The ONC Proposes Using EHR Certification Criteria For Patient Safety Event Reporting

Posted on by Frank J. Rosello

The Office of the National Coordinator for Health IT wants to use electronic health record certification criteria to make it easier for physicians to report patient safety events, which provide critical raw data for developers, healthcare providers, researchers and policymakers to improve the safety of health IT and make care safer.

The Agency for Healthcare Research and Quality will encourage providers to report adverse events to patient safety organizations (PSOs) and to use AHRQ’s Common Formats, a tool which offers common definitions and reporting formats to improve how they gather, review and report adverse event data, near misses and unsafe conditions.

ONC intends to propose certification requirements that, where appropriate, EHRs can report safety events in AHRQ’s Common Formats.

These are among the steps that are part of the Health IT Patient Safety Action and Surveillance Plan released Dec. 21 for comment by the Health and Human Services Department. Public comments are due Feb. 4, 2013.

The aim is to use health IT to make care safer and more efficient and to continuously improve the safety of health IT, according to the report. The plan covers actions to take through 2015.

While the plan lays out actions for federal agencies to take, “clinical users of health IT and health IT developers are primarily responsible for ensuring patient safety,” the plan said.

Rules from the Centers for Medicare and Medicaid Services and ONC for meaningful use and EHR certification criteria will continue to be used to improve patient safety, such as maintaining lists of patient medications, allergies and problems and the use of computerized provider order entry (CPOE). As part of EHR certification and post-market surveillance, ONC Authorized Accrediting Bodies will test that safety features function in live environments and scrutinize that developers fix safety complaints, according to the ONC patient safety plan.

CMS will work with ONC to align its health and safety standards and guidance for providers and suppliers. CMS will also develop training for state agencies that conduct complaint investigation surveys to improve their ability to identify safe and unsafe practices associated with health IT.

ONC will analyze data from reporting programs, reduce the inefficiencies across the programs, continuously evaluate the effectiveness of the Health IT Safety Plan and decide whether additional actions are needed to better use health IT’s potential to improve patient safety.

The National Institute for Standards and Technology (NIST) and ONC’s Strategic Health IT Advanced Research Projects program are developing usability testing tools to make sure that certified EHRs perform correctly.

And winners of a recent developer’s patient safety reporting challenge will make tools and applications more readily available to reduce adverse events and better manage patient safety.

AHRQ has also developed guides for reducing unintended consequences of EHRs to help avoid and troubleshoot problems associated with the use of health IT and a guide for developers and systems designers of consumer health IT to incorporate safe design.

ONC will also monitor health IT adverse event reports in the Manufacturer and User Facility Device Experience (MAUDE) database provided by the Food and Drug Administration to track potential trends in health IT patient safety risks.

Among other actions in 2013, ONC:

  • Contracted with Westat to develop health IT safety guides and checklists, such as Safety Assurance Factors for EHR Resilience (SAFER) Guides
  • Contracted with RAND Corp. to work with hospitals and physician practices to put in place health IT risk management tools
  • Will encourage work groups or common interest organizations to be established at professional forums, such as HIMSS, AMIA and AMA

Article written by Mary Mosquera, Senior Editor for Healthcare IT News

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