Regulating Patient Safety: The Patient Protection and Affordable Care Act

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injury is a predictable feature of health care, particularly in hospitals,
in the United States and elsewhere. Since publication of the Institute
of Medicine (IOM) report To Err Is Human in 2000,
patient safety has come to the forefront of U.S. health care.
The IOM’s projection of 44,000 to 98,000 deaths per year due to hospital
errors, and hundreds of thousands of avoidable injuries and extra days
of hospitalization, fueled the patient-safety movement in
the United States. Ten years after the IOM report,
the level of adverse events in hospitals has not improved in any major
way. A recent HealthGrades analysis of Medicare data estimates
that more than 230,000 hospital deaths from 2007 to 2009 could have
been prevented within the Medicare population alone.

A study of ten North Carolina hospitals concluded that the rate of patient
harm from medical care had not decreased substantially over a six-year
period ending in December 2007.

of patient safety rests on four basic propositions. First, patient
injury (ranging from minor injuries to death) is a recurring feature
of health care and negatively affects roughly one in every ten patients,
according to a systematic review of the literature.
Findings by the Inspector General within the Medicare context support
this estimated patient-injury rate. As these statistics
attest, patient injury eludes easy solutions.

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