Updated: Nov 3, 2020
I recently read a 2019 article from the NY Times about a tragedy that struck too close to home. The article was about the deaths of three premature infants in the neonatal intensive care unit at a hospital in PA. You can read the whole article here:
In root cause analysis we have a mantra: the level of rigor must be commensurate with the significance of the event. I can’t imagine a more significant event than the deaths of 3 infants under the care of a highly trained workforce with many protocols in place to protect those newborns. Yet flaws in the hospital's system of protocols resulted in this tragedy.
The hospital identified the root cause to be a bacteria that grows in water and was present in the equipment used to measure donor breast milk. The bacteria is a danger to premature babies with compromised immune systems.
From the perspective of a root cause subject matter expert (and not a healthcare expert), there are lines of inquiry that should be or should have been addressed. For example:
Why did the infections start in July (i.e. what were the protocols prior to July when there were no cases and what changed in those protocols or in the equipment)? A timeline should be developed to help capture the sequence of events so that they can be better analyzed.
Was the potential for this specific type of bacteria to be present in the equipment considered when setting up the protocols, and were those protocols effective enough to eliminate the bacteria? A detailed process map would be useful to analyze the protocols for disinfecting and using the breast milk measuring equipment, to identify exactly where the process failed.
If the protocols were adequate, were they followed by the staff? What aspects of the processes used to disinfect the equipment used to measure the milk for those premature babies fail, or were not performed correctly? If protocols were not followed correctly, did the investigation continue to determine why? Is there a potential systemic issue with following protocols to the letter at this hospital?
Are the protocols used to disinfect that measuring equipment specifically designed for the neonatal intensive care unit, or are they general protocols in place for other tools, materials or equipment used in other parts of the hospital? If so, are those protocols more relaxed than the ones needed for the neonatal unit?
If those protocols for disinfecting the measuring equipment are found to be flawed, are there other equipment or tools or materials that were disinfected using the same protocols, and could those equipment contain bacteria or other contaminants that could pose a risk? Have a sample of other equipment disinfected using the same protocols been tested for bacteria and other contaminants?
Were industry best practices used to develop the necessary level of understanding of the need for extra care when dealing with babies with compromised immune systems? If not, how were the protocols developed?
If the root cause that was offered by the hospital was the only root cause they identified, then the investigation stopped too soon; at the immediate cause of death. If indeed that is all they found for an investigation into a loss of life, it would call into question their level of proficiency in conducting root cause analysis and complex problem-solving. For a loss of life, investigations should receive the highest level of rigor.
From anecdotal data I suspect the investigative methods in the healthcare industry may not be as developed and as rigorous as the methods we have in the nuclear industry. The goal of many of our laws and regulations in these and other industries is the same: to protect human life. These regulations require that we identify the root causes of significant issues and take actions to prevent recurrence. To identify the deepest-seated root causes in complex and highly regulated environments requires skill and experience in solving complex, human-centric problems.
As an exercise, let's continue to explore this tragedy in PA. The bacteria in the equipment used to prepare the milk for those premature babies should be the starting point for further causal analysis. Here are some of the things we can do to investigate further.
We could establish a list of all defenses (i.e. protocols, processes, procedures and physical barriers) that are in place to prevent bacteria and other pathogens from reaching babies with compromised immune systems. Each of those defenses must be evaluated to determine which ones failed to perform as expected, which ones were weak, which ones were not implemented correctly due to human error or other factors, and if there are missing defenses that should be in place based on best industry practices.
We could search the hospital's incident database and conduct an an analysis to determine if there are any negative trends in performance at the facility (i.e. a common cause analysis), such as other incidents involving exposure of patients to bacteria.
We should be looking for more than one root cause. Highly regulated operating environments such as hospitals have many defenses in place to prevent tragedies such as this one. Because there are so many defenses in place to protect human life, we know that it takes a complex set of causes and significant contributing factors to create the perfect set of circumstances that get past all of the defenses. Translation: many things have to fail before an event as big as a fatality takes place.
Another mantra of root cause analysis is that the deepest-seated root causes are the points of origin for many incidents, not just the single event we are investigating. We should be looking for root causes that explain what is happening beyond just what happened to those babies. There are deeper root causes that will continue to cause incidents in the future and have likely caused other incidents in the past (but previous investigations never identified them). In the case of the loss of human life, we cannot stop until those deepest-seated causes and significant contributing factors are found and eliminated.
It is a tragedy to lose a human life, much less three infants. Just think of how we would feel if it happened to us. It would be adding insult to injury if the investigations into those deaths did not identify the deepest-seated causes, and other (seemingly unrelated) tragedies were to take place.