The Office of the National Coordinator for Health Information Technology has released its final Health I.T. Patient Safety Plan, following issuance of a draft plan for public comment last December.

The final plan has two core objectives: To use health I.T. to make care safer and to continuously improve the safety of I.T. “Achieving these objectives is a shared responsibility,” the ONC report states. “No one entity or group can fully realize the potential of health I.T. to improve patient safety.”

Consequently, ONC wants to coordinate actions among a wide range of stakeholders. These include clinicians, administrators, I.T. staff, quality improvement staff, patients and caregivers, federal and state governments, health I.T. developers, usability experts, patient safety organizations, accrediting bodies, educational organizations, health insurers, professional associations and publishers.

The ONC health information safety strategy includes multiple initiatives in three core areas: Learn more about I.T. safety issues, improve safety and lead to promote a culture of safety. Following are the core components of each of the three areas:


* Make it easier for clinicians to electronically report safety events and hazards to patient safety organizations using AHRQ Common Formats.

* Support patient safety organizations to identify, aggregate and analyze safety event and hazard reports.

* Have electronic health records certification bodies conduct post-market surveillance to ensure the capabilities of EHRs work in operational settings to the same extent as when they were certified.

* Align CMS patient safety standards and initiatives with the safety of health information systems. CMS and ONC will develop I.T. safety training for state survey agencies and surveyors who conduct complaint investigations on CMS’s behalf. When deficient practices are identified, providers and suppliers must submit to CMS a plan of correction.

* Collect data on health I.T. safety events through the Quality & Safety Review System that AHRQ is building to perform retrospective surveillance for adverse events. This is a replacement for the Medicare Patient Safety Monitoring System.

* ONC will coordinate with the FDA to identify and evaluate adverse event reports made to the FDA’s MAUDE database of adverse reports on medical devices. This will give ONC insight via an additional data source into potential safety risks and trends.

* ONC will work with public and private initiatives to identify programs to make care through use of health I.T. safer.


* Use meaningful use criteria and the National Quality Strategy to establish priorities for improving safety. For instance, ONC is developing electronic clinical quality measures for specific adverse drug events and will develop additional measures for other patient safety domains.

* ONC will update meaningful use standards and certification criteria to ensure the capabilities of certified EHR technology support safety improvement priorities. Stage 2 has two such measures already, requiring software vendors to identify the method used to incorporate user-centered design processes into EHR development of medication management functions, and to provide vendor transparency on their approach to quality management systems. “ONC intends to build on these certification criteria in future rulemaking as means for enhancing health I.T. patient safety through continued focus on human factors, safety culture, and user-centered design in EHR technology development,” according to the plan.

* Support research and development of testing, user tools and best practices related to health I.T. safety. “In 2013, ONC will begin packaging and disseminating a new class of health I.T. safety tools and interventions designed to improve the ability of health I.T. implementers and users to assess patient safety within their organizations and benefit from the latest applied knowledge of health I.T. safety.”

* Incorporate I.T. safety into education and training for health care professionals. For instance, the stimulus law-funded Workforce Development Program has trained more than 18,000 health I.T. professionals as of May 2013. Most of these programs, ONC says, are self-sustaining after federal funding ends this year. ONC will work with these programs and other organizations to add a focus on I.T. safety to existing education and training programs.

* The Joint Commission, under a new contract with ONC, will investigate the role of I.T. as a cause of adverse events and will develop educational materials and training opportunities to aid providers in identifying, investigating, analyzing and mitigating adverse events.


* ONC will encourage health I.T. industry groups and associations--with specific mention of the Electronic Health Record Association which recently adopted a voluntary industry code of conduct--to educate members on shared responsibilities for a culture of I.T. safety.

* Encourage state governments to incorporate health I.T. into their patient safety oversight programs, such as mandatory reporting of adverse patient events in 26 states.

* HHS will encourage ways that providers can educate patients and family caregivers in safer use of I.T. ONC will encourage providers and vendors to develop safer consumer eHealth products.

* The chief medical officer of ONC will oversee implementation and coordination of ONC’s new I.T. safety plan and analysis of data from multiple sources.

* ONC, FDA and the Federal Communications Commission under a 2012 law are expected to issue a report by January 2012 on a proposed strategy and recommendations for an appropriate risk-based regulatory framework for health I.T. ONC sees this initiative as complementary to its new health I.T. safety plan that lays out immediate and short-term actions to improve safety, and expects the regulatory plan will not replace actions in the ONC plan.

Text of the safety plan and the Joint Commission surveillance strategy, along with guidance and a fact sheet, are available here.

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