Pediatric Informatics: Computer Applications in Child Health (Health ...

374 M. Apkon
of failures experienced, the consequences of those failures, and the likelihoods of
specific failure types occurring. 8–10 FMEA considers risk to be a consequence of not
only the likelihood of failure occurring, but also the severity of the consequence of
failure and the ease with which failures are detected prior to the consequences
occurring. Failures that occur more frequently, cause more significant harm, or
which can not be detected before harm occurs are considered higher risk than other
failure types.
FMEA is a multistep process described in List 29.2.
List 29.2 Failure mode and effects analysis
Characterize the elements or steps of the process
Identify modes of failures
For each process element, score each of the following (10 point scales are
common)
� Severity (S) of failure, if not detected prior to causing harm
� Likelihood of occurrence (O) for each failure
� Likelihood that failures will escape detection (D) before causing harm
For each calculate a risk-priority-number (RPN) to assess riskiness
�
RPN = S × O × D
Prioritize countermeasures to improve those process elements with the highest
RPN
FMEA is generally conducted by a multidisciplinary team so that a range of
perspectives are applied to the analysis. FMEA begins by identifying the steps in a
process and then identifying all of the ways that each component of a process might
fail. For each failure mode, the consequences of failure are identified and then the
severity, likelihood of occurrence for each failure, and the likelihood of detection
in time for corrective action are evaluated. Typically, the severity, likelihood, and
detectability are characterized according to a 5 or 10 point scale. Data to characterize
the severity and likelihoods of occurrence and detection may come from direct
measurement, the literature, or expert opinion. The results of root cause analyses
provide important information that helps characterize each of these parameters.
FMEA has been applied to a diverse set of healthcare processes such as
medication administration, 8,11–13 blood product administration, 14 case management, 15
diagnostic testing, 16 as well as medical device use and maintenance. 17–19 FMEA is
also applied in planning new processes where it can be used to forecast risk so that
safer processes can be selected at the time of design. For example, one hospital
applied FMEA to the process for electronic ordering of chemotherapy in advance of
moving from handwritten orders. 20 This led to specific decisions about the implementation
of ordering and documentation systems that were believed to create a
safer system. Similarly, another hospital used FMEA to plan the introduction of
“smart” IV pumps that incorporated dose-error prevention software. 21 This process
led to a better ability to anticipate and plan for failures as well as to design care
processes that minimized risk.