Correct site verification and consent—two separate legal issues

Ellen K. Murphy

In this column, I would like to address the legalities of a question that was sent to me.

Question: The hospital where I currently work has a consent form for correct site verification. It must be signed by the surgeon, anesthesia care provider, and circulating nurse. The circulating nurse must verify and sign that the surgeon documented relevant films reviewed. The circulating nurse is verifying only that the surgeon documented this, not that the surgeon was observed reviewing the films. Legal team members and administrators say this protects the nurse should the wrong site be operated on. I say this only relieves the hospital of its duties as the employer, and should the wrong site still be operated on, the circulating nurse could be sued for malpractice since he or she did not review the films with the surgeon. The hospital says the nurse does not read films, and I say the nurse must prove that every step was taken to ensure proper site verification.

Answer: Implicit in this question are two separate legal issues--correct site verification and consent. I will present the background regarding both of these subjects before answering the specific question.

SITE VERIFICATION

Many facilities have or are considering adopting a formal correct site verification process that requires both separate and communal site verification and documentation by the nurse, surgeon, and anesthesia care provider. In August 1998, the Joint Commission on Accreditation of Healthcare Organizations issued a Sentinel Event Alert that examines the problem of wrong site surgery. At that time, 15 cases of wrong site surgery had been reported. By December 2001, 150 cases of wrong site, wrong procedure, or wrong person surgery had been reported. (1)

Although this number probably is underreported, it only represents an extremely small percentage of the several million surgical procedures performed annually. When an incorrect procedure or contralateral side procedure occurs, however, it is devastating for the patient and perioperative team members involved.

Accordingly, many professional associations (eg, AORN, Federated Ambulatory Surgery Association) have urged their members to adopt procedures for site verification (eg, AORN position statement on correct site surgery; Advisory statement: Wrong site surgery). (2) Some regulatory bodies also have requested that health care facilities adopt such procedures. Surgical site verification procedures typically follow the Joint Commission's recommendations, which suggest that the process include

* marking the surgical site and involving the patient in the marking process;

* creating and using a verification checklist that includes appropriate documents (eg, medical records, x-rays, imaging studies);

* obtaining oral verification of the patient, surgical site, and procedure in the OR from each member of the surgical team; and

* monitoring compliance with these procedures.

The Joint Commission also urges perioperative team members to consider taking a "time-out" in the OR to verify the correct patient, procedure, and site using active, not passive, communication techniques.

If your facility has not yet adopted such procedures, it would be well advised to do so. When doing so, however, ensure that the site verification process does not divert attention from or obscure the importance of other safety checks (eg, electrocautery bum prevention, positioning injury prevention) that are the responsibility of perioperative team members.

LEGALITIES

One step in the verification process at many facilities involves checking the scheduled procedure and site for consistency with what is documented on the informed consent form. There is nothing wrong with including a check of the consent documentation as part of the verification process, but legally, consent and verification are separate processes with separate legal ramifications.

The legal responsibility for obtaining the patient's informed consent continues to rest solely with the surgeon. The surgeon must inform the patient regarding the risks of, benefits of, and available alternatives to the proposed procedure. A patient who sues the surgeon for alleged lack of informed consent has the burden to prove that the surgeon did not provide the needed information or operated without consent (ie, was negligent). Though the nurse may have some responsibility for ensuring that documentation of informed consent was obtained and is on the chart before commencing the procedure, I am unaware of any reported legal cases that have held a nurse liable for informed consent.

Correct procedure and correct site surgery, on the other hand, are the joint responsibility of the facility, nurses, surgeons, and anesthesia care providers. Incorrect or contralateral side procedures rarely result in reported legal cases because they are settled before litigation unless there is a question about how much the case is worth. If they were litigated, the law would recognize that operating on the incorrect site usually does not occur in the absence of negligence. Thus, the legal doctrine of res ipse loquitor (ie, the thing speaks for itself) would apply. Unlike most negligence cases in which the plaintiff must prove the defendants did not act reasonably or conform to the standard of care (ie, were negligent), in wrong site surgery cases, the res ipse doctrine shifts the burden of proof to the defendants. The plaintiff would not have to prove negligence; instead, the defendants would have to prove they were not negligent. This usually is impossible; therefore, these cases usually are settled, and insurers for the various defendants negotiate contribution.

REVISITING THE QUESTION

Understanding this background, let us return to the question. First, the correct site verification process and documentation are not a "consent." They are a mechanism to document that the nurse, surgeon, and anesthesia care provider each independently verified the site and agree collectively on the site and procedure. Different facilities may have different steps that each person must follow as part of his or her independent and collective verification.

Most policies require the surgeon to review the x-ray and imaging scans as part of his or her verification process. Most policies do not include imaging report review as part of the nurse's process. The nurse's, anesthesia care provider's, and surgeon's signatures on this form attest only to the fact that they each complied with their part of the process and that they all agreed on the procedure and site. It does not mean that each observed the other completing his or her part of the process. The nurse is entitled to rely on the surgeon's documentation and verbal statement that he or she reviewed the films. The nurse need not have observed the surgeon doing so unless this is part of the facility's policy. Hospital administrators are correct that nurses do not read films, but they are incorrect that this procedure protects the nurse should the wrong site be operated on. In addition, this procedure does not relieve the hospital if the wrong site is operated on.

The legal value of the recommended verification process is to avoid the injury that would result if the wrong site were operated on. This process prevents injury from happening and a case from being filed. If the wrong site is operated on despite having a site verification procedure in place, this procedure will not protect the nurse, surgeon, anesthesia care provider, or facility from potential liability. If the wrong procedure is performed, the contralateral side operated on, or the wrong patient involved in either situation, any or all of the involved parties still could be found liable.

The above information is intended for general information only. Specific situations should be reviewed by legal counsel.

NOTES

(1.) Joint Commission on Accreditation of Healthcare Organizations, "A follow-up review of wrong site surgery," in Sentinel Event Alert, no 24, http://www.jcaho.org/about+us/news+letters/sentinel+event+alert/sea_24.htm (accessed 9 July 2002).

(2.) "AORN position statement on correct site surgery," in Standards, Recommended Practices, and Guidelines (Denver: AORN, Inc, 2002) 123-125; "Advisory statement: Wrong site surgery," American Association of Orthopaedic Surgeons, http://www.aaos.org/wordhtml/papers/advistmt/wrong.htm (accessed 20 June 2002).

ELLEN K. MURPHY
RN, JD, FAAN
UNIVERSITY OF WISCONSIN, MILWAUKEE
SCHOOL OF NURSING

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