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Original Research Articles: Original Clinical Research Report

Prospective Investigation of the Operating Room Time-Out Process

Freundlich, Robert E. MD, MS*,†; Bulka, Catherine M. PhD; Wanderer, Jonathan P. MD, MPhil*,†; Rothman, Brian S. MD*,†; Sandberg, Warren S. MD, PhD*,†,§; Ehrenfeld, Jesse M. MD, MPH*,†,§,‖

Author Information
doi: 10.1213/ANE.0000000000004126

Abstract

KEY POINTS

  • Question: What is the quality of execution of the preoperative time-out in routine clinical practice?
  • Findings: Direct observation of 166 time-outs in 2016 revealed that time-outs may be completed quickly and efficiently; critical team members are frequently distracted during the time-out (10.2% of observations).
  • Meaning: We conclude that the simple act of performing a preprocedure checklist may be completed quickly and 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-outs8 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 <.05 was considered statistically significant.

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 time-out 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
Characteristic N = 166
Type of surgery, N (%)
 General 45 (27.1)
 Otolaryngology 27 (16.3)
 Orthopedic 22 (13.3)
 Urology 23 (13.9)
 Neurosurgery 10 (6.0)
 Vascular 12 (7.2)
 Plastics/reconstructive 12 (7.2)
 Ophthalmology 4 (2.4)
 Cardiac 4 (2.4)
 Other 7 (4.2)
Time-out before incision, N (%) 166 (100.0)
Announcement made at start of time-out, N (%) 163 (98.2)
Surgical team members, median (interquartile range) 6 (5–6)
 Anesthesia team 1 (1–1)
 Surgeons 2 (2–2)
 Nurses 1 (1–1)
 Scrub technicians 1 (1–1)

Table 2. - Characteristics of Completed Time-Outs
Characteristic N = 166
Performed time-out, N (%)
 Circulator nurse 163 (98.2)
Verbally communicated during time-out, N (%)
 Presence of required members of the procedural team 163 (98.2)
 Presence of person who marked patient 156 (94.0)
 Patient identity (name, medical record number) 163 (98.2)
 Surgical site and site marking 152 (91.6)
 Procedure to be performed 165 (99.4)
 Relevant diagnostic or radiological studies (images) 151 (91.0)
 Availability of necessary blood products, implants, devices, and/or equipment required for procedure 159 (95.8)
 Allergies 156 (94.0)
 Start of antibiotics 164 (98.8)
 Discussion of any special considerations relevant to procedure 156 (94.0)
Completed without interruption, N (%) 154 (92.8)
Stopped due to safety concern, N (%) 156 (94.0)
Operating room members actively distracted, N (%) 17 (10.2)
≤60 s spent on time-out, N (%) 106 (63.9)
Average time-out duration in seconds, mean (SD) 60.8 (21.3)

Most time-outs were completed without interruption (92.8%). A list of interruptions is shown in Table 3, with the most common being to verify patient information and eliminate distractions in the operating room (asking distracted individuals to participate in the time-out). Ten time-out procedures were stopped due to a safety concern. Safety concerns raised are shown in Table 4. These included verifying patient medications, postoperative plans, and procedural issues. In 10.2% of the time-out procedures observed, ≥1 member of the operating room team was actively distracted. Based on the comments written down by observers, distractions included music playing, unrelated conversations, and prepping of the patient.

Table 3. - Interruption Details
Characteristic N = 12
Type of interruption, N (%)
 Eliminating distractions in operating room 5 (41.7)
 Verifying patient information 5 (41.7)
Other 2 (16.7)

Table 4. - Safety Concern Details
Characteristic N = 10
Safety concern, N (%)
 Medications 4 (40.0)
 Postoperative plan 2 (20.0)
 Related to procedure 4 (40.0)

Our retrospective analysis of Vanderbilt University Medical Center institution-wide time-stamp data found that, for 59.8% of surgeries performed at Vanderbilt University Medical Center between August 2010 and December 2016 (n = 300,373), the time between checking off the first and last elements of the time-out procedure in the operating room was ≤2 minutes. The median documented time-out duration was 98 seconds, with an interquartile range from 35 to 168 seconds. Furthermore, 1.3% (n = 3846) of the time-outs were documented as having been completed after the start of surgical incision.

DISCUSSION

This study extends our current understanding of the time-out process from 2 separate perspectives: direct observation of a sample of cases and a large retrospective evaluation of time-out documentation patterns. There was a high compliance rate for the time-out procedure at our institution. Consistent with our previous study, time-outs were performed quickly, with most taking ≤1 minute.9 Nevertheless, we observed that in >10% of the completed time-outs, ≥1 critical member of the operating room team was distracted.

Distractions during surgical procedures have been shown to prolong surgical duration and result in surgical errors.12,13 While some distractions are potentially beneficial, such as critical alerts or alarms, we attempted to assess the precise nature of the distraction to better assess this (Tables 3–4). It is unknown how distractions during the preincision time-out procedure may impact the performance of the operating room team. It is also possible that distractions may be a marker for poor team communication skills. The quality of surgery depends on more than just the surgical team’s technical skills. Human factors such as effective communication, coping with distractions, stress, and fatigue are critical.14 Wiegmann et al15 determined that issues with communication and teamwork in the operating room were significant predictors of surgical errors. Preoperative checklists are intended to improve patient safety but may also positively impact teamwork and communication in the operating room.16–18

One criticism of checklists is that they may unnecessarily prolong the surgical procedure. We have demonstrated that most time-outs were completed quickly and that using time-outs can identify safety concerns. Time-out procedure element compliance was not 100%, and distractions during the time-out are common. This did not lead to any wrong-site or wrong-person surgeries during the study period. It is important to recognize, however, that the study was not designed to assess the incidence of wrong-site or wrong-person surgeries, and these findings should be interpreted appropriately. Regardless, it is possible that the act of going of through the time-out checklist itself is effective at improving communication among surgical team members and reducing surgical errors, even if compliance for each element of the time-out procedure is not perfect and distractions in the operating room are commonplace.

There are limitations to the study that deserve further elaboration. We asked our observers not to enter rooms in which emergent surgeries were being performed because we were concerned about the possibility, however remote, that their presence could potentially interfere with patient care. It is likely that emergent surgeries are at higher risk for process performance errors and that the time-out process may be compromised in these situations. Our most emergent surgeries, those with an immediate risk to life, are termed “level 1 cases.” Timeouts for level 1 cases are conducted with an abbreviated “essential” 3-question time-out that is a separate checklist. Again, these timeouts were not included in the study due to concerns that the presence of observers could interfere with patient safety. Our estimates should be interpreted accordingly. Our study population targeted a broad distribution of surgical cases, with many observations. Despite this, it is still possible that our observations exhibited sampling bias and are not representative of a larger surgical population. Additionally, given the single-institution nature of the study, we did not assess the generalizability of our findings. Multicenter studies would help determine if our findings may be replicated elsewhere.

In summary, we have demonstrated that, while compliance with the time-out process is high and team members stop the process to address safety concerns, distractions remain common, and performance of a “complete” time-out to the exact specification of the procedure does not always happen. Despite this, preventable medical errors have not occurred at our institution during the study period.

DISCLOSURES

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.

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