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Automated informed consent: Reducing risk and improving care

December 18th, 2012

by Barbara Lightizer

Newton-Wellesley Hospital (NWH) has an established reputation as a high-performing facility, this year ranking among the top 15 Boston metro area hospitals, according to U.S. News & World Report. Yet a few years ago, the community medical center in Newton, Mass., uncovered an area of potential compliance risk.

The organization's aging, home-grown electronic approach to informed consent was becoming difficult to administer from a risk management standpoint. Informed consent is the critical communication process where patients agree to procedures after a thorough discussion with their providers of the risks, benefits and alternatives to those contemplated treatments.

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Although a standard template for documenting informed consent interfaced with the hospital's Admissions-Discharge-Transfer (ADT) system, it had been customized by various providers into about 180 procedure-specific forms.

Some providers were using paper-based forms, while others were using the electronic system--but there was no way to run reports to see who was doing what. Some forms were not compliant with Centers for Medicare & Medicaid Services requirements, and it was hard to determine who was using which forms because utilization data was lacking.

We had additional issues with version control due to the multiple sources of access for consent forms. As is the case for many healthcare facilities, our informed consent processes were all over the map.

In reviewing our consent forms in 2010 we identified the need to ensure that all consent forms contained documentation of time of consent and updated transfusion risk information. We also were anticipating a Joint Commission survey in early 2011, and recognized this as an area of vulnerability.

Unfortunately, support for our legacy consent application no longer existed. It would have been nearly impossible to amend the couple hundred forms then in distribution throughout the hospital in a coherent, efficient and timely manner with certainty that all consent forms had been addressed.

That's what led us to investigate new, centralized options. Flexibility and accountability in the informed consent process were significant requirements. The ability to make global changes--such as adding time documentation and updated blood transfusion risks--was essential. So was accessibility. NWH providers already were accustomed to electronic forms, but it would have been difficult to gain buy-in for any new system that required multiple steps to access.

In line with our progressive reputation, we decided instead to deploy an automated procedure-specific consent technology that not only provides a stronger defense in potential professional liability cases, but also offers materials to better educate patients and families in an effort to avoid these claims in the first place. From a risk management perspective, this was important.

Within a few months of our Joint Commission survey, we implemented the centralized consent technology. While change is always hard for providers--especially when they feel they're being asked to fix something that's not perceived as broken--they adapted nicely through education, personal outreach, one-on-one training sessions (for those who wanted them) and the engagement of leadership.

In fact, one key to our success was the early involvement of clinical leaders and IT in the process. It never works to try to force change from the top. The workgroup that selected and implemented the technology was comprised of physicians, nurse educators and IT staff, as well as risk management. As a team, we were able to explain to providers why the change was necessary from a compliance angle, and the benefits it could bring from a patient care standpoint.

To me, simple and centralized management of all consent forms offers very clear compliance and risk avoidance benefits. However, the patient care benefits are equally important. By making sure all of our consent forms are procedure-specific, patient-specific and current, we have strengthened the informed consent discussion itself. At the end of the day, that's the real goal.

Truly informed consent is about more than just a signed piece of paper--it's about enabling an indispensable provider/patient communication process.

Barbara Lightizer, MS, MA, CPHRM, is manager of Risk Management, Patient Relations & Interpreter Services at Newton-Wellesley Hospital in Massachusetts.

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