CDC Recommendations for Preventing Transmission of Infections Among Chronic Hemo Patients

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April 27, 2001 / 50(RR05);1-43
Recommendations for Preventing Transmission of Infections Among
Chronic Hemodialysis Patients
Terms and Abbreviations Used in This Publication
Acute hepatitis B Newly acquired symptomatic hepatitis B virus (HBV)
infection.
Acute hepatitis C Newly acquired symptomatic hepatitis C virus (HCV)
infection.
ALT Alanine aminotransferase, previously called SGPT.
Anti-HBc Antibody to hepatitis B core antigen.
Anti-HBe Antibody to hepatitis B e antigen.
Anti-HBs Antibody to hepatitis B surface antigen.
Anti-HCV Antibody to hepatitis C virus.
Anti-HDV Antibody to hepatitis D virus.
AST Aspartate aminotransferase, previously called SGOT.
AV Arteriovenous.
Chronic (persistent) HBV infection Persistent infection with HBV;
characterized by detection of HBsAg >6 months after newly acquired
infection.
Chronic (persistent) HCV infection Persistent infection with HCV;
characterized by detection of HCV RNA >6 months after newly acquired
infection.
Chronic hepatitis B Liver inflammation in patients with chronic HBV
infection; characterized by abnormal levels of liver enzymes.
Chronic hepatitis C Liver inflammation in patients with chronic HCV
infection; characterized by abnormal levels of liver enzymes.
CNS Coagulase negative staphylococci.
EIA Enzyme immunoassay.
EPA U.S. Environmental Protection Agency.
ESRD End-stage renal disease.
FDA U.S. Food and Drug Administration.
GISA Glycopeptide-resistant Staphylococcus aureus.
HBcAg Hepatitis B core antigen
HBeAg Hepatitis B e antigen.
HBsAg Hepatitis B surface antigen.
HBV Hepatitis B virus.
HBV DNA Hepatitis B virus deoxyribonucleic acid.
HCV Hepatitis C virus.
HCV RNA Hepatitis C virus ribonucleic acid.
HDV Hepatitis D virus.
HIV Human immunodeficiency virus.
Isolated anti-HBc Anti-HBc positive, HBsAg negative, and anti-HBs
negative.
MRSA Methicillin-resistant Staphylococcus aureus.
NNIS National Nosocomial Infections Surveillance system.
RIBA™ Recombinant immunoblot assay.
RT-PCR Reverse transcriptase polymerase chain reaction.
SGOT Serum glutamic-oxaloacetic transaminase, now called AST.
SGPT Serum glutamic-pyruvic transaminase, now called ALT.
VISA Vancomycin-intermediate Staphylococcus aureus.
VRE Vancomycin-resistant enterococci.

Consultant Meeting to Update Recommendations for the Prevention and
Control of Bloodborne and Other Infections Among Chronic Hemodialysis
Patients
October 5-6, 1999 Atlanta, Georgia
EXPERT CONSULTANTS

James L. Bailey, M.D.
Emory University School of Medicine
Atlanta, Georgia

Paul Balter, M.D.
Everest Health Care
Oakville, Illinois

Jeffrey Berns, M.D.
American Society of Nephrology
Washington, D.C.

Evelyn Butera, M.S.
Satellite Dialysis Center
Redwood City, California

Thomas Depner, M.D.
American Society for Artificial Internal Organs
Boca Raton, Florida

Claudia Douglas
Hackensack University Medical Center
Hackensack, New Jersey

Evelyn Duncan
Everest Health Care
Oakville, Illinois

B.F. Edwards, M.D.
Emory University School of Medicine
Atlanta, Georgia

Martin S. Favero, Ph.D.
Advanced Sterilization Products
Irvine, California

John Foreman, M.D.
American Society of Pediatric Nephrology
Cleveland, Ohio

Michael W. Fried, M.D.
University of North Carolina
Chapel Hill, North Carolina

Vasant Gandhi, M.D.
Vines Veteran's Administration Hospital
Vines, Illinois

Clifford Glynn
National Association of Nephrology Technicians
Dayton, Ohio

Ray Hakim, M.D., Ph.D.
Renal Care Group, Inc.
Nashville Tennessee

Norma Heard
Grady Dialysis Unit
Atlanta, Georgia

J. Michael Lazarus, M.D.
Fresenius Medical Care, NA
Lexington, Massachusetts

Nathan Levin, M.D.
Association for the Advancement of Medical Instrumentation
New York, New York

Paul Light, M.D.
Forum of ESRD Networks
Baltimore, Maryland

Stan Lindenfield, M.D.
Total Renal Care
Torrance, California

Cynthia Marshall
Renal Treatment Center
Atlanta, Georgia

Bela T. Matyas, M.D., M.P.H.
Council of State and Territorial Epidemologists
Atlanta, Georgia

Joseph Mazilli
Hackensack University Medical Center
Hackensack, New Jersey

Barbara McCool, M.S.
U.S. Food and Drug Administration
Rockville, Maryland

Ira Meisels, M.D.
Renal Physicians Association
Rockville, Maryland

Catherine M. Meyers, M.D.
U.S. Food and Drug Administration
Rockville, Maryland

Svetlozar Natov, M.D.
Tufts University School of Medicine
Newton, Massachusetts

Cathy D. Nutter
U.S. Food and Drug Administration
Rockville, Maryland

Stephen Pastan, M.D.
Emory University School of Medicine
Atlanta, Georgia

Eileen Peacock, M.S.N.
Total Renal Care
Maple Glen, Pennsylvania

Jacquelyn Polder, M.P.H.
Health Care Financing Administration
Seattle, Washington

Robert Sharbaugh, Ph.D.
Association for Professionals in Infection Control, Inc.
Charleston, South Carolina

Gayle Shimokura
University of North Carolina
Chapel Hill, North Carolina

James Steinberg, M.D.
Emory University School of Medicine
Atlanta, Georgia

Charlotte Thomas-Hawkins, Ph.D.
American Nephrology Nurses Association
Pitman, New Jersey

Stephen Vas, M.D.
Toronto Western Hospital
Toronto, Ontario, Canada

Brian A.J. Walters, Ph.D.
Gambro Healthcare
Ft Lauderdale, Florida

David J. Weber, M.D.
University of North Carolina-Chapel Hill Medical School
Chapel Hill, North Carolina

Rebecca Wingard, M.S.N.
Renal Care Group, Inc.
Nashville, Tennessee

Jay Wish, M.D.
Forum of ESRD Networks
Cleveland, Ohio

AGENCY LIAISON CONSULTANT

Paul W. Eggers, Ph.D.
Health Care Financing Administration
Baltimore, Maryland

The following CDC staff members prepared this report:

Miriam J. Alter, Ph.D.
Rob L. Lyerla, Ph.D.
Division of Viral and Rickettsial Diseases
National Center for Infectious Diseases

Jerome I. Tokars, M.D., M.P.H.
Elaine R. Miller, M.P.H.
Matthew J. Arduino, M.S., Dr.P.H.
Hospital Infections Program
National Center for Infectious Diseases

in consultation with

Lawrence Y.C. Agodoa, M.D.
National Institute of Diabetes and Digestive and Kidney Diseases
National Institutes of Health

Carolyn Y. Neuland, Ph.D.
Center for Devices and Radiologic Health
U.S. Food and Drug Administration

Summary
These recommendations replace previous recommendations for the
prevention of bloodborne virus infections in hemodialysis centers and
provide additional recommendations for the prevention of bacterial
infections in this setting. The recommendations in this report provide
guidelines for a comprehensive infection control program that includes
a) infection control practices specifically designed for the
hemodialysis setting, including routine serologic testing and
immunization; b) surveillance; and c) training and education.
Implementation of this program in hemodialysis centers will reduce
opportunities for patient-to-patient transmission of infectious
agents, directly or indirectly via contaminated devices, equipment and
supplies, environmental surfaces, or hands of personnel. Based on
available knowledge, these recommendations were developed by CDC after
consultation with staff members from other federal agencies and
specialists in the field who met in Atlanta on October 5--6, 1999.
They are summarized in the Recommendations section. This report is
intended to serve as a resource for health-care professionals, public
health officials, and organizations involved in the care of patients
receiving hemodialysis.

INTRODUCTION
The number of patients with end-stage renal disease treated by
maintenance hemodialysis in the United States has increased sharply
during the past 30 years. In 1999, more than 3,000 hemodialysis
centers had >190,000 chronic hemodialysis patients and >60,000 staff
members (1). Chronic hemodialysis patients are at high risk for
infection because the process of hemodialysis requires vascular access
for prolonged periods. In an environment where multiple patients
receive dialysis concurrently, repeated opportunities exist for
person-to-person transmission of infectious agents, directly or
indirectly via contaminated devices, equipment and supplies,
environmental surfaces, or hands of personnel. Furthermore,
hemodialysis patients are immunosuppressed (2), which increases their
susceptibility to infection, and they require frequent
hospitalizations and surgery, which increases their opportunities for
exposure to nosocomial infections.

Historically, surveillance for infections associated with chronic
hemodialysis focused on viral hepatitis, particularly hepatitis B
virus (HBV) infection. CDC began conducting national surveillance for
hemodialysis-associated hepatitis in 1972 (3,4). Since 1976, this
surveillance has been performed in collaboration with the Health Care
Financing Administration (HCFA) during its annual facility survey.
Other hemodialysisassociated diseases and practices not related to
hepatitis have been included over the years (e.g., pyrogenic
reactions, dialysis dementia, vascular access infections, reuse
practices, vancomycin use), and the system is continually updated to
collect data regarding hemodialysisassociated practices and diseases
of current interest and importance (5--18).

Recommendations for the control of hepatitis B in hemodialysis centers
were first published in 1977 (19), and by 1980, their widespread
implementation was associated with a sharp reduction in incidence of
HBV infection among both patients and staff members (5). In 1982,
hepatitis B vaccination was recommended for all susceptible patients
and staff members (20). However, outbreaks of both HBV and hepatitis C
virus (HCV) infections continue to occur among chronic hemodialysis
patients. Epidemiologic investigations have indicated substantial
deficiencies in recommended infection control practices, as well as a
failure to vaccinate hemodialysis patients against hepatitis B
(21,22). These practices apparently are not being fully implemented
because staff members a) are not aware of the practices and their
importance, b) are confused regarding the differences between standard
(i.e., universal) precautions recommended for all health-care settings
and the additional precautions necessary in the hemodialysis setting,
and c) believe that hepatitis B vaccine is ineffective for preventing
HBV infection in chronic hemodialysis patients (22).

Bacterial infections, especially those involving vascular access, are
the most frequent infectious complication of hemodialysis and a major
cause of morbidity and mortality among hemodialysis patients (1).
During the 1990s, the prevalence of antimicrobial-resistant bacteria
(e.g., methicillin-resistant Staphylococcus aureus [MRSA] and
vancomycin-resistant enterococci [VRE]) increased rapidly in
health-care settings, including hemodialysis units (18,23). Although
numerous outbreaks of bacterial infections in the hemodialysis setting
have been reported (24), few studies exist regarding the epidemiology
and prevention of endemically occurring bacterial infections in
hemodialysis patients, and formal recommendations to prevent such
infections have not been published previously. In 1999, CDC initiated
a surveillance system for bloodstream and vascular access infections
in outpatient hemodialysis centers to determine the frequency of and
risk factors for these complications in order to formulate and
evaluate strategies for control (25).

The recommendations contained in this report were developed by
reviewing available data and are based on consultations with
specialists in the field. These recommendations provide guidelines for
infection control strategies, unique to the hemodialysis setting, that
should be used to prevent patient-to-patient transmission of
bloodborne viruses and pathogenic bacteria. They are summarized on
pages 20--21.

These recommendations do not address sources of bacterial and chemical
contaminants in dialysis systems, water treatment or distribution,
specific procedures for reprocessing dialyzers, clinical practice
methods to prevent bacterial infections (e.g., techniques for skin
preparation and access), or comprehensive strategies for preventing
infections among health-care workers (see Suggested Readings for
information on these topics).

BACKGROUND
Hepatitis B Virus Infection

Epidemiology

Incidence and Prevalence. In 1974, the incidence of newly acquired
(i.e., acute) HBV infection among chronic hemodialysis patients in the
United States was 6.2%, and selected hemodialysis centers reported
rates as high as 30% (4). By 1980, nationwide incidence among patients
had decreased to 1% (5), and by 1999, to 0.06% (18) (CDC, unpublished
data, 2001), with only 3.5% of all centers reporting newly acquired
infections. Prevalence of chronic HBV infection (i.e., hepatitis B
surface antigen [HBsAg] positivity) among hemodialysis patients
declined from 7.8% in 1976 to 3.8% in 1980 and to 0.9% by 1999 (5,18)
(CDC, unpublished data, 2001). In 1999, a total of 27.7% of 3,483
centers provided dialysis to >1 patient with either acute or chronic
HBV infection (CDC, unpublished data, 2001).

Transmission. HBV is transmitted by percutaneous (i.e., puncture
through the skin) or permucosal (i.e., direct contact with mucous
membranes) exposure to infectious blood or to body fluids that contain
blood, and the chronically infected person is central to the
epidemiology of HBV transmission. All HBsAg-positive persons are
infectious, but those who are also positive for hepatitis B e antigen
(HBeAg) circulate HBV at high titers in their blood (108--9
virions/mL) (26,27). With virus titers in blood this high, body fluids
containing serum or blood also can contain high levels of HBV and are
potentially infectious. Furthermore, HBV at titers of 102--3
virions/mL can be present on environmental surfaces in the absence of
any visible blood and still result in transmission (28,29).

HBV is relatively stable in the environment and remains viable for at
least 7 days on environmental surfaces at room temperature (29). HBsAg
has been detected in dialysis centers on clamps, scissors, dialysis
machine control knobs, and doorknobs (30). Thus, blood-contaminated
surfaces that are not routinely cleaned and disinfected represent a
reservoir for HBV transmission. Dialysis staff members can transfer
virus to patients from contaminated surfaces by their hands or gloves
or through use of contaminated equipment and supplies (30).

Most HBV infection outbreaks among hemodialysis patients were caused
by cross-contamination to patients via a) environmental surfaces,
supplies (e.g., hemostats, clamps), or equipment that were not
routinely disinfected after each use; b) multiple dose medication
vials and intravenous solutions that were not used exclusively for one
patient; c) medications for injection that were prepared in areas
adjacent to areas where blood samples were handled; and d) staff
members who simultaneously cared for both HBV-infected and susceptible
patients (21,31--35). Once the factors that promote HBV transmission
among hemodialysis patients were identified, recommendations for
control were published in 1977 (19). These recommendations included a)
serologic surveillance of patients (and staff members) for HBV
infection, including monthly testing of all susceptible patients for
HBsAg; b) isolation of HBsAg-positive patients in a separate room; c)
assignment of staff members to HBsAg-positive patients and not to
HBV-susceptible patients during the same shift; d) assignment of
dialysis equipment to HBsAg-positive patients that is not shared by
HBV-susceptible patients; e) assignment of a supply tray to each
patient (regardless of serologic status); f) cleaning and disinfection
of nondisposable items (e.g., clamps, scissors) before use on another
patient; g) glove use whenever any patient or hemodialysis equipment
is touched and glove changes between each patient (and station); and
h) routine cleaning and disinfection of equipment and environmental
surfaces.

The segregation of HBsAg-positive patients and their equipment from
HBV-susceptible patients resulted in 70%--80% reductions in incidence
of HBV infection among hemodialysis patients (7,36--38). National
surveillance data for 1976--1989 indicated that incidence of HBV
infection was substantially lower in hemodialysis units that isolated
HBsAg-positive patients, compared with those that did not (7,10). The
success of isolation practices in preventing transmission of HBV
infection is linked to other infection control practices, including
routine serological surveillance and routine cleaning and
disinfection. Frequent serologic testing for HBsAg detects patients
recently infected with HBV quickly so isolation procedures can be
implemented before cross-contamination can occur. Environmental
control by routine cleaning and disinfection procedures reduces the
opportunity for cross-contamination, either directly from
environmental surfaces or indirectly by hands of personnel.

Despite the current low incidence of HBV infection among hemodialysis
patients, outbreaks continue to occur in chronic hemodialysis centers.
Investigations of these outbreaks have documented that HBV
transmission resulted from failure to use recommended infection
control practices, including a) failure to routinely screen patients
for HBsAg or routinely review results of testing to identify infected
patients; b) assignment of staff members to the simultaneous care of
infected and susceptible patients; and c) sharing of supplies,
particularly multiple dose medication vials, among patients (21). In
addition, few patients had received hepatitis B vaccine (21). National
surveillance data have demonstrated that independent risk factors
among chronic hemodialysis patients for acquiring HBV infection
include the presence of >1 HBV-infected patient in the hemodialysis
center who is not isolated, as well as a <50% hepatitis B vaccination
rate among patients (15).

HBV infection among chronic hemodialysis patients also has been
associated with hemodialysis provided in the acute-care setting
(21,39). Transmission appeared to stem from chronically infected HBV
patients who shared staff members, multiple dose medication vials, and
other supplies and equipment with susceptible patients. These episodes
were recognized when patients returned to their chronic hemodialysis
units, and routine HBsAg testing was resumed. Transmission from
HBV-infected chronic hemodialysis patients to patients undergoing
hemodialysis for acute renal failure has not been documented, possibly
because these patients are dialyzed for short durations and have
limited exposure. However, such transmission could go unrecognized
because acute renal failure patients are unlikely to be tested for HBV
infection.

Clinical Features and Natural History

HBV causes both acute and chronic hepatitis. The incubation period
ranges from 45--160 days (mean: 120 days), and the onset of acute
disease is usually insidious. Infants, young children (aged <10
years), and immunosuppressed adults with newly acquired HBV infection
are usually asymptomatic (40). When present, clinical symptoms and
signs might include anorexia, malaise, nausea, vomiting, abdominal
pain, and jaundice. Extrahepatic manifestations of disease (e.g., skin
rashes, arthralgias, and arthritis) can also occur (41). The case
fatality rate after acute hepatitis B is 0.5%--1%.

In adults with normal immune status, most (94%--98%) recover
completely from newly acquired HBV infections, eliminating virus from
the blood and producing neutralizing antibody that creates immunity
from future infection (40,42). In immunosuppressed persons (including
hemodialysis patients), infants, and young children, most newly
acquired HBV infections result in chronic infection. Although the
consequences of acute hepatitis B can be severe, most of the serious
sequelae associated with the disease occur in persons in whom chronic
infection develops. Although persons with chronic HBV infection are
often asymptomatic, chronic liver disease develops in two-thirds of
these persons, and approximately 15%--25% die prematurely from
cirrhosis or liver cancer (43--45).

Subtypes of HBV exist, and infection or immunization with one subtype
confers immunity to all subtypes. However, reinfection or reactivation
of latent HBV infection has been reported among certain groups of
immunosuppressed patients, including those who have undergone renal
transplant and those infected with human immunodeficiency virus (HIV)
(46,47). These patients were positive for antibody to hepatitis B core
antigen (anti-HBc), with or without antibody to HBsAg (anti-HBs), and
subsequently developed detectable levels of HBsAg. The frequency with
which this occurs is unknown.

Monotherapy with alpha interferon or lamivudine is approved by the
U.S. Food and Drug Administration (FDA) to treat patients with chronic
hepatitis B (48,49). Although the dosage of lamivudine should be
modified based on creatinine clearance in patients with renal
impairment, no additional dose modification is necessary after routine
hemodialysis. The emergence of lamivudine-resistant variants has
caused concern regarding long-term use of this drug.

Screening and Diagnostic Tests

Serologic Assays. Several well-defined antigen-antibody systems are
associated with HBV infection, including HBsAg and anti-HBs; hepatitis
B core antigen (HBcAg) and anti-HBc; and HBeAg and antibody to HBeAg
(anti-HBe). Serologic assays are commercially available for all of
these except HBcAg because no free HBcAg circulates in blood. One or
more of these serologic markers are present during different phases of
HBV infection (Table 1) (42).

The presence of HBsAg is indicative of ongoing HBV infection and
potential infectiousness. In newly infected persons, HBsAg is present
in serum 30--60 days after exposure to HBV and persists for variable
periods. Transient HBsAg positivity (lasting <18 days) can be detected
in some patients during vaccination (50,51). Anti-HBc develops in all
HBV infections, appearing at onset of symptoms or liver test
abnormalities in acute HBV infection, rising rapidly to high levels,
and persisting for life. Acute or recently acquired infection can be
distinguished by presence of the immunoglobulin M (IgM) class of
anti-HBc, which persists for approximately 6 months.

In persons who recover from HBV infection, HBsAg is eliminated from
the blood, usually in 2--3 months, and anti-HBs develops during
convalescence. The presence of anti-HBs indicates immunity from HBV
infection. After recovery from natural infection, most persons will be
positive for both anti-HBs and anti-HBc, whereas only anti-HBs
develops in persons who are successfully vaccinated against hepatitis
B. Persons who do not recover from HBV infection and become
chronically infected remain positive for HBsAg (and anti-HBc),
although a small proportion (0.3% per year) eventually clear HBsAg and
might develop anti-HBs (45).

In some persons, the only HBV serologic marker detected is anti-HBc
(i.e., isolated anti-HBc). Among most asymptomatic persons in the
United States tested for HBV infection, an average of 2% (range:
<0.1%--6%) test positive for isolated anti-HBc (52); among
injecting-drug users, however, the rate is 24% (53). In general, the
frequency of isolated anti-HBc is directly related to the frequency of
previous HBV infection in the population and can have several
explanations. This pattern can occur after HBV infection among persons
who have recovered but whose anti-HBs levels have waned or among
persons who failed to develop anti-HBs. Persons in the latter category
include those who circulate HBsAg at levels not detectable by current
commercial assays. However, HBV DNA has been detected in <10% of
persons with isolated anti-HBc, and these persons are unlikely to be
infectious to others except under unusual circumstances involving
direct percutaneous exposure to large quantities of blood (e.g.,
transfusion) (54). In most persons with isolated anti-HBc, the result
appears to be a false positive. Data from several studies have
demonstrated that a primary anti-HBs response develops in most of
these persons after a three-dose series of hepatitis B vaccine
(55,56). No data exist on response to vaccination among hemodialysis
patients with this serologic pattern.

A third antigen, HBeAg, can be detected in serum of persons with acute
or chronic HBV infection. The presence of HBeAg correlates with viral
replication and high levels of virus (i.e., high infectivity).
Anti-HBe correlates with the loss of replicating virus and with lower
levels of virus. However, all HBsAg-positive persons should be
considered potentially infectious, regardless of their HBeAg or
anti-HBe status.

Nucleic Acid Detection. HBV infection can be detected using
qualitative or quantitative tests for HBV DNA. These tests are not
FDA-approved and are most commonly used for patients being managed
with antiviral therapy (49,57).

Hepatitis B Vaccine

Hepatitis B vaccine has been recommended for both hemodialysis
patients and staff members since the vaccine became available in 1982
(20). By 1999, a total of 55% of patients and 88% of staff members had
been vaccinated (18) (CDC, unpublished data, 2001). Two types of
vaccine have been licensed and used in the United States:
plasma-derived and recombinant. Plasma-derived vaccine is no longer
available in the United States, but is produced in several countries
and used in many immunization programs worldwide. Recombinant vaccines
available in the United States are Recombivax HB&#8482; (Merck &
Company, Inc., West Point, Pennsylvania) and Engerix-B® (SmithKline
Beecham Biologicals, Philadelphia, Pennsylvania). Recombivax HB&#8482;
contains 10--40 µg of HBsAg protein per mL, whereas Engerix-B®
contains 20 µg/mL.

Primary vaccination comprises three intramuscular doses of vaccine,
with the second and third doses given 1 and 6 months, respectively,
after the first. An alternative schedule of four doses given at 0, 1,
2, and 12 months to persons with normal immune status or at 0, 1, 2,
and 6 months to hemodialysis patients has been approved for
Engerix-B®.

Immunogenicity. The recommended primary series of hepatitis B vaccine
induces a protective anti-HBs response (defined as >10
milli-International Units [mIU]/mL) in 90%--95% of adults with normal
immune status. The major determinant of vaccine response is age, with
the proportion of persons developing a protective antibody response
declining to 84% among adults aged >40 years and to 75% by age 60
years (58,59). Other host factors that contribute to decreased
immunogenicity include smoking, obesity, and immune suppression.
Compared with adults with normal immune status, the proportion of
hemodialysis patients who develop a protective antibody response after
vaccination (with higher dosages) is lower. For those who receive the
three-dose schedule, the median is 64% (range: 34%--88%) (60--65), and
for those who receive the four-dose schedule, the median is 86%
(range: 40%--98%) (66--72). Limited data indicate that concurrent
infection with HCV does not interfere with development of protective
levels of antibody after vaccination, although lower titers of
anti-HBs have been reported after vaccination of HCV-positive patients
compared with HCV-negative patients (65,73--75).

Some studies have demonstrated that higher antibody response rates
could be achieved by vaccinating patients with chronic renal failure
before they become dialysis dependent, particularly patients with mild
or moderate renal failure. After vaccination with four 20 µg doses of
recombinant vaccine, a protective antibody response developed in 86%
of predialysis adult patients with serum creatinine levels <4.0 mg/dl
(mean: 2.0 mg/dl) compared with 37% of those with serum creatinine
levels >4.0 mg/dl (mean: 9.5 mg/dl), only 12% of whom were predialysis
patients (76). In an earlier study, a lower response to recombinant
vaccine among predialysis patients was reported, possibly because
patients with more severe renal failure were included (77,78).

Although no data exist on the response of pediatric hemodialysis
patients to vaccination with standard pediatric doses, 75%--97% of
those who received higher dosages (20 µg) on either the three- or
four-dose schedule developed protective levels of anti-HBs (79--81).
In the one study that evaluated vaccine response among children with
chronic renal failure before they became dialysis dependent, high
response rates were achieved after four-20 µg doses in both
predialysis and dialysis-dependent patients, although predialysis
patients had higher peak antibody titers (82).

Vaccine Efficacy. For persons with normal immune status, controlled
clinical trials have demonstrated that protection from acute and
chronic HBV infection is virtually complete among those who develop a
protective antibody response after vaccination (83,84). Among
hemodialysis patients, controlled clinical trials conducted in other
countries demonstrated efficacy of 53%--78% after preexposure
immunization (85,86). However, no efficacy was demonstrated in the one
trial performed in the United States (62). When the latter trial was
designed, the sample size was calculated based on an annual incidence
rate among susceptible patients of 13.8% (i.e., the rate observed
during 1976--1979, the period before the start of the trial). However,
by the time the trial was conducted, the incidence rate had declined
by >60%, and the sample size was inadequate for detecting a difference
in infection rates between vaccinated and placebo groups. Although
efficacy was not demonstrated in this study, no infections occurred
among persons who developed and maintained protective levels of
anti-HBs.

Furthermore, since the hepatitis B vaccine became available, no HBV
infections have been reported among vaccinated hemodialysis patients
who maintained protective levels of anti-HBs. This observation has
been particularly striking during HBV infection outbreaks in this
setting (21). In addition, a case-control study indicated that the
risk for HBV infection was 70% lower among hemodialysis patients who
had been vaccinated (87). Thus, most hemodialysis patients can be
protected from hepatitis B by vaccination, and maintaining immunity
among these patients reduces the frequency and costs of serologic
screening (88).

Revaccination of Nonresponders. Among persons who do not respond to
the primary three-dose series of hepatitis B vaccine, 25%--50% of
those with normal immune status respond to one additional vaccine
dose, and 50%--75% respond to three additional doses (59,84). A
revaccination regimen that includes serologic testing after one or two
additional doses of vaccine appears to be no more cost-effective than
serologic testing performed after all three additional doses (89). For
persons found to be nonresponders after six doses of vaccine, no data
exist to indicate that additional doses would induce an antibody
response. Few studies have been conducted of the effect of
revaccination among hemodialysis patients who do not respond to the
primary vaccine series. Response rates to revaccination varied from
40%--50% after two or three additional 40 µg intramuscular doses to
64% after four additional 10 µg intramuscular doses (69,70,90--94).

Antibody Persistence. Among adults with normal immune status who
responded to a primary vaccine series with a protective antibody
level, antibody remained above protective levels in 40%--87% of
persons after 9--15 years (95--98). Only short-term data are available
for hemodialysis patients. Among adults who responded to the primary
vaccination series, antibody remained detectable for 6 months in
80%--100% (median: 100%) of persons and for 12 months in 58%--100%
(median: 70%) (61,64--69,71,85,99--103). Among successfully immunized
hemodialysis patients whose antibody titers subsequently declined
below protective levels, limited data indicate that virtually all
respond to a booster dose (75).

Duration of Vaccine-Induced Immunity. Among persons with normal immune
status who respond to the primary series of hepatitis B vaccine,
protection against hepatitis B persists even when antibody titers
become undetectable (97). However, among hemodialysis patients who
respond to the vaccine, protection against hepatitis B is not
maintained when antibody titers fall below protective levels. In the
U.S. vaccine efficacy trial, three hemodialysis patients who responded
to the primary vaccination series developed HBV infection (62). One
had received a kidney transplant 6 months before onset of infection,
and anti-HBs had declined to borderline protective levels in the other
two persons. In all three patients, infection resolved.

Alternative Routes of Administration. Among adults with normal immune
status, intradermal administration of low doses of hepatitis B vaccine
results in lower seroconversion rates (55%--81%) (104--106), and no
data exist on long-term protection from this route of administration.
Among infants and children, intradermal vaccination results in poor
immunogenicity. Data are insufficient to evaluate alternative routes
(e.g., intradermal) for vaccination among hemodialysis patients.

Hepatitis C Virus Infection

Epidemiology

Incidence and Prevalence. Data are limited on incidence of HCV
infection among chronic hemodialysis patients. During 1982--1997, the
incidence of non-A, non-B hepatitis among patients reported to CDC's
national surveillance system decreased from 1.7% to 0.2% (18). The
validity of these rates is uncertain because of inherent difficulties
in diagnosing non-A, non-B hepatitis and probable variability in the
application of diagnostic criteria by different dialysis centers.
However, the downward trend can partially be explained by a decline in
the rate of transfusion-associated disease after 1985 (107,108).

Since 1990, limited data from U.S. studies using testing for antibody
to HCV (anti-HCV) to evaluate the incidence of HCV infection have
reported annual rates of 0.73%--3% among hemodialysis patients
(109,110). None of the patients who seroconverted had received
transfusions in the interim or were injecting-drug users.

During 1992--1999, national surveillance data indicated that the
proportion of centers that tested patients for anti-HCV increased from
22% to 56% (18) (CDC, unpublished data, 2001). In 1999, nationwide
prevalence of anti-HCV was 8.9%, with some centers reporting
prevalences >40% (CDC, unpublished data, 2001). Other studies of
hemodialysis patients in the United States have reported anti-HCV
prevalences of 10%--36% among adults (109,111,112) and 18.5% among
children (113).

Transmission. HCV is most efficiently transmitted by direct
percutaneous exposure to infectious blood, and like HBV, the
chronically infected person is central to the epidemiology of HCV
transmission. Risk factors associated with HCV infection among
hemodialysis patients include history of blood transfusions, the
volume of blood transfused, and years on dialysis (114). The number of
years on dialysis is the major risk factor independently associated
with higher rates of HCV infection. As the time patients spent on
dialysis increased, their prevalence of HCV infection increased from
an average of 12% for patients receiving dialysis <5 years to an
average of 37% for patients receiving dialysis >5 years (109,112,115).

These studies, as well as investigations of dialysis-associated
outbreaks of hepatitis C, indicate that HCV transmission most likely
occurs because of inadequate infection control practices. During
1999--2000, CDC investigated three outbreaks of HCV infection among
patients in chronic hemodialysis centers (CDC, unpublished data, 1999
and 2000). In two of the outbreaks, multiple transmissions of HCV
occurred during periods of 16--24 months (attack rates: 6.6%--17.5%),
and seroconversions were associated with receiving dialysis
immediately after a chronically infected patient. Multiple
opportunities for cross-contamination among patients were observed,
including a) equipment and supplies that were not disinfected between
patient use; b) use of common medication carts to prepare and
distribute medications at patients' stations; c) sharing of multiple
dose medication vials, which were placed at patients' stations on top
of hemodialysis machines; d) contaminated priming buckets that were
not routinely changed or cleaned and disinfected between patients; e)
machine surfaces that were not routinely cleaned and disinfected
between patients; and f) blood spills that were not cleaned up
promptly. In the third outbreak, multiple new infections clustered at
one point in time (attack rate: 27%), suggesting a common exposure
event. Although the specific results of this investigation are
pending, multiple opportunities for cross-contamination from
chronically infected patients also were observed in this unit. In
particular, supply carts were moved from one station to another and
contained both clean supplies and blood-contaminated items, including
small biohazard containers, sharps disposal boxes, and used
vacutainers containing patients' blood.

Clinical Features and Natural History

HCV causes both acute and chronic hepatitis. The incubation period
ranges from 14--180 days (average: 6--7 weeks) (116). Persons with
newly acquired (acute) HCV infection typically are either asymptomatic
or have a mild clinical illness. The course of acute hepatitis C is
variable, although elevations in serum alanine aminotransferase (ALT)
levels, often in a fluctuating pattern, are the most characteristic
feature. Fulminant hepatic failure after acute hepatitis C is rare.

Most (average: 94%) hemodialysis patients with newly acquired HCV
infection have elevated serum ALT levels (117--121). Elevations in
serum ALT levels often precede anti-HCV seroconversion. Among
prospectively followed transfusion recipients who developed acute HCV
infection, elevated ALT levels preceded anti-HCV seroconversion (as
measured by second generation assays) in 59%, and anti-HCV was
detectable in most patients (78%) within 5 weeks after their first ALT
elevation (122). However, elevations in ALT or aspartate
aminotransferase (AST) levels can occur that are not related to viral
hepatitis, and compared with ALT, AST is a less specific indicator of
HCV-related liver disease among hemodialysis patients. In a recent
outbreak investigation, only 28% of 25 hemodialysis patients with
newly observed elevations in AST levels tested anti-HCV positive (CDC,
unpublished data, 1999).

After acute HCV infection, 15%--25% of persons with normal immune
status appear to resolve their infection without sequelae as defined
by sustained absence of HCV RNA in serum and normalization of ALT
(123). In some persons, ALT levels normalize, suggesting full
recovery, but this is frequently followed by ALT elevations that
indicate progression to chronic disease. Chronic HCV infection
develops in most infected persons (75%--85%). Of persons with chronic
HCV infection, 60%--70% have persistent or fluctuating ALT elevations,
indicating active liver disease (123). Although similar rates of
chronic liver disease have been observed among HCV-infected chronic
hemodialysis patients (based on liver biopsy results), these patients
might be less likely to have biochemical evidence of active liver
disease (124). In seroprevalence studies of chronic hemodialysis
patients, ALT elevations were reported in a median of 33.9% (range:
6%--73%) of patients who tested positive for anti-HCV (117,124--136).

No clinical or epidemiologic features among patients with acute
infection have been reported to be predictive of either persistent
infection or chronic liver disease. Most studies have reported that
cirrhosis develops in 10%--20% of persons who have had chronic
hepatitis C for 20--30 years, and hepatocellular carcinoma in 1%--5%
(123). Extrahepatic manifestations of chronic HCV infection are
considered to be of immunologic origin and include cryoglobulinemia,
membranoproliferative glomerulonephritis, and porphyria cutanea tarda
(137).

At least six different genotypes and >90 subtypes of HCV exist, with
genotype 1 being the most common in the United States (138,139).
Unlike HBV, infection with one HCV genotype or subtype does not
protect against reinfection or superinfection with other HCV strains
(139).

Alpha interferon alone or in combination with ribavirin is
FDA-approved for the treatment of chronic hepatitis C (48,140,141).
Combination therapy should be used with caution in patients with
creatinine clearance <50 mL/minute and generally is contraindicated in
patients with renal failure (141,142). Interferon monotherapy results
in low sustained virologic response rates (141,142).

Screening and Diagnostic Tests

Serologic Assays. The only FDA-approved tests for diagnosis of HCV
infection are those that measure anti-HCV and include enzyme
immunoassays (EIAs) and a supplemental recombinant immunoblot assay
(RIBA&#8482;) (116). These tests detect anti-HCV in >97% of infected
persons, but do not distinguish between acute, chronic, or resolved
infection. The average time from exposure to seroconversion is 8--9
weeks (122). Anti-HCV can be detected in 80% of patients within 15
weeks after exposure, in >90% within 5 months, and in >97% within 6
months (122,143). In rare instances, seroconversion can be delayed
until 9 months after exposure (143,144). Anti-HCV persists
indefinitely in most persons, but does not protect against
reinfection.

As with any screening test, the positive predictive value of EIAs for
anti-HCV is directly related to the prevalence of infection in the
population and is low in populations with an HCV-infection prevalence
<10% (145,146). Supplemental testing with a more specific assay (i.e.,
RIBA&#8482;) of a specimen with a positive anti-HCV result by EIA
prevents reporting of false-positive results, particularly in settings
where asymptomatic persons are being tested. Results of seroprevalence
studies among chronic hemodialysis patients have indicated that
57%--100% of EIA positive results were RIBA&#8482; positive
(124,126,128,133,135,147--152), and 53%--100% were HCV RNA positive by
reverse transcriptase polymerase chain reaction (RT-PCR) testing
(117,127,129,134,135).

Nucleic Acid Detection. The diagnosis of HCV infection also can be
made by qualitatively detecting HCV RNA using gene amplification
techniques (e.g., RT-PCR) (116). HCV RNA can be detected in serum or
plasma within 1--2 weeks after exposure and weeks before onset of ALT
elevations or the appearance of anti-HCV. In rare instances, detection
of HCV RNA might be the only evidence of HCV infection. Although a
median of 3.4% (range: 0%--28%) of chronic hemodialysis patients who
tested anti-HCV negative were HCV RNA positive, this might be an
overestimate because follow-up samples to detect possible antibody
seroconversions were not obtained on these patients
(117,118,126--128,130,131,133,134,148--154).

Although not FDA-approved, RT-PCR assays for HCV infection are used
commonly in clinical practice and are commercially available. Most
RT-PCR assays have a lower limit of detection of 100--1,000 viral
genome copies per mL. With adequate optimization of RT-PCR assays,
75%--85% of persons who are positive for anti-HCV and >95% of persons
with acute or chronic hepatitis C will test positive for HCV RNA. Some
HCV-infected persons might be only intermittently HCV RNA positive,
particularly those with acute hepatitis C or with end-stage liver
disease caused by hepatitis C. To minimize false-negative results,
blood samples collected for RT-PCR should not contain heparin, and
serum must be separated from cellular components within 2--4 hours
after collection and preferably stored frozen at -20 C or -70 C (155).
If shipping is required, frozen samples should be protected from
thawing. Because of assay variability, rigorous quality assurance and
control should be in place in clinical laboratories performing this
assay, and proficiency testing is recommended.

Quantitative assays for measuring the concentration (i.e., titer) of
HCV RNA have been developed and are available from commercial
laboratories (156). These assays also are not FDA-approved and are
less sensitive than qualitative RT-PCR assays (157). Quantitative
assays should not be used as a primary test to confirm or exclude the
diagnosis of HCV infection or to monitor the endpoint of treatment,
and sequential measurement of HCV RNA levels has not proven useful in
managing patients with hepatitis C.

Other Bloodborne Viruses

Hepatitis Delta Virus Infection

Delta hepatitis is caused by the hepatitis delta virus (HDV), a
defective virus that causes infection only in persons with active HBV
infection. The prevalence of HDV infection is low in the United
States, with rates of <1% among HBsAg-positive persons in the general
population and >10% among HBsAg-positive persons with repeated
percutaneous exposures (e.g., injecting-drug users, persons with
hemophilia) (158). Areas of the world with high endemic rates of HDV
infection include southern Italy, parts of Africa, and the Amazon
Basin.

Few data exist on the prevalence of HDV infection among chronic
hemodialysis patients, and only one transmission of HDV between such
patients has been reported in the United States (159). In this
episode, transmission occurred from a patient who was chronically
infected with HBV and HDV to an HBsAg-positive patient after a massive
bleeding incident; both patients received dialysis at the same
station.

HDV infection occurs either as a co-infection with HBV or as a
superinfection in a person with chronic HBV infection. Co-infection
usually resolves, but superinfection frequently results in chronic HDV
infection and severe disease. High mortality rates are associated with
both types of infection. A serologic test that measures total antibody
to HDV (anti-HDV) is commercially available.

Human Immunodeficiency Virus Infection

During 1985--1999, the percentage of U.S. hemodialysis centers that
reported providing chronic hemodialysis for patients with HIV
infection increased from 11% to 39%, and the proportion of
hemodialysis patients with known HIV infection increased from 0.3% to
1.4% (18) (CDC, unpublished data, 2001).

HIV is transmitted by blood and other body fluids that contain blood.
No patient-to-patient transmission of HIV has been reported in U.S.
hemodialysis centers. However, such transmission has been reported in
other countries; in one case, HIV transmission was attributed to
mixing of reused access needles and inadequate disinfection of
equipment (160).

HIV infection is usually diagnosed with assays that measure antibody
to HIV, and a repeatedly positive EIA test should be confirmed by
Western blot or another confirmatory test. Antiretroviral therapies
for HIV-infected hemodialysis patients are commonly used and appear to
be improving survival rates among this population. However,
hepatotoxicity associated with certain protease inhibitors might limit
the use of these drugs, especially in patients with underlying liver
dysfunction (161).

Bacterial Infections

Epidemiology

Disease Burden. The annual mortality rate among hemodialysis patients
is 23%, and infections are the second most common cause, accounting
for 15% of deaths (1). Septicemia (10.9% of all deaths) is the most
common infectious cause of mortality. In various studies evaluating
rates of bacterial infections in hemodialysis outpatients, bacteremia
occurred in 0.63%--1.7% of patients per month and vascular access
infections (with or without bacteremia) in 1.3%--7.2% of patients per
month (162--170). National surveillance data indicated that 4%--5% of
patients received intravenous vancomycin during a 1-month period (and
additional patients received other antimicrobials) (18). Although data
on vancomycin use can be used to derive an estimate of the prevalence
of suspected infections, the proportion of patients receiving
antimicrobials who would fit a formal case definition for bacterial
infection is unknown.

Infection Sites. In a study of 27 French hemodialysis centers, 28% of
230 infections in hemodialysis patients involved the vascular access,
whereas 25% involved the lung, 23% the urinary tract, 9% the skin and
soft tissues, and 15% other or unknown sites (165). Thirty-three
percent of infections involved either the vascular access site or were
bacteremias of unknown origin, many of which might have been caused by
occult access infections. Thus, the vascular access site was the most
common site for infection, but accounted for only one-third of
infections. However, access site infections are particularly important
because they can cause disseminated bacteremia or loss of the vascular
access.

Vascular Access Infections. Vascular access infections are caused (in
descending order of frequency) by S. aureus, coagulase-negative
staphylococci (CNS), gram-negative bacilli, nonstaphylococcal
gram-positive cocci (including enterococci), and fungi (171). The
proportion of infections caused by CNS is higher among patients
dialyzed through catheters than among patients dialyzed through
fistulas or grafts.

The primary risk factor for access infection is access type, with
catheters having the highest risk for infection, grafts intermediate,
and native arteriovenous (AV) fistulas the lowest (168). Other
potential risk factors for vascular access infections include a)
location of the access in the lower extremity; b) recent access
surgery; c) trauma, hematoma, dermatitis, or scratching over the
access site; d) poor patient hygiene; e) poor needle insertion
technique; f) older age; g) diabetes; h) immunosuppression; and i)
iron overload (164,167,172--175).

Transmission. Bacterial pathogens causing infection can be either
exogenous (i.e, acquired from contaminated dialysis fluids or
equipment) or endogenous (i.e., caused by invasion of bacteria present
in or on the patient). Exogenous pathogens have caused numerous
outbreaks, most of which resulted from inadequate dialyzer
reprocessing procedures (e.g., contaminated water or inadequate
disinfectant) or inadequate treatment of municipal water for use in
dialysis. During 1995--1997, four outbreaks were traced to
contamination of the waste drain port on one type of dialysis machine
(176). Recommendations to prevent such outbreaks are published
elsewhere (171).

Contaminated medication vials also are a potential source of bacterial
infection for patients. In 1999, an outbreak of Serratia liquefaciens
bloodstream infections and pyrogenic reactions among hemodialysis
patients was traced to contamination of vials of erythropoietin. These
vials, which were intended for single use, were contaminated by
repeated puncture to obtain additional doses and by pooling of
residual medication into a common vial (177).

Endogenous pathogens first colonize the patient and later cause
infection. Colonization means that microorganisms have become resident
in or on the body (e.g., in the nares or stool); a culture from the
site is positive, but no symptoms or signs of infection exist.
Colonization with potentially pathogenic microorganisms, often unknown
to staff members, is common in patients with frequent exposure to
hospitals and other health-care settings. Colonization most often
occurs when microorganisms are transmitted from a colonized or
infected source patient to another patient on the hands of health-care
workers who do not comply with infection control precautions. Less
commonly, contamination of environmental surfaces (e.g., bed rails,
countertops) plays a role (178).

Infection occurs when microorganisms invade the body, damaging tissue
and causing signs or symptoms of infection, and is aided by invasive
devices (e.g., the hemodialysis vascular access). Evidence exists that
when prevalence of colonization in a population is less frequent,
infection in that population will also be less frequent, and infection
control recommendations for hemodialysis units are designed to prevent
colonization (179). Additional measures designed to prevent infection
from colonizing organisms (e.g., using aseptic technique during
vascular access) are presented elsewhere (180).

Antimicrobial Resistance

Antimicrobial-resistant bacteria are more common in patients with
severe illness, who often have had multiple hospitalizations or
surgical procedures, and in those who have received prolonged courses
of antimicrobial agents. In health-care settings, including
hemodialysis centers, such patients can serve as a source for
transmission.

Clinically important drug-resistant bacteria that commonly cause
health-care--associated infections include MRSA, methicillin-resistant
CNS, VRE, and multidrug-resistant gram negative rods, including
strains of Pseudomonas aeruginosa, Stenotrophomonas maltophilia, and
Acinetobacter species, some of which are resistant to all available
antimicrobials. In addition, strains of S. aureus with intermediate
resistance to vancomycin and other glycopeptide antibiotics have
recently been reported; these strains are called
vancomycin-intermediate S. aureus (VISA) or glycopeptide-intermediate
S. aureus (GISA) (181,182). Intermediate resistance to vancomycin is
reported even more frequently among CNS (183,184).

Hemodialysis patients have played a prominent role in the epidemic of
vancomycin resistance. In 1988, a renal unit in London, England,
reported one of the first cases of VRE (185). In three studies,
12%--22% of hospitalized patients infected or colonized with VRE were
receiving hemodialysis (178,186,187). Furthermore, three of the first
five patients identified with VISA (or GISA) were on chronic
hemodialysis, and one had received acute dialysis (182).

Prevalence of VRE has increased rapidly at U.S. hospitals; among
intensive care unit patients with nosocomial infections reported to
the National Nosocomial Infections Surveillance (NNIS) system, the
percentage of enterococcal isolates resistant to vancomycin increased
from 0.5% in 1989 to 25.2% in 1999 (23) (CDC, unpublished data, 2000).
This increase is attributable to patient-to-patient transmission in
health-care settings and transmission of resistant genes among
previously susceptible enterococci. Once vancomycin resistance has
been transferred to a patient, antimicrobials select for resistant
organisms, causing them to increase in number relative to susceptible
organisms. Prevalence of VRE colonization among patients varies in
different health-care settings; in hemodialysis centers, the reported
prevalence in stool samples ranged from 1% to 9% (188,189). In one
center with a prevalence of 9%, three patients developed VRE
infections in 1 year (188).

Vancomycin Use

Dialysis patients have played a prominent role in the epidemic of
vancomycin resistance because this drug is used commonly in these
patients, in part because vancomycin can be conveniently administered
to patients when they come in for hemodialysis treatments. However,
two studies indicate that cefazolin, a first-generation cephalosporin,
could be substituted for vancomycin in many patients (190,191). One of
these studies reported that many pathogens causing infections in
hemodialysis patients are susceptible to cefazolin (190), and both
studies reported therapeutic cefazolin blood levels 48--72 hours after
dosing, making in-center administration three times a week after
dialysis feasible.

Equipment, Supplies, and Environmental Surfaces

The hemodialysis machine and its components also can be vehicles for
patient-to-patient transmission of bloodborne viruses and pathogenic
bacteria (24,192). The external surfaces of the machine are the most
likely sources for contamination. These include not only frequently
touched surfaces (e.g., the control panel), but also attached waste
containers used during the priming of the dialyzers, blood tubing
draped or clipped to waste containers, and items placed on tops of
machines for convenience (e.g., dialyzer caps and medication vials).

Sterilization, Disinfection, and Cleaning

A sterilization procedure kills all microorganisms, including highly
resistant bacterial spores (24). Sterilization procedures are most
commonly accomplished by steam or ethylene oxide gas. For products
that are heat sensitive, an FDA-cleared liquid chemical sterilant can
be used with a long exposure time (i.e., 3--10 hours).

High-level disinfection kills all viruses and bacteria, but not high
numbers of bacterial spores. High-level disinfection can be
accomplished by heat pasteurization or, more commonly, by an
FDA-cleared chemical sterilant, with an exposure time of 12--45
minutes. Sterilants and high-level disinfectants are designed to be
used on medical devices, not environmental surfaces.
Intermediate-level disinfection kills bacteria and most viruses and is
accomplished by using a tuberculocidal "hospital disinfectant" (a term
used by the U.S. Environmental Protection Agency [EPA] in registering
germicides) or a 1:100 dilution of bleach (300--600 mg/L free
chlorine). Low-level disinfection kills most bacteria and is
accomplished by using general purpose disinfectants. Intermediate and
low-level disinfectants are designed to be used on environmental
surfaces; they also can be used on noncritical medical devices,
depending on the design and labeling claim.

Cleaning eliminates dirt and some bacteria and viruses and is
accomplished by using a detergent or detergent germicide. Antiseptics
(e.g., formulations with povidone-iodine, hexachlorophene, or
chlorhexidene) are designed for use on skin and tissue and should not
be used on medical equipment or environmental surfaces.

Regardless of the procedure used, cleaning with a germicidal detergent
before disinfection (or sterilization) is essential to remove organic
material (e.g., blood, mucous, or feces), dirt, or debris. The
presence of such material protects microorganisms from the
sterilization or disinfection process by physically blocking or
inactivating the disinfectant or sterilant.

The choice of what procedure or which chemical germicide to use for
medical devices, instruments, and environmental surfaces depends on
several factors, including the need to maintain the structural
integrity and function of the item and how the item will be used.
Three general categories of use for medical items are recognized, each
of which require different levels of sterilization or disinfection
(193). These categories are a) critical, which includes items
introduced directly into the bloodstream or normally sterile areas of
the body (e.g., needles, catheters, hemodialyzers, blood tubing); b)
semicritical, which includes equipment that comes in contact with
intact mucous membranes (e.g., fiberoptic endoscopes, glass
thermometers); and c) noncritical, which includes equipment that
touches only intact skin (e.g., blood pressure cuffs). Semicritical
items are not generally used in dialysis units.

Internal Pathways of Hemodialysis Machines. In single-pass
hemodialysis machines, the internal fluid pathways are not subject to
contamination with blood. If a dialyzer leak occurs, dialysis fluid
might become contaminated with blood, but this contaminated fluid is
discarded through a drain and does not return to the dialysis machine
to contaminate predialyzer surfaces. For dialysis machines that use a
dialysate recirculating system (e.g., some ultrafiltration control
machines and those that regenerate the dialysate), a blood leak in a
dialyzer could contaminate the internal pathways of the machine, which
could in turn contaminate the dialysis fluid of subsequent patients
(192). However, procedures normally practiced after each use (i.e.,
draining the dialysis fluid and rinsing and disinfecting the machine)
will reduce the level of contamination to below infectious levels. In
addition, an intact dialyzer membrane will not allow passage of
bacteria or viruses (24).

Pressure transducer filter protectors are used primarily to prevent
contamination and preserve the functioning of the pressure monitoring
(i.e., arterial, venous, or both) components of the hemodialysis
machine. Hemodialysis machines usually have both external (typically
supplied with the blood tubing set) and internal protectors, with the
internal protector serving as a backup in case the external transducer
protector fails. Failure to use an external protector or to replace
the protector when it becomes contaminated (i.e., wetted with saline
or blood) can result in contamination of the internal transducer
protector, which in turn could allow transmission of bloodborne
pathogens (24). However, no epidemiologic evidence exists that
contamination of the internal transducer protector caused by failure
of the external transducer protector has led to either mixing of blood
or the transmission of bloodborne agents.

Dialyzer Reprocessing. Approximately 80% of U.S. chronic hemodialysis
centers reprocess (i.e., reuse) dialyzers for the same patient (18),
and guidelines for reprocessing have been published elsewhere (see
Suggested Readings). Although outbreaks of bacterial infections and
pyrogenic reactions have occurred because of inadequate reprocessing
procedures and failure to maintain standards for water quality, reuse
has not been associated with transmission of bloodborne viruses. Any
theoretical risk for HBV transmission from reuse of dialyzers would
primarily affect staff members who handle these dialyzers. Although no
increase in HBV (or HCV) infection among staff members who work in
such centers has been reported, many centers do not reuse dialyzers
from HBsAg-positive patients (24).

Infection Control Precautions for Outpatient Hemodialysis Settings
Compared with Inpatient Hospital Settings

Contact transmission is the most important route by which pathogens
are transmitted in health-care settings, including hemodialysis units.
Contact transmission occurs most commonly when microorganisms from a
patient are transferred to the hands of a health-care worker who does
not comply with infection control precautions, then touches another
patient. Less commonly, environmental surfaces (e.g., bed rails,
countertops) become contaminated and serve as an intermediate
reservoir for pathogens; transmission can occur when a worker touches
the surface then touches a patient or when a patient touches the
surface.

In the hemodialysis setting, contact transmission plays a major role
in transmission of bloodborne pathogens. If a health-care worker's
hands become contaminated with virus-infected blood from one patient,
the worker can transfer the virus to a second patient's skin or blood
line access port, and the virus can be inoculated into that patient
when the skin or access port is punctured with a needle.

Contact transmission can be prevented by hand hygiene (i.e., hand
washing or use of a waterless hand rub), glove use, and disinfection
of environmental surfaces. Of these, hand hygiene is the most
important. In addition, nonsterile disposable gloves provide a
protective barrier for workers' hands, preventing them from becoming
soiled or contaminated, and reduce the likelihood that microorganisms
present on the hands of personnel will be transmitted to patients.
However, even with glove use, hand washing is needed because pathogens
deposited on the outer surface of gloves can be detected on hands
after glove removal, possibly because of holes or defects in the
gloves, leakage at the wrist, or contamination of hands during glove
removal (194).

Standard Precautions are the system of infection control precautions
recommended for the inpatient hospital setting (195). Standard
Precautions are used on all patients and include use of gloves, gown,
or mask whenever needed to prevent contact of the health-care worker
with blood, secretions, excretions, or contaminated items.

In addition to Standard Precautions, more stringent precautions are
recommended for hemodialysis units because of the increased potential
for contamination with blood and pathogenic microorganisms (see
Infection Control Practices Recommended for Hemodialysis Units). For
example, infection control practices for hemodialysis units restrict
the use of common supplies, instruments, medications, and medication
trays and prohibit the use of a common medication cart.

For certain patients, including those infected or colonized with MRSA
or VRE, contact precautions are used in the inpatient hospital
setting. Contact precautions include a) placing the patient in a
single room or with another patient infected or colonized with the
same organism; b) using gloves whenever entering the patient's room;
and c) using a gown when entering the patient's room if the potential
exists for the worker's clothing to have substantial contact with the
patient, environmental surfaces, or items in the patient's room.
Workers also should wear a gown if the patient has diarrhea, an
ileostomy, a colostomy, or wound drainage not contained by a dressing.

However, contact precautions are not recommended in hemodialysis units
for patients infected or colonized with pathogenic bacteria for
several reasons. First, although contact transmission of pathogenic
bacteria is well-documented in hospitals, similar transmission has not
been well-documented in hemodialysis centers. Transmission might not
be apparent in dialysis centers, possibly because it occurs less
frequently than in acute-care hospitals or results in undetected
colonization rather than overt infection. Also, because dialysis
patients are frequently hospitalized, determining whether transmission
occurred in the inpatient or outpatient setting is difficult. Second,
contamination of the patient's skin, bedclothes, and environmental
surfaces with pathogenic bacteria is likely to be more common in
hospital settings (where patients spend 24 hours a day) than in
outpatient hemodialysis centers (where patients spend approximately 10
hours a week). Third, the routine use of infection control practices
recommended for hemodialysis units, which are more stringent than the
Standard Precautions routinely used in hospitals, should prevent
transmission by the contact route.

RECOMMENDATIONS
Rationale

Preventing transmission among chronic hemodialysis patients of
bloodborne viruses and pathogenic bacteria from both recognized and
unrecognized sources of infection requires implementation of a
comprehensive infection control program. The components of such a
program include infection control practices specifically designed for
the hemodialysis setting, including routine serologic testing and
immunization, surveillance, and training and education (Box).

The infection control practices recommended for hemodialysis units
will reduce opportunities for patient-to-patient transmission of
infectious agents, directly or indirectly via contaminated devices,
equipment and supplies, environmental surfaces, or hands of personnel.
These practices should be carried out routinely for all patients in
the chronic hemodialysis setting because of the increased potential
for blood contamination during hemodialysis and because many patients
are colonized or infected with pathogenic bacteria. Such practices
include additional measures to prevent HBV transmission because of the
high titer of HBV and its ability to survive on environmental
surfaces. For patients at increased risk for transmission of
pathogenic bacteria, including antimicrobial-resistant strains,
additional precautions also might be necessary in some circumstances.
Furthermore, surveillance for infections and other adverse events is
required to monitor the effectiveness of infection control practices,
as well as training and education of both staff members and patients
to ensure that appropriate infection control behaviors and techniques
are carried out.

Infection Control Practices for Hemodialysis Units

In each chronic hemodialysis unit, policies and practices should be
reviewed and updated to ensure that infection control practices
recommended for hemodialysis units are implemented and rigorously
followed (see Recommended Infection Control Practices for Hemodialysis
Units at a Glance). Intensive efforts must be made to educate new
staff members and reeducate existing staff members regarding these
practices.

Infection Control Precautions for All Patients

During the process of hemodialysis, exposure to blood and potentially
contaminated items can be routinely anticipated; thus, gloves are
required whenever caring for a patient or touching the patient's
equipment. To facilitate glove use, a supply of clean nonsterile
gloves and a glove discard container should be placed near each
dialysis station. Hands always should be washed after gloves are
removed and between patient contacts, as well as after touching blood,
body fluids, secretions, excretions, and contaminated items. A
sufficient number of sinks with warm water and soap should be
available to facilitate hand washing. If hands are not visibly soiled,
use of a waterless antiseptic hand rub can be substituted for hand
washing.

Any item taken to a patient's dialysis station could become
contaminated with blood and other body fluids and serve as a vehicle
of transmission to other patients either directly or by contamination
of the hands of personnel. Therefore, items taken to a patient's
dialysis station, including those placed on top of dialysis machines,
should either be disposed of, dedicated for use only on a single
patient, or cleaned and disinfected before being returned to a common
clean area or used for other patients. Unused medications or supplies
(e.g., syringes, alcohol swabs) taken to the patient's station should
not be returned to a common clean area or used on other patients.

Additional measures to prevent contamination of clean or sterile items
include a) preparing medications in a room or area separated from the
patient treatment area and designated only for medications; b) not
handling or storing contaminated (i.e., used) supplies, equipment,
blood samples, or biohazard containers in areas where medications and
clean (i.e., unused) equipment and supplies are handled; and c)
delivering medications separately to each patient. Common carts should
not be used within the patient treatment area to prepare or distribute
medications. If trays are used to distribute medications, clean them
before using for a different patient.

Intravenous medication vials labeled for single use, including
erythropoetin, should not be punctured more than once (196,197). Once
a needle has entered a vial labeled for single use, the sterility of
the product can no longer be guaranteed. Residual medication from two
or more vials should not be pooled into a single vial.

If a common supply cart is used to store clean supplies in the patient
treatment area, this cart should remain in a designated area at a
sufficient distance from patient stations to avoid contamination with
blood. Such carts should not be moved between stations to distribute
supplies.

Staff members should wear gowns, face shields, eye wear, or masks to
protect themselves and prevent soiling of clothing when performing
procedures during which spurting or spattering of blood might occur
(e.g., during initiation and termination of dialysis, cleaning of
dialyzers, and centrifugation of blood). Such protective clothing or
gear should be changed if it becomes soiled with blood, body fluids,
secretions, or excretions. Staff members should not eat, drink, or
smoke in the dialysis treatment area or in the laboratory. However,
patients can be served meals or eat food brought from home at their
dialysis station. The glasses, dishes, and other utensils should be
cleaned in the usual manner; no special care of these items is needed.

Cleaning and Disinfection. Establish written protocols for cleaning
and disinfecting surfaces and equipment in the dialysis unit,
including careful mechanical cleaning before any disinfection process
(Table 2). If the manufacturer has provided instructions on
sterilization or disinfection of the item, these instructions should
be followed. For each chemical sterilant and disinfectant, follow the
manufacturer's instructions regarding use, including appropriate
dilution and contact time.

After each patient treatment, clean environmental surfaces at the
dialysis station, including the dialysis bed or chair, countertops,
and external surfaces of the dialysis machine, including containers
associated with the prime waste. Use any soap, detergent, or detergent
germicide. Between uses of medical equipment (e.g., scissors,
hemostats, clamps, stethoscopes, blood pressure cuffs), clean and
apply a hospital disinfectant (i.e., low-level disinfection); if the
item is visibly contaminated with blood, use a tuberculocidal
disinfectant (i.e., intermediate-level disinfection).

For a blood spill, immediately clean the area with a cloth soaked with
a tuberculocidal disinfectant or a 1:100 dilution of household bleach
(300--600 mg/L free chlorine) (i.e., intermediate-level disinfection).
The staff member doing the cleaning should wear gloves, and the cloth
should be placed in a bucket or other leakproof container. After all
visible blood is cleaned, use a new cloth or towel to apply
disinfectant a second time.

Published methods should be used to clean and disinfect the water
treatment and distribution system and the internal circuits of the
dialysis machine, as well as to reprocess dialyzers for reuse (see
Suggested Readings). These methods are designed to control bacterial
contamination, but will also eliminate bloodborne viruses. For
single-pass machines, perform rinsing and disinfection procedures at
the beginning or end of the day. For batch recirculating machines,
drain, rinse, and disinfect after each use. Follow the same methods
for cleaning and disinfection if a blood leak has occurred, regardless
of the type of dialysis machine used. Routine bacteriologic assays of
water and dialysis fluids should be performed according to the
recommendations of the Association for the Advancement of Medical
Instrumentation (see Suggested Readings).

Venous pressure transducer protectors should be used to cover pressure
monitors and should be changed between patients, not reused. If the
external transducer protector becomes wet, replace immediately and
inspect the protector. If fluid is visible on the side of the
transducer protector that faces the machine, have qualified personnel
open the machine after the treatment is completed and check for
contamination. This includes inspection for possible blood
contamination of the internal pressure tubing set and pressure sensing
port. If contamination has occurred, the machine must be taken out of
service and disinfected using either 1:100 dilution of bleach
(300--600 mg/L free chlorine) or a commercially available,
EPA-registered tuberculocidal germicide before reuse. Frequent blood
line pressure alarms or frequent adjusting of blood drip chamber
levels can be an indicator of this problem. Taken separately, these
incidents could be characterized as isolated malfunctions. However,
the potential public health significance of the total number of
incidents nationwide make it imperative that all incidents of
equipment contamination be reported immediately to the FDA
(800-FDA-1088).

Housekeeping staff members in the dialysis facility should promptly
remove soil and potentially infectious waste and maintain an
environment that enhances patient care. All disposable items should be
placed in bags thick enough to prevent leakage. Wastes generated by
the hemodialysis facility might be contaminated with blood and should
be considered infectious and handled accordingly. These solid medical
wastes should be disposed of properly in an incinerator or sanitary
landfill, according to local and state regulations governing medical
waste disposal.

Hemodialysis in Acute-Care Settings. For patients with acute renal
failure who receive hemodialysis in acute-care settings, Standard
Precautions as applied in all health-care settings are sufficient to
prevent transmission of bloodborne viruses. However, when chronic
hemodialysis patients receive maintenance hemodialysis while
hospitalized, infection control precautions specifically designed for
chronic hemodialysis units (see Recommended Practices at a Glance)
should be applied to these patients. If both acute and chronic renal
failure patients receive hemodialysis in the same unit, these
infection control precautions should be applied to all patients.

Regardless of where in the acute-care setting chronic hemodialysis
patients receive dialysis, the HBsAg status of all such patients
should be ascertained at the time of admission to the hospital, by
either a written report from the referring center (including the most
recent date testing was performed) or by a serologic test. The HBV
serologic status should be prominently placed in patients' hospital
records, and all health-care personnel assigned to these patients, as
well as the infection control practitioner, should be aware of the
patients' serologic status. While hospitalized, HBsAg-positive chronic
hemodialysis patients should undergo dialysis in a separate room and
use separate machines, equipment, instruments, supplies, and
medications designated only for HBsAg-positive patients (see
Prevention and Management of HBV Infection). While HBsAg-positive
patients are receiving dialysis, staff members who are caring for them
should not care for susceptible patients.

Routine Serologic Testing

Chronic Hemodialysis Patients. Routinely test all chronic hemodialysis
patients for HBV and HCV infection (see Recommended Practices at a
Glance), promptly review results, and ensure that patients are managed
appropriately based on their testing results (see later
recommendations for each virus). Communicate test results (positive
and negative) to other units or hospitals when patients are
transferred for care. Routine testing for HDV or HIV infection for
purposes of infection control is not recommended.

The HBV serologic status (i.e., HBsAg, total anti-HBc, and anti-HBs)
of all patients should be known before admission to the hemodialysis
unit. For patients transferred from another unit, test results should
be obtained before the patients' transfer. If a patient's HBV
serologic status is not known at the time of admission, testing should
be completed within 7 days. The hemodialysis unit should ensure that
the laboratory performing the testing for anti-HBs can define a 10
mIU/mL concentration to determine protective levels of antibody.

Routine HCV testing should include use of both an EIA to test for
anti-HCV and supplemental or confirmatory testing with an additional,
more specific assay (Figure). Use of RT-PCR for HCV RNA as the primary
test for routine screening is not recommended because few HCV
infections will be identified in anti-HCV negative patients. However,
if ALT levels are persistently abnormal in patients who are anti-HCV
negative in the absence of another etiology, testing for HCV RNA
should be considered (for proper specimen collection and handling, see
Hepatitis C Virus Infection, Screening and Diagnostic Tests).

Hemodialysis Staff Members. Previously, testing for HBV infection was
recommended for all staff members at the time of employment and for
susceptible staff members at routine intervals thereafter (198);
however, such testing is no longer considered necessary. The risk for
HBV infection among hemodialysis staff members is no greater than that
for other health-care workers. Thus, routine testing of staff members
is not recommended except when required to document response to
hepatitis B vaccination (see Postvaccination Testing and Revaccination
of Nonresponders). Routine testing of staff members for HCV, HDV, or
HIV infection is not recommended.

Hepatitis B Vaccination

Vaccine Schedule and Dose. Hepatitis B vaccination is recommended for
all susceptible chronic hemodialysis patients and for all staff
members (Table 3). Vaccination is recommended for pre--end-stage renal
disease patients before they become dialysis dependent and for
peritoneal and home dialysis patients because they might require
in-center hemodialysis. Hepatitis B vaccine should be administered by
the intramuscular route and only in the deltoid muscle for adults and
children. Intradermal or subcutaneous administration of hepatitis B
vaccine is not recommended.

If an adult patient begins the vaccine series with a standard dose
before beginning hemodialysis treatment, then moves to hemodialysis
treatment before completing the series, complete the series using the
higher dose recommended for hemodialysis patients (Table 3). No
specific recommendations have been made for higher doses for pediatric
hemodialysis patients. If a lower than recommended vaccine dose is
administered to either adults or children, the dose should be
repeated.

If the vaccination series is interrupted after the first dose, the
second dose should be administered as soon as possible. For the
three-dose primary vaccine series, the second and third doses should
be separated by an interval of at least 2 months; if only the third
dose is delayed, that dose should be administered when convenient.
When hepatitis B vaccine has been administered at the same time as
other vaccines, no interference with the antibody response of the
other vaccines has been demonstrated.

Postvaccination Testing and Revaccination of Nonresponders. Test all
vaccinees for anti-HBs 1--2 months after the last primary vaccine
dose, to determine their response to the vaccine (adequate response is
defined as >10 mIU/mL). Patients and staff members who do not respond
to the primary vaccine series should be revaccinated with three
additional doses and retested for response. No additional doses of
vaccine are warranted for those who do not respond to the second
series.

Evaluate staff members who do not respond to revaccination to
determine if they are HBsAg positive (199). Persons who are HBsAg
positive should be counseled accordingly (e.g., need for medical
evaluation, vaccination of sexual and household contacts). Primary
nonresponders to vaccination who are HBsAg negative should be
considered susceptible to HBV infection and counseled regarding
precautions to prevent HBV infection and the need to obtain
postexposure prophylaxis with hepatitis B immune globulin for any
known or probable percutaneous or mucosal exposure to HBsAg-positive
blood (199).

Follow-Up of Vaccine Responders. Retest patients who respond to the
vaccine annually for anti-HBs. If anti-HBs declines to <10 mIU/mL,
administer a booster dose of hepatitis B vaccine and continue to
retest annually. Retesting immediately after the booster dose is not
necessary. For staff members who respond to the vaccine, booster doses
of vaccine are not necessary, and periodic serologic testing to
monitor antibody concentrations is not recommended (199).

Patients with a History of Vaccination. Routine childhood vaccination
against hepatitis B has been recommended since 1991 and routine
adolescent vaccination since 1995 (89,198). Thus, many persons who
develop end-stage renal failure will have a history of vaccination
against hepatitis B. These persons should have responded to the
vaccine when their immune status was normal, but if their anti-HBs
levels are <10 mIU/mL when they begin dialysis, they should be
revaccinated with a complete primary series.

Prevention and Management of HBV Infection

Preventing HBV transmission among chronic hemodialysis patients
requires a) infection control precautions recommended for all
hemodialysis patients; b) routine serologic testing for markers of HBV
infection and prompt review of results; c) isolation of HBsAg-positive
patients with dedicated room, machine, other equipment, supplies, and
staff members; and d) vaccination. Additional infection control
practices are needed because of the potential for environmentally
mediated transmission of HBV, rather than internal contamination of
dialysis machines. The need for routine follow-up testing,
vaccination, or isolation is based on patients' serologic status
(Table 1 and Recommended Practices at a Glance).

HBV-Susceptible Patients. Vaccinate all susceptible patients (see
Hepatitis B Vaccination). Test susceptible patients monthly for HBsAg,
including those who a) have not yet received hepatitis B vaccine, b)
are in the process of being vaccinated, or c) have not adequately
responded to vaccination. Although the incidence of HBV infection is
low among chronic hemodialysis patients, preventing transmission
depends on timely detection of patients converting from HBsAg negative
to HBsAg positive and rapid implementation of isolation procedures
before cross-contamination can occur.

HBsAg Seroconversions. Report HBsAg-positive seroconversions to the
local health department as required by law or regulation. When a
seroconversion occurs, review all patients' routine laboratory test
results to identify additional cases. Perform additional testing as
indicated later in this section. Investigate potential sources for
infection to determine if transmission might have occurred within the
dialysis unit, including review of newly infected patients' recent
medical history (e.g., blood transfusion, hospitalization), history of
high-risk behavior (e.g., injecting-drug use, sexual activity), and
unit practices and procedures.

In patients newly infected with HBV, HBsAg often is the only serologic
marker initially detected; repeat HBsAg testing and test for anti-HBc
(including IgM anti-HBc) 1--2 months later. Six months later, repeat
HBsAg testing and test for anti-HBs to determine clinical outcome and
need for counseling, medical evaluation, and vaccination of contacts.
Patients who become HBsAg negative are no longer infectious and can be
removed from isolation.

HBV-Infected Patients. To isolate HBsAg-positive patients, designate a
separate room for their treatment and dedicate machines, equipment,
instruments, supplies, and medications that will not be used by
HBV-susceptible patients. Most importantly, staff members who are
caring for HBsAg-positive patients should not care for susceptible
patients at the same time, including during the period when dialysis
is terminated on one patient and initiated on another.

Newly opened units should have isolation rooms for the dialysis of
HBsAg-positive patients. For existing units in which a separate room
is not possible, HBsAg-positive patients should be separated from
HBV-susceptible patients in an area removed from the mainstream of
activity and should undergo dialysis on dedicated machines. If a
machine that has been used on an HBsAg-positive patient is needed for
an HBV-susceptible patient, internal pathways of the machine can be
disinfected using conventional protocols and external surfaces cleaned
using soap and water or a detergent germicide.

Dialyzers should not be reused on HBsAg-positive patients. Because HBV
is efficiently transmitted through occupational exposure to blood,
reprocessing dialyzers from HBsAg-positive patients might place
HBV-susceptible staff members at increased risk for infection.

Chronically infected patients (i.e., those who are HBsAg positive,
total anti-HBc positive, and IgM anti-HBc negative) are infectious to
others and are at risk for chronic liver disease. They should be
counseled regarding preventing transmission to others, their household
and sexual partners should receive hepatitis B vaccine, and they
should be evaluated (by consultation or referral, if appropriate) for
the presence or development of chronic liver disease according to
current medical practice guidelines. Persons with chronic liver
disease should be vaccinated against hepatitis A, if susceptible.

Chronically infected patients do not require any routine follow-up
testing for purposes of infection control. However, annual testing for
HBsAg is reasonable to detect the small percentage of HBV-infected
patients who might lose their HBsAg.

HBV-Immune Patients. Annual anti-HBs testing of patients who are
positive for anti-HBs (>10 mIU/mL) and negative for anti-HBc
determines the need for booster doses of vaccine to ensure that
protective levels of antibody are maintained. No routine follow-up
testing is necessary for patients who are positive for both anti-HBs
and anti-HBc.

HBV-immune patients can undergo dialysis in the same area as
HBsAg-positive patients, or they can serve as a geographic buffer
between HBsAg-positive and HBV-susceptible patients. Staff members can
be assigned to care for both infected and immune patients on the same
shift.

Isolated Anti-HBc--Positive Patients. Patients who test positive for
isolated anti-HBc (i.e., those who are anti-HBc positive, HBsAg
negative, and anti-HBs negative) should be retested on a separate
serum sample for total anti-HBc, and if positive, for IgM anti-HBc.
The following guidelines should be used for interpretation and
follow-up:

If total anti-HBc is negative, consider patient susceptible, and
follow recommendations for vaccination.
If total anti-HBc is positive and IgM anti-HBc is negative, follow
recommendations for vaccination.
If anti-HBs is <10 mIU/mL even after revaccination, test for HBV DNA.
If HBV DNA is negative, consider patient susceptible (i.e., the
anti-HBc result is a false positive), and test monthly for HBsAg.
If HBV DNA is positive, consider patient as having past infection or
"low-level" chronic infection (i.e., the anti-HBc result is a true
positive); no further testing is necessary.
Isolation is not necessary because HBsAg is not detectable.
If both total and IgM anti-HBc are positive, consider patient recently
infected and test for anti-HBs in 4--6 months; no further routine
testing is necessary.
Isolation is not necessary because HBsAg is not detectable.
Prevention and Management of HCV Infection

HCV transmission within the dialysis environment can be prevented by
strict adherence to infection control precautions recommended for all
hemodialysis patients (see Recommended Practices at a Glance).
Although isolation of HCV-infected patients is not recommended,
routine testing for ALT and anti-HCV is important for monitoring
transmission within centers and ensuring that appropriate precautions
are being properly and consistently used.

HCV-Negative Patients. Monthly ALT testing will facilitate timely
detection of new infections and provide a pattern from which to
determine when exposure or infection might have occurred. In the
absence of unexplained ALT elevations, testing for anti-HCV every 6
months should be sufficient to monitor the occurrence of new HCV
infections. If unexplained ALT elevations are observed in patients who
are anti-HCV negative, repeat anti-HCV testing is warranted. If
unexplained ALT elevations persist in patients who repeatedly test
anti-HCV negative, testing for HCV RNA should be considered.

Anti-HCV Seroconversions. Report anti-HCV--positive seroconversions to
the local health department as required by law or regulation. When a
seroconversion occurs, review all other patients' routine laboratory
test results to identify additional cases. Perform additional testing
as indicated later in this section. Investigate potential sources for
infection to determine if transmission might have occurred within the
dialysis unit, including review of newly infected patients' recent
medical history (e.g., blood transfusion, hospitalization), history of
high-risk behavior (e.g., injecting-drug use, sexual activity), and
unit practices and procedures.

If >1 patient seroconverts from anti-HCV negative to positive during a
6-month period, more frequent (e.g., every 1--3 months) anti-HCV
testing of HCV-negative patients could be warranted for a limited time
(e.g., 3--6 months) to detect additional infections. If no additional
newly infected patients are identified, resume semiannual testing. If
ongoing HCV transmission among patients is identified, implement
control measures based on results of investigation of potential
sources for transmission and monitor their effectiveness (e.g.,
perform more frequent anti-HCV testing of HCV-negative patients for
6--12 months before resuming semiannual testing).

HCV-Positive Patients. Patients who are anti-HCV positive (or HCV RNA
positive) do not have to be isolated from other patients or dialyzed
separately on dedicated machines. Furthermore, they can participate in
dialyzer reuse programs. Unlike HBV, HCV is not transmitted
efficiently through occupational exposures. Thus, reprocessing
dialyzers from HCV-positive patients should not place staff members at
increased risk for infection.

HCV-positive persons should be evaluated (by consultation or referral,
if appropriate) for the presence or development of chronic liver
disease according to current medical practice guidelines. They also
should receive information concerning how they can prevent further
harm to their liver and prevent transmitting HCV to others (116,141).
Persons with chronic liver disease should be vaccinated against
hepatitis A, if susceptible.

Prevention and Management of HDV Infection

Because of the low prevalence of HDV infection in the United States,
routine testing of hemodialysis patients is not necessary or
recommended. However, if a patient is known to be infected with HDV,
or if evidence exists of transmission of HDV in a dialysis center,
screening for delta antibody is warranted. Because HDV depends on an
HBV-infected host for replication, prevention of HBV infection will
prevent HDV infection in a person susceptible to HBV. Patients who are
known to be infected with HDV should be isolated from all other
dialysis patients, especially those who are HBsAg-positive.

Prevention and Management of HIV Infection

Routine testing of hemodialysis patients for HIV infection for
infection control purposes is not necessary or recommended. However,
patients with risk factors for HIV infection should be tested so that,
if infected, they can receive proper medical care and counseling
regarding preventing transmission of the virus (201).

Infection control precautions recommended for all hemodialysis
patients (see Recommended Practices at a Glance) are sufficient to
prevent HIV transmission between patients. HIV-infected patients do
not have to be isolated from other patients or dialyzed separately on
dedicated machines. In addition, they can participate in dialyzer
reuse programs. Because HIV is not transmitted efficiently through
occupational exposures, reprocessing dialyzers from HIV-positive
patients should not place staff members at increased risk for
infection.

Prevention and Management of Bacterial Infections

Follow published guidelines for judicious use of antimicrobials,
particularly vancomycin, to reduce selection for
antimicrobial-resistant pathogens (202). Infection control precautions
recommended for all hemodialysis patients (see Recommended Practices
at a Glance) are adequate to prevent transmission for most patients
infected or colonized with pathogenic bacteria, including
antimicrobial-resistant strains. However, additional infection control
precautions should be considered for treatment of patients who might
be at increased risk for transmitting pathogenic bacteria. Such
patients include those with either a) an infected skin wound with
drainage that is not contained by dressings (the drainage does not
have to be culture positive for VRE, MRSA, or any specific pathogen)
or b) fecal incontinence or diarrhea uncontrolled with personal
hygiene measures. For these patients, consider using the following
additional precautions: a) staff members treating the patient should
wear a separate gown over their usual clothing and remove the gown
when finished caring for the patient and b) dialyze the patient at a
station with as few adjacent stations as possible (e.g., at the end or
corner of the unit).

SURVEILLANCE FOR INFECTIONS AND OTHER ADVERSE EVENTS
Develop and maintain a separate centralized record-keeping system
(e.g., log book or electronic file) to record the results of patients'
vaccination status, serologic testing results for viral hepatitis
(including ALT), episodes of bacteremia or loss of the vascular access
caused by infection (including date of onset, site of infection, genus
and species of the infecting organism, and selected antimicrobial
susceptibility results),* and adverse events (e.g., blood leaks and
spills, dialysis machine malfunctions). Designate a staff person to
promptly review the results of routine testing each time such testing
is performed and periodically review recorded episodes of bacteremia
or vascular access infections. Specify a procedure for actions
required when changes occur in test results or in the frequency of
episodes of bacteremias or vascular access loss because of infection.
Maintain records for each patient that include the location of the
dialysis station and machine number used for each dialysis session and
the names of staff members who connect and disconnect the patient to
and from a machine.

INFECTION CONTROL TRAINING AND EDUCATION
Training and education is recommended for both staff members and
patients (or their family care givers). Training should be appropriate
to the cognitive level of the staff member, patient, or family member,
and rationales should be provided for appropriate infection control
behaviors and techniques to increase compliance. Regulations and
recommendations regarding infection control training for health-care
workers in general, and dialysis personnel in particular, have been
previously published (180,203--205). The following recommendations are
intended to highlight and augment the earlier recommendations.

Training and education for all employees at risk for occupational
exposure to blood should be provided at least annually, given to new
employees before they begin working in the unit, and documented. At a
minimum, they should include information on the following topics:
proper hand hygiene technique;
proper use of protective equipment;
modes of transmission for bloodborne viruses, pathogenic bacteria, and
other microorganisms as appropriate;
infection control practices recommended for hemodialysis units and how
they differ from Standard Precautions recommended for other
health-care settings;
proper handling and delivery of patient medications;
rationale for segregating HBsAg-positive patients with a separate
room, machine, instruments, supplies, medications, and staff members;
proper infection control techniques for initiation, care, and
maintenance of access sites;
housekeeping to minimize transmission of microorganisms, including
proper methods to clean and disinfect equipment and environmental
surfaces; and
centralized record keeping to monitor and prevent complications,
including routine serologic testing results for HBV and HCV, hepatitis
B vaccine status, episodes of bacteremia and loss of access caused by
infection, and other adverse events. Records of surveillance for water
and dialysate quality should also be maintained.
Training and education of patients (or family members for patients
unable to be responsible for their own care) regarding infection
control practices should be given on admission to dialysis and at
least annually thereafter and should address the following topics:
personal hygiene and hand washing technique;
patient responsibility for proper care of the access and recognition
of signs of infection, which should be reviewed each time the patient
has a change in access type; and
recommended vaccinations (206).
FUTURE DIRECTIONS
Infection control strategies that prevent and control HBV infection
among hemodialysis patients are well-established. Areas that need
additional research include determining the ideal hepatitis B vaccine
dosage regimen for pre- and postdialysis pediatric patients and for
predialysis adult patients, as well as the optimal timing for
follow-up testing and administration of booster doses among vaccine
responders. In addition, further studies are needed to clarify the
specific factors responsible for transmission of HCV among
hemodialysis patients and to evaluate the effect of the current
recommendations on prevention and control of HCV infection in this
setting.

Many areas related to bacterial infections in chronic hemodialysis
patients need additional information. Studies are needed on the
prevalence and epidemiology of bacterial infections among chronic
hemodialysis patients and the patient care practices (e.g., those
related to vascular access care and puncture) that would be most
useful in preventing bacterial infections. Because of the prominent
role of dialysis patients in the epidemic of antimicrobial resistance,
researchers need to learn more regarding optimal strategies to ensure
judicious use of antimicrobials in these patients. Additional topics
for future research include determining the frequency of transmission
of pathogenic bacteria in the dialysis unit and whether additional
precautions are necessary to prevent such transmission.

This document is available on the Internet at
<http://www.cdc.gov/hepatitis>. Copies also can be obtained by using
the order form at this Internet site or by writing the Hepatitis
Branch, Mailstop G37, CDC, Atlanta, GA 30333.

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Suggested Readings
Cleaning, disinfection, sterilization, and monitoring of hemodialysis
fluids and equipment.
Favero MS, Tokars JI, Arduino MJ, Alter MJ. Nosocomial infections
associated with hemodialysis. In: Mayhall CG, ed. Hospital
epidemiology and infection control, 2nd ed. Philadelphia, PA:
Lippincott, Williams & Wilkins, 1999:897--917.

Tokars JI, Alter MJ, Arduino MJ. Nosocomial infections in hemodialysis
units: strategies for control. In: Owen WF, Pereira BJG, Sayegh MH,
eds. Dialysis and transplantation: a companion to Brenner and Rector's
THE KIDNEY. Philadelphia, PA: W.B. Saunders Company, 2000:337--57.

Association for the Advancement of Medical Instrumentation. AAMI
standards and recommended practices, vol. 3: dialysis. Arlington, VA:
Association for the Advancement of Medical Instrumentation, 1998.

General information on cleaning and disinfection.
Favero MS, Bond WW. Chemical disinfection of medical and surgical
materials. In: Block SS, ed. Disinfection, sterilization, and
preservation, 5th ed. Philadelphia, PA: Lippincott, Williams &
Wilkins, 2000:881--917.

CDC. Guideline for handwashing and hospital environmental control,
1985. Atlanta, GA: US Department of Health and Human Services, Public
Health Service, CDC. Available on the Internet at
<http://www.cdc.gov/ncidod/hip/Guide/handwash.htm>.

General information on vancomycin-resistant enterococci epidemiology
and control in hospitals.
CDC. Recommendations for preventing the spread of vancomycin
resistance: recommendations of the Hospital Infection Control
Practices Advisory Committee (HICPAC). MMWR 1995;44(No. RR-12):1--13.
Available on the Internet at <http://www.cdc.gov/ncidod/hip>.

Hepatitis C virus infection.
CDC. Recommendations for prevention and control of hepatitis C virus
(HCV) infection and HCV-related chronic disease. MMWR 1998;47(No.
RR-19):1--33. Available on the Internet at
<http://www.cdc.gov/hepatitis>.

Preventing infections in patients with central venous hemodialysis
catheters.
National Kidney Foundation. Dialysis outcomes quality initiative.
Clinical practice guidelines. Am J Kidney Dis 1997;30(Suppl
3):S137--S240. Available on the Internet at <http://www.kidney.org>.

Pearson ML, Hierholzer WJ Jr, Garner JS, et al. Guideline for
prevention of intravascular device-related infections: part I.
Intravascular device-related infections: an overview. Am J Infect
Control 1996;24:262--77. Available on the Internet at
<http://www.cdc.gov/ncidod/hip>.

Standard Precautions and infection control precautions for
hospitalized patients.
Garner JS and the Hospital Infection Control Practices Advisory
Committee. Guideline for isolation precautions in hospitals. Infect
Control Hosp Epidemiol 1996;17:53--80. Available on the Internet at
<http://www.cdc.gov/ncidod/hip>.

Summaries of outbreaks in hemodialysis units and recommendations to
prevent similar outbreaks.
Favero MS, Tokars JI, Arduino MJ, Alter MJ. Nosocomial infections
associated with hemodialysis. In: Mayhall CG, ed. Hospital
epidemiology and infection control, 2nd ed. Philadelphia, PA:
Lippincott, Williams & Wilkins, 1999:897--917.

Tokars JI, Alter MJ, Arduino MJ. Nosocomial infections in hemodialysis
units: strategies for control. In: Owen WF, Pereira BJG, Sayegh MH,
eds. Dialysis and transplantation: a companion to Brenner and Rector's
THE KIDNEY. Philadelphia, PA: W.B. Saunders Company, 2000:337--57.

Tuberculosis skin testing and treatment of patients with active
disease.
CDC. Guidelines for preventing the transmission of Mycobacterium
tuberculosis in health-care facilities, 1994. MMWR 1994;43(No.
RR-13):1--32. Available on the Internet at
<http://www.cdc.gov/mmwr/preview/mmwrhtml/00035909.htm>.

Tokars JI, Miller B. Tuberculin skin testing of ESRD patients
[Letter]. Am J Kidney Dis 1997:30:456--7.

Vaccination and other health-care worker topics.
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):1--42. Available on the Internet at
<http://www.cdc.gov/ncidod/hip>.

Bolyard EA, Tablan OC, Williams WW, et al, and the Hospital Infection
Control Practices Advisory Committee. Guideline for infection control
in health care personnel, 1998. Am J Infect Control 1998;26:289--354.
Available on the Internet at <http://www.cdc.gov/ncidod/hip>.

Vascular access skin site preparation and aseptic technique.
National Kidney Foundation. Dialysis outcomes quality initiative.
Clinical practice guidelines. Am J Kidney Dis 1997;30(Suppl
3):S137--S240. Available on the Internet at <http://www.kidney.org>.

* Hemodialysis units interested in participating in a formal
surveillance system for bacterial infections should consult CDC's
Surveillance for Bloodstream and Vascular Access Infections in
Outpatient Hemodialysis Centers. More information is available on the
Internet at <http://www.cdc.gov/ncidod/hip/Dialysis/DSN_manual.PDF>.

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Figure

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