Surgical errors on the wrong body are occurrences that may be more frequent and more costly than many realize and, as a result, states and organizations are taking steps to identify and mitigate these preventable events.
Medical errors involving wrong-site/wrong-procedure/wrong-patient surgery have been estimated to potentially impact a patient once per year in a 300-bed hospital. This startling analysis, published by Clarke and others in Annals of Surgery, was based on data from a state that requires mandatory reporting of all near misses as well as complete wrong-site events. The latest data from The Joint Commission suggests that the voluntary reporting of these sentinel events – actual errors which cause death, serious injury or the risk thereof – may be on the rise. Many experts believe that the frequency of wrong-site/wrong-procedure/wrong-patient surgeries is not necessarily increasing; rather it is the reporting of these “never events” which may be on the increase. Thoughtful discussions of these errors, such as a recent case study presented by Ring and others in The New England Journal of Medicine, may make providers and organizations more willing to talk about these events and seek solutions.
The state of California, for instance, fosters dialogue by issuing a quarterly report summarizing the administrative penalties that are levied against hospitals for failing to follow established policies and procedures. In a recent California Department of Public Health report, 14 hospitals were assessed penalties – one case involved an instance of wrong-procedure surgery and one case involved an instance of wrong-site surgery. The administrative penalties in those two cases were $50,000 and $75,000, respectively. Any medical liability settlements arising from those errors and loss to an organization’s good will far eclipse the costs associated with any fines. Medical Liability Mutual Insurance Company recently provided case examples to its policyholders that ranged from a $230,000 settlement of a wrong-procedure surgery to a $992,000 jury award for a wrong-site surgery.
In the California case involving wrong-procedure surgery, the patient’s consent form had indicated the procedure the patient expected. In the case involving wrong-site surgery, the consent form had indicated the correct site of the procedure. In fact, verification of the consent form has been found to be a major factor in avoiding wrong-site/wrong-procedure/wrong-patient surgery (Clarke, et al. Ann Surg.). One of the solutions advocated under the Wrong Site Surgery Project of The Joint Commission Center for Transforming Healthcare is that providers, “perform a pause between each procedure that occurs within a single case to ensure that each procedure is performed accurately and according to the procedure, site and laterality contained within the signed surgical consent.”
If consent forms are to be employed during the pre-procedure verification process, however, ensuring that they are detailed and complete is critical. According to McKenzie and Karnstedt in Patient Safety & Quality Healthcare, organizations like the Los Angeles County Department of Health Services’ hospitals have worked toward that goal by employing an automated informed consent software tool which ensures that the procedure(s) and surgical sites are clearly enumerated on every consent form.
Other states and organizations also are committed to improving perioperative safety. For example, the North Carolina Center for Hospital Quality and Patient Safety reports that more than 75 North Carolina have committed to implementing use of the World Health Organization (WHO) Surgical Safety Checklist. An analysis presented by Panesar and others in the Journal of Orthopaedic Surgery and Research indicates that use of the WHO Checklist should result in a reduction in cases of wrong-site/wrong-procedure/wrong-patient surgery. In addition to confirming that the operative site has been marked, the WHO Surgical Safety Checklist specifically calls for confirmation of the consent prior to the induction of anesthesia.
Some organizations are very prescriptive relative to their use of checklists. The Department of Veterans Affairs (VA) Directive for Ensuring Correct Surgery and Invasive Procedures, for instance, requires that the Time-Out process be facilitated with a checklist. The minimum requirements of that checklist include verification of a consent form which identifies, “the procedure site, including laterality if applicable; the name and brief description of the procedure; and the reason (condition or diagnosis) for performing the procedure.” The VA accomplishes this by mandating (except in specific circumstances) the use of a software program to document the informed consent process (VHA Handbook 1004.01, August 14, 2009 and VHA Handbook 1004.05, March 19, 2009).
According to the Joint Commission Center for Transforming Healthcare, the incidence of wrong-site/wrong-procedure/wrong-patient surgery may be as high as 40 per week. Forward-thinking efforts by states and organizations to employ checklists and to leverage readily available documentation, such as procedure and site-specific consent forms, will make a significant impact upon this critical patient safety issue.
Tim Kelly serves as Vice President for Dialog Medical, a provider of informed consent and patient education systems for physician practices and hospitals.