The National Healthcare Safety Network s (NHSN) Urinary Tract Infection Definition: Time for Review

Transcription

1 The National Healthcare Safety Network s (NHSN) Urinary Tract Infection Definition: Time for Review Katherine Allen-Bridson, BSN, MScPH, CIC Nurse Consultant Division of Healthcare Quality Promotion Carolyn Gould, MD, MSCR Medical Officer Division of Healthcare Quality Promotion Healthcare Infection Control Practices Advisory Committee June 5-6, 2013 National Center for Emerging and Zoonotic Infectious Diseases Place Descriptor Here

2 Background URINARY TRACT INFECTION SURVEILLANCE USING THE NHSN

3 Healthcare Facility HAI Reporting Requirements to CMS via NHSN-- Healthcare Personnel Influenza Photo Title Myriad Pro, Bold, Shadow, 20pt Caption for photo, references, citations, or credits Myriad Pro, 14pt Current and Proposed Requirements DRAFT (9/6/2012) CMS Reporting Program HAI Event Reporting Specifications Reporting Start Date Hospital Inpatient Quality Reporting (IQR) Program Hospital Inpatient Quality Reporting (IQR) Program Hospital Inpatient Quality Reporting (IQR) Program CLABSI CAUTI SSI Acute Care Hospitals: Adult, Pediatric, and Neonatal ICUs Acute Care Hospitals: Adult and Pediatric ICUs Acute Care Hospitals: Inpatient COLO and HYST Procedures Proposed expansion of CLABSI and CAUTI surveillance to Medical, Surgical, and Medical-Surgical Wards: 2014 January 2011 January 2012 January 2012 ESRD Quality Incentive Program (QIP) I.V. antimicrobial start Outpatient Dialysis January 2012 ESRD Quality Incentive Program (QIP) Positive blood culture Outpatient Dialysis January 2012 ESRD Quality Incentive Program (QIP) Signs of vascular access infection Outpatient Dialysis January 2012 Long Term Care Hospital Quality Reporting (LTCHQR) Program Long Term Care Hospital Quality Reporting (LTCHQR) Program Inpatient Rehabilitation Facility Quality Reporting Program Hospital Inpatient Quality Reporting (IQR) Program Hospital Inpatient Quality Reporting (IQR) Program Hospital Inpatient Quality Reporting (IQR) Program PPS-Exempt Cancer Hospital Quality Reporting (PCHQR) Program PPS-Exempt Cancer Hospital Quality Reporting (PCHQR) Program Ambulatory Surgery Centers Quality Reporting Program CLABSI CAUTI CAUTI Long Term Care Hospitals *: Adult and Pediatric LTAC ICUs and Wards Long Term Care Hospitals *: Adult and Pediatric LTAC ICUs and Wards Inpatient Rehabilitation Facilities: Adult and Pedatric IRF Wards October 2012 October 2012 October 2012 MRSA Bacteremia LabID Event Acute Care Hospitals: FacWideIN January 2013 C. difficile LabID Event Acute Care Hospitals: FacWideIN January 2013 Vaccination Acute Care Hospitals January 2013 CLABSI PPS-Exempt Cancer Hospitals: all locations January 2013 CAUTI PPS-Exempt Cancer Hospitals: all locations January 2013 Healthcare Personnel Influenza Vaccination * Long Term Care Hospitals are called Long Term Acute Care Hospitals in NHSN Ambulatory Surgery Centers October 2014

4 January 2009 NHSN UTI Criteria Changes Purposes Increase specificity of UTI definitions Decrease potentially associated unnecessary antimicrobial use Removal of Asymptomatic Bacteriuria (ASB) Removal of physician diagnosis/treatment as UTI criteria Removal of elements of UTI criteria for currently catheterized patients Symptoms related to catheter use: dysuria, urgency, frequency Retained symptoms: suprapubic tenderness, costovertebral angle pain/tenderness, and/or fever

5 January 2013 NHSN Healthcare Associated Infection (HAI) Definition Changes Purposes 1. Increase specificity/ clinical credibility of HAIs 2. Increase objectivity of criteria 3. Improve metrics capture of effects of prevention activities 4. Advance electronic surveillance capabilities Institution of > 2 day stay rule for infection = HAI Institution of > 2 day device use for infection = deviceassociated infection e.g., CAUTI Move from 48 hour timeframes to 2 calendar days E.g., UTI in patient with catheter removed in past 2 calendar days = CAUTI Date of infection changed from first element to last Maximum time between 2 criterion elements = 1 day

6 NHSN Surveillance Criteria 2013 URINARY TRACT INFECTION

7 NHSN Urinary Tract Infection (UTI) Types Symptomatic UTI (SUTI) Asymptomatic Bacteremic UTI (ABUTI) SUTIs and ABUTIs may be: Catheter-associated (CAUTI) or Non-Catheter-associated NOTE: Some facilities are mandated by their state to report ALL healthcare-associated UTIs

8 NHSN UTI Overview Symptomatic UTI Criterion 1: 100,000 CFU/ml of no more than 2 organisms in urine + symptom Criterion 2: 1,000 CFU/ml < 100,000 CFU/ml of no more than 2 organisms in urine; requires supportive positive urinalysis (U/A) + symptom Sub criteria of Criterion 1 and Criterion 2 a: Indwelling urinary catheter-associated b: Non-Indwelling urinary catheter-associated Criterion 3: Infant version of Criterion 1 Criterion 4: Infant version of Criterion 2 ABUTI

9 1a Symptomatic UTI SUTI 1a Patient had an indwelling urinary catheter in place for >2 calendar days, with day of device placement being Day 1, and catheter was in place on the date of event and at least 1 of the following signs or symptoms: fever (>38 C); suprapubic tenderness*; costovertebral angle pain or tenderness* and a positive urine culture of 10 5 colony-forming units (CFU)/ml with no more than 2 species of microorganisms. Elements of the criterion must occur within a timeframe that does not exceed a gap of 1 calendar day between any two elementsbetween any two elements OR Patient had an indwelling urinary catheter in place for >2 calendar days and had it removed the day of or the day before the date of event and at least 1 of the following signs or symptoms: fever (>38 C); urgency*; frequency*; dysuria*; suprapubic tenderness*; costovertebral angle pain or tenderness* and a positive urine culture of 10 5 colony-forming units (CFU)/ml with no more than 2 species of microorganisms. Elements of the criterion must occur within a timeframe that does not exceed a gap of 1 calendar day between any two elementsbetween any two elements. *With no other recognized cause

10 Symptomatic UTI SUTI 1b

11 2a Symptomatic UTI SUTI 2a Patient had an indwelling urinary catheter in place for > 2 calendar days, with day of device placement being Day 1, and catheter was in place on the date of event and at least 1 of the following signs or symptoms: fever (>38 C), suprapubic tenderness*, or costovertebral angle pain or tenderness* and at least 1 of the following findings: a. positive dipstick for leukocyte esterase and/or nitrite b. pyuria (urine specimen with 10 white blood cells [WBC]/mm3 of unspun urine or >5 WBC/high power field of spun urine) c. microorganisms seen on Gram stain of unspun urine and a positive urine culture of 10 3 and <10 5 CFU/ml with no more than 2 species of microorganisms OR Patient had indwelling urinary catheter > 2 calendar days and had it removed the day of or the day before the date of event and at least 1 of the following signs or symptoms: fever (>38 C), urgency*, frequency*, dysuria*, suprapubic tenderness*, or costovertebral angle pain or tenderness* and at least 1 of the following findings: a. positive dipstick for leukocyte esterase and/or nitrite b. pyuria (urine specimen with 10 white blood cells [WBC]/mm 3 of unspun urine or >5 WBC/high power field of spun urine) c. microorganisms seen on Gram stain of unspun urine and a positive urine culture of 10 3 and <10 5 CFU/ml with no more than 2 species of microorganisms. * With no other recognized cause

12 Symptomatic UTI SUTI 2b

13 Symptomatic UTI Criteria 3 & 4 ( 1 year old) 3 Patient 1 year of age with** or without an indwelling urinary catheter has at least 1 of the following signs or symptoms: fever (>38 C core), hypothermia (<36 C core), apnea*, bradycardia*, dysuria*, lethargy*, or vomiting* and a positive urine culture of 10 5 CFU/ml with no more than 2 species of microorganisms *With no other recognized cause 4 Patient 1 year of age with** or without an indwelling urinary catheter has at least 1 of the following signs or symptoms: fever (>38 C core), hypothermia (<36 C core), apnea*, bradycardia*, dysuria*, lethargy*, or vomiting* and At least one of the following findings: a. positive dipstick for leukocyte esterase and/or nitrite b. pyuria (urine specimen with 10 WBC/mm 3 of unspun urine or >5 WBC/high power field of spun urine) c. microorganisms seen on Gram s stain of unspun urine and a positive urine culture of between 10 3 and <10 5 CFU/ml with no more than two species of microorganisms *With no other recognized cause

14 Asymptomatic Bacteremic UTI (ABUTI) Patient with* or without an indwelling urinary catheter has no signs or symptoms (i.e., for any age patient, no fever (>38 C), urgency, frequency, dysuria, suprapubic tenderness, or costovertebral angle pain or tenderness, OR for a patient 1 year of age, no fever (>38 C core), hypothermia (<36 C core), apnea, bradycardia, dysuria, lethargy, or vomiting) and a positive urine culture of 10 5 CFU/ml with no more than 2 species of uropathogen microorganisms** (see comments section below). and a positive blood culture with at least 1 matching uropathogen microorganism to the urine culture, or at least 2 matching blood cultures drawn on separate occasions if the matching pathogen is a common skin commensal. *Patient had an indwelling urinary catheter was in place for > 2 calendar days, with day of device placement being Day 1, and catheter was in place on the date of event or had just been removed the day of or day before the date of event. **Uropathogen microorganisms are: Gram-negative bacilli, Staphylococcus spp., yeasts, beta-hemolytic Streptococcus spp., Enterococcus spp., G. vaginalis, Aerococcus urinae, and Corynebacterium (urease positive) +. Note: All ABUTIs will have a secondary bloodstream infection

15 ABUTI ABUTI definition developed to prevent reporting of Central Line-associated Bloodstream Infection (CLABSI) if: Positive blood culture in presence of central line AND Positive urine culture with matching organism 100,000 CFU/ml to the blood culture AND Lack of UTI symptoms (ASB no longer available) CLABSI should never be associated with infection at another site

16 Definition Issues Perceived low sensitivity level for UTI in special populations Due to limited symptom elements in currently catheterized patients In some patient populations Spinal cord injury Ventilated/sedated/unable to verbalize Elderly/Decreased cognition Immunocompromised Inclusion of funguria in CAUTI surveillance? Role in UTI Variability in laboratories reporting methods * Citations, references, and credits Myriad Pro, 11pt

17 Definition Issues Laboratory variations in quantitative reporting of urine culture and urinalysis results Utility of urinalysis as element of UTI criteria Clinical significance of lower microbial counts Attribution of fever to UTI with other possible causes Inclusion of patients with renal or urinary instrumentation Suprapubic catheters Nephrostomy tubes Etc.

18 Definition Issues Perceived need for additional/alternative metrics to demonstrate quality improvement Potential for exclusion of true CAUTI with > 2 day device-association rule

19 CAUTI Definitional Review: Timeline January 2012 and October 2012 CMS IPPS requires CAUTI surveillance in Acute Care Facilities (January) Long-Term Acute Care Facilities and Inpatient Rehabilitation Facilities (October) January 2013 NHSN creates minimum durations of facility stay for HAI definition and device use for device-associated infection definition February 2013 DHQP reviews user concerns, UTI definitions DHQP identifies CAUTI ad-hoc expert panel Infection Preventionists, Hospital Epidemiologists, Microbiologists, Infection Disease Physicians, State HAI Program Staff, Facility-type Representatives (ACF, LTAC, IRF), CAUTI Subject Matter Experts

20 CAUTI Definitional Review: Timeline March May 2013 Ad-hoc expert panel meets semi-weekly Internal literature review on funguria Laboratory survey developed, piloted June-July, 2013 Distribute lab survey, collect, & analyze results CDC Core Ad-hoc group develops proposed definition modifications Proposal(s) shared with ad-hoc expert panel for input?summer 2013 Pilot testing of modifications? Revision of definitions based on pilot January 2014 & : Revisions not requiring changes to data collection form 2015: Revisions requiring changes to data collection form

21 Improving the UTI Surveillance Definitions Definitions should be: Credible Sensitive & specific favoring specificity Objective minimizing need for interpretation/decision making Easy to capture ideally, amenable to electronic reporting Minimal burden Appropriate for current laboratory protocols criteria should be applicable in most cases

22 Major questions addressed 1. Should inclusion of yeasts as urinary pathogens continue? 2. Should urine cultures with > 2 organisms continue to be excluded? 3. Should quantitative culture categories be modified? 4. Should clinical criteria be modified for special populations? 5. In the presence of fever, should a UTI be reported if criteria are met, even if another cause is identified? 6. Should 2 day rule for urinary catheter continue? 7. Should urinalysis continue to be included in UTI definitions? 8. Should patients with other urinary devices continue to be included in CAUTI surveillance? 9. Should new CAUTI metrics be adopted?

23 Major questions addressed 1. Should inclusion of yeasts as urinary pathogens continue? Problems: Rare cause of UTI Treatment of candiduria not associated with clinical benefit 1 Inclusion may encourage inappropriate antifungal prescribing Lack of clinical credibility leads to adjudication Some labs do not quantitatively report yeasts 1. Sobel et al. Clin Infect Dis 2000;30:19-24

24 Yeast Retain Remove Require Recommend Pros: Cons: Allow exclusion additional removing Improved or credibility May miss some if repeat urine criteria replacing Improved specificity preventable culture after catheters No in lab reporting infections catheter is place > 2 weeks variability issues negative prior to culture Potentially 1 less Pros: Cons: antifungal use Improved Paucity of practical, Pros: specificity Pros: Cons: specific criteria to Cons: May reduce May reduce Likely would reduce distinguish between Hard to amount of amount reported candiduria infection of and operationalize colonization contamination by < 40% colonization 2 reported 1. Hooton et al. Clin Infect Dis 2010;50: reported 3 2. Kauffman et al. Clin Infect Dis 2000;30: Kauffman et al. Clin Infect Dis 2011;52suppl 6:S452-6

25 Retain Yeast Require additional criteria Laboratory Imaging Patient populations Casts containing yeasts 1 Radiologic evidence of infection e.g., fungus ball, abscesses, etc. 1 Immunocompromised, neutropenic Pros: Specific indicator of upper tract infection Pros: Specific indicator of Cons: upper tract Insensitive infection Requires time and expertise Lab variability Cons: Institutional variability in use Rare Pros: Limited to highest-risk population Cons: for true How to define infection different Neutropenia groups? defined in Burdensome NHSN (MBI- BSI) 1. Kauffman et al. Clin Infect Dis 2011;52suppl 6:S452-6

26 Yeast Retain Remove Require additional Consider limiting criteria to populations at highest risk Recommend Highlight removing best or replacing practices: remove/replace catheters in place long-term > 2 weeks catheters prior to culture prior to culture if infection suspected Allow exclusion if repeat urine culture after catheter is negative Potential impacts: Reductions in UTI reporting: CAUTI: 15% o ICU: 20% o Non-ICU: 9% Non-CAUTIs: 2%

27 Major questions addressed 1. Should inclusion of yeasts as urinary pathogens continue? 2. Should urine cultures with > 2 organisms continue to be excluded? 3. Should quantitative culture categories be modified? 4. Should clinical criteria be modified for special populations? 5. In the presence of fever, should a UTI be reported if criteria are met, even if another cause is identified? 6. Should 2 day rule for urinary catheter continue? 7. Should urinalysis continue to be included in UTI definitions? 8. Should patients with other urinary devices continue to be included in CAUTI surveillance? 9. Should new CAUTI metrics be adopted?

28 Major questions addressed 2. Should urine cultures with > 2 organisms continue to be excluded? Problems: Current criteria potentially exclude some clinically significant UTIs e.g., significant pathogen in presence of contaminants Variation in lab identification protocols leads to lack of uniformity

29 Urine culture with > 2 organisms Include Continue to exclude If at least one organism present at 100K CFU/ml (+/- pathogenspecific) Pros: May capture some clinically relevant infections If lab recognizes as acceptable culture Recommend removing or replacing catheters in place > 2 weeks prior to culture 1 Pros: May capture Cons: Cons: some clinically May misclassify Variability Pros: in relevant contaminated laboratory May reduce infections urine cultures practice colonization/ as UTI contamination Feasibility of pathogen list More burden Pros: More specific Cons: May miss preventable infections Cons: Some data suggest little utility in distinguishing between colonization and infection 2, 3 1. Hooton et al. Clin Infect Dis 2010;50: Kauffman et al. Clin Infect Dis 2000;30: Tenney et al. J Infect Dis 1988;157:

30 Urine culture with > 2 organisms Include Continue to exclude If at least one If at least one organism is organism is present at present at 100K CFU/ml 100K CFU/ml (+/- pathogenspecific) If lab recognizes as acceptable culture Recommend removing Highlight or best replacing practices: remove/replace catheters in place long-term > 2 catheters weeks prior prior to to culture culture if infection suspected

31 Major questions addressed 1. Should inclusion of yeasts as urinary pathogens continue? 2. Should urine cultures with > 2 organisms continue to be excluded? 3. Should quantitative culture categories be modified? 4. Should clinical criteria be modified for special populations? 5. In the presence of fever, should a UTI be reported if criteria are met, even if another cause is identified? 6. Should 2 day rule for urinary catheter continue? 7. Should urinalysis continue to be included in UTI definitions? 8. Should patients with other urinary devices continue to be included in CAUTI surveillance? 9. Should new CAUTI metrics be adopted?

32 Major questions addressed 3. Should quantitative culture categories be modified? Current categorizations: 100,000 CFU/ml (SUTI 1) 1000 and < 100,000 CFU/ml (SUTI 2) Problems: Laboratory variation in quantitative reporting of urine cultures Lower colony counts may be less specific for true infection

33 Quantitative culture categories Modify Maintain Modify based on most common laboratory protocols Remove lower colony count definition Use one category and lower threshold Pros: Might capture true SUTIs with lower colony counts Cons: Less credible Lab variability Relies on U/A Pros: Could capture how majority of labs report Pros: Increased May be large credibility laboratory Reduces variability lab variability problems Cons: Would miss some clinically Pros: recognized UTIs Simplifies Low-level definition Captures bacteriuria potential true quickly UTIs with rises lower to colony high levels counts 1 Cons: Less credibility Lab variability in workup of lower-colony counts 1. Stark, Maki NEJM 1984;311:560-4

34 Quantitative culture categories Modify Maintain Modify based on most common laboratory protocols Remove lower colony count definition Use one category and lower threshold Awaiting laboratory survey Potential impacts: Reductions in UTI reporting CAUTI: 10% non-cauti: 7%

35 Major questions addressed 1. Should inclusion of yeasts as urinary pathogens continue? 2. Should urine cultures with > 2 organisms continue to be excluded? 3. Should quantitative culture categories be modified? 4. Should clinical criteria be modified for special populations? 5. In the presence of fever, should a UTI be reported if criteria are met, even if another cause is identified? 6. Should 2 day rule for urinary catheter continue? 7. Should urinalysis continue to be included in UTI definitions? 8. Should patients with other urinary devices continue to be included in CAUTI surveillance? 9. Should new CAUTI metrics be adopted?

36 Major questions addressed 4. Should clinical criteria be modified for special populations? Problems: CAUTI may be underreported in some patient populations Populations identified: o Elderly o Ventilated o Depressed level of consciousness o Spinal cord injury o Immunosuppressed

37 Frequency of signs/symptoms CAUTI NCAUTI SUTI 1 (n = 73,448) SUTI 2 (n = 8162) SUTI 1 (n = 10,117) SUTI 2 (n = 810) Fever 65,076 (88.6%) 7,372 (90.3%) 3,779 (37.3%) 306 (37.8%) Fever alone* 62,934 (85.7%) 6,994 (85.7%) 3,396 (33.6%) 274 (33.8%) SP tenderness 5,142 (7%) 446 (5.5%) 807 (8%) 67 (8.3%) CVA pain/tenderness 2,115 (2.9%) 208 (2.5%) 373 (3.7%) 36 (4.4%) Urgency 3,006 (4.1%) 238 (2.9%) 2,553 (25.2%) 156 (19.3%) Frequency 3,450 (4.7%) 287 (3.5%) 4,032 (39.8%) 287 (35.4%) Dysuria 4,996 (6.8%) 430 (5.3%) 3,934 (38.9%) 308 (38%) * Fever alone cannot be used for those > 65 who are not catheterized For CAUTI, symptom only applies if catheter no longer present when CAUTI identified

38 Signs & symptoms Modify Maintain Develop specific criteria for different populations Develop single, expanded set of criteria More Pros: complexity Pros: Increased Could burden Could How to accommodate define capture populations special and UTIs more criteria populations accurately Feasibility Less of electronic complexity capture Similar to LTC component Retain single set of criteria but identify populations to exclude Cons: Need to define objective criteria, Pros: amenable to electronic Less complex capture than multiple May criteria not accommodate SCI patients Pros: Less complex Cons: UTIs potentially underreported Poor documentation of current criteria Low clinical Cons: credibility How to define populations and exclude their denominator days Increased burden Would lead to underreporting

39 Signs & symptoms Modify Maintain Develop specific criteria for different populations Develop single, expanded set of criteria Retain single set of criteria but identify populations to exclude With possible separate criteria for spinal cord injury Could draw from McGeer definitions 1 in LTC component 1. Stone et al. ICHE 2012;33:965-77

40 Major questions addressed 1. Should inclusion of yeasts as urinary pathogens continue? 2. Should urine cultures with > 2 organisms continue to be excluded? 3. Should quantitative culture categories be modified? 4. Should clinical criteria be modified for special populations? 5. In the presence of fever, should a UTI be reported if criteria are met, even if another cause is identified? 6. Should 2 day rule for urinary catheter continue? 7. Should urinalysis continue to be included in UTI definitions? 8. Should patients with other urinary devices continue to be included in CAUTI surveillance? 9. Should new CAUTI metrics be adopted?

41 Major questions addressed 5. In the presence of fever, should a UTI be reported if criteria are met, even if another cause is identified? Problems: CAUTIs are most often identified solely on basis of fever and a positive urine culture (>85%) Must report UTI even if another possible source of fever present NHSN newsletter clarification March 2012 Variable adherence to reporting rules

42 Fever and bacteriuria with other possible cause for fever Modify rules Report UTI Allow adjudication Develop specific criteria to allow not reporting UTI Pros: Relies Pros: on More clinical More clinical judgment clinical credibility Problematic credibility for public Less reporting reliance on judgment If fever resolves without rx of UTI, don t report Cons: No specific Pros: criteria agreed- More upon clinical by experts credibility Biomarkers not yet available NHSN criteria for other HAIs won t capture other sources of fever Pros: Does not rely on judgment Bias toward Cons: reporting Less clinical more CAUTIs credibility Variable adherence to rules Might Cons: encourage More data collection inappropriate burden treatment Difficult to implement Rates may not antibiotics prescribed conducive for another source to may showing treat UTI, short course improvement may partially treat

43 Fever and bacteriuria with other potential cause for fever Modify rules Report UTI Allow adjudication Exclude Develop UTI if specific other NHSNdefined to allow source not criteria reporting of feveruti If fever resolves without rx of UTI, don t report Problems may be mitigated by other definition changes (e.g., for candiduria)

44 Major questions addressed 1. Should inclusion of yeasts as urinary pathogens continue? 2. Should urine cultures with > 2 organisms continue to be excluded? 3. Should quantitative culture categories be modified? 4. Should clinical criteria be modified for special populations? 5. In the presence of fever, should a UTI be reported if criteria are met, even if another cause is identified? 6. Should 2 day rule for urinary catheter continue? 7. Should urinalysis continue to be included in UTI definitions? 8. Should patients with other urinary devices continue to be included in CAUTI surveillance? 9. Should new CAUTI metrics be adopted?

45 Major questions addressed 6. Should 2 day rule for urinary catheter continue? Problems: Would not pick up potential UTIs developing within the first 2 days (presumably due to insertion techniques)

46 2-day rule Remove Maintain Pros: Might capture more early CAUTIs Cons: Might result in overreporting of CAUTIs Pros: Consistent with other deviceassociated Cons: infection Might miss reporting cases caused by Likely few CAUTIs poor insertion missed within techniques this window (1%- Might lead to 2%) 1 and would less attention be captured later on proper insertion 1. Tambyah et al. Mayo Clin Proc 1999;74:131-6

47 2-day rule Remove Maintain 1. Tambyah et al. Mayo Clin Proc 1999;74:131-6

48 Major questions addressed 1. Should inclusion of yeasts as urinary pathogens continue? 2. Should urine cultures with > 2 organisms continue to be excluded? 3. Should quantitative culture categories be modified? 4. Should clinical criteria be modified for special populations? 5. In the presence of fever, should a UTI be reported if criteria are met, even if another cause is identified? 6. Should 2 day rule for urinary catheter continue? 7. Should urinalysis continue to be included in UTI definitions? 8. Should patients with other urinary devices continue to be included in CAUTI surveillance? 9. Should new CAUTI metrics be adopted?

49 Major questions addressed 7. Should urinalysis continue to be included in UTI definitions? Problems: Up to 70% of catheterized patients with bacteriuria have accompanying pyuria 1 Variability in laboratory reporting methods of pyuria 2009 IDSA guideline indicates lack of utility of pyuria for differentiating CA-bacteriuria from CAUTI 2 1. Nicolle LE. Int J Antimicrob Agents 2006;28S:S Hooton et al. Clin Infect Dis 2010;50:625-63

50 2009 IDSA Guideline for Diagnosis, Prevention, and Treatment of CAUTI Hooton et al. Clin Infect Dis 2010;50:625-63

51 Urinalysis Remove Modify Maintain Pros: Poor specificity Cons: Need to consider alternatives for lower colony counts Refine urinalysis parameters Cons: Pros: Pros: No specific Might Might improve parameters improve specificity identified specificity Lab variability (awaiting lab survey) Use lack of pyuria to exclude UTI Pros: Relatively Cons: objective Poor specificity Lab variability in reporting Not Cons: recommended May not apply to in IDSA immunocompromised guideline patients Lab variability in reporting High prevalence of pyuria at baseline in patients with catheters, elderly, etc. Not recommended in IDSA guideline

52 Urinalysis Remove Modify Maintain Eliminate lower colony count criteria Roll lower Refine urinalysis colony counts parameters into SUTI 1 Use lack of pyuria to exclude UTI

53 Major questions addressed 1. Should inclusion of yeasts as urinary pathogens continue? 2. Should urine cultures with > 2 organisms continue to be excluded? 3. Should quantitative culture categories be modified? 4. Should clinical criteria be modified for special populations? 5. In the presence of fever, should a UTI be reported if criteria are met, even if another cause is identified? 6. Should 2 day rule for urinary catheter continue? 7. Should urinalysis continue to be included in UTI definitions? 8. Should patients with other urinary devices continue to be included in CAUTI surveillance? 9. Should new CAUTI metrics be adopted?

54 Major questions addressed 8. Should patients with other urinary devices continue to be included in CAUTI surveillance? Problems: Patients with nephrostomy tubes, stents, etc. are likely to be higher risk for UTI than those with catheters alone Difficult to determine source of infection

55 Patients with other urinary devices Exclude from surveillance Continue to include in surveillance Pros: Facilities with complex urologic patients won t be at a disadvantage Cons: Increased data collection burden How to identify patients and exclude denominator days? Excludes patients who may have preventable CAUTI Pros: Simpler Cons: Facilities with complex urologic patients may have higher CAUTI rates 1. Tambyah et al. Mayo Clin Proc 1999;74:131-6

56 Patients with other urinary devices Exclude from surveillance Continue to include in surveillance 1. Tambyah et al. Mayo Clin Proc 1999;74:131-6

57 Major questions addressed 1. Should inclusion of yeasts as urinary pathogens continue? 2. Should urine cultures with > 2 organisms continue to be excluded? 3. Should quantitative culture categories be modified? 4. Should clinical criteria be modified for special populations? 5. In the presence of fever, should a UTI be reported if criteria are met, even if another cause is identified? 6. Should 2 day rule for urinary catheter continue? 7. Should urinalysis continue to be included in UTI definitions? 8. Should patients with other urinary devices continue to be included in CAUTI surveillance? 9. Should new CAUTI metrics be adopted?

58 Major questions addressed 9. Should new CAUTI metrics be adopted? Problems: Current catheter-day CAUTI rate may not reflect facility quality improvement measures Patient-day rate may be more appropriate to account for reductions in catheter use

59 Additional question under consideration Should antimicrobial treatment be added (back) to UTI definitions? Rationale: Capturing the relatively few symptomatic UTIs by NHSN definition does not account for large number of clinically diagnosed UTIs If a facility is diagnosing and treating more UTIs then they are reporting, shouldn t they be accountable for that? Large proportion of antibiotics for CAUTI is inappropriate 1-4 Current model is infection-related ventilator-associated complication (IVAC) However, CAUTI algorithm would not start with a catheter-associated condition but rather with presence of bacteriuria Shaughnessy et al. ICHE 2013;34: Gandhi et al. ICHE 2009;30:193-5 Gross, Patel. Clin Infect Dis 2007;45: Cope et al. Clin Infect Dis 2009;48:1182-8

60 Incorporate antimicrobial treatment into definitions NO YES Pros: Maintain focus on collecting true SUTIs Cons: Current surveillance definition doesn t reflect clinical practice Pros: May decrease the Cons: gap between Would capture clinical and more than true surveillance- SUTIs defined UTIs Increased data May help facilities collection assess their current burden practices and How to discourage operationalize? inappropriate antimicrobial use

61 Incorporate antimicrobial treatment into definitions NO YES Highly specific capture of true SUTIs Improving patient care What should be the role of surveillance?

62 Yeast Culture with > 2 organisms Include Remove Include Continue to exclude Limit to populations at highest risk Recommend removing/replacing long-term catheters prior to culture If at least one organism is present at 100K CFU/ml Recommend removing/replacing long-term catheters prior to culture Signs & symptoms Fever rule SUTI 2: Low colony counts and U/A Modify Maintain Modify rules Maintain Modify Remove Develop single, expanded set of criteria Antimicrobial treatment Develop specific criteria? Eliminate U/A and roll lower colony counts into SUTI 1 (based on lab survey) Yes No Summary of potentially feasible options on the table

63 Approach #1 Goal: Most specific SUTI surveillance definition Exclude yeast Exclude U/A and low colony counts (SUTI 2) Continue to exclude cxs with > 2 organisms No other changes Simplest approach Likely to result in greatest reduction of UTIs reported

64 Yeast Culture with > 2 organisms Include Remove Include Continue to exclude Limit to populations at highest risk Recommend removing/replacing long-term catheters prior to culture CAUTI 15% NCAUTI 2% If at least one organism is present at 100K CFU/ml Recommend removing/replacing long-term catheters prior to culture Signs & symptoms Fever rule SUTI 2: Low colony counts and U/A Modify Maintain Modify rules Maintain Modify Remove Develop single, expanded set of criteria Yes Antimicrobial treatment Develop specific criteria? No Eliminate U/A and roll lower colony counts into SUTI 1 (based on lab survey) Conservative estimates of reductions: CAUTI: 25% NCAUTI: 9% CAUTI 10% NCAUTI 7%

65 Approach #1: For identification of SUTI with indwelling catheter in place Signs and Symptoms At least 1 of the following: fever (>38 C) suprapubic tenderness* costovertebral angle pain or tenderness* *With no other recognized cause Laboratory Evidence At least 1 of the following findings: positive dipstick for leukocyte esterase and/or nitrite pyuria (urine specimen with 10 WBC/mm³ of unspun urine or >5 WBC/high power field of spun urine) microorganisms seen on Gram s stain of unspun urine A positive urine culture of 10 5 CFU/ml with no more than 2 species of microorganisms bacteria A positive urine culture of 10 3 and <10 5 CFU/ml with no more than 2 species of microorganisms SUTI-Criterion 1a SUTI-Criterion 2a CAUTI CAUTI

66 Approach #2 Goal: Improve specificity +/- sensitivity (2A vs 2B vs 2C) Eliminate U/A (Recommend removing/replacing chronic catheters prior to cx) U/A Urine cultures > 2 organisms Low colony counts 2A (most restrictive) B (more inclusive) C (most inclusive) - + +

67 Yeast Culture with > 2 organisms 2B,2C 2A Include Remove Include Continue to exclude Limit to populations at highest risk Recommend removing/replacing long-term catheters prior to culture If at least one organism is present at 100K CFU/ml Recommend removing/replacing long-term catheters prior to culture Signs & symptoms Fever rule SUTI 2: Low colony counts and U/A 2C 2A,2B Modify Maintain Modify rules Maintain Modify Remove Develop single, expanded set of criteria Antimicrobial treatment Develop specific criteria? Eliminate U/A and roll lower colony counts into SUTI 1 (based on lab survey) CAUTI 10% NCAUTI 7% Yes No

68 Approach #2: For identification of SUTI with indwelling catheter in place Signs and Symptoms At least 1 of the following: fever (>38 C) suprapubic tenderness* costovertebral angle pain or tenderness* *With no other recognized cause 2A U/A > 2 organisms Low colony counts Laboratory Evidence At least 1 of the following findings: positive dipstick for leukocyte esterase and/or nitrite pyuria (urine specimen with 10 WBC/mm³ of unspun urine or >5 WBC/high power field of spun urine) microorganisms seen on Gram s stain of unspun urine A positive urine culture of 10 5 CFU/ml with no more than 2 species of microorganisms A positive urine culture of 10 3 and <10 5 CFU/ml with no more than 2 species of microorganisms SUTI-Criterion 1a SUTI-Criterion 2a CAUTI CAUTI

69 Approach #2: For identification of SUTI with indwelling catheter in place Signs and Symptoms At least 1 of the following: fever (>38 C) suprapubic tenderness* costovertebral angle pain or tenderness* *With no other recognized cause 2B U/A > 2 organisms Low colony counts Laboratory Evidence At least 1 of the following findings: positive dipstick for leukocyte esterase and/or nitrite pyuria (urine specimen with 10 WBC/mm³ of unspun urine or >5 WBC/high power field of spun urine) microorganisms seen on Gram s stain of unspun urine A positive urine culture of 10 5 CFU/ml with no more than 2 species of microorganisms A positive urine culture of 10 3 and <10 5 CFU/ml with no more than 2 species of microorganisms SUTI-Criterion 1a SUTI-Criterion 2a CAUTI CAUTI

70 Approach #2: For identification of SUTI with indwelling catheter in place Signs and Symptoms At least 1 of the following: fever (>38 C) suprapubic tenderness* costovertebral angle pain or tenderness* *With no other recognized cause 2C U/A > 2 organisms Low colony counts Laboratory Evidence At least 1 of the following findings: positive dipstick for leukocyte esterase and/or nitrite pyuria (urine specimen with 10 WBC/mm³ of unspun urine or >5 WBC/high power field of spun urine) microorganisms seen on Gram s stain of unspun urine A positive urine culture of of CFU/ml CFU/ml with no more than 2 species of microorganisms Quantitative threshold TBD A positive urine culture of 10 3 and <10 based on laboratory 5 CFU/ml with no more than 2 species of microorganisms survey SUTI-Criterion 1a SUTI-Criterion 2a CAUTI CAUTI

71 Approach #3 Goal: More accurately capture clinically diagnosed UTIs Incorporate antimicrobial treatment (regardless of appropriateness) Do not exclude yeast, polymicrobial cxs, low colony counts Expand clinical criteria (possibly) Allow for exclusion of UTIs diagnosed by fever alone if not treated A complete definition overhaul A potential opportunity to make major inroads on facilities attention to stewardship

72 Yeast Culture with > 2 organisms Include Remove Include Continue to exclude Limit to populations at highest risk Recommend removing/replacing long-term catheters prior to culture If at least one organism is present at 100K CFU/ml Recommend removing/replacing long-term catheters prior to culture Signs & symptoms Fever rule SUTI 2: Low colony counts and U/A Modify Maintain Modify rules Maintain Modify Remove Develop single, expanded set of criteria Antimicrobial treatment Develop specific criteria? Eliminate U/A and roll lower colony counts into SUTI 1 (based on lab survey) Yes No

73 Approach 3 (example) Positive urine culture ( 10 3 CFU/ml) Signs and symptoms (expanded?) Yes No Treatment? Treatment? Yes No Yes No UTI-specific signs/symptoms Fever alone Report UTI (Symptomatic, Treated) Report UTI (Symptomatic, Untreated) Do not report UTI Report UTI (Asymptomatic, Treated) Do not report UTI

74 Approach 3: Considerations Need to: Determine expanded list of signs/symptoms (if possible) Create algorithm for defining treatment of UTI (IVAC experience) Think about any potential unintended consequences Simplify and minimize burden as much as possible e.g., UTI calculator A pilot study to evaluate proposed definition(s) Possible summer/early fall?

75 CDC Core Ad-Hoc Group Division of Healthcare Quality Promotion Kathy Allen-Bridson Scott Fridkin Carolyn Gould Erin Stone CDC Division of Healthcare Quality Promotion Janet Brooks Margaret Dudek Gloria Morrell Ronda Sinkowitz-Cochran Nimalie Stone Lindsey Weiner CDCSAIC Team Office of Informatics NCEZID Mark Lamias Acknowledgments CAUTI Ad-Hoc Expert Panel Linda Adcock Duke Infection Control Outreach Network Brian Callister Lifecare Hospitals Ann Corrigan Lifecare Hospitals Lauren Backman Connecticut State Department of Public Health Dexanne Clohan HealthSouth Daniel Diekema University of Iowa Sheila Fletcher Kindred Healthcare Susan Hadley Tufts Medical Center Susan Huang University of California Irvine Lindsay Nicolle University of Manitoba Health Sciences Center Sanjay Saint University of Michigan Suzanne Snyder Carolinas Healthcare Deborah Yokoe Brigham & Women s Hospital & Channing Laboratory Carolyn Zollar America Medical Rehabilitation Providers Association (AMRA) CAUTI Lab Survey Experts Steven Ewers St. Francis Hospital Deirdre Church University of Calgary

76 Thank you! Questions/Feedback?