Adverse event reporting.pdf

Medical record review
Medical record review has historically been the major method for oversight of quality.
While labour intensive, record review often provides the reviewer with the story
and context in which to understand events. In addition, medical record review
allows for evaluation of processes as well as outcomes, and can yield information
about whether important processes occurred, such as communication, documentation,
use of a checklist, or administration of an evidence-based therapy.
Record reviews may be explicit, in which the reviewer searches for specific types
of data that define events (such as “failure to rescue”) or implicit, in which a clinical
expert makes a judgment as to whether an adverse event and/or error has occurred
(such as failure to follow up a positive laboratory test). Record reviews have been the
cornerstone of the major population-based studies that defined the extent of medical
injury (2-6). They are also widely used to monitor progress in preventing adverse
events when new safe practices are implemented.
The major limitations of record review are its cost, and variability of content.
Aside from laboratory reports and orders, much of the content is determined by the
subjective judgments of those who write notes. While serious adverse events are
almost always mentioned, errors and underlying conditions almost never are. “Near
misses” are rarely noted. Thus, records can be valuable for case finding, but provide
only limited contextual information.
Focused review
Medical record reviews that focus on a specific type of event can identify critical
points of care that represent widespread vulnerabilities. Focused reviews of adverse
drug events, for example, might show that ordering medications for patients with
renal impairment, managing anticoagulation, and tracking allergies are areas that
warrant widespread, systematic improvements. A focused record review might
reveal not only the incidence of wrong-site surgery, but also whether a site checklist
was executed and a time-out took place during each operation. Other focused
analyses might include identifying high complexity processes.
Failure modes and effects analysis
Adverse events can be viewed as the outcomes of vulnerable systems. In addition
to acquiring information about the outcomes, or events, it is very helpful to learn
about the vulnerabilities in the system and about possible solutions to buffer and
strengthen the systems of care.
Failure modes and effects analysis (FMEA) is a widely used tool for proactively
identifying process vulnerabilities. It begins by systematically identifying each step
in the process and then searches out “failure modes”, that is, noticing what could go
wrong. The next step is to evaluate how the failure mode could occur, and what are
the “effects” of this failure. If a failure mode could result in catastrophic effects, the