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Service Delivery Innovation Profile

Checklist-Plus-Technology System Eliminates Wrong-Site Surgery and Near-Misses, Enhances Required Preoperative Process Compliance


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Snapshot

Summary

Barnes-Jewish Hospital has adopted a wrong-site surgery prevention system that integrates technology with a procedural checklist to ensure completion of essential steps during the preoperative process. The checklist enables clinicians to confirm that the patient's history and physical examination reports are in the chart, that the circulating nurse visits the patient before surgery, and that the surgical site is ink marked. To further prevent wrong-site surgery, an electronic patient wristband with an embedded sensor is deactivated when the correct surgical site is definitively marked. The program has eliminated wrong-site surgeries and near-misses at Barnes-Jewish Hospital's ambulatory and the short-stay operating room suite and has led to full compliance with required preoperative processes.

Evidence Rating (What is this?)

Moderate: The evidence consists of pre- and post-implementation comparisons of key outcomes measures, including number of wrong-site surgeries and near-misses and compliance with preoperative requirements.
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Developing Organizations

Barnes-Jewish Hospital; CheckSite Medical, Inc.; Washington University in St. Louis
Barnes-Jewish Hospital, Washington University in St. Louis, and CheckSite Medical, Inc., are located in St. Louis, MO.end do

Use By Other Organizations

To date, the integrated CheckSite® system has been implemented in six hospitals across the country.4 As of August 2009, several large hospitals in the Chicago area were also considering system implementation.

Date First Implemented

2004

Problem Addressed

Since 2004, surgeons have been required by The Joint Commission to mark the surgical site while consulting with the patient before surgery.1 Nevertheless, wrong-site surgeries persist at low but unacceptable rates, leading to devastating consequences for those affected. Wrong-site surgeries occur due to a lack of formal systems that ensure compliance with surgical site marking requirements.
  • A relatively rare, but devastating problem: A study supported by the Agency for Healthcare Research and Quality that analyzed data from nearly 3 million operations between 1985 and 2004 found that 1 in 112,994 surgeries occurred at the wrong surgical site.2 Other studies have reported incidence rates up to five times higher. Because not all sentinel events are reported, these figures are likely underestimated.3 Wrong-site surgery results in devastating consequences for the patient in terms of morbidity and mortality, as well as negative financial consequences for surgeons and hospitals. For example, studies have shown that 79 percent of wrong-site eye surgeries and 84 percent of wrong-site orthopedic surgeries result in malpractice claims.3
  • An easily prevented problem: Wrong-site surgery is almost always due to the absence of a formal system to ensure that the proper surgical site is ink marked. Studies show that some surgeons consistently mark sites, while others mark them sporadically or not at all. Other risk factors associated with wrong-site surgery include lack of a checklist for preoperative activities; time pressure in preoperative preparation; involvement of multiple surgeons; and clinician miscommunication.3

What They Did

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Description of the Innovative Activity

Barnes-Jewish Hospital uses a multicomponent wrong-site surgery detection system that integrates a checklist process with an electronic armband sensor to ensure compliance with surgical site marking. The checklist is used by clinicians to ensure that the surgical site is marked and that other appropriate presurgical activities are undertaken. As a further safety feature, a patient wristband with an electronic sensor is deactivated when the surgical site is marked. Key elements of the program include the following:
  • Checklist card: A checklist card is used to help operating room (OR) staff ensure that all appropriate preoperative steps are followed, including marking of the appropriate surgical site. The card includes a box to be checked by the physician once the surgical site is marked. The card can be customized to include additional preoperative steps at the hospital’s discretion. At Barnes-Jewish Hospital, the card includes two additional boxes: one for ensuring that the patient’s history and physical is included in the chart and one for ensuring that the OR circulating nurse has visited the patient before surgery.
  • Marking pen: A small, sterile, one-time-use surgical marking pen is provided with the card. The pen contains gentian violet ink, one of the only U.S. Food and Drug Administration–approved substances for marking skin.
  • Patient wristband: At the start of the preoperative process, the patient is given a disposable wristband with an embedded miniature electronic microchip (similar to those used in antitheft devices affixed to consumer goods). These wristbands are compatible with most label-style systems used in patient identification bracelets.3 The wristband is marked with the word “Hold” in red.
    • Deactivating sticker: A green “OK” sticker is located on the card. When this sticker is peeled off and placed over the red “Hold” symbol, a thin plate of foil embedded in the sticker deactivates the wristband’s electronic sensor. The circulating nurse is responsible for reviewing the card and placing the “OK” sticker on the patient’s wristband.
    • Alarm system: Electronic sensor alarms installed on either side of the hallway connecting the preoperative area to the surgery suite activate an audible alarm and a flashing light if a patient is wheeled into surgery wearing a wristband that has not been deactivated. When this happens, a surgical team member checks the card and alerts the surgeon about the omitted step.
    • Alarm tracking: The alarm system automatically tabulates the number of alarms that are activated. A plug-in device located on the sensor is used to download data, providing direct audit of compliance with surgical site marking.

Context of the Innovation

Barnes-Jewish Hospital in St. Louis, MO, is an 1,124-bed academic medical center with 54 ORs; approximately 50,000 surgical procedures are performed annually, with about 16,000 of these performed in the short stay/ambulatory pod. A hospital review of sentinel events revealed that surgical sites were not marked in all surgery patients; other preoperative steps were also periodically overlooked in the rush to prepare patients for surgery. An otolaryngology surgeon who had been thinking about a fail-safe method to ensure prevention of wrong-site surgery developed the idea for the system after watching a store clerk scan his purchase over a metal plate to deactivate an electronic sensor that otherwise would have set off the store’s antitheft alarm.

Did It Work?

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Results

The program has eliminated wrong-site surgeries and near-misses at Barnes-Jewish Hospital and has led to full compliance with required preoperative processes. Results are as follows:
  • Elimination of wrong-site surgeries and near-misses: Before implementation, wrong-site surgeries at Barnes-Jewish Hospital occurred at a rate comparable to the national average. Since implementation in 2004, Barnes-Jewish Hospital has experienced no wrong-site surgeries or near-misses (defined as the identification of the wrong site in the OR suite, just before incision) (updated September 2009). In the weeks immediately following implementation, the alarm went off fairly often, but once surgeons and staff became acclimated to the new process, the alarm has rarely been activated.
  • Full compliance with preoperative requirements: Barnes-Jewish Hospital policy requires that a circulating nurse visit the patient before surgery. Before implementation, only 10 to 20 percent of surgical patients received these visits; since implementation, all surgical patients receive them. Hospital policy also requires the inclusion of the patient's history and physical in the chart; this occurred an estimated 80 to 90 percent of the time before implementation. Since implementation, the history and physical examination reports have been included in 100 percent of surgical patient charts.

Evidence Rating (What is this?)

Moderate: The evidence consists of pre- and post-implementation comparisons of key outcomes measures, including number of wrong-site surgeries and near-misses and compliance with preoperative requirements.

How They Did It

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Planning and Development Process

Key elements of the planning and development process included the following:
  • Prototype and patent: Based on the surgeon’s concept, a prototype of the electronic wristband was developed by a technology company; the Washington University in St. Louis Office of Technology Management contracted with a patent attorney to patent the prototype. The checklist card was designed to allow checking off of preoperative steps, including surgical site marking.
  • Senior management approval for pilot test: The surgeon obtained approval from Barnes-Jewish Hospital's senior management (i.e., the president, OR nurse supervisor, and vice president for perioperative services) to pilot the system. The pilot test was performed using the checklist card, the electronic wristbands, and portable electronic scanners in the outpatient surgery area.
  • Refinement of technology: Based on the pilot, the developers refined the technical aspects of the product; for example, the sensors were adjusted so that they did not react to interference from radiofrequency noise in the hospital.
  • Approval for permanent installation: Based on the pilot’s success, senior management granted approval for a permanent installation of the system in outpatient surgery (ambulatory/short stay pod).
  • Education for hospital staff and physicians: OR staff attended a 1-hour inservice training session during which use of the checklist card and electronic wristband was demonstrated. Small posters describing the system were placed on the doors in the locker rooms used by surgeons and anesthesiologists. OR staff members also helped to introduce the system to surgeons.
  • Amending the checklist: After approximately 1 year, the hospital added a checkbox to confirm the preoperative circulating nurse visit to ensure compliance with hospital policy.

Resources Used and Skills Needed

  • Staffing: No staffing changes were required to implement the system.
  • Costs: The cost of installing the electronic sensors is approximately $8,000. Each patient kit (i.e., the electronic wristband, card, and marking pen) costs roughly $3.
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Funding Sources

Barnes-Jewish Hospital
Barnes-Jewish Hospital funds the purchase of the cards, pens, and wristbands; the pilot was funded through private equity.end fs

Tools and Other Resources

The Joint Commission’s Universal Protocol for preventing wrong site, wrong procedure, wrong person surgery is available at http://www.jointcommission.org/standards_information/up.aspx.

Adoption Considerations

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Getting Started with This Innovation

  • Seek approval from a broad group of hospital leaders: The system affects several hospital departments and processes, including those related to patient safety, finance, and surgery. Therefore, support from a number of different hospital administrators will be required before implementation.
  • Emphasize system benefits when seeking approval: These benefits include the fail-safe nature of the system, which reduces liability risk and enhances patient safety.
  • Maintain resolve in the face of initial physician and nurse push-back: A few clinicians may complain about the new procedural requirements, but such complaints typically cease within a few days of implementation as use of the system becomes routine.

Sustaining This Innovation

  • Review the preoperative process for potential improvements: The checklist card can be revised to include additional process steps that are deemed to be important.

Use By Other Organizations

To date, the integrated CheckSite® system has been implemented in six hospitals across the country.4 As of August 2009, several large hospitals in the Chicago area were also considering system implementation.

More Information

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Contact the Innovator

Richard A. Chole, MD, PhD
Professor and Chairman
Department of Otolaryngology
Washington University School of Medicine
660 S. Euclid, Box 8115
St. Louis, MO 63110
Phone: (314) 362-7395
E-mail: CholeR@ent.wustl.edu; rchole@wustl.edu

Innovator Disclosures

Dr. Chole has not indicated whether he has financial interests or business/professional affiliations relevant to the work described in this profile.

References/Related Articles

CheckSite Medical Web site: http://www.checksitemedical.com.

Footnotes

1 The Joint Commission. Universal Protocol for preventing wrong site, wrong procedure, wrong person surgery. Available at http://www.jointcommission.org/standards_information/up.aspx
2 Kwaan MR, Studdert DM, Zinner MJ, et al. Incidence, patterns, and prevention of wrong-site surgery. Arch Surg. 2006;141:353-8. [PubMed]
3 Mulloy DF, Hughes RG. Chapter 36: Wrong-site surgery: a preventable medical error. In: Hughes RG, editor. Patient safety and quality: an evidence-based handbook for nurses. Agency for Healthcare Research and Quality Publication No. 08-0043; April 2008. Available at: http://www.ahrq.gov/nurseshdbkch36
4 CheckSite Medical Web site. Available at: http://www.checksitemedical.com/
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Disclaimer: The inclusion of an innovation in the Innovations Exchange does not constitute or imply an endorsement by the U.S. Department of Health and Human Services, the Agency for Healthcare Research and Quality, or Westat of the innovation or of the submitter or developer of the innovation. Read more.

Original publication: September 29, 2008.
Original publication indicates the date the profile was first posted to the Innovations Exchange.

Last updated: July 30, 2014.
Last updated indicates the date the most recent changes to the profile were posted to the Innovations Exchange.

Date verified by innovator: August 12, 2010.
Date verified by innovator indicates the most recent date the innovator provided feedback during the annual review process. The innovator is invited to review, update, and verify the profile annually.