If a patient files a claim when a physician operates on the wrong body part or patient, or performs the wrong operation, chances are you're going to pay up. One report shows that, while wrong-site surgeries account for only 2 percent of all orthopedic claims, 84 percent of those claims result in monetary settlement. And wrong-site surgery doesn't just create direct liability for the surgeon - OR staff could be held liable, too. Here's how to reduce the legal risks of wrong-site surgery.

A new standard
When more than 40 organizations endorsed JCAHO's Universal Protocol in 2003, the healthcare community took a no-tolerance stance regarding wrong-site surgery. The protocol establishes a three-step process:

• verifying patient information pre-op,
• marking the operative site and
• taking a time out immediately before beginning the procedure.

The guidelines require that you use a marker pen to unambiguously verify the operative site. They let you use adhesive labels in addition to the ink marking, but no longer permit an "X" as an identifying mark; instead mark the site with a "yes" or initials.

Reviewing the risks
If a wrong-site surgery occurs, a patient can sue for monetary compensation on several grounds:

• general negligence, in which the plaintiff must prove a healthcare provider breached a standard of care and that the breach caused injury;
• lack of informed consent (while the patient signed a consent form, he didn't consent to that procedure or in that location) and
• corporate negligence (the surgical facility has a duty to ensure patient safety and well-being).

Plaintiffs' lawyers are beginning to take advantage of this third reason, as hospitals have deeper pockets than individuals. Some of the at least 20 states that recognize hospitals under the corporate negligence theory of liability also recognize as many as four duties hospitals owe directly to patients; one is significant in the context of the Universal Protocol: a duty to formulate, adopt and enforce adequate rules and policies to ensure quality care for patients.

Lessening the liability
Here are three risk-reduction tips from JCAHO's International Center for Patient Safety.

• Communication. Lack of communication - between patient and provider and among OR staffers - is one of the major causes of wrong-site surgery. One reported wrong-site surgery involved an informed consent form posted in the OR that identified a finger other than the one the physician began operating on, yet no one in the OR stopped him. Involving patients in the marking of the operative site lets them verbalize their name, the correct site and the correct surgery, information that you can reconcile with your documentation. When you prep the surgical site, the patient is again in the best position to know whether it's the correct site being prepped (provided anesthesia hasn't been initiated).
• Documentation. Checklists and procedure-specific informed consents are two ways to document that identification, marking and the time-out occurred. You might also use adhesive labeling products in addition to the pen marking. While pen markings alone generally accomplish the task of marking the operative site, they won't do much good as evidence in a corporate negligence claim. The Universal Protocol permits the use of adhesive site markers in addition to the pen markings, which builds redundancy into the system. Some let you not only identify and verify, but also create evidence of documentation by having a space in which you write the patient's name, procedure, surgical site and implant, if applicable. You then place it near the incision site and affix a correspondingly numbered label to the patient's medical chart.
• Surveys and audits. Auditing and surveying are further evidence of compliance. For example, a label affixed to the medical chart contributes to evidence that the facility and its employees follow an established procedure. All you have to do is go through a sample of patient charts to demonstrate this. Because the adhesive labels are uniquely numbered, there is no way for an insertion of evidence into the medical chart after a claim or lawsuit has been initiated, or in retrospect for any reason. Adhesive labels can thereby help reduce the frequency and severity of claims and lawsuits. And, as mentioned earlier, they're accepted as part of the industry-standard Universal Protocol when used as an adjunct to pen markings.

Making a mark
A wrong-site surgery claim's effects go beyond the surgeon; nurses, nurse managers and other staff may be witnesses in such a claim and could be involved in witness interviews, depositions and even testifying at the trial. With the implementation of the Universal Protocol, we can expect to see more claims of corporate negligence. Taking the actions we've outlined here can help reduce your risk while increasing your compliance.