1. 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
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2. No disclosures

3. 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

4. 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.

5. 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.

6. 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

7. 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

8. 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)

9. 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)

10. Hepatitis B incidence
Decreasing

11. Chronic Hepatitis B
Also decreasing

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

13. 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

14. 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

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

16. Hepatitis B Serology Timing
Chronic Hepatitis B

17. 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

18. 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.

19. 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:

21. 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

22. Total of 8 HCV infections identified

23. - Not just colonoscopy, endoscopy too.

26. HBV Transmission
Percutaneous or mucosal exposure to blood or body fluids
Environmental
HBV remains viable for up to 7 days
HBV at titers of 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

27. 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.

28. “Patient to patient transmission of hepatitis B virus: a systemic review of reports on outbreaks between ”
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.

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

30. “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:

31. “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:

32. Update: Healthcare-associated Hepatitis B & C Outbreaks reported to CDC
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

33. Update: Healthcare-associated Hepatitis B & C Outbreaks reported to CDC
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

34. Hepatitis B incidence

36. 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

37. 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

38. 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

39. 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

40. 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

41. 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.

42. 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

43. 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.

44. 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

45. 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.

46. 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.

47. 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).

48. 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.

49. 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.

50. 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

51. 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.

52. 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

53. 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

54. 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.

55. 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

56. 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

59. 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.

60. 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

61. The environment

62. The environment

63. The environment

64. The environment

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

66. 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.

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

68. Questions?

69. Thank You