On the CUSP: Stop CAUTI National Content Webinar Welcome to the National Content Webinar! Today’s Topic: 2015 NHSN CAUTI Definition Changes Access slides, audio recording and transcript of today’s webinar on the national project website: http://www.onthecuspstophai.org/on-the-cuspstop-cauti/educational-sessions/content-calls/

Katherine Allen-Bridson, BSN, RN, MScPH, CIC Changes to NHSN Catheter-Associated Urinary Tract Infection Surveillance in 2015 Katherine Allen-Bridson, BSN, RN, MScPH, CIC Nurse Consultant Division of Healthcare Quality Promotion Centers for Disease Control and Prevention On the CUSP: Stop CAUTI March 10, 2015 National Center for Emerging and Zoonotic Infectious Diseases Division of Healthcare Quality Promotion

Objectives Identify the major changes for 2015 for CDC/NHSN CAUTI surveillance and general surveillance changes that will impact CAUTI reporting. Apply the CAUTI definitions to case studies. Identify the limitations on anticipating changes to CAUTI rates. Identify ways that facilities may appreciate the effects that some of the measurable changes may have on their CAUTI rates.

For More Information….. Please see the following for more in-depth guidance: NHSN Definition and Rules Changes for 2015 CAUTI: Definition Changes for 2015 Device-associated Denominator Sampling for 2015 Available at http://www.cdc.gov/nhsn/acute-care-hospital/CAUTI/index.html UTI protocol available at http://www.cdc.gov/nhsn/PDFs/pscManual/7pscCAUTIcurrent.pdf

General NHSN HAI changes for 2015

General NHSN HAI Changes for 2015 Addition of the following surveillance rules: Infection Window Period Repeat Infection Timeframe (RIT) Secondary BSI Attribution Period (not pertinent) Date of event Optional weekly denominator sampling

Major UTI Changes for 2015 Requirement for ≥ 100,000 CFU/ml organisms in urine culture Exclusion of non-bacteria as sole pathogens Use of same pathogen list for symptomatic UTI (SUTI) and asymptomatic bacteremic UTI (ABUTI)

What Hasn’t Changed for 2015 Present on Admission Healthcare-associated infection Timeframe for associating use of indwelling urinary catheter to UTI Transfer Rule Symptoms for SUTI (except removal of dysuria from infant) Fever still cannot be excluded as due to another source of infection Definition of indwelling urinary catheter

UTI Infection Window Period 1 3 days before 2 3 Date of urine culture 1st positive Diagnostic Test after A positive urine culture is always required for NHSN UTI criteria and therefore it is used for the diagnostic test to set the infection window period. The patient then has the date of the culture and the 3 days before and after the culture to meet the other UTI elements. This is the 7-day UTI infection window period.

UTI Repeat Infection Timeframe (RIT) 14 day timeframe No new UTIs are reported Date of event = Day 1 Additional pathogens from urine cultures during RIT are added to the event Note: Can add only 1 additional unless also has secondary BSI then can enter a 3rd organism.

14 Day Repeat Infection Timeframe (RIT) Gen Def changes2 4/13/2017 Hospital Day SUTI Criterion 8 9 10 11 Temp = 101.5° F 12 Temp = 102.1° F 13 Urine culture: >100,000 cfu/ml, E. coli 14 15 16 17 18 19 20 21 22 23 24 Timeframe 14 Day Repeat Infection Timeframe (RIT)

NHSN CAUTI definitions for 2015 (non-infantile)

SUTI 1 SUTI 2 ABUTI UTI Overview Any Age Infant ≤ 1 yr Any Age A: Catheter-associated B: Non-catheter associated SUTI 2 Non-catheter-associated ABUTI Non-Catheter-associated Any Age Infant ≤ 1 yr Any Age The 2 types of UTIs, can be categorized by the age of eligible patients, and their association with indwelling urinary catheters. Patients of any age (including infants) are eligible to meet SUTI criterion 1 and ABUTI. Only infants that are 1 year of age or less are eligible to meet SUTI criterion 2. Each type of UTI, SUTI 1, 2 and ABUTI, can be either catheter-associated or non-catheter-associated. It is only the catheter-associated (animate) SUTIs and ABUTIs that are reportable as part of CMS quality reporting programs for CAUTI.

SUTI 1a (catheter in place) Patient must meet 1, 2, and 3 below:   Patient has an indwelling urinary catheter in place for the entire day on the date of event and such catheter had been in place for >2 calendar days, on that date (day of device placement = Day 1). Patient has at least one of the following signs or symptoms: fever (>38.0°C) suprapubic tenderness* costovertebral angle pain or tenderness* Patient has a urine culture with no more than two species of organisms, at least one of which is a bacteria of ≥105 CFU/ml. All elements of the UTI criterion must occur during the Infection Window Period.    

SUTI 1a (catheter recently removed) Patient must meet 1, 2, and 3 below:   Patient has an indwelling urinary catheter in place for greater than 2 days which was removed on the day of or the day before the date of event. Patient has at least one of the following signs or symptoms: fever (>38.0°C) suprapubic tenderness* costovertebral angle pain or tenderness* urinary urgency* urinary frequency* dysuria* Patient has a urine culture with no more than two species of organisms, at least one of which is a bacteria of ≥105 CFU/ml. All elements of the UTI criterion must occur during the Infection Window Period.  After reviewing, go back to previous slide and Note intention of “entire day”-

Criterion Rationale – SUTI 1a Catheter removed UTIs with event date on the day of device discontinuation or the following calendar day are considered device-associated UTIs if the device had been in place already for >2 calendar days. For this criterion urgency, frequency and dysuria are symptoms. Day 1 Day 2 Day 3 Day 4 CAUTI? Foley placed Foley in place Foley in place for part of day only then removed Date of event Yes Foley in place for part of day then removed No Foley No

Asymptomatic Bacteremic UTI (ABUTI) Patient must meet 1, 2, and 3 below: Patient with* or without an indwelling urinary catheter has no signs or symptoms of SUTI 1 or 2 according to age. (Note: Patients > 65 years of age with a non-catheter-associated ABUTI may have a fever and still meet the ABUTI criterion.) Patient has a urine culture with no more than two species of organisms, at least one of which is a bacteria of ≥105 CFU/ml. Patient has a positive blood culture with at least one matching bacteria to the urine culture, or meets LCBI criterion 2 (without fever) and matching common commensal(s) in the urine. All elements of the ABUTI criterion must occur during the Infection Window Period. 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 or the day before.   The bacteria in the urine culture that matches the blood culture must have at least 100,000 CFU/ml.

ABUTI Note: Only events with catheters in place for >2 calendar days prior to date of event are catheter-associated.

UTI Flow Diagram Original colors were hard to read and print. New version coming out in March will be white like this. This flowchart is able to capture what took 3 or 4 flowcharts in 2014. All UTI determinations.

Optional Denominator Sampling

Collecting Summary Denominator Data Options: Manually collected every day Electronically collected every day Following validation of the electronic method against the manual method 3 months concurrent data collection with both methods Difference between methods must be within +/- 5% of each other Weekly sampling

Denominator Sampling Summed sampling data for month

Denominator Sampling If weekly sampling is used, upon entry of the monthly data into NHSN, an estimate of central-line days or urinary-catheter days will be automatically calculated and used as CLABSI and CAUTI denominator data.   Estimated urinary catheter days = # sample UC days # sample pt. days X Total pt. days

Denominator Sampling To ensure the accuracy of the estimated denominator data, only non-oncology ICU and ward location types with 75 or more device days per month are eligible to use the alternative method. Review of each location’s prior year (i.e., 12 months) of CLABSI or CAUTI denominator data in NHSN will help determine which locations are eligible.

Resources for NHSN

Resources for Surveillance NHSN Forms 57.106: Monthly Reporting Plan 57.114: Urinary Tract Infection 57.118: Denominators for Intensive Care Unit (ICU)/Other locations (not NICU or SCA)

Available Resources and Training CDC/HICPAC Guideline for Prevention of Catheter- associated Urinary Tract Infections1 Training Device-Associated Module Pre-recorded Webinars Lectoras (interactive with knowledge checks) http://www.cdc.gov/nhsn/training 1Gould CV, Umscheid CA, Agarwal RK, Kuntz G, Pegues DA. Guideline for prevention of catheter-associated urinary tract infections 2009. Infect Control Hosp Epidemiol. 2010;31(4):319-26.

How might these changes Affect CAUTI data?

Background Information NHSN serves multiple purposes. UTI changes were made alongside other HAI definitional changes for 2015. Changes make trend analysis challenging. Incorporated NHSN user and internal and external subject matter input. Non-arbitrary Before we discuss what can and cannot be anticipated regarding changes in CAUTI rates, it’s important to remember a few things. The NHSN is a system which serves many purposes including being used by facilities and organizations to measure the success of infection prevention efforts, by agencies to determine reimbursement for patient care, and by individuals in healthcare decisions. All of these purposes are important and must be considered when changes are contemplated. Significant changes were made to several NHSN infection definitions in 2015 to try to bring the definitions closer to clinical determinations and current diagnostic practices as well as to increase the objectivity and consistency of the definitions and their application. We recognize that changes to the definitions make trend analysis challenging. However, we did feel that these changes were necessary given significant NHSN user-input as well as work undertaken over an 18-month period involving internal and external subject matter experts. The decisions were made using NHSN data and published research when available and were not arbitrary.

Limitations in Quantifying Effects Effects of some changes cannot be quantified. Variables are not measured E.g., Infection Window Period, Date of Event: do not collect dates of cultures or symptoms. We are limited in being about to quantify the changes that can be expected as a result of the general HAI definition changes as well as the UTI specific definitional changes. The Paperwork Reduction Act of 1995 limits the amount of data that NHSN may collect. Simply put, some of the variables necessary to analyze the effects of such rules as the Infection Window Period and the change in the definition of Date of Event to the date of the first element rather than the last are not collected in NHSN. Therefore no effect can be measured.

Locations and Facilities are Unique Variations in proportions of: Non-bacterial vs bacterial CAUTIs High colony count vs low colony count CAUTIs Variations in: Urine culturing practices Laboratory reporting practices Antimicrobial use More importantly there are variations between facilities and even between locations within the same facility, which will impact the effects that are experienced. For some facilities and some locations a high proportion of their reported CAUTIs are due to yeast alone, as high as 50% or more in some cases, while in others the proportion is quite low. Likewise there is great variation in the proportions of SUTIs meeting criterion 2 (lower colony count) vs 1 (higher colony count). This will also influence the amount of change in a location’s CAUTI rates. Some of these differences can be explained, at least in part by differences in practices of urine culturing, laboratory reporting and antibiotic use (which can increase the proportion of urine organisms that are yeast). So, each location or facility is likely to experience unique effects on their CAUTI rates.

Possible Directional Effects of Changes Exclusion of non-bacterial pathogens for UTI Decrease the numbers of reported UTIs Institution of minimum urinary colony count of 100,000 CFU/ml Having prefaced what we can and cannot say about anticipating the changes to CAUTI rates, what is likely in the way of directional change? Well some are things are easy to predict. Both of the major UTI changes, should result in decreasing numbers of reported UTIs.

Possible Directional Effects of Changes Infection Window Period Increase the numbers of reported UTIs as IWP > “no more than a single gap day between adjacent elements” Date of Event Decrease number of reported UTIs More POA vs HAI More non-catheter-associated UTI vs CAUTI Repeat Infection Timeframe Decrease the numbers of events reported The institution of a 7-day infection window period instead of allowing no more than a single gap day between adjacent elements to meet all UTI criteria will likely increase the numbers of UTIs that are reported. On the other hand moving the date of event from the previous definition of the date of the last element to the date of the first element in the infection window period would seem to result in more infections being identified as POA than HAI and non-catheter-associated rather than CAUTI. The RIT is also likely to result in fewer CAUTIs being reported.

What’s an IP to do So what’s a guy/girl/IP/ facility to do????

Assess the likely effect of major changes for your location/facility Assess frequency of yeast CAUTIs Assess frequency of CAUTIs with < 100,000 CFU/ml By running a frequency table of CAUTIs that have a non-bacterial pathogen listed as the sole pathogen and a frequency table that shows the proportion of CAUTIs reported with the lower colony count (≥ 1,000 but < 100,000 CFU/ml) in a location or facility, a crude estimate of the amount of change can be determined. NHSN can assist users who undertake these analyses if they have questions. NHSN can assist users with creating output options to measure the impact of these variables.

What will this mean for SIRs reported to CMS? 2015: SIRs submitted to CMS this year will use existing, historical baseline. 2016: Data reported to NHSN for events in 2015 will be used as the new baseline for SIRs.

Summary Significant changes for NHSN UTI surveillance for 2015. Changes made following thorough review of issues and with input from NHSN users and subject matter experts. Decrease subjectivity, increase consistency.

Summary A national projected effect on CAUTI rates is not possible. Limitations of data variables collected Facility practice variations Facilities/groups can analyze past data to anticipate some major effects.

Case Studies

Investigating a Positive Urine Culture as Possible CAUTI Proceed in this order*: 1. Determine infection window period (IWP). 2. Determine if all criteria occur within IWP, i.e., is it an event? Yes= continue; No = Stop, no event. 3. Determine date of event (DOE). 4. Determine if present on admission (POA) or healthcare-associated (HAI). If POA, previously discharged that day or day before? Yes = UTI attributable to discharging location; No = Stop, POA. If HAI, continue 5. Determine if device-associated. 6. Determine attributable location/facility. 7. Determine Repeat Infection Timeframe. 8. Determine Secondary BSI Attribution Period (if necessary).

Device Associated Example #1 Day 5 –Foley inserted; asymptomatic Day 6 – Foley remains in place; Fever 38.2ºC Day 7 – Fever 38.6°C Day 8 – 100,000 CFU E. coli in urine

Polling Question Is this an NHSN CAUTI? Yes No

Device Associated Example #2 1/7 Patient admitted 1/8 Temperature 100.9°F; Foley inserted 1/9 Temp 102°F 1/10 Foley, temp 100.9°F 1/11 Foley, temp 101.6° F 1/12 Foley, Urine culture collected and positive for 100,000 CFU/ml Enterococcus faecium

Polling Question Is this an NHSN CAUTI? Yes No

Device Associated Example #3 Day 1 – Admit to ICU Day 4 – Foley inserted Day 8 – Foley removed; asymptomatic Day 9 – No Foley in place; Fever 100.5 º F Day 10 – Fever 100.5º F; Urine (+) 100,000CFU/ml E. faecium Rationale: This is a CAUTI. The date of event (day 9) was the day after catheter removal and catheter in place >2 calendar days. IWP= day 7-13

Device Associated Example #4 Day 1 – Admit to ICU Day 4 – Foley inserted Day 8 – Foley removed Day 9 – Foley inserted Day 10 – Temp of 100.6° F; Urine (+) 100,000 CFU E. coli; meets criteria for a symptomatic UTI here. Rationale: This is a CAUTI. This patient has had a Foley in place for some part of > 2 calendar days on the date of event. There was not a full calendar day without a Foley in place. IWP=day7-13

Case 1 Patient is transferred to your hospital from inpatient rehabilitation facility with a Foley catheter that has been in place for 2 weeks. He had a fever of 38.5°C and a change in mental status the day before transfer, reported by a health care worker. He is afebrile on admission. Urine cultures collected on admission are positive for 10,000 CFU/ml of E. coli and U/A is positive for nitrites.

Polling Question Which of the following is most accurate? Patient does not have an NHSN CAUTI. Patient has a CAUTI attributed to the new hospital. Patient has a CAUTI attributable to the rehab facility and POA to the hospital.

Case 1 Rationale Answer: Patient does not have an NHSN CAUTI. Urine cultures must have a minimum of 100,000 CFU/ml to be used as an element of 2015 NHSN UTI criteria.

What If? Patient is transferred to your hospital from inpatient rehabilitation facility with a Foley catheter that has been in place for 2 weeks. He had a fever of 38.5°C and a change in mental status the day before transfer, reported by a health care worker. He is afebrile on admission. Urine cultures collected on admission are positive for 10,000 ≥ 10,000-100,000 CFU/ml of E. coli and U/A is positive for nitrites.

Polling Question Which is the best determination of whether an NHSN CAUTI is present? Patient does not have an NHSN CAUTI. Patient has a CAUTI attributed to the new hospital. Patient has a CAUTI attributable to the rehab facility and POA to the hospital. Determination cannot be made without understanding the laboratory’s reporting protocols.

Case 1 Rationale Answer: Determination cannot be made without understanding the laboratory’s reporting protocols. Check with laboratory to determine if they can confirm that at least 100,000CFU/ml of E. coli is present in culture. If yes, CAUTI Is attributable to the rehab facility. If not, no NHSN UTI as required minimal colony count cannot be confirmed.

Case 2 February 1, hospital day 4. Foley has been in place for >2 days and patient spikes temp of >38.0°C. Urine culture collected and positive for 105 CFU/ml of Klebsiella pneumoniae, and Citrobacter freundii (2 species) February 3, urine culture collected and positive for 105 CFU/ml Klebsiella ornithinolytica

Polling Question Which of the following is correct: Patient does not have an NHSN CAUTI because there are more than 2 organisms in the urine culture. Patient has a CAUTI with date of February 1.

Case 3 Day 1: 58-year-old patient is admitted to the ED with GI bleed. Foley inserted. Day 2: Patient spikes temp of 38.6°C. Indwelling catheter remains in place. Day 3: Urine specimen is collected. Day 4: Culture results 100,000 CFU/ml Pseudomonas aeruginosa. Antibiotics started. Day 5: Patient asymptomatic and afebrile. This is a SUTI that is present on admission for NHSN purposes. Date of event = day 2.

Case 3 – Continued Day 15: Foley remains in place. Patient completed treatment for UTI on hospital day 11 and has been afebrile since. Temperature today 38.1°C. Cough productive of yellow phlegm. Rhonchi present. Day 16: Urine cloudy. Fever 37.9°C. Cough continues. Sputum specimen collected. Day 17: Urine specimen collected. Day 18: Urine and sputum cultures both positive for S. aureus with > 100,000 CFU/ml in urine.

Should another CAUTI be reported? No, the date of event for a UTI related to this culture occurs during the RIT of previous UTI.

14 Day Repeat Infection Timeframe (RIT) Hosp Day Dev-ice UTI Criterion 1 Foley (F) 2 F Temp 38.6°C 3 Urine culture (“+” 105 CFU/ml P. aeruginosa) 4 5 6 7 8 9 10 11 12 13 14 timeline Date of event Infection Window Period 14 Day Repeat Infection Timeframe (RIT) Although the urine culture was collected outside of the RIT, the date of event was the last day of the RIT. See that when this is done, it is not necessary to work up urine cultures occurring within the RIT Date of event

Case 3 Rationale Unlike CLABSI, CAUTIs may NOT be excluded as secondary to another infection. Fever cannot be attributed to another source of infection.‡ The date of event for this UTI would be Day 15 (date of fever) which is within RIT for POA UTI from Day 2. If earlier UTI was HAI and was reported, S. aureus would be added as pathogen to that event. ‡ See March 2012 Newsletter; also note the lack of “*” following fever in criteria.

Case 4 04/05/15: Patient admitted from LTAC at 8 a.m. for surgical debridement of sacral decubitus. Routine admission U/A performed, positive for leukocyte esterase, and 3 WBC by HPF of spun urine. Patient afebrile, denies urinary urgency, frequency or pain. No suprapubic or CVA pain. Foley catheter present on admission. Admit postoperatively to telemetry unit. 04/06/15: Wound clean. Temperature 37.4°C. Foley draining cloudy urine.

Case 4 – Continued 04/07/15: Transfer to surgical unit. WBCs 12,100/mcL. Temp of 37.9°C. Foley removed. Urine sent to lab for culture and sensitivity. 04/08/15: Dysuria and suprapubic tenderness. Bactrim started. 04/09/15: 04/07 urine culture positive for Candida albicans 100,000 CFU/ml. Patient afebrile.

Polling Question As of 4/9 does this patient have a UTI and if so, is it a CAUTI? No. UTI criterion not yet met. No, UTI was present on admission. Yes, patient has a SUTI 1a. and it is a CAUTI.

Case 4 – Continued What if everything was the same except that the urine culture result was positive for S. aureus 100,000 CFU/ml and Candida albicans 100,000 CFU/ml? Answer: CAUTI

Case 4 Rationale DOE = 4/7 – Date of urine culture No more than 2 organisms in urine, 1 of which was bacteria > 100,000 CFU/ml. SUTI 1a criterion met; Infection Window Period = 4/4 - 4/10. Foley had been in > 2 days on DOE and removed that day = catheter-associated.

Infection Window Period Timeframe 2 Date of event Hosp Day Device UTI Criterion 1 (4/5) Telemetry unit Foley (F) 2 F 3 (4/7) Telemetry ►surgical unit F discont. Urine culture: (“+” 105 CFU/ml S. aureus and Candida albicans) 4 (4/8) Dysuria and suprapubic tenderness 5 6 (4/10) Discharged 7 Infection Window Period 14 Day Repeat Infection Timeframe (RIT) (abbreviated due to facility discharge) See that when this is done, it is not necessary to work up urine cultures occurring within the RIT; Infection window period extends to the

Great Job!!!

Questions? For questions about CAUTI rates for 2015 vs 2014: 2015 CAUTI SIRs will use 2009 baseline; FY 2017 will use this comparison and facilities will probably look good. After 2015 is complete, a new baseline for 2015 will be computed and this will be used for subsequent SIRs. We understand that changes that we have made and continue to make to HAI definitions can create a tension for participant usability needs Makes trend analysis challenging The changes are not arbitrary The system is used for multiple purposes The changes that can be expected in trends will vary from facility to facility and will be based on several variables: Culturing practices Laboratory reporting practices Antimicrobial prescribing practices (may impact the proportion of yeast) We cannot provide an anticipated percent of reduction. Such a reduction would be a national figure and not account for the great amount of variability between facilities which is contained within. Besides the changes due to the UTI definitional changes there will be changes that are due to the general definitions modifications identified earlier. The effects of these changes are not easily quantifiable either.

Questions: email user support Contact us Questions: email user support nhsn@cdc.gov NHSN website: http://www.cdc.gov/nhsn/

Next Steps Review and reference the guidance documents and Kathy provided: NHSN Definition and Rules Changes for 2015 CAUTI: Definition Changes for 2015 Device-associated Denominator Sampling for 2015 To help determine what impact these changes may have on your facility: Assess frequency of yeast CAUTIs Assess frequency of CAUTIs with < 100,000 CFU/ml

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