1. Preventing Infections in Hemodialysis
Priti R. Patel, MD, MPH
Division of Healthcare Quality Promotion
Centers for Disease Control and Prevention
Nothing to disclose
July 28, 2010
The findings and conclusions in this presentation are those of the author and do not necessarily represent the views of the Centers for Disease Control and Prevention.

2. Have you..
Been involved in central line associated bloodstream infection (CLABSI) prevention efforts in your facility?
Had any involvement in your facility’s dialysis center?

3. Important Trends Growing dialysis population; ~350,000
Mortality, increasing morbidity from infections
Antimicrobial resistant infections, emerging patterns of resistance
In 10 years (2020), number is projected to be ~530,000
United States Renal Data System (USRDS) 2008 Annual Data Report

4. Invasive Methicillin-Resistant S. aureus (MRSA) Infections, 2005
Incidence of invasive MRSA infections
45.2 cases per 1,000 dialysis population
= 100 X rate in general population (0.2 – 0.4 per 1000)
Dialysis patients
~0.1% of the U.S. population
15% of all invasive MRSA infections
Invasive MRSA in dialysis
86% were bloodstream infections (BSIs)
90% required hospitalization, mortality = 17%
The incidence of invasive MRSA infections is approximately 45.2 cases per 1000 dialysis popn, a rate that is 100 times greater than in the general population.
Dialysis patients make up approximately 0.1% of the US population but accounted for 15% of all invasive MRSA infections reported to CDC’s Active Bacterial Core surveillance system in 2005.
Of these invasive MRSA infections in dialysis patients, 86% were bloodstream infections, 90% required hospitalization and the in-hospital mortality was 17%
(Of 5287 cases of invasive MRSA reported to CDC in 2005, 813 (15%) occurred in dialysis patients)
Most invasive MRSA infections are healthcare-associated community onset. Dialysis is a major component of that. And whereas there has evidence of reductions in BSI
CDC. MMWR 2007; 56(09):197-9

5. Delivery of Dialysis Care
5,240 dialysis facilities nationwide
~850 are hospital-based
Increasingly consolidated ownership
2 large, for-profit chains treat ~60% of all patients
Medicare primary payor (ESRD program)
Economic incentives – major driver
Facilities frequently lack infection control expertise
United States Renal Data System (USRDS) 2008 Annual Data Report

6. Nonhospital Healthcare Settings: The Next Frontier

7. What can be done about infections in outpatient populations?
Improve infection control practices in outpatient settings
Regulatory efforts
Engage hospital infection control expertise
Prevention research / initiatives
Demonstrate preventability
Could there be a dialysis “bundle”?
Efforts in inpatient settings

8. Regulatory Changes
April 2008 – The Centers for Medicare and Medicaid Services (CMS) released new conditions for coverage for End Stage Renal Disease (ESRD) facilities
First comprehensive revision since 1976
Incorporates CDC / HICPAC infection control recommendations
First time infection control is a separate condition
Explain ESRD
Since rules were first adopted in 1976
What is a condition
Infection control used to only be citable under “environmental conditions” whereas now, it is it’s own separate condition that involves everything from HH to hep B isolation

9. New CMS Conditions for Coverage
Includes by reference:
Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients, 2001
Guidelines for the Prevention of Intravascular Catheter-Related Infections, 2002
Links:

10. Early Impact & Perspective
New Conditions went into effect October 2008
Has helped to highlight the importance of infection control in dialysis settings
Infection control has been the most common category of citation during the new survey process
Demonstrated gaps:
In adherence to recommendations prior to the new conditions
In the recommendations and conditions

11. CMS Conditions for Coverage: New Opportunities
Improving infection control
Reduce infections and improve patient outcomes
Infection prevention & the Conditions
Conditions are a floor, not a ceiling
Need to go beyond requirements to truly prevent infections
Is a starting point for many other opportunities

12. BSIs in Hemodialysis: Capturing our Attention

13. Epidemiology of Infections among Hemodialysis Patients
Infections are the 2nd leading cause of death (15% of deaths)
Site of infection
57% vascular access
23% wound
15% lung
5% urinary tract
Dialysis Surveillance Network looks at the breakdown of incidents/ events (10/99 – 5/01)
Including hospitalizations, antimicrobial starts, positive blood cultures.
USRDS 2005 Annual Data Report
Tokars, Miller, Stein. AJIC 2002;30:

14. How Common are Vascular Access Infections, Including BSIs?
Estimate in the literature
Catheter-related BSI:
2.5 – 5.5 per 1000 patient-days
0.9 – 2.0 episodes per patient-year
Surveillance data
CDC’s National Healthcare Safety Network
(NHSN) dialysis event module
Allon. AJKD 2004; 44:779-91

15. Outcomes of S. aureus BSI
Among hemodialysis patients admitted with
S. aureus bacteremia1:
Avg. length of stay: 13 days
Cost of hospital admission = $20,685
31% had complications
21% had to be readmitted
Within 12 weeks,
19% died from any cause
11% died due to S. aureus
1. Engemann. ICHE 2005(26): Nissenson. AJKD 2005(46):301-8

16. Hospitalization Rates
Cause-specific hospitalization rates among hemodialysis patients, 2006:
Vascular access infection = ~125 admissions / 1000 pt-yrs
Bloodstream infection = 103 admissions / 1000 pt-yrs
Pneumonia = 76 admissions / 1000 pt-yrs
Since 1993, rates* have increased for:
All infections (+34%)
Bloodstream infection (+31%)
Cellulitis (+20%)
Pneumonia (+7%)
% change since 1993
Change in hospitalization rate
Year
Cellulitis (+20%)
Pneumonia (+7%)
(* adjusted for age, race, sex, and cause of ESRD)
USRDS 2008 Annual Data Report

17. CLABSIs per 1,000 Central Line Days
Trends in Incidence of Central Line-Associated Bloodstream Infections by ICU Type—United States,
CLABSIs per 1,000 Central Line Days
Has led many people to view outpatient BSIs as the next frontier †
Slide courtesy: Deron Burton, CDC Source: NNIS (< 2005) and NHSN (> 2005). Data represents 1,681 units, 16,225,498 patient days, and 33,587 CLABSIs
Year 17

18. BSIs per 100 patient-months
Distribution of Facility BSI Rates by Vascular Access Type, NHSN (N=49)
BSIs per 100 patient-months
Percentile
Fistula
Graft
Tunneled CVC
10th
0.00
1.50
25th
0.27
2.54
50th (median)
0.66
1.02
4.76
75th
1.13
1.88
8.89
90th
3.17
3.81
14.39
Pooled mean
0.68
1.14
3.93 18

19. BSIs per 100 patient-months
Distribution of Facility BSI Rates by Vascular Access Type, NHSN (N=49)
BSIs per 100 patient-months
Percentile
Fistula
Graft
Tunneled CVC
10th
0.00
1.50
25th
0.27
2.54
50th (median)
0.66
1.02
4.76
75th
1.13
1.88
8.89
90th
3.17
3.81
14.39
~0.5 per 1,000 catheter-days
~1.6 per 1,000 catheter-days
~4.8 per 1,000 catheter-days
Pooled mean
0.68
1.14
3.93 19

20. BSI Rate in Patients with Tunneled CVC by Facility Type, NHSN 2007-2008
# BSIs in tunneled CVC patients
# Tunneled CVC patient-months
Pooled mean rate (per 100 CVC patient-months)
RR (95% CI)
Hospital-based (n=26)
490
13,018
3.76
Ref.
Other outpatient (n=23)
433
8,208
5.28
1.40 (1.23,1.60)

21. Vascular Access

22. Vascular Access Infections Risk Factors
Type of access
catheter >>
graft >
fistula
Lower extremity access
Recent access surgery
Trauma, hematoma, dermatitis, scratching
Poor hygiene
Poor needle insertion technique
Older age
Diabetes
Iron overload
Others 22

23. Differences in Event Rates: Fistula vs. Catheter
Infections at access site
Lowest
Highest
Infections at other sites
Hospitalizations
Deaths from Infection
Deaths from all causes
Tokars, Miller, Stein. AJIC 2002;30:
Pastan, Soucie, McClellan. Kidney Int 2002;62:

24. Rate of Access-Related Bloodstream Infection by Vascular Access Type
Dialysis Surveillance Network

25. Types of Vascular Access, U.S. Hemodialysis Patients, by Year
Rate of fistulas increasing but catheter rate also increasing
From an infection standpoint, increasing fistulas is not enough so long as catheters remain in as well. The goal of getting fistulas in, is to get the catheters out!
Finelli, Miller, Tokars. Semin Dial 2005;18:52-61

26. Prevalent Hemodialysis Patients with AV Fistula
USRDS 2008 Annual Data Report

27. Prevalent Hemodialysis Patients with AV Graft
USRDS 2008 Annual Data Report

28. Prevalent Hemodialysis Patients with Catheter
USRDS 2008 Annual Data Report

29. Fistula First Initiative
Goals:
66% AV fistula use
<10% long term catheter use
Spergel LM. Seminars in Dial.

30. Vascular Access at First Outpatient Dialysis, 2006
Catheter – 82%
17% maturing fistula
3% maturing graft
AV graft – 4%
AV fistula – 12%
USRDS 2008 Annual Data Report

31. Vascular Access Distribution Among Patient Census, NHSN 2007-2008 (N=49)
Fistula
Graft
Tunneled CVC
Nontunneled CVC
Median
48.1%
15.5%
34.8%
0.0%
Range % % % %

32. Hospital-Affiliated vs. Other Outpatient Facilities, NHSN 2007-2008
Median by Facility Type
Fistula
Graft
Tunneled CVC
Nontunneled CVC
Hospital-based (n=26)
45.9%
14.2%
37.7%
0.0%
Other outpatient (n=23)
51.7%
17.8%
27.7%
p=0.10
p=0.02

33. Prevention

34. Prevent Infection:
Get the catheters out
Fact: Indwelling catheters are the single most important factor contributing to bloodstream infection in hemodialysis patients.
Actions:
Hemodialysis:
Use catheters only when essential
Maximize use of fistulas
Remove catheters when they are no longer essential
The most effective way to decrease catheter-associated infections is to decrease catheter utilization.
In other words, get the catheters out!
For hemodialysis patients:
- Catheters should only be used when essential to patient care, not for convenience or as a “routine” practice,.
- The need for a catheter should be assessed on a daily basis so that unnecessary catheters will be recognized and removed.
- The use of fistulas and grafts should be maximized.
For peritoneal dialysis patients, infected catheters should be removed or replaced. 34

35. Prevent Infection
Optimize access care
Fact: Careful infection control can prevent dialysis-related infections.
Actions:
Follow established guidelines for access care
Use proper insertion and catheter-care protocols
Remove access device when infected
Adherence to Kidney Disease Outcomes Quality Initiative and CDC guidelines for access care will prevent infections and help ensure successful dialysis access.
Use proper insertion and catheter-care protocols.
When the catheter device is infected, it should be removed to prevent further infection from occurring.
Use of the correct catheter is important for both controlling infections and successful vascular access. 35

36. BSIs in Hemodialysis: Achieving Success
Prevention Collaboratives
Surveillance & Feedback
Intervention Bundle

37. Bloodstream Infection Interventions: Pittsburgh Regional Healthcare Initiative,
32 hospitals, 66 ICUs
Intervention:
Promotion of evidence-based catheter insertion practices
Development / promotion of educational module
Promotion of standardized tools for recording catheter insertion practices
Promotion of standardized catheter insertion supply kits
Regular feedback of BSI rates
Standardized definitions and case finding methods
Process to share information and experience
MMWR 2005;54:

38. Overall rate reduction of 68%
As previously published in the MMWR in 2005, there was an overall observed reduction of 68% in the central line-associated bloodstream infection rate among ICUs in facilities. When evaluated by unit-type, the observed reduction was 67% in medical surgical ICUs shown by the lower dashed line on the graph, and 69% in all other unit types denoted in the upper solid line. However, no comparison to hospitals outside the collaborative has been reported. Such a evaluation is important to help determine whether or not this reduction reflects changes in the underlying national secular trends for central line-associated rates.
MMWR 2005;54:1013-6 38

39. Semi-Annual Central Line-associated Bloodstream Infection Rates in Medical-Surgical Intensive Care Units Participating in the Southwest Pennsylvania Collaborative and NNIS,
p=NS *
p<0.001
This is illustrated graphically here. The Y axis shows central line-associated rate per 1000 central line days, and the x axis semi-annual period. The trend for the collaborative facilities, again in yellow, shows a decline in slope confirmed by the model. The NNIS comparison group in blue shows no significant linear change in trend. 39

40. Michigan Keystone Initiative

41. Michigan Keystone ICU Project (103 ICUs, 67 hospitals)
Intervention:
Training of team leaders in science of safety
Standardized central-line cart with necessary supplies
Checklist was used to ensure adherence to catheter-insertion practices
Providers were stopped (in nonemergency situations) if these practices were not being followed
Removal of catheters was discussed at daily rounds
Regular feedback of BSI rates
Pronovost et al. NEJM 2006;355:

42. Michigan Keystone ICU Project (103 ICUs, 67 hospitals)
Overall rate reduction of 66%
Pronovost et al. NEJM 2006;355:

43. Conclusions from Pittsburgh and Michigan Experiences
Decreases in central line-associated BSI rates >60% achieved in hospital ICUs of varying types
The prevention practices utilized during these interventions were not novel
Improving adherence to existing evidence-based practices can prevent BSIs
Collaboration may be helpful in identifying and overcoming commonly shared barriers to adherence

44. Conclusions from Pittsburgh and Michigan Experiences
Results from successful collaborative demonstration projects may be an important strategy for influencing global changes in practice in ways that improve quality
Disarms uncertainties about preventability that can hamper improvement efforts
Helps identify practical strategies that can be successful across many facilities

45. A Successful, Multi-Center BSI Prevention Collaborative For Hemodialysis Patients Will Have National Impact
Motivated hemodialysis centers who are interested in working in partnership with others to:
Identify setting-specific barriers and challenges (because dialysis centers are very different from ICUs)
Identify workable and practical solutions to those barriers
Be open to innovation
Collect and share data in a uniform fashion
Contribute to an effort that will likely have major and enduring impact on the health of hemodialysis patients not only in your center, but across the Nation

46. CDC-Sponsored Dialysis Collaborative
Establish collaboration of outpatient dialysis facilities all reporting to NHSN
Share information related to best practices
Work to develop and implement practical solutions
Prevent BSI & improve patient outcomes 46

47. BSI Prevention, Bundles & Collaboratives
Good evidence-base for interventions
Logical extension of efforts to reduce BSIs in inpatient settings
Recognizing challenges unique to dialysis
Early evidence supports the preventability of these infections

48. Proposed Core Interventions for CDC Dialysis Collaborative
1. Surveillance for positive blood cultures, antimicrobial starts, and hospitalizations using NHSN – Conduct monthly surveillance for dialysis events and enter events into NHSN. CDC will provide facility rates and comparisons to other facilities. Facilities should actively share results with front-line providers. 2. Chlorhexidine for skin antisepsis – Use chlorhexidine (2% or greater) as the first line agent for skin antisepsis. Povidone-iodine, preferably with alcohol, is an alternative. 3. Antimicrobial ointments – Apply bacitracin/gramicidin/polymixin B or povidone-iodine ointment to catheter exit sites at each dressing change. 4. Hand hygiene surveillance – Perform monthly hand hygiene audits with feedback of results.

49. Proposed Core Interventions for Dialysis Collaborative
5. Catheter care/ access observations – Perform monthly audits of catheter care and accessing practices to ensure adherence to facility guidelines. This may include use of a mask while connecting and disconnecting catheters and during dressing changes.
6. Patient education/engagement – Provide standardized, basic education to all patients including (but not limited to) care of vascular access, hand hygiene, cleansing vascular access, and instructions for access management when away from the dialysis unit.
7. Staff education and competency – Provide regular training for staff on infection control topics, including care of access and aseptic technique. Perform evaluation of competency for skills such as catheter care and accessing at least yearly and upon hire.
8. Catheter reduction – Incorporate efforts within the facility (e.g., patient education) to reduce catheters by identifying barriers to permanent vascular access placement and catheter removal.

50. The Value of Surveillance
Busy London dialysis unit: 112 patients
Implemented CDC dialysis surveillance; described their experience over 18 months
After initial set up, required 2 hours per month
Outcomes: Reductions in
Access-related bacteremia
Antibiotic usage
Hospital admissions
George A, Tokars JI, Clutterbuck EJ, et al. BMJ 2006; 332:

51. Antimicrobial Starts
George A, Tokars JI, Clutterbuck EJ, et al. BMJ 2006; 332:

52. Access-Related Bacteremia
George A, Tokars JI, Clutterbuck EJ, et al. BMJ 2006; 332:

53. Observations
“Surveillance raised awareness and provided a cornerstone for improved infection control and line care involving all staff of the dialysis unit.”
“The data feedback generated unit led programmes of risk reduction and infection control.”
George A, Tokars JI, Clutterbuck EJ, et al. BMJ 2006; 332:

54. Collaborative Feedback Report
Median
Facility

55. Example of an Intervention Involving A Vascular Access “Bundle”
Healthcare worker education (May 2006)
Hand hygiene, aseptic technique, access site care
Feedback of VAA-BSI surveillance data to facility staff and physicians (May 2006)
Use of 2% chlorhexidine-70% alcohol solution for catheter site care and prior to accessing A-V fistulas and grafts (July 2006)
Patient education (January 2007)
Access site care
Benefits of an A-V fistula
Vascular Access Liaison (May 2007)
Data presented at SHEA Annual Conference, Mar. 2009
Slide courtesy: David Calfee, MD, Mount Sinai School of Medicine

56. Results: Incidence of VAA-BSI Over Time
p=0.03
p=0.01
p=0.16
Data presented at SHEA Annual Conference, Mar. 2009
Slide courtesy: David Calfee, MD, Mount Sinai School of Medicine

57. Highlights from their “expanded” bundle:
Getting to Zero: Outpatient Hemodialysis Catheter-Associated Bloodstream Infections
Virginia R. Bren, RN, MPH, Altru Health System, Grand Forks, ND
Friday, March 19, SHEA poster presentation
Highlights from their “expanded” bundle:
Catheter hub disinfection with chlorhexidine gluconate 3.15%
Hand hygiene plus gloving prior to contacting patients or machines
Relocating supplies, from near the patient to a central area
Strengthening environmental cleaning practices
Chlorhexidine-impregnated sponge dressing for catheters deemed high risk
Strengthening of a comprehensive fistula placement program
Results:
Reduction in central line BSI rate from 2.4 per 100 patient-months to 0
i.e. a previous infection, a femoral site, or patients with limited access alternatives 

58. Where Do We Go From Here? Prevention Efforts Studies
Collaborative approach
Improving adherence to evidence-based practices
Expanding surveillance & enhancing it’s utility
Studies
Target prevention efforts
Identify new strategies
Creative Thinking & Strategic Partnerships
How to bridge the inpatient-outpatient gap
Overcoming challenges in resources and expertise
Role of infection preventionists

59. BSIs in Hemodialysis: Achieving Success
Prevention Collaboratives
Surveillance & Feedback
Intervention Bundle 59

60. Contact: NHSN@cdc.gov or Ppatel@cdc.gov
Join Us!
Easy transition if you’re already reporting to NHSN
Contact: or

61. What else can be done? Check out practices in your inpatient unit
Interface with dialysis staff
Join our conference calls
Check out new APIC Guide

62. PREVENTION
IS PRIMARY!
Thank you!

63. Methicillin-resistant Staphylococcus aureus bloodstream infections
Epidemiological category
2005 pooled mean incidence (per 10,000 person years)
2008 pooled mean incidence (per 10,000 person years)
Modeled yearly percent change ( )
P-value
Hospital-Onset
0.88
0.62
-11.2%
0.001
Healthcare-associated Community-onset
1.97
1.62
-6.6%
<0.001
Dialysis in last year
501.5
404.48
-6.4%
0.02
No dialysis in last year
1.58
1.31
-7.2%
0.006

64. Median
Facility

65. Summary of Vascular Access Infections
Major cause of morbidity & mortality
Indicators moving in the wrong direction:
Increasing morbidity, catheter use
New regulatory efforts
CMS requirements probably not sufficient to solve the problem
Prevention efforts are underway; more needed
Evaluate current initiatives
Strategies to improve adherence
New technologies

66. Landscape & New Requirements
Gaps
Lack of reimbursement for HCV screening
Regulations can’t solve every problem
Requiring components (e.g., surveillance & QI) doesn’t necessarily equate to a functional IC program
Overcoming challenges in resources and expertise 66

67. Landscape of Infection Control in Dialysis: New Requirements
Early successes
Increased awareness of infection control issues
Improved adherence to HBV testing & isolation requirements
Essentially eliminated some breaches: re-use of single dose medication vials
Innovative uses
Promote interaction with public health & reporting
Promising
Focus on immunizations
Dialysis technician certification requirements 67

68. Bridging the Gap: What is the Role of Acute Care Hospitals?
Why do 60% of all patients start dialysis with a catheter and no permanent access?
Could this be addressed prior to discharge?
Can hospitals improve pre-ESRD vaccinations?
Communication of laboratory and other information during a hospitalization