CMS SOM App. H, Tag V124

Routine Testing for Hepatitis B

The HBV serological status (i.e. HBsAg, total anti-HBc and anti-HBs) of all patients should

be known before admission to the hemodialysis unit.

Routinely test all patients [as required by the referenced schedule for routine testing for

Hepatitis B Virus].

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Promptly review results, and ensure that patients are managed appropriately based on

their testing results.

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

Clarification of terminology: “HBsAg positive” is used synonymously with “HBV+” meaning

that an individual has tested positive for the presence of Hepatitis B surface antigen. “HBsAg

negative” is used synonymously with “HBV-” meaning that the person does not have the

Hepatitis B surface antigen. “HBV susceptible” means that the person does not have sufficient

Hepatitis B surface antibody levels to achieve immunity to the virus. “HBV immune” means the

person has sufficient Hepatitis B surface antibodies to achieve immunity to the virus.

According to the CDC, 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.

In order to prevent the transmission of Hepatitis B among ESRD patients, all new patients

should be tested, and their HBV serologic status (i.e., HBsAg, total anti-HBc, and anti-HBs

results) should be known prior to admission for treatment. If the results of this testing are not

known at admission because of an emergency situation, the patient should be tested immediately

upon intake and results known within 7 days of admission.

CDC’s schedule for Hepatitis B testing is below:

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HBV-Susceptible Patients: Susceptible patients should begin receipt of Hepatitis B vaccine

immediately upon admission. 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. Note that, while the patient’s anti-HBs level is <10

mIU/mL, they are considered susceptible to Hepatitis B and should be tested for HBsAg on a

monthly basis.

Follow-up of Vaccine Responders: Retest patients who respond to the vaccine annually for anti-HBs antibodies.

HBV-Infected Patient: Chronically infected patients do not require routine follow-up testing for

infection control. 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. Follow-up testing after booster doses of

vaccine are given is not recommended, nor is routine follow-up testing necessary for patients

who are positive for both anti- HBs and anti-HBc.

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A facility should have systems in place for communicating these test results to other units or

hospitals when patients are transferred for care.