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REGULATORY REVIEW


Serious Reportable Events Current requirements reflect the evolution of this national patient safety initiative BY STEVEN SELDE


Overview


Today, “never events” are referred to by a variety of terms, including “adverse patient events,” “patient safety


events,” “sentinel


events” and “serious reportable events” (SRE). While there are minute differ- ences in the definitions of these terms, they aim to capture injuries that are caused by avoidable errors while pro- viding medical care. ASC clinicians and administrators are familiar and experi- enced with documenting and reporting these events, but state and federal leg- islation and regulations requiring they do so are relatively modern develop- ments. The Medicare Access and CHIP Reauthorization Act of 2015 presents an opportunity for federal SRE require- ments to change, and that change will likely be influenced by the unique pol- icy context SREs are situated in. Quality measures of every sort are at the forefront of today’s health care policy considerations. However, the context and background of measur- ing SREs is noticeably different. Two milestones mark the development of both the public’s and health care com- munity’s focus on tracking and reduc- ing SREs. The first is the Institute of Medicine report “To Err is Human: Building a Safer Health System,” pub- lished in 1999. This report estimated that up to 98,000 people die because of mistakes made in hospitals each year. The second is a hearing held by the US Senate Committee on Health, Education, Labor & Pensions on the “Need to Improve Patient Safety,” in 2014. There, John James, the founder of Patients Safety America in Houston, Texas, and others famously testified that as many as 200,000 to 400,000


36 ASC FOCUS JUNE/JULY 2016


patients experience preventable harms that contribute to their death each year. Reducing errors while caring for patients is critical for both providers and patients, and these two milestones signif- icantly influence efforts today aimed at making health care as safe as possible. That is not to say they are beyond scru- tiny. Their respective findings and fig- ures are polarizing, and each, especially in the case of James’ testimony, continue to elicit strong reactions from the pub- lic and health care community at-large. Nevertheless, these milestones play a significant role in SRE research and measure development and are often cited as bases for legislation and regulations. SRE measures that have been devel- oped in response to these findings are equally controversial, largely on the basis that the measures go beyond truly avoidable errors. The National Quality Forum (NQF) published its first list of specific SREs in 2002 and contin- ues to update it. NQF’s exhaustive list


of SREs includes 29 measures that are organized into seven categories: Sur- gical or Invasive Procedure Events; Product or Device Events; Patient Protection Events; Care Management Events; Environmental Events; Radio- logic Events; and Potential Criminal Events. All 29 measures have been deemed applicable to ASCs, although some will not be relevant depending on an ASC’s specialty and focus. Measures that are more pertinent to ASCs can be found in the ASC Quality Collaboration (ASC QC) quality mea- sures list. This list of nine measures was designed specifically for ASCs and includes many SREs. The ASC QC’s measures list and accompanying implementation guide have been vet- ted by the ASC QC’s internal panel of technical experts and an external panel of individuals and organizations. All of their measures have been pilot-tested in ASCs and assessed for validity, fea- sibility and reliability.


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