The U.S. Department of Health and Human Services (HHS) has released the Health IT Patient Safety Action and Surveillance Plan. The action plan promotes the vision that health IT can help to eliminate medical errors, improve the quality of care, protect patients and make the health care system more efficient. The Plan has two related objectives: to use health IT to make care safer, and to continuously improve the safety of health IT.
The Plan builds on the Department’s overall commitment to patient safety, and addresses recommendations made in the 2011 Institute of Medicine (IOM) Report, Health IT and Patient Safety: Building Safer Systems for Better Care.
“When implemented and used properly, health IT is an important tool in finding and avoiding medical errors and protecting patients,” said National Coordinator for Health IT Farzad Mostashari, M.D. “This Plan will help us make sure that these new technologies are used to make health care safer.”
The Plan outlines the responsibilities to be shared across HHS and details significant participation from the private sector. Through the Plan:
- ONC will make it easier for clinicians to report health IT-related incidents and hazards through the use of certified electronic health record technology (CEHRT).
- The Agency for Healthcare Research and Quality will encourage reporting to Patient Safety Organizations and will update its standardized reporting forms to enable ambulatory reporting of health IT events.
- The Centers for Medicare & Medicaid Services (CMS) will encourage the use of the standardized reporting forms in hospital incident reporting systems, and train surveyors to identify safe and unsafe practices associated with health IT.
- Working through a public-private process, ONC will develop priorities for improving the safety of health IT.
- ONC and CMS consider adopting safety-related objectives, measures, and capabilities for CEHRTs through the Medicare and Medicaid EHR Incentive Programs and ONC’s standards and certification criteria.
ONC also established the Health IT Patient Safety Program, led by ONC’s Chief Medical Officer Jacob Reider, MD, in coordination with the Office of Policy and Planning, to coordinate and implement this Plan.
“Through the Safety Program, ONC will collaborate with stakeholders to incorporate health IT and patient safety into their organizations, and will work closely with all actors to help them fulfill their responsibilities under this Plan. ONC will oversee the aggregation and analysis of data from the sources identified in this Plan, among others, in order to identify trends in patient safety and health IT, provide feedback to developers and providers, and inform policies and interventions to achieve this Plan’s objectives,” says the Plan.
To accompany the Plan’s surveillance of safety-related capabilities in Certified EHR Technology (CEHRT), the ONC has also issued guidance clarifying that ONC-Authorized Certification Bodies will be expected to verify whether safety-related capabilities work properly in live clinical settings in which they are implemented. ONC is coordinating the implementation of the Plan through the ONC Health IT Safety Program. They will be updating the Health IT and Patient Safety website regularly to reflect progress towards implementation and make available resources and other materials developed under the Plan.
In addition to the Plan, Dr. Mostashari announced ONC has contracted with The Joint Commission to better detect and proactively address potential health IT-related safety issues across a variety of health care settings. The Joint Commission will expand its capacity to investigate the role of health IT as a contributing cause of adverse events and will identify high priority areas for expected types of health IT-related events.
It will be interesting to see how the industry responds to the final Plan being published. One of the strategies of the Plan is to incorporate health IT safety in post-market surveillance of certified EHR technology.
HHS had released a draft of the plan in December 2012 along with a request for public comment. State and national medical societies responded, and the American Medical Association called for more research on the intersection of IT and patient safety. “Physicians are concerned about potential liabilities from EHR system design and software flaws, as well as lack of interoperability among EHR systems that could result in incomplete or missing information, which may lead to errors in patient diagnosis and treatment,” they said.
In a comment letter on the draft plan, the Texas Medical Association expressed concern that “the proposed plan lacks the specificity necessary for success.”
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