Category Archives: Root Cause

Root Cause, Root Cause Analysis

A Blood Test for Depression?

By Kim Smiley

A new study has determined that it may be possible to develop a blood test to diagnose depression in teens.  Finding better ways to treat depressed teens is important because untreated depressed teens are at higher risk for substance abuse, social difficulties, physical illness and suicide. Teens are particularly at risk from depression because this is an age when depression frequently hits and teens can be difficult to properly diagnose and treat.

Currently, the process to diagnose depression is subjective and relies on a patient’s ability to identify and describe symptoms, something that is typically more difficult for teens.  Depressed teens are even more likely to struggle with steps needed to receive treatment for depressions.  Teens are also typically more worried about others opinions than adults and the fear of judgment from their peers may prevent depressed teens from seeking treatment.

An objective blood test would help simplify the process of diagnosing teens with depression and should help more depressed teens receive appropriate treatment.  A straight forward test, like a test for blood sugar or for cholesterol, should also help remove any remaining social stigma of depression treatment so hopefully more affected individuals would seek treatment.

In this study, experimental blood tests were done looking for genetic markers that had been identified in earlier studies using rats.  Eleven genetic markers were found that were tied to depression. The researchers were also able to identify which participants had major depression and which suffered from major depression with anxiety.  The hope is that a blood test could eventually be used not only to diagnosis depression, but also to differentiate between subtypes of depression, information that would certainly be useful when determining the best course of treatment for patients.

Significantly more work is needed to develop an effective blood test, but this early study hints that it could be possible to create an objective test for depression.  This study used a limited number of subjects, 28 teens between 15 and 19 years old, so larger studies will be needed in the future.

This issue can be analyzed by building a Cause Map, a visual root cause analysis.  To view the Cause Map, click on “Download PDF” above.

Root Cause

Airman Loses Both Legs After Gallbladder Surgery

By ThinkReliability Staff

A former member of the US Air Force lost both legs after a routine gallbladder surgery and was medically retired.  During the surgery, his aorta was lacerated.  Subsequent delays meant his legs were without blood flow for hours.

After the damage to the aortic laceration was repaired, still more time passed before the patient was transferred to a civilian hospital for treatment.  The Air Force Medical Center did not have a vascular surgeon on-site.  By the time the legs were removed, the patient had lost more than 2/3 of his blood volume.

Multiple issues contributed to the injuries received by the airman.  We can examine these issues in a visual root cause analysis presented as a Cause Map.  First we determine the impacts to the goals.  The patient safety goal was impacted due to the potential for patient death during the surgery and aftermath.  Although there was no disciplinary action taken by the Air Force, a $54.8 million lawsuit has been filed that claims negligence.  Last but certainly not least, the loss of both of the patient’s legs can be considered an impact to the patient services goal.

We begin with the impacted goals and ask “Why” questions to determine the cause-and-effect relationships that led to the impacted goals.  In this case, the patient’s legs had to be removed after they were without blood flow for several hours.  The blood loss was caused by a laceration to the aorta, made during the gallbladder surgery, and the subsequent accidental suturing of the aorta during the repair.  The repair to the aorta was delayed as it was not immediately recognized.  A surgical resident was performing the operation, and it is likely inexperience and lack of supervisor from the supervising surgeon contributed to this delay.  Additionally, although the operating room staff was unable to get a blood pressure reading from the patient, it was assumed that the machine was malfunctioning. After the aorta repair, there was further delay in recognizing and treating the loss of blood flow to the legs.  As there was no vascular surgeon on-site, the patient was eventually transferred to a civilian facility, where both legs were amputated.

The facility has not commented on the case and so it is unclear what actions might be taken to protect patients.  There have been several charges of negligence at the facility in recent years.

To view the Outline and Cause Map, please click “Download PDF” above.  Or click here to read more.

Root Cause

Five Receive HIV Postive Organs

By Kim Smiley

Waiting on a transplant list must be a nerve racking, intensely stressful time.  But what if the problems only get more complicated once the long awaited organ is transplanted?  In a terrible case of miscommunication, two respected hospitals in Taiwan recently performed five transplants using organs from a HIV positive donor.

How did this happen?

A Cause Map, an intuitive form of root cause analysis, can be used to analyze this incident.  As is typically the case, this is an example of multiple errors combining to cause a major issue.  The proper tests were performed.  The lab results showed that the donor was HIV positive, but the test results were never known by the right people.  The initial results were given over the phone and misheard.  One cause of this confusion is that similar words are used for negative and positive tests.  The English word “reactive” is used for a positive HIV test and “non-reactive” is used for a negative test result so a single syllable made all the difference.  But this mistake alone was not the sole cause of the HIV positive organs being transplanted.

Standard procedure requires that surgeons take a time out prior to surgery and verify all information, including important lab test results.  If the final checks were performed as specified, the surgical team would have seen the positive HIV results.  Additionally, the transplants were performed at two separate hospitals so final checks were truncated at two different locations.

The most poignant element of this example may be the fact that the correct information was known prior to the surgeries.  If the test results had been effectively communicated, the HIV positive organs would never have been transplanted.  This example has several lessons learned that can be applied across industries.  This issue highlights the importance of following procedures, even if they seem redundant, and using checklists, even if they seem unnecessary.  The importance of effective communication is also evident.  When using verbal communication, little steps like repeating back information to verify understanding and using words that sound distinctively different from each other can help eliminate errors.

The investigation of this case is still ongoing and the hospitals are working to make necessary changes to ensure an incident of this type never happens again.  The five patients who received the organs are being treated with antiviral HIV medications, but doctors state it is very likely that they will contract HIV as a result of their organ transplants.

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

Diagnosing Hearing Loss in Babies

By ThinkReliability Staff

All new parents wait to hear that first wail in the delivery room, followed by a quick counting of fingers and toes.  Satisfied with their healthy new baby and exhausted from delivery, few notice the battery of tests newborns face in their first few days of life.  Thanks to these tests, many serious problems can be detected and treated before they become life-threatening.

Many states now mandate hearing screening at birth.  Even minor hearing loss, if not caught early, can seriously impede language and social development.  Nearly 2% of babies fail their initial screening, prompting more through testing.  Approximately 0.2% of children born in the U.S. will be diagnosed with hearing loss.  While most children with hearing loss have conductive (outer or middle ear) or sensorineural (inner ear) hearing loss, there is another type of hearing loss.  With auditory neuropathy (AN) spectrum disorder, sound enters the ear normally; but because of damage to the inner ear or hearing nerve, the brain isn’t able to understand the signal.  The sound is similar to what you might hear underwater or on radio with a lot of static.

Little is known about AN, including what causes it and how to treat it.  Hearing aids seem to help in about half of AN cases, although sometimes children and adults grow out of it.  And some patients thrive with cochlear implants.  Until recently, most weren’t certain how many even suffered from the condition.  A recent study shows that this condition may affect up to 15% of children with born hearing loss.

With all the confusion surrounding AN, few pediatricians and audiologists are aware of this condition or what treatment options are available.  Often the first course of treatment is a hearing aid.  Unfortunately this treatment, which amplifies sound entering the ear canal, can be exactly the wrong treatment for some types of AN.  For those with damage to the hearing nerve, blasting noise into the ear canal simply damages the external, working portions of the ear.  Infants have very sensitive hearing, and just a week of continuous hearing aid use can be enough to cause permanent damage.  Unwitting parents, worried about their children and eager to follow the doctor’s orders, may not realize their children are capable of “hearing”, albeit distortedly, until it’s too late.

A Cause Map can help sort out the factors contributing to this problem.  The top of the Cause Map shows the desired outcome.  Mandatory or recommended screening in infancy results in earlier diagnoses of hearing loss, which limits developmental delays further down the road.  However the bottom portion of the Cause Map shows how current screening practices can often lead to misdiagnosis and the wrong treatment.  By focusing on this area of the Cause Map, solutions can be identified to eliminate the unintended effect.

Two such potential solutions have been identified.  First, changes to the screening process might identify AN early on.  Considering that up to 15% of hearing loss may be caused by AN, this may be a more feasible solution than previously thought.  Second, an awareness campaign may help doctors and audiologists become more aware of AN and how to properly treat it.

With more research and greater awareness, there is hope that those with auditory neuropathy spectrum disorder will not accidently suffer more.  For more information on AN, please visit the National Institute on Deafness and Other Communications Disorders website.

Root Cause

Patient Death from Complications of Liposuction

By ThinkReliability Staff

On July 18, 2008, a young mother of two went in for a routine tummy tuck (abdominoplasty).  Although liposuction was frequently performed along with the surgery, the patient had declined the liposuction option.  Although there were some complications related to low oxygen during the procedure, the patient was released to her husband that evening.  She was sick the remainder of the evening but assumed it was reaction from the anesthesia.  The next morning she woke with a severe headache that worsened until she asked her husband to call an ambulance.  The paramedic consulted with the attending physician and gave the patient morphine for her pain. The patient then went into convulsions and stopped breathing.  The patient was put into a chemically reduced coma to relieve swelling on her brain.  She never recovered and was taken off life support on July 31, 2008.

The medical examiner determined that it was likely that a fat embolism, a rare complication of liposuction, had prevented blood flow to her brain, causing her death. Because the patient had declined liposuction, it’s unclear how she ended up having the procedure.  It appears that the patient may not have known that she had liposuction, and hence, was not aware of the potential complications including fat embolisms, from liposuction.  The nurse who presented the surgical consent form to the patient said she hadn’t brought up liposuction because it was “implied” as part of a tummy tuck.

It is unclear if the outcome would have been different had the patient received treatment more quickly.  The patient was released to her husband the day of the surgery, as it was considered an outpatient procedure, even though there were complications related to low oxygen.  She was not taken to the emergency room until more than 24 hours after the surgery, possibly because of her and her husband’s insufficient understanding of the risks of liposuction.

The public inquiry into improvements to the healthcare system that might reduce the risks of similar incidents occurring (though the risks for fat embolisms causing brain blood flow blockage are very low) ended last week.  When the results of the public inquiry are released, our initial Cause Map can be updated and the potential action items resulting can be added.

Root Cause

Developing a Meningitis Vaccine Program to Prevent Epidemics in Africa

By ThinkReliability Staff

Meningitis epidemics occur on a regular basis in Africa. Last year, there were more than 88,000 reported cases.  In 1996-1997, during the largest reported epidemic, more than 250,000 cases were reported.  Meningitis is highly contagious and approximately one in ten cases are fatal.  Disability occurs in approximately one in five cases.

The vaccine that was previously available in Africa was a polysaccharide vaccine, which did not prevent transmission of the disease. Understanding that the current situation was dire, the Meningitis Vaccine Project was formed.  With funding from various donors including The Gates Foundation and money raised in Africa, a vaccine that protects against the group A meningitis strain – responsible for more than eight out of ten infections in Africa – has been developed at a cost of less than $.50 (US) a dose.  More funding is still needed to meet the goal of vaccinating 300 million people across 25 nations.    However, the steps that have already been made are remarkable and represent a huge step forward in helping fight this dreadful disease.

Click on “Download PDF” to see the outline and Cause Map of the 1996-1997 meningitis epidemic and the timeline of the progress of the Meningitis Vaccine Project.  To learn more, see the Meningitis Vaccine Project.

Root Cause

Using Root Cause Analysis to Achieve Organizational Goals

By Kim Smiley

The Commonwealth Fund’s healthcare improvement website (www.whynotthebest.org) provides case studies of medical facilities that have been improving various performance measures.   One of these cases involves Holland Hospital, in Michigan, which has improved its pneumonia process-of-care over the last five years and is now in the top three percent of hospitals in the U.S. for these core measures.

The process for establishing goals and implementing process improvements to meet those goals is the same process that is used for Cause Mapping.  I’d like to highlight some of the tips from Holland Hospital’s success.  (You can read the whole case study at http://www.whynotthebest.org/contents/view/61.)

Establish a team to develop and work towards goals:  The hospital’s “core measures leadership team” contains physicians, clinical directors and other leaders to ensure buy-in from those closest to the work and management.  The team meets to review noncompliant cases (called “opportunities for improvement”) on a monthly basis.  Additionally, the hospital created a respiratory disease core measure team which developed improvement strategies specific to the pneumonia core measures.

Focus on the system, not on blame: According to the hospital’s director of quality and risk: “the hospital’s patient safety culture means being blame-free. Unless the case is egregious, we assume mistakes occurred because the established care process failed our staff and/or physicians.”  Rather than focusing energy on assigning blame, the team focuses on improving systems to reduce the occurrence of similar incidents, improving the core measures performance for all staff members, not just the ones involved in the noncompliant cases.  As an example, the hospital increased screening for the pneumonia vaccine by reprogramming the electronic nursing record to require an answer to

Get everyone involved: If performance goals are met, and money is available, a bonus pool is established for all full-time employees (even those not directly involved in patient care), except hospital executives.  If the performance goals are not met, no bonus money is distributed.

Adjust responsibilities when necessary: The hospital discovered some difficulties with one measure – taking a blood culture prior to giving antibiotics.  The team discovered that there was a delay in taking the blood culture because a phlebotomist had to be called into the emergency room.  The team also discovered delays in administering antibiotics when a patient was transferred to another unit from the emergency department. A process change resolved these difficulties.  Emergency room nurses now take the blood culture (contacting a phlebotomist assigned to the emergency department if necessary) and administer the first dose of antibiotics before the patient leaves the emergency department.

Root Cause

New Research May Lead to Reduced Deaths from Sepsis

By ThinkReliability Staff

Sepsis kills about 200,000 people in the U.S. every year, about 30% of those afflicted. Millions die every year from sepsis worldwide.

Sepsis is a whole-body inflammatory state that occurs in the presence of an infection, and was previously known as a blood infection. The exact causes of sepsis are unclear. However, new research from Portugal’s Instituto Gulbenkian de Cienci has shown that during sepsis, red blood cells may be injured and leak a substance called heme. In combination with inflammation that is present during an infection, the high levels of heme become toxic to the body’s organs, causing organ failure.

The body produces a substance called hemopexin that cleans up the leaking heme. However, as levels of heme rise, levels of hemopexin fall, increasing the amount of heme in the body. The Instituto Gulbenkian de Cienci researchers have had success injecting mice with hemopexin to aid their body in reducing levels of heme. We can show the results of their research in Cause Mapping form, which can be viewed by clicking “Download PDF” above.

This potential solution to reduce the impact of sepsis still requires more research before it can be applied to humans, but may indicate a first step towards reducing the high impact of sepsis on mortality.