Patient Safety and Patient Centered Health IT

The Adoption/Certification Workgroup of the federal Health IT Policy Committee met March 12, 2010. The Patient Safety Working document and analysis are below. Here is the audio of the meeting:

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The workgroup proposed to create a new national database and reporting system to track health information technology-related hazards that could affect patient safety. In a draft paper discussed at their meeting they considered a national health IT reporting system where providers could report data on all incidents and potential hazards to a patient safety organization.

“Overall, patient safety is better in health care organizations with IT than in health care organizations without IT, provided that the IT systems have been implemented correctly, and provided that an appropriate improvement culture exists,” the paper states.

The paper also addresses four key areas where potential safety hazards exist. They include technology issues such as hardware failures and software bugs; complex interactions of professionals, workflows, and user interfaces; interoperability problems between applications (such as lab results never making it into the EHR) and implementation and training deficiencies.

“The complexity of the health care activity coupled with the number of individuals involved with an activity influences the probability of an incident,” according to the paper.

In the previous February 25, 2010 Adoption/Certification Workgroup meeting, Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, outlined some of the health and safety risks associated with health IT. Over the last two years, the FDA has received 260 reports of health IT-related malfunctions that could have potentially caused bodily harm, and did actually injure 44 people and kill another six, Shuren said.

These figures were supplied to the FDA voluntarily by patients, clinicians, and user facilities, so they may “represent only the tip of the iceberg in terms of the health IT-related problems that exist,” he said.

Shuren had said these adverse events fall into four categories: errors of commission, such as accessing the wrong patient’s record or overwriting one patient’s information with another’s; errors of omission or transmission, such as the loss or corruption of vital patient data; errors in data analysis, including medication dosing errors of several orders of magnitude; and incompatibility between multi-vendor software applications and systems, which can lead to any of the above. It seems the committee is responding to many of the FDA's concerns in this paper.

Under the draft plan, the national health IT reporting system ideally would be patient-centered and consistent with the vision of a learning health care system. “A ‘patient-centered’ approach focuses more on the patient and less on accountability for an error,” the draft proposal states. “We also want to focus attention on hazards and "near-misses". We want to prevent unsafe conditions that might lead to serious injuries or deaths.”