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Delivered at APIC New Jersey 11/14/12
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Michael Edmond, MD, MPH, MPARichard P. Wenzel Professor of Internal Medicine
Chair, Division of Infectious DiseasesHospital Epidemiologist
Challenges in Surveillance for Healthcare Associated Infections
Goals of this presentation: • To critically examine “getting to zero” HAIs• To look beyond the infection rate to appreciate
the complexity of its derivation
2.7 CLABSI / 1,000 LINE DAYS
Shifting Paradigms
Many infections are inevitable, although
some can be prevented
Each infection is potentially
preventable unless proven otherwise
Little attention given to HAI rates given
lack of consequences
High visibility issue with high stakes
Patients Consumers
Genesis of External Pressures on Infection Prevention Programs
Higher accountability
Increased transparency
Rapid solutions to highly complex problems
Edmond MB, Eickhoff T. Clin Infect Dis 2008;46:1746-50.
Edmond MB, Eickhoff T. Clin Infect Dis 2008;46:1746-50.
Mandatory Reporting for HAIs
Source: APIC, July 2011.
Mandates public reporting Passed a bill to study the issue
10 reasons why “Getting to Zero HAIs” is not the right medicine
1. It’s dishonest!• Despite strong
efforts to reduce HAIs, patients are sicker, more immunosuppressed, and devices are ever more invasive
Preventable HAIs
Preventable (%)CLABSI 65-70CAUTI 65-70VAP 55SSI 55
Umscheid CA. Infect Control Hosp Epidemiol 2011;32:101-14.
Federally funded systematic review of the literature to assess the theoretical impact of implementation of best infection prevention practices at all US hospitals
Postmodernism• Philosophical paradigm in which there is no absolute truth
– To the post-modernist “scientific medicine is no more valid a construct to describe reality than that of the shaman who invokes incantations and prayers to heal, the homeopath who postulates “healing mechanisms” that blatantly contradict everything we know about multiple areas of science, or reiki practitioners who think they can redirect “life energy” for therapeutic effect. In the postmodernist realm all are equally valid, as there is no solid reason to make distinctions between these competing “narratives” and the “narrative” of scientific or evidence-based medicine.
Gorski D. Science-based medicine. http://www.sciencebasedmedicine.org/index.php/postmodernist-attacks-on-science-based-medicine/
Truthiness
• To know intuitively
"from the gut" without
regard to evidence,
logic, intellectual
examination, or facts
http://en.wikipedia.org/wiki/Truthiness
10 reasons why “Getting to Zero HAIs” is not the right medicine
2. Drives a punitive culture
Getting to Zero
Zero HAIs is attainable
All HAIs are preventable
The occurrence of an HAI is someone’s fault
10 reasons why “Getting to Zero HAIs” is not the right medicine
3. Places enormous pressure on infection preventionists & IP programs; creates adversarial relationships between IPs, clinicians & administrators
10 reasons why “Getting to Zero HAIs” is not the right medicine
4. Fosters problems with surveillance
10 reasons why “Getting to Zero HAIs” is not the right medicine
5. Leads to inappropriate medical practices
Inappropriate medical practices driven by Getting to Zero
• Urine cultures on hospital admission for patients with urinary catheters
• Blood cultures on admission for patients with central lines
• Treatment of infections without cultures• Increased antimicrobial utilization
10 reasons why “Getting to Zero HAIs” is not the right medicine
6. Disintegrates infection prevention from Quality/Safety Safety
Infectionprevention
Quality
10 reasons why “Getting to Zero HAIs” is not the right medicine
7. Fosters opportunity for expedient solutions rather than focusing on the hard work of behavior change
HAI “Market”
2011 20160.0
5.0
10.0
15.0
20.0
10.3
18.3
4.56.0
Infection control devices/products
HAI treatments
$, billions
BCC Research. http://www.bccresearch.com/report/healthcare-acquired-infections-hlc092a.html
10 reasons why “Getting to Zero HAIs” is not the right medicine
8. Drives conflict of interest with industry
http://www.centerfortransforminghealthcare.org/sponsors/how.aspxAccessed October 4, 2012.
APIC.http://www.apic.org/Partners/Strategic-Partners. Accessed October 4, 2012.
10 reasons why “Getting to Zero HAIs” is not the right medicine
9. Punishes hospitals that care for the poor and those that care for the sickest patients
http://www.consumerreports.org/health/doctors-hospitals/hospital-infection/deadly-infections-hospitals-can-lower-the-danger/hospitals-with-no-infections/index.htm
Accessed 10/4/12
10 reasons why “Getting to Zero HAIs” is not the right medicine
10. Weakens the rationale for funding research in HAI prevention
Rationale for HAI surveillance
• To establish endemic rates of HAIs• To identify outbreaks• To allow prioritization of problems & the
development of interventions to reduce infections
• To determine the impact of interventions to improve the quality of care
• Public reporting: to assist consumers in assessing quality of care across hospitals
Characteristics of the ideal HAI surveillance system
• Unambiguous definitions• Minimizes surveyor time input• Maximally sensitive• Maximally specific• Low inter-observer variability• Clinically relevant output• Validated• Useful output for consumers
What’s 2 + 2?
Count von Count
What’s 2 + 2?
The mathematician says:
“I believe it’s 4, but I’ll have to prove it.”
What’s 2 + 2?
The engineer says:
“The answer is 4, but I’ll have to add a safety factor so we’ll call it 5.”
What’s 2 +2?
The biostatistician says:
“The sample is too small to give a precise answer, but based on the data set, there is a high probability it is somewhere between 3 and 5.”
What’s 2 + 2?
The clinical microbiologist says:
“We don’t deal with numbers that small.”
What’s 2 + 2?
The infection preventionist says:
“I think it’s 4, but I’ll have to ask the hospital epidemiologist.”
What’s 2 + 2?
The hospital epidemiologists say:
“What do you want it to be?”
The journey from definition to rate
HAIdefinition
HAIrate
Resources
Validity
Bias
Local effects
Ethical
issues
SurveillanceChallenges
HAI Definitions
National Healthcare Safety Network
• NHSN HAI definitions have become the national standard
• An increasing number of states mandating that hospitals join NHSN
• NHSN definitions initially created in a different era; erred on the side of sensitivity rather than specificity
CDC CLABSI Definition• Central line is present• Must meet 1 of the following criteria:
– Criterion 1: Patient has a recognized pathogen cultured from 1 or more blood cultures and organism cultured from blood is not related to an infection at another site.
– Criterion 2: • Patient has at least 1 of the following signs or symptoms: fever
(>38°C), chills, or hypotension and • Signs and symptoms and positive laboratory results are not related to
an infection at another site and • Common commensal (i.e., diphtheroids, Bacillus spp [not B. anthracis],
Propionibacterium spp, coagulase-negative staphylococci, viridans group streptococci, Aerococcus spp, and Micrococcus spp) is cultured from 2 or more blood cultures drawn on separate occasions.
http://www.cdc.gov/nhsn/PDFs/pscManual/4PSC_CLABScurrent.pdf
CDC CLABSI definition, January 2012. Accessed 3/5/12.
CLABSIx 1,000 = CLABSI rate
Central line days
Epidemiologist
Clinician
Clinical Validity
Surveillance definitions Disease concepts
• Does the patient who meets the definition of CLABSI, really have a CLABSI?
• Increasingly important as front line clinicians face pressure to reduce HAIS
Surveillance
• Efficacy: how well do the case definitions identify HAIs in the ideal world (i.e., the definitions are applied perfectly)– Measures the validity of the definition purely
• Effectiveness: how well do the case definitions identify HAIs in the real world– Measures the validity of the definition + the
ability of IP surveyors to apply the definition
The journey from definition to rate
HAIdefinition
HAIrate
Patient populations
Special patient populations
• Patient populations at high risk for bloodstream infections being misclassified as central-line associated– Hematologic malignancies– Short bowel syndrome– Solid organ transplant– Critically ill patients undergoing abdominal
surgery– Cardiac surgery patients with vasoplegic
shock and small bowel ischemia
Fraser TG, Gordon SM. Clin Infect Dis 2011;52:1446-1450.
Impact of special populations
Q1 Q2 Q3 Q40
2
4
6
8
10
12
NHSNModified
Modified definition excludes:• Viridans strep BSI in pts
with neutropenia & mucositis
• Gram-negative bacilli, Candida spp, & enterococci in patients with neutropenia from dose-intensive chemotherapy or BMT patients with graft vs host disease of the gut
Fraser TG, Gordon SM. Clin Infect Dis 2011;52:1446-1450.
CLABSI/1,000 line days
Cleveland Clinic Medical ICU
Changes in CLABSI rates by pathogenNHSN, 2001 vs 2009
Series1
-80
-70
-60
-50
-40
-30
-20
-10
0
-73
-37
-55
-46
S. aureus GNR Enterococci Candida%
Srinivasan A. MMWR 2011;60:243-248.
The journey from definition to rate
HAIdefinition
HAIrate
Patient populations
Deviceutilization
Impact of device utilization onCAUTI rates
Hospital A Hospital B
8.0/1,000 catheter days 10.0/1,000 catheter days
80 UTIs 50 UTIs
10,000 catheter days 5,000 catheter days
8.0/10,000 patient days 5.0/10,000 patient days
Assume:2 similar hospitalsSame number of bedsSame number of patient days (100,000/year)Same case mix indexNo differences in surveillance
No good deed goes unpunished
Most catheter sparing interventions remove catheter days from relatively less ill patients,
who likely have a lower risk of infection
Remaining patients with catheters are at higher risk for UTI
CA-UTI rate will increase
Trick WE, Samore M. Infect Control Hosp Epidemiol 2011;32:641-643.
Not all catheter days are created equalHospital A Hospital B
1,000 urinary catheter days: 50 pts have devices for 10 days (last 5 days are unnecessary—250 unnecessary days)
500 pts have devices for 1 day (half unnecessary—250 unnecessary days)
Intervention:Eliminate unnecessary post-insertion
catheter days
Intervention:Eliminate unnecessary insertions
Outcome:250 catheter days eliminated
Outcome:250 catheter days eliminated
CA-UTI rate decreases(eliminated relatively high-risk catheter days & retained relatively low-risk days)
CA-UTI rate increases(eliminated relatively low-risk days, retained
relatively high-risk days)
Trick WE, Samore M. Infect Control Hosp Epidemiol 2011;32:641-643.
1 + 1 + 1 = 1• NHSN allows only 1 central line to be counted
per day• Number of central lines may be a crude marker
for severity of illness• Impact of allowing all central lines to be counted:
– Cleveland Clinic: 30% decrease in CLABSI rate– Johns Hopkins: 36% decrease in CLABSI rate– VCU Medical Center: 20% decrease in CLABSI rate
Fraser TG, Gordon SM. Clin Infect Dis 2011;52:1446-1450.Aslakson RA et al. Infect Control Hosp Epidemiol 2011;32:121-124.Nalepa M, Bearman G, Edmond M. SHEA 2010.
The journey from definition to rate
HAIdefinition
HAIrate
Patient populations
Bed management
Deviceutilization
Bed management impacts HAI rates• How hospitals utilize ICU beds will impact
ICU HAI rates:– Hospitals with easy access to LTACHs are able
to transfer out high-risk patients (long-term device patients) from their ICUs, reducing their ICU infection rates
– Hospitals with a relative shortage of ICU beds will concentrate the sickest, highest risk patients in their ICUs, likely increasing ICU HAI rates
– Providing critical care services in non-ICU settings
The journey from definition to rate
HAIdefinition
HAIrate
Patient populations
Microbiology culture
practices
Bed management
Deviceutilization
Practices affecting the blood culture positivity• CLABSI requires a positive blood culture• Blood culture practices impact the rate of
positive cultures:– Body temperature threshold for obtaining BC– How often are temperatures measured– Number of cultures obtained– Volume of blood in each culture– Threshold for repeating cultures– Use of antipyretics– No cultures obtained and broad-spectrum antibiotics
given
Surveillance Aggressiveness ScoreSurvey of 16 PICUs at 14 hospitals
+1 point for each:• Blood cultures (BC) obtained from
each CVL present• BC obtained from each lumen• No antipyretics before BC Antibiotics
not initiated prior to BC• BC done <15 minutes after fever• Temp monitored at least hourly• Anaerobic & fungal BC usually sent• BC most commonly sent for
T<38.5°C• Repeat BC more often than every
24 hours• Neonatal BC >1 mL• Adolescent BC >3 mL
-1 point for each:• BC sent from single lumen• Antipyretics prior to BC threshold• Aerobic cultures only• BC most commonly sent for
T>38.5°C• Repeat BC sent less often than 24
hours• BC most commonly sent >1 hour
after fever• Temp monitored > every 2 hours• Neonatal BC <1 mL• Adolescent BC <3 mL
Neidner MF. AM J Infect Control 2010;38:585-595.
Surveillance Aggressiveness ScoreSurvey of 16 PICUs at 14 hospitals
Neidner MF. AM J Infect Control 2010;38:585-595.
The harder you look, the more you find
The journey from definition to rate
HAIdefinition
HAIrate
Patient populations
Microbiology culture
practices
Bed management
Deviceutilization Antimicrobial
utilization
Antimicrobial utilization
• Aggressive use of empiric antibiotics may reduce infections or partially treat infections leading to negative blood cultures
The journey from definition to rate
HAIdefinition
HAIrate
Patient populations
Microbiology culture
practices
Bed management
Deviceutilization
Resources Administrative pressure
C-suite
Antimicrobialutilization
Impact of hospital administrators
• Allocation of resources– Surveillance is resource intense– Requires trained nurses– In most hospitals concurrent surveillance for HAIs still
requires ICPs to review paper-based charts or EMRs without decision support capability
– Under-resourcing of IP programs will likely lead to “lower” rates of HAIs
• Administrative pressure– Aggressive talk & actions regarding HAI reduction may
lead to intentional or unintentional alterations in application of HAI definitions
The journey from definition to rate
HAIdefinition
HAIrate
Patient populations
Microbiology culture
practices
Bed management
Deviceutilization
Surveillance bias
Resources Administrative pressure
C-suite
Antimicrobialutilization
Surveillance Bias
• In the case of two hypothetical hospitals with truly identical rates of infection, the hospital with the better surveillance system for detecting cases will appear to have higher rates of infection– the more you look, the more you find
• Importance of surveillance bias is magnified is magnified in the era of public reporting
Surveillance Bias
IP at Hospital A
IP at Hospital B
The journey from definition to rate
HAIdefinition
HAIrate
Patient populations
Microbiology culture
practices
Bed management
Deviceutilization
Surveillance bias
Resources Administrative pressure
C-suite
IP application of definitions
Antimicrobialutilization
Application of HAI definitions• Data collection errors• Errors in the application of definitions• Variability in interpretation of definitions
• Examples:– Conversion of primary BSI to secondary by falsely classifying
colonization as infection (e.g., E. faecium grows in blood culture & perirectal surveillance culture; BC is falsely classified as secondary)
– Redefining PICC lines as peripheral lines– IP is unaware that Abiotriophia is a viridans group streptococcus– IP mistakenly believes that device must be present for > 48
hours
Intentional or unintentional
Lin MY et al. JAMA 2010;304:2035-2041.
Surveillance: Human vs Computer
• Comparison of CLABSI rates in 20 ICUs at 4 academic medical centers comparing IP surveillance to computerized surveillance using the CDC definition
• Median CLABSI rates:– IP: 3.3/1,000 CL days– Computer: 9.0/1,000 CL
days
Validation of CLABSI• Over 3-month period, validation of CLABSI
surveillance was performed in 30 adult & 3 pediatric ICUs
• Utility of surveillance by local IPs:– Sensitivity 48% (local IPs captured 23/48
cases)– Specificity 99%
• Overall CLABSI rate:– Local IPs: 1.97/1,000 catheter days– Validators: 3.51/1,000 catheter days
Backman LA et al. Am J Infect Control 2010;38:832-838.
Validation of CLABSI
Backman LA et al. Am J Infect Control 2010;38:832-838.
Error N %
Incorrectly classified primary vs secondary BSI 16 46
Misinterpreted microbiologic data 4 11
CLABSI rules* 6 17
CLABSI terms† 4 11
Other 5 14
29 discordant cases involving 35 errors
*minimum time period rule, patient transfer rule, location of attribution rule, 2 or blood culture rule, sameness of organism rule
†types of central lines, location of devices, definition of infusion
The journey from definition to rate
HAIdefinition
HAIrate
Patient populations
Microbiology culture
practices
Bed management
Deviceutilization
Surveillance bias
Resources Administrative pressure
C-suite
IP application of definitions
Post-ascertainment review & censure
Antimicrobialutilization
Post case ascertainment review
• Following case ascertainment by IPs, a review is conducted and cases may be censured– Consensus– Clinician veto– Interpretation & certification by an authority
• Overall impact is a reduction in HAI rates
The journey from definition to rate
HAIdefinition
HAIrate
Patient populations
Microbiology culture
practices
Bed management
Deviceutilization
Surveillance bias
Resources Administrative pressure
C-suite
IP application of definitions
Post-ascertainment review & censure
Antimicrobialutilization
Conclusions• Getting to zero HAIs is a concept not
grounded in reality• HAI rates appear deceptively simple but in
actuality are remarkably complex metrics with many confounding influences
• Local practices and inadequate risk adjustments make HAI rates difficult to compare across hospitals
• Better HAI definitions that are more precise and less prone to interpretation are needed
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