HHS panel advises on data glitches that affect patient safety

Hospitals and doctors should be required to report data glitches that create “hazards and near-misses” that affect patient safety to a national patient safety organization starting in 2013, according to recommendations proposed today by a Health and Human Services Department advisory workgroup.

In addition, patients also should be encouraged to report errors, omissions and other mistakes in their medical records, and electronic health record (EHR) systems should include “feedback” buttons to quickly report data problems that occur when using the systems.

The Adoption/Certification Workgroup of the HHS Health Information Technology Policy Committee considered a draft proposal today that outlined best practices for electronic reporting of patient safety hazards and near misses. The practices are expected to be included in the second phase of “meaningful use” of EHR systems, starting in fiscal 2013.

Under the economic stimulus law, Congress approved $17 billion to be distributed to hospitals and doctors who demonstrate meaningful use of EHR systems. The first phase of the distribution begins Oct. 1.

Although using digitized records can lead to improved patient safety, it also has been associated with some safety risks that may affect patient care. These include technology problems such as hardware failures, software bugs, and incompatibility between applications and interfaces. Implementation and training deficiencies also create risks.

Workgroup members said the goal is to establish a “patient-centered” approach to health IT safety, which includes confidential reporting, liability protections, whistle-blower protections, patients engaged in the system and transparency.

“Most unsafe conditions are not the result of a single software error. Instead, multiple factors are involved, including challenges with usability, processes, and interoperability,” the draft proposal states.

The reporting system would cover usability, processes, and training, and would span all software, including that software sold by vendors, self-developed and open-source software.

To encourage reporting, vendors should include feedback buttons that appear on the screens allowing quick and easy reporting of data errors, omissions, or other data problems. Certification of record systems should include a requirement for this functionality, the draft report recommended.

Vendors also should maintain records on all patient safety concerns reported by their customers and provide safety alerts to customers on such concerns. They should also build in patient safety testing into their products.

Patients also should be encouraged in finding errors and mistakes in their electronic records, either by accessing their provider’s EHR system or by downloading the information to a personal health record. Feedback buttons to report errors also are recommended for those applications.

For a more comprehensive picture of patient safety issues related to data errors, the panel recommended that the Office of the National Coordinator for Health IT commission a formal study to thoroughly evaluate health IT patient safety concerns and to look into the possibility of audit trails for health information exchange activities.