A New Federal Agency to Oversee Patient Safety?

flying cadeuciiPatient safety should be a major priority for the United States, and that requires designating a centralized entity or coordinating body to oversee efforts to ensure it. Such centralized oversight is one of the key recommendations of “Free from Harm,” a report published in December by the National Patient Safety Foundation. The report highlights the need to create a safety culture, since preventable medical errors in hospitals are estimated to result in as many as 440,000 deaths annually. That would make it the third leading cause of death – after heart disease and cancer.

A new report by the U.S. Government Accounting Office illuminates the challenges that hospitals face in implementing evidence-based safety practices. One of those challenges – determining which patient safety practices should be implemented – underscores the need for a coordinating entity and resource. The report states: “(Hospital) Officials noted that they face challenges identifying which evidence-based patient safety practices should be implemented in their own hospitals, such as when only limited evidence exists on which practices are effective. For example, officials from one hospital told GAO that the hospital tried several different practices in an effort to reduce patient falls without knowing which, if any, would prove effective.”

What’s more, preventing medical errors in hospitals is only part of the national challenge, as most health care is provided outside of hospital settings: in physicians’ offices and clinics; in outpatient surgical, medical, and imaging centers; and, in long-term, hospice, and home-care settings, among others. There are about 1 billion ambulatory visits each year in the United States, compared to 35 million hospital admissions. Those ambulatory settings are subject to medical errors as well. According to studies cited in “Free from Harm,” more than half of annual, paid, medical malpractice claims were for events in the outpatient setting.

Reducing the incidence of preventable medical errors in all settings requires the designation of a centralized entity or coordinating body to oversee patient safety. Such an entity exists for other high-risk industries. The Federal Aviation Administration oversees aviation; the Nuclear Regulatory Commission does the same for the nuclear power industry. These agencies investigate safety issues and then create and disseminate best practices to drive effective improvement. A similar vehicle is needed for patient safety, and it could be an existing or newly formed entity or coordinating body.

A number of federal agencies are already involved in valuable patient safety initiatives. The Centers for Disease Control and Prevention (CDC) has launched major initiatives to prevent healthcare-associated infections and to reduce the risk of unintentional medication overdose among children. The Centers for Medicare and Medicaid Services (CMS) launched the Partnership for Patients, a public-private partnership focused on reducing preventable hospital-acquired conditions and improving care transitions. The U.S. Agency for Healthcare Research and Quality (AHRQ) funds research and worked to create patient safety organizations that promote shared learning to enhance quality and safety nationally.

The CDC, CMS, and AHRQ are all part of the Department of Health and Human Services, but there are other federal regulatory bodies also involved in patient safety activities and oversight including the Food and Drug Administration and the U.S. Office of the National Coordinator for Health Information Technology. There are nonprofit safety organizations such as the National Patient Safety Foundation, the Leapfrog Group, The Joint Commission, and the Institute for Healthcare Improvement. There are patient advocacy groups as well as collaboratives of health care providers. All are testing or advancing patient safety innovations of one kind or another.

But there is no central entity in the United States designated to coordinate and align the initiatives and best practices emerging from various organizations involved in patient safety. Without a designated entity or coordinating body to galvanize will and act as a focal point for prioritizing patient safety efforts, there will be fragmentation, duplication, inefficiency, and unacceptably high levels of preventable medical errors. The idea of designating such an agency is not a new one. The Institute of Medicine’s landmark study To Err Is Human called in 2000 for coordinating patient safety efforts.

One option is to create a new agency, analogous to the FAA or the NRC. Another is to designate an existing agency – perhaps the AHRQ, CDC, or CMS. A third would be a public-private partnership. Regardless of the structure, it’s time to create a focal point for patient safety. The rate at which patients are dying from preventable errors cannot be accepted as business as usual.