Process metabolism is a concocted term to describe and hopefully understand how our processes work in their environment. It’s a concept that we need to begin to embrace if we want to improve our patient safety. Embracing and understanding process metabolism in our high-risk processes will allow for better process design and therefore yield more reliable results.

I would venture to say that most all of our recurring patient safety issues are a result of poorly designed processes. Updating policies and re-training users have not proven effective or sustainable.

Reviewing just the last three years of the Top Ten Sentinel Events as reported to The Joint Commission, I realized that about 80% of this unfortunate Top 10 list repeats the following year. “Unintentional retention of a foreign body” was number one in 2014 and 2015. My quick analysis, though unscientific, reveals that our reaction plans are for these sentinel events are not working. These are reported sentinel events to TJC, therefore “near misses” are not included in this data. Bottom line- our current process to fix these issues is not working.

Process metabolism involves gaining a deeper understanding of all the influences on our process. Let me explain with a new drug development example:

First, only one in 10,000 drugs in development ever make it to market. That’s because of the exhaustive (but not perfect) disciplines to ensure the drug is both safe and effective. Here’s a short list of the considerations just from a drug interaction perspective in the development of a new drug. This includes, other drugs, foods, nutraceuticals, therapeutic protein, disease, etc. Each of these considerations is a science in itself containing many layers.

Process metabolism looks like this. Processes consist of three main parts: the input, the activity (process) and the output. The objective is to fully understand the input. We do not want the input to adversely affect the ability of the activity to produce the intended output. Process metabolism includes an exhaustive discipline that includes ensuring the integrity of the input. In the process, include the materials used, the competency and certifications of persons in the process, the methods used in the process and the parameters and measures for process performance.

As in new drug development, each of these considerations in process metabolism may have many layers. For instance, consider the competency and certifications of those in the process and those working indirectly in the process. Environmental Services (EVS) affects surgery, yet they do not perform surgery. Purchasing Department affects the products used by EVS, yet Purchasing does not perform terminal cleaning;   Staff Education/Training affects how EVS uses these new products; and Risk may dictate when education is needed for significant process/policy changes. The assessment that Risk uses to determine when education is needed….you get the picture, many layers. These vertical interactions are often overlooked or minimized during the process design phase.

When we overlook or minimize process metabolism in new drug development, we get Thalidomide, Dantron, Zelnorm, Vioxx… The process is not perfect, but it is improving.

The magnitude of risk in drug development is enormous. Likewise, there are huge risks in our hospitals. At a minimum, the processes involved here should be very well designed through a disciplined process. Understanding our process metabolism will help reduce our sentinel events and create a safer environment for our patients.

Bio:

Ted Schmidt is a Pharmacist, a Certified Enterprise Risk Manager (CERM©), and a Senior Advisor with BlueSynergy Associates, LLC. BlueSynergy Associates maximize innovation, experience and customer perspective to reduce risk and make hospitals a safer environment. He currently advises and instructs hospitals in quality, risk, safety and environmental management systems. Ted led the largest ISO 9001 implementation in healthcare at the Veterans Administration. He is a Senior Member of the American Society for Quality and a certified Lead Auditor in quality management systems by Exemplar Global. He can be reached by email at tschmidt@bluesynergyassociates.com. Follow BlueSynergy on LinkedIn and Twitter