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Infection Control Requirements for Dialysis Facilities and
Clarification Regarding Guidance on Parenteral Medication Vials
In April 2008, the Centers for Medicare and Medicaid Services (CMS) published in the
Federal Register its final rule on Conditions for Coverage for End-Stage Renal Disease (ESRD)
Facilities (1). The rule establishes new conditions
dialysis
facilities must meet to be certified under the Medicare program and is intended to update CMS standards for delivery
of quality care to dialysis patients. CDC's 2001
Recommendations for Preventing Transmission of Infections among
Chronic Hemodialysis Patients (2) have been incorporated by reference into the new CMS conditions for coverage. Thus,
effective October 14, 2008, all ESRD facilities are expected to follow the CDC recommendations as a condition for receiving
Medicare payment for outpatient dialysis services.
In recent years, outbreak investigations in dialysis and other health-care settings have demonstrated that mishandling
of parenteral medication vials can contribute to the risk for hepatitis C virus (HCV) infection and bacterial and other
infections (3--7). In 2002, a CDC communication to CMS suggested that reentry into single-use parenteral medication vials (i.e.,
to administer medication to more than one patient), when performed on a limited basis and under strict conditions
in hemodialysis settings, likely would result in low risk for bacterial infection
(8). However, the 2002 communication did
not address risks for bloodborne viral infections (e.g., HCV and hepatitis B virus infection). This report is intended to clarify
and restate CDC's recommendation on parenteral medication to include bloodborne viral infections. The recommendations in
this report supersede the 2002 CDC communication to CMS.
To prevent transmission of both bacteria and bloodborne viruses in hemodialysis settings, CDC recommends that all
single-use injectable medications and solutions be dedicated for use on a single patient and be entered one time only.
Medications packaged as multidose should be assigned to a single patient whenever possible. All parenteral medications should be
prepared in a clean area separate from potentially contaminated items and surfaces. In hemodialysis settings where
environmental surfaces and medical supplies are subjected to frequent blood contamination, medication preparation should occur in a
clean area removed from the patient treatment area. Proper infection control practices must be followed during the preparation
and administration of injected medications
(9). This is consistent with official CDC recommendations for infection
control precautions in hemodialysis (2) and other health-care settings
(9).
Health departments and other public health partners should be aware of the new CMS conditions for ESRD facilities.
All dialysis providers are advised to follow official CDC recommendations regarding Standard Precautions and
infection control in dialysis settings (2,9). Specifically, CDC has
recommended the following: "Intravenous medication vials labeled
for single use, including erythropoietin, should not be punctured more than once. Once a needle has entered a vial labeled
for single use, the sterility of the product can no longer be guaranteed"
(2). Additional guidance on safe injection practices can
be found in the Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings
2007 (9).
Dialysis providers also should be aware of their responsibility to report clusters of infections or other adverse events to
the appropriate local or state public health authority. Failure to report illness clusters to public health authorities can result
in delays in recognition of disease outbreaks
(10) and implementation of control measures. Additional information
regarding the new CMS Conditions for Coverage for End-Stage Renal Disease
Facilities is available at
http://www.cms.hhs.gov/cfcsandcops/13_esrd.asp.
References
US Department of Health and Human Services. Centers for Medicare and Medicaid Services. Medicare and Medicaid programs; conditions
for coverage for end-stage renal disease
facilities.42 CFR Parts 405, 410, 413, 414, 488, and 494. Available at
http://www.cms.hhs.gov/cfcsandcops/downloads/esrdfinalrule0415.pdf
Thompson N, Bialek S. Hepatitis C virus transmission in the hemodialysis setting: importance of infection control practices and aseptic
technique [Abstract]. In: programs and abstracts of the National Kidney Foundation Spring Meeting; April 3, 2008; Grapevine, TX.
Williams IT, Perz JF, Bell BP. Viral hepatitis transmission in ambulatory health care settings. Clin Infect Dis 2004;38:1592--8.
Alter MJ. Healthcare should not be a vehicle for transmission of hepatitis C virus. J Hepatol 2008;48:2--4.
Grohskopf LA, Roth VR, Feikin DR, et al.
Serratia liquefaciens bloodstream infections from contamination of epoetin alfa at a hemodialysis
center. N Engl J Med 2001;344:1491--7.
Siegel JD, Rhinehart E, Jackson M, Chiarello L, and the Healthcare Infection Control Practices Advisory Committee. Guideline for
isolation precautions: preventing transmission of infectious agents in healthcare settings 2007. Atlanta, GA: US Department of Health and Human
Services, CDC; 2007. Available at
http://www.cdc.gov/ncidod/dhqp/gl_isolation.html.
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