New federal guidelines aim for electronic health record systems to be used in a way that improves care and patient safety, and to ensure that system designs don't make certain types of errors more likely to happen.
Providers will make fewer medical errors that can harm patients—at least in theory—after implementation of a federal health IT safety plan unveiled this month. The plan recommends prohibitions of so-called vendor contract gag clauses and says demonstration of electronic health record systems' safety features should be a prerequisite for certification.
The 10-point plan, issued by the Office of National Coordinator for Health IT, seeks to resolve problems highlighted in the Institute of Medicine's November, 2011 report, Health IT and Patient Safety: Building Safer Systems for Better Care, by allowing electronic health record system users to report on problems using the Common Formats protocol, under development by the Agency for Healthcare Research and Quality.
"Health information technology enables substantial improvements in health care quality and safety, compared to paper records," the ONC said in a fact sheet accompanying release of the plan. "Yet health IT can only fulfill its enormous potential if risks associated with its use are identified, if there is a coordinated effort to mitigate those risks, and if it is used to make care safer."
The 50-page report's two main purposes are to use electronic health records in a way that improves care and patient safety, and to make sure electronic health record and computerized physician order entry system designs don't make certain types of mistakes more likely to happen.
"Because health IT is so tightly integrated into care delivery today, the extent to which health IT may have caused or contributed to medical errors is often unclear," the report begins. "For example, determining whether an error was caused by or associated with health IT is problematic where:
- "The harm to the patient could have been prevented by more sophisticated or improved implementation of computerized physician order entry or CDs,; or
- " The clinician did not use certain health IT functionality that could have prevented the error."
The plan seeks to make it easier for front line staff to report health IT-related safety events and hazards by enabling their reports to be covered under liability protections of Patient Safety Organizations, made possible by the Patient Safety Act of 2005.
"Because PSOs and their members have federal privilege and confidentiality protections for patient safety work product, PSOs provide a secure environment where clinicians and provider organizations can collect, aggregate, and analyze data in order to identify and reduce risks associated with patient care, including issues related to health IT," the report says.
That's where AHRQ's Common Formats comes in. The template provides common definitions that enable providers to report events in the same way in terms of their potential for harm. Versions of Common Formats now available for acute care hospitals are being adapted for skilled nursing facilities, nursing homes, and ambulatory care settings.
As a side-note to the release of the plan, the ONC also announced a contract with The Joint Commission to enhance its Sentinel Events reporting program "to better identify and address health IT-related events."
The contract includes provisions for the commission to develop a de-identified database of events, and investigate the role of health IT as a cause of such events, and develop educational materials and training opportunities, "which will be widely available publicly, to enable health care providers to better identify, investigate, and analyze health IT-related adverse events and develop follow-up and corrective action."
Electronic health record errors have been a source of increasing concern from front line providers. For example, a recent report from an American College of Emergency Physicians panel detailed potentially critical errors in patient care when hospitals have tried to adapt inpatient electronic record systems for the much different, hurried and transitory environment of the ED.
The ONC plan makes 10 recommendations. They are:
1. The Secretary of Health and Human Services should publish an action and surveillance plan within 12 months that includes a schedule for working with the private sector to assess the impact of health IT on patient safety and minimizing the risk of its implementation and use.
2. The HHS Secretary should ensure "insofar as possible that health IT developers support the free exchange of information about health IT experiences and issues and not prohibit sharing of such information, including details (e.g., screenshots) relating to patient safety."
3. The ONC should work with private and public sectors to make comparative user experiences across vendors publicly available.
4. The HHS Secretary should fund a new Health IT Safety Council to evaluate criteria for assessing and monitoring the safe use of health IT and the use of health IT to enhance safety.
5. All health IT developers should be required to publicly register and list their products with the ONC, initially beginning with EHRs certified for the meaningful use program.
6. The HHS Secretary should specify the quality and risk management process requirements that health IT developers must adopt, with a particular focus on human factors, safety culture, and usability.
7. The HHS Secretary should establish a mechanism for both developers and users to report heath IT-related deaths, serious injuries, or unsafe conditions. Reporting of health IT related adverse events should be mandatory for developers, but voluntary, confidential and nonpunitive for users. Efforts to encourage reporting should be developed, such as removing the perceptual cultural, contractual, legal, and logistical barriers to reporting.
8. The HHS Secretary should recommend that Congress establish an independent federal entity for investigating patient safety deaths, serious injuries, or potentially unsafe conditions associated with health IT. The entity also should monitor and analyze data and publicly report results of these activities.
9. The HHS Secretary should monitor and publicly report on health IT safety progress. The Secretary also should immediately direct the Federal Food and Drug Administration to begin developing the necessary framework for regulation.
10. HHS, in collaboration with other research groups, should support cross-disciplinary research toward the use of health IT as part of a learning healthcare system. Specific areas of research include user-centered design and human factors, safe implementation use of health IT by all users, socio-technical systems associated with health IT, and the impact of policy decisions on health IT use in clinical practice.