CMS SOM App. H, Tag V112

The facility must demonstrate

that it follows standard infection control precautions by implementing— (1)(i) The

recommendations (with the exception of screening for Hepatitis C), found in

“Recommendations for Preventing Transmission of Infections Among Chronic

Hemodialysis Patients,” developed by the Centers for Disease Control and Prevention,

Morbidity and Mortality Weekly Report, volume 50, number RR05, April 27, 2001,

pages 18 to 28. The Director of the Federal Register approves this incorporation by

reference in accordance with 5 U.S.C. 552(a) and 1 CFR Part 51. This publication is

available for inspection at the CMS Information Resource Center, 7500 Security

Boulevard, Central Building, Baltimore, MD or at the National Archives and Records

Administration (NARA). Copies may be obtained at the CMS Information Resource

Center. For information on the availability of this material at NARA, call 202–741–6030,

or go to:

http://www.archives.gov/federal_register/code_of_regulations/ibr_locations.html. The

recommendation found under section header “HBV-Infected Patients”, found on pages

27 and 28 of RR05 (“Recommendations for Preventing Transmission of Infections

Among Chronic Hemodialysis Patients”), concerning isolation rooms, must be complied

with by February 9, 2009.

Interpretive Guidelines § 494.30(a)

Page 6 of 420

The CDC “Recommendations for Preventing Transmission of Infections among Chronic

Hemodialysis Patients” (MMWR, Vol. 50/No. RR-05), pages 18 to 28, including the

“Recommended Infection Control Practices for Hemodialysis Units at a Glance,” found at:

https://www.cdc.gov/mmwr/preview/mmwrhtml/rr5005a1.htm is incorporated by reference into

the regulation and, thus, facilities must demonstrate that they follow standard infection control

precautions by implementing its recommendations. For the purposes of these Conditions for

Coverage, the portions of the CDC infection control recommendations incorporated by reference

are mandatory and must be adhered to and demonstrated within the dialysis facility. When

serving as Regulation text, the words of the CDC document are excerpted exactly as written. The

entire CDC document includes background information and rationale for the CDC-recommended practices and can be used as an informational resource.

Note: When words are inserted or altered in a direct quotation, square brackets—[]—are

placed around the change. The brackets enclose words intended to explain the quote or to help

integrate the quote into the guidance.

According to the CDC, “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, training

and education.”

CDC’s components of a comprehensive infection control program to prevent transmission of

infections among chronic hemodialysis patients include:

• Infection control practices for hemodialysis units.

• Infection control precautions specifically designed to prevent transmission of

bloodborne viruses and pathogenic bacteria among patients.

• Routine serologic testing for Hepatitis B virus infections.

• Vaccination of susceptible patients against Hepatitis B.

• Isolation of patients who test positive for Hepatitis B surface antigen.

• Surveillance for infections and other adverse events.

• Infection control training and education.

The infection control practices recommended by CDC for hemodialysis units will reduce

opportunities for patient-to-patient transmission of infectious agents, directly or indirectly

through 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.

These infection control practices include additional measures to prevent Hepatitis B Virus

(HBV) transmission because of the high titer of HBV in each milliliter of infected blood and its

ability to survive on environmental surfaces.

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According to the CDC, for patients at increased risk for transmission of pathogenic bacteria,

including antimicrobial-resistant strains, additional precautions might also be necessary.

Patients with either an infected skin wound with drainage uncontrolled by dressings, or

uncontrolled fecal incontinence or diarrhea, should be dialyzed at a station with as few adjacent

stations as possible. Staff members treating the patient should wear a separate gown for patient

care, and supplies and equipment (such as blood pressure cuffs) should not be shared between

patients with uncontrolled draining wounds.

Surveillance for infections and other adverse events is necessary to monitor the effectiveness of

infection control practices, as well as to train and educate both staff members and patients on

appropriate infection control behaviors and techniques.