October 2017

EHR Insider: Patient Safety Is a Shared Responsibility
By Shari Medina, MD, and Janet Campbell
For The Record
Vol. 29 No. 10 P. 8

For those who work in health care—including clinicians, HIM professionals, payers, and HIT developers—the patient must be the central focus. Even those who don't directly interact with patients support patient care by seeking the best use of technology. In fact, patient safety is the profession's most fundamental principle.

The EHR incentive program, established by the HITECH Act, accelerated the technology's adoption. One of the policy rationales for HITECH was that EHRs would improve patient safety relative to paper records. Research, including a 2015 report from the Office of the National Coordinator for Health Information Technology (ONC), bears out this premise.

For example, medication errors have been central to many patient safety concerns. EHRs can help clinicians avoid errors by presenting alerts and reminders at multiple points in the medication administration process, including when providers make prescribing decisions, when pharmacists prepare the drug, when nurses administer medication, and as providers monitor patient status for efficacy and possible side effects.

Also, legibility is no longer a significant issue. Potential errors such as interactions or mistyped dosages can be flagged and addressed earlier in the process as compared with handwritten paper records.

Responsibilities
While many errors have been prevented using technology, the industry must be cautious that EHRs don't introduce new areas of vulnerability. Improved usability goes hand in hand with reducing medical errors and enhancing patient safety; however, it is important to recognize that patient safety issues cannot simply be diagnosed as usability issues and vice versa. Patient safety is a shared responsibility, with each stakeholder playing a key role.

• EHR developers have the responsibility to apply recognized evidence-based usability principles and to incorporate new methods as research evolves and the industry moves forward. Developers also have an obligation to their customers to continuously improve usability through research, innovation, testing, user feedback, and observation.

• EHR purchasers have the responsibility to perform the due diligence that should accompany any system purchase, especially one as crucial to its clinical and business functions as an EHR. In addition to standard evaluation processes, purchase decisions must consider the needs of a wide variety of end users.

• Health care delivery organizations have the responsibility to consider usability in their initial implementation and configuration of the EHR system. They must communicate problems to the EHR developer and correct usability problems related to configuration to the extent reasonable. Along with individual users, organizations have the responsibility to take advantage of training opportunities and stay informed as new releases are delivered to the market. This ensures their configured implementation will continue to be optimized relative to the features and functionality available.

What Is Usability?
Usability can mean different things to different audiences, which is why EHR developers are constantly talking to end users to learn what they like, what frustrates them, and how they think the product could be improved. But here's where it gets complicated—what one user sees as an improvement, another may view as an impediment. As HIT becomes more prevalent throughout health care, balancing the needs of various user perspectives poses usability challenges. This spectrum of user roles, as well as the critical nature of the environment, the breadth of specialized terminology, and other factors, make this predicament unique to the health care arena.

In June, the Electronic Health Records Association (EHRA) hosted a Usability Summit where participants ranging from physicians and nurses to government officials and EHR developers worked together to create 10 "personas," including a primary care physician, a nurse, a hospital IT professional, and a chronically ill patient, to represent the wide variety of groups who rely on EHRs. Summit participants considered how each persona used HIT and what its vision of the ideal technology looked like.

Recently, EHRA released "Electronic Health Record Design Patterns for Patient Safety," which highlights many of the ways consistency across HIT platforms can help clinicians boost patient safety, including accurately interpreting test results and prescribing the right medication at the right dose.

Many issues identified as usability problems actually have multiple sources, amplifying the point that a learning health care system requires collaboration that must include end users. When providers identify an EHR problem or frustration, they should feel empowered to engage with their local organization and their EHR vendor to evaluate and solve the issue rather than create workarounds that might inadvertently lead to additional patient safety risks.

Sometimes it's a problem in the EHR that can be easily remedied, and sometimes it's a usability issue that can be addressed in a software update. Sometimes it's the provider's configuration or poorly optimized institution-specific workflows causing the problem, or a workaround for one issue creates a new and potentially more serious patient safety issue. In many instances, a simple configuration change or a feature already in the software could resolve the issue through client and developer collaboration. In all cases, it's important that every issue is flagged and that the EHR developer is part of the solution.

On the Developer Side
EHR developers have a longstanding commitment to patient safety. Instilling a patient safety approach isn't solely reactive—it must be considered from the earliest stages of the development process. The goal is to ensure patients get the best possible care. It takes collaboration to share experiences relative to patient safety and the reduction of errors.

That's why developers work with the ONC, the Agency for Healthcare Research and Quality, the National Institute for Standards and Testing, the FDA, and other federal agencies, in addition to a broader stakeholder group that includes HIMSS, patient safety organizations (PSOs) such as the ECRI Institute, The Joint Commission, trade associations, professional societies, liability carriers, and academics to foster a nonpunitive national learning system.

Developers participate in the ongoing dialog about adverse event reporting and advocate a PSO approach as one important element of such reporting. EHRA worked with congressional staff to include language in the 21st Century Cures Act to enable EHR developers to directly participate in PSO root cause analyses by expanding PSO protections.

EHRA is also involved in several other initiatives, including the following:

• EHRA has a long-standing patient safety workgroup comprising representatives across the vendor community led by clinicians committed to improving patient safety in HIT.

• The EHRA-sponsored EHR Developer Code of Conduct features several major points that promote patient safety. Version 2, which strengthens adopters' commitment to patient safety and improved usability, was made available in February 2016.

• EHRA is supportive of the principles and goals of the Bipartisan Policy Center report "An Oversight Framework for Assuring Patient Safety in Health Information Technology," published in February 2013.

• In 2013, EHRA worked with the ONC to review and refine the SAFER Guides that were published in January 2014 and updated in March 2017.

• EHRA participated in an ONC/Pew Charitable Trusts HIT safety colloquium in December 2016, which brought together safety advocates to identify ways to move the health care industry forward.

• At the HIMSS Annual Conference in 2016, EHRA cosponsored a preconference symposium on achieving a "culture of safety" in health care and HIT.

As EHRs evolve, EHR developers are committed to improving products where it really matters—in hospitals and physician exam rooms where the technology is used to help deliver patient care.

It is expected that EHRA members will continue to encourage their provider customers—hospitals and ambulatory practices across the United States—to collaborate in user groups, training opportunities, and focus groups where direct feedback and dialog on this important topic can result in continuous and substantial progress toward the shared goal of a safer, more effective, more efficient health care system for all Americans.

Clearly, patient safety is job one for those working in health care. Therefore, EHRA is committed to identifying and capitalizing on opportunities to develop HIT into an even more effective tool in making health care safer.

— Shari Medina, MD, is vice chairwoman of the EHRA Patient Safety Workgroup.

— Janet Campbell is vice chairwoman of the EHRA Clinician Experience Workgroup.