1. Validation of Central-Line Associated Bloodstream Infection (CLABSI) Data Reporting, Oregon, 2009
Zintars Beldavs, MS
Manager Healthcare-Associated Infections Program
Acute and Communicable Disease Prevention Section
Office of Disease Prevention and Epidemiology
Public Health Division
Oregon Health Authority
October 13, 2011

2. Oregon HAI
OPHD
OHPR
OPSC
NHSN
Validation
NHSN
Reporting
Multi-hospital
Collaborative
CLABSI
SSI
HAI EIP
Projects
Candidemia
Surveillance
HAI Point
Prevalence
Denominator
Simplification
MDRO
Surveillance
C. difficile
Surveillance

3. Validation for Accurate Data
Research indicates surveillance definitions applied differently by different IPs
Demonstrated by poor inter-rater reliability (agreement between different people reporting on same case): kappas of .30 to .58
Previous validation studies: potentially more than half of cases not reported
If the rationale behind mandatory reporting is to enable the consumer to choose the best hospital, we have the obligation to provide reliable, generalizable data that are internally and externally valid.
Oregon hospitals:Lin MY, et al., SHEA % of 661 positive blood cultures considered CLABSIs:
Infection Preventionists: 21%
Standardized review: 35%
Electronic algorithm: 57
Kappa values 0.43, 0.30, 0.58
Mayer J, et al., SHEA 2010: 120 VAMC records, 18 IPs compared to electronic algorithm
Overall kappa 0.42, range 0.30–0.50
Individual IPs varied up to 2-fold in CLABSI assessments

4. Central Line-Associated Bloodstream Infection (CLABSI)
Attributable mortality ~18%
14,000 deaths/ year in ICU patients
Estimated cost per episode $3,700 to $29,000
Prolong hospitalization by mean of 7 days
Preventable through hand hygiene, barrier precautions, skin antisepsis, catheter site selection
Chosen by our HAI advisory committee based on its morbidity, mortality, and costs --- and its preventability
A bloodstream infection can occur when pathogens travel down a central catheter - that is, a catheter terminating at or near the heart or one of the great vessels - and enter the blood.
Pittet D, Tarara D, Wenzel RP. Nosocomial bloodstream infection in critically ill patients. Excess length of stay, extra costs, and attributable mortality. JAMA. 1994;271:
Soufir L et al. Infect Control Hosp Epidemiol 1999 Jun;20(6):

5. Objectives Evaluate quality of reported data
Assess under- and over-reporting
Gauge the reliability and consistency of surveillance case definitions
Provide feedback and guidance to facilities on surveillance case definitions and reporting methods

6. Methods Study period: calendar year 2009
Included: 44 acute care hospitals
28 with <50 beds
10 with >200 beds
Median central line days 210, range
OPHD validation team:
Research analyst
Epidemiologist
EIS Officer/Physician
3 public health nurses
Hospitals in OR
One major teaching hosp, 25 critical access hospitals
Bed size:
As you can imagine, there is tremendous variation in the levels of resources available, as well as the patient populations being served, the kinds of procedures being done…
Map: Oregon Association of Hospitals and Healthcare Systems, oahhs.org

7. Methods
March April 2011: on-site hospital visit for chart review
Retrospective record review by 1-4 reviewers
At 37 hospitals: all ICU patients blood culture(+)
At 7 largest hospitals: all reported CLABSI plus random sample of 60 patients with ICU blood-culture(+) not reported as CLABSI
Validators blinded as to whether cases reported as CLABSI

8. Methods
After visit, all cases with discordant CLABSI determinations (suspected false positives or false negatives) adjudicated by phone with hospital staff
Participants
Hospital IP staff
Hospital physician
OPHD validators
OPHD physician
Review of all findings for final CLABSI determination
If no consensus reached, case referred to CDC staff
This step unique to Oregon’s validation project (not previously attempted by other states)

9. Results 1199 medical records reviewed
549 at 7 highest-volume facilities (records sampled)
722 at small- and medium- volume facilities
817 record reviews included in final analysis
382 records censored as could not meet ICU CLABSI case definition due to timing rules (positive blood cultures were obtained prior admit or > 48 hours after discharge from ICU)

10. CLABSI rate before and after validation
Validation increased the statewide ICU CLABSI rate from 1.21 (95% CI: 0.95–1.51) to 1.54 (95% CI: 1.25–1.88) CLABSI per 1,000 central-line days
Change after validation in CLABSI rate
No. hospitals %
Rate decreased 0.70 1 2
No change
33a 75
0.01–0.50 higher 5
0.51–1.00 higher
>1.00 higher 6b 14
Total 44
a 23/33 had no CLABSI identified either before or after the validation.
b 3/6 had no CLABSI before the validation.

11. Results Validation outcome, unadjusted
Validation findings
(after chart review and adjudication)
Originally reported to NHSN?
Yes No
CLABSI
70 (True Positives)
16 (False Negatives)
Non-CLABS I
6 (False Positives)
712 (True Negatives)

12. Results Estimated number of CLABSI adjusted for sampling fraction
Estimated CLABSIs among All ICU Patients with Positive Blood Cultures, by Initial Hospital Report — Oregon, 2009
CLABSI
Final determination
Present
Absent
Total
Hospital report
70 (TP)
6 (FP) 76
27a (FN)
1089a (TN)
1116 97
1095
1192
Sensitivity = 0.72 (95% CI: 0.62–0.81); Specificity = 0.99 (95% CI: 0.99–1.00).
Positive predictive value = 0.92 (95% CI: 0.83–0.77).
Negative predictive value = 0.98 (95% CI: 0.96–0.98).
Prevalence = 0.08 (95% CI: 0.07–0.10).

13. Importance of Inter-Agency Follow-up Discussion
Of 27 unreported cases initially identified as possible CLABSI by OPHD, 16 (59%) actual CLABSI
Sensitivity of reporting:
72% based on follow-up adjudication
vs. 60% based on OPHD review alone (P= 0.07), closer to some previous validation efforts

14. Reasons for discrepancies
6 CLABSI “just missed”: at some facilities, IP staff had changed since 2009 and current staff unaware of rationale for previous CLABSI reporting/ non-reporting decisions.

15. CLABSI Pathogens before and after validation
Charts indicate primary organism associated with for each (~4 true pos cases had secondary and tertiary orgs).
This is statewide aggregate data.
“other” = 1 Moraxella (gram neg diplococcus),1 Stenotrophomonas, 1 Veillonella.
All but 2 “other yeast” are non- albicans Candida spp.
Before validation (n=76)
After validation (n= 86)

16. Conclusions
Validating hospital CLABSI reporting improves accuracy of hospital-based CLABSI surveillance
Discussing discordant findings improves the quality of validation

17. Acknowledgments Questions? 971-673-1111 zintars.g.beldavs@state.or.us
OPHD HAI program staff and others assisting
Paul Cieslak – Public Health Physician
Ann Thomas – Public Health Physician
Margaret Cunningham – HAI Epidemiologist
Diane Roy – HAI Administrative Assistant
John Oh – EIS Officer
Steve Moore – Public Health Nurse
Jennifer Tujo – Infection Preventionist
Valerie Ocampo – HAI Public Health Nurse
Oregon Patient Safety Commission
Office for Oregon Health Policy and Research
Association of Professionals in Infection Control, Oregon-SW
Washington Chapter
Questions?