Risk-Based Thinking in Healthcare

Recent articles in healthcare journals reveal a sad truth: hospitals are still not as safe as they should be.  One article states that one in three patients are harmed during a hospital stay and of this 33%, 7% either die or are permanently harmed.  There has been an emphasis on patient safety for over a decade now, yet we still have continual issues with medication management in our hospitals, wrong site surgery, surgical instruments left in patients, etc. This is not what we envisioned when we chose a career in healthcare.

Most healthcare providers are compassionate professionals who consider their career also as a vocation. We pledge to “First, do no harm”.  And, yet, it seems that after much effort with many smart people working diligently to reduce risk and make our hospitals safer, we still see adverse outcomes.

One would ask, how long can we continue to do the same things and expect different results?  The 2013 study by 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”.  This eclipses the Institute of Medicine (IOM) “To Err is Human” study that estimated that same number at 98,000.  That study alone caused a Herculean effort to create a culture of safety to be implemented in our hospitals.  And, yet, a study just 15 years later question the accuracy of the IOM study and states that we have four times the amount of premature deaths than previously thought. When a 2014 Leapfrog study states: “Hospitals struggle to implement NQF (National Quality Forum) endorsed safe practices”, one might wonder if we can really improve.

We have heard that our profession is “siloed”.  Hospitals around the country, governmental and non-governmental alike, all appear to suffer from this.  Individually, we do a great job in our own silo.  The negative issues manifest when our efforts or our final products do not meet the need of the person or service downstream.

To illustrate, when asking healthcare professionals their experience with Lean or Six Sigma, there is a positive response.  Many are willing to share their successes.  When asking these same professionals about the sustainability of these efforts, most go quiet.  In some cases, there were unintended consequences that actually caused disruption in another area.  Select individuals accomplish many of these successes.  When the focus changes, or these heroes retire, the success is not sustained.  A success was created by and dependent on heroics.  These heroes made a “people-dependent” process more efficient for a time or temporarily reduced the variation in a process.  This equates to unsustainable improvements.

To fix the broken processes, we need to make those processes repeatable, based on process design, not heroics.  Basic process management (understanding the processes and their sequence and interaction) will enable one to better control and sustain those processes, especially those that require a higher degree of consistency.  When controlling the processes, as a healthcare delivery system, one must include a risk consideration and work to improve consistency in those processes with the greatest risk.

This is a new perspective for some in healthcare.  We are familiar with risk and work hard to manage it, yet we still see adverse outcomes.  However, when hospitals create a risk management framework, a defined organizational structure to manage risks, there are better outcomes.  By creating a risk framework, integrated with our processes, we can produce a safer environment for our patients.  The need for heroics is diminished, since our processes are no longer “people- dependent”.

Unfortunately, these concepts are contrary to how many have operated in hospitals for too long.  By now, as a trusted profession, we should have sustainable processes that produce predictable results, while managing risks.

Consider an exercise in flow mapping or value stream mapping to gain a good understanding of how our activities work together.  A multidisciplinary team is imperative for meaningful results. Using a simple means to categorize our processes, such as clinical processes (treating the patients), support processes (such as Biomed, Dietary, Lab, etc.) and management processes (planning, providing resources, etc.), we can better understand their sequence and how they might interact with each other.  Incorporating a risk discussion in these mapping activities will identify where risks exist that should be managed.

There are a few basic risk tools to consider. The most elementary risk tool is a checklist.  We often use them for certain processes or activities. We also use Failure Modes and Effects Analysis (FMEAs). Others that might also prove beneficial are Heat Maps (Risk Maps) and Cause and Effect diagrams.  These simple tools will allow this multidisciplinary team to work through a risky process and create a sustainable change to the process that will manage the risk.

While it is not a difficult process, it is the discipline to make these changes that is difficult.  Many of our contemporaries may not be open to change, so that hurdle must be addressed early.

Can this actually help us reduce that 400,000 number that haunts us?  Certainly it can.  We have been told by several leading authorities (The Joint Commission, Center for Patient Safety, etc.) to benchmark the commercial aviation industry to develop processes with more of a preventive posture.  That will help us to a certain extent.  We have to open our minds to a fresh perspective in our profession.  As healthcare professionals, no one comes to work to fail our patients.  We have to move from the silos we have created and understand how our processes affect other processes, directly and indirectly.

The commercial aviation industry did not change overnight.  It was a major shift in their culture that moved them to a higher reliability.  Everyone in that industry understood.  First Officers no longer held back concerns from Captains and Captains welcomed the feedback.  Because of the high level of risk involved in the activity, they embraced the change.

The greatest gains made in the commercial aviation industry were their desire to work together, to break out of their silos and manage risks together.  They changed their culture and created a safer environment for their customer.

As W. Edwards Deming, the “Father of Quality” might say, if commercial aviation can do it, why can’t we?


00141Ted is a Pharmacist, a Certified Enterprise Risk Manager (CERM©), and a Senior Advisor with BlueSynergy Associates.  He advises and instructs hospitals in quality, risk and environmental management systems.  Ted led the largest ISO 9001 implementation in healthcare at the Veterans Administration.  He is a Senior Member of ASQ and a certified Lead Auditor in quality management systems by Exemplar Global.  He can be reached by email at tschmidt@bluesynergyassociates.com.

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