Effects of a Safety Checklist on Surgical Patient Outcomes

To date, efforts to prevent adverse events in surgical patients have primarily focused on safety interventions within the 4 walls of the operating room. Researchers in the Netherlands recently conducted a study designed to address patient safety issues along the entire surgical pathway, from admission to discharge. This controlled, multicenter prospective study compared incidences of adverse outcomes and mortality rates in surgical patients before and after the implementation of a comprehensive surgical safety checklist. The results of the study were reported in the New England Journal of Medicine [2010;363(20):1928-1937]. The Surgical Patient Safety System (SURPASS) was developed to address surgical errors, the majority of which—53% to 70% according to numerous studies—occur outside the operating room. The checklist is organized to correspond with the preoperative, operative, recovery, and postoperative phases of the surgical pathway. It also reflects the multidisciplinary nature of surgical care with input from the ward physician, nurse, surgeon, anesthesiologist, and operating assistant. Review of imaging and other presurgical tests, tracking of all surgical equipment, marking of the patient’s operative side, and careful conveyance of postoperative instructions and medication prescriptions at the time of discharge are among the items on the checklist. Two academic centers and 4 teaching hospitals, all with high baseline standards of care, were selected for the observational study. Five similar hospitals (1 academic center and 4 teaching hospitals) were selected as control hospitals. Data on patient outcomes were gathered over the same time period and in the same manner in both groups of hospitals. When introduced to all departments within the participating intervention hospitals, the checklist was presented as a means for improving quality care without specific mention of its research aspect. Implementation of the checklist required a 9-month period, with pre- and postimplementation periods of 3 months. Patient data (age, sex, coexisting conditions, length of stay, surgical procedures) and outcome data (12 complication categories such as respiratory, cardiac, abdominal, and infection) were collected. The Dutch National Adverse Event Registration System (LHCR), in use for >10 years in the Netherlands, provided the outcome data. All patient complications are registered with the LHCR except for those occurring after discharge. Statistical analyses examined 12 categories of complications. The rate of complications is representative of the number of complications per 100 patients per category. Potential confounders were considered in assessing differences between surgical patients in the pre- and postimplementation groups. A P value of <.05 indicated statistical significance, and exact 95% confidence intervals (CIs) were calculated for complication rates. The effect of the checklist on mortality was also assessed. Results compared 3760 patients in the baseline, preimplementation group with 4364 patients in the postimplementation group. Approximately 10% of patients in both groups underwent >1 procedure. A random sample (26%) of SURPASS checklists used with patients in the intervention hospitals revealed that a median of 80% of items on the sample checklists were completed. Complication rates in the intervention hospitals were stable during the 3-month preimplementation period. Following implementation of the SURPASS checklist, there was a decrease in complication rates; “the total number of complications decreased from 27.3 per 100 patients (95% CI, 25.9-28.7) to 16.7 per 100 patients (95% CI, 15.6-17.9), corresponding to an absolute reduction of 10.6 complications (95% CI, 8.7-12.4).” Patients with ≥1 complications fell from 15.4% during the preimplementation phase to 10.6% in the postimplementation period (P<.001). In-hospital mortality rates also decreased from 1.5% (95% CI, 1.2-2.0) to 0.8% (95% CI, 0.6-1.1). Data collected during the same study period and in the same manner in the 5 control hospitals showed no significant change in outcomes. Absolute reduction of complications ranged from 0.3 to 19.5 per 100 patients, with the likely reason for these considerable differences being wide variations in the use of the checklist, the researchers said. Support for the efficacy of the checklist in reducing adverse outcomes is further supported by the fact that when checklist completion was above the median (80% of items completed), the complication rate fell to 7.1 per 100 patients compared with a rate of 11.7 per 100 patients when checklist completion was below the median. Limitations cited by the authors included the possibility that any change observed in relation to the intervention might have been affected by other change in each hospital or by a difference in the mix of cases, the manner in which the outcomes data were collected, and limiting the documentation of complications to the period of admission. In conclusion, the researchers said that use of the comprehensive SURPASS checklist, targeting all phases of surgery from admission to discharge, leads to reduced surgical patient complication and mortality rates.