American Journal of Infection Control* 26; 289-354 and
*Infection Control and Hospital Epidemiology* 19; 407-463.

# Dickinson E. (1999). Infection control and body substance isolation. *Fire Service Emergency Care* (35-50). Upper Saddle River, NJ: Prentice-Hall, Inc.

# 

# Mistovich J., Hafen, B., & Karren, K. (2000) Ambulance operations. *Prehospital Emergency Care* (810-830). Upper Saddle River, NJ: Prentice-Hall, Inc.

# 

# National Fire Academy. (1999). Student Manual*: Advanced leadership issues in EMS*. Emmitsburg, MD: NFA.

#  . (1992). Student Manual*: Infection control for emergency response personnel: The supervisor's role*. Emmitsburg, MD: NFA. 

# 

#  . (1998). Student Manual*: Management of emergency medical services*. Emmitsburg, MD: NFA. 

# 

# National Fire Protection Association. (1997). NFPA 1500: *Standard on fire department occupational safety and health program*. Quincy, MA: NFPA.

# 

#  . (1997b). NFPA 1521: *Standard on fire department safety officer*. Quincy, MA: NFPA.

#  . (2000). NFPA 1581: *Standard on fire department infection control program*. Quincy, MA: NFPA.

# 

#  . (2000b). NFPA 1582: *Standard on medical requirements for fire fighters and information for fire department physicians*. Quincy, MA: NFPA.

# National Highway and Transportation Safety Administration. (1997). *A leadership guide to quality improvement for emergency medical services (EMS) systems*. 

# 

# U.S. Department of Health and Human Services, Centers for Disease Control. (1994). Guidelines for preventing the transmission of mycobacterium tuberculosis in health-care facilities. *Morbidity Mortality Weekly Report*. Vol. 43, No. RR-13. 

. (1989). Guidelines for prevention of transmission of human
immunodeficiency virus and hepatitis B Virus to health care and public
safety workers. *Morbidity Mortality Weekly Report*. Vol. 38, No.2-6.

. (1997). Immunization of health-care workers: Recommendations of the
advisory committee on immunization practices (ACIP) and the hospital
infection control practices advisory committee (HICPAC). *Morbidity
Mortality Weekly Report*. Vol. 46, No. RR-18.

. (1998). Public health service guidelines for the management of
health-care worker exposures to HIV and recommendations for post
exposure prophylaxis. *Morbidity Mortality Weekly Report*. Vol. 47, No.
RR-7.

#  . (1991). Recommendations for preventing transmission of human immunodeficiency virus and hepatitis B virus to patients during exposure-prone invasive procedures. *Morbidity Mortality Weekly Report*. Vol. 40, No. RR-08.

#  . (1998). Recommendations for prevention and control of hepatitis C virus (HCV) infection and HCV-related chronic disease. *Morbidity Mortality Weekly Report*. Vol. 47, No. 19. 

# 

#  . (1999). *Preventing occupational HIV transmission to health care workers*. 

# 

#  . (2000). Recommendations for prevention and control of mennigococcal disease. *Morbidity Mortality Weekly Report*. Vol. 49, No. RR-07.

# 

#  . (1987). Recommendations for prevention of HIV transmission in health-care settings. *Morbidity Mortality Weekly Report.* Vol. 36 No.2

. (2000b). Updated U.S. Public Health Service guidelines for the
management for occupational exposures to HBV, HCV, and HIV and
recommendations for postexposure prophylaxis. *Morbidity Mortality
Weekly Report.* Vol. 50, No. 11.

. (1988). Universal precautions for prevention of transmission of human
immunodeficiency virus, hepatitis B virus, and other bloodborne
pathogens in health care settings. *Morbidity Mortality Weekly Report.*
Vol. 37, No. 24.

. National Center for HIV, STD, and TB Prevention. *Reported
tuberculosis in the United States, 1999*.
http://www.cdc.gov/nchstp/tb/surv/surv99/surv99.htm.

####  . (1999). National Institute for Occupational Safety and Health. *Preventing needlestick injuries in health care settings*, Pub. No.2000-108. 

U.S. Department of Labor, Occupational Safety and Health Administration.
(1991). *Occupational exposure to bloodborne pathogens: Final rule (29
CFR Part 1910.1030)*. Washington, DC: Federal Register. Vol. 56, No.
235.

. (1997). *Safer needle devices: Protecting health care workers*.
Washington, DC.

. (1999). *Enforcement procedures for the occupational exposure to
bloodborne pathogens* *(CPL 2-2.44D)*. Washington, DC.

U.S. Environmental Protection Agency, Office of Solid Waste. (1986).
*EPA guide for infectious waste management*. Washington, DC.

U.S. Fire Administration. (1999). *Developing effective standard
operating procedures for fire and EMS departments.* Federal Emergency
Management Agency: Washington, D.C.

. (1992). *Guide to developing and managing an emergency service
infection control program*. Federal Emergency Management Agency:
Washington, DC.

. (1997). *Safety and health considerations for the design of fire and
emergency medical services stations*. Federal Emergency Management
Agency: Washington, DC.

# APPENDICES

## **A. Glossary of Common Terms**

## **B. Laws, Standards, and Guidelines**

#######  C. Sources of Additional Information

# APPENDIX A

# GLOSSARY OF COMMON TERMS

### GLOSSARY OF COMMON TERMS

**AIDS:** Acquired Immune Deficiency Syndrome, a communicable disease
caused by Human Immunodeficiency Virus (HIV).

**Advanced Life Support (ALS):** Emergency medical treatment at an
advanced level, usually provided by paramedics, and including use of
drugs, cardiac monitoring and intervention, and intravenous fluids.

**Airborne Pathogen:** Pathologic microorganisms spread by droplets
expelled into the air or aerosol, typically through a productive cough
or sneeze.

**Antibody:** A component of the immune system which eliminates or
counteracts a foreign substance (antigen) in the body.

**Antigen:** A foreign substance which stimulates the production of
antibodies in the immune system.

**ARC (AIDS-Related Complex):** An outdated term used to describe
symptoms of HIV infection in patients who have not developed AIDS. These
include fatigue, diarrhea, night sweats, and enlarged lymph nodes. ARC
is not included in the current CDC classification of HIV infection.

**Bacteria:** A type of living microorganism that can produce disease in
a suitable host. Bacteria can self-reproduce, and some forms may produce
toxins harmful to their host.

**Basic Life Support (BLS):** "Emergency medical treatment at a level
authorized to be performed by emergency medical technicians as defined
by the medical authority having jurisdiction" (NFPA 1500). Generally
refers to treatment provided at EMT-B levels.

**Biohazard:** A risk of exposure to harmful bacteria, viruses, or other
dangerous biological agents

**Bloodborne Pathogen:** Pathologic microorganisms that are present in
human blood and that can cause disease in humans. (OSHA) Note: the term
"blood" includes blood, blood components, and products made from human
blood.

**Body Fluids:** "Fluids that have been recognized by the CDC as
directly linked to the transmission of HIV and/or HBV and/or to which
Universal Precautions apply: blood, semen, blood products, vaginal
secretions, cerebrospinal fluid, synovial fluid, pericardial fluid,
amniotic fluid, and concentrated HIV or HBV viruses." (OSHA)

**Body Substance Isolation (BSI):** An infection control strategy that
considers all body substances potentially infectious. This protective
measure is accomplished through barrier protection using personal
protective equipment (gloves, masks, protective eyewear, gowns, and
resuscitation devices, as appropriate) to prevent personal contact with
any body fluids or other potentially infectious material.

**CDC (Centers for Disease Control and Prevention):** A branch of the
Department of Health and Human Services, Public Health Service, that
serves as the national focus for developing and applying disease
prevention and control, environmental health, and health promotion and
education activities designed to improve the health of the people of the
United States.

**Chickenpox (Varicella):** A vaccine-preventable, highly communicable
disease caused by a herpes virus resulting in skin vesicles. Commonly
occurs in childhood.

**CISD (Critical Incident Stress Debriefing):** Stress reduction
processes designed to address the special needs of emergency response
personnel in dealing with situations which cause strong emotional
reactions or interfere with the ability to function.

**Cleaning:** The physical removal of dirt and debris, generally
accomplished with soap and water and physical scrubbing. (NFPA 1581)

**Communicable (Contagious) Disease:** A disease that can be transmitted
from one person to another.

**Contamination:** Soiling or pollution, as by the introduction of
organisms into a wound or onto equipment.

**Debilitating Illness or Injury:** "A condition that temporarily or
permanently prevents a member of the fire department from engaging in
normal duties and activities as a result of illness or injury." (NFPA
1500)

**Decontamination:** The use of physical or chemical means to remove,
inactivate, or destroy bloodborne, airborne, or foodborne pathogens on a
surface or item to the point they are not longer capable of transmitting
infectious particles. (NFPA 1581)

**Disease:** An alteration of health, with a characteristic set of
symptoms, which may affect the entire body or specific organs.

**Contagious:** Infectious disease that can be transmitted from one
person to another from either direct or indirect contact.

**Infectious:** Disease due to a pathogenic microorganism such as a
bacteria, virus, or fungus.

**Disease Transmission:**

> **Direct:** Communicable disease is transmitted from one person to
> another due to direct contact with infected blood, body fluids, or
> other infectious material.

**Indirect:** Communicable disease is transmitted from one person to
another without direct contact.

**Infectious:** An illness or disease resulting from invasion of a host
by disease-producing organisms such as bacteria, viruses, fungi, or
parasites.

**Disinfection:** "A procedure which inactivates virtually all
recognized pathogenic microorganisms, but not necessarily all microbial
forms (ex. Bacterial endospores) or inanimate objects." (OSHA)

**ELISA:** Enzyme-linked immunosorbent assay. A test used to detect
antibodies to the AIDS virus, indicating infection. For accuracy, a
positive ELISA test is always repeated. If still positive, a Western
Blot test is then performed to confirm the diagnosis.

**Emergency Medical Care:** The provision of treatment to patients,
including first aid, cardiopulmonary resuscitation, basic life support,
advanced life support a, and other medical procedures that occur prior
to arrival at a hospital or other health-care facility. (NFPA 1581)

**Emergency Medical Operations:** Delivery of emergency medical care and
transportation prior to arrival at a hospital or other health care
facility. (NFPA 1581)

**EMS (Emergency Medical Services):** A group, department, or agency
that is trained and equipped to respond in an organized manner to any
emergency situation where there is the potential need for the delivery
of prehospital emergency medical care and/or transportation. EMS can be
provided by fire department, private, third service, or hospital-based
systems or any combination thereof.

**Enteric Precautions:** A system of precautions to prevent transmission
of disease by the oral/fecal route.

**Etiologic Agent:** The agent that is the cause or origin of a disease.

**Exposure:** Eye, mouth, other mucous membrane, non-related skin, or
parenteral contact with blood, other body fluids, or other potentially
infectious material.

**Parenteral:** "Exposure which occurs through a break in the skin
barrier." (OSHA) Includes injections, needle sticks, human bites, and
cuts contaminated with blood.

**First Responder:** Personnel who arrive first on the scene at
emergency incidents and have the responsibility to act. Includes fire,
police, EMS, and other public safety workers.

**Fluid Resistant Clothing:** Clothing designed and constructed to
provide a barrier against accidental contact with body fluids.

**Fungus:** A group of microorganisms including molds and yeasts,
similar to the cellular structure of plants. Some fungi can cause
disease.

**German Measles:** See Rubella.

**Gloves, Emergency Medical:** Single-use, patient examination gloves
that are designed to provide a barrier against body fluids meeting.
(NFPA 1581)

**Gonorrhea:** A sexually transmitted disease caused by the bacteria
*Neisseria* *gonorrhea*.

**Health-Care Worker:** "An employee of a health care facility
including, but not limited to, nurses, physicians, dentists, and other
dental workers, optometrists, podiatrists, chiropractors, laboratory and
blood bank technologists and technician, research laboratory scientists,
phlebotomists, dialysis personnel, **paramedics, emergency medical
technicians,** medical examiners, morticians, housekeepers, laundry
workers, **and others whose work may involve direct contact with body
fluids** from living individuals or corpses." (OSHA, bold added.)

**Health Database:** "A compilation of records and data relating to the
health experience of a group of individuals, maintained in such a manner
that it is retrievable for study and analysis over a period of time."
(NFPA 1581)

**Health Promotion:** "Preventive health activities that identify real
and potential risks in the work environment, and that inform, motivate,
and otherwise help people to adopt and maintain healthy practices and
lifestyles." (NFPA 1500)

**Health and Safety Officer:** "The member of the fire department
assigned and authorized by the fire chief as the manager of the safety
and health program and who performs the duties and responsibilities
specified in NFPA 1581." (NFPA 1581)

**Hepatitis:** Inflammation or swelling of the liver. Hepatitis can be
caused by certain drugs, toxins, or infectious agents, including
viruses. Hepatitis caused by viruses include A,B, C, D, E, F G, and
other, as yet unclassified, types.

> **Hepatitis A (Infectious):** Viral infection normally spread by fecal
> contamination.

**Hepatitis B (HBV, Serum):** Viral infection spread through blood
contact, and also as a sexually transmitted disease. Infection may
result in chronic hepatitis, liver cancer, cirrhosis of the liver, or
death.

**Hepatitis C (HCV):** Viral infection spread through blood contact.
Currently, no prophylaxis is available.

**Hepatitis D (HDV, Delta):** Viral infection occurring in people with
present or past HBV infection. A complication of HBV infection and can
increase the severity of HBV infection.

**Hepatitis E:** Viral infection spread by the fecal-oral route.

**Hepatitis F:** Viral infection with mode of transmission unknown, but
may be bloodborne.

**Hepatitis G:** Viral infection spread through blood contact.

**Herpes:** A family of similar viruses which can cause different
diseases, including chickenpox, zoster, "cold sores," and genital herpes
type II.

**Zoster (Shingles):** A painful skin rash caused by recurrence of a
past case of chickenpox. Herpes zoster is not typically spread
person-to-person, but persons who have not had chickenpox previously can
contract chickenpox after exposure to a patient with zoster.

**HIV Infection (HIV Positive):** A person who has tested positive for
HIV antibodies on two ELISA tests, confirmed with Western Blot testing.
HIV-infected patients can spread the virus through blood and body
fluids.

**Host:** The person who harbors or nourishes a disease-producing
organism.

**Human Immunodeficiency Virus:** The causative agent of AIDS. HIV type
1 causes most cases of AIDS. A second virus, HIV-2 is a less common
cause of the disease.

**Iatrogenic:** A complication, injury, or disease state resulting from
medical treatment.

**Immediately Dangerous to Life or Health (IDLH):** "Any atmosphere that
poses an immediate hazard to life or produces immediate irreversible
debilitating effects on health." (NFPA 1500).

**Immunization:** The process of rendering a person immune, or highly
resistant to a disease.

**Incident Commander:** "The person in overall command of an emergency
incident." (NFPA 1500)

**Incident Management System (IMS):** "An organized system of roles,
responsibilities, and standard operating procedures used to manage
emergency operations" (NFPA 1500) Such system often is referred to as an
Incident Command System.

**Incubation Period:** The time from exposure to the disease until the
first appearance of symptoms.

**Infection:** Growth of pathogenic organisms in the tissues of a host,
with or without detectable signs of injury.

**Infection Control Officer:** "The person within the fire department
who is responsible for managing the department infection control program
and for coordinating efforts surrounding the investigation of an
exposure." (NFPA 1581)

**Infection Control Practitioner:** A medical professional with a
specialty interest in infection control.

**Infection Control Program:** "The establishment's oral or written
policy and implementation of procedures relating to the control of
infectious disease hazards where employees may be exposed to direct
contact with body fluids." (OSHA)

**Infectious:** Capable of causing infection in a suitable host.

**Infectious Waste:** "Blood and blood products, pathological wastes,
microbiological wastes, and contaminated sharps." (MMWR)

**Joint Advisory Notice:** A list of recommendations developed by the
Department of Labor/Department of Health and Human Services to assist
employers in implementing the Centers for Disease Control and Prevention
guidelines.

**Leakproof Bag:** A bag that is sufficiently sturdy to prevent tearing
or breaking and can be sealed securely to prevent leakage. Such bags are
red in color or display the universal biohazard symbol. (NFPA 1581)

**Measles:** A vaccine-preventable viral communicable disease causing a
skin rash. Usually occurs in childhood.

**Member:** "A person involved in performing the duties and
responsibilities of a fire department, under the auspices of the
organization. A member can be full-time, part-time, paid, or unpaid, can
occupy any position or rank within the fire department, and might or
might not engage in emergency operations." (NFPA 1581)

**Member Assistance Program:** "A generic term used to describe the
various methods used in the workplace for the control of alcohol and
other substance abuse, stress, and personal problems that adversely
affect job performance." (NFPA 1500)

**Meningitis:** An infection of the meninges (layers covering the brain
and spinal cord). May be caused by a bacteria or virus; considered a
communicable disease.

**Microorganism:** A living organism, usually visible only with a
microscope, including bacteria, viruses, fungi, and parasites.

**Morbidity and Mortality Weekly Report (MMWR):** A weekly publication
from the Centers for Disease Control and Prevention presenting
up-to-date information on communicable diseases.

**Mucous Membrane:** The lining of the nose, mouth, eyes, vagina, and
rectum. Mucous membranes are not as durable as other skin; contact of
infected body fluids with intact mucous membranes may transmit disease.

**Mumps:** A vaccine-preventable virus resulting in inflamed and swollen
parotid glands. Usually occurring in childhood.

**Nosocomial:** Originating in the hospital.

**Occupational:** Related to the performance of duties and
responsibilities of the job.

> **Exposure:** "Reasonably anticipated skin, eye, mucous membrane, or
> parenteral contact with blood or other potentially infectious
> materials that may result from the performance of an employee's
> duties." (OSHA) This definition excludes incidental exposures that may
> take place on the job, that are neither reasonable or routinely
> expected, and that the worker is not required to incur in the normal
> course of employment.
>
> **Illness:** "An illness or disease contracted through or aggravated
> by the performance of the duties, responsibilities, and functions of a
> fire department member." (NFPA 1500)

**Injury:** "An injury sustained during the performance of the duties,
responsibilities, and functions of a fire department member." (NFPA
1500).

**Pathogen:** A microorganism that can cause disease. Pathogens can be
bacteria, viruses, fungi, or parasites.

**Personal Protective Equipment (PPE):** "Specialized clothing or
equipment worn by an employee for protection from a hazard. General work
clothes (e.g. uniforms, pants, shirts, or blouses) not intended to
function as protection against a hazard are not considered to be
personal protective equipment." (OSHA)

**Phlebotomist:** Any health care worker who draws blood samples. (OSHA)

**Pneumocyctis Pneumonia:** A type of pneumonia caused by a parasite,
seen in patients with impaired immune systems.

**Purified Protein Derivative (PPD):** A skin test for exposure to
tuberculosis.

**Recombinant Vaccine:** A vaccine produced by genetic manipulation
(gene splicing), usually in yeast.

**RPR:** A blood test for syphilis.

**Rubella:** A vaccine-preventable viral disease. Rubella infection
during pregnancy can cause birth defects.

**Sexually Transmitted Disease (STD):** A disease spread through sexual
contact or activities. HIV and HBV are both bloodborne and sexually
transmitted diseases.

**Seroconversion:** A change in the status of one's serum test. For
example, someone initially tests negative for HIV, then tests positive
at a later date.

**Sharps:** "Any object that can penetrate the skin including, but not
limited to needles, lancets, scalpels, and broken capillary tubes."
(OSHA)

**Sharps Container:** "Container that is closable, puncture-resistant,
disposable, and leakproof on the sides and bottom; red in color or
displays the universal biohazard symbol; and designed to store sharp
objects after use." (NFPA 1581)

**Standard Precautions:** "Synthesize the major features of universal
precautions and body substance isolation and applies them to all
patients receiving care in the hospital. Apply to blood, all body fluids
except sweat regardless of whether or not they contain visible blood,
non-intact skin, and mucous membranes." (CDC)

**Sterilization:** "The use of a physical or chemical procedure to
destroy all microbial life, including highly resistant bacterial
endospores." (OSHA)

**Syphilis:** A sexually transmitted infectious disease. Syphilis is
uncommonly transmitted through blood exposure or transfusion.

**Tuberculocidal:** Capable of killing tuberculosis bacteria. Used as a
guideline for effectiveness of disinfecting/sterilizing agents.

**Tuberculosis (TB):** A communicable disease caused by the bacteria
*Mycobacterium tuberculosis*, usually affecting the lungs.

**Universal Precautions:** Infection control strategy developed by the
CDC for **hospital workers**. Universal precautions are based on the
concept that blood and **certain** body fluids (any body fluids
containing visible blood, semen, vaginal secretions, tissues,
cerebrospinal fluid (CSF), synovial fluid, pleural fluid, peritoneal
fluid, pericardial fluid, and amniotic fluid) of all patients should be
considered potentially infectious for HIV, HBV, and other bloodborne
pathogens.

**Vaccine:** A suspension of attenuated or killed microorganisms
(bacteria, viruses or rickettsiae), administered to prevent or reduce
the chance of contracting infectious diseases.

**VDRL:** Blood test for syphilis. Stands for Venereal Disease Research
Laboratory, where the test was designed.

**Venereal:** Due to or propagated by sexual contact.

**Virulence:** The disease-evoking power of a microorganism in a given
host.

**Virus:** A microorganism usually only visible with the electron
microscope. Normally reside within other living (host) cells and cannot
reproduce outside a living cell.

**Western Blot:** A test for HIV, used to confirm a positive ELISA test.
More expensive and time consuming that the ELISA, but more specific.
Diagnosis of HIV infection requires two positive ELISA tests, confirmed
with a positive Western Blot test.

**Whitlow:** A fingertip infection commonly caused by herpes virus.
Spread by contact with respiratory secretions.

**Window Phase:** The time from exposure to the disease to positive
testing.

# APPENDIX B

**LAWS, REGULATIONS, AND STANDARDS**

1.  *Health Care Worker Needlestick Prevention Act* (PL 106-430).

2\. *Occupational Exposure to Bloodborne Pathogens: Final Rule.* (OSHA
29 CFR Part 1910.1030).

> *3. Occupational Exposure to Bloodborne Pathogens: Needlesticks and
> Other Sharps Injuries: Final Rule.* (OSHA 29 CFS Part 1910).
>
> 4\. Updated U.S. Public Health Service. *Guidelines for the Management
> of Occupational Exposures to HBV, HCV, and HIV and Recommendations for
> Postexposure Prophylaxis* (Morbidity and Mortality Weekly, June 29,
> 2001 / 50(RR-11); 1-42.

# 

#  

**APPENDIX B-1**

Health Care Worker Needlestick Prevention Act (PL 106-430)

To require changes in the bloodborne pathogens standard in effect under
the Occupational Safety and Health Act of 1970.

Be it enacted by the Senate and House of Representatives of the United
States of America in Congress assembled,

SECTION 1. SHORT TITLE.

This Act may be cited as the "Needlestick Safety and Prevention Act".

SEC. 2. FINDINGS.

The Congress finds the following:

\(1\) Numerous workers who are occupationally exposed to bloodborne
pathogens have contracted fatal and other serious viruses and diseases,
including the human immunodeficiency virus (HIV), hepatitis B, and
hepatitis C from exposure to blood and other potentially infectious
materials in their workplace.

\(2\) In 1991 the Occupational Safety and Health Administration issued a
standard regulating occupational exposure to bloodborne pathogens,
including the human

immunodeficiency virus, (HIV), the hepatitis B virus (HBV), and the
hepatitis C virus (HCV).

\(3\) Compliance with the bloodborne pathogens standard has
significantly reduced the risk that workers will contract a bloodborne
disease in the course of their work.

\(4\) Nevertheless, occupational exposure to bloodborne pathogens from
accidental sharps injuries in health care settings continues to be a
serious problem. In March 2000, the Centers for Disease Control and
Prevention estimated that more than 380,000 percutaneous injuries from
contaminated sharps occur annually among health care workers in United
States hospital settings. Estimates for all health care settings are
that 600,000 to 800,000 needlestick and other percutaneous injuries
occur among health care workers annually. Such injuries can involve
needles or other sharps contaminated with bloodborne pathogens, such as
HIV, HBV, or HCV.

\(5\) Since publication of the bloodborne pathogens standard in 1991
there has been a substantial increase in the number and assortment of
effective engineering controls available to employers. There is now a
large body of research and data concerning the effectiveness of newer
engineering controls, including safer medical devices.

\(6\) 396 interested parties responded to a Request for Information (in
this section referred to as the "RFI") conducted by the Occupational
Safety and Health Administration in 1998 on engineering and work
practice controls used to eliminate or minimize the risk of occupational
exposure to bloodborne pathogens due to percutaneous injuries from
contaminated sharps. Comments were provided by health care facilities,
groups representing healthcare workers, researchers, educational
institutions, professional and industry associations, and manufacturers
of medical devices.

\(7\) Numerous studies have demonstrated that the use of safer medical
devices, such as needleless systems and sharps with engineered sharps
injury protections, when they are part of an overall bloodborne
pathogens risk-reduction program, can be extremely effective in reducing
accidental sharps injuries.

\(8\) In March 2000, the Centers for Disease Control and Prevention
estimated that, depending on the type of device used and the procedure
involved, 62 to 88 percent of sharps injuries can potentially be
prevented by the use of safer medical devices.

\(9\) The OSHA 200 Log, as it is currently maintained, does not
sufficiently reflect injuries that may involve exposure to bloodborne
pathogens in healthcare facilities. More than 98 percent of healthcare
facilities responding to the RFI have adopted surveillance systems in
addition to the OSHA 200 Log. Information gathered through these
surveillance systems is commonly used for hazard identification and
evaluation of program and device effectiveness.

\(10\) Training and education in the use of safer medical devices and
safer work practices are significant elements in the prevention of
percutaneous exposure incidents. Staff involvement in the device
selection and evaluation process is also an important element to
achieving a reduction in sharps injuries, particularly as new safer
devices are introduced into the work setting.

\(11\) Modification of the bloodborne pathogens standard is appropriate
to set forth in greater detail its requirement that employers identify,
evaluate, and make use of effective safer medical devices.

SEC. 3. BLOODBORNE PATHOGENS STANDARD.

The bloodborne pathogens standard published at 29 CFR 1910.1030 shall be
revised as follows:

\(1\) The definition of "Engineering Controls" (at 29 CFR 1910.1030(b))
shall include as additional examples of controls the following:
\`\`safer medical devices, such as sharps with engineered sharps injury
protections and needleless systems\'\'.

\(2\) The term "Sharps with Engineered Sharps Injury Protections" shall
be added to the definitions (at 29 CFR 1910.1030(b)) and defined as
\`\`a nonneedle sharp or a needle device used for withdrawing body
fluids, accessing a vein or artery, or administering medications or
other fluids, with a built-in safety feature or mechanism that
effectively reduces the risk of an exposure incident\'\'.

\(3\) The term "Needleless Systems" shall be added to the definitions
(at 29 CFR 1910.1030(b)) and defined as "a device that does not use
needles for: (A) the collection of bodily fluids or withdrawal of body
fluids after initial venous or arterial access is established; (B) the
administration of medication or fluids; or (C) any other procedure
involving the potential for occupational exposure to bloodborne
pathogens due to percutaneous injuries from contaminated sharps".

\(4\) In addition to the existing requirements concerning exposure
control plans (29 CFR 1910.1030(c)(1)(iv)), the review and update of
such plans shall be required to also\--

\(A\) "reflect changes in technology that eliminate or reduce exposure
to bloodborne pathogens"; and

\(B\) "document annually consideration and implementation of appropriate
commercially available and effective safer medical devices designed to
eliminate or minimize occupational exposure".

\(5\) The following additional recordkeeping requirement shall be added
to the bloodborne pathogens standard at 29 CFR 1910.1030(h): "The
employer shall establish and maintain a sharps injury log for the
recording of percutaneous injuries from contaminated sharps. The
information in the sharps injury log shall be recorded and maintained in
such manner as to protect the confidentiality of the injured employee.
The sharps injury log shall contain, at a minimum\--

\(A\) the type and brand of device involved in the incident,

\(B\) the department or work area where the exposure incident occurred,
and

\(C\) an explanation of how the incident occurred".

The requirement for such sharps injury log shall not apply to any
employer who is not required to maintain a log of occupational injuries
and illnesses under 29 CFR 1904 and the sharps injury log shall be
maintained for the period required by 29 CFR 1904.6.

\(6\) The following new section shall be added to the bloodborne
pathogens standard: "An employer, who is required to establish an
Exposure Control Plan shall solicit input from non-managerial employees
responsible for direct patient care who are potentially exposed to
injuries from contaminated sharps in the identification, evaluation, and
selection of effective engineering and work practice controls and shall
document the

solicitation in the Exposure Control Plan".

SEC. 4. EFFECT OF MODIFICATIONS.

The modifications under section 3 shall be in force until superseded in
whole or in part by regulations promulgated by the Secretary of Labor
under section 6(b) of the Occupational Safety and Health Act of 1970 (29
U.S.C. 655(b)) and shall be enforced in the same manner and to the same
extent as any rule or regulation promulgated under section 6(b).

SEC. 5. PROCEDURE AND EFFECTIVE DATE.

\(a\) Procedure \--The modifications of the bloodborne pathogens
standard prescribed by section 3 shall take effect without regard to the
procedural requirements applicable to regulations promulgated under
section 6(b) of the Occupational Safety and Health Act of 1970 (29
U.S.C. 655(b)) or the procedural requirements of chapter 5 of title 5,
United States Code.

\(b\) Effective Date \--The modifications to the bloodborne pathogens
standard required by section 3 shall\--

\(1\) within 6 months of the date of the enactment of this Act, be made
and published in the Federal Register by the Secretary of Labor acting
through the Occupational Safety and Health Administration; and

\(2\) at the end of 90 days after such publication, take effect.

**APPENDIX B-2**

**DEPARTMENT OF LABOR,** **OCCUPATIONAL SAFETY and HEALTH
ADMINISTRATION** **29 CFR part 1910.1030, SubPart:** **Z: Occupational
Exposure to Bloodborne Pathogens** **(Final Rule)**

**(a)** *Scope and Application*. This section applies to all
occupational exposure to blood or other potentially infectious materials
as defined by paragraph (b) of this section.

**(b)** *Definitions*. For purposes of this section, the following shall
apply:

*Assistant Secretary* means the Assistant Secretary of Labor for
Occupational Safety and Health, or designated representative.

*Blood* means human blood, human blood components, and products made
from human blood.

*Bloodborne Pathogens* means pathogenic microorganisms that are present
in human blood and can cause disease in humans. These pathogens include,
but are not limited to, hepatitis B virus (HBV) and human
immunodeficiency virus (HIV).

*Clinical Laboratory* means a workplace where diagnostic or other
screening procedures are performed on blood or other potentially
infectious materials.

*Contaminated* means the presence or the reasonably anticipated presence
of blood or other potentially infectious materials on an item or
surface.

*Contaminated Laundry* means laundry which has been soiled with blood or
other potentially infectious materials or may contain sharps.

*Contaminated Sharps* means any contaminated object that can penetrate
the skin including, but not limited to, needles, scalpels, broken glass,
broken capillary tubes, and exposed ends of dental wires.

*Decontamination* means the use of physical or chemical means to remove,
inactivate, or destroy bloodborne pathogens on a surface or item to the
point where they are no longer capable of transmitting infectious
particles and the surface or item is rendered safe for handling, use, or
disposal.

*Director* means the Director of the National Institute for Occupational
Safety and Health, U.S. Department of Health and Human Services, or
designated representative.

*Engineering Controls* means controls (e.g., sharps disposal containers,
self-sheathing needles) that isolate or remove the bloodborne pathogens
hazard from the workplace.

*Exposure Incident* means a specific eye, mouth, other mucous membrane,
non-intact skin, or parenteral contact with blood or other potentially
infectious materials that results from the performance of an employee\'s
duties.

*Handwashing Facilities* means a facility providing an adequate supply
of running potable water, soap and single use towels or hot air drying
machines.

*Licensed Healthcare Professional* is a person whose legally permitted
scope of practice allows him or her to independently perform the
activities required by paragraph (f) Hepatitis B Vaccination and
Post-exposure Evaluation and Follow-up.

*HBV* means hepatitis B virus.

*HIV* means human immunodeficiency virus.

*Occupational Exposure* means reasonably anticipated skin, eye, mucous
membrane, or parenteral contact with blood or other potentially
infectious materials that may result from the performance of an
employee\'s duties.

*Other Potentially Infectious Materials* means (1) The following human
body fluids: semen, vaginal secretions, cerebrospinal fluid, synovial
fluid, pleural fluid, pericardial fluid, peritoneal fluid, amniotic
fluid, saliva in dental procedures, any body fluid that is visibly
contaminated with blood, and all body fluids in situations where it is
difficult or impossible to differentiate between body fluids; (2) Any
unfixed tissue or organ (other than intact skin) from a human (living or
dead); and (3) HIV-containing cell or tissue cultures, organ cultures,
and HIV- or HBV-containing culture medium or other solutions; and blood,
organs, or other tissues from experimental animals infected with HIV or
HBV.

*Parenteral* means piercing mucous membranes or the skin barrier through
such events as needlesticks, human bites, cuts, and abrasions.

*Personal Protective Equipment* is specialized clothing or equipment
worn by an employee for protection against a hazard. General work
clothes (e.g., uniforms, pants, shirts or blouses) not intended to
function as protection against a hazard are not considered to be
personal protective equipment.

*Production Facility* means a facility engaged in industrial-scale,
large-volume or high concentration production of HIV or HBV.

*Regulated Waste* means liquid or semi-liquid blood or other potentially
infectious materials; contaminated items that would release blood or
other potentially infectious materials in a liquid or semi-liquid state
if compressed; items that are caked with dried blood or other
potentially infectious materials and are capable of releasing these
materials during handling; contaminated sharps; and pathological and
microbiological wastes containing blood or other potentially infectious
materials.

*Research Laboratory* means a laboratory producing or using
research-laboratory-scale amounts of HIV or HBV. Research laboratories
may produce high concentrations of HIV or HBV but not in the volume
found in production facilities.

*Source Individual* means any individual, living or dead, whose blood or
other potentially infectious materials may be a source of occupational
exposure to the employee. Examples include, but are not limited to,
hospital and clinic patients; clients in institutions for the
developmentally disabled; trauma victims; clients of drug and alcohol
treatment facilities; residents of hospices and nursing homes; human
remains; and individuals who donate or sell blood or blood components.

*Sterilize* means the use of a physical or chemical procedure to destroy
all microbial life including highly resistant bacterial endospores.

*Universal Precautions* is an approach to infection control. According
to the concept of Universal Precautions, all human blood and certain
human body fluids are treated as if known to be infectious for HIV, HBV,
and other bloodborne pathogens.

*Work Practice Controls* means controls that reduce the likelihood of
exposure by altering the manner in which a task is performed (e.g.,
prohibiting recapping of needles by a two-handed technique).

**(c)** Exposure Control.

**(c)(1)** Exposure Control Plan.

**(c)(1)(i)** Each employer having an employee(s) with occupational
exposure as defined by paragraph (b) of this section shall establish a
written Exposure Control Plan designed to eliminate or minimize employee
exposure.

**(c)(1)(ii)** The Exposure Control Plan shall contain at least the
following elements:

**(c)(1)(ii)(A)** The exposure determination required by paragraph
(c)(2),

**(c)(1)(ii)(B)** The schedule and method of implementation for
paragraphs (d) Methods of Compliance, (e) HIV and HBV Research
Laboratories and Production Facilities, (f) Hepatitis B Vaccination and
Post-Exposure Evaluation and Follow-up, (g) Communication of Hazards to
Employees, and (h) Recordkeeping, of this standard, and

**(c)(1)(ii)(C)** The procedure for the evaluation of circumstances
surrounding exposure incidents as required by paragraph (f)(3)(i) of
this standard.

**(c)(1)(iii)** Each employer shall ensure that a copy of the Exposure
Control Plan is accessible to employees in accordance with 29 CFR
1910.1020(e).

**(c)(1)(iv)** The Exposure Control Plan shall be reviewed and updated
at least annually and whenever necessary to reflect new or modified
tasks and procedures which affect occupational exposure and to reflect
new or revised employee positions with occupational exposure.

**(c)(1)(v)** The Exposure Control Plan shall be made available to the
Assistant Secretary and the Director upon request for examination and
copying.

**(c)(2)** Exposure Determination.

**(c)(2)(i)** Each employer who has an employee(s) with occupational
exposure as defined by paragraph (b) of this section shall prepare an
exposure determination. This exposure determination shall contain the
following:

**(c)(2)(i)(A)** A list of all job classifications in which all
employees in those job classifications have occupational exposure;

**(c)(2)(i)(B)** A list of job classifications in which some employees
have occupational exposure, and

**(c)(2)(i)(C)** A list of all tasks and procedures or groups of closely
related task and procedures in which occupational exposure occurs and
that are performed by employees in job classifications listed in
accordance with the provisions of paragraph (c)(2)(i)(B) of this
standard.

**(c)(2)(ii)** This exposure determination shall be made without regard
to the use of personal protective equipment.

**(d)** Methods of Compliance.

**(d)(1)** General. Universal precautions shall be observed to prevent
contact with blood or other potentially infectious materials. Under
circumstances in which differentiation between body fluid types is
difficult or impossible, all body fluids shall be considered potentially
infectious materials.

**(d)(2)** Engineering and Work Practice Controls.

**(d)(2)(i)** Engineering and work practice controls shall be used to
eliminate or minimize employee exposure. Where occupational exposure
remains after institution of these controls, personal protective
equipment shall also be used.

**(d)(2)(ii)** Engineering controls shall be examined and maintained or
replaced on a regular schedule to ensure their effectiveness.

**(d)(2)(iii)** Employers shall provide handwashing facilities which are
readily accessible to employees.

**(d)(2)(iv)** When provision of handwashing facilities is not feasible,
the employer shall provide either an appropriate antiseptic hand
cleanser in conjunction with clean cloth/paper towels or antiseptic
towelettes. When antiseptic hand cleansers or towelettes are used, hands
shall be washed with soap and running water as soon as feasible.

**(d)(2)(v)** Employers shall ensure that employees wash their hands
immediately or as soon as feasible after removal of gloves or other
personal protective equipment.

**(d)(2)(vi)** Employers shall ensure that employees wash hands and any
other skin with soap and water, or flush mucous membranes with water
immediately or as soon as feasible following contact of such body areas
with blood or other potentially infectious materials.

**(d)(2)(vii)** Contaminated needles and other contaminated sharps shall
not be bent, recapped, or removed except as noted in paragraphs
(d)(2)(vii)(A) and (d)(2)(vii)(B) below. Shearing or breaking of
contaminated needles is prohibited.

**(d)(2)(vii)(A)** Contaminated needles and other contaminated sharps
shall not be bent, recapped or removed unless the employer can
demonstrate that no alternative is feasible or that such action is
required by a specific medical or dental procedure.

**(d)(2)(vii)(B)** Such bending, recapping or needle removal must be
accomplished through the use of a mechanical device or a one-handed
technique.

**(d)(2)(viii)** Immediately or as soon as possible after use,
contaminated reusable sharps shall be placed in appropriate containers
until properly reprocessed. These containers shall be:

**(d)(2)(viii)(A)** puncture resistant;

**(d)(2)(viii)(B)** labeled or color-coded in accordance with this
standard;

**(d)(2)(viii)(C)** leakproof on the sides and bottom; and

**(d)(2)(viii)(D)** in accordance with the requirements set forth in
paragraph(d)(4)(ii)(E) for reusable sharps.

**(d)(2)(ix)** Eating, drinking, smoking, applying cosmetics or lip
balm, and handling contact lenses are prohibited in work areas where
there is a reasonable likelihood of occupational exposure.

**(d)(2)(x)** Food and drink shall not be kept in refrigerators,
freezers, shelves, cabinets or on countertops or benchtops where blood
or other potentially infectious materials are present.

**(d)(2)(xi)** All procedures involving blood or other potentially
infectious materials shall be performed in such a manner as to minimize
splashing, spraying, spattering, and generation of droplets of these
substances.

**(d)(2)(xii)** Mouth pipetting/suctioning of blood or other potentially
infectious materials is prohibited.

**(d)(2)(xiii)** Specimens of blood or other potentially infectious
materials shall be placed in a container which prevents leakage during
collection, handling, processing, storage, transport, or shipping.

**(d)(2)(xiii)(A)** The container for storage, transport, or shipping
shall be labeled or color-coded according to paragraph (g)(1)(i) and
closed prior to being stored, transported, or shipped. When a facility
utilizes Universal Precautions in the handling of all specimens, the
labeling/color-coding of specimens is not necessary provided containers
are recognizable as containing specimens. This exemption only applies
while such specimens/containers remain within the facility. Labeling or
color-coding in accordance with paragraph (g)(1)(i) is required when
such specimens/containers leave the facility.

**(d)(2)(xiii)(B)** If outside contamination of the primary container
occurs, the primary container shall be placed within a second container
which prevents leakage during handling, processing, storage, transport,
or shipping and is labeled or color-coded according to the requirements
of this standard.

**(d)(2)(xiii)(C)** If the specimen could puncture the primary
container, the primary container shall be placed within a secondary
container which is puncture-resistant in addition to the above
characteristics.

**(d)(2)(xiv)** Equipment which may become contaminated with blood or
other potentially infectious materials shall be examined prior to
servicing or shipping and shall be decontaminated as necessary, unless
the employer can demonstrate that decontamination of such equipment or
portions of such equipment is not feasible.

**(d)(2)(xiv)(A)** A readily observable label in accordance with
paragraph (g)(1)(i)(H) shall be attached to the equipment stating which
portions remain contaminated.

**(d)(2)(xiv)(B)** The employer shall ensure that this information is
conveyed to all affected employees, the servicing representative, and/or
the manufacturer, as appropriate, prior to handling, servicing, or
shipping so that appropriate precautions will be taken.

**(d)(3)** Personal Protective Equipment.

**(d)(3)(i)** Provision. When there is occupational exposure, the
employer shall provide, at no cost to the employee, appropriate personal
protective equipment such as, but not limited to, gloves, gowns,
laboratory coats, face shields or masks and eye protection, and
mouthpieces, resuscitation bags, pocket masks, or other ventilation
devices. Personal protective equipment will be considered
\"appropriate\" only if it does not permit blood or other potentially
infectious materials to pass through to or reach the employee\'s work
clothes, street clothes, undergarments, skin, eyes, mouth, or other
mucous membranes under normal conditions of use and for the duration of
time which the protective equipment will be used.

**(d)(3)(ii)** Use. The employer shall ensure that the employee uses
appropriate personal protective equipment unless the employer shows that
the employee temporarily and briefly declined to use personal protective
equipment when, under rare and extraordinary circumstances, it was the
employee\'s professional judgment that in the specific instance its use
would have prevented the delivery of health care or public safety
services or would have posed an increased hazard to the safety of the
worker or co-worker. When the employee makes this judgement, the
circumstances shall be investigated and documented in order to determine
whether changes can be instituted to prevent such occurrences in the
future.

**(d)(3)(iii)** Accessibility. The employer shall ensure that
appropriate personal protective equipment in the appropriate sizes is
readily accessible at the worksite or is issued to employees.
Hypoallergenic gloves, glove liners, powderless gloves, or other similar
alternatives shall be readily accessible to those employees who are
allergic to the gloves normally provided.

**(d)(3)(iv)** Cleaning, Laundering, and Disposal. The employer shall
clean, launder, and dispose of personal protective equipment required by
paragraphs (d) and (e) of this standard, at no cost to the employee.

**(d)(3)(v)** Repair and Replacement. The employer shall repair or
replace personal protective equipment as needed to maintain its
effectiveness, at no cost to the employee.

**(d)(3)(vi)** If a garment(s) is penetrated by blood or other
potentially infectious materials, the garment(s) shall be removed
immediately or as soon as feasible.

**(d)(3)(vii)** All personal protective equipment shall be removed prior
to leaving the work area.

**(d)(3)(viii)** When personal protective equipment is removed it shall
be placed in an appropriately designated area or container for storage,
washing, decontamination or disposal.

**(d)(3)(ix)** Gloves. Gloves shall be worn when it can be reasonably
anticipated that the employee may have hand contact with blood, other
potentially infectious materials, mucous membranes, and non-intact skin;
when performing vascular access procedures except as specified in
paragraph (d)(3)(ix)(D); and when handling or touching contaminated
items or surfaces.

**(d)(3)(ix)(A)** Disposable (single use) gloves such as surgical or
examination gloves, shall be replaced as soon as practical when
contaminated or as soon as feasible if they are torn, punctured, or when
their ability to function as a barrier is compromised.

**(d)(3)(ix)(B)** Disposable (single use) gloves shall not be washed or
decontaminated for re-use.

**(d)(3)(ix)(C)** Utility gloves may be decontaminated for re-use if the
integrity of the glove is not compromised. However, they must be
discarded if they are cracked, peeling, torn, punctured, or exhibit
other signs of deterioration or when their ability to function as a
barrier is compromised.

**(d)(3)(ix)(D)** If an employer in a volunteer blood donation center
judges that routine gloving for all phlebotomies is not necessary then
the employer shall:

**(d)(3)(ix)(D)(1)** Periodically reevaluate this policy;

**(d)(3)(ix)(D)(2)** Make gloves available to all employees who wish to
use them for phlebotomy;

**(d)(3)(ix)(D)(3)** Not discourage the use of gloves for phlebotomy;
and

**(d)(3)(ix)(D)(4)** Require that gloves be used for phlebotomy in the
following circumstances:

\[i\] When the employee has cuts, scratches, or other breaks in his or
her skin;

\[ii\] When the employee judges that hand contamination with blood may
occur, for example, when performing phlebotomy on an uncooperative
source individual; and

\[iii\] When the employee is receiving training in phlebotomy.

**(d)(3)(x)** Masks, Eye Protection, and Face Shields. Masks in
combination with eye protection devices, such as goggles or glasses with
solid side shields, or chin-length face shields, shall be worn whenever
splashes, spray, spatter, or droplets of blood or other potentially
infectious materials may be generated and eye, nose, or mouth
contamination can be reasonably anticipated.

**(d)(3)(xi)** Gowns, Aprons, and Other Protective Body Clothing.
Appropriate protective clothing such as, but not limited to, gowns,
aprons, lab coats, clinic jackets, or similar outer garments shall be
worn in occupational exposure situations. The type and characteristics
will depend upon the task and degree of exposure anticipated.

**(d)(3)(xii)** Surgical caps or hoods and/or shoe covers or boots shall
be worn in instances when gross contamination can reasonably be
anticipated (e.g., autopsies, orthopaedic surgery).

**(d)(4)** Housekeeping.

**(d)(4)(i)** General. Employers shall ensure that the worksite is
maintained in a clean and sanitary condition. The employer shall
determine and implement an appropriate written schedule for cleaning and
method of decontamination based upon the location within the facility,
type of surface to be cleaned, type of soil present, and tasks or
procedures being performed in the area.

**(d)(4)(ii)** All equipment and environmental and working surfaces
shall be cleaned and decontaminated after contact with blood or other
potentially infectious materials.

**(d)(4)(ii)(A)** Contaminated work surfaces shall be decontaminated
with an appropriate disinfectant after completion of procedures;
immediately or as soon as feasible when surfaces are overtly
contaminated or after any spill of blood or other potentially infectious
materials; and at the end of the work shift if the surface may have
become contaminated since the last cleaning.

**(d)(4)(ii)(B)** Protective coverings, such as plastic wrap, aluminum
foil, or imperviously-backed absorbent paper used to cover equipment and
environmental surfaces, shall be removed and replaced as soon as
feasible when they become overtly contaminated or at the end of the
workshift if they may have become contaminated during the shift.

**(d)(4)(ii)(C)** All bins, pails, cans, and similar receptacles
intended for reuse which have a reasonable likelihood for becoming
contaminated with blood or other potentially infectious materials shall
be inspected and decontaminated on a regularly scheduled basis and
cleaned and decontaminated immediately or as soon as feasible upon
visible contamination.

**(d)(4)(ii)(D)** Broken glassware which may be contaminated shall not
be picked up directly with the hands. It shall be cleaned up using
mechanical means, such as a brush and dust pan, tongs, or forceps.

**(d)(4)(ii)(E)** Reusable sharps that are contaminated with blood or
other potentially infectious materials shall not be stored or processed
in a manner that requires employees to reach by hand into the containers
where these sharps have been placed.

**(d)(4)(iii)** Regulated Waste.

**(d)(4)(iii)(A)** Contaminated Sharps Discarding and Containment.

**(d)(4)(iii)(A)(1)** Contaminated sharps shall be discarded immediately
or as soon as feasible in containers that are:

\[a\] Closable;

\[b\] Puncture resistant;

\[c\] Leakproof on sides and bottom; and

\[d\] Labeled or color-coded in accordance with paragraph (g)(1)(i) of
this standard.

**(d)(4)(iii)(A)(2)** During use, containers for contaminated sharps
shall be:

\[a\] Easily accessible to personnel and located as close as is feasible
to the immediate area where sharps are used or can be reasonably
anticipated to be found (e.g., laundries);

\[b\] Maintained upright throughout use; and

\[c\] Replaced routinely and not be allowed to overfill.

**(d)(4)(iii)(A)(3)** When moving containers of contaminated sharps from
the area of use, the containers shall be:

\[a\] Closed immediately prior to removal or replacement to prevent
spillage or protrusion of contents during handling, storage, transport,
or shipping;

\[b\] Placed in a secondary container if leakage is possible. The second
container shall be:

\[i\] Closable;

\[ii\] Constructed to contain all contents and prevent leakage during
handling, storage, transport, or shipping; and

\[iii\] Labeled or color-coded according to paragraph (g)(1)(i) of this
standard.

**(d)(4)(iii)(A)(4)** Reusable containers shall not be opened, emptied,
or cleaned manually or in any other manner which would expose employees
to the risk of percutaneous injury.

**(d)(4)(iii)(B)** Other Regulated Waste Containment.

**(d)(4)(iii)(B)(1)** Regulated waste shall be placed in containers
which are:

\[a\] Closable;

\[b\] Constructed to contain all contents and prevent leakage of fluids
during handling, storage, transport or shipping;

\[c\] Labeled or color-coded in accordance with paragraph (g)(1)(i) this
standard; and

\[d\] Closed prior to removal to prevent spillage or protrusion of
contents during handling, storage, transport, or shipping.

**(d)(4)(iii)(B)(2)** If outside contamination of the regulated waste
container occurs, it shall be placed in a second container. The second
container shall be:

\[a\] Closable;

\[b\] Constructed to contain all contents and prevent leakage of fluids
during handling, storage, transport or shipping;

\[c\] Labeled or color-coded in accordance with paragraph (g)(1)(i) of
this standard; and

\[d\] Closed prior to removal to prevent spillage or protrusion of
contents during handling, storage, transport, or shipping.

**(d)(4)(iii)(C)** Disposal of all regulated waste shall be in
accordance with applicable regulations of the United States, States and
Territories, and political subdivisions of States and Territories.

**(d)(4)(iv)** Laundry.

**(d)(4)(iv)(A)** Contaminated laundry shall be handled as little as
possible with a minimum of agitation.

**(d)(4)(iv)(A)(1)** Contaminated laundry shall be bagged or
containerized at the location where it was used and shall not be sorted
or rinsed in the location of use.

**(d)(4)(iv)(A)(2)** Contaminated laundry shall be placed and
transported in bags or containers labeled or color-coded in accordance
with paragraph (g)(1)(i) of this standard. When a facility utilizes
Universal Precautions in the handling of all soiled laundry, alternative
labeling or color-coding is sufficient if it permits all employees to
recognize the containers as requiring compliance with Universal
Precautions.

**(d)(4)(iv)(A)(3)** Whenever contaminated laundry is wet and presents a
reasonable likelihood of soak-through of or leakage from the bag or
container, the laundry shall be placed and transported in bags or
containers which prevent soak-through and/or leakage of fluids to the
exterior.

**(d)(4)(iv)(B)** The employer shall ensure that employees who have
contact with contaminated laundry wear protective gloves and other
appropriate personal protective equipment.

**(d)(4)(iv)(C)** When a facility ships contaminated laundry off-site to
a second facility which does not utilize Universal Precautions in the
handling of all laundry, the facility generating the contaminated
laundry must place such laundry in bags or containers which are labeled
or color-coded in accordance with paragraph (g)(1)(i).

**(e)** HIV and HBV Research Laboratories and Production Facilities.

**(e)(1)** This paragraph applies to research laboratories and
production facilities engaged in the culture, production, concentration,
experimentation, and manipulation of HIV and HBV. It does not apply to
clinical or diagnostic laboratories engaged solely in the analysis of
blood, tissues, or organs. These requirements apply in addition to the
other requirements of the standard.

**(e)(2)** Research laboratories and production facilities shall meet
the following criteria:

**(e)(2)(i)** Standard Microbiological Practices. All regulated waste
shall either be incinerated or decontaminated by a method such as
autoclaving known to effectively destroy bloodborne pathogens.

**(e)(2)(ii)** Special Practices

**(e)(2)(ii)(A)** Laboratory doors shall be kept closed when work
involving HIV or HBV is in progress.

**(e)(2)(ii)(B)** Contaminated materials that are to be decontaminated
at a site away from the work area shall be placed in a durable,
leakproof, labeled or color-coded container that is closed before being
removed from the work area.

**(e)(2)(ii)(C)** Access to the work area shall be limited to authorized
persons. Written policies and procedures shall be established whereby
only persons who have been advised of the potential biohazard, who meet
any specific entry requirements, and who comply with all entry and exit
procedures shall be allowed to enter the work areas and animal rooms.

**(e)(2)(ii)(D)** When other potentially infectious materials or
infected animals are present in the work area or containment module, a
hazard warning sign incorporating the universal biohazard symbol shall
be posted on all access doors. The hazard warning sign shall comply with
paragraph (g)(1)(ii) of this standard.

**(e)(2)(ii)(E)** All activities involving other potentially infectious
materials shall be conducted in biological safety cabinets or other
physical-containment devices within the containment module. No work with
these other potentially infectious materials shall be conducted on the
open bench.

**(e)(2)(ii)(F)** Laboratory coats, gowns, smocks, uniforms, or other
appropriate protective clothing shall be used in the work area and
animal rooms. Protective clothing shall not be worn outside of the work
area and shall be decontaminated before being laundered.

**(e)(2)(ii)(G)** Special care shall be taken to avoid skin contact with
other potentially infectious materials. Gloves shall be worn when
handling infected animals and when making hand contact with other
potentially infectious materials is unavoidable.

**(e)(2)(ii)(H)** Before disposal all waste from work areas and from
animal rooms shall either be incinerated or decontaminated by a method
such as autoclaving known to effectively destroy bloodborne pathogens.

**(e)(2)(ii)(I)** Vacuum lines shall be protected with liquid
disinfectant traps and high-efficiency particulate air (HEPA) filters or
filters of equivalent or superior efficiency and which are checked
routinely and maintained or replaced as necessary.

**(e)(2)(ii)(J)** Hypodermic needles and syringes shall be used only for
parenteral injection and aspiration of fluids from laboratory animals
and diaphragm bottles. Only needle-locking syringes or disposable
syringe-needle units (i.e., the needle is integral to the syringe) shall
be used for the injection or aspiration of other potentially infectious
materials. Extreme caution shall be used when handling needles and
syringes. A needle shall not be bent, sheared, replaced in the sheath or
guard, or removed from the syringe following use. The needle and syringe
shall be promptly placed in a puncture-resistant container and
autoclaved or decontaminated before reuse or disposal.

**(e)(2)(ii)(K)** All spills shall be immediately contained and cleaned
up by appropriate professional staff or others properly trained and
equipped to work with potentially concentrated infectious materials.

**(e)(2)(ii)(L)** A spill or accident that results in an exposure
incident shall be immediately reported to the laboratory director or
other responsible person.

**(e)(2)(ii)(M)** A biosafety manual shall be prepared or adopted and
periodically reviewed and updated at least annually or more often if
necessary. Personnel shall be advised of potential hazards, shall be
required to read instructions on practices and procedures, and shall be
required to follow them.

**(e)(2)(iii)** Containment Equipment.

**(e)(2)(iii)(A)** Certified biological safety cabinets (Class I, II, or
III) or other appropriate combinations of personal protection or
physical containment devices, such as special protective clothing,
respirators, centrifuge safety cups, sealed centrifuge rotors, and
containment caging for animals, shall be used for all activities with
other potentially infectious materials that pose a threat of exposure to
droplets, splashes, spills, or aerosols.

**(e)(2)(iii)(B)** Biological safety cabinets shall be certified when
installed, whenever they are moved and at least annually.

**(e)(3)** HIV and HBV research laboratories shall meet the following
criteria:

**(e)(3)(i)** Each laboratory shall contain a facility for hand washing
and an eye wash facility which is readily available within the work
area.

**(e)(3)(ii)** An autoclave for decontamination of regulated waste shall
be available.

**(e)(4)** HIV and HBV production facilities shall meet the following
criteria:

**(e)(4)(i)** The work areas shall be separated from areas that are open
to unrestricted traffic flow within the building. Passage through two
sets of doors shall be the basic requirement for entry into the work
area from access corridors or other contiguous areas. Physical
separation of the high-containment work area from access corridors or
other areas or activities may also be provided by a double-doored
clothes-change room (showers may be included), airlock, or other access
facility that requires passing through two sets of doors before entering
the work area.

**(e)(4)(ii)** The surfaces of doors, walls, floors and ceilings in the
work area shall be water resistant so that they can be easily cleaned.
Penetrations in these surfaces shall be sealed or capable of being
sealed to facilitate decontamination.

**(e)(4)(iii)** Each work area shall contain a sink for washing hands
and a readily available eye wash facility. The sink shall be foot,
elbow, or automatically operated and shall be located near the exit door
of the work area.

**(e)(4)(iv)** Access doors to the work area or containment module shall
be self-closing.

**(e)(4)(v)** An autoclave for decontamination of regulated waste shall
be available within or as near as possible to the work area.

**(e)(4)(vi)** A ducted exhaust-air ventilation system shall be
provided. This system shall create directional airflow that draws air
into the work area through the entry area. The exhaust air shall not be
recirculated to any other area of the building, shall be discharged to
the outside, and shall be dispersed away from occupied areas and air
intakes. The proper direction of the airflow shall be verified (i.e.,
into the work area).

**(e)(5)** Training Requirements. Additional training requirements for
employees in HIV and HBV research laboratories and HIV and HBV
production facilities are specified in paragraph (g)(2)(ix).

**(f)** Hepatitis B Vaccination and Post-exposure Evaluation and
Follow-up.

**(f)(1)** General.

**(f)(1)(i)** The employer shall make available the hepatitis B vaccine
and vaccination series to all employees who have occupational exposure,
and post-exposure evaluation and follow-up to all employees who have had
an exposure incident.

**(f)(1)(ii)** The employer shall ensure that all medical evaluations
and procedures including the hepatitis B vaccine and vaccination series
and post-exposure evaluation and follow-up, including prophylaxis, are:

**(f)(1)(ii)(A)** Made available at no cost to the employee;

**(f)(1)(ii)(B)** Made available to the employee at a reasonable time
and place;

**(f)(1)(ii)(C)** Performed by or under the supervision of a licensed
physician or by or under the supervision of another licensed healthcare
professional; and

**(f)(1)(ii)(D)** Provided according to recommendations of the U.S.
Public Health Service current at the time these evaluations and
procedures take place, except as specified by this paragraph (f).

**(f)(1)(iii)** The employer shall ensure that all laboratory tests are
conducted by an accredited laboratory at no cost to the employee.

**(f)(2)** Hepatitis B Vaccination.

**(f)(2)(i)** Hepatitis B vaccination shall be made available after the
employee has received the training required in paragraph (g)(2)(vii)(I)
and within 10 working days of initial assignment to all employees who
have occupational exposure unless the employee has previously received
the complete hepatitis B vaccination series, antibody testing has
revealed that the employee is immune, or the vaccine is contraindicated
for medical reasons.

**(f)(2)(ii)** The employer shall not make participation in a
prescreening program a prerequisite for receiving hepatitis B
vaccination.

**(f)(2)(iii)** If the employee initially declines hepatitis B
vaccination but at a later date while still covered under the standard
decides to accept the vaccination, the employer shall make available
hepatitis B vaccination at that time.

**(f)(2)(iv)** The employer shall assure that employees who decline to
accept hepatitis B vaccination offered by the employer sign the
statement in Appendix A.

**(f)(2)(v)** If a routine booster dose(s) of hepatitis B vaccine is
recommended by the U.S. Public Health Service at a future date, such
booster dose(s) shall be made available in accordance with section
(f)(1)(ii).

**(f)(3)** Post-exposure Evaluation and Follow-up. Following a report of
an exposure incident, the employer shall make immediately available to
the exposed employee a confidential medical evaluation and follow-up,
including at least the following elements:

**(f)(3)(i)** Documentation of the route(s) of exposure, and the
circumstances under which the exposure incident occurred;

**(f)(3)(ii)** Identification and documentation of the source
individual, unless the employer can establish that identification is
infeasible or prohibited by state or local law;

**(f)(3)(ii)(A)** The source individual\'s blood shall be tested as soon
as feasible and after consent is obtained in order to determine HBV and
HIV infectivity. If consent is not obtained, the employer shall
establish that legally required consent cannot be obtained. When the
source individual\'s consent is not required by law, the source
individual\'s blood, if available, shall be tested and the results
documented.

**(f)(3)(ii)(B)** When the source individual is already known to be
infected with HBV or HIV, testing for the source individual\'s known HBV
or HIV status need not be repeated.

**(f)(3)(ii)(C)** Results of the source individual\'s testing shall be
made available to the exposed employee, and the employee shall be
informed of applicable laws and regulations concerning disclosure of the
identity and infectious status of the source individual.

**(f)(3)(iii)** Collection and testing of blood for HBV and HIV
serological status;

**(f)(3)(iii)(A)** The exposed employee\'s blood shall be collected as
soon as feasible and tested after consent is obtained.

**(f)(3)(iii)(B)** If the employee consents to baseline blood
collection, but does not give consent at that time for HIV serologic
testing, the sample shall be preserved for at least 90 days. If, within
90 days of the exposure incident, the employee elects to have the
baseline sample tested, such testing shall be done as soon as feasible.

**(f)(3)(iv)** Post-exposure prophylaxis, when medically indicated, as
recommended by the U.S. Public Health Service;

**(f)(3)(v)** Counseling; and

**(f)(3)(vi)** Evaluation of reported illnesses.

**(f)(4)** Information Provided to the Healthcare Professional.

**(f)(4)(i)** The employer shall ensure that the healthcare professional
responsible for the employee\'s Hepatitis B vaccination is provided a
copy of this regulation.

**(f)(4)(ii)** The employer shall ensure that the healthcare
professional evaluating an employee after an exposure incident is
provided the following information:

**(f)(4)(ii)(A)** A copy of this regulation;

**(f)(4)(ii)(B)** A description of the exposed employee\'s duties as
they relate to the exposure incident;

**(f)(4)(ii)(C)** Documentation of the route(s) of exposure and
circumstances under which exposure occurred;

**(f)(4)(ii)(D)** Results of the source individual\'s blood testing, if
available; and

**(f)(4)(ii)(E)** All medical records relevant to the appropriate
treatment of the employee including vaccination status which are the
employer\'s responsibility to maintain.

**(f)(5)** Healthcare Professional\'s Written Opinion. The employer
shall obtain and provide the employee with a copy of the evaluating
healthcare professional\'s written opinion within 15 days of the
completion of the evaluation.

**(f)(5)(i)** The healthcare professional\'s written opinion for
Hepatitis B vaccination shall be limited to whether Hepatitis B
vaccination is indicated for an employee, and if the employee has
received such vaccination.

**(f)(5)(ii)** The healthcare professional\'s written opinion for
post-exposure evaluation and follow-up shall be limited to the following
information:

**(f)(5)(ii)(A)** That the employee has been informed of the results of
the evaluation; and

**(f)(5)(ii)(B)** That the employee has been told about any medical
conditions resulting from exposure to blood or other potentially
infectious materials which require further evaluation or treatment.

**(f)(5)(iii)** All other findings or diagnoses shall remain
confidential and shall not be included in the written report.

**(f)(6)** Medical Recordkeeping. Medical records required by this
standard shall be maintained in accordance with paragraph (h)(1) of this
section.

**(g)** Communication of Hazards to Employees.

**(g)(1)** Labels and Signs.

**(g)(1)(i)** Labels.

**(g)(1)(i)(A)** Warning labels shall be affixed to containers of
regulated waste, refrigerators and freezers containing blood or other
potentially infectious material; and other containers used to store,
transport or ship blood or other potentially infectious materials,
except as provided in paragraph (g)(1)(i)(E), (F) and (G).

**(g)(1)(i)(B)** Labels required by this section shall include the
following legend:

BIOHAZARD

![](media/image18.png){width="1.25in" height="1.0118055555555556in"}

**(g)(1)(i)(C)** These labels shall be fluorescent orange or orange-red
or predominantly so, with lettering and symbols in a contrasting color.

**(g)(1)(i)(D)** Labels shall be affixed as close as feasible to the
container by string, wire, adhesive, or other method that prevents their
loss or unintentional removal.

**(g)(1)(i)(E)** Red bags or red containers may be substituted for
labels.

**(g)(1)(i)(F)** Containers of blood, blood components, or blood
products that are labeled as to their contents and have been released
for transfusion or other clinical use are exempted from the labeling
requirements of paragraph (g).

**(g)(1)(i)(G)** Individual containers of blood or other potentially
infectious materials that are placed in a labeled container during
storage, transport, shipment or disposal are exempted from the labeling
requirement.

**(g)(1)(i)(H)** Labels required for contaminated equipment shall be in
accordance with this paragraph and shall also state which portions of
the equipment remain contaminated.

**(g)(1)(i)(I)** Regulated waste that has been decontaminated need not
be labeled or color-coded.

**(g)(1)(ii)** Signs.

**(g)(1)(ii)(A)** The employer shall post signs at the entrance to work
areas specified in paragraph (e), HIV and HBV Research Laboratory and
Production Facilities, which shall bear the following legend:

BIOHAZARD

![](media/image18.png){width="1.25in" height="1.0118055555555556in"}

(Name of the Infectious Agent)

(Special requirements for entering the area)

(Name, telephone number of the laboratory director or other

responsible person.)

**(g)(1)(ii)(B)** These signs shall be fluorescent orange-red or
predominantly so, with lettering and symbols in a contrasting color.

**(g)(2)** Information and Training.

**(g)(2)(i)** Employers shall ensure that all employees with
occupational exposure participate in a training program which must be
provided at no cost to the employee and during working hours.

**(g)(2)(ii)** Training shall be provided as follows:

**(g)(2)(ii)(A)** At the time of initial assignment to tasks where
occupational exposure may take place;

**(g)(2)(ii)(B)** Within 90 days after the effective date of the
standard; and

**(g)(2)(ii)(C)** At least annually thereafter.

**(g)(2)(iii)** For employees who have received training on bloodborne
pathogens in the year preceding the effective date of the standard, only
training with respect to the provisions of the standard which were not
included need be provided.

**(g)(2)(iv)** Annual training for all employees shall be provided
within one year of their previous training.

**(g)(2)(v)** Employers shall provide additional training when changes
such as modification of tasks or procedures or institution of new tasks
or procedures affect the employee\'s occupational exposure. The
additional training may be limited to addressing the new exposures
created.

**(g)(2)(vi)** Material appropriate in content and vocabulary to
educational level, literacy, and language of employees shall be used.

**(g)(2)(vii)** The training program shall contain at a minimum the
following elements:

**(g)(2)(vii)(A)** An accessible copy of the regulatory text of this
standard and an explanation of its contents;

**(g)(2)(vii)(B)** A general explanation of the epidemiology and
symptoms of bloodborne diseases;

**(g)(2)(vii)(C)** An explanation of the modes of transmission of
bloodborne pathogens;

**(g)(2)(vii)(D)** An explanation of the employer\'s exposure control
plan and the means by which the employee can obtain a copy of the
written plan;

**(g)(2)(vii)(E)** An explanation of the appropriate methods for
recognizing tasks and other activities that may involve exposure to
blood and other potentially infectious materials;

**(g)(2)(vii)(F)** An explanation of the use and limitations of methods
that will prevent or reduce exposure including appropriate engineering
controls, work practices, and personal protective equipment;

**(g)(2)(vii)(G)** Information on the types, proper use, location,
removal, handling, decontamination and disposal of personal protective
equipment;

**(g)(2)(vii)(H)** An explanation of the basis for selection of personal
protective equipment;

**(g)(2)(vii)(I)** Information on the hepatitis B vaccine, including
information on its efficacy, safety, method of administration, the
benefits of being vaccinated, and that the vaccine and vaccination will
be offered free of charge;

**(g)(2)(vii)(J)** Information on the appropriate actions to take and
persons to contact in an emergency involving blood or other potentially
infectious materials;

**(g)(2)(vii)(K)** An explanation of the procedure to follow if an
exposure incident occurs, including the method of reporting the incident
and the medical follow-up that will be made available;

**(g)(2)(vii)(L)** Information on the post-exposure evaluation and
follow-up that the employer is required to provide for the employee
following an exposure incident;

**(g)(2)(vii)(M)** An explanation of the signs and labels and/or color
coding required by paragraph (g)(1); and

**(g)(2)(vii)(N)** An opportunity for interactive questions and answers
with the person conducting the training session.

**(g)(2)(viii)** The person conducting the training shall be
knowledgeable in the subject matter covered by the elements contained in
the training program as it relates to the workplace that the training
will address.

**(g)(2)(ix)** Additional Initial Training for Employees in HIV and HBV
Laboratories and Production Facilities. Employees in HIV or HBV research
laboratories and HIV or HBV production facilities shall receive the
following initial training in addition to the above training
requirements.

**(g)(2)(ix)(A)** The employer shall assure that employees demonstrate
proficiency in standard microbiological practices and techniques and in
the practices and operations specific to the facility before being
allowed to work with HIV or HBV.

**(g)(2)(ix)(B)** The employer shall assure that employees have prior
experience in the handling of human pathogens or tissue cultures before
working with HIV or HBV.

**(g)(2)(ix)(C)** The employer shall provide a training program to
employees who have no prior experience in handling human pathogens.
Initial work activities shall not include the handling of infectious
agents. A progression of work activities shall be assigned as techniques
are learned and proficiency is developed. The employer shall assure that
employees participate in work activities involving infectious agents
only after proficiency has been demonstrated.

**(h)** Recordkeeping.

**(h)(1)** Medical Records.

**(h)(1)(i)** The employer shall establish and maintain an accurate
record for each employee with occupational exposure, in accordance with
29 CFR 1910.1020.

**(h)(1)(ii)** This record shall include:

**(h)(1)(ii)(A)** The name and social security number of the employee;

**(h)(1)(ii)(B)** A copy of the employee\'s hepatitis B vaccination
status including the dates of all the hepatitis B vaccinations and any
medical records relative to the employee\'s ability to receive
vaccination as required by paragraph (f)(2);

**(h)(1)(ii)(C)** A copy of all results of examinations, medical
testing, and follow-up procedures as required by paragraph (f)(3);

**(h)(1)(ii)(D)** The employer\'s copy of the healthcare professional\'s
written opinion as required by paragraph (f)(5); and

**(h)(1)(ii)(E)** A copy of the information provided to the healthcare
professional as required by paragraphs (f)(4)(ii)(B)(C) and (D).

**(h)(1)(iii)** Confidentiality. The employer shall ensure that employee
medical records required by paragraph (h)(1) are:

**(h)(1)(iii)(A)** Kept confidential; and

**(h)(1)(iii)(B)** Not disclosed or reported without the employee\'s
express written consent to any person within or outside the workplace
except as required by this section or as may be required by law.

**(h)(1)(iv)** The employer shall maintain the records required by
paragraph (h) for at least the duration of employment plus 30 years in
accordance with 29 CFR 1910.1020.

**(h)(2)** Training Records.

**(h)(2)(i)** Training records shall include the following information:

**(h)(2)(i)(A)** The dates of the training sessions;

**(h)(2)(i)(B)** The contents or a summary of the training sessions;

**(h)(2)(i)(C)** The names and qualifications of persons conducting the
training; and

**(h)(2)(i)(D)** The names and job titles of all persons attending the
training sessions.

**(h)(2)(ii)** Training records shall be maintained for 3 years from the
date on which the training occurred.

**(h)(3)** Availability.

**(h)(3)(i)** The employer shall ensure that all records required to be
maintained by this section shall be made available upon request to the
Assistant Secretary and the Director for examination and copying.

**(h)(3)(ii)** Employee training records required by this paragraph
shall be provided upon request for examination and copying to employees,
to employee representatives, to the Director, and to the Assistant
Secretary.

**(h)(3)(iii)** Employee medical records required by this paragraph
shall be provided upon request for examination and copying to the
subject employee, to anyone having written consent of the subject
employee, to the Director, and to the Assistant Secretary in accordance
with 29 CFR 1910.1020.

**(h)(4)** Transfer of Records.

**(h)(4)(i)** The employer shall comply with the requirements involving
transfer of records set forth in 29 CFR 1910.1020(h).

**(h)(4)(ii)** If the employer ceases to do business and there is no
successor employer to receive and retain the records for the prescribed
period, the employer shall notify the Director, at least three months
prior to their disposal and transmit them to the Director, if required
by the Director to do so, within that three month period.

**(i)** Dates.

**(i)(1)** Effective Date. The standard shall become effective on March
6, 1992.

**(i)(2)** The Exposure Control Plan required by paragraph (c) of this
section shall be completed on or before May 5, 1992.

**(i)(3)** Paragraph (g)(2) Information and Training and (h)
Recordkeeping shall take effect on or before June 4, 1992.

**(i)(4)** Paragraphs (d)(2) Engineering and Work Practice Controls,
(d)(3) Personal Protective Equipment, (d)(4) Housekeeping, (e) HIV and
HBV Research Laboratories and Production Facilities, (f) Hepatitis B
Vaccination and Post-Exposure Evaluation and Follow-up, and (g)(1)
Labels and Signs, shall take effect July 6, 1992.

\[56 FR 64004, Dec. 06, 1991, as amended at 57 FR 12717, April 13, 1992;
57 FR 29206, July 1, 1992; 61 FR 5507, Feb. 13, 1996\]

**(NOTE)**

*Hazardous Waste Operations and Emergency Response Standard*

The Hazardous Waste Operations and Emergency Response (HAZWOPER)
Standard (29 CFR 1910.120) covers three groups of employees: workers at
uncontrolled hazardous waste remediation sites; workers at Resource
Conservation Recovery Act (RCRA) permitted hazardous waste treatment,
storage, and disposal facilities; and those workers expected to respond
to emergencies caused by the uncontrolled release of hazardous
substances.

The definition of hazardous substance includes any biological agent or
infectious material which may cause disease or death. There are three
potential scenarios where the bloodborne and hazardous waste operations
and emergency response standard may interface. These scenarios include:
workers involved in cleanup operations at hazardous waste sites
involving regulated waste; workers at RCRA permitted incinerators that
burn infectious waste; and workers responding to an emergency caused by
the uncontrolled release of regulated waste (e.g., a transportation
accident).

Employers of employees engaged in these three activities must comply
with the requirements in 29 CFR 1910.120 as well as the Bloodborne
Pathogens Standard. If there is a conflict or overlap, the provision
that is more protective of employee health and safety applies.

**APPENDIX B-3**

**DEPARTMENT OF LABOR,** **OCCUPATIONAL SAFETY and HEALTH
ADMINISTRATION** **29 CFR part 1910.1030, Occupational** **Exposure to
Bloodborne Pathogens; Needlesticks and Other Sharps Injuries; Final
Rule**

**§ 1910.1030 Bloodborne Pathogens**

\(a\) **Scope and Application**. This section applies to all
occupational exposure to blood or other potentially infectious materials
as defined by paragraph (b) of this section.

\(b\) **Definitions**. For purposes of this section, the following shall
apply:

**Assistant Secretary** means the Assistant Secretary of Labor for
Occupational Safety and Health, or designated representative.

**Blood** means human blood, human blood components, and products made
from human blood.

**Bloodborne Pathogens** means pathogenic microorganisms that are
present in human blood and can cause disease in humans. These pathogens
include, but are not limited to, hepatitis B virus (HBV) and human
immunodeficiency virus (HIV).

**Clinical Laboratory** means a workplace where diagnostic or other
screening procedures are performed on blood or other potentially
infectious materials.

**Contaminated** means the presence or the reasonably anticipated
presence of blood or other potentially infectious materials on an item
or surface.

**Contaminated Laundry** means laundry which has been soiled with blood
or other potentially infectious materials or may contain sharps.

**Contaminated Sharps** means any contaminated object that can penetrate
the skin including, but not limited to, needles, scalpels, broken glass,
broken capillary tubes, and exposed ends of dental wires.

**Decontamination** means the use of physical or chemical means to
remove, inactivate, or destroy bloodborne pathogens on a surface or item
to the point where they are no longer capable of transmitting infectious
particles and the surface or item is rendered safe for handling, use, or
disposal.

**Director** means the Director of the National Institute for
Occupational Safety and Health, U.S. Department of Health and Human
Services, or designated representative.

**Engineering Controls** means controls (e.g., sharps disposal
containers, self-sheathing needles, safer medical devices, such as
sharps with engineered sharps injury protections and needleless systems)
that isolate or remove the bloodborne pathogens hazard from the
workplace.

**Exposure Incident** means a specific eye, mouth, other mucous
membrane, non-intact skin, or parenteral contact with blood or other
potentially infectious materials that results from the performance of an
employee\'s duties.

**Handwashing Facilities** means a facility providing an adequate supply
of running potable water, soap and single use towels or hot air drying
machines.

**Licensed Healthcare Professional** is a person whose legally permitted
scope of practice allows him or her to independently perform the
activities required by paragraph (f) Hepatitis B Vaccination and
Post-exposure Evaluation and Follow-up.

**HBV** means hepatitis B virus.

**HIV** means human immunodeficiency virus.

**Needleless Systems** means a device that does not use needles for (1)
the collection of bodily fluids or withdrawal of body fluids after
initial venous or arterial access is established; (2) the administration
of medication or fluids; or (3) any other procedure involving the
potential for occupational exposure to bloodborne pathogens due to
percutaneous injuries from contaminated sharps.

**Occupational Exposure** means reasonably anticipated skin, eye, mucous
membrane, or parenteral contact with blood or other potentially
infectious materials that may result from the performance of an
employee\'s duties.

**Other Potentially Infectious Materials** means (1) The following human
body fluids: semen, vaginal secretions, cerebrospinal fluid, synovial
fluid, pleural fluid, pericardial fluid, peritoneal fluid, amniotic
fluid, saliva in dental procedures, any body fluid that is visibly
contaminated with blood, and all body fluids in situations where it is
difficult or impossible to differentiate between body fluids; (2) Any
unfixed tissue or organ (other than intact skin) from a human (living or
dead); and (3) HIV-containing cell or tissue cultures, organ cultures,
and HIV- or HBV-containing culture medium or other solutions; and blood,
organs, or other tissues from experimental animals infected with HIV or
HBV.

**Parenteral** means piercing mucous membranes or the skin barrier
through such events as needlesticks, human bites, cuts, and abrasions.

**Personal Protective Equipment** is specialized clothing or equipment
worn by an employee for protection against a hazard. General work
clothes (e.g., uniforms, pants, shirts or blouses) not intended to
function as protection against a hazard are not considered to be
personal protective equipment.

**Production Facility** means a facility engaged in industrial-scale,
large-volume or high concentration production of HIV or HBV.

**Regulated Waste** means liquid or semi-liquid blood or other
potentially infectious materials; contaminated items that would release
blood or other potentially infectious materials in a liquid or
semi-liquid state if compressed; items that are caked with dried blood
or other potentially infectious materials and are capable of releasing
these materials during handling; contaminated sharps; and pathological
and microbiological wastes containing blood or other potentially
infectious materials.

**Research Laboratory** means a laboratory producing or using
research-laboratory-scale amounts of HIV or HBV. Research laboratories
may produce high concentrations of HIV or HBV but not in the volume
found in production facilities.

**Sharps with Engineered Sharps Injury Protections** means a nonneedle
sharp or a needle device used for withdrawing body fluids, accessing a
vein or artery, or administering medications or other fluids, with a
built-in safety feature or mechanism that effectively reduces the risk
of an exposure incident.

**Source Individual** means any individual, living or dead, whose blood
or other potentially infectious materials may be a source of
occupational exposure to the employee. Examples include, but are not
limited to, hospital and clinic patients; clients in institutions for
the developmentally disabled; trauma victims; clients of drug and
alcohol treatment facilities; residents of hospices and nursing homes;
human remains; and individuals who donate or sell blood or blood
components.

**Sterilize** means the use of a physical or chemical procedure to
destroy all microbial life including highly resistant bacterial
endospores.

**Universal Precautions** is an approach to infection control. According
to the concept of Universal Precautions, all human blood and certain
human body fluids are treated as if known to be infectious for HIV, HBV,
and other bloodborne pathogens.

**Work Practice Controls** means controls that reduce the likelihood of
exposure by altering the manner in which a task is performed (e.g.,
prohibiting recapping of needles by a two-handed technique).

\(c\) **Exposure Control -**

(c)(1) **Exposure Control Plan**.

(c)(1)(i) Each employer having an employee(s) with occupational exposure
as defined by paragraph (b) of this section shall establish a written
Exposure Control Plan designed to eliminate or minimize employee
exposure.

(c)(1)(ii) The Exposure Control Plan shall contain at least the
following elements:

(c)(1)(ii)(A) The exposure determination required by paragraph (c)(2),

(c)(1)(ii)(B) The schedule and method of implementation for paragraphs
(d) Methods of Compliance, (e) HIV and HBV Research Laboratories and
Production Facilities, (f) Hepatitis B Vaccination and Post-Exposure
Evaluation and Follow-up, (g) Communication of Hazards to Employees, and
(h) Recordkeeping, of this standard, and

(c)(1)(ii)(C) The procedure for the evaluation of circumstances
surrounding exposure incidents as required by paragraph (f)(3)(i) of
this standard.

(c)(1)(iii) Each employer shall ensure that a copy of the Exposure
Control Plan is accessible to employees in accordance with 29 CFR
1910.1020(e).

(c)(1)(iv) The Exposure Control Plan shall be reviewed and updated at
least annually and whenever necessary to reflect new or modified tasks
and procedures which affect occupational exposure and to reflect new or
revised employee positions with occupational exposure. The review and
update of such plans shall also:

(c)(1)(iv)(A) reflect changes in technology that eliminate or reduce
exposure to bloodborne pathogens; and

(c)(1)(iv)(B) document annually consideration and implementation of
appropriate commercially available and effective safer medical devices
designed to eliminate or minimize occupational exposure.

(c)(1)(v) An employer, who is required to establish an Exposure Control
Plan shall solicit input from non-managerial employees responsible for
direct patient care who are potentially exposed to injuries from
contaminated sharps in the identification, evaluation, and selection of
effective engineering and work practice controls and shall document the
solicitation in the Exposure Control Plan.

(c)(1)(vi) The Exposure Control Plan shall be made available to the
Assistant Secretary and the Director upon request for examination and
copying.

(c)(2) **Exposure Determination**.

(c)(2)(i) Each employer who has an employee(s) with occupational
exposure as defined by paragraph (b) of this section shall prepare an
exposure determination. This exposure determination shall contain the
following:

(c)(2)(i)(A) A list of all job classifications in which all employees in
those job classifications have occupational exposure;

(c)(2)(i)(B) A list of job classifications in which some employees have
occupational exposure, and

(c)(2)(i)(C) A list of all tasks and procedures or groups of closely
related task and procedures in which occupational exposure occurs and
that are performed by employees in job classifications listed in
accordance with the provisions of paragraph (c)(2)(i)(B) of this
standard.

(c)(2)(ii) This exposure determination shall be made without regard to
the use of personal protective equipment.

\(d\) **Methods of Compliance -**

(d)(1) **General**. Universal precautions shall be observed to prevent
contact with blood or other potentially infectious materials. Under
circumstances in which differentiation between body fluid types is
difficult or impossible, all body fluids shall be considered potentially
infectious materials.

(d)(2) **Engineering and Work Practice Controls**.

(d)(2)(i) Engineering and work practice controls shall be used to
eliminate or minimize employee exposure. Where occupational exposure
remains after institution of these controls, personal protective
equipment shall also be used.

(d)(2)(ii) Engineering controls shall be examined and maintained or
replaced on a regular schedule to ensure their effectiveness.

(d)(2)(iii) Employers shall provide handwashing facilities which are
readily accessible to employees.

(d)(2)(iv) When provision of handwashing facilities is not feasible, the
employer shall provide either an appropriate antiseptic hand cleanser in
conjunction with clean cloth/paper towels or antiseptic towelettes. When
antiseptic hand cleansers or towelettes are used, hands shall be washed
with soap and running water as soon as feasible.

(d)(2)(v) Employers shall ensure that employees wash their hands
immediately or as soon as feasible after removal of gloves or other
personal protective equipment.

(d)(2)(vi) Employers shall ensure that employees wash hands and any
other skin with soap and water, or flush mucous membranes with water
immediately or as soon as feasible following contact of such body areas
with blood or other potentially infectious materials.

(d)(2)(vii) Contaminated needles and other contaminated sharps shall not
be bent, recapped, or removed except as noted in paragraphs
(d)(2)(vii)(A) and (d)(2)(vii)(B) below. Shearing or breaking of
contaminated needles is prohibited.

(d)(2)(vii)(A) Contaminated needles and other contaminated sharps shall
not be bent, recapped or removed unless the employer can demonstrate
that no alternative is feasible or that such action is required by a
specific medical or dental procedure.

(d)(2)(vii)(B) Such bending, recapping or needle removal must be
accomplished through the use of a mechanical device or a one-handed
technique.

(d)(2)(viii) Immediately or as soon as possible after use, contaminated
reusable sharps shall be placed in appropriate containers until properly
reprocessed. These containers shall be:

(d)(2)(viii)(A) puncture resistant;

(d)(2)(viii)(B) labeled or color-coded in accordance with this standard;

(d)(2)(viii)(C) leakproof on the sides and bottom; and

(d)(2)(viii)(D) in accordance with the requirements set forth in
paragraph (d)(4)(ii)(E) for reusable sharps.

(d)(2)(ix) Eating, drinking, smoking, applying cosmetics or lip balm,
and handling contact lenses are prohibited in work areas where there is
a reasonable likelihood of occupational exposure.

(d)(2)(x) Food and drink shall not be kept in refrigerators, freezers,
shelves, cabinets or on countertops or benchtops where blood or other
potentially infectious materials are present.

(d)(2)(xi) All procedures involving blood or other potentially
infectious materials shall be performed in such a manner as to minimize
splashing, spraying, spattering, and generation of droplets of these
substances.

(d)(2)(xii) Mouth pipetting/suctioning of blood or other potentially
infectious materials is prohibited.

(d)(2)(xiii) Specimens of blood or other potentially infectious
materials shall be placed in a container which prevents leakage during
collection, handling, processing, storage, transport, or shipping.

(d)(2)(xiii)(A) The container for storage, transport, or shipping shall
be labeled or color-coded according to paragraph (g)(1)(i) and closed
prior to being stored, transported, or shipped. When a facility utilizes
Universal Precautions in the handling of all specimens, the
labeling/color-coding of specimens is not necessary provided containers
are recognizable as containing specimens. This exemption only applies
while such specimens/containers remain within the facility. Labeling or
color-coding in accordance with paragraph (g)(1)(i) is required when
such specimens/containers leave the facility.

(d)(2)(xiii)(B) If outside contamination of the primary container
occurs, the primary container shall be placed within a second container
which prevents leakage during handling, processing, storage, transport,
or shipping and is labeled or color-coded according to the requirements
of this standard.

(d)(2)(xiii)(C) If the specimen could puncture the primary container,
the primary container shall be placed within a secondary container which
is puncture-resistant in addition to the above characteristics.

(d)(2)(xiv) Equipment which may become contaminated with blood or other
potentially infectious materials shall be examined prior to servicing or
shipping and shall be decontaminated as necessary, unless the employer
can demonstrate that decontamination of such equipment or portions of
such equipment is not feasible.

(d)(2)(xiv)(A) A readily observable label in accordance with paragraph
(g)(1)(i)(H) shall be attached to the equipment stating which portions
remain contaminated.

(d)(2)(xiv)(B) The employer shall ensure that this information is
conveyed to all affected employees, the servicing representative, and/or
the manufacturer, as appropriate, prior to handling, servicing, or
shipping so that appropriate precautions will be taken.

(d)(3) **Personal Protective Equipment -**

(d)(3)(i) **Provision**. When there is occupational exposure, the
employer shall provide, at no cost to the employee, appropriate personal
protective equipment such as, but not limited to, gloves, gowns,
laboratory coats, face shields or masks and eye protection, and
mouthpieces, resuscitation bags, pocket masks, or other ventilation
devices. Personal protective equipment will be considered
\"appropriate\" only if it does not permit blood or other potentially
infectious materials to pass through to or reach the employee\'s work
clothes, street clothes, undergarments, skin, eyes, mouth, or other
mucous membranes under normal conditions of use and for the duration of
time which the protective equipment will be used.

(d)(3)(ii) **Use**. The employer shall ensure that the employee uses
appropriate personal protective equipment unless the employer shows that
the employee temporarily and briefly declined to use personal protective
equipment when, under rare and extraordinary circumstances, it was the
employee\'s professional judgment that in the specific instance its use
would have prevented the delivery of health care or public safety
services or would have posed an increased hazard to the safety of the
worker or co-worker. When the employee makes this judgement, the
circumstances shall be investigated and documented in order to determine
whether changes can be instituted to prevent such occurrences in the
future.

(d)(3)(iii) **Accessibility**. The employer shall ensure that
appropriate personal protective equipment in the appropriate sizes is
readily accessible at the worksite or is issued to employees.
Hypoallergenic gloves, glove liners, powderless gloves, or other similar
alternatives shall be readily accessible to those employees who are
allergic to the gloves normally provided.

(d)(3)(iv) **Cleaning, Laundering, and Disposal**. The employer shall
clean, launder, and dispose of personal protective equipment required by
paragraphs (d) and (e) of this standard, at no cost to the employee.

(d)(3)(v) **Repair and Replacement**. The employer shall repair or
replace personal protective equipment as needed to maintain its
effectiveness, at no cost to the employee.

(d)(3)(vi) If a garment(s) is penetrated by blood or other potentially
infectious materials, the garment(s) shall be removed immediately or as
soon as feasible.

(d)(3)(vii) All personal protective equipment shall be removed prior to
leaving the work area.

(d)(3)(viii) When personal protective equipment is removed it shall be
placed in an appropriately designated area or container for storage,
washing, decontamination or disposal.

(d)(3)(ix) **Gloves**. Gloves shall be worn when it can be reasonably
anticipated that the employee may have hand contact with blood, other
potentially infectious materials, mucous membranes, and non-intact skin;
when performing vascular access procedures except as specified in
paragraph (d)(3)(ix)(D); and when handling or touching contaminated
items or surfaces.

(d)(3)(ix)(A) Disposable (single use) gloves such as surgical or
examination gloves, shall be replaced as soon as practical when
contaminated or as soon as feasible if they are torn, punctured, or when
their ability to function as a barrier is compromised.

(d)(3)(ix)(B) Disposable (single use) gloves shall not be washed or
decontaminated for re-use.

(d)(3)(ix)(C) Utility gloves may be decontaminated for re-use if the
integrity of the glove is not compromised. However, they must be
discarded if they are cracked, peeling, torn, punctured, or exhibit
other signs of deterioration or when their ability to function as a
barrier is compromised.

(d)(3)(ix)(D) If an employer in a volunteer blood donation center judges
that routine gloving for all phlebotomies is not necessary then the
employer shall:

(d)(3)(ix)(D)(**1**) Periodically reevaluate this policy;

(d)(3)(ix)(D)(**2**) Make gloves available to all employees who wish to
use them for phlebotomy;

(d)(3)(ix)(D)(**3**) Not discourage the use of gloves for phlebotomy;
and

(d)(3)(ix)(D)(**4**) Require that gloves be used for phlebotomy in the
following circumstances:

(d)(3)(ix)(D)(**4**)(**i**) When the employee has cuts, scratches, or
other breaks in his or her skin;

(d)(3)(ix)(D)(**4**)(**ii**) When the employee judges that hand
contamination with blood may occur, for example, when performing
phlebotomy on an uncooperative source individual; and

(d)(3)(ix)(D)(**4**)(**iii**) When the employee is receiving training in
phlebotomy.

(d)(3)(x) **Masks, Eye Protection, and Face Shields**. Masks in
combination with eye protection devices, such as goggles or glasses with
solid side shields, or chin-length face shields, shall be worn whenever
splashes, spray, spatter, or droplets of blood or other potentially
infectious materials may be generated and eye, nose, or mouth
contamination can be reasonably anticipated.

(d)(3)(xi) **Gowns, Aprons, and Other Protective Body Clothing**.
Appropriate protective clothing such as, but not limited to, gowns,
aprons, lab coats, clinic jackets, or similar outer garments shall be
worn in occupational exposure situations. The type and characteristics
will depend upon the task and degree of exposure anticipated.

(d)(3)(xii) Surgical caps or hoods and/or shoe covers or boots shall be
worn in instances when gross contamination can reasonably be anticipated
(e.g., autopsies, orthopaedic surgery).

(d)(4) **Housekeeping -**

(d)(4)(i) **General**. Employers shall ensure that the worksite is
maintained in a clean and sanitary condition. The employer shall
determine and implement an appropriate written schedule for cleaning and
method of decontamination based upon the location within the facility,
type of surface to be cleaned, type of soil present, and tasks or
procedures being performed in the area.

(d)(4)(ii) All equipment and environmental and working surfaces shall be
cleaned and decontaminated after contact with blood or other potentially
infectious materials.

(d)(4)(ii)(A) Contaminated work surfaces shall be decontaminated with an
appropriate disinfectant after completion of procedures; immediately or
as soon as feasible when surfaces are overtly contaminated or after any
spill of blood or other potentially infectious materials; and at the end
of the work shift if the surface may have become contaminated since the
last cleaning.

(d)(4)(ii)(B) Protective coverings, such as plastic wrap, aluminum foil,
or imperviously-backed absorbent paper used to cover equipment and
environmental surfaces, shall be removed and replaced as soon as
feasible when they become overtly contaminated or at the end of the
workshift if they may have become contaminated during the shift.

(d)(4)(ii)(C) All bins, pails, cans, and similar receptacles intended
for reuse which have a reasonable likelihood for becoming contaminated
with blood or other potentially infectious materials shall be inspected
and decontaminated on a regularly scheduled basis and cleaned and
decontaminated immediately or as soon as feasible upon visible
contamination.

(d)(4)(ii)(D) Broken glassware which may be contaminated shall not be
picked up directly with the hands. It shall be cleaned up using
mechanical means, such as a brush and dust pan, tongs, or forceps.

(d)(4)(ii)(E) Reusable sharps that are contaminated with blood or other
potentially infectious materials shall not be stored or processed in a
manner that requires employees to reach by hand into the containers
where these sharps have been placed.

(d)(4)(iii) **Regulated Waste\-\--**

(d)(4)(iii)(A) **Contaminated Sharps Discarding and Containment**.

(d)(4)(iii)(A)(**1**) Contaminated sharps shall be discarded immediately
or as soon as feasible in containers that are:

(d)(4)(iii)(A)(**1**)(**i**) Closable;

(d)(4)(iii)(A)(**1**)(**ii**) Puncture resistant;

(d)(4)(iii)(A)(**1**)(**iii**) Leakproof on sides and bottom; and

(d)(4)(iii)(A)(**1**)(**iv**) Labeled or color-coded in accordance with
paragraph (g)(1)(i) of this standard.

(d)(4)(iii)(A)(**2**) During use, containers for contaminated sharps
shall be:

(d)(4)(iii)(A)(**2**)(**i**) Easily accessible to personnel and located
as close as is feasible to the immediate area where sharps are used or
can be reasonably anticipated to be found (e.g., laundries);

(d)(4)(iii)(A)(**2**)(**ii**) Maintained upright throughout use; and

(d)(4)(iii)(A)(**2**)(**iii**) Replaced routinely and not be allowed to
overfill.

(d)(4)(iii)(A)(**3**) When moving containers of contaminated sharps from
the area of use, the containers shall be:

(d)(4)(iii)(A)(**3**)(**i**) Closed immediately prior to removal or
replacement to prevent spillage or protrusion of contents during
handling, storage, transport, or shipping;

(d)(4)(iii)(A)(**3**)(**ii**) Placed in a secondary container if leakage
is possible. The second container shall be:

(d)(4)(iii)(A)(**3**)(**ii**)(**A**) Closable;

(d)(4)(iii)(A)(**3**)(**ii**)(**B**) Constructed to contain all contents
and prevent leakage during handling, storage, transport, or shipping;
and

(d)(4)(iii)(A)(**3**)(**ii**)(**C**) Labeled or color-coded according to
paragraph (g)(1)(i) of this standard.

(d)(4)(iii)(A)(**4**) Reusable containers shall not be opened, emptied,
or cleaned manually or in any other manner which would expose employees
to the risk of percutaneous injury.

(d)(4)(iii)(B) **Other Regulated Waste Containment -**

(d)(4)(iii)(B)(1) Regulated waste shall be placed in containers which
are:

(d)(4)(iii)(B)(1)(**i**) Closable;

(d)(4)(iii)(B)(1)(**ii**) Constructed to contain all contents and
prevent leakage of fluids during handling, storage, transport or
shipping;

(d)(4)(iii)(B)(1)(**iii**) Labeled or color-coded in accordance with
paragraph (g)(1)(i) this standard; and

(d)(4)(iii)(B)(1)(**iv**) Closed prior to removal to prevent spillage or
protrusion of contents during handling, storage, transport, or shipping.

(d)(4)(iii)(B)(**2**) If outside contamination of the regulated waste
container occurs, it shall be placed in a second container. The second
container shall be:

(d)(4)(iii)(B)(**2**)(**i**) Closable;

(d)(4)(iii)(B)(**2**)(**ii**) Constructed to contain all contents and
prevent leakage of fluids during handling, storage, transport or
shipping;

(d)(4)(iii)(B)(**2**)(**iii**) Labeled or color-coded in accordance with
paragraph (g)(1)(i) of this standard; and

(d)(4)(iii)(B)(**2**)(**iv**) Closed prior to removal to prevent
spillage or protrusion of contents during handling, storage, transport,
or shipping.

(d)(4)(iii)(C) Disposal of all regulated waste shall be in accordance
with applicable regulations of the United States, States and
Territories, and political subdivisions of States and Territories.

(d)(4)(iv) **Laundry**.

(d)(4)(iv)(A) Contaminated laundry shall be handled as little as
possible with a minimum of agitation.

(d)(4)(iv)(A)(1) Contaminated laundry shall be bagged or containerized
at the location where it was used and shall not be sorted or rinsed in
the location of use.

(d)(4)(iv)(A)(2) Contaminated laundry shall be placed and transported in
bags or containers labeled or color-coded in accordance with paragraph
(g)(1)(i) of this standard. When a facility utilizes Universal
Precautions in the handling of all soiled laundry, alternative labeling
or color-coding is sufficient if it permits all employees to recognize
the containers as requiring compliance with Universal Precautions.

(d)(4)(iv)(A)(3) Whenever contaminated laundry is wet and presents a
reasonable likelihood of soak-through of or leakage from the bag or
container, the laundry shall be placed and transported in bags or
containers which prevent soak-through and/or leakage of fluids to the
exterior.

(d)(4)(iv)(B) The employer shall ensure that employees who have contact
with contaminated laundry wear protective gloves and other appropriate
personal protective equipment.

(d)(4)(iv)(C) When a facility ships contaminated laundry off-site to a
second facility which does not utilize Universal Precautions in the
handling of all laundry, the facility generating the contaminated
laundry must place such laundry in bags or containers which are labeled
or color-coded in accordance with paragraph (g)(1)(i).

\(e\) **HIV and HBV Research Laboratories and Production Facilities**.

(e)(1) This paragraph applies to research laboratories and production
facilities engaged in the culture, production, concentration,
experimentation, and manipulation of HIV and HBV. It does not apply to
clinical or diagnostic laboratories engaged solely in the analysis of
blood, tissues, or organs. These requirements apply in addition to the
other requirements of the standard.

(e)(2) Research laboratories and production facilities shall meet the
following criteria:

(e)(2)(i) **Standard Microbiological Practices**. All regulated waste
shall either be incinerated or decontaminated by a method such as
autoclaving known to effectively destroy bloodborne pathogens.

(e)(2)(ii) **Special Practices**.

(e)(2)(ii)(A) Laboratory doors shall be kept closed when work involving
HIV or HBV is in progress.

(e)(2)(ii)(B) Contaminated materials that are to be decontaminated at a
site away from the work area shall be placed in a durable, leakproof,
labeled or color-coded container that is closed before being removed
from the work area.

(e)(2)(ii)(C) Access to the work area shall be limited to authorized
persons. Written policies and procedures shall be established whereby
only persons who have been advised of the potential biohazard, who meet
any specific entry requirements, and who comply with all entry and exit
procedures shall be allowed to enter the work areas and animal rooms.

(e)(2)(ii)(D) When other potentially infectious materials or infected
animals are present in the work area or containment module, a hazard
warning sign incorporating the universal biohazard symbol shall be
posted on all access doors. The hazard warning sign shall comply with
paragraph (g)(1)(ii) of this standard.

(e)(2)(ii)(E) All activities involving other potentially infectious
materials shall be conducted in biological safety cabinets or other
physical-containment devices within the containment module. No work with
these other potentially infectious materials shall be conducted on the
open bench.

(e)(2)(ii)(F) Laboratory coats, gowns, smocks, uniforms, or other
appropriate protective clothing shall be used in the work area and
animal rooms. Protective clothing shall not be worn outside of the work
area and shall be decontaminated before being laundered.

(e)(2)(ii)(G) Special care shall be taken to avoid skin contact with
other potentially infectious materials. Gloves shall be worn when
handling infected animals and when making hand contact with other
potentially infectious materials is unavoidable.

(e)(2)(ii)(H) Before disposal all waste from work areas and from animal
rooms shall either be incinerated or decontaminated by a method such as
autoclaving known to effectively destroy bloodborne pathogens.

(e)(2)(ii)(I) Vacuum lines shall be protected with liquid disinfectant
traps and high-efficiency particulate air (HEPA) filters or filters of
equivalent or superior efficiency and which are checked routinely and
maintained or replaced as necessary.

(e)(2)(ii)(J) Hypodermic needles and syringes shall be used only for
parenteral injection and aspiration of fluids from laboratory animals
and diaphragm bottles. Only needle-locking syringes or disposable
syringe-needle units (i.e., the needle is integral to the syringe) shall
be used for the injection or aspiration of other potentially infectious
materials. Extreme caution shall be used when handling needles and
syringes. A needle shall not be bent, sheared, replaced in the sheath or
guard, or removed from the syringe following use. The needle and syringe
shall be promptly placed in a puncture-resistant container and
autoclaved or decontaminated before reuse or disposal.

(e)(2)(ii)(K) All spills shall be immediately contained and cleaned up
by appropriate professional staff or others properly trained and
equipped to work with potentially concentrated infectious materials.

(e)(2)(ii)(L) A spill or accident that results in an exposure incident
shall be immediately reported to the laboratory director or other
responsible person.

(e)(2)(ii)(M) A biosafety manual shall be prepared or adopted and
periodically reviewed and updated at least annually or more often if
necessary. Personnel shall be advised of potential hazards, shall be
required to read instructions on practices and procedures, and shall be
required to follow them.

(e)(2)(iii) **Containment Equipment**.

(e)(2)(iii)(A) Certified biological safety cabinets (Class I, II, or
III) or other appropriate combinations of personal protection or
physical containment devices, such as special protective clothing,
respirators, centrifuge safety cups, sealed centrifuge rotors, and
containment caging for animals, shall be used for all activities with
other potentially infectious materials that pose a threat of exposure to
droplets, splashes, spills, or aerosols.

(e)(2)(iii)(B) Biological safety cabinets shall be certified when
installed, whenever they are moved and at least annually.

(e)(3) HIV and HBV research laboratories shall meet the following
criteria:

(e)(3)(i) Each laboratory shall contain a facility for hand washing and
an eye wash facility which is readily available within the work area.

(e)(3)(ii) An autoclave for decontamination of regulated waste shall be
available.

(e)(4) HIV and HBV production facilities shall meet the following
criteria:

(e)(4)(i) The work areas shall be separated from areas that are open to
unrestricted traffic flow within the building. Passage through two sets
of doors shall be the basic requirement for entry into the work area
from access corridors or other contiguous areas. Physical separation of
the high-containment work area from access corridors or other areas or
activities may also be provided by a double-doored clothes-change room
(showers may be included), airlock, or other access facility that
requires passing through two sets of doors before entering the work
area.

(e)(4)(ii) The surfaces of doors, walls, floors and ceilings in the work
area shall be water resistant so that they can be easily cleaned.
Penetrations in these surfaces shall be sealed or capable of being
sealed to facilitate decontamination.

(e)(4)(iii) Each work area shall contain a sink for washing hands and a
readily available eye wash facility. The sink shall be foot, elbow, or
automatically operated and shall be located near the exit door of the
work area.

(e)(4)(iv) Access doors to the work area or containment module shall be
self-closing.

(e)(4)(v) An autoclave for decontamination of regulated waste shall be
available within or as near as possible to the work area.

(e)(4)(vi) A ducted exhaust-air ventilation system shall be provided.
This system shall create directional airflow that draws air into the
work area through the entry area. The exhaust air shall not be
recirculated to any other area of the building, shall be discharged to
the outside, and shall be dispersed away from occupied areas and air
intakes. The proper direction of the airflow shall be verified (i.e.,
into the work area).

(e)(5) **Training Requirements**. Additional training requirements for
employees in HIV and HBV research laboratories and HIV and HBV
production facilities are specified in paragraph (g)(2)(ix).

\(f\) **Hepatitis B Vaccination and Post-exposure Evaluation and
Follow-up -**

(f)(1) **General**.

(f)(1)(i) The employer shall make available the hepatitis B vaccine and
vaccination series to all employees who have occupational exposure, and
post-exposure evaluation and follow-up to all employees who have had an
exposure incident.

(f)(1)(ii) The employer shall ensure that all medical evaluations and
procedures including the hepatitis B vaccine and vaccination series and
post-exposure evaluation and follow-up, including prophylaxis, are:

(f)(1)(ii)(A) Made available at no cost to the employee;

(f)(1)(ii)(B) Made available to the employee at a reasonable time and
place;

(f)(1)(ii)(C) Performed by or under the supervision of a licensed
physician or by or under the supervision of another licensed healthcare
professional; and

(f)(1)(ii)(D) Provided according to recommendations of the U.S. Public
Health Service current at the time these evaluations and procedures take
place, except as specified by this paragraph (f).

(f)(1)(iii) The employer shall ensure that all laboratory tests are
conducted by an accredited laboratory at no cost to the employee.

(f)(2) **Hepatitis B Vaccination**.

(f)(2)(i) Hepatitis B vaccination shall be made available after the
employee has received the training required in paragraph (g)(2)(vii)(I)
and within 10 working days of initial assignment to all employees who
have occupational exposure unless the employee has previously received
the complete hepatitis B vaccination series, antibody testing has
revealed that the employee is immune, or the vaccine is contraindicated
for medical reasons.

(f)(2)(ii) The employer shall not make participation in a prescreening
program a prerequisite for receiving hepatitis B vaccination.

(f)(2)(iii) If the employee initially declines hepatitis B vaccination
but at a later date while still covered under the standard decides to
accept the vaccination, the employer shall make available hepatitis B
vaccination at that time.

(f)(2)(iv) The employer shall assure that employees who decline to
accept hepatitis B vaccination offered by the employer sign the
statement in Appendix A.

(f)(2)(v) If a routine booster dose(s) of hepatitis B vaccine is
recommended by the U.S. Public Health Service at a future date, such
booster dose(s) shall be made available in accordance with section
(f)(1)(ii).

(f)(3) **Post-exposure Evaluation and Follow-up**. Following a report of
an exposure incident, the employer shall make immediately available to
the exposed employee a confidential medical evaluation and follow-up,
including at least the following elements:

(f)(3)(i) Documentation of the route(s) of exposure, and the
circumstances under which the exposure incident occurred;

(f)(3)(ii) Identification and documentation of the source individual,
unless the employer can establish that identification is infeasible or
prohibited by state or local law;

(f)(3)(ii)(A) The source individual\'s blood shall be tested as soon as
feasible and after consent is obtained in order to determine HBV and HIV
infectivity. If consent is not obtained, the employer shall establish
that legally required consent cannot be obtained. When the source
individual\'s consent is not required by law, the source individual\'s
blood, if available, shall be tested and the results documented.

(f)(3)(ii)(B) When the source individual is already known to be infected
with HBV or HIV, testing for the source individual\'s known HBV or HIV
status need not be repeated.

(f)(3)(ii)(C) Results of the source individual\'s testing shall be made
available to the exposed employee, and the employee shall be informed of
applicable laws and regulations concerning disclosure of the identity
and infectious status of the source individual.

(f)(3)(iii) Collection and testing of blood for HBV and HIV serological
status;

(f)(3)(iii)(A) The exposed employee\'s blood shall be collected as soon
as feasible and tested after consent is obtained.

(f)(3)(iii)(B) If the employee consents to baseline blood collection,
but does not give consent at that time for HIV serologic testing, the
sample shall be preserved for at least 90 days. If, within 90 days of
the exposure incident, the employee elects to have the baseline sample
tested, such testing shall be done as soon as feasible.

(f)(3)(iv) Post-exposure prophylaxis, when medically indicated, as
recommended by the U.S. Public Health Service;

(f)(3)(v) Counseling; and

(f)(3)(vi) Evaluation of reported illnesses.

(f)(4) **Information Provided to the Healthcare Professional**.

(f)(4)(i) The employer shall ensure that the healthcare professional
responsible for the employee\'s Hepatitis B vaccination is provided a
copy of this regulation.

(f)(4)(ii) The employer shall ensure that the healthcare professional
evaluating an employee after an exposure incident is provided the
following information:

(f)(4)(ii)(A) A copy of this regulation;

(f)(4)(ii)(B) A description of the exposed employee\'s duties as they
relate to the exposure incident;

(f)(4)(ii)(C) Documentation of the route(s) of exposure and
circumstances under which exposure occurred;

(f)(4)(ii)(D) Results of the source individual\'s blood testing, if
available; and

(f)(4)(ii)(E) All medical records relevant to the appropriate treatment
of the employee including vaccination status which are the employer\'s
responsibility to maintain.

(f)(5) **Healthcare Professional\'s Written Opinion**. The employer
shall obtain and provide the employee with a copy of the evaluating
healthcare professional\'s written opinion within 15 days of the
completion of the evaluation.

(f)(5)(i) The healthcare professional\'s written opinion for Hepatitis B
vaccination shall be limited to whether Hepatitis B vaccination is
indicated for an employee, and if the employee has received such
vaccination.

(f)(5)(ii) The healthcare professional\'s written opinion for
post-exposure evaluation and follow-up shall be limited to the following
information:

(f)(5)(ii)(A) That the employee has been informed of the results of the
evaluation; and

(f)(5)(ii)(B) That the employee has been told about any medical
conditions resulting from exposure to blood or other potentially
infectious materials which require further evaluation or treatment.

(f)(5)(iii) All other findings or diagnoses shall remain confidential
and shall not be included in the written report.

(f)(6) **Medical Recordkeeping**. Medical records required by this
standard shall be maintained in accordance with paragraph (h)(1) of this
section.

\(g\) **Communication of Hazards to Employees -**

(g)(1) **Labels and Signs -**

(g)(1)(i) **Labels**.

(g)(1)(i)(A) Warning labels shall be affixed to containers of regulated
waste, refrigerators and freezers containing blood or other potentially
infectious material; and other containers used to store, transport or
ship blood or other potentially infectious materials, except as provided
in paragraph (g)(1)(i)(E), (F) and (G).

(g)(1)(i)(B) Labels required by this section shall include the following
legend:

![](media/image19.png)

(g)(1)(i)(C) These labels shall be fluorescent orange or orange-red or
predominantly so, with lettering and symbols in a contrasting color.

(g)(1)(i)(D) Labels shall be affixed as close as feasible to the
container by string, wire, adhesive, or other method that prevents their
loss or unintentional removal.

(g)(1)(i)(E) Red bags or red containers may be substituted for labels.

(g)(1)(i)(F) Containers of blood, blood components, or blood products
that are labeled as to their contents and have been released for
transfusion or other clinical use are exempted from the labeling
requirements of paragraph (g).

(g)(1)(i)(G) Individual containers of blood or other potentially
infectious materials that are placed in a labeled container during
storage, transport, shipment or disposal are exempted from the labeling
requirement.

(g)(1)(i)(H) Labels required for contaminated equipment shall be in
accordance with this paragraph and shall also state which portions of
the equipment remain contaminated.

(g)(1)(i)(I) Regulated waste that has been decontaminated need not be
labeled or color-coded.

(g)(1)(ii) **Signs**.

(g)(1)(ii)(A) The employer shall post signs at the entrance to work
areas specified in paragraph (e), HIV and HBV Research Laboratory and
Production Facilities, which shall bear the following legend:

![](media/image20.png)

(Name of the Infectious Agent)\
(Special requirements for entering the area)\
(Name, telephone number of the laboratory director or other responsible
person.)

(g)(1)(ii)(B) These signs shall be fluorescent orange-red or
predominantly so, with lettering and symbols in a contrasting color.

(g)(2) **Information and Training**.

(g)(2)(i) Employers shall ensure that all employees with occupational
exposure participate in a training program which must be provided at no
cost to the employee and during working hours.

(g)(2)(ii) Training shall be provided as follows:

(g)(2)(ii)(A) At the time of initial assignment to tasks where
occupational exposure may take place;

(g)(2)(ii)(B) Within 90 days after the effective date of the standard;
and

(g)(2)(ii)(C) At least annually thereafter.

(g)(2)(iii) For employees who have received training on bloodborne
pathogens in the year preceding the effective date of the standard, only
training with respect to the provisions of the standard which were not
included need be provided.

(g)(2)(iv) Annual training for all employees shall be provided within
one year of their previous training.

(g)(2)(v) Employers shall provide additional training when changes such
as modification of tasks or procedures or institution of new tasks or
procedures affect the employee\'s occupational exposure. The additional
training may be limited to addressing the new exposures created.

(g)(2)(vi) Material appropriate in content and vocabulary to educational
level, literacy, and language of employees shall be used.

(g)(2)(vii) The training program shall contain at a minimum the
following elements:

(g)(2)(vii)(A) An accessible copy of the regulatory text of this
standard and an explanation of its contents;

(g)(2)(vii)(B) A general explanation of the epidemiology and symptoms of
bloodborne diseases;

(g)(2)(vii)(C) An explanation of the modes of transmission of bloodborne
pathogens;

(g)(2)(vii)(D) An explanation of the employer\'s exposure control plan
and the means by which the employee can obtain a copy of the written
plan;

(g)(2)(vii)(E) An explanation of the appropriate methods for recognizing
tasks and other activities that may involve exposure to blood and other
potentially infectious materials;

(g)(2)(vii)(F) An explanation of the use and limitations of methods that
will prevent or reduce exposure including appropriate engineering
controls, work practices, and personal protective equipment;

(g)(2)(vii)(G) Information on the types, proper use, location, removal,
handling, decontamination and disposal of personal protective equipment;

(g)(2)(vii)(H) An explanation of the basis for selection of personal
protective equipment;

(g)(2)(vii)(I) Information on the hepatitis B vaccine, including
information on its efficacy, safety, method of administration, the
benefits of being vaccinated, and that the vaccine and vaccination will
be offered free of charge;

(g)(2)(vii)(J) Information on the appropriate actions to take and
persons to contact in an emergency involving blood or other potentially
infectious materials;

(g)(2)(vii)(K) An explanation of the procedure to follow if an exposure
incident occurs, including the method of reporting the incident and the
medical follow-up that will be made available;

(g)(2)(vii)(L) Information on the post-exposure evaluation and follow-up
that the employer is required to provide for the employee following an
exposure incident;

(g)(2)(vii)(M) An explanation of the signs and labels and/or color
coding required by paragraph (g)(1); and

(g)(2)(vii)(N) An opportunity for interactive questions and answers with
the person conducting the training session.

(g)(2)(viii) The person conducting the training shall be knowledgeable
in the subject matter covered by the elements contained in the training
program as it relates to the workplace that the training will address.

(g)(2)(ix) Additional Initial Training for Employees in HIV and HBV
Laboratories and Production Facilities. Employees in HIV or HBV research
laboratories and HIV or HBV production facilities shall receive the
following initial training in addition to the above training
requirements.

(g)(2)(ix)(A) The employer shall assure that employees demonstrate
proficiency in standard microbiological practices and techniques and in
the practices and operations specific to the facility before being
allowed to work with HIV or HBV.

(g)(2)(ix)(B) The employer shall assure that employees have prior
experience in the handling of human pathogens or tissue cultures before
working with HIV or HBV.

(g)(2)(ix)(C) The employer shall provide a training program to employees
who have no prior experience in handling human pathogens. Initial work
activities shall not include the handling of infectious agents. A
progression of work activities shall be assigned as techniques are
learned and proficiency is developed. The employer shall assure that
employees participate in work activities involving infectious agents
only after proficiency has been demonstrated.

\(h\) **Recordkeeping -**

(h)(1) **Medical Records**.

(h)(1)(i) The employer shall establish and maintain an accurate record
for each employee with occupational exposure, in accordance with 29 CFR
1910.1020.

(h)(1)(ii) This record shall include:

(h)(1)(ii)(A) The name and social security number of the employee;

(h)(1)(ii)(B) A copy of the employee\'s hepatitis B vaccination status
including the dates of all the hepatitis B vaccinations and any medical
records relative to the employee\'s ability to receive vaccination as
required by paragraph (f)(2);

(h)(1)(ii)(C) A copy of all results of examinations, medical testing,
and follow-up procedures as required by paragraph (f)(3);

(h)(1)(ii)(D) The employer\'s copy of the healthcare professional\'s
written opinion as required by paragraph (f)(5); and

(h)(1)(ii)(E) A copy of the information provided to the healthcare
professional as required by paragraphs (f)(4)(ii)(B)(C) and (D).

(h)(1)(iii) Confidentiality. The employer shall ensure that employee
medical records required by paragraph (h)(1) are:

(h)(1)(iii)(A) Kept confidential; and

(h)(1)(iii)(B) Not disclosed or reported without the employee\'s express
written consent to any person within or outside the workplace except as
required by this section or as may be required by law.

(h)(1)(iv) The employer shall maintain the records required by paragraph
(h) for at least the duration of employment plus 30 years in accordance
with 29 CFR 1910.1020.

(h)(2) **Training Records**.

(h)(2)(i) Training records shall include the following information:

(h)(2)(i)(A) The dates of the training sessions;

(h)(2)(i)(B) The contents or a summary of the training sessions;

(h)(2)(i)(C) The names and qualifications of persons conducting the
training; and

(h)(2)(i)(D) The names and job titles of all persons attending the
training sessions.

(h)(2)(ii) Training records shall be maintained for 3 years from the
date on which the training occurred.

(h)(3) **Availability**.

(h)(3)(i) The employer shall ensure that all records required to be
maintained by this section shall be made available upon request to the
Assistant Secretary and the Director for examination and copying.

(h)(3)(ii) Employee training records required by this paragraph shall be
provided upon request for examination and copying to employees, to
employee representatives, to the Director, and to the Assistant
Secretary.

(h)(3)(iii) Employee medical records required by this paragraph shall be
provided upon request for examination and copying to the subject
employee, to anyone having written consent of the subject employee, to
the Director, and to the Assistant Secretary in accordance with 29 CFR
1910.1020.

(h)(4) **Transfer of Records**.

(h)(4)(i) The employer shall comply with the requirements involving
transfer of records set forth in 29 CFR 1910.1020(h).

(h)(4)(ii) If the employer ceases to do business and there is no
successor employer to receive and retain the records for the prescribed
period, the employer shall notify the Director, at least three months
prior to their disposal and transmit them to the Director, if required
by the Director to do so, within that three month period.

(h)(5) **Sharps Injury Log**.

(h)(5)(i) The employer shall establish and maintain a sharps injury log
for the recording of percutaneous injuries from contaminated sharps. The
information in the sharps injury log shall be recorded and maintained in
such manner as to protect the confidentiality of the injured employee.
The sharps injury log shall contain, at a minimum:

(h)(5)(i)(A) the type and brand of device involved in the incident,

(h)(5)(i)(B) the department or work area where the exposure incident
occurred, and

(h)(5)(i)(C) an explanation of how the incident occurred.

(h)(5)(ii) The requirement to establish and maintain a sharps injury log
shall apply to any employer who is required to maintain a log of
occupational injuries and illnesses under 29 CFR 1904.

(h)(5)(iii) The sharps injury log shall be maintained for the period
required by 29 CFR 1904.6.

\(i\) **Dates -**

(i)(1) **Effective Date**. The standard shall become effective on March
6, 1992.

(i)(2) The Exposure Control Plan required by paragraph (c) of this
section shall be completed on or before May 5, 1992.

(i)(3) Paragraph (g)(2) Information and Training and (h) Recordkeeping
shall take effect on or before June 4, 1992.

(i)(4) Paragraphs (d)(2) Engineering and Work Practice Controls, (d)(3)
Personal Protective Equipment, (d)(4) Housekeeping, (e) HIV and HBV
Research Laboratories and Production Facilities, (f) Hepatitis B
Vaccination and Post-Exposure Evaluation and Follow-up, and (g)(1)
Labels and Signs, shall take effect July 6, 1992.

APPENDIX A TO SECTION 1910.1030 - HEPATITIS B DECLINATION (MANDATORY)

I understand that due to my occupational exposure to blood or other
potentially infectious materials I may be at risk of acquiring hepatitis
B virus (HBV) infection. I have been given the opportunity to be
vaccinated with hepatitis B vaccine, at no charge to myself. However, I
decline hepatitis B vaccination at this time. I understand that by
declining this vaccine, I continue to be at risk of acquiring hepatitis
B, a serious disease. If in the future I continue to have occupational
exposure to blood or other potentially infectious materials and I want
to be vaccinated with hepatitis B vaccine, I can receive the vaccination
series at no charge to me.

**APPENDIX B-4**

**Updated U.S. Public Health Service Guidelines for the Management of
Occupational Exposures to HBV, HCV, and HIV and Recommendations for
Postexposure Prophylaxis** (*Morbidity and Mortality Weekly,* June 29,
2001 / 50(RR11);1-42)

#### Summary 

This report updates and consolidates all previous U.S. Public Health
Service recommendations for the management of health-care personnel
(HCP) who have occupational exposure to blood and other body fluids that
might contain hepatitis B virus (HBV), hepatitis C virus (HCV), or human
immunodeficiency virus (HIV).

Recommendations for HBV postexposure management include initiation of
the hepatitis B vaccine series to any susceptible, unvaccinated person
who sustains an occupational blood or body fluid exposure. Postexposure
prophylaxis (PEP) with hepatitis B immune globulin (HBIG) and/or
hepatitis B vaccine series should be considered for occupational
exposures after evaluation of the hepatitis B surface antigen status of
the source and the vaccination and vaccine-response status of the
exposed person. Guidance is provided to clinicians and exposed HCP for
selecting the appropriate HBV PEP.

Immune globulin and antiviral agents (e.g., interferon with or without
ribavirin) are not recommended for PEP of hepatitis C. For HCV
postexposure management, the HCV status of the source and the exposed
person should be determined, and for HCP exposed to an HCV positive
source, follow-up HCV testing should be performed to determine if
infection develops.

Recommendations for HIV PEP include a basic 4-week regimen of two drugs
(zidovudine \[ZDV\] and lamivudine \[3TC\]; 3TC and stavudine \[d4T\];
or didanosine \[ddI\] and d4T) for most HIV exposures and an expanded
regimen that includes the addition of a third drug for HIV exposures
that pose an increased risk for transmission. When the source person\'s
virus is known or suspected to be resistant to one or more of the drugs
considered for the PEP regimen, the selection of drugs to which the
source person\'s virus is unlikely to be resistant is recommended.

In addition, this report outlines several special circumstances (e.g.,
delayed exposure report, unknown source person, pregnancy in the exposed
person, resistance of the source virus to antiretroviral agents, or
toxicity of the PEP regimen) when consultation with local experts and/or
the National Clinicians\' Post-Exposure Prophylaxis Hotline (\[PEPline\]
1-888-448-4911) is advised.

Occupational exposures should be considered urgent medical concerns to
ensure timely postexposure management and administration of HBIG,
hepatitis B vaccine, and/or HIV PEP.

#### INTRODUCTION 

Avoiding occupational blood exposures is the primary way to prevent
transmission of hepatitis B virus (HBV), hepatitis C virus (HCV), and
human immunodeficiency virus (HIV) in health-care settings (*1*).
However, hepatitis B immunization and postexposure management are
integral components of a complete program to prevent infection following
bloodborne pathogen exposure and are important elements of workplace
safety (*2*).

The U.S. Public Health Service (PHS) has published previous guidelines
for the management of HIV exposures that included considerations for
postexposure prophylaxis (PEP) (*3\--5*). Since publication of the 1998
HIV exposure guidelines (*5*), several new antiretroviral agents have
been approved by the Food and Drug Administration (FDA), and more
information is available about the use and safety of HIV PEP (*6\--11*).
In addition, questions exist regarding considerations about PEP regimens
when the source person\'s virus is known or suspected to be resistant to
one or more of the antiretroviral agents that might be used for PEP.
Concern also has arisen about the use of PEP when it is not warranted.
Data indicate that some health-care personnel (HCP) take a full course
of HIV PEP after exposures that do not confer an HIV transmission risk
(*10,11*).

In September 1999, a meeting of a PHS interagency working group\* and
expert consultants was convened by CDC. The PHS working group decided to
issue updated recommendations for the management of occupational
exposure to HIV. In addition, the report was to include recommendations
for the management of occupational HBV and HCV exposures so that a
single document could comprehensively address the management of
occupational exposures to bloodborne pathogens. This report updates and
consolidates the previous PHS guidelines and recommendations for
occupational HBV, HCV, and HIV exposure management for HCP. Specific
practice recommendations for the management of occupational bloodborne
pathogen exposures are outlined to assist health-care institutions with
the implementation of these PHS guidelines (Appendices A and B). As
relevant information becomes available, updates of these recommendations
will be published. Recommendations for nonoccupational (e.g., sexual,
pediatric, and perinatal) HBV, HCV, and HIV exposures are not addressed
in these guidelines and can be found elsewhere (*12\--15*).

**Definition of Health-Care Personnel and Exposure**

In this report, health-care personnel (HCP) are defined as persons
(e.g., employees, students, contractors, attending clinicians,
public-safety workers*,* or volunteers) whose activities involve contact
with patients or with blood or other body fluids from patients in a
health-care, laboratory, or public-safety setting. The potential exists
for blood and body fluid exposure to other workers, and the same
principles of exposure management could be applied to other settings.

An exposure that might place HCP at risk for HBV, HCV, or HIV infection
is defined as a percutaneous injury (e.g., a needlestick or cut with a
sharp object) or contact of mucous membrane or nonintact skin (e.g.,
exposed skin that is chapped, abraded, or afflicted with dermatitis)
with blood, tissue, or other body fluids that are potentially infectious
(*16,17*).

In addition to blood and body fluids containing visible blood, semen and
vaginal secretions also are considered potentially infectious. Although
semen and vaginal secretions have been implicated in the sexual
transmission of HBV, HCV, and HIV, they have not been implicated in
occupational transmission from patients to HCP. The following fluids
also are considered potentially infectious: cerebrospinal fluid,
synovial fluid, pleural fluid, peritoneal fluid, pericardial fluid, and
amniotic fluid. The risk for transmission of HBV, HCV, and HIV infection
from these fluids is unknown; the potential risk to HCP from
occupational exposures has not been assessed by epidemiologic studies in
health-care settings. Feces, nasal secretions, saliva, sputum, sweat,
tears, urine, and vomitus are not considered potentially infectious
unless they contain blood. The risk for transmission of HBV, HCV, and
HIV infection from these fluids and materials is extremely low.

Any direct contact (i.e., contact without barrier protection) to
concentrated virus in a research laboratory or production facility is
considered an exposure that requires clinical evaluation. For human
bites, the clinical evaluation must include the possibility that both
the person bitten and the person who inflicted the bite were exposed to
bloodborne pathogens. Transmission of HBV or HIV infection only rarely
has been reported by this route (*18\--20*) (CDC, unpublished data,
1998).

#### BACKGROUND 

This section provides the rationale for the postexposure management and
prophylaxis recommendations presented in this report. Additional details
concerning the risk for occupational bloodborne pathogen transmission to
HCP and management of occupational bloodborne pathogen exposures are
available elsewhere (*5,12,13,21-24*).

**Occupational Transmission of HBV**

***Risk for Occupational Transmission of HBV***

HBV infection is a well recognized occupational risk for HCP (*25*). The
risk of HBV infection is primarily related to the degree of contact with
blood in the work place and also to the hepatitis B e antigen (HBeAg)
status of the source person. In studies of HCP who sustained injuries
from needles contaminated with blood containing HBV, the risk of
developing clinical hepatitis if the blood was both hepatitis B surface
antigen (HBsAg)- and HBeAg-positive was 22%\--31%; the risk of
developing serologic evidence of HBV infection was 37%\--62%. By
comparison, the risk of developing clinical hepatitis from a needle
contaminated with HBsAg-positive, HBeAg-negative blood was 1%\--6%, and
the risk of developing serologic evidence of HBV infection, 23%\--37%
(*26*).

Although percutaneous injuries are among the most efficient modes of HBV
transmission, these exposures probably account for only a minority of
HBV infections among HCP. In several investigations of nosocomial
hepatitis B outbreaks, most infected HCP could not recall an overt
percutaneous injury (*27,28*), although in some studies, up to one third
of infected HCP recalled caring for a patient who was HBsAg-positive
(*29,30*). In addition, HBV has been demonstrated to survive in dried
blood at room temperature on environmental surfaces for at least 1 week
(*31*). Thus, HBV infections that occur in HCP with no history of
nonoccupational exposure or occupational percutaneous injury might have
resulted from direct or indirect blood or body fluid exposures that
inoculated HBV into cutaneous scratches, abrasions, burns, other
lesions, or on mucosal surfaces (*32\--34*). The potential for HBV
transmission through contact with environmental surfaces has been
demonstrated in investigations of HBV outbreaks among patients and staff
of hemodialysis units (*35\--37*).

Blood contains the highest HBV titers of all body fluids and is the most
important vehicle of transmission in the health-care setting. HBsAg is
also found in several other body fluids, including breast milk, bile,
cerebrospinal fluid, feces, nasopharyngeal washings, saliva, semen,
sweat, and synovial fluid (*38*). However, the concentration of HBsAg in
body fluids can be 100\--1000\-\--fold higher than the concentration of
infectious HBV particles. Therefore, most body fluids are not efficient
vehicles of transmission because they contain low quantities of
infectious HBV, despite the presence of HBsAg.

In serologic studies conducted in the United States during the 1970s,
HCP had a prevalence of HBV infection approximately 10 times higher than
the general population (*39\--42*). Because of the high risk of HBV
infection among HCP, routine preexposure vaccination of HCP against
hepatitis B and the use of standard precautions to prevent exposure to
blood and other potentially infectious body fluids have been recommended
since the early 1980s (*43*). Regulations issued by the Occupational
Safety and Health Administration (OSHA) (*2*) have increased compliance
with these recommendations. Since the implementation of these
recommendations, a sharp decline has occurred in the incidence of HBV
infection among HCP.

***PEP for HBV***

**Efficacy of PEP for HBV.** The effectiveness of hepatitis B immune
globulin (HBIG) and/or hepatitis B vaccine in various postexposure
settings has been evaluated by prospective studies. For perinatal
exposure to an HBsAg-, HBeAg-positive mother, a regimen combining HBIG
and initiation of the hepatitis B vaccine series at birth is 85%\--95%
effective in preventing HBV infection (*44,45*). Regimens involving
either multiple doses of HBIG alone or the hepatitis B vaccine series
alone are 70%\--75% effective in preventing HBV infection (*46*). In the
occupational setting, multiple doses of HBIG initiated within 1 week
following percutaneous exposure to HBsAg-positive blood provides an
estimated 75% protection from HBV infection (*47\--49*). Although the
postexposure efficacy of the combination of HBIG and the hepatitis B
vaccine series has not been evaluated in the occupational setting, the
increased efficacy of this regimen observed in the perinatal setting,
compared with HBIG alone, is presumed to apply to the occupational
setting as well. In addition, because persons requiring PEP in the
occupational setting are generally at continued risk for HBV exposure,
they should receive the hepatitis B vaccine series.

**Safety of PEP for HBV.** Hepatitis B vaccines have been found to be
safe when administered to infants, children, or adults (*12,50*).
Through the year 2000, approximately 100 million persons have received
hepatitis B vaccine in the United States. The most common side effects
from hepatitis B vaccination are pain at the injection site and mild to
moderate fever (*50\--55*). Studies indicate that these side effects are
reported no more frequently among persons vaccinated than among those
receiving placebo (*51,52*).

Approximately 45 reports have been received by the Vaccine Adverse Event
Reporting System (VAERS) of alopecia (hair loss) in children and adults
after administration of plasma-derived and recombinant hepatitis B
vaccine; four persons sustained hair loss following vaccination on more
than one occasion (*56*). Hair loss was temporary for approximately two
thirds of persons who experienced hair loss. An epidemiologic study
conducted in the Vaccine Safety Datalink found no statistical
association between alopecia and receipt of hepatitis B vaccine in
children (CDC, unpublished data, 1998). A low rate of anaphylaxis has
been observed in vaccine recipients based on reports to VAERS; the
estimated incidence is 1 in 600,000 vaccine doses distributed. Although
none of the persons who developed anaphylaxis died, anaphylactic
reactions can be life-threatening; therefore, further vaccination with
hepatitis B vaccine is contraindicated in persons with a history of
anaphylaxis after a previous dose of vaccine.

Hepatitis B immunization programs conducted on a large scale in Taiwan,
Alaska, and New Zealand have observed no association between vaccination
and the occurrence of serious adverse events. Furthermore, in the United
States, surveillance of adverse events following hepatitis B vaccination
has demonstrated no association between hepatitis B vaccine and the
occurrence of serious adverse events, including Guillain-Barré syndrome,
transverse myelitis, multiple sclerosis, optic neuritis, and seizures
(*57\--59*) (CDC, unpublished data, 1991). However, several case reports
and case series have claimed an association between hepatitis B
vaccination and such syndromes and diseases as multiple sclerosis, optic
neuritis, rheumatoid arthritis, and other autoimmune diseases
(*57,60\--66*). Most of these reported adverse events have occurred in
adults, and no report has compared the frequency of the purported
vaccine-associated syndrome/disease with the frequency in an
unvaccinated population. In addition, recent case-control studies have
demonstrated no association between hepatitis B vaccination and
development or short-term risk of relapse of multiple sclerosis
(*67,68*), and reviews by international panels of experts have concluded
that available data do not demonstrate a causal association between
hepatitis B vaccination and demyelinating diseases, including multiple
sclerosis (*69*).

HBIG is prepared from human plasma known to contain a high titer of
antibody to HBsAg (anti-HBs). The plasma from which HBIG is prepared is
screened for HBsAg and antibodies to HIV and HCV. The process used to
prepare HBIG inactivates and eliminates HIV from the final product.
Since 1996, the final product has been free of HCV RNA as determined by
the polymerase chain reaction (PCR), and, since 1999, all products
available in the United States have been manufactured by methods that
inactivate HCV and other viruses. No evidence exists that HBV, HCV, or
HIV have ever been transmitted by HBIG commercially available in the
United States (*70,71*).

Serious adverse effects from HBIG when administered as recommended have
been rare. Local pain and tenderness at the injection site, urticaria
and angioedema might occur; anaphylactic reactions, although rare, have
been reported following the injection of human immune globulin (IG)
preparations (*72*). Persons with a history of anaphylactic reaction to
IG should not receive HBIG.

**PEP for HBV During Pregnancy.** No apparent risk exists for adverse
effects to developing fetuses when hepatitis B vaccine is administered
to pregnant women (CDC, unpublished data, 1990). The vaccine contains
noninfectious HBsAg particles and should pose no risk to the fetus. HBV
infection during pregnancy might result in severe disease for the mother
and chronic infection for the newborn. Therefore, neither pregnancy nor
lactation should be considered a contraindication to vaccination of
women. HBIG is not contraindicated for pregnant or lactating women.

**Occupational Transmission of HCV**

***Risk for Occupational Transmission of HCV***

HCV is not transmitted efficiently through occupational exposures to
blood. The average incidence of anti-HCV seroconversion after accidental
percutaneous exposure from an HCV-positive source is 1.8% (range:
0%\--7%) (*73\--76*), with one study indicating that transmission
occurred only from hollow-bore needles compared with other sharps
(*75*). Transmission rarely occurs from mucous membrane exposures to
blood, and no transmission in HCP has been documented from intact or
nonintact skin exposures to blood (*77,78*). Data are limited on
survival of HCV in the environment. In contrast to HBV, the
epidemiologic data for HCV suggest that environmental contamination with
blood containing HCV is not a significant risk for transmission in the
health-care setting (*79,80*), with the possible exception of the
hemodialysis setting where HCV transmission related to environmental
contamination and poor infection-control practices have been implicated
(*81\--84*). The risk for transmission from exposure to fluids or
tissues other than HCV-infected blood also has not been quantified but
is expected to be low.

***Postexposure Management for HCV***

In several studies, researchers have attempted to assess the
effectiveness of IG following possible exposure to non-A, non-B
hepatitis. These studies have been difficult to interpret because they
lack uniformity in diagnostic criteria and study design, and, in all but
one study, the first dose of IG was administered before potential
exposure (*48,85,86*). In an experiment designed to model HCV
transmission by needlestick exposure in the health-care setting, high
anti-HCV titer IG administered to chimpanzees 1 hour after exposure to
HCV-positive blood did not prevent transmission of infection (*87*). In
1994, the Advisory Committee on Immunization Practices (ACIP) reviewed
available data regarding the prevention of HCV infection with IG and
concluded that using IG as PEP for hepatitis C was not supported (*88*).
This conclusion was based on the following facts:

-   No protective antibody response has been identified following HCV
    infection.

-   Previous studies of IG use to prevent posttransfusion non-A, non-B
    hepatitis might not be relevant in making recommendations regarding
    PEP for hepatitis C.

-   Experimental studies in chimpanzees with IG containing anti-HCV
    failed to prevent transmission of infection after exposure.

No clinical trials have been conducted to assess postexposure use of
antiviral agents (e.g., interferon with or without ribavirin) to prevent
HCV infection, and antivirals are not FDA-approved for this indication.
Available data suggest that an established infection might need to be
present before interferon can be an effective treatment. Kinetic studies
suggest that the effect of interferon on chronic HCV infection occurs in
two phases. During the first phase, interferon blocks the production or
release of virus from infected cells. In the second phase, virus is
eradicated from the infected cells (*89*); in this later phase, higher
pretreatment alanine aminotransferase (ALT) levels correlate with an
increasing decline in infected cells, and the rapidity of the decline
correlates with viral clearance. In contrast, the effect of
antiretrovirals when used for PEP after exposure to HIV is based on
inhibition of HIV DNA synthesis early in the retroviral replicative
cycle.

In the absence of PEP for HCV, recommendations for postexposure
management are intended to achieve early identification of chronic
disease and, if present, referral for evaluation of treatment options.
However, a theoretical argument is that intervention with antivirals
when HCV RNA first becomes detectable might prevent the development of
chronic infection. Data from studies conducted outside the United States
suggest that a short course of interferon started early in the course of
acute hepatitis C is associated with a higher rate of resolved infection
than that achieved when therapy is begun after chronic hepatitis C has
been well established (*90\--92*). These studies used various treatment
regimens and included persons with acute disease whose peak ALT levels
were 500\--1,000 IU/L at the time therapy was initiated (2.6\--4 months
after exposure).

No studies have evaluated the treatment of acute infection in persons
with no evidence of liver disease (i.e., HCV RNA-positive \<6 months
duration with normal ALT levels); among patients with chronic HCV
infection, the efficacy of antivirals has been demonstrated only among
patients who also had evidence of chronic liver disease (i.e., abnormal
ALT levels). In addition, treatment started early in the course of
chronic HCV infection (i.e., 6 months after onset of infection) might be
as effective as treatment started during acute infection (*13*). Because
15%\--25% of patients with acute HCV infection spontaneously resolve
their infection (*93*), treatment of these patients during the acute
phase could expose them unnecessarily to the discomfort and side effects
of antiviral therapy.

Data upon which to base a recommendation for therapy of acute infection
are insufficient because a) no data exist regarding the effect of
treating patients with acute infection who have no evidence of disease,
b) treatment started early in the course of chronic infection might be
just as effective and would eliminate the need to treat persons who will
spontaneously resolve their infection, and c) the appropriate regimen is
unknown.

**Occupational Transmission of HIV**

***Risk for Occupational Transmission of HIV***

In prospective studies of HCP, the average risk of HIV transmission
after a percutaneous exposure to HIV-infected blood has been estimated
to be approximately 0.3% (95% confidence interval \[CI\] = 0.2%\--0.5%)
(*94*) and after a mucous membrane exposure, approximately 0.09% (95% CI
= 0.006%\--0.5%) (*95*). Although episodes of HIV transmission after
nonintact skin exposure have been documented (*96*), the average risk
for transmission by this route has not been precisely quantified but is
estimated to be less than the risk for mucous membrane exposures (*97*).
The risk for transmission after exposure to fluids or tissues other than
HIV-infected blood also has not been quantified but is probably
considerably lower than for blood exposures (*98*).

As of June 2000, CDC had received voluntary reports of 56 U.S. HCP with
documented HIV seroconversion temporally associated with an occupational
HIV exposure. An additional 138 episodes in HCP are considered possible
occupational HIV transmissions. These workers had a history of
occupational exposure to blood, other infectious body fluids, or
laboratory solutions containing HIV, and no other risk for HIV infection
was identified, but HIV seroconversion after a specific exposure was not
documented (*99*).

Epidemiologic and laboratory studies suggest that several factors might
affect the risk of HIV transmission after an occupational exposure. In a
retrospective case-control study of HCP who had percutaneous exposure to
HIV, the risk for HIV infection was found to be increased with exposure
to a larger quantity of blood from the source person as indicated by a)
a device visibly contaminated with the patient\'s blood, b) a procedure
that involved a needle being placed directly in a vein or artery, or c)
a deep injury (*100*). The risk also was increased for exposure to blood
from source persons with terminal illness, possibly reflecting either
the higher titer of HIV in blood late in the course of AIDS or other
factors (e.g., the presence of syncytia-inducing strains of HIV). A
laboratory study that demonstrated that more blood is transferred by
deeper injuries and hollow-bore needles lends further support for the
observed variation in risk related to blood quantity (*101*).

The use of source person viral load as a surrogate measure of viral
titer for assessing transmission risk has not yet been established.
Plasma viral load (e.g., HIV RNA) reflects only the level of cell-free
virus in the peripheral blood; latently infected cells might transmit
infection in the absence of viremia. Although a lower viral load (e.g.,
\<1,500 RNA copies/mL) or one that is below the limits of detection
probably indicates a lower titer exposure, it does not rule out the
possibility of transmission.

Some evidence exists regarding host defenses possibly influencing the
risk for HIV infection. A study of HIV-exposed but uninfected HCP
demonstrated an HIV-specific cytotoxic T-lymphocyte (CTL) response when
peripheral blood mononuclear cells were stimulated in vitro with
HIV-specific antigens (*102*). Similar CTL responses have been observed
in other groups who experienced repeated HIV exposure without resulting
infection (*103\--108*). Among several possible explanations for this
observation is that the host immune response sometimes might prevent
establishment of HIV infection after a percutaneous exposure; another is
that the CTL response simply might be a marker for exposure. In a study
of 20 HCP with occupational exposure to HIV, a comparison was made of
HCP treated with zidovudine (ZDV) PEP and those not treated. The
findings from this study suggest that ZDV blunted the HIV-specific CTL
response and that PEP might inhibit early HIV replication (*109*).

***Rationale for HIV PEP***

Considerations that influence the rationale and recommendations for PEP
include

-   the pathogenesis of HIV infection, particularly the time course of
    early infection;

-   the biological plausibility that infection can be prevented or
    ameliorated by using antiretroviral drugs;

-   direct or indirect evidence of the efficacy of specific agents used
    for prophylaxis; and

-   the risk and benefit of PEP to exposed HCP.

The following discussion considers each of these concerns.

**Role of Pathogenesis in Considering Antiretroviral Prophylaxis.**
Information about primary HIV infection indicates that systemic
infection does not occur immediately, leaving a brief window of
opportunity during which postexposure antiretroviral intervention might
modify or prevent viral replication. In a primate model of simian
immunodeficiency virus (SIV) infection, infection of dendritic-like
cells occurred at the site of inoculation during the first 24 hours
following mucosal exposure to cell-free virus. Over the subsequent
24\--48 hours, migration of these cells to regional lymph nodes
occurred, and virus was detectable in the peripheral blood within 5 days
(*110*). Theoretically, initiation of antiretroviral PEP soon after
exposure might prevent or inhibit systemic infection by limiting the
proliferation of virus in the initial target cells or lymph nodes.

**Efficacy of Antiretrovirals for PEP in Animal Studies.** Data from
animal studies have been difficult to interpret, in part, because of
problems identifying an animal model that is comparable to humans. In
early studies, differences in controlled variables (e.g., choice of
viral strain \[based on the animal model used\], inoculum size, route of
inoculation, time of prophylaxis initiation, and drug regimen) made
extrapolation of the results to humans difficult. Recently, refinements
in methodology have facilitated more relevant studies; in particular,
the viral inocula used in animal studies have been reduced to levels
more analogous to human exposures but sufficient to cause infection in
control animals (*111\--113*). These studies provide encouraging
evidence of postexposure chemoprophylactic efficacy.

Studies among primates and in murine and feline animal models have
demonstrated that larger viral inocula decrease prophylactic efficacy
(*114\--117*). In addition, delaying initiation, shortening the
duration, or decreasing the antiretroviral dose of PEP, individually or
in combination, decreased prophylactic efficacy (*113,118\--124*). For
example, when (R)-9-(2-phosphonylmethoxypropyl) adenine (tenofovir) was
administered 48 hours before, 4 hours after, or 24 hours after
intravenous SIV inoculation to long-tailed macaques, a 4-week regimen
prevented infection in all treated animals (*122*). A subsequent study
confirmed the efficacy of tenofovir PEP when administered 24 hours after
intravenous inoculation of a dose of SIV that uniformly results in
infection in untreated macaques. In the same study, protection was
incomplete if the tenofovir administration was delayed to 48 or 72 hours
postexposure or if the total duration of treatment was curtailed to 3 or
10 days (*123*).

**Efficacy of Antiretrovirals for PEP in Human Studies.** Little
information exists from which the efficacy of PEP in humans can be
assessed. Seroconversion is infrequent following an occupational
exposure to HIV-infected blood; therefore, several thousands of exposed
HCP would need to enroll in a prospective trial to achieve the
statistical power necessary to directly demonstrate PEP efficacy
(*125*).

In the retrospective case-control study of HCP, after controlling for
other risk factors for HIV transmission, use of ZDV as PEP was
associated with a reduction in the risk of HIV infection by
approximately 81% (95% CI = 43%\--94%) (*100*). Although the results of
this study suggest PEP efficacy, its limitations include the small
number of cases studied and the use of cases and controls from different
cohorts.

In a multicenter trial in which ZDV was administered to HIV-infected
pregnant women and their infants, the administration of ZDV during
pregnancy, labor, and delivery and to the infant reduced transmission by
67% (*126*). Only part of the protective effect of ZDV was explained by
reduction of the HIV viral load in the maternal blood, suggesting that
ZDV prophylaxis, in part, involves a mechanism other than the reduction
of maternal viral burden (*127,128*). Since 1998, studies have
highlighted the importance of PEP for prevention of perinatal HIV
transmission. In Africa, the use of ZDV in combination with lamivudine
(3TC) decreased perinatal HIV transmission by 50% when administered
during pregnancy, labor, and for 1 week postpartum, and by 37% when
started at the onset of labor and continued for 1 week postpartum
(*129*). Studies in the United States and Uganda also have demonstrated
that rates of perinatal HIV transmission have been reduced with the use
of abbreviated PEP regimens started intrapartum or during the first
48\--72 hours of life (*130\--132*).

The limitations of all of these studies with animals and humans must be
considered when reviewing evidence of PEP efficacy. The extent to which
data from animal studies can be extrapolated to humans is largely
unknown, and the exposure route for mother-to-infant HIV transmission is
not similar to occupational exposures; therefore, these findings might
not be directly applicable to PEP in HCP.

**Reports of Failure of PEP.** Failure of PEP to prevent HIV infection
in HCP has been reported in at least 21 instances (*78,133\--139*). In
16 of the cases, ZDV was used alone as a single agent; in two cases, ZDV
and didanosine (ddI) were used in combination (*133,138*); and in three
cases, [\>]{.underline}3 drugs were used for PEP (*137\--139*). Thirteen
of the source persons were known to have been treated with
antiretroviral therapy before the exposure. Antiretroviral resistance
testing of the virus from the source person was performed in seven
instances, and in four, the HIV infection transmitted was found to have
decreased sensitivity to ZDV and/or other drugs used for PEP. In
addition to possible exposure to an antiretroviral-resistant strain of
HIV, other factors that might have contributed to these apparent
failures might include a high titer and/or large inoculum exposure,
delayed initiation and/or short duration of PEP, and possible factors
related to the host (e.g., cellular immune system responsiveness) and/or
to the source person\'s virus (e.g., presence of syncytia-forming
strains) (*133*). Details regarding the cases of PEP failure involving
combinations of antiretroviral agents are included in this report (Table
1).

***Antiretroviral Agents for PEP***

Antiretroviral agents from three classes of drugs are available for the
treatment of HIV infection. These agents include the nucleoside reverse
transcriptase inhibitors (NRTIs), nonnucleoside reverse transcriptase
inhibitors (NNRTIs), and protease inhibitors (PIs). Only antiretroviral
agents that have been approved by FDA for treatment of HIV infection are
discussed in these guidelines.

Determining which agents and how many to use or when to alter a PEP
regimen is largely empiric. Guidelines for the treatment of HIV
infection, a condition usually involving a high total body burden of
HIV, include recommendations for the use of three drugs (*140*);
however, the applicability of these recommendations to PEP remains
unknown. In HIV-infected patients, combination regimens have proved
superior to monotherapy regimens in reducing HIV viral load, reducing
the incidence of opportunistic infections and death, and delaying onset
of drug resistance (*141,142*). A combination of drugs with activity at
different stages in the viral replication cycle (e.g., nucleoside
analogues with a PI) theoretically could offer an additional preventive
effect in PEP, particularly for occupational exposures that pose an
increased risk of transmission. Although the use of a three-drug regimen
might be justified for exposures that pose an increased risk of
transmission, whether the potential added toxicity of a third drug is
justified for lower-risk exposures is uncertain. Therefore, the
recommendations at the end of this document provide guidance for two-
and three-drug PEP regimens that are based on the level of risk for HIV
transmission represented by the exposure.

NRTI combinations that can be considered for PEP include ZDV and 3TC,
3TC and stavudine (d4T), and ddI and d4T. In previous PHS guidelines, a
combination of ZDV and 3TC was considered the first choice for PEP
regimens (*3*). Because ZDV and 3TC are available in a combination
formulation (Combivir™, manufactured by Glaxo Wellcome, Inc., Research
Triangle Park, NC), the use of this combination might be more convenient
for HCP. However, recent data suggest that mutations associated with ZDV
and 3TC resistance might be common in some areas (*143*). Thus,
individual clinicians might prefer other NRTIs or combinations based on
local knowledge and experience in treating HIV infection and disease.

The addition of a third drug for PEP following high-risk exposures is
based on demonstrated effectiveness in reducing viral burden in
HIV-infected persons. Previously, indinavir (IDV) or nelfinavir (NFV)
were recommended as first-choice agents for inclusion in an expanded PEP
regimen (*5*). Since the publication of the 1998 PEP guidelines,
efavirenz (EFV), an NNRTI; abacavir (ABC), a potent NRTI; and Kaletra™,
a PI, have been approved by FDA. Although side effects might be common
with the NNRTIs, EFV might be considered for expanded PEP regimens,
especially when resistance to PIs in the source person\'s virus is known
or suspected. ABC has been associated with dangerous hypersensitivity
reactions but, with careful monitoring, may be considered as a third
drug for PEP. Kaletra, a combination of lopinavir and ritonavir, is a
potent HIV inhibitor that, with expert consultation, may be considered
in an expanded PEP regimen.

**Toxicity and Drug Interactions of Antiretroviral Agents.** When
administering PEP, an important goal is completion of a 4-week PEP
regimen when PEP is indicated. Therefore, the toxicity profile of
antiretroviral agents, including the frequency, severity, duration, and
reversibility of side effects, is a relevant consideration. All of the
antiretroviral agents have been associated with side effects (Table 2).
However, studies of adverse events have been conducted primarily with
persons who have advanced disease (and longer treatment courses) and who
therefore might not reflect the experience in persons who are uninfected
(*144*).

Several primary side effects are associated with antiretroviral agents
(Table 2). Side effects associated with many of the NRTIs are chiefly
gastrointestinal (e.g., nausea or diarrhea); however, ddI has been
associated with cases of fatal and nonfatal pancreatitis among
HIV-infected patients treated for \>4 weeks. The use of PIs has been
associated with new onset diabetes mellitus, hyperglycemia, diabetic
ketoacidosis, exacerbation of preexisting diabetes mellitus, and
dyslipidemia (*145\--147*). Nephrolithiasis has been associated with IDV
use; however, the incidence of this potential complication might be
limited by drinking at least 48 ounces (1.5 L) of fluid per 24-hour
period (e.g., six 8- ounce glasses of water throughout the day) (*148*).
NFV has been associated with the development of diarrhea; however, this
side effect might respond to treatment with antimotility agents that can
be prescribed for use, if necessary, at the time the drug is recommended
for PEP. The NNRTIs have been associated with severe skin reactions,
including life-threatening cases of Stevens-Johnson syndrome and toxic
epidermal necrolysis. Hepatotoxicity, including fatal hepatic necrosis,
has occurred in patients treated with nevirapine (NVP); some episodes
began during the first few weeks of therapy (FDA, unpublished data,
2000). EFV has been associated with central nervous system side effects,
including dizziness, somnolence, insomnia, and abnormal dreaming.

All of the approved antiretroviral agents might have potentially serious
drug interactions when used with certain other drugs (Appendix C).
Careful evaluation of concomitant medications used by an exposed person
is required before PEP is prescribed, and close monitoring for toxicity
is also needed. Further information about potential drug interactions
can be found in the manufacturer\'s package insert.

**Toxicity Associated with PEP.** Information from the National
Surveillance System for Health Care Workers (NaSH) and the HIV
Postexposure Registry indicates that nearly 50% of HCP experience
adverse symptoms (e.g., nausea, malaise, headache, anorexia, and
headache) while taking PEP and that approximately 33% stop taking PEP
because of adverse signs and symptoms (*6,7,10,11*). Some studies have
demonstrated that side effects and discontinuation of PEP are more
common among HCP taking three-drug combination regimens for PEP compared
with HCP taking two-drug combination regimens (*7,10*). Although similar
rates of side effects were observed among persons who took PEP after
sexual or drug use exposures to HIV in the San Francisco Post-Exposure
Prevention Project, 80% completed 4 weeks of therapy (*149*).
Participants in the San Francisco Project were followed at 1, 2, 4, 26,
and 52 weeks postexposure and received medication adherence counseling;
most participants took only two drugs for PEP.

Serious side effects, including nephrolithiasis, hepatitis, and
pancytopenia have been reported with the use of combination drugs for
PEP (*6,7,150,151*). One case of NVP-associated fulminant liver failure
requiring liver transplantation and one case of hypersensitivity
syndrome have been reported in HCP taking NVP for HIV PEP (*152*).
Including these two cases, from March 1997 through September 2000, FDA
received reports of 22 cases of serious adverse events related to NVP
taken for PEP (*153*). These events included 12 cases of hepatotoxicity,
14 cases of skin reaction (including one documented and two possible
cases of Stevens-Johnson syndrome), and one case of rhabdomyolysis; four
cases involved both hepatotoxicty and skin reaction, and one case
involved both rhabdomyolysis and skin reaction.

**Resistance to Antiretroviral Agents.** Known or suspected resistance
of the source virus to antiretroviral agents, particularly to agents
that might be included in a PEP regimen, is a concern for persons making
decisions about PEP. Resistance to HIV infection occurs with all of the
available antiretroviral agents, and cross-resistance within drug
classes is frequent (*154*). Recent studies have demonstrated an
emergence of drug-resistant HIV among source persons for occupational
exposures (*143,155*). A study conducted at seven U.S. sites during
1998\--1999 found that 16 (39%) of 41 source persons whose virus was
sequenced had primary genetic mutations associated with resistance to
RTIs, and 4 (10%) had primary mutations associated with resistance to
PIs (*143*). In addition, occupational transmission of resistant HIV
strains, despite PEP with combination drug regimens, has been reported
(*137,139*). In one case, a hospital worker became infected after an HIV
exposure despite a PEP regimen that included ddI, d4T, and NVP (*139*).
The transmitted HIV contained two primary genetic mutations associated
with resistance to NNRTIs (the source person was taking EFV at the time
of the exposure). Despite recent studies and case reports, the relevance
of exposure to a resistant virus is still not well understood.

Empiric decisions about the presence of antiretroviral drug resistance
are often difficult to make because patients generally take more than
one antiretroviral agent. Resistance should be suspected in source
persons when they are experiencing clinical progression of disease or a
persistently increasing viral load, and/or decline in CD4 T-cell count,
despite therapy or a lack of virologic response to therapy. However,
resistance testing of the source virus at the time of an exposure is not
practical because the results will not be available in time to influence
the choice of the initial PEP regimen. Furthermore, in this situation,
whether modification of the PEP regimen is necessary or will influence
the outcome of an occupational exposure is unknown. No data exist to
suggest that modification of a PEP regimen after receiving results from
resistance testing (usually a minimum of 1\--2 weeks) improves efficacy
of PEP.

**Antiretroviral Drugs During Pregnancy.** Data are limited on the
potential effects of antiretroviral drugs on the developing fetus or
neonate (*156*). Carcinogenicity and/or mutagenicity is evident in
several in vitro screening tests for ZDV and all other FDA-licensed
NRTIs. The relevance of animal data to humans is unknown; however,
because teratogenic effects were observed in primates at drug exposures
similar to those representing human therapeutic exposure, the use of EFV
should be avoided in pregnant women (*140*). IDV is associated with
infrequent side effects in adults (i.e., hyperbilirubinemia and renal
stones) that could be problematic for a newborn. Because the half-life
of IDV in adults is short, these concerns might be relevant only if the
drug is administered shortly before delivery.

In a recent study in France of perinatal HIV transmission, two cases of
progressive neurologic disease and death were reported in uninfected
infants exposed to ZDV and 3TC (*157*). Laboratory studies of these
children suggested mitochondrial dysfunction. In a careful review of
deaths in children followed in U.S. perinatal HIV cohorts, no deaths
attributable to mitochondrial disease have been found (*158*).

Recent reports of fatal and nonfatal lactic acidosis in pregnant women
treated throughout gestation with a combination of d4T and ddI have
prompted warnings about use of these drugs during pregnancy (*159*).
Although the case-patients were HIV-infected women taking the drugs for
\>4 weeks, pregnant women and their providers should be advised to
consider d4T and ddI only when the benefits of their use outweigh the
risks.

**PEP Use in Hospitals in the United States.** Analysis of data from
NaSH provides information on the use of PEP following occupational
exposures in 47 hospitals in the United States. A total of 11,784
exposures to blood and body fluids was reported from June 1996 through
November 2000 (CDC, unpublished data, 2001). For all exposures with
known sources, 6% were to HIV-positive sources, 74% to HIV-negative
sources, and 20% to sources with an unknown HIV status. Sixty-three
percent of HCP exposed to a known HIV-positive source started PEP, and
54% of HCP took it for at least 20 days, whereas 14% of HCP exposed to a
source person subsequently found to be HIV-negative initiated PEP, and
3% of those took it for at least 20 days. Information recorded about HIV
exposures in NaSH indicates that 46% of exposures involving an
HIV-positive source warranted only a two-drug PEP regimen (i.e., the
exposure was to mucous membranes or skin or was a superficial
percutaneous injury and the source person did not have end-stage AIDS or
acute HIV illness); however, 53% of these exposed HCP took
[\>]{.underline}3 drugs (CDC, unpublished data, 2000). Similarly, the
National Clinicians\' Post-Exposure Prophylaxis Hotline (PEPline)
reported that PEPline staff recommended stopping or not starting PEP for
approximately one half of the HCP who consulted them about exposures (D.
Bangsberg, San Francisco General Hospital, unpublished data, September
1999). The observation that some HCP exposed to HIV-negative source
persons take PEP from several days to weeks following their exposures
suggests that strategies be employed such as the use of a rapid HIV
antibody assay, which could minimize exposure to unnecessary PEP (*11*).
A recent study demonstrated that use of a rapid HIV test for evaluation
of source persons after occupational exposures not only resulted in
decreased use of PEP, but also was cost-effective compared with use of
the standard enzyme immunoassay (EIA) test for source persons
subsequently found to be HIV-negative (*160*).

#### RECOMMENDATIONS FOR THE MANAGEMENT OF HCP POTENTIALLY EXPOSED TO HBV, HCV, or HIV 

Exposure prevention remains the primary strategy for reducing
occupational bloodborne pathogen infections; however, occupational
exposures will continue to occur. Health-care organizations should make
available to their personnel a system that includes written protocols
for prompt reporting, evaluation, counseling, treatment, and follow-up
of occupational exposures that might place HCP at risk for acquiring a
bloodborne infection. HCP should be educated concerning the risk for and
prevention of bloodborne infections, including the need to be vaccinated
against hepatitis B *(17,21,161\--163*). Employers are required to
establish exposure-control plans that include postexposure follow-up for
their employees and to comply with incident reporting requirements
mandated by the 1992 OSHA bloodborne pathogen standard (*2*). Access to
clinicians who can provide postexposure care should be available during
all working hours, including nights and weekends. HBIG, hepatitis B
vaccine, and antiretroviral agents for HIV PEP should be available for
timely administration (i.e., either by providing access on-site or by
creating linkages with other facilities or providers to make them
available off-site). Persons responsible for providing postexposure
management should be familiar with evaluation and treatment protocols
and the facility\'s plans for accessing HBIG, hepatitis B vaccine, and
antiretroviral drugs for HIV PEP.

HCP should be educated to report occupational exposures immediately
after they occur, particularly because HBIG, hepatitis B vaccine, and
HIV PEP are most likely to be effective if administered as soon after
the exposure as possible. HCP who are at risk for occupational exposure
to bloodborne pathogens should be familiarized with the principles of
postexposure management as part of job orientation and ongoing job
training.

**Hepatitis B Vaccination**

Any person who performs tasks involving contact with blood,
blood-contaminated body fluids, other body fluids, or sharps should be
vaccinated against hepatitis B (*2,21*). Prevaccination serologic
screening for previous infection is not indicated for persons being
vaccinated because of occupational risk, unless the hospital or
health-care organization considers screening cost-effective.

Hepatitis B vaccine should always be administered by the intramuscular
route in the deltoid muscle with a needle 1\--1.5 inches long. Hepatitis
B vaccine can be administered at the same time as other vaccines with no
interference with antibody response to the other vaccines (*164*). If
the vaccination series is interrupted after the first dose, the second
dose should be administered as soon as possible. The second and third
doses should be separated by an interval of at least 2 months. If only
the third dose is delayed, it should be administered when convenient.
HCP who have contact with patients or blood and are at ongoing risk for
percutaneous injuries should be tested 1\--2 months after completion of
the 3dose vaccination series for anti-HBs (*21*). Persons who do not
respond to the primary vaccine series (i.e., anti-HBs \<10 mIU/mL)
should complete a second 3-dose vaccine series or be evaluated to
determine if they are HBsAg-positive. Revaccinated persons should be
retested at the completion of the second vaccine series. Persons who do
not respond to an initial 3-dose vaccine series have a 30%\--50% chance
of responding to a second 3-dose series (*165*). Persons who prove to be
HBsAg-positive should be counseled regarding how to prevent HBV
transmission to others and regarding the need for medical evaluation
(*12,163,166*). Nonresponders to vaccination who are HBsAg-negative
should be considered susceptible to HBV infection and should be
counseled regarding precautions to prevent HBV infection and the need to
obtain HBIG prophylaxis for any known or probable parenteral exposure to
HBsAg-positive blood. Booster doses of hepatitis B vaccine are not
necessary, and periodic serologic testing to monitor antibody
concentrations after completion of the vaccine series is not
recommended. Any blood or body fluid exposure sustained by an
unvaccinated, susceptible person should lead to the initiation of the
hepatitis B vaccine series.

**Treatment of an Exposure Site**

Wounds and skin sites that have been in contact with blood or body
fluids should be washed with soap and water; mucous membranes should be
flushed with water. No evidence exists that using antiseptics for wound
care or expressing fluid by squeezing the wound further reduces the risk
of bloodborne pathogen transmission; however, the use of antiseptics is
not contraindicated. The application of caustic agents (e.g., bleach) or
the injection of antiseptics or disinfectants into the wound is not
recommended.

**Exposure Report**

If an occupational exposure occurs, the circumstances and postexposure
management should be recorded in the exposed person\'s confidential
medical record (usually on a form the facility designates for this
purpose) (Box 1). In addition, employers should follow all federal
(including OSHA) and state requirements for recording and reporting
occupational injuries and exposures.

**Evaluation of the Exposure and the Exposure Source**

***Evaluation of the Exposure***

The exposure should be evaluated for the potential to transmit HBV, HCV,
and HIV based on the type of body substance involved and the route and
severity of the exposure (Box 2). Blood, fluid containing visible blood,
or other potentially infectious fluid (including semen; vaginal
secretions; and cerebrospinal, synovial, pleural, peritoneal,
pericardial, and amniotic fluids) or tissue can be infectious for
bloodborne viruses. Exposures to these fluids or tissue through a
percutaneous injury (i.e., needlestick or other penetrating
sharps-related event) or through contact with a mucous membrane are
situations that pose a risk for bloodborne virus transmission and
require further evaluation. For HCV and HIV, exposure to a blood-filled
hollow needle or visibly bloody device suggests a higher risk exposure
than exposure to a needle that was most likely used for giving an
injection. In addition, any direct contact (i.e, personal protective
equipment either was not present or was ineffective in protecting skin
or mucous membranes) with concentrated virus in a research laboratory or
production facility is considered an exposure that requires clinical
evaluation.

For skin exposure, follow-up is indicated only if it involves exposure
to a body fluid previously listed and evidence exists of compromised
skin integrity (e.g., dermatitis, abrasion, or open wound). In the
clinical evaluation for human bites, possible exposure of both the
person bitten and the person who inflicted the bite must be considered.
If a bite results in blood exposure to either person involved,
postexposure follow-up should be provided.

***Evaluation of the Exposure Source***

The person whose blood or body fluid is the source of an occupational
exposure should be evaluated for HBV, HCV, and HIV infection (Box 3).
Information available in the medical record at the time of exposure
(e.g., laboratory test results, admitting diagnosis, or previous medical
history) or from the source person, might confirm or exclude bloodborne
virus infection.

If the HBV, HCV, and/or HIV infection status of the source is unknown,
the source person should be informed of the incident and tested for
serologic evidence of bloodborne virus infection. Procedures should be
followed for testing source persons, including obtaining informed
consent, in accordance with applicable state and local laws. Any persons
determined to be infected with HBV, HCV, or HIV should be referred for
appropriate counseling and treatment. Confidentiality of the source
person should be maintained at all times.

Testing to determine the HBV, HCV, and HIV infection status of an
exposure source should be performed as soon as possible. Hospitals,
clinics and other sites that manage exposed HCP should consult their
laboratories regarding the most appropriate test to use to expedite
obtaining these results. An FDA-approved rapid HIV-antibody test kit
should be considered for use in this situation, particularly if testing
by EIA cannot be completed within 24\--48 hours. Repeatedly reactive
results by EIA or rapid HIV-antibody tests are considered to be highly
suggestive of infection, whereas a negative result is an excellent
indicator of the absence of HIV antibody. Confirmation of a reactive
result by Western blot or immunofluorescent antibody is not necessary to
make initial decisions about postexposure management but should be done
to complete the testing process and before informing the source person.
Repeatedly reactive results by EIA for anti-HCV should be confirmed by a
supplemental test (i.e., recombinant immunoblot assay \[RIBA™\] or HCV
PCR). Direct virus assays (e.g., HIV p24 antigen EIA or tests for HIV
RNA or HCV RNA) for routine HIV or HCV screening of source persons are
not recommended.

If the exposure source is unknown or cannot be tested, information about
where and under what circumstances the exposure occurred should be
assessed epidemiologically for the likelihood of transmission of HBV,
HCV, or HIV. Certain situations as well as the type of exposure might
suggest an increased or decreased risk; an important consideration is
the prevalence of HBV, HCV, or HIV in the population group (i.e.,
institution or community) from which the contaminated source material is
derived. For example, an exposure that occurs in a geographic area where
injection-drug use is prevalent or involves a needle discarded in a
drug-treatment facility would be considered epidemiologically to have a
higher risk for transmission than an exposure that occurs in a nursing
home for the elderly.

Testing of needles or other sharp instruments implicated in an exposure,
regardless of whether the source is known or unknown, is not
recommended. The reliability and interpretation of findings in such
circumstances are unknown, and testing might be hazardous to persons
handling the sharp instrument.

Examples of information to consider when evaluating an exposure source
for possible HBV, HCV, or HIV infection include laboratory information
(e.g., previous HBV, HCV, or HIV test results or results of immunologic
testing \[e.g., CD4+ T-cell count\]) or liver enzymes (e.g., ALT),
clinical symptoms (e.g., acute syndrome suggestive of primary HIV
infection or undiagnosed immunodeficiency disease), and history of
recent (i.e., within 3 months) possible HBV, HCV, or HIV exposures
(e.g., injection-drug use or sexual contact with a known positive
partner). Health-care providers should be aware of local and state laws
governing the collection and release of HIV serostatus information on a
source person, following an occupational exposure.

If the source person is known to have HIV infection, available
information about this person\'s stage of infection (i.e., asymptomatic,
symptomatic, or AIDS), CD4+ T-cell count, results of viral load testing,
current and previous antiretroviral therapy, and results of any
genotypic or phenotypic viral resistance testing should be gathered for
consideration in choosing an appropriate PEP regimen. If this
information is not immediately available, initiation of PEP, if
indicated, should not be delayed; changes in the PEP regimen can be made
after PEP has been started, as appropriate. Reevaluation of exposed HCP
should be considered within 72 hours postexposure, especially as
additional information about the exposure or source person becomes
available.

If the source person is HIV seronegative and has no clinical evidence of
AIDS or symptoms of HIV infection, no further testing of the person for
HIV infection is indicated. The likelihood of the source person being in
the \"window period\" of HIV infection in the absence of symptoms of
acute retroviral syndrome is extremely small.

**Management of Exposures to HBV**

For percutaneous or mucosal exposures to blood, several factors must be
considered when making a decision to provide prophylaxis, including the
HBsAg status of the source and the hepatitis B vaccination and
vaccine-response status of the exposed person. Such exposures usually
involve persons for whom hepatitis B vaccination is recommended. Any
blood or body fluid exposure to an unvaccinated person should lead to
initiation of the hepatitis B vaccine series.

The hepatitis B vaccination status and the vaccine-response status (if
known) of the exposed person should be reviewed. A summary of
prophylaxis recommendations for percutaneous or mucosal exposure to
blood according to the HBsAg status of the exposure source and the
vaccination and vaccine-response status of the exposed person is
included in this report (Table 3).

When HBIG is indicated, it should be administered as soon as possible
after exposure (preferably within 24 hours). The effectiveness of HBIG
when administered \>7 days after exposure is unknown. When hepatitis B
vaccine is indicated, it should also be administered as soon as possible
(preferably within 24 hours) and can be administered simultaneously with
HBIG at a separate site (vaccine should always be administered in the
deltoid muscle).

For exposed persons who are in the process of being vaccinated but have
not completed the vaccination series, vaccination should be completed as
scheduled, and HBIG should be added as indicated (Table 3). Persons
exposed to HBsAg-positive blood or body fluids who are known not to have
responded to a primary vaccine series should receive a single dose of
HBIG and reinitiate the hepatitis B vaccine series with the first dose
of the hepatitis B vaccine as soon as possible after exposure.
Alternatively, they should receive two doses of HBIG, one dose as soon
as possible after exposure, and the second dose 1 month later. The
option of administering one dose of HBIG and reinitiating the vaccine
series is preferred for nonresponders who did not complete a second
3-dose vaccine series. For persons who previously completed a second
vaccine series but failed to respond, two doses of HBIG are preferred.

**Management of Exposures to HCV**

Individual institutions should establish policies and procedures for
testing HCP for HCV after percutaneous or mucosal exposures to blood and
ensure that all personnel are familiar with these policies and
procedures. The following are recommendations for follow-up of
occupational HCV exposures:

-   For the source, perform testing for anti-HCV.

-   For the person exposed to an HCV-positive source

> \-\-- perform baseline testing for anti-HCV and ALT activity; and
>
> \-\-- perform follow-up testing (e.g., at 4\--6 months) for anti-HCV
> and ALT activity (if earlier diagnosis of HCV infection is desired,
> testing for HCV RNA may be performed at 4\--6 weeks).

-   Confirm all anti-HCV results reported positive by enzyme immunoassay
    using supplemental anti-HCV testing (e.g., recombinant immunoblot
    assay \[RIBA™\]) (*13*).

Health-care professionals who provide care to persons exposed to HCV in
the occupational setting should be knowledgeable regarding the risk for
HCV infection and appropriate counseling, testing, and medical
follow-up.

IG and antiviral agents are not recommended for PEP after exposure to
HCV-positive blood. In addition, no guidelines exist for administration
of therapy during the acute phase of HCV infection. However, limited
data indicate that antiviral therapy might be beneficial when started
early in the course of HCV infection. When HCV infection is identified
early, the person should be referred for medical management to a
specialist knowledgeable in this area.

***Counseling for HCP Exposed to Viral Hepatitis***

HCP exposed to HBV- or HCV-infected blood do not need to take any
special precautions to prevent secondary transmission during the
follow-up period (*12,13*); however, they should refrain from donating
blood, plasma, organs, tissue, or semen. The exposed person does not
need to modify sexual practices or refrain from becoming pregnant. If an
exposed woman is breast feeding, she does not need to discontinue.

No modifications to an exposed person\'s patient-care responsibilities
are necessary to prevent transmission to patients based solely on
exposure to HBV- or HCV-positive blood. If an exposed person becomes
acutely infected with HBV, the person should be evaluated according to
published recommendations for infected HCP (*165*). No recommendations
exist regarding restricting the professional activities of HCP with HCV
infection (*13*). As recommended for all HCP, those who are chronically
infected with HBV or HCV should follow all recommended infection-control
practices, including standard precautions and appropriate use of hand
washing, protective barriers, and care in the use and disposal of
needles and other sharp instruments (*162*).

**Management of Exposures to HIV**

***Clinical Evaluation and Baseline Testing of Exposed HCP***

HCP exposed to HIV should be evaluated within hours (rather than days)
after their exposure and should be tested for HIV at baseline (i.e., to
establish infection status at the time of exposure). If the source
person is seronegative for HIV, baseline testing or further follow-up of
the exposed person normally is not necessary. Serologic testing should
be made available to all HCP who are concerned that they might have been
occupationally infected with HIV. For purposes of considering HIV PEP,
the evaluation also should include information about medications the
exposed person might be taking and any current or underlying medical
conditions or circumstances (i.e., pregnancy, breast feeding, or renal
or hepatic disease) that might influence drug selection.

***PEP for HIV***

The following recommendations (Table 4 and Table 5) apply to situations
when a person has been exposed to a source person with HIV infection or
when information suggests the likelihood that the source person is
HIV-infected. These recommendations are based on the risk for HIV
infection after different types of exposure and on limited data
regarding efficacy and toxicity of PEP. Because most occupational HIV
exposures do not result in the transmission of HIV, potential toxicity
must be carefully considered when prescribing PEP. To assist with the
initial management of an HIV exposure, health-care facilities should
have drugs for an initial PEP regimen selected and available for use.
When possible, these recommendations should be implemented in
consultation with persons who have expertise in antiretroviral therapy
and HIV transmission (Box 4).

**Timing and Duration of PEP.** PEP should be initiated as soon as
possible. The interval within which PEP should be initiated for optimal
efficacy is not known. Animal studies have demonstrated the importance
of starting PEP soon after an exposure (*111,112,118*). If questions
exist about which antiretroviral drugs to use or whether to use a basic
or expanded regimen, starting the basic regimen immediately rather than
delaying PEP administration is probably better. Although animal studies
suggest that PEP probably is substantially less effective when started
more than 24\--36 hours postexposure (*112,119,122*), the interval after
which no benefit is gained from PEP for humans is undefined. Therefore,
if appropriate for the exposure, PEP should be started even when the
interval since exposure exceeds 36 hours. Initiating therapy after a
longer interval (e.g., 1 week) might be considered for exposures that
represent an increased risk for transmission. The optimal duration of
PEP is unknown. Because 4 weeks of ZDV appeared protective in
occupational and animal studies (*100,123*), PEP probably should be
administered for 4 weeks, if tolerated.

**Use of PEP When HIV Infection Status of Source Person is Unknown.** If
the source person\'s HIV infection status is unknown at the time of
exposure, use of PEP should be decided on a case-by-case basis, after
considering the type of exposure and the clinical and/or epidemiologic
likelihood of HIV infection in the source (Table 4 and Table 5). If
these considerations suggest a possibility for HIV transmission and HIV
testing of the source person is pending, initiating a two-drug PEP
regimen until laboratory results have been obtained and later modifying
or discontinuing the regimen accordingly is reasonable. The following
are recommendations regarding HIV postexposure prophylaxis:

-   If indicated, start PEP as soon as possible after an exposure.

-   Reevaluation of the exposed person should be considered within 72
    hours postexposure, especially as additional information about the
    exposure or source person becomes available.

-   Administer PEP for 4 weeks, if tolerated.

-   If a source person is determined to be HIV-negative, PEP should be
    discontinued.

**PEP for Pregnant HCP.** If the exposed person is pregnant, the
evaluation of risk of infection and need for PEP should be approached as
with any other person who has had an HIV exposure. However, the decision
to use any antiretroviral drug during pregnancy should involve
discussion between the woman and her health-care provider(s) regarding
the potential benefits and risks to her and her fetus.

Certain drugs should be avoided in pregnant women. Because teratogenic
effects were observed in primate studies, EFV is not recommended during
pregnancy. Reports of fatal lactic acidosis in pregnant women treated
with a combination of d4T and ddI have prompted warnings about these
drugs during pregnancy. Because of the risk of hyperbilirubinemia in
newborns, IDV should not be administered to pregnant women shortly
before delivery.

**Recommendations for the Selection of Drugs for HIV PEP**

Health-care providers must strive to balance the risk for infection
against the potential toxicity of the agent(s) used when selecting a
drug regimen for HIV PEP. Because PEP is potentially toxic, its use is
not justified for exposures that pose a negligible risk for transmission
(Table 4 and Table 5). Also, insufficient evidence exists to support
recommending a three-drug regimen for all HIV exposures. Therefore, two
regimens for PEP are provided (Appendix C): a \"basic\" two-drug regimen
that should be appropriate for most HIV exposures and an \"expanded\"
three-drug regimen that should be used for exposures that pose an
increased risk for transmission (Table 4 and Table 5). When possible,
the regimens should be implemented in consultation with persons who have
expertise in antiretroviral treatment and HIV transmission.

Most HIV exposures will warrant a two-drug regimen using two nucleoside
analogues (e.g., ZDV and 3TC; or 3TC and d4T; or d4T and ddI). The
addition of a third drug should be considered for exposures that pose an
increased risk for transmission. Selection of the PEP regimen should
consider the comparative risk represented by the exposure and
information about the exposure source, including history of and response
to antiretroviral therapy based on clinical response, CD4+ T-cell
counts, viral load measurements, and current disease stage. When the
source person\'s virus is known or suspected to be resistant to one or
more of the drugs considered for the PEP regimen, the selection of drugs
to which the source person\'s virus is unlikely to be resistant is
recommended; expert consultation is advised. If this information is not
immediately available, initiation of PEP, if indicated, should not be
delayed; changes in the PEP regimen can be made after PEP has been
started, as appropriate. Reevaluation of the exposed person should be
considered within 72 hours postexposure, especially as additional
information about the exposure or source person becomes available.

***Follow-up of HCP Exposed to HIV***

**Postexposure Testing.** HCP with occupational exposure to HIV should
receive follow-up counseling, postexposure testing, and medical
evaluation, regardless of whether they receive PEP. HIV-antibody testing
should be performed for at least 6 months postexposure (e.g., at 6
weeks, 12 weeks, and 6 months). Extended HIV follow-up (e.g., for 12
months) is recommended for HCP who become infected with HCV following
exposure to a source coinfected with HIV and HCV. Whether extended
follow-up is indicated in other circumstances (e.g., exposure to a
source coinfected with HIV and HCV in the absence of HCV seroconversion
or for exposed persons with a medical history suggesting an impaired
ability to develop an antibody response to acute infection) is unclear.
Although rare instances of delayed HIV seroconversion have been reported
(*167,168*), the infrequency of this occurrence does not warrant adding
to the anxiety level of the exposed persons by routinely extending the
duration of postexposure follow-up. However, this recommendation should
not preclude a decision to extend follow-up in an individual situation
based on the clinical judgement of the exposed person\'s health-care
provider. HIV testing should be performed on any exposed person who has
an illness that is compatible with an acute retroviral syndrome,
regardless of the interval since exposure. When HIV infection is
identified, the person should be referred to a specialist knowledgeable
in the area of HIV treatment and counseling for medical management.

HIV-antibody testing with EIA should be used to monitor for
seroconversion. The routine use of direct virus assays (e.g., HIV p24
antigen EIA or tests for HIV RNA) to detect infection in exposed HCP
generally is not recommended (*169*). The high rate of false-positive
results of these tests in this setting could lead to unnecessary anxiety
and/or treatment (*170,171*). Despite the ability of direct virus assays
to detect HIV infection a few days earlier than EIA, the infrequency of
occupational seroconversion and increased costs of these tests do not
warrant their routine use in this setting.

-   HIV-antibody testing should be performed for at least 6 months
    postexposure.

-   Direct virus assays for routine follow-up of HCP are not
    recommended.

-   HIV testing should be performed on any exposed person who has an
    illness compatible with an acute retroviral syndrome.

**Monitoring and Management of PEP Toxicity.** If PEP is used, HCP
should be monitored for drug toxicity by testing at baseline and again 2
weeks after starting PEP. The scope of testing should be based on
medical conditions in the exposed person and the toxicity of drugs
included in the PEP regimen. Minimally, lab monitoring for toxicity
should include a complete blood count and renal and hepatic function
tests. Monitoring for evidence of hyperglycemia should be included for
HCP whose regimens include any PI; if the exposed person is receiving
IDV, monitoring for crystalluria, hematuria, hemolytic anemia, and
hepatitis also should be included. If toxicity is noted, modification of
the regimen should be considered after expert consultation; further
diagnostic studies may be indicated.

Exposed HCP who choose to take PEP should be advised of the importance
of completing the prescribed regimen. Information should be provided to
HCP about potential drug interactions and the drugs that should not be
taken with PEP, the side effects of the drugs that have been prescribed,
measures to minimize these effects, and the methods of clinical
monitoring for toxicity during the follow-up period. HCP should be
advised that the evaluation of certain symptoms should not be delayed
(e.g., rash, fever, back or abdominal pain, pain on urination or blood
in the urine, or symptoms of hyperglycemia \[increased thirst and/or
frequent urination\]).

HCP who fail to complete the recommended regimen often do so because of
the side effects they experience (e.g., nausea and diarrhea). These
symptoms often can be managed with antimotility and antiemetic agents or
other medications that target the specific symptoms without changing the
regimen. In other situations, modifying the dose interval (i.e.,
administering a lower dose of drug more frequently throughout the day,
as recommended by the manufacturer), might facilitate adherence to the
regimen. Serious adverse events should be reported to FDA\'s MedWatch
Program.

**Counseling and Education.** Although HIV infection following an
occupational exposure occurs infrequently, the emotional effect of an
exposure often is substantial (*172\--174*). In addition, HCP are given
seemingly conflicting information. Although HCP are told that a low risk
exists for HIV transmission, a 4-week regimen of PEP might be
recommended, and they are asked to commit to behavioral measures (e.g.,
sexual abstinence or condom use) to prevent secondary transmission, all
of which influence their lives for several weeks to months (*172*).
Therefore, access to persons who are knowledgeable about occupational
HIV transmission and who can deal with the many concerns an HIV exposure
might generate for the exposed person is an important element of
postexposure management. HIV-exposed HCP should be advised to use the
following measures to prevent secondary transmission during the
follow-up period, especially the first 6\--12 weeks after the exposure
when most HIV-infected persons are expected to seroconvert: exercise
sexual abstinence or use condoms to prevent sexual transmission and to
avoid pregnancy; and refrain from donating blood, plasma, organs,
tissue, or semen. If an exposed woman is breast feeding, she should be
counseled about the risk of HIV transmission through breast milk, and
discontinuation of breast feeding should be considered, especially for
high-risk exposures. Additionally, NRTIs are known to pass into breast
milk, as is NVP; whether this also is true for the other approved
antiretroviral drugs is unknown.

The patient-care responsibilities of an exposed person do not need to be
modified, based solely on an HIV exposure, to prevent transmission to
patients. If HIV seroconversion is detected, the person should be
evaluated according to published recommendations for infected HCP
(*175*).

Exposed HCP should be advised to seek medical evaluation for any acute
illness that occurs during the follow-up period. Such an illness,
particularly if characterized by fever, rash, myalgia, fatigue, malaise,
or lymphadenopathy, might be indicative of acute HIV infection but also
might be indicative of a drug reaction or another medical condition.

For exposures for which PEP is considered appropriate, HCP should be
informed that a) knowledge about the efficacy of drugs used for PEP is
limited; b) experts recommend combination drug regimens because of
increased potency and concerns about drug-resistant virus; c) data
regarding toxicity of antiretroviral drugs in persons without HIV
infection or in pregnant women are limited; d) although the short-term
toxicity of antiretroviral drugs is usually limited, serious adverse
events have occurred in persons taking PEP; and e) any or all drugs for
PEP may be declined or stopped by the exposed person. HCP who experience
HIV occupational exposures for which PEP is not recommended should be
informed that the potential side effects and toxicity of taking PEP
outweigh the negligible risk of transmission posed by the type of
exposure.

***Guidelines for counseling and educating HCP with HIV exposure
include***

-   Exposed HCP should be advised to use precautions to prevent
    secondary transmission during the follow-up period.

-   For exposures for which PEP is prescribed, HCP should be informed
    about possible drug toxicities and the need for monitoring, and
    possible drug interactions.

**Occupational Exposure Management Resources**

Several resources are available that provide guidance to HCP regarding
the management of occupational exposures. These resources include
PEPline; the Needlestick! website; the Hepatitis Hotline; CDC (receives
reports of occupationally acquired HIV infections and failures of PEP);
the HIV Antiretroviral Pregnancy Registry; FDA (receives reports of
unusual or severe toxicity to antiretroviral agents); and the HIV/AIDS
Treatment Information Service (Box 5).

\*This interagency working group comprised representatives of CDC, the
Food and Drug Administration (FDA), the Health Resources and Services
Administration, and the National Institutes of Health. Information
included in these recommendations may not represent FDA approval or
approved labeling for the particular product or indications in question.
Specifically, the terms \"safe\" and \"effective\" may not be synonymous
with the FDA-defined legal standards for product approval.

### References

1.  CDC. NIOSH alert: preventing needlestick injuries in health care
    settings. Cincinnati, OH: Department of Health and Human Services,
    CDC, 1999; DHHS publication no. (NIOSH)2000-108.

2.  Department of Labor, Occupational Safety and Health Administration.
    29 CFR Part 1910.1030. Occupational exposure to bloodborne
    pathogens; final rule. Federal Register 1991; 56:64004\--182.

3.  CDC. Public Health Service statement on management of occupational
    exposure to human immunodeficiency virus, including considerations
    regarding zidovudine postexposure use. MMWR 1990;39(No. RR-1).

4.  CDC. Update: provisional Public Health Service recommendations for
    chemoprophylaxis after occupational exposure to HIV. MMWR
    1996;45:468\--72.

5.  CDC. Public Health Service guidelines for the management of
    health-care worker exposures to HIV and recommendations for
    postexposure prophylaxis. MMWR 1998;47(No. RR-7).

6.  Panlilio AL, Cardo DM, Campbell S, Srivastava P, NaSH Surveillance
    Group. Experience of health care workers taking antiretroviral
    agents as postexposure prophylaxis for occupational exposure to HIV
    \[Abstract 489\]. In: Proceedings of the 1999 National HIV
    Prevention Conference. Atlanta, GA, 1999.

7.  Wang SA, Panlilio AL, Doi PA, et al. Experience of healthcare
    workers taking postexposure prophylaxis after occupational HIV
    exposures: findings of the HIV postexposure prophylaxis registry.
    Infect Control Hosp Epidemiol 2000;21:780\--5.

8.  Puro V, Ippolito G, Italian Registry PEP. Antiretroviral
    post-exposure prophylaxis \[Abstract 515\]. In: Proceedings of the
    1999 National HIV Prevention Conference. Atlanta, GA, 1999.

9.  Parkin JM, Murphy M, Anderson J, El-Gadi S, Forster G, Pinching AJ.
    Tolerability and side-effects of post-exposure prophylaxis for HIV
    infection \[Letter\]. Lancet 2000;355:722\--3.

10. Jochimsen EM, Srivastava PU, Campbell SR, Cardo DM, NaSH
    Surveillance Group. Postexposure prophylaxis (PEP) use among health
    care workers (HCWs) after occupational exposures to blood \[Abstract
    W6-F\]. In: Keynote addresses and abstracts of the 4th ICOH
    International Conference on Occupational Health for Health Care
    Workers. Montreal, Canada, 1999.

11. Critchley SE, Srivastava PU, Campbell SR, Cardo DM, NaSH
    Surveillance Group. Postexposure prophylaxis use among healthcare
    workers who were exposed to HIV-negative source persons \[Abstract
    P-S2-64\]. In: Program and Abstracts of the 4th Decennial
    International Conference on Nosocomial and Healthcare-Associated
    Infections. Atlanta, GA: CDC in conjunction with the 10th Annual
    Meeting of SHEA, 2000:126.

12. CDC. Hepatitis B virus: a comprehensive strategy for eliminating
    transmission in the United States through universal childhood
    vaccination: recommendations of the Immunization Practices Advisory
    Committee (ACIP). MMWR 1991;40(No. RR-13).

13. CDC. Recommendations for the prevention and control of hepatitis C
    virus (HCV) infection and HCV-related chronic disease. MMWR
    1998;47(No. RR-19).

14. CDC. Management of possible sexual, injecting-drug\--use, or other
    nonoccupational exposure to HIV, including considerations related to
    antiretroviral therapy: Public Health Service statement. MMWR
    1998;47(no. RR-17).

15. CDC. Recommendations of the U.S. Public Health Service Task Force on
    the use of zidovudine to reduce perinatal transmission of human
    immunodeficiency virus. MMWR 1994;43(No. RR-11).

16. CDC. Recommendations for prevention of HIV transmission in
    health-care settings. MMWR 1987;36(suppl no. 2S).

17. CDC. Update: universal precautions for prevention of transmission of
    human immunodeficiency virus, hepatitis B virus, and other
    bloodborne pathogens in health-care settings. MMWR
    1988;37:377\--82,387\--8.

18. Shapiro CN, McCaig LF, Gensheimer KF, et al. Hepatitis B virus
    transmission between children in day care. Pediatr Infect Dis J
    1989;8:870\--5.

19. Richman KM, Rickman LS. The potential for transmission of human
    immunodeficiency virus through human bites. J Acquir Immune Defic
    Syndr 1993;6:402\--6.

20. Vidmar L, Poljak M, Tomazic J, Seme K, Klavs I. Transmission of
    HIV-1 by human bite \[Letter\]. Lancet 1996;347:1762\--3.

21. CDC. Immunization of health-care workers: recommendations of the
    Advisory Committee on Immunization Practices (ACIP) and the Hospital
    Infection Control Practices Advisory Committee (HICPAC). MMWR
    1997;46(No. RR-18).

22. Chiarello LA, Gerberding JL. Human immunodeficiency virus in health
    care settings. In: Mandell GL, Bennett JE, Dolin R, eds. Mandell,
    Douglas, and Bennett\'s principles and practice of infectious
    diseases. 5th ed. Philadelphia, PA: Churchill Livingstone,
    2000:3052\--66.

23. Cardo DM, Smith DK, Bell DM. Postexposure Management. In: Dolin R,
    Masur H, Saag MS, eds. AIDS Therapy. New York, NY: Churchill
    Livingstone, 1999:236\--47.

24. Beltrami EM, Williams IT, Shapiro CN, Chamberland ME. Risk and
    management of blood-borne infections in health care workers. Clin
    Microbiol Rev 2000;13:385\--407.

25. Mast EE, Alter MJ. Prevention of hepatitis B virus infection among
    health-care workers. In: Ellis RW, ed. Hepatitis B vaccines in
    clinical practice. New York, NY: Marcel Dekker, 1993:295\--307.

26. Werner BG, Grady GF. Accidental hepatitis-B-surface-antigen-positive
    inoculations: use of e antigen to estimate infectivity. Ann Intern
    Med 1982;97:367\--9.

27. Garibaldi RA, Hatch FE, Bisno AL, Hatch MH, Gregg MB. Nonparenteral
    serum hepatitis: report of an outbreak. JAMA 1972;220:963\--6.

28. Rosenberg JL, Jones DP, Lipitz LR, Kirsner JB. Viral hepatitis: an
    occupational hazard to surgeons. JAMA 1973;223:395\--400.

29. Callender ME, White YS, Williams R. Hepatitis B virus infection in
    medical and health care personnel. Br Med J 1982;284:324\--6.

30. Chaudhuri AKR, Follett EAC. Hepatitis B virus infection in medical
    and health care personnel \[Letter\]. Br Med J 1982;284:1408.

31. Bond WW, Favero MS, Petersen NJ, Gravelle CR, Ebert JW, Maynard JE.
    Survival of hepatitis B virus after drying and storage for one week
    \[Letter\]. Lancet 1981;1:550\--1.

32. Francis DP, Favero MS, Maynard JE. Transmission of hepatitis B
    virus. Semin Liver Dis 1981;1:27\--32.

33. Favero MS, Maynard JE, Petersen NJ, et al. HepatitisB antigen on
    environmental surfaces \[Letter\]. Lancet 1973;2:1455.

34. Lauer JL, VanDrunen NA, Washburn JW, Balfour HH Jr. Transmission of
    hepatitis B virus in clinical laboratory areas. J Infect Dis
    1979;140:513\--6.

35. Hennekens CH. Hemodialysis-associated hepatitis: an outbreak among
    hospital personnel. JAMA 1973;225:407\--8.

36. Garibaldi RA, Forrest JN, Bryan JA, Hanson BF, Dismukes WE.
    Hemodialysis-associated hepatitis. JAMA 1973;225:384\--9.

37. Snydman DR, Bryan JA, Macon EJ, Gregg MB. Hemodialysis-associated
    hepatitis: a report of an epidemic with further evidence on
    mechanisms of transmission. Am J Epidemiol 1976;104:563\--70.

38. Bond WW, Petersen NJ, Favero MS. Viral hepatitis B: aspects of
    environmental control. Health Lab Sci 1977;14:235\--52.

39. Segal HE, Llewellyn CH, Irwin G, Bancroft WH, Boe GP, Balaban DJ.
    Hepatitis B antigen and antibody in the U.S. Army: prevalence in
    health care personnel. Am J Pub Health 1976;55:667\--71.

40. Denes AE, Smith JL, Maynard JE, Doto IL, Berquist KR, Finkel AJ.
    Hepatitis B infection in physicians: results of a nationwide
    seroepidemiologic survey. JAMA 1978;239:210\--2.

41. Dienstag JL, Ryan DM. Occupational exposure to hepatitis B virus in
    hospital personnel: infection or immunization? Am J Epidemiol
    1982;115:26\--39.

42. West DJ. The risk of hepatitis B infection among health
    professionals in the United States: a review. Am J Med Sci
    1984;287:26\--33.

43. CDC. Recommendation of the Immunization Practices Advisory Committee
    (ACIP) inactivated hepatitis B virus vaccine. MMWR 1982;31:317\--28.

44. Beasley RP, Hwang L-Y, Lee G C-Y, et al. Prevention of perinatally
    transmitted hepatitis B virus infections with hepatitis B immune
    globulin and hepatitis B vaccine. Lancet 1983;2:1099\--102.

45. Stevens CE, Toy PT, Tong MJ, et al. Perinatal hepatitis B virus
    transmission in the United States: prevention by passive-active
    immunization. JAMA 1985;253:1740\--5.

46. Beasley RP, Hwang L-Y, Stevens CE, et al. Efficacy of hepatitis B
    immune globulin for prevention of perinatal transmission of the
    hepatitis B virus carrier state: final report of a randomized
    double-blind, placebo-controlled trial. Hepatology 1983;3:135\--41.

47. Grady GF, Lee VA, Prince AM, et al. Hepatitis B immune globulin for
    accidental exposures among medical personnel: final report of a
    multicenter controlled trial. J Infect Dis 1978;138:625\--38.

48. Seeff LB, Zimmerman HJ, Wright EC, et al. A randomized, double blind
    controlled trial of the efficacy of immune serum globulin for the
    prevention of post-transfusion hepatitis: a Veterans Administration
    cooperative study. Gastroenterology 1977;72:111\--21.

49. Prince AM, Szmuness W, Mann MK, et al. Hepatitis B \"immune\"
    globulin: effectiveness in prevention of dialysis-associated
    hepatitis. N Engl J Med 1975;293:1063\--7.

50. Greenberg DP. Pediatric experience with recombinant hepatitis B
    vaccines and relevant safety and immunogenicity studies. Pediatr Inf
    Dis J 1993;12:438\--45.

51. Szmuness W, Stevens CE, Harley EJ, et al. Hepatitis B vaccine:
    demonstration of efficacy in a controlled clinical trial in a
    high-risk population in the United States. N Engl J Med
    1980;303:833\--41.

52. Francis DP, Hadler SC, Thompson SE, et al. The prevention of
    hepatitis B with vaccine: report of the Centers for Disease Control
    multi-center efficacy trial among homosexual men. Ann Intern Med
    1982;97:362\--6.

53. Stevens CE, Alter HJ, Taylor PE, et al. Hepatitis B vaccine in
    patients receiving hemodialysis: immunogenicity and efficacy. N Engl
    J Med 1984;311:496\--501.

54. André FE. Summary of safety and efficacy data on a yeast-derived
    hepatitis B vaccine. Am J Med 1989;87(suppl 3A):14S\--20S.

55. Zajac BA, West DJ, McAleer WJ, Scolnick EM. Overview of clinical
    studies with hepatitis B vaccine made by recombinant DNA. J Infect
    1986;13(suppl A):39\--45.

56. Wise RP, Kiminyo KP, Salive ME. Hair loss after routine
    immunizations. JAMA 1997;278:1176\--8.

57. Shaw FE, Graham DJ, Guess HA, et al. Postmarketing surveillance for
    neurologic adverse events reported after hepatitis B vaccination:
    experience of the first three years. Am J Epidemiol
    1988;127:337\--52.

58. Chen D-S. Control of hepatitis B in Asia: mass immunization program
    in Taiwan. In: Hollinger FB, Lemon SM, Margolis HS, eds. Viral
    hepatitis and liver disease. Baltimore, MD: Williams and Wilkins,
    1991:716\--9.

59. Niu MT, Rhodes P, Salive M, et al. Comparative safety of two
    recombinant hepatitis B vaccines in children: data from the Vaccine
    Adverse Event Reporting System (VAERS) and Vaccine Safety Datalink
    (VSD). J Clin Epidemiol 1998;51:503\--10.

60. Ribera EF, Dutka AJ. Polyneuropathy associated with administration
    of hepatitis B vaccine \[Letter\]. N Engl J Med 1983;309:614\--5.

61. Tuohy PG. Guillain-Barré syndrome following immunisation with
    synthetic hepatitis B vaccine \[Letter\]. N Z Med J
    1989;102:114\--5.

62. Herroelen L, de Keyser J, Ebinger G. Central-nervous-system
    demyelination after immunisation with recombinant hepatitis B
    vaccine. Lancet 1991;338:1174\--5.

63. Gross K, Combe C, Krüger K, Schattenkirchner M. Arthritis after
    hepatitis B vaccination: report of three cases. Scand J Rheumatol
    1995;24:50\--2.

64. Pope JE, Stevens A, Howson W, Bell DA. The development of rheumatoid
    arthritis after recombinant hepatitis B vaccination. J Rheumatol
    1998;25:1687\--93.

65. Hassan W, Oldham R. Reiter\'s syndrome and reactive arthritis in
    health care workers after vaccination. Br Med J 1994;309:94.

66. Grotto I, Mandel Y, Ephros M, Ashkenazi I, Shemer J. Major adverse
    reactions to yeast-derived hepatitis B vaccines\-\--a review.
    Vaccine 1998;16:329\--34.

67. Confavreux C, Suissa S, Saddier P, Bourdès V, Vukusic S, Vaccines in
    Multiple Sclerosis Study Group. Vaccinations and the risk of relapse
    in multiple sclerosis. N Engl J Med 2001;344:319\--26.

68. Ascherio A, Zhang SM, Hernán MA, et al. Hepatitis B vaccination and
    the risk of multiple sclerosis. N Engl J Med 2001;344:327\--32.

69. Halsey NA, Duclos P, Van Damme P, Margolis H. Hepatitis B vaccine
    and central nervous system demyelinating diseases. Viral Hepatitis
    Prevention Board. Pediatr Infect Dis J 1999;18:23\--4.

70. CDC. Safety of therapeutic immune globulin preparations with respect
    to transmission of human T-lymphotropic virus type
    III/lymphadenopathy-associated virus infection. MMWR
    1986;35:231\--3.

71. CDC. Outbreak of hepatitis C associated with intravenous
    immunoglobulin administration\-\--United States, October 1993\--June
    1994, MMWR 1994;43:505\--9.

72. Ellis EF, Henney CS. Adverse reactions following administration of
    human gamma globulin. J Allerg 1969;43:45\--54.

73. Alter MJ. The epidemiology of acute and chronic hepatitis C. Clin
    Liver Dis 1997;1:559\--68.

74. Lanphear BP, Linnemann CC Jr., Cannon CG, DeRonde MM, Pendy L,
    Kerley LM. Hepatitis C virus infection in healthcare workers: risk
    of exposure and infection. Infect Control Hosp Epidemiol
    1994;15:745\--50.

75. Puro V, Petrosillo N, Ippolito G, Italian Study Group on
    Occupational Risk of HIV and Other Bloodborne Infections. Risk of
    hepatitis C seroconversion after occupational exposure in health
    care workers. Am J Infect Control 1995;23:273\--7.

76. Mitsui T, Iwano K, Masuko K, et al. Hepatitis C virus infection in
    medical personnel after needlestick accident. Hepatology
    1992;16:1109\--14.

77. Sartori M, La Terra G, Aglietta M, Manzin A, Navino C, Verzetti G.
    Transmission of hepatitis C via blood splash into conjunctiva
    \[Letter\]. Scand J Infect Dis 1993;25:270\--1.

78. Ippolito G, Puro V, Petrosillo N, et al. Simultaneous infection with
    HIV and hepatitis C virus following occupational conjunctival blood
    exposure \[Letter\]. JAMA 1998;280:28.

79. Davis GL, Lau J Y-N, Urdea MS, et al. Quantitative detection of
    hepatitis C virus RNA with a solid-phase signal amplification
    method: definition of optimal conditions for specimen collection and
    clinical application in interferon-treated patients. Hepatology
    1994;19:1337\--41.

80. Polish LB, Tong MJ, Co RL, Coleman PJ, Alter MJ. Risk factors for
    hepatitis C virus infection among health care personnel in a
    community hospital. Am J Infect Control 1993;21:196\--200.

81. Niu MT, Coleman PJ, Alter MJ. Multicenter study of hepatitis C virus
    infection in chronic hemodialysis patients and hemodialysis center
    staff members. Am J Kidney Dis 1993;22:568\--73.

82. Hardy NM, Sandroni S, Danielson S, Wilson WJ. Antibody to hepatitis
    C virus increases with time on hemodialysis. Clin Nephrol
    1992;38:44\--8.

83. Niu MT, Alter MJ, Kristensen C, Margolis HS. Outbreak of
    hemodialysis-associated non-A, non-B hepatitis and correlation with
    antibody to hepatitis C virus. Am J Kidney Dis 1992;19:345\--52.

84. Favero MS, Alter MJ. The reemergence of hepatitis B virus infection
    in hemodialysis centers. Semin Dial 1996;9:373\--4.

85. Knodell RG, Conrad ME, Ginsberg AL, Bell CJ, Flannery EPR. Efficacy
    of prophylactic gamma-globulin in preventing non-A, non-B
    post-transfusion hepatitis. Lancet 1976;1:557\--61.

86. Sanchez-Quijano A, Pineda JA, Lissen E, et al. Prevention of
    post-transfusion non-A, non-B hepatitis by non-specific
    immunoglobulin in heart surgery patients. Lancet 1988;1:1245\--9.

87. Krawczynski K, Alter MJ, Tankersley DL, et al. Effect of immune
    globulin on the prevention of experimental hepatitis C virus
    infection. J Infect Dis 1996;173:822\--8.

88. Alter MJ. Occupational exposure to hepatitis C virus: a dilemma.
    Infect Control Hosp Epidemiol 1994;15:742\--4.

89. Peters M, Davis GL, Dooley JS, Hoofnagle JH. The interferon system
    in acute and chronic viral hepatitis. Progress in Liver Diseases
    1986;8:453\--67.

90. Fried MW, Hoofnagle JH. Therapy of hepatitis C. Semin Liver Dis
    1995;15:82\--91.

91. Vogel W, Graziadei I, Umlauft F, et al. High-dose interferon-a~2b~
    treatment prevents chronicity in acute hepatitis C: a pilot study.
    Dig Dis Sci 1996;41(suppl 12):81S\--85S.

92. Quin JW. Interferon therapy for acute hepatitis C viral
    infection\-\--a review by meta-analysis. Aust N Z J Med
    1997;27:611\--7.

93. Seeff LB, Hollinger FB, Alter HJ, et al. Long-term mortality and
    morbidity of transfusion-associated non-A, non-B, and type C
    hepatitis: a National Heart, Lung, and Blood Institute collaborative
    study. Hepatology 2001;33:455\--63.

94. Bell DM. Occupational risk of human immunodeficiency virus infection
    in healthcare workers: an overview. Am J Med 1997;102(suppl
    5B):9\--15.

95. Ippolito G, Puro V, De Carli G, Italian Study Group on Occupational
    Risk of HIV Infection. The risk of occupational human
    immunodeficiency virus in health care workers. Arch Int Med
    1993;153:1451\--8.

96. CDC. Update: human immunodeficiency virus infections in health-care
    workers exposed to blood of infected patients. MMWR 1987;36:285\--9.

97. Fahey BJ, Koziol DE, Banks SM, Henderson DK. Frequency of
    nonparenteral occupational exposures to blood and body fluids before
    and after universal precautions training. Am J Med 1991;90:145\--53.

98. Henderson DK, Fahey BJ, Willy M, et al. Risk for occupational
    transmission of human immunodeficiency virus type 1 (HIV-1)
    associated with clinical exposures: a prospective evaluation. Ann
    Intern Med 1990;113:740\--6.

99. CDC. HIV/AIDS Surveillance Report. Atlanta, GA: Department of Health
    and Human Services, CDC, 2000:24. (vol 12, no. 1).

100. Cardo DM, Culver DH, Ciesielski CA, et al. A case-control study of
     HIV seroconversion in health care workers after percutaneous
     exposure. N Engl J Med 1997;337:1485\--90.

101. Mast ST, Woolwine JD, Gerberding JL. Efficacy of gloves in reducing
     blood volumes transferred during simulated needlestick injury. J
     Infect Dis 1993;168:1589\--92.

102. Pinto LA, Landay AL, Berzofsky JA, Kessler HA, Shearer GM. Immune
     response to human immunodeficiency virus (HIV) in healthcare
     workers occupationally exposed to HIV-contaminated blood. Am J Med
     1997;102(suppl 5B):21\--4.

103. Clerici M, Giorgi JV, Chou C-C, et al. Cell-mediated immune
     response to human immunodeficiency virus (HIV) type 1 in
     seronegative homosexual men with recent sexual exposure to HIV-1. J
     Infect Dis 1992;165:1012\--9.

104. Ranki A, Mattinen S, Yarchoan R, et al. T-cell response towards HIV
     in infected individuals with and without zidovudine therapy, and in
     HIV-exposed sexual partners. AIDS 1989;3:63\--9.

105. Cheynier R, Langlade-Demoyen P, Marescot M-R, et al. Cytotoxic T
     lymphocyte responses in the peripheral blood of children born to
     human immunodeficiency virus-1-infected mothers. Eur J Immunol
     1992;22:2211\--7.

106. Kelker HC, Seidlin M, Vogler M, Valentine FT. Lymphocytes from some
     long-term seronegative heterosexual partners of HIV-infected
     individuals proliferate in response to HIV antigens. AIDS Res Hum
     Retroviruses 1992;8:1355\--9.

107. Langlade-Demoyen P, Ngo-Giang-Huong N, Ferchal F, Oksenhendler E.
     Human immunodeficiency virus (HIV) *nef*-specific cytotoxic T
     lymphocytes in noninfected heterosexual contact of HIV-infected
     patients. J Clin Invest 1994;93:1293\--7.

108. Rowland-Jones S, Sutton J, Ariyoshi K, et al. HIV-specific
     cytotoxic T-cells in HIV-exposed but uninfected Gambian women. Nat
     Med 1995;1:59\--64.

109. D\'Amico R, Pinto LA, Meyer P, et al. Effect of zidovudine
     postexposure prophylaxis on the development of HIV-specific
     cytotoxic T-lymphocyte responses in HIV-exposed healthcare workers.
     Infect Control Hosp Epidemiol 1999;20:428\--30.

110. Spira AI, Marx PA, Patterson BK, et al. Cellular targets of
     infection and route of viral dissemination after an intravaginal
     inoculation of simian immunodeficiency virus into rhesus macaques.
     J Exp Med 1996;183:215\--25.

111. McClure HM, Anderson DC, Ansari AA, Fultz PN, Klumpp SA, Schinazi
     RF. Nonhuman primate models for evaluation of AIDS therapy. In:
     AIDS: anti-HIV agents, therapies and vaccines. Ann N Y Acad Sci
     1990;616:287\--98.

112. Böttiger D, Johansson N-G, Samuelsson B, et al. Prevention of
     simian immunodeficiency virus, SIV~sm~, or HIV-2 infection in
     cynomolgus monkeys by pre- and postexposure administration of
     BEA-005. AIDS 1997;11:157\--62.

113. Otten RA, Smith DK, Adams DR, et al. Efficacy of postexposure
     prophylaxis after intravaginal exposure of pig-tailed macaques to a
     human-derived retrovirus (human immunodeficiency virus type 2). J
     Virol 2000;74:9771\--5.

114. Sinet M, Desforges B, Launay O, Colin J-N, Pocidalo J-J. Factors
     influencing zidovudine efficacy when administered at early stages
     of Friend virus infection in mice. Antiviral Res 1991;16:163\--71.

115. Ruprecht RM, Bronson R. Chemoprevention of retroviral infection:
     success is determined by virus inoculum strength and cellular
     immunity. DNA Cell Biol 1994;13:59\--66.

116. Fazely F, Haseltine WA, Rodger RF, Ruprecht RM. Postexposure
     chemoprophylaxis with ZDV or ZDV combined with interferon-a:
     failure after inoculating rhesus monkeys with a high dose of SIV. J
     Acquir Immune Defic Syndr 1991;4:1093\--7.

117. Böttiger D, Oberg B. Influence of the infectious dose of SIV on the
     acute infection in cynomolgus monkeys and on the effect of
     treatment with 3\'-fluorothymidine \[Abstract no. 81\]. In:
     Symposium on Nonhuman Primate Models for AIDS. Seattle, WA, 1991.

118. Martin LN, Murphey-Corb M, Soike KF, Davison-Fairburn B, Baskin GB.
     Effects of initiation of 3\'-azido,3\'-deoxythymidine (zidovudine)
     treatment at different times after infection of rhesus monkeys with
     simian immunodeficiency virus. J Infect Dis 1993;168:825\--35.

119. Shih C-C, Kaneshima H, Rabin L, et al. Postexposure prophylaxis
     with zidovudine suppresses human immunodeficiency virus type 1
     infection in SCID-hu mice in a time-dependent manner. J Infect Dis
     1991;163:625\--7.

120. Mathes LE, Polas PJ, Hayes KA, Swenson CL, Johnson S, Kociba GJ.
     Pre- and postexposure chemoprophylaxis: evidence that
     3\'-azido-3\'dideoxythymidine inhibits feline leukemia virus
     disease by a drug-induced vaccine response. Antimicrob Agents
     Chemother 1992;36:2715\--21.

121. Tavares L, Roneker C, Johnston K, Lehrman SN, de Noronha F.
     3\'-azido-3\'-deoxythymidine in feline leukemia virus-infected
     cats: a model for therapy and prophylaxis of AIDS. Cancer Res
     1987;47:3190\--4.

122. Tsai C-C, Follis KE, Sabo A, et al. Prevention of SIV infection in
     macaques by (*R*)-9-(2-phosphonylmethoxypropyl) adenine. Science
     1995;270:1197\--9.

123. Tsai C-C, Emau P, Follis KE, et al. Effectiveness of
     postinoculation (*R*)-9-(2-phosphonylmethoxypropyl) adenine
     treatment for prevention of persistent simian immunodeficiency
     virus SIV~mne~ infection depends critically on timing of initiation
     and duration of treatment. J Virol 1998;72:4265\--73.

124. Le Grand R, Vaslin B, Larghero J, et al. Post-exposure prophylaxis
     with highly active antiretroviral therapy could not protect
     macaques from infection with SIV/HIV chimera. AIDS
     2000;14:1864\--6.

125. LaFon SW, Mooney BD, McMullen JP, et al. A double-blind,
     placebo-controlled study of the safety and efficacy of retrovir^®^
     (zidovudine, ZDV) as a chemoprophylactic agent in health care
     workers exposed to HIV \[Abstract 489\]. In: Program and abstracts
     of the 30th Interscience Conference on Antimicrobial Agents and
     Chemotherapy. Atlanta, GA: American Society for Microbiology,
     1990:167.

126. Connor EM, Sperling RS, Gelber R, et al. Reduction of
     maternal-infant transmission of human immunodeficiency virus type 1
     with zidovudine treatment. N Engl J Med 1994;331:1173\--80.

127. Sperling RS, Shapiro DE, Coombs RW, et al. Maternal viral load,
     zidovudine treatment, and the risk of transmission of human
     immunodeficiency virus type 1 from mother to infant. N Engl J Med
     1996;335:1621\--9.

128. Shaffer N, Chuachoowong R, Mock PA, et al. Short-course zidovudine
     for perinatal HIV-1 transmission in Bangkok, Thailand: a randomised
     controlled trial. Lancet 1999;353: 773\--80.

129. Saba J, PETRA Trial Study Team. Interim analysis of early efficacy
     of three short ZDV/3TC combination regimens to prevent
     mother-to-child transmission of HIV-1: the PETRA trial \[Abstract
     S-7\]. In: Program and abstracts of the 6th Conference on
     Retroviruses and Opportunistic Infections. Chicago, IL: Foundation
     for Retrovirology and Human Health in scientific collaboration with
     the National Institute of Allergy and Infectious Diseases and CDC,
     1999.

130. Wade NA, Birkhead GS, Warren BL, et al. Abbreviated regimens of
     zidovudine prophylaxis and perinatal transmission of the human
     immunodeficiency virus. N Engl J Med 1998;339:1409\--14.

131. Musoke P, Guay LA, Bagenda D, et al. A phase I/II study of the
     safety and pharmacokinetics of nevirapine in HIV-1-infected
     pregnant Ugandan women and their neonates (HIVNET 006). AIDS
     1999;13:479\--86.

132. Guay LA, Musoke P, Fleming T, et al. Intrapartum and neonatal
     single-dose nevirapine compared with zidovudine for prevention of
     mother-to-child transmission of HIV-1 in Kampala, Uganda: HIVNET
     012 randomised trial. Lancet 1999;354:795\--802.

133. Jochimsen EM. Failures of zidovudine postexposure prophylaxis. Am J
     Med 1997;102(suppl 5B):52\--5.

134. Pratt RD, Shapiro JF, McKinney N, Kwok S, Spector SA. Virologic
     characterization of primary human immunodeficiency virus type 1
     infection in a health care worker following needlestick injury. J
     Infect Dis 1995;172:851\--4.

135. Lot F, Abiteboul D. Infections professionnelles par le V.I.H. en
     France chez le personnel de santé\-\--le point au 30 juin 1995.
     Bulletin Épidémiologique Hebdomadiaire 1995;44:193\--4.

136. Weisburd G, Biglione J, Arbulu MM, Terrazzino JC, Pesiri A. HIV
     seroconversion after a work place accident and treated with
     zidovudine \[Abstract Pub.C.1141\]. In: Abstracts of the XI
     International Conference on AIDS. Vancouver, British Columbia,
     Canada, 1996:460.

137. Perdue B, Wolderufael D, Mellors J, Quinn T, Margolick J. HIV-1
     transmission by a needlestick injury despite rapid initiation of
     four-drug postexposure prophylaxis \[Abstract 210\]. In: Program
     and abstracts of the 6th Conference on Retroviruses and
     Opportunistic Infections. Chicago, IL: Foundation for Retrovirology
     and Human Health in scientific collaboration with the National
     Institute of Allergy and Infectious Diseases and CDC, 1999:107.

138. Lot F, Abiteboul D. Occupational HIV infection in France \[Abstract
     WP-25\]. In: Keynote addresses and abstracts of the 4th ICOH
     International Conference on Occupational Health for Health Care
     Workers. Montreal, Canada, 1999.

139. Beltrami EM, Luo C-C, Dela Torre N, Cardo DM. HIV transmission
     after an occupational exposure despite postexposure prophylaxis
     with a combination drug regimen \[Abstract P-S2-62\]. In: Program
     and abstracts of the 4th Decennial International Conference on
     Nosocomial and Healthcare-Associated Infections in conjunction with
     the 10th Annual Meeting of SHEA. Atlanta, GA: CDC, 2000:125\--6.

140. Panel on Clinical Practices for Treatment of HIV Infection.
     Guidelines for the use of antiretroviral agents in HIV-infected
     adults and adolescents. Available at
     \<http://hivatis.org/trtgdlns.html\>. Accessed May 9, 2001.

141. Manion DJ, Hirsch MS. Combination chemotherapy for human
     immunodeficiency virus-1. Am J Med 1997;102(suppl 5B):76\--80.

142. Lafeuillade A, Poggi C, Tamalet C, Profizi N, Tourres C, Costes O.
     Effects of a combination of zidovudine, didanosine, and lamivudine
     on primary human immunodeficiency virus type 1 infection. J Infect
     Dis 1997;175:1051\--5.

143. Beltrami EM, Cheingsong R, Respess R, Cardo DM. Antiretroviral drug
     resistance in HIV-infected source patients for occupational
     exposures to healthcare workers \[Abstract P-S2-70\]. In: Program
     and Abstracts of the 4th Decennial International Conference on
     Nosocomial and Healthcare-Associated Infections. Atlanta, GA: CDC,
     2000:128.

144. Struble KA, Pratt RD, Gitterman SR. Toxicity of antiretroviral
     agents. Am J Med 1997;102(suppl 5B):65\--7.

145. Food and Drug Administration. Protease inhibitors may increase
     blood glucose in HIV patients. FDA Medical Bulletin 1997;27(2).

146. Dever LL, Oruwari PA, O\'Donovan CA, Eng RHK. Hyperglycemia
     associated with protease inhibitors in HIV-infected patients
     \[Abstract LB-4\]. In: Abstracts of the 37th Interscience
     Conference on Antimicrobial Agents and Chemotherapy. Toronto,
     Ontario, Canada: American Society for Microbiology, 1997.

147. Dubé MP, Johnson DL, Currier JS, Leedom JM. Protease
     inhibitor-associated hyperglycaemia \[Letter\]. Lancet
     1997;350:713\--4.

148. Abramowicz M, ed. New drugs for HIV infection. The Medical Letter
     on Drugs and Therapeutics 1996;38:35\--7.

149. Martin JN, Roland ME, Bamberger JD, et al. Postexposure prophylaxis
     after sexual or drug use exposure to HIV: final results from the
     San Francisco Post-Exposure Prevention (PEP) Project \[Abstract
     196\]. In: Program and abstracts of the 7th Conference on
     Retroviruses and Opportunistic Infections. San Francisco, CA:
     Foundation for Retrovirology and Human Health in scientific
     collaboration with the National Institute of Allergy and Infectious
     Diseases and CDC, 2000:112.

150. Steger KA, Swotinsky R, Snyder S, Craven DE. Recent experience with
     post-exposure prophylaxis (PEP) with combination antiretrovirals
     for occupational exposure (OE) to HIV \[Abstract 480\]. In: Program
     and abstracts of the 35th annual meeting of the Infectious Diseases
     Society of America. Alexandria, VA: Infectious Diseases Society of
     America, 1997:161.

151. Henry K, Acosta EP, Jochimsen E. Hepatotoxicity and rash associated
     with zidovudine and zalcitabine chemoprophylaxis \[Letter\]. Ann
     Intern Med 1996;124:855.

152. Johnson S, Baraboutis JG; Sha BE, Proia LA, Kessler HA. Adverse
     effects associated with use of nevirapine in HIV postexposure
     prophylaxis for 2 health care workers \[Letters\]. JAMA
     2000;284:2722\--3.

153. CDC. Serious adverse events attributed to nevirapine regimens for
     postexposure prophylaxis after HIV exposures\-\--worldwide,
     1997\--2000. MMWR 2001;49:1153\--6.

154. Hirsch MS, Brun-Vézinet F, D\'Aquila RT, et al. Antiretroviral drug
     resistance testing in adult HIV-1 infection: recommendations of an
     international AIDS Society\-\--USA panel. JAMA 2000;283:2417\--26.

155. Tack PC, Bremer JW, Harris AA, Landay AL, Kessler HA. Genotypic
     analysis of HIV-1 isolates to identify antiretroviral resistance
     mutations from source patients involved in health care worker
     occupational exposures \[Letter\]. JAMA 1999;281:1085\--6.

156. CDC. Public Health Service task force recommendations for use of
     antiretroviral drugs in pregnant women infected with HIV-1 for
     maternal health and for reducing perinatal HIV-1 transmission in
     the United States. MMWR 1998;47(RR-2).

157. Blanche S, Tardieu M, Rustin P, et al. Persistent mitochondrial
     dysfunction and perinatal exposure to antiretroviral nucleoside
     analogues. Lancet 1999;354:1084\--9.

158. Smith ME, US Nucleoside Safety Review Working Group. Ongoing
     nucleoside safety review of HIV exposed children in US studies
     \[Abstract 96\]. In: Final program and abstracts for the Second
     Conference on Global Strategies for the Prevention of HIV
     Transmission from Mothers to Infants. Montreal, Canada: New York
     Academy of Sciences, 1999:49.

159. Food and Drug Administration. Important drug warning. Available at
     \<http://www.fda.gov/medwatch/safety/2001/zerit&videx_letter.htm\>.
     Accessed May 9, 2001.

160. Veeder AV, McErlean M, Putnam K, Caldwell WC, Venezia RA. The
     impact of a rapid HIV test to limit unnecessary post exposure
     prophylaxis following occupational exposures \[Abstract P-S2-66\].
     In: Program and Abstracts of the 4th Decennial International
     Conference on Nosocomial and Healthcare-Associated Infections in
     conjunction with the 10th Annual Meeting of SHEA. Atlanta, GA: CDC,
     2000:127.

161. CDC. Guidelines for prevention of transmission of human
     immunodeficiency virus and hepatitis B virus to health-care and
     public-safety workers. MMWR 1989;38(No. S-6).

162. Garner JS, Hospital Infection Control Practices Advisory Committee.
     Guideline for isolation precautions in hospitals. Infect Control
     Hosp Epidemiol 1996;17:54\--80.

163. CDC. Recommendations for preventing transmission of human
     immunodeficiency virus and hepatitis B virus to patients during
     exposure-prone invasive procedures. MMWR 1991;40(No. RR-8).

164. Coursaget P, Yvonnet B, Relyveld EH, Barres JL, DiopMar I, Chiron
     JP. Simultaneous administration of diphtheriatetanuspertussispolio
     and hepatitis B vaccines in a simplified immunization program:
     immune response to diphtheria toxoid, tetanus toxoid, pertussis,
     and hepatitis B surface antigen. Infect Immun 1986;51:784\--7.

165. Hadler SC, Francis DP, Maynard JE, et al. Long-term immunogenicity
     and efficacy of hepatitis B vaccine in homosexual men. N Engl J Med
     1986;315:209\--14.

166. CDC. Public Health Service inter-agency guidelines for screening
     donors of blood, plasma, organs, tissues, and semen for evidence of
     hepatitis B and hepatitis C. MMWR 1991;40(No. RR-4):1\--17.

167. Ridzon R, Gallagher K, Ciesielski C, et al. Simultaneous
     transmission of human immunodeficiency virus and hepatitis C virus
     from a needle-stick injury. N Engl J Med 1997;336:919\--22.

168. Ciesielski CA, Metler RP. Duration of time between exposure and
     seroconversion in healthcare workers with occupationally acquired
     infection with human immunodeficiency virus. Am J Med
     1997;102(suppl 5B):115\--6.

169. Busch MP, Satten GA. Time course of viremia and antibody
     seroconversion following human immunodeficiency virus exposure. Am
     J Med 1997;102(suppl 5B):117\--24.

170. Rich JD, Merriman NA, Mylonakis E, et al. Misdiagnosis of HIV
     infection by HIV-1 plasma viral load testing: a case series. Ann
     Intern Med 1999;130:37\--9.

171. Roland ME, Elbeik TA, Martin JN, et al. HIV-1 RNA testing by bDNA
     and PCR in asymptomatic patients following sexual exposure to HIV
     \[Abstract 776\]. In: Program and abstracts of the 7th Conference
     on Retroviruses and Opportunistic Infections. San Francisco, CA:
     Foundation for Retrovirology and Human Health in scientific
     collaboration with the National Institute of Allergy and Infectious
     Diseases and CDC, 2000:220.

172. Gerberding JL, Henderson DK. Management of occupational exposures
     to bloodborne pathogens: hepatitis B virus, hepatitis C virus, and
     human immunodeficiency virus. Clin Inf Dis 1992;14:1179\--85.

173. Armstrong K, Gorden R, Santorella G. Occupational exposures of
     health care workers (HCWs) to human immunodeficiency virus (HIV):
     stress reactions and counseling interventions. Soc Work Health Care
     1995;21:61\--80.

174. Henry K, Campbell S, Jackson B, et al. Long-term follow-up of
     health care workers with work-site exposure to human
     immunodeficiency virus \[Letter\]. JAMA 1990;263:1765.

175. AIDS/TB Committee of the Society for Healthcare Epidemiology of
     America. Management of healthcare workers infected with hepatitis B
     virus, hepatitis C virus, human immunodeficiency virus, or other
     bloodborne pathogens. Infect Control Hosp Epidemiol
     1997;18:349\--63.

![](media/image21.png){width="5.997916666666667in"
height="6.205555555555556in"}

![](media/image22.png){width="5.999305555555556in"
height="6.5993055555555555in"}

![](media/image23.png){width="5.999305555555556in"
height="3.8513888888888888in"}

![](media/image24.png){width="6.0in" height="4.972222222222222in"}

![](media/image25.png){width="5.995833333333334in"
height="4.004166666666666in"}

![](media/image26.png){width="5.997916666666667in"
height="6.804166666666666in"}

![](media/image27.png){width="8.5in" height="6.1819444444444445in"}

![](media/image28.png){width="5.995833333333334in" height="7.0875in"}

![](media/image29.png){width="6.239583333333333in"
height="7.947916666666667in"}

![](media/image30.png){width="6.25in" height="2.7083333333333335in"}

**Disclaimer   All *MMWR* HTML versions of articles are electronic
conversions from ASCII text into HTML. This conversion may have resulted
in character translation or format errors in the HTML version. Users
should not rely on this HTML document, but are referred to the
electronic PDF version and/or the original *MMWR* paper copy for the
official text, figures, and tables. An original paper copy of this issue
can be obtained from the Superintendent of Documents, U.S. Government
Printing Office (GPO), Washington, DC 20402-9371; telephone: (202)
512-1800. Contact GPO for current prices.**

# APPENDIX C

SOURCES OF ADDITIONAL INFORMATION

+----------------------------------------+-----------------------------+
| federal                                |                             |
+----------------------------------------+-----------------------------+
| #  AGENCY NOTES                        |                             |
+----------------------------------------+-----------------------------+
| United States Fire Administration      | Developed *Guide to         |
|                                        | Managing an Emergency       |
| National Fire Programs                 | Service Infection Control   |
|                                        | Program*                    |
| 16825 South Seton Avenue               |                             |
|                                        | Two-day course: *Infection  |
| Emmitsburg, MD 21727                   | Control for Emergency       |
|                                        | Response Personnel: The     |
| http://www.usfa.fema.gov/              | Supervisor's Role*          |
+----------------------------------------+-----------------------------+
| U.S. Department of Health and Human    | Conducts ongoing research   |
| Services                               |                             |
|                                        | Oversees National           |
| Public Health Service, Centers for     | Prevention Information      |
| Disease Control                        | Network                     |
|                                        |                             |
| 1600 Clifton Rd.                       | Publishes MMWR              |
|                                        |                             |
| Atlanta, GA 30333                      |                             |
|                                        |                             |
| http://www.cdc.gov                     |                             |
+----------------------------------------+-----------------------------+
| Morbidity and Mortality Weekly Report  | Weekly reports from CDC on  |
|                                        | communicable diseases       |
| Epidemiology Program Office MS C-08\   |                             |
| Centers for Disease Control and        |                             |
| Prevention\                            |                             |
| 1600 Clifton Rd.\                      |                             |
| Atlanta, GA 30333\                     |                             |
| http://www2.cdc.gov/mmwr/              |                             |
+----------------------------------------+-----------------------------+
| National Highway Traffic Safety        | Developed *A Leadership     |
| Administration                         | Guide to Quality            |
|                                        | Improvement for Emergency   |
| Division of EMS                        | Medical Services Systems*   |
|                                        |                             |
| Department of Transportation           |                             |
|                                        |                             |
| 400 7^th^ Street, N.W.                 |                             |
|                                        |                             |
| Washington, D.C. 20590                 |                             |
|                                        |                             |
| http:                                  |                             |
| //www.nhtsa.dot.gov/people/injury/ems/ |                             |
+----------------------------------------+-----------------------------+
| U.S. Department of Labor               | 29 CFR Part 1910.1030       |
|                                        | *Occupational Exposure to   |
| Occupational Health & Safety           | Bloodborne Pathogens; Final |
| Administration                         | Rule                        |
|                                        | (*ht                        |
| Office of Public Affairs, Room N3647   | tp://www.osha-slc.gov/Pream |
|                                        | ble/Blood_data/BLOOD9.html) |
| 200 Constitution Avenue, N.W.          |                             |
|                                        |                             |
| Washington, D.C. 20210                 |                             |
|                                        |                             |
| http://www.osha.gov/                   |                             |
+----------------------------------------+-----------------------------+
| # [[state]{.underline}]{.smallcaps}    |                             |
+----------------------------------------+-----------------------------+
| Public Health Agencies                 | Liaison with CDC            |
|                                        |                             |
|                                        | Enforce CDC guidelines      |
+----------------------------------------+-----------------------------+
| Fire and EMS Agencies                  | Liaison with USFA and NFA   |
|                                        |                             |
|                                        | Sponsor training on         |
|                                        | infection control           |
+----------------------------------------+-----------------------------+
| **AGENCY NOTES**                       |                             |
+----------------------------------------+-----------------------------+
| State OSHA (where applicable)          | Enforce OSHA regulations    |
|                                        | and CDC guidelines          |
|                                        |                             |
|                                        | http:                       |
|                                        | //www.osha-slc.gov/fso/osp/ |
|                                        | provides links to State     |
|                                        | OSHA contacts               |
+----------------------------------------+-----------------------------+
| # [[local]{.underline}]{.smallcaps}    |                             |
+----------------------------------------+-----------------------------+
| Public Health Agencies                 | Liaison with State, public, |
|                                        | health agencies             |
|                                        |                             |
|                                        | Screening, testing,         |
|                                        | evaluation, immunization,   |
|                                        | and treatment capabilities  |
+----------------------------------------+-----------------------------+
| Regional EMS Agencies                  | Liaison to State EMS        |
|                                        | agencies                    |
+----------------------------------------+-----------------------------+
| Hospitals                              | Access to current           |
|                                        | information on infection    |
|                                        | control                     |
|                                        |                             |
|                                        | Notify responders of        |
|                                        | possible exposures          |
+----------------------------------------+-----------------------------+
| # [[other helpf                        |                             |
| ul web sites]{.underline}]{.smallcaps} |                             |
+----------------------------------------+-----------------------------+
| http://www.osha-sl                     | 29 CFR Part 1910,           |
| c.gov/FedReg_osha_pdf/FED20010118A.pdf | *Occupational Exposure to   |
|                                        | Bloodborne Pathogens;       |
|                                        | Needlesticks and Other      |
|                                        | Sharps Injuries; Final      |
|                                        | Rule*                       |
+----------------------------------------+-----------------------------+
| http://                                | *Safer Needle Devices:      |
| www.osha-slc.gov/SLTC/needlestick/safe | Protecting Health Care      |
| rneedledevices/saferneedledevices.html | Workers* (OSHA)             |
+----------------------------------------+-----------------------------+
| http://www.osha-slc.                   | *Technical Information      |
| gov/html/hotfoias/tib/TIB19990412.html | Bulletin - Potential for    |
|                                        | Allergy to Natural Rubber   |
|                                        | Latex Gloves and other      |
|                                        | Natural Rubber Products*    |
|                                        | (OSHA)                      |
+----------------------------------------+-----------------------------+
| http://www.osha-slc.gov/               | CPL 2-2.44D - *Enforcement  |
| OshDoc/Directive_data/CPL_2-2_44D.html | Procedures for the          |
|                                        | Occupational Exposure to    |
|                                        | Bloodborne Pathogens*       |
|                                        | (OSHA)                      |
+----------------------------------------+-----------------------------+

+----------------------------------------+-----------------------------+
| **AGENCY NOTES**                       |                             |
+----------------------------------------+-----------------------------+
| http://www.cdc.g                       | *Viral Hepatitis* (CDC)     |
| ov/ncidod/diseases/hepatitis/index.htm |                             |
+----------------------------------------+-----------------------------+
| http:                                  | *The Deadly Intersection    |
| //www.cdc.gov/hiv/pubs/facts/hivtb.pdf | between TB and HIV* (CDC)   |
+----------------------------------------+-----------------------------+
| http://www.cdc.gov/                    | *Guidelines for Preventing  |
| epo/mmwr/preview/mmwrhtml/00035909.htm | the Transmission of         |
|                                        | Mycobacterium tuberculosis  |
|                                        | in Health-Care Facilities,  |
|                                        | 1994* (CDC)                 |
+----------------------------------------+-----------------------------+
| http://www.cdc.gov/                    | *Measles, Mumps, and        |
| epo/mmwr/preview/mmwrhtml/00053391.htm | Rubella \-- Vaccine Use and |
|                                        | Strategies for Elimination  |
|                                        | of Measles, Rubella, and    |
|                                        | Congenital Rubella Syndrome |
|                                        | and Control of Mumps:       |
|                                        | Recommendations of the      |
|                                        | Advisory Committee on       |
|                                        | Immunization Practices      |
|                                        | (ACIP)* (CDC)               |
+----------------------------------------+-----------------------------+
| http://www                             | *Prevention and Control of  |
| .cdc.gov/epo/mmwr/preview/mmwrhtml/top | Meningococcal Disease*      |
|                                        | (CDC)                       |
+----------------------------------------+-----------------------------+
| http://www.o                           | 29 CFR *Respiratory         |
| sha-slc.gov/OshStd_data/1910_0134.html | Protection* (OSHA 1910.134) |
+----------------------------------------+-----------------------------+
| http://www.osha-slc.gov/               | *Enforcement Procedures for |
| OshDoc/Directive_data/CPL_2-2_44D.html | the Occupational Exposure   |
|                                        | to Bloodborne Pathogens*    |
|                                        | (OSHA Directive CPL2-2.44D) |
+----------------------------------------+-----------------------------+
| ht                                     | *Occupational Exposure to   |
| tp://www.osha.gov/oshpubs/osha3130.pdf | Bloodborne Pathogens --     |
|                                        | Precautions for Emergency   |
|                                        | Responders* ((OSHA 3130     |
|                                        | Revised)                    |
+----------------------------------------+-----------------------------+
| #                                      |                             |
|                                        |                             |
| # [[national o                         |                             |
| rganizations]{.underline}]{.smallcaps} |                             |
+----------------------------------------+-----------------------------+
| Association for Professionals in       | Published *APIC Text of     |
| Infection Control                      | Infection Control and       |
|                                        | Epidemiology*               |
| 1275 K. St. N.W., Suite 1000           |                             |
|                                        |                             |
| Washington, D.C. 20005-4006            |                             |
|                                        |                             |
| \(202\) 789-1890                       |                             |
|                                        |                             |
| http://www.apic.org/                   |                             |
+----------------------------------------+-----------------------------+

+----------------------------------------+-----------------------------+
| **AGENCY NOTES**                       |                             |
+----------------------------------------+-----------------------------+
| National Fire Protection Association   | NFPA 1581, *Standard on     |
|                                        | Fire Department Infection   |
| Batterymarch Park                      | Control Program*            |
|                                        |                             |
| Quincy, MA 02269-9904                  |                             |
|                                        |                             |
| \(800\) 344-3555 (to order documents)  |                             |
|                                        |                             |
| http://www.nfpa.org                    |                             |
+----------------------------------------+-----------------------------+
| International Association of           | Develops knowledge within   |
| Firefighters                           | the fire service so         |
|                                        | firefighters, paramedics    |
| Department of Occupational Health &    | and EMT's can recognize and |
| Safety                                 | control the safety and      |
|                                        | health hazards associated   |
| 1750 New York Avenue, N.W.             | with the profession         |
|                                        |                             |
| Washington, D.C. 20006                 |                             |
|                                        |                             |
| \(202\) 737-8484                       |                             |
|                                        |                             |
| http://www.iaff.org                    |                             |
| /iaff/Health_Safety/health_safety.html |                             |
+----------------------------------------+-----------------------------+
| International Association of Fire      | Promotes infection control  |
| Chiefs                                 | policies and practices      |
|                                        |                             |
| 1329 18^th^ St., N.W.                  |                             |
|                                        |                             |
| Washington, D.C. 20036                 |                             |
|                                        |                             |
| \(202\) 833-3420                       |                             |
|                                        |                             |
| http://www.iafc.org/                   |                             |
+----------------------------------------+-----------------------------+
| National Prevention Information        | Formerly AIDS Information   |
| Network                                | Clearinghouse. Distributes  |
|                                        | HIV/AIDS, STD, and TB       |
| P.O. Box 6003                          | information                 |
|                                        |                             |
| Rockville, MD 20850                    |                             |
|                                        |                             |
| 800-458-5231                           |                             |
|                                        |                             |
| h                                      |                             |
| ttp://www.cdc.gov/hiv/hivinfo/npin.htm |                             |
+----------------------------------------+-----------------------------+

[^1]:
    > Swinker, M. (1997). Occupational Infections in Health Care
    > workers: Prevention and intervention. *American Family Physician*,
    > 56 (9), 2291-2303.

[^2]:
    #  U.S. Department of Health and Human Services, Centers for Disease Control. (1997). Immunization of health-care workers: Recommendations of the advisory committee on immunization practices (ACIP) and the hospital infection control practices advisory committee (HICPAC). *Morbidity Mortality Weekly Report*; 46 (RR-18):1-42.

[^3]:
    #  U.S. Department of Health and Human Services, Centers for Disease Control. (2000). Hepatitis C virus infection among firefighters, emergency medical technicians, and paramedics - Selected Locations, United States, 1991\--2000. *Morbidity Mortality Weekly Report*; 49 (29); 660-665.

[^4]:
    #  U.S. Department of Health and Human Services, Centers for Disease Control. (1997). Immunization of health-care workers: Recommendations of the advisory committee on immunization practices (ACIP) and the hospital infection control practices advisory committee (HICPAC). *Morbidity Mortality Weekly Report*; 46 (RR-18):1-42.

[^5]:
    > Brunacini, A. (1985). *Fire command*. National Fire Protection
    > Association; College Park, MD: YBS Productions; p. 244.

[^6]:
    #  American Heart Association. (2000). Guidelines for cardiopulmonary resuscitation and emergency cardiovascular care; Supplement to *Circulation*; 12(8).