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.

13 replies »

  1. A friend went to the ER at Christus Santa Rosa in the Med Center in San Antonio today and was not checked to see if she was ok before they told her to go to another hospital. Isn’t that illegal? Would this group be one to look into this? Forgive my ignorance, I just don’t want this to happen to someone else who really shouldn’t get in a car to go to another ER when they have arrived at one already.

  2. I agree. I have been studying the UK and they are way ahead of us. Our competitive market is vying for shares of “healthcare dollars” & has forgotten about the child, or the father, or the wife….I’ll work with anyone on creating a system where providers are safe to report the system failures that prevent them from the patient healing they long create. Let’s do this.

  3. Left unchecked, increasing healthcare could cause more deaths and injuries. It’s counter intuitive… but possible and probable as medical errors rise with increasing healthcare.

    According to Pew Research Center, roughly 10,000 Baby Boomers will turn 65 today. About 10,000 more will cross that threshold every day for the next 19 years. Healthcare is expanding as our population ages.


    Software and robots are helping to improve our healthcare and reduce medical errors.

  4. Tejal: Great article. While I agree with your premise, our cultural attitude towards government control runs contrary to the need for action. While Americans love to hate the government, that same government is expected to protect citizens from everything from a flood to famine. Why not leverage an organization like JACHO to inspect what we expect? JACHO understands healthcare culture and is particularly adept at accountability. I’m afraid that our government would spend a lot of time, effort, and money and never get to the level of expertise and impact that currently exists with JACHO. What are your thoughts?

  5. Just like the feds come up with colorful War and Peace-length PDF Ten Year Plans via which to define “interoperability” down to interoperababble (while concomitantly claiming ad nauseum that voluminous Process Indicators constitute “Clinical Quality Measures”), so too would they define “patient safety” down. We could have, say, a new, granular nomenclature for EHR inclusion — the PSO-10 code set, “Patient Safety Outcome.”

  6. When markets fail we have less markets and when regulators fail we have more regulators. Whether or not medical errors are as big a problem as some believe, and many fear disbelieving, I doubt another agency is the answer.

  7. Patient safety: vital. But the idea of yet another regulatory body fills me with despair. Step 1 from my point of view of a clinician with “boots on the ground”: give me, and all the other physicians and nurses, an EHR that would actually free us up to take care of patients instead of so many hours of data entry with our backs turned toward the patients. Eliminate the relentless production pressure–think of Lucille Ball trying to deal with the chocolates on the assembly line, only not funny. Give us time to breathe, freedom from checkboxes, and time to spend actually giving care and time to patients. I guarantee we’ll wash our hands more and morale would improve. And I bet patient safety would improve too. Everyone is demoralized and pride in health care work has nearly disappeared.

  8. Yes another agency.. More bureaucracy that will no doubt come up with more checkboxes, and increase data reporting for physicians / hospitals. All of which will result in no fewer preventable harms. Never mind that preventable death estimates are a guesstimate, so what metric will we follow to make sure this agency is doing its job?

  9. When known problems with known (minimally burdensome) solutions exist and are ignored
    – via TweetBot

  10. Yawn. 4 people cared in December. Fewer today: Drug prices! Repeal the ACA!

  11. I appreciate the sentiment here. I just wonder how much duplication of effort there will be. To the extent that many organizations are already involved in the patient safety issue, they’ve got data that arguably would be re-created by this new agency (unless you’re envisioning more of a warehouse).

    I don’t think it’s a terrible idea, but are we looking for basically the equivalent of the USPSTF? My sense is they move pretty slow when it comes to new evidence. There are also some really basic safety processes that, in my mind, don’t need a massive new federal agency. Hand-washing, for instance. Based on what I’ve read, even in ICUs, hand-washing rates are only about 50 percent. How would this new agency change that? We know pretty well that hand washing is important, and so do management teams at hospitals.