Process Design for Patient Safety- 2.0
By: Ted Schmidt, R.Ph., CERM
January 8, 2020
In the past, I’ve written about the benefits of using the SIPOC diagram for process identification and process control. As a profession, we still struggle with the concept of process approach or process management and how to fully optimize it for our benefit. We too often revert back to our old practices of addressing issues (nonconformances) by revising our procedures and conducting training on the newly revised procedure. We should be smart enough not to keep doing the same things and expect different results.
Here’s a summary of the effects of our decades of addressing issues mostly by procedural changes and subsequent training:
- Medication errors occur in one-half (50%) of all surgeries
- One in three patients are harmed during a hospital stay and of this 33%, 7% either die or are permanently harmed
- John James, Ph.D., states, “the true number of premature deaths associated with preventable harm to patients was estimated at more than 400,000 per year”
- ECRI Institutes List of Top 10 patient safety concerns continue to be all process safety related.
Recently, the “To Err is Human” report celebrated a twenty (20) year anniversary. It was mostly without pomp and circumstance and rightfully so, as we haven’t really progressed in attacking the issues in 20 years! How does this continue to be acceptable in 2020? I realize that many smart people are working diligently to fix these issues. However, until we change how we look at our hospitals as a series of critical and complex processes and begin to manage these processes, we will never make any meaningful effect on these dire statistics. Our opinion is that the best part of ISO 9001 is that it’s all about process management!
Enter ISO 9001:2015, Clause 8.3 Design and development of products and services. It’s that last word “services” that gives us the hook. Design and development in ISO 9001:2008 only required products and “may also apply the requirements given in 7.3…of product realization processes”. The option for processes (aka services) disappears in 2015. This presents an opportunity to make a cultural shift in how we now address issues from a process perspective. This cultural shift must occur if we want to see meaningful change in patient safety and this shift must include better process management.
By taking the time to understand our critical processes, their sequence and interaction, we are more capable of improving our processes. The disciplines of Clause 8.3 (Design and development) now provide for us a structured method of redesigning these processes for sustainable solutions. While this is not rocket science, it is often perceived as such. In truly high-reliability organizations, there is robust attention to process management. As a result, the risk assessments begin with a full understanding of the process being assessed. That’s the first column in a FMEA! So, ask NASA or the National Nuclear Security Administration (NNSA- an adjacent organization to the US Dept. of Energy), you can’t manage the risk unless you manage the process. This means considering all relevant inputs to the process, even those that are indirectly effect the process (think calibration, supplier management, real competencies, etc.). The disciplines of the requirements for Design and Development in our accreditation can help us design better processes for higher reliability! After some bad advice early in this NIAHO journey, DNV GL is moving away from accepting the common “non-applicability” of design and development in our QMS. You may have been challenged by your surveyors recently to use Design and development in your QMS….good for them! Look for more of this in the future!
Case in point, while I was conducting training at a very respected hospital system during the height of the “Ebola Crisis”, every participant would leave intermittently to attend training on how to manage an Ebola patient should one present to their hospital. The individual responsible for creating and conducting the training was also in our class. When we began using the Ebola crisis as an example of managing processes, I was shocked when that individual bolted out of the class. We simply discussed all of the possible “inputs” to managing an Ebola patient by including the Valet Parking attendants as one possible input. That’s when he bolted. This respected hospital system had not considered that possible input of an Ebola patient. Didn't Deming say that if you put a good person in a bad process, the bad process always wins?
This new requirement for controlling the design and development of our processes could not have come at a better time for healthcare. Implementing this new requirement should not be taken lightly. The lives that it may save will help us begin to whittle away at those shocking statistics. Let’s make Deming’s saying passé in healthcare. Let’s only accept what our patients’ expect- good processes and safer outcomes….and not just as a result of an issue/nonconformance, we’ll talk more about prospective risk management through robust process management in future articles!
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 high-reliability organizations and 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 firstname.lastname@example.org. Follow BlueSynergy on LinkedIn and Twitter