CMS SOM App. H, Tag V128

Isolation of HBV+ Patients

To isolate HBsAg positive patients, designate a separate room for their treatment.

For existing units in which a separate room is not possible, HBsAg positive patients should

be separated from HBsAg susceptible patients in an area removed from the mainstream of

activity.

Interpretive Guidance § 494.30(a)(1)(i)

Beginning February 9, 2009, all new facilities have been required to have a separate isolation

room unless the facility has obtained a waiver from CMS for this requirement. See V129 for the

details of this requirement.

According to the CDC, HBV+ patients must dialyze in a separate isolation room during dialysis

to prevent contact and transmission by contact with blood spills, splattering, or spurting of blood

and other body fluids.

A separate room with a door is required to contain any spillage of blood, body fluids, and other

contaminants, as well as to prevent cross-contamination that can occur due to environmental

contamination. HBV is stable in the environment and can survive on surfaces (and remain

infectious) for at least 1 week. Since Hepatitis B is not airborne, the walls of the room do not

need to reach the ceiling, but they must extend to the floor to contain blood spills. The door must

also be closed during times when blood spurting or spattering is possible, such as at the

initiation and termination of treatment. The walls must allow for visual monitoring of the

patients in the room (unless a staff member is continually present) and contain any potential

blood or fluid spills.

A separate room is the safer and preferred method of isolation; however, “existing” facilities,

meaning those facilities that were treating HBV+ patients as of the effective date of the

regulations, i.e. October 14, 2008, and that were using a separate area rather than a separate

room, may continue to use the separate “isolation” area, unless they are expanding the physical

location, in which case they must add an isolation room or obtain a waiver of the requirement. If

an existing facility uses a designated isolation area rather than a room, the area used for HBV+

patients should be separated from other stations by a space at least equivalent to the width of

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one hemodialysis station. The “isolation” station could be an “end of row” station to facilitate

the separation of the area from the mainstream of the dialysis facility’s activities and to decrease

the number of adjacent dialysis stations.

If there are current HBV+ patients on census, the isolation area/room and equipment cannot be

used for HBV- patients on other shifts or days due to the risk of cross-contamination. When any

HBV+ patients are no longer on census, the “isolation” area/room may be terminally cleaned,

disinfected and used for HBV- patients.

Existing units, currently without HBV+ patients, that accept HBV+ patients after the effective

date of these regulations may establish a separate area (as described above) for the care of these

patients. Any facility that expands its physical capacity after February 9, 2009, must include an

isolation room or secure a waiver. See V129.

Every facility must have the capacity to separate potentially HBV+ patients during treatment.

Existing units that do not currently accept or treat HBV+ patients may have a transfer

agreement with a local chronic facility that has capacity for isolation stations. If no local facility

is available to accept such transfers, the existing facility must establish an isolation room or

area for use with HBV+ patients.

If an HBV+ patient chooses home dialysis, precautions must be exercised during the training of

that patient to prevent potential cross-contamination of the training environment and other home

patients. These could include conducting the training in the patient’s home, rather than at the

dialysis facility, or limiting the use of the training space to the HBV+ patient until training is

completed. Different precautions would be necessary depending on the modality: home HD vs.

PD. Relatives or other individuals who assist with dialysis for an HBV+ patient should be

instructed to ask their physician regarding vaccination against Hepatitis B infection.