Infection Prevention and Control in Dialysis
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1 Infection Prevention and Control in Dialysis Priti R. Patel, MD, MPH Division of Healthcare Quality Promotion Centers for Disease Control and Prevention June 10, 2009 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. Where does infection control fit in for dialysis providers?... Where does dialysis fit in for infection preventionists?
2 Important Trends Growing dialysis population; ~350,000 Mortality, increasing morbidity from infections Antimicrobial resistant infections, emerging patterns of resistance United States Renal Data System (USRDS) 2008 Annual Data Report 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 ( per 1000) Dialysis patients ~0.1% of the U.S. population 15% of all invasive MRSA infections Invasive MRSA in dialysis 86% were BSIs 90% required hospitalization, mortality = 17% CDC. MMWR 2007; 56(09): Time from Prior Discharge to Community-Onset MRSA Bacteremia in 10 Veterans Administration Hospitals, Number of cases of community-onset MRSA bacteremia (24.7%) within 4 weeks 675 (37.3%) within 8 weeks 883 (48.8%) within 16 weeks 1215 (67.2%) within 1 year 282 (15.6%) without prior in-patient stay n=1808 * Time (weeks) *>208 weeks
3 Trends in Incidence of Central Line-Associated Bloodstream Infections by ICU Type United States, Cardiothoracic Coronary Medical Medical/Surgical--Major Teaching Medical/Surgical--Non-Major Teaching Pediatric Surgical Slide courtesy: Deron Burton, CDC Source: NNIS (< 2005) and NHSN (> 2005). Data Year represents 1,681 units, 16,225,498 patient days, and 33,587 CLABSIs CLABSIs per 1,000 Central Line Days Delivery of Dialysis Care 5,000 dialysis facilities nationwide ~850 are hospital-based Increasingly consolidated ownership 2 large, for-profit chains treat ~60% of all patients Economic incentives major driver Facilities frequently lack infection control expertise Nonhospital Healthcare Settings: The Next Frontier
4 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 Demonstrate preventability Could there be a dialysis bundle? Efforts in inpatient settings What s new in dialysis 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 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:
5 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 commonly cited violation identified during the new survey process Demonstrated gaps: In adherence to recommendations prior to the new conditions In the recommendations and conditions Mortality and Survival on Dialysis Annual death rate: ~23% Adjusted five-year survival, by modality ~33% alive at 5 years Months after initiation USRDS 2008 Annual Data Report Epidemiology of Infections among Hemodialysis Patients Infections are the 2 nd leading cause of death (15% of deaths) Site of infection 57% vascular access 23% wound 15% lung 5% urinary tract USRDS 2005 Annual Data Report Tokars, Miller, Stein. AJIC 2002;30:
6 Vascular Access & Bloodstream Infections (BSI) Vascular access infections Local access site infection or bloodstream infection (BSI) Catheter-related BSI: per 1000 patient-days episodes per patient-year Allon. AJKD 2004; 44: 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%) (* adjusted for age, race, sex, and cause of ESRD) USRDS 2008 Annual Data Report % change since 1993 Change in hospitalization rate Year Outcomes of S. aureus BSI Among hemodialysis patients admitted with S. aureus bacteremia 1 : 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
7 Vascular Access Differences in Event Rates: Fistula vs. Catheter Fistula Catheter Infections at access site Lowest Highest Infections at other sites Lowest Highest Hospitalizations Lowest Highest Deaths from Infection Lowest Highest Deaths from all causes Lowest Highest Tokars, Miller, Stein. AJIC 2002;30: Pastan, Soucie, McClellan. Kidney Int 2002;62: Rate of Vascular Access Infection by Vascular Access Type 12 Vascular access infection rate (per 100 patient-months) Fistula Graft Cuffed Catheter Noncuffed catheter Dialysis Surveillance Network
8 Rate of Access-Related Bloodstream Infection by Vascular Access Type Access-related bacteremia rate (per 100 patient-months) Fistula Graft Cuffed Catheter Noncuffed catheter Dialysis Surveillance Network Types of Vascular Access, U.S. Hemodialysis Patients, by Year % of Patients Dialyzed Through Graft Fistula Catheter Year Finelli, Miller, Tokars. Semin Dial 2005;18:52-61 Prevalent HD Patients with AV fistula USRDS 2008 Annual Data Report
9 Prevalent HD Patients with AV graft USRDS 2008 Annual Data Report Prevalent HD Patients with Catheter USRDS 2008 Annual Data Report Vascular Access at First Outpatient Dialysis, 2006 Catheter 75% 17% maturing fistula 3% maturing graft AV graft 4% AV fistula 12% USRDS 2008 Annual Data Report
10 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 Fistula First Initiative Goals: 66% AV fistula use <10% long term catheter use Spergel LM. Seminars in Dial. Issues to Resolve Conflicting data on catheter use over time Catheter placements decreasing Cause of increased infectious hospitalizations Any connection with fistula first and these outcomes How to achieve fistula first catheter reduction goals Is the 90 day cut-off relevant?
11 Vascular Access Infections Risk Factors Type of access catheter >> graft > fistula Lower extremity Recent access surgery Trauma, hematoma, dermatitis, scratching Poor hygiene Poor needle insertion technique Older age Diabetes Iron overload Others 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 Prevention of Intravascular Catheter-Related Infections Dressing changes or skin prep: 2 % chlorhexidine, preferred* 10 % povidone-iodine 70 % alcohol Catheter exit site: Povidone-iodine ointment compatible with catheter material Education & Training: appropriate infection control measures to prevent intravascular catheter-related infections assess knowledge of and adherence to guidelines periodically for all persons who insert and manage intravascular catheters
12 What s in the New Conditions? Surveillance: requirement to track and monitor vascular access infections (e.g., NHSN dialysis module) Improve documentation of culture and susceptibility results Staff training Infection control and vascular access care Certification requirements Hand hygiene specifics Prior to contact with vascular access In between tasks at the HD station Environmental cleaning & disinfection CDC-Sponsored Project Underway 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 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
13 Hepatitis B & C Hepatitis B Epidemiology of HBV infection among dialysis patients Prevalence In 2002, 1.0% Compared to 1976, 7.8% 1980, 3.8% In 2002, 27% of 4,035 centers reported 1 patient with HBV infection Risk factors for HBV infection 1 HBV-infected patient in center, not isolated Center with fewer than 50% patients vaccinated against HBV
14 Causes of HBV outbreaks in dialysis setting Environmental surfaces or supplies (e.g., hemostat, clamps) not disinfected after each use Multiple dose medication vials or intravenous solutions not used exclusively for one patient Medications for injection prepared in areas adjacent to areas where blood samples were handled Staff members simultaneously cared for HBV-infected and susceptible patients Prevention of HBV transmission in dialysis setting Recommendations Isolate HBsAg positive patients in separate room** Dedicated staff Dedicated equipment Dialyzers should not be re-used Conduct surveillance for HBV infection Supply tray to each patient (regardless of status) Cleaning/disinfection of non-disposable items Glove use Routine cleaning/disinfection of equipment and surfaces All patients HBV-susceptible Anti-HBs 10, anti-hbc (-) Anti-HBs (+), anti-hbc (+) Schedule for Routine HBV Testing On admission Monthly Semi-annual Annual HBsAg Anti-HBs Total-anti-HBc Anti-HCV ALT HBsAg Anti-HBs No additional HBV testing needed HCV-susceptible ALT Anti-HCV Source: MMWR 2001;50(No. RR-5)
15 Hepatitis B Vaccination All susceptible patients (and staff) should be vaccinated Patients should be vaccinated pre-esrd, before requiring maintenance hemodialysis Patients who respond to initial series Yearly anti-hbs titer Booster dose if anti-hbs < 10 What s new Hepatitis B isolation New facilities must have an isolation room Existing facilities may have an area: must be separated by at least width of 1 dialysis station from adjacent stations Follow recommended HBV testing schedule Injection safety requirements Medication handling and preparation Management Issues: Possible HBV Transmission and/or Exposure Real Scenarios 1) Patient develops new HBV infection, unclear if acquired in unit 2) Patient traveled abroad, returns to unit; identified as surface antigen positive through screening 3) New admit, unknown HBsAg status Problem: facilities with low hepatitis B vaccination rates Essential: ensure all patients are fully immunized as soon as possible, whether or not the facility treats HBV-positive patients
16 Hepatitis B Vaccination Rate in Incident ESRD Patients ~25% received 1 dose of vaccine during first year of treatment Year USRDS 2008 Annual Data Report Brief Summary: Hepatitis B among dialysis patients Primary strategy for prevention of hepatitis B is vaccination Improvement of vaccination among patients can help reduce the burden of long-term sequelae (cirrhosis and liver cancer) Following infection control practices for all patients reduces risk of transmission Hepatitis C
17 Epidemiology of HCV Infection Among Hemodialysis Patients Prevalence: 8-10% vs. 1.6% in general population In 2002, 11.5% of 4,035 centers reported 1 patient who became anti-hcv positive Risk factors for HCV infection Blood transfusion Years on dialysis Prevalence increased with increasing years on dialysis (12% for <5 years to 37% for >5 years) Finelli et al. Semin Dial 2005;18:52-61 Hepatitis C Virus Infections in Hemodialysis Majority of infections are asymptomatic; most develop chronic infection Isolation is not recommended, no vaccine Prevention requires strict attention to infection control practices HCV Transmission in Dialysis Centers Mechanism of transmission Blood contamination of the environment, medication vials, and medical devices Implicated practices Inadequate cleaning of dialysis machines / station between patients Use of mobile medication or supply carts Preparation of injected medications in potentially contaminated areas Re-entry and re-use of medication vials N. Thompson. NKF Spring Meeting. Grapevine, TX. April 3, 2008
18 Schedule for Routine HCV Testing On admission Monthly Semi-annual Annual HBsAg Anti-HBs All patients Total-anti-HBc Anti-HCV ALT HBV-susceptible HBsAg HCV Screening Anti-HBs 10, Anti-HBs anti-hbc (-) Excluded from CMS Anti-HBs (+), Requirements No additional HBV testing needed anti-hbc (+) HCV-susceptible ALT Anti-HCV Source: MMWR 2001; 50(No. RR-5) HCV Testing Diagnostic testing E.g., for symptoms or ALT elevation Screening Recommended by CDC & KDOQI Not required or reimbursed by CMS Only realistic way to identify transmission and rectify incorrect practices Must review and act upon results in a timely manner HCV Transmission: A Failure of Surveillance
19 HCV Transmission, NYS Dialysis Facility Identified 9 cases of HCV seroconversion (patients who tested anti-hcv negative and subsequently anti-hcv positive) Documented transmission occurring at the facility over 8 years Uncovered multiple infection control breaches Facility surrendered its operating certificate and paid $300K civil penalty Additional Problems No management of HCV-positive test results Health department was not notified of seroconversions Patients themselves were not informed that they tested positive No follow-up studies or medical evaluation Did anyone even look at the results?? Promoting HCV Screening Lack of CMS reimbursement poses a challenge Concern about the liability surrounding screening What you don t know doesn t require any further action At least one chain introducing widespread HCV screening
20 Summary: Hepatitis C among dialysis patients A majority of patients infected with hepatitis C develop chronic infection a reservoir for transmission There is no vaccine available to prevent infection with hepatitis C Adherence to infection control practices are crucial to prevent transmission Screening essential to detect transmission Prevention of HBV and HCV infections Medication prep areas should be physically separated from patient stations and other treatment areas One-way flow of materials and supplies (items at the treatment station are contaminated) Proper cleaning and disinfection of machine surfaces Medication vials Multi-dose vials - Have preservative to prevent bacterial growth preservative has no impact on HBV, HCV Single dose vials - No preservative - Pooling of medications caused outbreak of Serratia bloodstream infections Problem: common practice to re-enter and re-use single dose medication vials
21 What s new when it comes to single-dose medication vials? Intravenous medication vials labeled for single use, including erythropoietin, should not be punctured more than once. Once a needle has entered a vial labeled for single use, the sterility of the product can no longer be guaranteed. No pooling meds 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 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
22 Where Do We Go From Here? Prevention Efforts 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 Role of infection preventionists 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 PREVENTION IS PRIMARY! Thank you!
23 Preventing bacterial transmission in outpatient dialysis facilities Additional precautions for patients at increased risk of transmitting pathogenic bacteria Criteria: Infected skin wound with drainage not contained by dressings Fecal incontinence or diarrhea uncontrolled with personal hygiene measures Regardless of pathogen (need not be drug resistant) Preventing bacterial transmission in outpatient dialysis facilities Additional precautions for patients at increased risk of transmitting pathogenic bacteria Precautions: Wear a separate gown over clothing and remove gown when finished caring for the patient Dialyze the patient at a station with as few adjacent stations as possible (e.g., at end or corner of unit) Issues Surrounding Anti-HBc Total anti-hbc should be tested once on admission Result is not required before admitting the patient If not done, should be ordered on admission Confusion surrounding interpretation and management of anti-hbc Is not a criteria for isolation HBsAg status is the only determinant of isolation, not anti-hbc or HBV DNA
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