Tag Archives: solutions

Root Cause Analysis

Heatstroke Deaths of Football Players

By Kim Smiley

A study released in 2010 shed some light on what seems like a high number of football players dying of heat-related deaths.  The study determined that the number of heat-related deaths have actually increased in recent years from less than two per year in the early 90s to nearly 3 currently.  The study outlined some of the causes for the increase.  We can look at these causes in a thorough root cause analysis built as a Cause Map.

We begin with the outline, which captures the impact to the goals as well as the general information about the issue we are investigating.  In this case, we are looking at deaths of football players in the U.S.  The study determined that most deaths occur during football practice in August, in the morning, to linemen.  The impact to the goal of concern is risk of player death.

Beginning with the impacted goal, we can ask why questions to analyze the issue.  The player deaths occur from heatstroke that is not treated immediately, whether from players and/or coaches not recognizing the signs of heatstroke, or treatment being delayed while waiting for an ambulance or other medical professional.  Heatstroke occurs when a person’s heat generation is greater than their cooling ability.  This means there are two parts to the analysis: the heat generation, and the cooling ability.  In this case, increased heat generation occurs from high ambient heat and high levels of body heat being produced, caused by practicing outside in hot weather.

Insufficient cooling ability can occur when a player’s sweating isn’t doing enough to cool him – such as when a player isn’t producing sweat due to dehydration or when the sweat isn’t evaporating, such as in high humidity.  Additionally, players who are large (have a high BMI) tend to be more susceptible to heatstroke as their bodies tend to store more heat.  This is presumably why most deaths occur in linemen, who tend to be larger (79% of the players who died had a BMI above 30.)  Most deaths occur in August, which, in addition to being hot, tends to be the start of the season, meaning players are not accustomed to practicing in the heat.

What can players, coaches, school districts, and parents do to limit the risk of death from heatstroke?  First, ensure that everyone involved in a sporting program recognizes the signs of heat-related illness.  There is a CDC toolkit that provides important information.  Next, make sure that a player who has signs of heat-related illness is treated immediately – while waiting for the ambulance to arrive, take the player out of the sun and spray him with water.  To try and avoid heat-related illnesses, ease into practices at the beginning of the season, limit practice time in extremely high heat and/or humidity, and provide plenty of hydration.

To view the outline, Cause Map, and solutions, please click on “Download PDF” above.

Root Cause Analysis

Working to Ensure Safe Assembly of Surgical Tools

By ThinkReliability Staff

A 2-month old was undergoing a cystoscopy to incise a ureterocele in the bladder.  During the endoscopic procedure, a resectoscope was used to remove the unwanted tissue.  However, during the operation part of the resectoscope slipped off, exposing a hook-shaped internal piece of the instrument.  Fortunately the patient was not injured; however the potential for injury was very real.  How did the medical instrument come apart?

The first step in an incident investigation is to determine what the problem is and what the impacts to the organization’s goals are.  In this case, the problem is fairly straightforward – the resectoscope fell apart while inserted into a patient.  Although details are scant in this case, the problem statement is filled out as completely as possible to document what occurred.  The second part is to determine the impact to the organization’s goals.  An obvious impact is the potential harm to the patient, related to the hospital’s patient safety goal.  There was also the possibility of legal action, which would impact property goals.  Finally, there likely was the need to redo the procedure, taking additional time, thus impacting the organization’s labor goal.

The second step is to build a Cause Map by asking why an event occurred.   The Cause Map visually depicts what led to the young patient being exposed to harm.  In this case, the three goal impacts converge on the event where the hook electrode became uncovered.  It should be noted that multiple causes led to the patient being exposed to harm; if the resectoscope had been broken but had not been in use, then it would not have mattered.  It is crucial to include all reasons on the Cause Map because those reasons may be key to developing the optimal solution.

Facts that need to be captured about an investigation can be included in evidence boxes on the Cause Map.  They can provide the reader with important background information.  In this example, information about the hook electrode is included so that the reader knows what it is.

Reviewing the complete Cause Map, it turns out that the resectoscope was incorrectly assembled.  The third step in an incident investigation is to develop a set of solutions.  Remembering that all causes are necessary to produce an effect, the investigation team can brainstorm solutions to eliminate or counteract contributing causes.  In this case, three possible solutions were developed.  It is possible that the resectoscope could be designed differently so that the insulation would not be able to slip.  While this is a reasonable long term solution, it would not immediately remedy the problem.  Another solution would be to verify that the instrument is in working order before using on a patient.  This may have occurred, but it should be included until ruled out as a potential solution.  A final idea is to revise the assembly procedures for the resectoscope.  This is in fact what the FDA recommended.

The FDA recommends that the manufacturer’s assembly procedures always be carefully followed.  A process map is another helpful tool to determine where something went wrong.  The organization can build a process map depicting the ideal sequence of events, then compare that with what actually occurred.  The problem may not be in the instructions; the instructions might be perfect!  However, if someone doesn’t follow those instructions correctly, the process isn’t going to reach the desired outcome.

At this point, the investigation team might go back to the Cause Map to elaborate on the why the resectoscope was incorrectly assembled.  This might generate new solutions and changes to the ideal process map.  Through this iterative process, an optimum solution can be found.

This event was reported as part of the FDA’s MedWatch program.  The FDA encourages health professionals to voluntarily report problems on medical devices.  For more information on the MedWatch program, please visit their website.

Root Cause

Interpretation of Electronic Fetal Heart Rate Monitoring

By ThinkReliability Staff

Electronic fetal heart rate monitoring (EFM) is used to determine fetal distress.  When fetal distress is indicated, intervention and/or early delivery are generally performed.  Because of this, EFM is performed frequently, even in low risk births.  However, EFM has a high rate of false positives, resulting in unnecessary surgical intervention, which can impact both patient safety and an organization’s goals, especially as the rate of cesarean sections continue to increase.  One of the causes for these high rates of false positives is the variable and inconsistent interpretation of EFM data.  This is in itself an impact to the patient services goal.

This produces a highly simplified version of the Cause Map, but leads to a cause that has significant opportunity to provide improved results.  Specifically, the cause of “variable and inconsistent interpretation” suggests that guidance for more consistent interpretation may aid in reducing unnecessary surgical intervention due to false positives from EFM.

With guidance provided from the American Family Physician, we can create a process map to aid in the use of EFM.  A process map shows the steps and decision trees involved in a process, attempting to guide practitioners towards accepted best practices.

EFM is used continuously for high risk patients and intermittently for low risk patients  unless abnormalities occur.  There are three types of patterns produced by EFM: reassuring, non-reassuring, and ominous.  (Definitions for these patterns, as well as high risk patients are also from the American Family Physician).  Reassuring patterns generally are found to correlate with fetal health, and indicate that the delivery can continue.  Ominous patterns should lead to evaluation for immediate delivery.  Non-reassuring patterns are found between the two – and so lead to the most difficulty in interpretation.  Specific steps are outlined to be taken in the case of non-reassuring patterns which attempt to normalize the pattern.  Additionally, specific tests are recommended to attempt to determine the cause.  If the cause can be determined and corrected, continuous monitoring should accompany an attempt to continue the delivery.

If the pattern is not normalized, evaluation for immediate delivery should occur.  There is no decision tree at this stage  because the decision on whether (and how quickly) to perform delivery must be determined based on the patient’s specific state, based on the knowledge of the practitioner.  Although some steps remain subjective, attempting to fit those that are not into a process map can improve the odds for everyone.

Root Cause

Can Safety be Taken Too Far?

By Kim Smiley

Sometimes, what seems like a very simple, easy solution turns out to be much more complicated.  Unless a system is very well understood, implementing a solution can have unintended consequences.  Take for example, the changes made to playgrounds over the past couple of decades.  There was concern that children were being injured while playing, especially from falls from high playground equipment.  Removing any playground equipment that was deemed dangerous seemed like an obvious solution to this problem.

Gone are the metal merry-go-rounds and the ten feet tall monkey bars that many of us remember from our youth.  Modern playgrounds are populated by lower, enclosed platforms and soft ground coverings to prevent injuries and protect against lawsuits.

But are modern playgrounds better? According to a recent New York Times article , the answer isn’t the slam dunk you might expect.  There is mixed evidence about whether modern playgrounds actually reduce the number of injuries because children tend to take more risks on “safer” playgrounds.  There is also evidence that the value of playgrounds in childhood development might have been diminished by the increased focus on safety.

A recent paper by Norwegian scientists discusses the value of allowing children to face fears through “risky” play.  The concern is that children are developing more anxieties because they are losing the opportunity to face their fears by tackling challenging playground equipment. Part of the problem is also that safer playgrounds tend to be more boring which discourages children from playing at all.

There are a number of researchers asking whether the potential negative emotional impact of safer playgrounds outweigh the risk from physical injuries associated with taller, riskier playground equipment.  This is a hard question to answer because while it’s relatively easy to measure the number of bones broken on playgrounds, it’s very difficult to measure the intangible benefits of challenging playgrounds.

So can playgrounds be too safe?  It’s not clear that we have a definitive answer to that question, but what is clear is that the problem of playground safety is more complicated than originally assumed.  A Cause Map, a visual root cause analysis, can be built in cases like this to help clarify all known information.  Cause Maps are a very versatile format.  They can be created to incorporated any level of detail needed and can be added to as more information becomes available or as unexpected complications pop up.  To view a high level Cause Map of this problem, please click on “Download PDF” above.

Root Cause Analysis

A Controversial Approach to the Fight Against AIDS

By Kim Smiley

Not too long ago, the Downtown Eastside neighborhood in Vancouver, British Columbia had the fastest-growing AIDS epidemic in North America.  But that has is no longer true.  Vancouver has succeeded where many cities have failed and has recently seen a decrease in the rate of new AIDS infections.

How did Vancouver do it?  And can it be done elsewhere?

In order to understand how Vancouver has been successful in fighting the AIDS epidemic, we first need to understand why there were such high infection rates to begin with.  This problem can be approached by building a Cause Map, an intuitive visual root cause analysis method that lays out the Causes to a problem.  (Click on the “Download PDF button” to see a high level Cause Map of this example.)

A little research shows that one of the major contributors to this problem is that a significant percentage of the population in this area is engaged in high risk behavior.  The Downtown Eastside area has been called the center of the injection drug epidemic.  Along with rampant drug problems, this area is also home to a thriving sex trade.  Shared needles and unprotected sex significantly contributed to the fast growing rate of new infections in the area.

As many cities have found out, it is difficult to change behavior.  Drug addicts are typically one of the hardest to reach populations.

Vancouver’s approach has been to create a “safe injection site”, called Insite.  At Insite, addicts can inject drugs they bought on the street under the supervisor of nurses.  They are provided clean needles and a safe location.  To make this work, Insite currently has a special exemption from narcotics laws.

Insite also tests for HIV and provides aggressive treatment for those infected.  Aggressive treatment seems to be one of the main factors that has slowed the infection rate in Vancouver.  Antiretroviral medications lower the amount of virus in the blood, which in turn makes a person 90 percent less infective.

Research has shown that the rate at which the AIDS virus is transmitted can be lowered by treating infected people even if they still engage in high risk behavior.

Unfortunately, treatment can be expensive.  One of the reasons that aggressive treatment works in Canada is that the government provides free healthcare.  In the US, the fastest growing epidemics are typically in low income areas where health insurance is limited.

The antiretroviral medication can also have some unpleasant side effects so many doctors don’t prescribe it until there are signs that their patient’s immune system is compromised.

Vancouver’s approach is also obviously controversial.  Using government funds to provide a place for individuals to inject illegal drugs is going to raise a lot of questions.  Insite was created under a more liberal government and the issue is due to be reviewed by the Canadian supreme court this year.