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Could a federal patient safety agency offer a solution to rising number of errors?


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In the decade that has passed since the 1999 release of the Institute of Medicine’s To Err is Human, much headway has been made in terms of collecting data about medical errors and taking action in the industry to prevent those errors from occurring.

However, little has been done on a federal level to actively enforce public reporting of errors and compliance with evidence-based practice proven to reduce specific medical errors. Some members of the public are asking where the outrage is, and leading healthcare groups are recommending that the idea of a federal agency, a recommendation from To Err is Human, be revisited.

“In a not complicated way, we really would like to see a commission that has regulatory power,” says Karen Wolk Feinstein, PhD, CEO of the Pittsburgh Regional Health Initiative (PRHI). “People are calling for a national mandatory reporting system or more research, and although we have nothing against those, all of that doesn’t get us to where we need to go. Where we need to go is regulation.”

PRHI wants to see a federal agency with the power—either by withholding payment or some other form of authority—to require hospitals to carry out certain processes and procedures in a specific way so as to reduce the number of avoidable medical errors. At this point, the industry has enough research about certain medical errors to know how to prevent them from happening, says Wolk Feinstein. “It’s rather simple in a way,” she says. “I’m just saying it’s time to take action. We have lots of good data now—let’s act.”

The evidence already exists

PRHI has been working with hospitals in the Pittsburgh area for the past 11 years to teach them that many events that were thought at one time to have been unavoidable are in fact preventable with basic work redesign and new processes and procedures. Wolk Feinstein founded PRHI with former Secretary of Treasury Paul O’Neill, who at the time was president of Alcoa, the aluminum industry giant. They wanted to partner on applying industry principles of safety and high performance to healthcare.

“We looked at healthcare, spent some time at the front line of care. Both Paul and I said, ‘Wow, this is chaotic, inefficient, danger-prone, and unsafe,’ ” says Wolk Feinstein, who tried to prove that techniques that are effective in other sectors such as aviation and industry would work in healthcare. “The argument that we had to challenge was that ‘every patient is different’ and ‘the healthcare environment is very specialized and nothing that works well in other settings as far as good work design will work in healthcare.’ ”

Since then, PRHI has worked on many different issues, starting with an initiative to reduce central line infections at area hospitals, which lowered the infection rate by 68%.

“We said infections aren’t inevitable,” Wolk Feinstein says. “Good work design, good performance improvement techniques can do an amazing job of making healthcare safer. And when you do that, you have other advantages—patients are happier and workers are happier.”

Twenty-six states have error reporting systems in place, all but one of which require mandatory reporting. In addition, with the launch of Patient Safety Organizations earlier this year, hospitals have many options for reporting error-related data and receiving analysis and feedback as well as guidance. There is no lack of opportunities to report errors, says Wolk Feinstein, adding that the next logical step would be to create a federal body that has the power to enforce best practices and prevent further medical errors from occurring.

Current efforts fall short

Although error reporting and warnings within the industry have come a long way since 1999, those alone have not proven to be enough to save the estimated 98,000 patients who die from a medical error each year. The Joint Commission has been releasing Sentinel Event Alerts since 1998, warning those in the healthcare industry that certain patient safety events are occurring and offering tips and guidance on how to prevent them from happening again.

Although these alerts have been welcomed and helpful, Wolk Feinstein says more must be done.

“Alerts aren’t doing it,” she says. “They’ve been getting alerts from patient safety organizations for a while. It takes 10–20 years for anything to change in terms of behavior of healthcare professionals and even adoption of evidence-based practices. Why do we think alerts are going to do it?”

The agency’s design does not have to be complex, says Wolk Feinstein. This type of agency could be a part of the existing Department of Health and Human Services or Agency for Healthcare Research and Quality organizations, or it could be a private entity contracted by the government.

Wolk Feinstein says she doesn’t think that the right step would be to flood the field with more regulations. By requiring hospitals to adhere to a set of well-proven practices to reduce medication errors, for example, an agency with regulatory power would reduce the number of errors as well as inefficiency.

In August, Hearst Newspapers unveiled a consumer Web site called Dead by Mistake. It tells the story of 30 victims of medical error and how the healthcare system arrived at its current state. Wolk Feinstein says she hopes this series will open consumers’ eyes and inspire them to lobby their legislators to take action on reducing medical errors. The article series details the attempts of legislators in 2000 to create a federal patient safety agency, much like the one being discussed now. Those efforts were quashed due to, among other reasons, industry fears that making errors public would instead discourage healthcare providers from reporting errors.

Wolk Feinstein hopes that in another 10 years, real progress will have been made on reversing this trend of increasing numbers of unnecessary deaths due to medical errors. “There is often a simple solution to a major unsafe condition, but nobody has the power to say, ‘Do this differently,’ or ‘This is how this should be done,’ ” she says.