History

In the mid 1990's there were several high profile medical errors featured in the media.  These errors occurred in hospitals in the United States.  The heightened media attention spurred a new public awareness and outcry about the safety of patients in the health care arena.  

Several of the medical errors occurred in respected health care institutions accredited by the Joint Commission on Accreditation of Health Care Organizations (JCAHO).  In 1996, JCAHO implemented a Sentinel Event Policy.  Sentinel Events are defined by JCAHO as "an unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof. Serious injury specifically includes loss of limb or function. The phrase, "or the risk thereof" includes any process variation for which a recurrence would carry a significant chance of a serious adverse outcome. Such events are called "sentinel" because they signal the need for immediate investigation and response.¹"

Accredited organizations are required to identify and respond to Sentinel Events, and perform a timely, thorough, and credible root cause analysis on any "Sentinel Event".

In the years following, a number of private and public entities have either been established or newly focused on patient safety and the concerns surrounding the issue.  See the Patient Safety Links for more information on various patient safety focused agencies.

In 1999, the Institute of Medicine (IOM) released its landmark publication, "To Err Is Human," a study of the prevalence of medical errors.  Although the numbers were disputed by some (because of the extrapolation of data, and inferences drawn on the general population), this report was a national call to action.

In July 2001, JCAHO implemented an entire new set of Patient Safety Standards for its accredited organizations.  These new standards were not "stand alone" or grouped into a single chapter in the standards book, but were spread throughout the various functional chapters, with a number of them being integrated into existing standards by merely adding the words "patient safety".

One of the new standards requires organizations to annually select one high-risk process and perform a proactive risk assessment-- Failure Modes Effects and Analysis.  Instead of waiting for a Sentinel Event to bring patient safety issues to light in various system processes, proactive steps are to be taken to redesign process in consideration of safety.

There were some critics who argued that the patient safety standards were not effective enough, and would not bring about a fundamental change in institutions.  Then, in 2002 JCAHO formed an advisory group to establish National Patient Safety Goals.  The first National Patient Safety Goals (there were 6) were unveiled in July of 2002, with each accredited organization expected to fully implement by January 1, 2003.  In July 2003, the National Patient Safety Goals for 2004 were released, with the JCAHO simply adding a single goal to the previous year's goals, thus there are now a total of 7 goals.

So where is the Federal Government in all of this?  While some states have taken special measures to address the issue of medical errors, in particular the reporting of errors, the Feds have not been as aggressive in a regulatory sense.  

One development has been the "Validation Surveys"--Federal surveyors visit JCAHO accredited facilities to determine the validity of JCAHO's accreditation in terms of meeting the "Conditions of Participation."  If an organization meets JCAHO standards, they are typically not reviewed by HCFA/CMS, because JCAHO accreditation has recognized by the Federal Government as meeting the standards, and thus the term "deemed" status is used.  However, the validation surveys have evolved over the last few years due to public (See OIG Report, July 1991) and private concerns about the efficacy of JCAHO's survey process.

HCFA/CMS Conditions of Participation (CoP) for various health programs, in particular hospitals, have long been out of date and in need of revisions to "catch up with the times."

In March of 2003, CMS updated its antiquated "Quality Assurance" CoP (circa 1980's) to include a requirement for hospitals to have Performance Improvement Programs (JCAHO has required this since the early 1990's) and Patient Safety Programs.