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A featured contribution from Leadership Perspectives: a curated forum reserved for leaders nominated by our subscribers and vetted by our MedTech Outlook Advisory Board.

Steve Tierney, Senior Medical Director


Have you ever been in a meeting where someone has said “we can’t do that; it needs to be evidence-based?” Having been in many meetings where the evidence card was used as the means to kill a new approach, I certainly have. However, there are several problems with this argument.
Basic improvement should have clear and measurable aims, but to have real value, the aims cannot simply be the addition of a new process because it is being done elsewhere. While it is easy to copy and paste another system’s process and add it to your current work, that in and of itself is not improvement. It is standardization. But let’s think about that for a moment.
If two players on a baseball team had different approaches to batting, and you standardized those approaches, they would perform closer to the same. But what if one had a batting average of .450 and the other .200? Getting each closer to .325 would improve one performance but degrade the other. Forcing one healthcare program to adopt standard practices will result in some worsening of existing performance.
In low volume, high acuity, or high-risk procedures like the pre-op or post-op for total knee replacement, that may be warranted. But in high volume, low acuity environments demanding the same questions, charting steps or charting workflow risks a regression to a mean. Today we have regulatory agencies that are requiring specific sentences or questions be added to the charting workflow, as if more charting would result in better healthcare clinical outcomes. There is no measurement of any clinical outcome, just the charting process, as if additional typing alone was sufficient.
“While it is easy to copy and paste another system’s process and add it to your current work, that in and of itself is not improvement. It is standardization”
This happens because there is too simplistic a view of improvement. Someone reads an article published some time ago about a site that added a new process. That new process for that site resulted in an improvement. Both are true, but was that a program batting .200 or .450? Because if your program is currently batting .450, simply adding what another program has done in the past in another context may not be an improvement for you. “But it’s evidence” someone (who read the article) says. Which is true. But does it add value for your site? That is not clear. This new process can be measured. That measurement can be graphed. You can “improve” the performance of that process. But is any of that actually meaningful improvement?
Another approach is to consider clinical activity in two categories: process vs. outcome. A process might be an annual encounter with a dietitian for those with diabetes. An outcome might be the measured A1C for each diabetic. If the outcome is the primary focus, then the batting stance of any one player is less relevant than the hitting percentage. The goal is the outcome. The process is more open to individual variation. Suddenly the dietitian encounter becomes less relevant in the context of a tightly controlled A1C.
Here is the healthcare industry’s current problem. We are obsessively focused on process. Enforcing process seems to be the primary approach of all regulatory agencies. Worse is charting process. If you realize that a clinical staff member can either chart or interact with someone being cared for, but they cannot do both, you also have to accept that all charting comes at the expense of personal interaction.
What has happened is the current regulatory environment has resulted in the enforced standardization of the charting process. We have taken all the .450 batters and pulled them down to a mean while shifting the focus of daily clinical activity away from interpersonal interaction and toward charting. We have “very healthy charts,” all with more standard processes. Does that result in a more satisfied staff and consumer base, and better clinical outcomes? The answer is overwhelmingly no.
Improving information management systems and accessing more outcome-based measurement for consumer bases could offer the way forward. But that is not the current focus of all regulatory enforcement activity. They would rather take the easy road of standardization and hope that it results in clinical improvements. But as costs continue to climb at the same rate of clinical staff burnout, we are on the wrong path and unless our industry realizes that the regulatory agencies are the problem and not the solution, we cannot reverse course.
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