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By DAVE LENCKUS, a veteran business journalist who has covered the insurance industry for more than 20 years.

PHOENIX -- The rules for establishing a patient safety organization are complex, but some healthcare risk management professionals "overcomplicate" the decision process, according to an official for a patient safety organization that analyzes data and conducts research for medical-care providers.

And with a patient safety organization the provider can perform that analysis without fear the information can be turned against him or her in medical malpractice litigation, Solomon told attendees of a Monday session at the annual American Society for Healthcare Risk Management Conference in Phoenix.

Solomon traced the impetus for patient safety organizations to the Institute of Medicine's 1999 report "To Err is Human," which estimated that as many as 98,000 hospital patients die annually because of medical errors. The Institute of Medicine called for changes in the culture of medical care to reverse the numbers its report uncovered.

A cultural shift is under way, as healthcare professionals are responding differently following adverse treatment events, Solomon said. Previously, a provider typically investigated a treatment error, punished those involved in the incident and prepared for a claim.

Now, the investigation typically is focused on getting to the root cause of a problem. Rather than focusing on an individual's error, the investigation targets gaining an understanding of what established care delivery systems allowed the error to occur. That system then is modified or replaced to improve patient safety.

The Institute of Medicine, "has made a difference," Solomon said.

To support that cultural shift, Congress passed the Patient Safety and Quality Improvement Act of 2005, designed to promote the identification and reduction of potential risk through the collection and analysis of patient treatment and outcome data in a protected legal environment.

"It works," Solomon said, referring to the effect of patient data aggregated by patient safety organizations, which must be certified by the U.S. Department of Health and Human Services before they can shield findings from plaintiffs' attorneys.Once certified, a patient safety organization can "really dig down" into the cause of any incident and understand multiple ways to prevent it from happening again, she said.

The data and analysis then falls under "very broad federal legal protections," she said. The information is not subject to subpoenas, and the medical provider can't be compelled to submit it as evidence in a court case, she said. It also is not subject to Freedom of Information Act requests, and is beyond state laws in some cases.

Solomon also noted that the U.S. Agency for Health Reporting and Quality has developed a standardized method for data collection and reporting of patient safety event information. "This is a big deal," Solomon said.

Before forming or joining a patient safety organization, a medical provider should take into account the following considerations, Solomon said:

1) Forming or joining a patient safety organization is voluntary. But 50-bed and larger hospitals that will be part of qualified health plans involved with state insurance exchanges created by the 2010 healthcare reform law will have to be working with a patient safety organization by 2015.

2) The patient safety organization's mission and primary activity has to be patient safety.

3) If it forms a patient safety organization, the provider has to have the staff and the information technology infrastructure to support it. The provider must submit to audits and comply with regulations to qualify as a patient safety organization.

4) The provider must be capable of protecting patient information.

5) No federal funding is available to create and operate a patient safety organization.

October 18, 2011

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