THE JOINT COMMISSION recently announced changes to the Universal Protocol for Preventing Wrong Site, Wrong Procedure, Wrong Person Surgery, underscoring the vital role that informed consent plays in patient safety quality improvement.

In fact, the Universal Protocol now requires that informed consent documents be available in the pre-procedure area during the verification process and in the procedure area during the time-out process immediately prior to the start of the procedure.

This added emphasis has prompted leaders at healthcare facilities to step back and evaluate their approaches to informed consent. Many have come to the conclusion that, when viewed as model for shared decision-making between provider and patient, informed consent can serve as the ultimate patient safety tool. By recognizing the importance of ongoing dialogue, facilities acknowledge how vital it is that patients are truly “informed” as they provide their consent for tests and treatments.

To be successful, however, these organizations must transform both their thinking and their workflow processes. In terms of thinking, many progressive healthcare facilities and providers are borrowing the time-out process employed prior to a surgical procedure and are applying a similar process of checks and assessments immediately prior to the informed consent discussion. A “consent time out” evaluates the capacity of the patient to participate in the informed consent process. Auditory, visual, physical, speech, and cognitive capacities are assessed. In addition, an effective “consent time-out” will also consider the patient’s health literacy, cultural, language, and family participation needs.

Many effective healthcare providers intuitively perform many of the assessments that comprise a “consent time-out”. For providers who have a limited history with their patients, use of a checklist approach to the “consent time-out,” similar to the checklist mandated in the revised Universal Protocol, may prove helpful.
Armed with an understanding of the patient’s capacities, communication preferences, and limitations, informed consent discussions may and should begin as soon as diagnostic and therapeutic options are introduced, and follow the patient throughout care delivery. Paper-based consent documentation becomes unwieldy in this scenario and, increasingly, facilities are turning to automated applications.

Best-of-breed systems offer comprehensive libraries of procedure-specific consent documents – which are customized on a case-by-case basis to identify surgical site and other information that is pertinent to a patient’s unique circumstances. Because the documents are electronic they are easily accessible to all members of the care team whether in the office, testing facility, or operative suite.

These applications offer additional teaching tools including images and diagrams that address the needs of patients who best respond to visual discussions of their conditions and planned procedures. Likewise, automation facilitates the use of teach-back techniques which allow staff to evaluate comprehension, uncover misunderstandings, and confirm decisions.

An example of the value automated informed consent can offer is found with the Veteran’s Administration, which has deployed a tool called iMedConsent. Use of a software application to assist with chronicling informed consent, coupled with the VA’s comprehensive electronic medical record, makes treatment and patient-specific documentation immediately accessible in pre-procedure areas and during preoperative time-out for use in verification processes that serve to minimize the risk of error.

Healthcare organizations would be well advised to evaluate their current practices, and begin to implement changes to ensure informed consent processes include both a “consent time-out” as well as ready access to documents throughout the continuum of care.

Fay A. Rozovsky, JD, MPH, is president of the Rozovsky Group and a recognized authority on healthcare risk management and informed consent.