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

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380 M. Apkon<br />

Although it is tempt<strong>in</strong>g to def<strong>in</strong>e countermeasures effective aga<strong>in</strong>st each of these<br />

contributors, the team recognized that different failures occurred with different likelihoods.<br />

Moreover some failures are potentially detectable as <strong>in</strong> calculation errors<br />

that are found on double-check whereas other failures are undetectable as <strong>in</strong> plac<strong>in</strong>g<br />

an <strong>in</strong>correct mass of medication <strong>in</strong>to the diluent solution. It was also important to<br />

recognize that the two failure modes were not equivalent <strong>in</strong> severity: it was thought<br />

to be more dangerous to <strong>in</strong>fuse the medication at the wrong dose compared to the<br />

correct dose at too high a fluid adm<strong>in</strong>istration rate.<br />

Recogniz<strong>in</strong>g that a redesigned <strong>in</strong>fusion process would need to be compared<br />

aga<strong>in</strong>st the exist<strong>in</strong>g process, the team conducted a FMEA to characterize the<br />

risk<strong>in</strong>ess of the orig<strong>in</strong>al and improved <strong>in</strong>fusion processes. The FMEA takes <strong>in</strong>to<br />

account differences <strong>in</strong> likelihood of failure, ease of detection, and the severity of the<br />

consequences of failure. The FMEA identified three risky elements of the orig<strong>in</strong>al<br />

<strong>in</strong>fusion process: calculat<strong>in</strong>g the required formulation; prepar<strong>in</strong>g the formulation<br />

by comb<strong>in</strong><strong>in</strong>g drug and diluent; and programm<strong>in</strong>g the <strong>in</strong>fusion pump, particularly<br />

at the time of dose changes. It is important to note that although mistakes <strong>in</strong> prepar<strong>in</strong>g<br />

the <strong>in</strong>fusion solution are likely less common than calculation errors, preparation<br />

errors are considered riskier <strong>in</strong> this analysis because they are not detectable after they<br />

are committed whereas calculation errors can be detected by double-check<strong>in</strong>g.<br />

A number of improvements were identified to reduce the risk of these processes.<br />

It is useful to consider these improvements <strong>in</strong> the framework of the error-proof<strong>in</strong>g<br />

strategies described above. The task of formulation was elim<strong>in</strong>ated entirely for<br />

some <strong>in</strong>fusions by purchas<strong>in</strong>g premanufactured solutions. This required a change<br />

from formulations be<strong>in</strong>g def<strong>in</strong>ed at the po<strong>in</strong>t of care to be<strong>in</strong>g standardized with<br />

fixed concentrations of medications. Formulations were also elim<strong>in</strong>ated by <strong>in</strong>creas<strong>in</strong>g<br />

the “hang-time” of the solutions thereby reduc<strong>in</strong>g the number of solutions<br />

formulated over a course of therapy.<br />

The functions of “action” required to formulate solution <strong>in</strong> the more error-prone<br />

environment of the bedside was replaced by formulation <strong>in</strong> a central pharmacy by<br />

dedicated staff specifically tra<strong>in</strong>ed to the task. The functions of judgment as to the<br />

correct rates of fluid adm<strong>in</strong>istration were replaced as part of standardiz<strong>in</strong>g concentrations<br />

because the standards were designed to allow appropriate fluid adm<strong>in</strong>istration<br />

rates. The functions of “action” required to calculate the solution formulations<br />

were enhanced by a set of readily accessible <strong>in</strong>ternet-based calculators which drew<br />

from the standard concentration library.<br />

Detection of errors was also enhanced by hav<strong>in</strong>g the calculators pr<strong>in</strong>t out a<br />

spreadsheet <strong>in</strong>tended to be placed at the bedside which presented a set of dose/<br />

<strong>in</strong>fusion-rate comb<strong>in</strong>ations. This is <strong>in</strong>tended <strong>in</strong> part to enhance the ability to<br />

identify errors <strong>in</strong> pump programm<strong>in</strong>g. In addition, standardization itself makes<br />

detection of anomalous prescriptions easier.<br />

Together, these improvements reduced the risk<strong>in</strong>ess of the <strong>in</strong>fusion delivery<br />

process considerably. The ability to prospectively model the impact of these<br />

improvements was helpful <strong>in</strong> communicat<strong>in</strong>g the need for radical changes <strong>in</strong> practice<br />

<strong>in</strong>clud<strong>in</strong>g the need to standardize and give up <strong>in</strong>dividual autonomy <strong>in</strong> decid<strong>in</strong>g<br />

how to formulate <strong>in</strong>fusions.

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