What are the hepatitis testing and prevention requirements in a dialysis unit?

Hepatitis Testing Requirements in Dialysis Units

All patients starting in-center hemodialysis must be screened for hepatitis B (HBsAg, anti-HBs, and anti-HBc) and hepatitis C (anti-HCV antibody or NAT) before admission, with ongoing HCV surveillance every 6 months and monthly HBsAg testing for susceptible patients. 1

Initial Screening Requirements

Hepatitis B Testing at Admission

• Test all patients for HBsAg, anti-HBs, and anti-HBc before admission to any outpatient dialysis facility 1
• This comprehensive three-test panel is mandated by CDC and adopted by CMS as part of Medicare's Conditions for Coverage for End-Stage Renal Disease Facilities 1
• Testing determines infection status, immunity, and guides vaccination decisions 1

Hepatitis C Testing at Admission

• Screen all patients upon initiation of in-center hemodialysis or transfer from another facility using immunoassay or NAT (Grade 1A) 1
• For immunocompromised patients or high-prevalence units, NAT alone may be preferred as first-line testing to avoid false-negatives during the window period 1
• Draw blood samples before dialysis sessions, as hemodialysis reduces viremia levels 1

Additional Baseline Testing

• Check serum ALT level upon initiation of hemodialysis or transfer from another facility (Grade 2B) 1
• HIV screening is recommended for patients aged 13-64 years with voluntary consent 1

Ongoing Surveillance Requirements

Routine HCV Monitoring

• Screen all in-center hemodialysis patients for HCV infection every 6 months using immunoassay or NAT (Grade 1B) 1
• This applies to all HCV-negative patients and those with resolved infection (anti-HCV positive, HCV RNA negative) 1
• Patients with resolved HCV infection require NAT testing every 6 months to detect reinfection (Grade 1B) 1

Routine HBV Monitoring Based on Status

• Susceptible patients (HBsAg-negative, anti-HBs-negative): Screen monthly for HBsAg to identify seroconversion early 1, 2
• Immune patients (anti-HBs-positive): Check anti-HBs levels annually and revaccinate if levels fall below 10 IU/L 1, 2
• This stratified approach allows early detection while avoiding unnecessary testing in immune individuals 1

Monthly ALT Monitoring

• Check ALT levels monthly in all hemodialysis patients (Grade 2B) 1
• Elevated ALT may indicate acute HCV infection before antibody seroconversion occurs 1

Response to New Infections

Outbreak Investigation Protocol

When a new HCV or HBV infection is identified:

• Immediately test all patients in the facility for HCV infection (Grade 1A) 1
• Increase testing frequency temporarily: monthly for 3 months, then once at 6 months, then resume 6-month intervals if no additional cases 1
• Report any new HCV or HBV infection to public health authorities 1
• Review baseline test results to confirm new infection versus pre-existing infection 1
• Consider molecular sequencing to identify transmission sources 1

Special Population Testing

Peritoneal Dialysis and Home Hemodialysis

• Screen for HCV upon initiation of peritoneal dialysis or home hemodialysis (Grade 2D) 1
• If these patients receive temporary in-center hemodialysis, follow in-center screening protocols with continued surveillance until 6 months after returning to home modality 1

Kidney Transplant Candidates

• Screen all patients for HCV at time of transplant evaluation (Grade 1A) 1
• HCV status determination is essential for optimal management and donor kidney acceptance decisions 1

Critical Pitfalls to Avoid

• Do not rely solely on anti-HCV testing in immunocompromised patients or high-prevalence units—NAT may be necessary as first-line testing to avoid missing acute infections during the antibody window period 1
• Do not assume resolved HCV infection provides immunity—these patients remain at risk for reinfection and require ongoing NAT surveillance every 6 months 1
• Do not delay outbreak investigation—when one new infection is identified, all patients must be retested immediately as delayed seroconversions from the same exposure may occur 1
• Do not forget to draw HCV samples before dialysis—post-dialysis samples may have falsely low viremia levels 1
• Do not neglect annual anti-HBs monitoring in immune patients—antibody levels wane over time and booster vaccination is needed when levels drop below 10 IU/L 1, 2