Updates in Infection Prevention Prevention of Bloodborne Pathogen Transmission Presented to: NKF of Illinois 18th Annual Interdisciplinary Nephrology Conference October 30, 2017 Maureen K. Bolon, MD, MS Presented to: Insert relevant presenter information Calibri 16pt Presented on: Month day, Year Presented by: Insert relevant presenter information here

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The Page The staff educator of the inpatient dialysis unit contacted Infection Control regarding the discovery of a patient who had been receiving dialysis in the unit and was subsequently found to have active hepatitis B

The Case Patient JF is a 55 yo woman with a history of renal failure due to IgA nephropathy. She is s/p cadaveric renal transplant 5 years previously. She was admitted two weeks ago to re-initiate hemodialysis due to graft failure. She underwent dialysis on three separate days During that admission, she was noted to have elevated liver transaminases. Work-up revealed active hepatitis B.

The Case, continued PMH ESRD due to IgA nephropathy, previously received hemodialysis Cadaveric renal transplant 5 years prior, failed due to rejection Hepatitis B immune Lab data: Hepatitis B sAg: positive Hepatitis B cAb: positive Hepatitis B c IgM: nonreactive Hepatitis B sAb: positive Hepatitis B viral load PCR: > 50,000,000 Hepatitis C Ab: nonreactive No prior available serologies. A history of hep B immune discovered after the fact.

The Problem Patient with active hepatitis B underwent hemodialysis without use of a dedicated dialysis machine or an isolation room Process for monitoring hepatitis B status flawed Dialysis unit following standard precautions consistent with acute-care setting, but maintenance dialysis for chronic hemodialysis occurring in the same unit

Outline for Today’s Talk Hepatitis B Diagnostic challenges Hepatitis B transmission in the healthcare setting Recommendations for the dialysis setting Acute vs. chronic setting Investigation and findings

Hepatitis B Worldwide more than 350 million people with chronic hepatitis B In U.S. 850,000-2,000,000 Highly infectious 30% risk of seroconversion after percutaneous exposure Risk for Hepatitis C is 1.8% Risk for HIV is 0.3% Epi refers to chronic infxn and immune 350 million people worldwide with chronic hep B 75% of these in Asia-Pacific Dialysis population was formerly a high-prevalence population (still is, but better now) http://asiber.ifs.hr/galerija_virusa/virus_hepatitis_B.jpg

Epi refers to chronic infxn and immune 350 million people worldwide with chronic hep B 75% of these in Asia-Pacific Dialysis population was formerly a high-prevalence population (still is, but better now)

Hepatitis B incidence Decreasing

Chronic Hepatitis B Also decreasing

rachel.worldpossible.org/ocw.tufts.edu/data

Hepatitis B serologies Test Interpretation HBsAg Hepatitis B surface antigen HBV infection IgM anti-HBc Antibody to hepatitis B core antigen Acute or recent HBV infection IgG anti-HBc Chronic or remote HBV infection HBsAb (anti-HBs) Antibody to hepatitis B surface antigen Immunity to HBV (vaccine-induced or results of prior infection) HBeAg Hepatitis B e antigen Active replication HBV DNA HBV viremia www.clevelandclinicmeded.com/medicalpubs/diseasemanagement/hepatology/hepatitis-B/images

Hepatitis B serologies Test Interpretation HBsAg Hepatitis B surface antigen HBV infection IgM anti-HBc Antibody to hepatitis B core antigen Acute or recent HBV infection IgG anti-HBc Chronic or remote HBV infection HBsAb (anti-HBs) Antibody to hepatitis B surface antigen Immunity to HBV (vaccine-induced or results of prior infection) HBeAg Hepatitis B e antigen Active replication HBV DNA HBV viremia www.clevelandclinicmeded.com/medicalpubs/diseasemanagement/hepatology/hepatitis-B/images

Hepatitis B Serology Timing Acute infection followed by recovery AKA anti-HBsAb

Hepatitis B Serology Timing Chronic Hepatitis B

What explains the serologic profile of the case patient? Patient JF: Hepatitis B sAg: positive Hepatitis B cAb: positive Hepatitis B c IgM: nonreactive Hepatitis B sAb: positive Hepatitis B viral load PCR: > 50,000,000

Hepatitis B virus reactivation Recognized in heme-onc population following cytotoxic or immunosuppressive therapy Characterized by the reappearance of HBV DNA or hepatitis Be Ag in a person who is an inactive HBV carrier or has resolved HBV infection May be asymptomatic or associated with a clinical flare Risk factors: lymphoma or breast CA, male gender, young age, pre-existing hepatitis, certain cytotoxic drugs, higher HBV DNA levels Pathogenesis: change in the balance between immunologic response to HBV and the extent of viral proliferation - Cytotoxic therapy may suppress normal immune function, enhance viral replication, and, eventually, result in increased HBV DNA polymerase activity and HBV DNA and HBeAg levels, reappearance of HBsAg, and decreased HBsAb titers.

Hepatitis B reactivation also reported in solid organ transplant recipients 25-30 cases from renal transplant literature Reactivation from 8 weeks to 15 years after transplantation Recommend monitoring closely to detect occult HBV carrier status and HBV reactivation PCR technology has shown us that HBV DNA may persist for a long time, irrespective of the results from serologic assays. Savas N et al. Transplant International 2007; 20: 301-4.

http://static3.edashcms.com/img/240/0/0/0/images

Hepatitis transmission in the healthcare setting Both hepatitis B and C a concern Fairly high-profile due to transmissions related to endoscopy procedures and multi-dose vials HCW-to-patient transmission also a possibility Patient-to-patient transmission often reported in nonhospital settings IC resources and oversight lacking

Total of 8 HCV infections identified

- Not just colonoscopy, endoscopy too.

HBV Transmission Percutaneous or mucosal exposure to blood or body fluids Environmental HBV remains viable for up to 7 days HBV at titers of 102-3 virions in absence of visible blood HBV detected in dialysis setting: Clamps, scissors, dialysis machine control knobs, door knobs - HBV at low titers on environmental surfaces can result in transmissions - Present 2 recent reviews of transmissions

Single Pass Hemodialysis Machine Internal fluid pathways not generally a concern for bloodborne viruses In single-pass hemodialysis machines, the internal fluid pathways are not subject to contamination with blood; if there is a dialyzer leak, dialysis fluid might become contaminated with blood, but this contaminated dialysis fluid is discarded through a drain and does not return to the dialysis machine to contaminate predialyzer surfaces. In dialysis machines that use a dialysate recirculating system (e.g., some ultrafiltration control machines and those that regenerate the dialysate), a blood leak in a dialyzer can contaminate the internal pathways of the dialysis machine, which could in turn contaminate the dialysis fluid of subsequent patients. However, the procedures that are normally practiced after each use--draining of the dialysis fluid, rinsing, and disinfecting) will reduce the level of contamination below infectious levels. In addition, an intact dialyzer membrane will not allow passage of bacteria or viruses. www.wikipedia.com

“Patient to patient transmission of hepatitis B virus: a systemic review of reports on outbreaks between 1992-2007” Published reports from USA and EU 33 outbreaks 471 patients 16 fatalities Settings involved: 30.3% dialysis units 21.2% medical wards 21.2% nursing homes 15.2% surgery wards 12.1% outpatient clinics Dialysis most common location Heme-onc units most common medical ward Heart transplant units most common surgical ward Majority of patients already affected by one or more underlying conditions causing some degree of immunosuppression Lanini S et al. BMC Medicine 2009; 7: 15: 1-9.

“Patient to patient transmission of hepatitis B virus: a systemic review of reports on outbreaks between 1992-2007” Lanini S et al. BMC Medicine 2009; 7: 15: 1-9.

“Nonhospital health care-associated hepatitis B and C virus transmission: US, 1998-2008” Review of CDC records & reports + published medical literature HBV: 18 outbreaks resulting in 173 transmissions HCV: 16 outbreaks resulting in 275 transmissions No healthcare-associated HIV More than 60,000 persons at risk for bloodborne infections Thompson ND et al. Ann Intern Med 2009; 150: 33-39.

“Nonhospital health care-associated hepatitis B and C virus transmission: US, 1998-2008” All 6 dialysis outbreaks involved HCV transmissions (40) All 15 LTCF outbreaks involved HBV transmission (97) Mechanism for patient-to-patient transmission: For outpatient clinics and HD centers: syringe re-use, contamination of injectable medications or flush Single use medication vials and saline used for multiple patients Outbreaks in LTCF involved reuse of fingerstick devices meant for individual use or improper sharing of equipment Thompson ND et al. Ann Intern Med 2009; 150: 33-39.

Update: Healthcare-associated Hepatitis B & C Outbreaks reported to CDC 2008-2016 Hepatitis B 24 outbreaks 179 cases >10,935 persons notified for screening 18 outbreaks at LTCF 83% related to blood glucose monitoring 5 outbreaks in other settings No outbreaks in dialysis

Update: Healthcare-associated Hepatitis B & C Outbreaks reported to CDC 2008-2016 Hepatitis C 36 outbreaks 288 cases >105,048 persons notified for screening 20 outbreaks in dialysis settings 100 outbreak-associated cases of Hepatitis C Issues identified: Environmental cleaning & disinfection Hand hygiene & glove use Vascular access care Medication preparation close to treatment area Single dose vials for > 1 patient

Hepatitis B incidence

HBV in Dialysis: Timeline HBV incidence 6.2% in HD patients HBV incidence 0.6% in HD patients HBV incidence 1% in HD patients Current CDC recommendations for preventing transmission of infections among chronic hemodialysis patients Recommendations for HBV vaccine for HD patients and staff First CDC recommendations for control of HBV in dialysis Big gains initially in reduction of HBV among both patients & staff. Leveling off because staff are a) unaware; b) confused about differences between standard precautions & HD precautions; and c) belief that HBV vaccine is not efficacious 1974 1977 1980 1982 1996 2001

1977 CDC Recommendations HBV serologic surveillance of patients and staff Ongoing monthly surveillance for susceptible patients Isolation of HBsAg-positive patients in a separate room No shared staff during shift No shared dialysis equipment between HBsAg positive and negative patients Assignment of a supply tray to each patient Cleaning & disinfection of nondisposable items Glove use for contact with equipment or patients; change gloves between patients Routine cleaning & disinfection of equipment & environmental surfaces - Segregation of patients & equipment resulted in 70-80% reductions in incidence of HBV infection among dialysis patients

1977 CDC Recommendations HBV serologic surveillance of patients and staff Ongoing monthly surveillance for susceptible patients Isolation of HBsAg-positive patients in a separate room No shared staff during shift No shared dialysis equipment between HBsAg positive and negative patients Assignment of a supply tray to each patient Cleaning & disinfection of nondisposable items Glove use for contact with equipment or patients; change gloves between patients Routine cleaning & disinfection of equipment & environmental surfaces - Segregation of patients & equipment resulted in 70-80% reductions in incidence of HBV infection among dialysis patients

Reasons why Hepatitis B transmissions may continue to occur in hemodialysis Failure to routinely screen and failure to review results Failure to segregate: staff members, supplies, equipment Multi-dose vials - Risk factors for acquiring HBV: presence of >= 1 HBV-infected patient in the dialysis who is not isolated AND <50% vaccination rate among patients

2001 Recommendations for preventing transmission of infections among chronic hemodialysis patients Infection control precautions for all patients in the chronic HD setting Management of Hepatitis B surface antigen-positive patients Hemodialysis in acute care settings This document deals with HIV, Hep C, and bacterial infections as well MMWR 2001 / Vol. 50 / No. RR-5

Infection Control Precautions for All Patients (Chronic) Glove use and Hand Hygiene Wear disposable gloves when caring for the patient or touching the patient’s equipment at the dialysis station; remove gloves and wash hands between each patient or station.

Infection Control Precautions for All Patients (Chronic) Supply movement Items taken into the dialysis station should either be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before being taken to a common clean area or used on another patient. Nondisposable items that cannot be cleaned and disinfected (e.g., adhesive tape, cloth-covered blood pressure cuffs) should be dedicated for use only on a single patient. Unused medications (including multiple dose vials containing diluents) or supplies (e.g., syringes, alcohol swabs) taken to the patient’s station should be used only for that patient and should not be returned to a common clean area or used on other patients. Supplies move in one direction only

Infection Control Precautions for All Patients (Chronic) Separation of medication from dialysis stations When multiple dose medication vials are used (including vials containing diluents), prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station.

Infection Control Precautions for All Patients (Chronic) Medication movement Do not use common medication carts to deliver medications to patients. Do not carry medication vials, syringes, alcohol swabs, or supplies in pockets. If trays are used to deliver medications to individual patients, they must be cleaned between patients. Medication for individual patients kept separate Unidirectional movement of medications and related supplies

Infection Control Precautions for All Patients (Chronic) Separation of medication from dialysis stations Clean areas should be clearly designated for the preparation, handling, and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medications or clean supplies in the same or an adjacent area to where used equipment or blood samples are handled.

Infection Control Precautions for All Patients (Chronic) Changing of dialysis machine components between patients Use external venous and arterial pressure transducer filters/protectors for each patient treatment to prevent blood contamination of the dialysis machines’ pressure monitors. Change filters/protectors between each patient treatment, and do not reuse them. Internal transducer filters do not need to be changed routinely between patients.

Infection Control Precautions for All Patients (Chronic) Prevent cross-contamination Clean and disinfect the dialysis station (e.g., chairs, beds, tables, machines) between patients. Give special attention to cleaning control panels on the dialysis machines and other surfaces that are frequently touched and potentially contaminated with patients’ blood. Discard all fluid and clean and disinfect all surfaces and containers associated with the prime waste (including buckets attached to the machines).

Infection Control Precautions for All Patients (Chronic) Prevent environmental contamination For dialyzers and blood tubing that will be reprocessed, cap dialyzer ports and clamp tubing. Place all used dialyzers and tubing in leakproof containers for transport from station to reprocessing or disposal area.

Infection Control Precautions for All Patients (Chronic) Hepatitis B vaccination and Immunity Vaccinate all susceptible patients against hepatitis B Test for anti-HBs 1-2 months after last dose. If anti-HBs is <10 mIU/mL, consider patient susceptible, revaccinate with an additional three doses, and retest for anti-HBs. If anti-HBs is >10 mIU/mL, consider patient immune Retest annually Give booster dose of vaccine if anti-HBs declines to <10 mIU/mL and continue to retest annually.

Management of HBsAg-Positive Patients Separation of patients and staff Follow infection control practices for hemodialysis units for all patients in chronic HD setting. Dialyze HBsAg-positive patients in a separate room using separate machines, equipment, instruments, and supplies Staff members caring for HBsAg-positive patients should not care for HBV-susceptible patients at the same time (e.g., during the same shift or during patient changeover) Emphasizes separation of patients & staff

Hemodialysis in Acute Care Settings Important caveat For patients with acute renal failure who receive hemodialysis in acute care settings, Standard Precautions as applied in all healthcare settings are sufficient to prevent transmission of bloodborne viruses. However, if both acute and chronic renal failure patients receive hemodialysis in the same unit, infection control precautions specifically designed for chronic hemodialysis units should be applied to ALL patients.

Back to the exposure Patient with active hepatitis B underwent hemodialysis without use of a dedicated dialysis machine or an isolation room Process for monitoring hepatitis B status flawed Dialysis unit following standard precautions consistent with acute-care setting, but maintenance dialysis for chronic hemodialysis occurring in the same unit

The investigation Patient received dialysis February 7th through February 11th Hepatitis B survives in the environment for at least 7 days Case finding conducted to identify all patients who received dialysis in the inpatient unit between February 7th through February 18th + 7 Days The risk for transmission of hepatitis B in a dialysis unit relates as much if not more to environmental contamination as to the dialysis machine HBV may be present in the absence of visible blood

Exposure investigation Acute HD patients Determine HBV immune status Disclosure Initial testing Offer vaccination Follow-up testing 3 & 6 months Chronic HD patients Determine HBV immune status Disclosure Work through dialysis centers Initial testing Offer vaccination Follow-up testing as part of routine chronic HD testing monthly - HBV serologies + LFTs done initially - Disclosure through certified letters.

Exposure epidemiology 57 HD Inpatients 1 Index Case 56 Potential Exposures 6 (11%) Acute HD Pts 50 (89%) Chronic HD Pts 9 (18 %) Expired during investigation 31 (62%) Immune 1 (17 %) Expired during investigation 1 (25%) Lost to follow up 3 (30%) Lost to follow up 10 (20 %)Non-immune 4 ( 67%) Non-immune 1 (17 %) Immune 3 (75%) Completed follow up 7 (70%)Completed follow up Did not expire due to HBV 14 of 57 (24%) not counting expired were at risk No conversions at 6 mos

Hepatitis B testing in an inpatient dialysis unit Policy: Hepatitis B status must be determined prior to first dialysis Barrier: Turn around time for HBV serologies 24 hours Solution: Dialysis-specific order set Laboratory turn around time 3 hours Available 7A – 9:30P; 7 days a week

Hepatitis B testing in an inpatient dialysis unit Institutional Policy All susceptible hemodialysis patients should be vaccinated for protection against hepatitis B Patients receiving HD in the acute-care setting will be screened to ascertain their HBV status, by either a written report from the referring center or by serologic test Those patients that are hospitalized greater than 30 days must be tested monthly while an inpatient Outside tests obtained that are greater than 30 days from the first inpatient dialysis treatment will not be accepted. Serologies must be drawn. Patients who have an isolated anti-HBc status (i.e., HBsAg negative, anti-HBs negative, anti-HBc total positive) must be tested on admission and monthly thereafter while hospitalized Results will be recorded in the patient record and available to all HC personnel assigned to these patients as well as to IC.

Environment of Care Assessment Observations Environment, personnel, attire, HH, set-up and maintenance of the patient care area, catheter insertion, access, and maintenance practices Evaluated for adherence to accepted standards IDPH hospital licensing requirements CDC HIPCAC guidelines Institutional policies Manufacturer’s instructions

The environment

The environment

The environment

The environment

Other findings Hand Hygiene Glove use Common supply carts in treatment areas Movement of unused supplies between workstations and supply carts Crowding

Conclusions Hepatitis B exposure did not result in any conversions Infection Control investigation did identify many problems with practice and led to significant improvements in: HBV testing Environment IC practices - HBV testing including surveillance for reactivation in previously immune patients.

With thanks to NMH Healthcare Epidemiology and Infection Prevention and NMH Dialysis Unit

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