Wrong site, wrong procedure, and wrong patient events can be devastating to patients. Between 1300 and 2700 such events are estimated to occur annually in the United States.1 These are also called “never events” because processes can be implemented to prevent them.2 In 2004, The Joint Commission (TJC) created the Universal Protocol (UP) as a mandatory safety standard in an attempt to eliminate wrong procedures through a preprocedure verification process, procedure site marking, and a “time-out” (correct site, procedure, and patient).3 Up to 70% of wrong site procedures may be prevented if the time-out process is used.4- 5
Although a number of publications have documented successful interventions for improving compliance with the UP in the operating room,6- 8 to our knowledge there are no data on compliance with this protocol for bedside procedures. In fact, wrong site/wrong patient events outside the operating room constitute a significant problem and result in substantial harm.2,4We developed an innovative reengineered process for bedside procedures with an aim to improve compliance with the UP.
This pre- and postintervention study focused on medical inpatient bedside procedures (lumbar puncture, paracentesis, and thoracentesis) at a large academic medical center from July 2008 to May 2010. The Northwestern University institutional review board determined this project exempt.
As part of a quality improvement project, we redesigned our approach to bedside procedures incorporating TJC's UP. Using medical record review and billing data, an improvement team assessed staff compliance with the time-out process and identified the most frequently performed bedside procedures. The team also identified drivers of time-out noncompliance: a knowledge deficit of the UP and a primary communication gap because nurses were not notified when their patients underwent a bedside procedure. Time-outs relied completely on physician memory and vigilance, which is ineffective for successful process compliance.9
To address these issues, we implemented a physician-initiated process that incorporated task triggers, a forcing function, performance feedback, optimized use of the electronic medical record (EMR), and improved efficiency through supply design—elements that have been recognized in successful process change.9 The new process begins with the physician's decision to perform the procedure (Figure) and placing a procedure order in the EMR (Powerchart; Cerner Corporation, Kansas City, Missouri), specifying the anticipated procedure time. The nurse, who receives electronic notification triggered by the order, can plan time to participate. The order triggers the delivery of a time-out documentation form to the nurse's electronic task list and also notifies the nurse to collect the appropriate procedural supply kit.
Verification process to ensure correct site, procedure, and patient, every time.
Cost-efficient all-inclusive procedure kits for lumbar puncture, paracentesis, and thoracentesis were developed. Procedure kits are secured (only the charge nurse has the key), constituting a forcing function and requiring physician-nurse communication. As reinforcement, each procedure kit contains a large red “stop sign” reminder to perform a time-out.
At the scheduled procedure time, the nurse accesses the time-out checklist in the EMR at the bedside. Together, the physician and nurse conduct the time-out, verifying the correct site, procedure, and patient. After the nurse documents the time-out, the supply kit is passed to the physician. Medicine nurses, residents, and hospitalists were trained on the new process during educational sessions, staff meetings, and monthly physician unit orientations. The process was tested and implemented on seven 30-bed medicine units from May to August 2009.
Administrative data (International Classification of Diseases, Ninth Revision billing codes) were used to identify patients who underwent lumbar puncture, paracentesis, or thoracentesis on inpatient medicine units. Compliance with time-out was compared from baseline (July to April 2009 [10 months before]), to postintervention (September to May 2010 [9 months]). A time-out was confirmed through documentation in the procedure note or a completed time-out form in the EMR. All records were independently reviewed by one author (H.B.). Another author (T.C.), blind to the study purpose, reviewed the same records to ensure reliability.
Interrater agreement was calculated using the Cohen kappa coefficient. Pre- and postcompliance with the time-out process was evaluated using statistical process control and the χ2 statistic. Multivariate logistic regression was used to control for time of procedure (day or evening), weekend or holiday, and nursing unit.
There were 265 procedures (98 lumbar punctures, 115 paracenteses, and 52 thoracenteses) included in the study: 110 procedures before and 104 procedures after intervention. Interobserver agreement for medical record abstraction was high (κ = 0.94). Statistical process control revealed special cause variation at the time of the intervention (ie, significant improvement from sustained low compliance rates before the intervention to sustained high rates after; eFigure, http://www.archinternmed.com). Compliance with the time-out process significantly increased from 16% (18 of 110) at baseline to 94% (98 of 104) after intervention (Δ P = 78%; 95% confidence interval, 70%-86%). The multivariate analysis confirmed this result (odds ratio, 94.0; 95% confidence interval 33.9-260.3).
Our reengineered approach to TJC's UP for bedside procedures dramatically increased time-out compliance. To our knowledge, this is the first demonstration of such success for bedside procedures. Because UP compliance improves patient safety and reduces wrong site procedures in the operating room,5- 7 our intervention may also reduce wrong site bedside procedures up to 70%.4- 5 Periodic observation is needed to confirm that documentation reflects competent time-out performance.
As a pre- and postintervention study at a single institution we were unable to randomize or control for secular trends in compliance. However, there were no other known interventions during the study period, and given the large effect size of our intervention and use of a validated process to measure change pre- and postintervention (statistical process control), it is unlikely that the study design significantly biased our results. We were unable to measure adverse events from incorrect procedures because these events are extremely rare.4- 5 However, we expect this intervention will help reduce adverse events because of increased nurse awareness that a procedure is being performed and the use of time-outs to prevent wrong site or wrong patient procedures. In conclusion, a hospital-based intervention using a well-engineered process integrated with the EMR increases compliance with the UP for bedside procedures.
Correspondence: Dr Barsuk, Division of Hospital Medicine, Northwestern University Feinberg School of Medicine, 251 E Huron St, Feinberg 16-738, Chicago, IL 60611 (firstname.lastname@example.org).
Author Contributions:Study concept and design: Barsuk, Brake, Barnard, Anderson, and Williams. Acquisition of data: Barsuk, Brake, and Anderson. Analysis and interpretation of data: Barsuk, Brake, Caprio, Barnard, Anderson, and Williams. Drafting of the manuscript: Barsuk and Brake. Critical revision of the manuscript for important intellectual content: Barsuk, Brake, Caprio, Barnard, Anderson, and Williams. Statistical analysis: Barsuk. Administrative, technical, and material support: Brake, Caprio, Barnard, Anderson, and Williams. Study supervision: Barsuk, Caprio, Barnard, and Williams.
Financial Disclosure: None reported.
Online-Only Material: The eFigure is available at http://www.archinternmed.com.
Additional Contributions: Sarah Kier and Taylor Pomeranz provided administrative support for this project. We also thank Charles M. Watts, MD, Scott Greene, MD, Jay Anderson, the Northwestern Memorial Hospital quality improvement team, and our medical nurses and physicians, who are dedicated every day to improvement in health care quality and patient safety.
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