CMS SOM App. H, Tag V125

Hepatitis B Vaccination

Vaccinate all susceptible patients and staff members against Hepatitis B.

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

According to the CDC, Hepatitis B vaccination is recommended for all susceptible chronic

hemodialysis patients and staff members, regardless of whether the facility accepts patients with

hepatitis B virus (HBV) infection. OSHA mandates that each facility provide the HBV vaccine to

all susceptible staff members.

Hepatitis B vaccination is also recommended for patients with Stage 1-5 chronic kidney disease

who are not yet on dialysis, as well as for those undergoing peritoneal dialysis (PD) and home

hemodialysis (home HD), since they may require in-center hemodialysis. While not a

requirement, best practice suggests that the home training nurse advise anyone assisting in the

home hemodialysis treatment of an HBV+ patient to consult their physician about vaccinating

against Hepatitis B.

The patient’s physician should refer to the CDC recommendations or the vaccine literature for

guidance in dosing. Higher doses of the vaccine are recommended for hemodialysis patients due

to their immunocompromised state.

Since patients and staff have the right to refuse a vaccination, this rule is interpreted to mean

that all susceptible patients and staff are “offered” an appropriate Hepatitis B vaccination

schedule in an appropriate timeframe. “Appropriate timeframe” refers to the period during

which vaccinations should be offered and initiated for employees and patients, and the course

completed according to the timeline suggested by the vaccine manufacturer.

For employees, personnel files should demonstrate compliance with this regulation. OSHA

requires facilities to maintain a record of their employees’ Hepatitis B immunization history and

to contact past employers to obtain vaccination records, if applicable. OSHA requires these

records be maintained for 30 years after the person leaves employment. If the employee states

they have been vaccinated, but the records are not obtainable, the personnel record should

include a statement attesting to the employee having received the vaccine, along with the dates

(or approximate dates) signed by the employee.

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Patient medical and personnel records respectively must show whether susceptible patients and

staff are offered Hepatitis B vaccination. There must be a system in place to track vaccination

administration to ensure completion of the ordered course.