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Comparing Adverse Events Definitions

Adverse event reporting programs provide definitions for each of the reported adverse events. Experience has demonstrated that most of these definitions are imprecise with lots of interpretive ‘wiggle room’ that often results in definition ambiguity from multiple perspectives, most importantly from the perspective of the reporting institution. Definitions ambiguity varies by state.

The NQF and JCAHO have provide definitions of reportable events, the NQF providing a list of 27 Serious Reportable Events in Health Care and JCAHO providing Reviewable Sentinel Events, plus other lists of sentinel events on its website.

Some States' definitions preceded NQF and JCAHO definitions. In varying degrees, States with adverse events reporting programs have adopted definitions from NQF, JCAHO, or home-grown sources with the end result that no two states have the same definitions for adverse events and very few States report similar events. Even States with adverse event definitions patterned after NQF and/or JCAHO definitions include significant changes from those definitions.

States with Adverse Event DefinitionsAn Adverse event Definition Database includes over 650 definitions from the NQF, JCAHO, and 30 states that provide definitions for their voluntary and mandatory reporting programs. Included within this adverse event database are outcomes reporting program definitions used in two States. 10 of Ohio's 11 reportable measures are outcomes, so that Ohio does not have a true adverse event reporting program. North Carolina's voluntary medication-related error reporting in nursing homes is also an outcomes reporting program. Kansas and Nebraska report only physicians in association with adverse events and more-properly might be termed "physician-reporting programs."

The definitions have been aggregated into similar topic categories for comparison, and each aggregate group is broken down into groups of similar versions of the adverse event definition. For some definitions, only one or two definition versions may exist, whereas other adverse events may have as many different definition versions as there are contributing states and organizations. Some of the differences are subtle and some are profound. Users are encouraged to peruse definitions to understand the significance of these differences.

Links to the statutes, administrative rules, and/or definition guidelines are provided in the definitions database.



Figure 1.
Number of Specified Reportable Events
– 30 States, JCAHO, and NQF –

STATE DEFINITION ORIGINS NUMBER LISTED EVENTS
ICD-9 Occurence Codes
54
ICD-9 Occurence Codes
48
NQF (modified) + Unique
34
NQF (modified) + Unique
34
NQF + Unique
33
Unique
33
JCAHO + Unique
30
NQF (modified) + JCAHO
30
NQF
27
NQF
27
NQF
27
NQF
27
NQF (modified)
27
Unique
26
JCAHO + Unique
23
JCAHO + Unique
21
JCAHO
19
Quantros, Inc.
18
Unique
17
Unique
14
JCAHO + Unique
14
JCAHO + Unique
13
JCAHO + Unique
12
JCAHO + Unique
11
Ohio***
Unique (10 outcomes)
11
JCAHO, (?NQF in 2007)
10
Unique
10
Unique
7
Unique
5
Unique
3
Unique
1
Unique
1
Unique
0
 
 
*   JCAHO definitions based on JCAHO's ‘voluntary reportable sentinel events’ and other examples of sentinel events published on JCAHO's website. These definitions do not include the myriad of sentinel events defined via JCAHO's policy that requires organization-specific sentinel events.
 
**   West Virginia's definitions are based on the listing of Occurrence Type Categories provided by Quantros, Inc.. The Quantros, Inc. Occurrence Report Management System includes 18 major categories of Occurrence Types, each of which contains one or more reportable adverse event. The Quantros, Inc. system does not provide definitions for these events or the criteria for event reporting.
 
***   Ohio and North Carolina have outcomes reporting programs. Ohio's 11 events are included in this list, but only 1 is an adverse event and 10 of the 11 are outcome measures that are required for 6 types of health care facilities. North Carolina reports aggregate outcomes for medication-related errors in nursing homes. Therefore, while Ohio and North Carolina report patient safety measures, they do not have true adverse event reporting programs.
 
****   Maryland has released partially analyzed aggregate data for Level 1 Adverse Events only [PDF]. As defined by statute, each hospital is required to "list and describe examples of adverse events that shall be reported," thereby developing a unique hospital-specific list of Level 1 adverse events [COMAR 10.07.04B(2)]. As such there is no definition consistency across hospitals in the state, a situation reminiscent of JCAHO's methodology of requiring organization-specific definitions of sentinel events.
 
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