Engineering Health Information Systems

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How to Define Safety?

with 2 comments

In follow up to Jens’ post on Safety mandates in Canada, I agree that this is an important aspect that needs to be considered.

But how should we consider safety?

At a high-level, “Do no harm” resonates with many providers. We would need to be more precise in our definition of the domains of safety, so we can measure what is safe / unsafe. The US requirements on Meaningful Use does mention safety, but it appears to assume that safety is improved through use of systems (e.g. CPOE).

But with health information systems, how do we evaluate safety and harm? There are many aspects and we are only just beginning to turn a critical eye to some of the unintended consequences. Implementing systems does not equate to improved safety, de facto. We are seeing new kinds of errors that are happening and the heatlhcare systems are changed due to the introduction of technology. Even as academia is beginning to explore this, realizing that each system and even each installation is likely unique in its context, decision makers are not aware of these important distinctions. For many, adoption equates to an improvement in safety. So how do we go about defining aspects of safety in a manner that is measurable and digestible?

We can define it from an outcome (or potential outcome) perspective and measure quantitatively how many errors we have. Areas such as adverse drug events, unnecessary surgeries, mortality, excess hospital stays, etc. can be used. These are important. How to attribute them to the information system is another question as these are interventions into a complex space.

Looking upstream a bit, we can look at the system function and design. Usability testing and analysis is helpful here. While the errors can be more attributed to the information system, it is harder to predict the actual impact of design errors on patients. It is also harder for decision makers to wrap their head around some usability results, as they can be very detailed and not concrete in their outcomes.

Although I have moved a bit off topic, I think safety is something that needs to be considered, but how can we get safety design on the table?

Written by priceless

July 3rd, 2010 at 7:15 am

Posted in Quality,Safety

2 Responses to 'How to Define Safety?'

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  1. Morgan, you are making some excellent points here. It is indeed difficult to define a measure for the safety of eHealth systems, e.g., CPOE software. Perhaps we can learn from some areas, where the notion of safety seems to be better understood. How about the safety of medical drugs? The safety of drugs seems to be established in pre-market research as well as in post-market monitoring. The pharmaceutical company needs to provide evidence of drug safety to get the drug on the market (analogous to software test documents…?) and the FDA/Health Canada monitors the use of drugs for possible adverse effects even after the drug is on the market (analogous to reporting on software-caused adverse effects?). So, how do decision makers determine whether a drug is (remains) safe? Can we use a similar approach to software/systems? Whatever the answer will be, one prerequisite would be to get to the actual data on unsafe events caused by software. Right now, reporting on these events is voluntary for software (but mandatory for drugs?). This looks like a starting point for making improvements.


    5 Jul 10 at 12:41 pm

  2. Hello Jens

    I think looking at medication review is a useful activity, although it, too, poses many challenges. Was it REALLY due to the drug, or something else? Who do I report it to? Do I have the time? Where’s the unique form I need / what WAS my password??

    With drugs, we are also realizing that what happens in a drug trial (with select patients on a controlled regime) is actually not the same as what can happen in regular practice. The effects can be quite different (different populations, changes in comorbid conditions, etc etc).

    Software systems, especially those that are configurable, add at least one more wrinkle. What if I change the problem list term set? Have a improved safety in my office by having more specific (but uncoded) problems or made it worse by losing the ability to accurately report on my patient panels? At least medications stay (essentially) the same.

    This is a tricky one for me, but very important.

    — Morgan


    5 Jul 10 at 7:37 pm

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