title: When a checklist is not enough: How to improve them and what else is needed.
abstract: Checklists are being introduced to enhance patient safety, but the results have been mixed. The goal of this research is to understand why time-outs and checklists are sometimes not effective in preventing surgical adverse events and to identify additional measures needed to reduce these events.
  
  
  
  A total of 380 consecutive patients underwent complex cardiac surgery over a 24-month period between November 2011 and November 2013 at an academic medical center, out of a total of 529 cardiac cases. Elective isolated aortic valve replacements, mitral valve repairs, and coronary artery bypass graft surgical procedures (N = 149) were excluded. A time-out was conducted in a standard fashion in all patients in accordance with the World Health Organization surgical checklist protocol. Adverse events were classified as anything that resulted in an operative delay, nonavailability of equipment, failure of drug administration, or unexpected adverse clinical outcome. These events and their details were collected every week and analyzed using a systemic causal analysis technique using a technique called CAST (causal analysis based on systems theory). This analytic technique evaluated the sociotechnical system to identify the set of causal factors involved in the adverse events and the causal factors explored to identify reasons. Recommendations were made for the improvement of checklists and the use of system design changes that could prevent such events in the future.
  
  
  
  Thirty events were identified. The causal analysis of these 30 adverse events was carried out and actionable events classified. There were important limitations in the use of standard checklists as a stand-alone patient safety measure in the operating room setting, because of multiple factors. Major categories included miscommunication between staff, medication errors, missing instrumentation, missing implants, and improper handling of equipment or instruments. An average of 3.9 recommendations were generated for each adverse event scenario.
  
  
  
  Time-outs and checklists can prevent some types of adverse events, but they need to be carefully designed. Additional interventions aimed at improving safety controls in the system design are needed to augment the use of checklists. Customization of checklists for specialized surgical procedures may reduce adverse events.
authors.affiliation: Division of Cardiothoracic Surgery, Oregon Health & Science University, Portland, Ore. Electronic address: jairaman24@gmail.com.
authors.forename: Jaishankar
authors.initials: J
authors.lastname: Raman
authors.affiliation: Massachusetts Institute of Technology, Cambridge, Mass.
authors.forename: Nancy
authors.initials: N
authors.lastname: Leveson
authors.affiliation: Engineering Systems, Massachusetts Institute of Technology, Cambridge, Mass.
authors.forename: Aubrey Lynn
authors.initials: AL
authors.lastname: Samost
authors.affiliation: Cardiac Surgery, Rush University Medical Center, Chicago, Ill.
authors.forename: Nikola
authors.initials: N
authors.lastname: Dobrilovic
authors.affiliation: Healthcare Informatics Consultant, Independent Contractor, Nashville, Tenn.
authors.forename: Maggie
authors.initials: M
authors.lastname: Oldham
authors.affiliation: Safety Science Innovation Laboratory, School of Social Sciences, Griffith University, Queensland, Australia.
authors.forename: Sidney
authors.initials: S
authors.lastname: Dekker
authors.affiliation: Harvard Medical School and Beth Israel Deaconess Medical Center, Boston, Mass; Engineering Systems, Massachusetts Institute of Technology, Cambridge, Mass.
authors.forename: Stan
authors.initials: S
authors.lastname: Finkelstein
mesh_terms: D000046:Academic Medical Centers; D006348:Cardiac Surgical Procedures / Q000009:adverse effects*; D057189:Checklist; D002641:Chicago; D006801:Humans; D019300:Medical Errors / Q000517:prevention & control; D008508:Medication Errors / Q000517:prevention & control; D009741:Nursing Staff, Hospital / Q000458:organization & administration; D009873:Operating Rooms / Q000458:organization & administration*; D010348:Patient Care Team / Q000458:organization & administration; D061214:Patient Safety; D011183:Postoperative Complications / Q000517:prevention & control; D017064:Process Assessment, Health Care / Q000458:organization & administration*; D065840:Protective Factors; D058996:Quality Improvement; D012189:Retrospective Studies; D012307:Risk Factors; D013598:Systems Theory; D013997:Time Factors; D000067494:Time Out, Healthcare / Q000458:organization & administration*; D016896:Treatment Outcome
keywords: adverse events; checklists; perioperative; systems analysis; time-out