Prospective Investigation of the Operating Room Time-Out Process

§ Department of Surgery, Vanderbilt University Medical Center, Nashville, Tennessee.

Jesse M. Ehrenfeld

* Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, Tennessee;

† Department of Biomedical Informatics, Vanderbilt University Medical Center, Nashville, Tennessee;

§ Department of Surgery, Vanderbilt University Medical Center, Nashville, Tennessee.

∥ Department of Health Policy, Vanderbilt University Medical Center, Nashville, Tennessee.

‡ Division of Epidemiology and Biostatistics, School of Public Health, University of Illinois at Chicago, Chicago, Illinois;

Name: Robert E. Freundlich, MD, MS.

Contribution: This author helped draft the manuscript and perform the statistical analyses of the manuscript.

Name: Catherine M. Bulka, PhD.

Contribution: This author helped draft the manuscript and perform the statistical analyses of the manuscript.

Name: Jonathan P. Wanderer, MD, MPhil.

Contribution: This author helped critically revise the manuscript for important intellectual content.

Name: Brian S. Rothman, MD.

Contribution: This author helped critically revise the manuscript for important intellectual content.

Name: Warren S. Sandberg, MD, PhD.

Contribution: This author helped critically revise the manuscript for important intellectual content.

Name: Jesse M. Ehrenfeld, MD, MPH.

Contribution: This author helped critically revise the manuscript for important intellectual content.

This manuscript was handled by: Richard C. Prielipp, MD, MBA.

Institutional review board: Vanderbilt University Human Research Protection Program, Linda Gooch, Administrative Assistant, 1211 Medical Center Dr, Nashville, TN 37212. E-mail: ude.tlibrednav@hcoog.adnil.

Address correspondence to Robert E. Freundlich, MD, MS, Department of Anesthesiology, Vanderbilt University Medical Center, 1211 21st Ave S, MAB 422F, Nashville, TN 37212. ude.tlibrednav@hcildnuerf.e.trebor.

Associated Data

Abstract

BACKGROUND:

Although the surgical pause or time-out is a required part of most hospitals’ standard operating procedures, little is known about the quality of execution of the time-out in routine clinical practice. An interactive electronic time-out was implemented to increase surgical team compliance with the time-out procedure and to improve communication among team members in the operating room. We sought to identify nonroutine events that occur during the time-out procedure in the operating room, including distractions and interruptions, deviations from protocol, and the problem-solving strategies used by operating room team members to mitigate them.

METHODS:

Direct observations of surgical time-outs were performed on 166 nonemergent surgeries in 2016. For each time-out, the observers recorded compliance with each step, any nonroutine events that may have occurred, and whether any operating room team members were distracted.

RESULTS:

CONCLUSIONS:

Compliance with preincision time-outs is high at our institution, and nonroutine events are a rare occurrence. It is common for ≥1 member of the operating room team to be actively distracted during time-out procedures, even though most time-outs are completed in under 1 minute. Despite distractions, there were no wrong-site or wrong-person surgeries reported at our hospital during the study period. We conclude that the simple act of performing a preprocedure checklist may be completed quickly, but that distractions are common.

The universal protocol was designed by the Joint Commission to reduce the occurrence of wrong-site, wrong-procedure, and wrong-person surgery. 1 According to the protocol, organizations must conduct a “time-out” before the start of any surgical procedure. 2 During the time-out, the entire operating room team reviews the patient’s identity, the procedure, and the surgical site before surgical incision or the start of the procedure. 3 The time-out is also a time designated for team members to voice any concerns about the patient’s safety or the procedure. 3

Implementation of the time-out procedure has been associated with a decrease in preventable medical errors, patient morbidity, patient mortality, and surgical complication rates. 4–7 At Vanderbilt University Medical Center, an interactive electronic time-out was implemented in 2010 to increase surgical team compliance with the time-out procedure and to improve communication between team members in the operating room. 8,9 The electronic time-out uses an electronic whiteboard (40-inch television screen) to display a checklist with checkboxes for each component of the time-out. The circulator nurse normally runs the electronic time-out application using an operating room computer and is responsible for guiding the team through each item. As each step of the time-out is verbalized by a team member, the operating room team members are expected to respond. A nurse then documents these responses electronically by checking boxes within the electronic time-out application, which brings up the next question. Two previous studies conducted at Vanderbilt University Medical Center demonstrated that this electronic time-out application has both improved overall compliance with performing time-outs 8 and decreased wrong-surgery events relative to estimates of national wrong-surgery rates. 9

Despite those findings, little is known about the quality of execution of the time-out in routine clinical practice. Poor time-out execution, caused by nonroutine events, may diminish the expected beneficial effects of the time-out. We therefore sought to identify nonroutine events that occur during the time-out procedure in the operating room, including distractions and interruptions, deviations from protocol, and the problem-solving strategies used by operating room team members to mitigate these nonroutine events. Finally, as an additional verification of observed data, we queried our institution’s perioperative data warehouse for the electronic time stamps associated with each step of the electronic time-out that occurred between August 2010 and December 2016.

METHODS

Our study was approved by the Vanderbilt University Medical Center Institutional Review Board (#121049) with a waiver of informed consent. The Standards for QUality Improvement Reporting Excellence guidelines were consulted in the preparation of this manuscript. 10 Direct observations of preincision time-outs were performed on 166 nonemergent surgeries performed in December 2016 at Vanderbilt University Medical Center, a large, 1019-bed, tertiary academic hospital with 74 operating rooms in 6 semicontiguous locations. Although observations were not randomized and were sampled by convenience, no single service, type of surgery, or operating room location was specifically targeted for observation. No complete team was observed more than once. The observations were conducted by trained study staff using a standardized scoring sheet to assess surgical team compliance with the time-out protocol and to record general observations of the operating room environment (Supplemental Digital Content, Appendix A, http://links.lww.com/AA/C776). For each case, the investigators did not reveal their purpose when they entered the operating room to limit the impact of observation on surgical team behavior.

For each time-out procedure observed, the investigators recorded compliance for each element of the time-out. Elements that were clearly verbalized by the member of the operating room team performing the time-out were considered compliant. In addition to compliance, we noted any nonroutine events that occurred during the time-out process. Specifically, the following data elements were recorded: (1) whether a time-out procedure was conducted, (2) duration of the procedure, (3) the number of individuals present in the room, (4) occurrence and types of nonroutine events, (5) description of how nonroutine events were addressed, and (6) notation of any significant distractions during the time-out. Distractions were defined as any involvement in an activity concerning a non–life-threatening issue by any operating room team member, including conversations unrelated to the time-out, loud music playing, unexpected entrances, and personnel engaged in other tasks, among others. Deidentified study data were collected and managed using Research Electronic Data Capture (REDCap; Project REDcap, Nashville, TN) tools. 11

Finally, to evaluate the robustness of the observed data in relation to all time-out procedures performed at Vanderbilt University Medical Center, we retrospectively queried our institution’s perioperative data warehouse for all electronic time-out time stamps from August 2010 to December 2016. We then derived the length of each step of the time-out and how frequently time-outs were documented as being completed after documentation of surgical incision or start of the procedure.

Frequencies and percentages were calculated for categorical variables. Medians and interquartile ranges were calculated for continuous variables. All statistical analyses were performed using SAS 9.4 (SAS Institute, Cary, NC). A P value of

RESULTS

A time-out was performed before incision in 166 of 166 cases (100% compliance) ( Table 1 ). An announcement was made to indicate the start of the time-out procedure for 163 surgeries (98.2%). The circulator nurse performed the timeout in 163 cases (98.2%) ( Table 2 ). During the time-out, the procedure being performed, patient allergies, and the start of antibiotics were verbally acknowledged 99.4%, 94.0%, and 98.8% of the time, respectively. Of the 166 time-out procedures performed, 106 (63.9%) were completed in ≤1 minute (mean, 60.8 seconds; SD, 21.3 seconds). There were no wrong-site or wrong-person surgeries during the study period.

Table 1.

Time-Out Compliance and Operating Room Details