Adverse events continue to haunt medical care across the globe. A recent international meta-analysis yielded a 12% incidence of medical harm, including death and serious disability, across the medical care spectrum, with 6% of patients suffering preventable medical injury—many of which occurred during surgery [11]. An analysis from the United States found that such events occur in nearly 1 in 4 hospitalizations, and of those, 30% are surgical complications, including never-events like wrong-site surgery [1].
Why do surgical errors continue to occur with such frequency? An evaluation of 483 wrong-site, wrong-patient, wrong-implant, and close call events in US Veterans Health Administration Medical Centers provides a crucial clue: Problems with the time-out were the most common root cause [10]. And this is not just an American problem: Researchers in the Netherlands have demonstrated proper time-outs occur only 71% of the time [18], while a study of five English hospitals revealed team member absences in 40% of time-outs and failure to pause other work in 70% of time-outs [14]. Self-reported compliance rates with checklist-based time-outs can be as low as 45% [3].
This failure to perform time-outs adequately occurs despite convincing evidence of their effectiveness in reducing surgical errors [6, 20]. The World Health Organization has estimated that using them as a matter of routine can reduce postoperative complications by 30% and save 500,000 lives every year [18]. A particularly vivid example of the importance of checklist-based time-outs came from a Norwegian survey of surgeons, OR nurses, and anesthesia personnel that found 38% of respondents had experienced uncertainty with patient identity, 81% had experienced uncertainty with surgical site, and 60% had prepared for the wrong procedure [5].
With experiences like these, why are properly performed time-outs ever skipped? The answer depends upon who you ask. Nurses blame either passive noncompliance or active resistance from physicians [15, 16], or poor communication and the hierarchical nature of the OR [19]. Meanwhile, surgeons most frequently blame the time required to adequately complete the time-out [12] or disruption to their OR routines [2].
Many solutions have been offered to improve compliance with proper surgical time-outs. One hospital system working with the Association of Operative Registered Nurses has developed a set of metal instrument plates reminding the operative team to perform a time-out upon opening those instruments [12], while a United Kingdom hospital has developed audio prompts to remind teams to do a time-out [13]. But I believe interventions like this miss the crux of the problem: poor communication in the hierarchical OR setting, and surgeons’ resistance to any disruption in their OR routines. A time-out done by distracted and uninterested surgeons (along with nurses who feel inhibited about speaking up if they suspect a problem) is likely little better than skipping the time-out altogether. Any effective solution will have to simultaneously engage surgeons and empower all OR personnel to actively, and even forcefully, communicate their concerns.
Two strategies for improvement stand out to me. The first is mandatory reporting of all near-misses for wrong-site surgery or other serious errors (such as improper equipment available to perform the procedure). Near-miss events include bringing the wrong patient to the OR or prepping the wrong body part for surgery prior to realizing the mistake [5]. Mandatory reporting would be followed by a root cause analysis of each event and individualized debriefing for the entire surgical team. The FAA, for example, requires checklist use for many aspects of commercial aviation, and in the event of any near-misses—which airlines are required to report—inspectors independent of the airline evaluate the incident to determine its cause and appropriate remediation actions [17]. The analysis is nonjudgmental. I suggest hospital systems similarly mandate reporting of every near-miss event and procure a team independent of surgical services for an analysis. If a time-out violation contributed to the cause of the event, we can again follow the example of the FAA. First, informal discussions are required with those involved, which often resolves the safety issue. In the event of any further unsafe conduct, the FAA escalates to monetary fines or other enforcement action, including suspension of certificates to operate flights [4]. This type of program has been studied in an orthopaedic setting, and near-misses declined from 75% to 41% of cases, while improper time-outs declined from 19% to 6% [21]. The key feature of this program is risk reduction by mandated reporting of near-miss events rather than operative personnel ignoring or attempting to hide them. A self-learning safety culture is thus instituted.
My favored approach is a patient-centered time-out that is done while the patient is awake and engaged in the process. The patient’s identity, surgical consent, and allergies can be confirmed while the surgeon reviews the marked surgical site and procedure with the patient. NPO status and use of anticoagulants can also be reviewed. Depending on the checklist developed, postoperative pain medication and other potential sources of post-operative tension can also be discussed. I believe this patient-centered approach has two benefits. The first is the use of the patient as a direct source of information—rather than information filtered through the chart—in front of the surgical team. The second is that we all tend to be “on our best behavior,” so to speak, in front of our patients, so we will be more focused and communicative instead of hierarchical and passively noncompliant with the time-out when the patient is already asleep, and we are busy with patient positioning or tourniquet application.
One might fear such an approach can increase patient anxiety, but a study evaluating patient-centered time-outs before peripheral nerve block for orthopaedic procedures found the opposite: More than 90% of participants strongly agreed to feeling safe, confident, relaxed, and positive about their participation in the time-out, and researchers concluded patient-focused time-outs increase patient confidence and feelings of safety [8]. Such time-outs can occur during room turnover and do not cause operative delays [7]. Additionally, there is a robust relationship between patients’ perceptions of their physicians’ adherence to medical protocols and their satisfaction with the care delivered [9]. Involving patients in a well-done safety protocol may greatly impact their satisfaction with and perception of the quality of their surgical care.
As noted, surgeon complaints about disrupted work routines are perhaps the greatest obstacle to surgeon buy-in on proper checklist-based surgical time-outs. However, this is the very essence of the time-out: It is an opportunity for all team members to stop what they are doing and completely focus, for less than a minute (or 36 seconds, as reported in the literature [3]), on the safety of the patient before them. It is an opportunity to actively engage every OR participant to make sure that the upcoming procedure is performed safely, and on the right patient.
Footnotes
A note from the Editor-in-Chief: We are pleased to present our next installment of “On Patient Safety.” Dr. Rickert is on the clinical faculty at Indiana University School of Medicine and serves as President of The Society for Patient Centered Orthopedics. The goal of this quarterly column is to explore the relationships among patient safety, value, and clinical efficacy by engaging with diverse perspectives, including those of orthopaedic surgeons, patients, consumer and patient advocates, and medical insurers. We welcome reader feedback on all of our columns and articles; please send your comments to eic@clinorthop.org.
The author certifies that there are no funding or commercial associations (consultancies, stock ownership, equity interest, patent/licensing arrangements, etc.) that might pose a conflict of interest in connection with the submitted article related to the author or any immediate family members.
All ICMJE Conflict of Interest Forms for authors and Clinical Orthopaedics and Related Research® editors and board members are on file with the publication and can be viewed on request.
The opinions expressed are those of the writers, and do not reflect the opinion or policy of CORR® or The Association of Bone and Joint Surgeons®.
References
- 1.Bates DW, Levine DM, Salmasian H, et al. The safety of inpatient health care. N Engl J Med . 2023;388:142-153. [DOI] [PubMed] [Google Scholar]
- 2.Bergs J, Lambrechts F, Simons P, et al. Barriers and facilitators related to the implementation of surgical safety checklists: a systematic review of the qualitative evidence. BMJ Qual Saf . 2015;24:776-786. [DOI] [PubMed] [Google Scholar]
- 3.Cullati S, Le Du S, Raë AC, et al. Is the Surgical Safety Checklist successfully conducted? An observational study of social interactions in the operating rooms of a tertiary hospital. BMJ Qual Saf . 2013;22:639-646. [DOI] [PubMed] [Google Scholar]
- 4.Federal Aviation Administration. Legal enforcement actions. Accessed March 7, 2023. https://www.faa.gov/about/office_org/headquarters_offices/agc/practice_areas/enforcement/enforcement_actions. Accessed March 7, 2023.
- 5.Haugen AS, Murugesh S, Haaverstad R, Eide GE, Søfteland E. A survey of surgical team members’ perceptions of near misses and attitudes towards Time Out protocols. BMC Surg . 2013;13:46. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 6.Haynes AB, Weiser TG, Berry WR, et al. A surgical safety checklist to reduce morbidity and mortality in a global population. N Engl J Med . 2009;360:491-499. [DOI] [PubMed] [Google Scholar]
- 7.Kozusko SD, Elkwood L, Gaynor D, Chagares SA. An innovative approach to the surgical time out: a patient-focused model. AORN J . 2016;103:617-622. [DOI] [PubMed] [Google Scholar]
- 8.Lai YH, Anderson MR, Weinberg AD, Rosenblatt MA. Positive perceptions on safety and satisfaction during a patient-centered timeout before peripheral nerve blockade. J Clin Anesth. 2015;27:214-220. [DOI] [PubMed] [Google Scholar]
- 9.Leonard KL. Is patient satisfaction sensitive to changes in the quality of care? An exploitation of the Hawthorne effect. J Health Econ . 2008;27:444-459. [DOI] [PubMed] [Google Scholar]
- 10.Neily J, Soncrant C, Mills PD, et al. Assessment of incorrect surgical procedures within and outside the operating room: a follow-up study from US veterans health administration medical centers. JAMA Netw Open . 2018;1:e185147. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 11.Panagioti M, Khan K, Keers RN, et al. Prevalence, severity, and nature of preventable patient harm across medical care settings: systematic review and meta analysis. BMJ. 2019;366:4185. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 12.Papadakis M, Meiwandi A, Grzybowski A. The WHO safer surgery checklist time out procedure revisited: strategies to optimise compliance and safety. Int J Surg . 2019;69:19-22. [DOI] [PubMed] [Google Scholar]
- 13.Reed S, Ganyani R, King R, Pandit M. Does a novel method of delivering the safe surgical checklist improve compliance? A closed loop audit. Int J Surg . 2016;32:99-108. [DOI] [PubMed] [Google Scholar]
- 14.Russ S, Rout S, Caris J, et al. Measuring variation in use of the WHO surgical safety checklist in the operating room: a multicenter prospective cross-sectional study. J Am Coll Surg . 2015;220:1-11.e4. [DOI] [PubMed] [Google Scholar]
- 15.Russ SJ, Sevdalis N, Moorthy K, et al. A qualitative evaluation of the barriers and facilitators toward implementation of the WHO surgical safety checklist across hospitals in England: lessons from the “Surgical Checklist Implementation Project.” Ann Surg . 2015;261:81-91. [DOI] [PubMed] [Google Scholar]
- 16.Schwendimann R, Blatter C, Lüthy M, et al. Adherence to the WHO surgical safety checklist: an observational study in a Swiss academic center. Patient Saf Surg. 2019;13:14. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 17.Smiley K. FAA proposes Amazon fine for hazardous shipment. Root Cause Analysis. 2016. Accessed March 7, 2023. https://root-cause-analysis.info/tag/faa/ [Google Scholar]
- 18.van Schoten SM, Kop V, de Blok C, Spreeuwenberg P, Groenewegen PP, Wagner C. Compliance with a time-out procedure intended to prevent wrong surgery in hospitals: results of a national patient safety programme in the Netherlands. BMJ Open. 2014;4:e005075. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 19.Wæhle HV, Haugen AS, Søfteland E, Hjälmhult E. Adjusting team involvement: a grounded theory study of challenges in utilizing a surgical safety checklist as experienced by nurses in the operating room. BMC Nurs. 2012;11:16. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 20.Weiser TG, Haynes AB, Dziekan G, et al. Effect of a 19-item surgical safety checklist during urgent operations in a global patient population. Ann Surg. 2010;251:976-980. [DOI] [PubMed] [Google Scholar]
- 21.Yoon RS, Alaia MJ, Hutzler LH, Bosco JA, 3rd. Using “near misses” analysis to prevent wrong-site surgery. J Healthc Qual . 2015;37:126-132. [DOI] [PubMed] [Google Scholar]
