Infection Control & Hospital Epidemiology We conducted a multivariate analysis to identify factors
associated with disagreement on time zero. Covariates included age >65, sex, hospital length-of-stay >7 days, sepsis time zero occurring after hospital admission (per the hospital abstractor), and which organ dysfunction criteria triggered time zero per the hospital abstractor (ie, hypotension, lactate >2.0 mmol/L, provi- der documentation of severe sepsis/septic shock, or other organ dysfunction). Statistical analyses were performed using SAS version 9.3
software (SAS Institute, Cary, NC) and an online software package for interrater reliability calculations.8 The study was approved by the institutional review boards at Harvard Pilgrim Health Care Institute, Partners Healthcare, Washington University School of Medicine, and Duke University Health System.
Table 1. SEP-1 Criteria for Severe Sepsis “Time Zero” All three of the following within a 6-hour windowa
: 1. Documentation of suspected or confirmed infection
2. ≥2 Systemic Inflammatory Response Syndrome criteria: ∙ Temperature>38.3°C or<36.0°C; heart rate >90 beats per minute; respirations >20 per minute; white blood cell count >12 or <4×103/µL or >10% bands
3. ≥1 Organ dysfunctionb: ∙ Systolic blood pressure<90mmHg (or decrease by >40mmHg) or mean arterial blood pressure <65mmHg ∙ Lactate >2.0 mmol/L ∙ Initiation of mechanical ventilation or noninvasive positive pressure ventilation ∙ Creatinine >2.0 mg/dL, or urine output <0.5 mL/kg/hour for 2 hours ∙ Total bilirubin >2.0 mg/dL ∙ Platelet count <100,000 × 109/L ∙ International normalized ratio >1.5 or aPTT >60 seconds
Note. aPPT, activated partial thromboplastin time. aTime zero is the time at which the last sign of severe sepsis (documentation of suspected
infection, ≥2 systemic inflammatory response syndrome criteria, and organ dysfunction) within that 6-hour window is noted. Alternatively, severe sepsis criteria are met if provider
documentation of suspected or confirmed severe sepsis or septic shock is present. bExcludes organ dysfunction explicitly documented as chronic.
Results
Of the 80 study cases, all 3 abstractors agreed on time zero in 29 cases (36.3%). Agreement rates by hospital are shown in Table 2. Among the 51 cases for which there was a discrepancy, the median time-zero difference between clinician abstractors and hospital abstractorswas 40minutes(interquartile range [IQR], 0–70 minutes; range, 0 minutes to 11.6 days). Agreement on time zero was better but still marginal when the window for concordance was expanded to 1hour(47 of 80 cases, 58.9%) or 3hours (54of80cases,67.5%). Hospital abstractors identifiedtimezeroasoccurring in the
emergency department or day of admission in 55 of 80 cases (68.8%). Agreement among the 3 abstractors was better in these cases (25 of 55 cases, 45.5%) than in cases in which time zero occurred after hospital admission (4 of 25 cases, 16%; P=.01). On multivariate analysis, hospital-onset of sepsis was independently associated with at least 1 abstractor disagreeing on time zero (odds ratio [OR], 8.2; 95% confidence interval [CI], 1.6–40.7; P=.01), whereas age, sex, length of stay>7 days, and organ dysfunction criteria were not. Overall, hospital abstractors identified 19 of 80 cases (23.8%)
as passing SEP-1. Among the clinician abstractors, 9 cases (11.3%) passed when using the abstractor with the strictest assessments at each hospital. When using the highest pass rates per clinician abstractor at each hospital, 15 cases (18.8%) passed. Interrater reliability among the 3 abstractors for determining SEP-1 compliance was poor (Fleiss κ, 0.39). When assessing agreement by at least 1 clinician abstractor identifying the same time zero as the hospital abstractor, agree- ment increased to 56 of 80 cases (70.0%), and interrater reliability for determining SEP-1 compliance was better but still only moderate (Cohen κ, 0.67). When examining agreement only between the 2 clinician abstractors at each hospital, agreement on time zero occurred in 34 of 80 cases (42.5%) and interrater reliability for SEP-1 compliance was poor (Cohen κ, 0.28).
Discussion
We found poor agreement between abstractors for identifying sepsis time zero and whether cases passed the CMS SEP-1 measure.
Table 2. Agreement in Determining Sepsis Time Zero and SEP-1 Compliance by Hospitala
Overall (N=80), n/N (%)
Agreement (All 3 Abstractors) Exact (±1 minute) ± 1 hour ± 3 hours
Median difference in time zero for clinician vs hospital abstractors (IQR)b Agreement for sepsis occurring in emergency department (within ±1 min)c Agreement for sepsis occurring after admissionb (within ±1 min) Interrater reliability for overall SEP-1 pass vs fail (Fleiss κ)d
29/80 (36.3) 47/80 (58.8) 54/80 (67.5) 40 min (0–70) 25/55 (45.5) 4/25 (16) 0.39
Hospital 1 (N=29), n/N (%)
15/29 (51.7) 20/29 (69) 24/29 (82.8)
41 min (0–139) 13/23 (56.5) 2/6 (33.3) 0.39
Hospital 2 (N=21), n/N (%)
8/21 (38.1) 12/21 (57.1) 12/21 (57.1)
13 min (1–568) 7/11 (63.6) 1/10 (10) 0.24
Hospital 3 (N=30), n/N (%)
6/30 (20) 15/30 (50) 18/30 (60)
49 min (0–210) 5/21 (23.8) 1/9 (11.1) 0.37
Note. IQR, interquartile range. aData for each hospital are presented in no specific order. bRepresents the median difference in time zero determined by both clinician abstractors compared to each hospital’s official quality abstractor. Only cases where there was at least 1
disagreement were included in the analysis. cThe timing of sepsis onset was determined using the official hospital abstractor’s time zero. dInterrater reliability calculations included all 3 abstractors at each hospital.
995
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