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July 2014

Health IT-related patient safety risks should inspire Congress to create a national patient safety board

The idea’s time has come. The U.S. healthcare system needs a national, independent entity empowered by Congress to oversee health IT patient safety. Now.

In today's world a health IT-related patient safety issue that is identified by a physician practice or hospital is investigated and managed in a nontransparent manner by the individual provider and the EHR vendor.  

Although the issue may be escalated to a local accountable care organization (ACO) or patient safety organization (PSO) that providers are increasingly becoming associated with, neither the issue nor the results of the investigation are reported to a statewide or national oversight entity. The patient safety data is therefore not collected, aggregated and analyzed at a state or national level. Without such oversight we are missing out on the opportunity to identify known avoidable health IT risks to patient safety and failing to disseminate knowledge on how to manage those risks. For example, if an issue is resolved at the physician practice between the physicians and EHR vendor but is not addressed at other practices that use the same EHR, then patients at those other practices remain at risk. 

I have observed EHR vendors tune in to patient safety issues more keenly in the past decade and sometimes make more visible efforts to ensure identified issues are addressed with all customers and not just the ones who report issues. And let's be clear that a majority of EHR-related patient safety risks are related to how an EHR product is being used or implemented by their clients and not due to inherent technical flaws with the vendor's product. Nevertheless, patient safety should be viewed as a shared responsibility between the physicians, their practices or organizations and the health IT vendors. Identifying and managing patient safety risks is done most effectively when all cooperate in a team effort.

In Texas there had been discussions within the Texas Medical Association about establishing a central, statewide EHR patient safety entity to monitor and manage health IT-related patient safety issues. The data would be rolled up from hospitals, physician practices and patient safety organizations across the state for aggregation and analysis. However, it became evident during those discussions that it would be feasible and much more beneficial to establish governance at a national level.

So why does this need to be a new, independent national agency charged by Congress to oversee health IT patient safety? 

Today there are many government agencies and private entities that I believe could and should contribute to patient safety surveillance and improvements, but none have the expertise, assets and time that are necessary to coordinate a national effort. In addition to the complexity involved with collecting and analyzing data from hundreds of institutions and PSOs, there are hundreds of unrelated EHR vendor products being used. There is not yet any available registry of health IT products, many of which are subdivided into multiple versions that sometimes vary widely in their available functionality. As a result, I strongly agree with the observations and recommendations described in an article by Singh, Classen and Sittig (J Patient Saf, Dec 2011; 7(4): 169-174) calling for a national patient safety board that is an independent government agency structured similarly to the National Transportation Safety Board. This entity would be charged by Congress to oversee HIT patient safety and coordinate with other agencies who can contribute to improvement in patient safety such as the Office of the National Coordinator, the Federal Drug Administration, the National Institute of Standards and Technology, the Agency for Healthcare Research and Quality, the Center for Medicare and Medicaid Services, the National Quality Forum, local patient safety organizations, local healthcare organizations who collect patient safety data, other local EHR patient safety reporting entities and industrial (EHR and HIT) trade associations. All of these entities need to function in a cooperative fashion in order to effectively identify and manage health IT-related patient safety risks.

The recent health IT report from the Food and Drug Administration Safety Innovation Act (FDASIA Health IT Report) proposes a framework to improve health IT-related safety risks including a proposed National Patient Safety Center. 

I am concerned, however, that the proposal does not appear to provide this entity with enough authority to get the job done effectively. A national patient safety entity must have the authority to not only monitor activity and provide learning opportunities for vendors and providers, but also to regulate activities, investigate events, ensure issue resolution and require compliance. I do not see enough "teeth" given to the entity proposed by the FDASIA report. 

The primary focus of a national Health IT Patient Safety Center should be on the dedicated surveillance of HIT-related safety risks and to promote learning from identified issues, potential adverse events (“close calls”) and adverse events. But it must also have the authority to effectively manage identified risks and ensure compliance with best practices for health IT patient safety.