All posts by Kim Smiley

Mechanical engineer, consultant and blogger for ThinkReliability, obsessive reader and big believer in lifelong learning
Root Cause Analysis

The Low Survival Rate of Pancreatic Cancer

By Kim Smiley

Sally Ride, the first US woman in space and a national hero, died after a 17-month battle against pancreatic cancer on July 21, 2012.  Pancreatic cancer is a particularly deadly cancer with only a 6% five-year survival rate.  This disease also affects many people.  In 2010 alone, an estimated 43,000 people in the US were diagnosed with pancreatic cancer.

The reasons that pancreatic cancer is so deadly can be explored by building a Cause Map, a visual root cause analysis.  The first step in building a Cause Map is outlining the problem which includes defining how the problem impacts the organizational goals.  In this example, the primary goal considered is the impact to the safely goal since pancreatic cancer has such a low survival rate.

In order to build the Cause Map, “why” questions are asked and the answers are added to the Cause Map.  Why does pancreatic cancer have such a low survival rate?  The survival rate is low because the cancer has usually spread beyond the pancreas by the time it is detected and pancreatic cancer is difficult to treat.  The cancer has typically spread before detection because there are very few symptoms in the early stages of the cancer and any symptoms that do exist are usually vague, like aches and pains that could easily be attributed to other illnesses.  There is also no screening test like there are for breast or prostate cancer to detect pancreatic cancer at this time.

Pancreatic cancers are difficult to treat for several reasons.  First, pancreatic cancers are resistant to chemotherapy.  The best course of treatment is typically removal of the tumor, but many cases are caught too late for the tumor to be removed because the cancer has usually spread by the time it is detected.

Researchers are working on improving the survival rate for pancreatic cancer.  There are some promising studies that show it may be possible to develop a screening test that could detect pancreatic cancer at earlier stages, which could significantly improve the chances for survival.

To view a high level Cause Map of this issue, click on “Download PDF” above.

Root Cause Analysis

Accidentally Ingested Wire Bristles

By Kim Smiley

There have been a number of documented cases of people accidentally swallowing wire bristles from the brushes commonly used to clean grills.  If ingested, the bristles can cause significant pain and have the potential to puncture organs, including the intestine which can lead to dangerous infections.  There isn’t a lot of data available to determine how often this occurs, but a recent report discussing six cases of ingested wire bristles at a single hospital in a one year period hint that this may be more common than many realize.

This issue can be analyzed by building a Cause Map or visual root cause analysis.  The first step in creating a Cause Map is to determine how the issue impacts the overall goals of an organization.  In this example, we’ll consider the organization the general public and the main impacted goal is the safety goal since there is a risk of serious health issues.  Causes are now added to the Cause Map by asking “why” questions.  Why is there a risk of serious health issues?  Because there is the potential to swallow a wire bristle and the wire bristle can do a lot of damage within the body.   (To view a high level Cause Map of this issue, click “Download PDF” above.)

Continuing the “why” questions, we would now ask “why” is there a potential to swallow a wire bristle?  This possibilities exists because people may inadvertently swallow the bristles without realizing it, the bristles come from wire brushes that are often used to clean residential grills and the bristles sometimes fall out of the brushes and stick to the grill.  People may inadvertently ingest the bristles because the bristles can stick to meat and the texture can hide the presence of the bristle.  Many people are also unaware of the potential danger of eating a wire bristle so they aren’t looking to find bristles.  Investigation into this issue has not found any defects that are causing bristles to fall out.  No one brand or type of grill brushes has been singled out as the culprit in these causes, but a worn grill brush is more likely to shed bristles than a new brush.

All six patients in the report did make full recoveries after treatment.  In three of the cases, the wire bristles were stuck in the throat and required only laryngoscopic removal; the other three cases required more invasive surgery to remove the object.

The best way to protect yourself from the possibility of this occurring is to inspect the grill after using a wire grill brush or to find another method to clean your grill.  The Consumer Product Safety Commission has asked that medical professions or consumers report any incidents of swallow grill brush bristles to http://www.saferproducts.gov to help monitor this issue.

Root Cause Analysis

Abuse of “Good Grade” Pills

By Kim Smiley

A recent New York Times article, “Risky Rise of the Good-Grade Pill” talked about the dangers associated with abuse of prescription stimulants.  These stimulants are prescribed to treat attention deficit hyperactivity disorder (ADHD), but they cause individuals without the disorder to become hyper focused and better able to concentrate for long periods of time.  There isn’t good data on how many high school students are abusing the stimulants, but anecdotal evidence implies that a significant number of students, especially those at highly competitive high schools, use the prescription stimulants to help improve test score and grades.

This issue can be analyzed by building a Cause Map, a visual root cause analysis.  The first step when beginning a Cause Map is to determine the impact to the overall organizational goals.  In this example, the Safety Goal is impacted because there are risks to the students abusing the prescription stimulants.  Once the impact is defined, “why” questions are asked and causes are added to the Cause Map.

Why are there risks to students abusing prescription stimulants?  Students are at risk because students without medical need are using the stimulants, the stimulants can be dangerous and illegal sale or procession of these drugs can have severe consequences.

Students are using the stimulants because they are available and they can aid in earning good grades.  The stimulants are available because some people sell them and there is anecdotal evidence that some students fake the symptoms to get prescriptions for them.

Many of the students using these stimulants don’t realize that there can be serious health issues with using them.  First off, these drugs are one of the most addictive substances that have a medical use.  There is little known about the potential long term health issues of abusing prescription stimulants.  There is also a concern that these drugs may act as a gateway drug which has the potential to open the door to more drug abuse as students get more comfortable with the idea of taking pills. In the short term, there are a number of health issues to consider including heart irregularities, exhaustion and even psychosis during withdrawal.

Another important fact many students are unaware of is that giving these drugs to a friend can have heavy legal consequences.  Distribution of prescription stimulants is considered a felony.  Adderall, Ritalin and other name brand stimulants used to treat ADHD are controlled as Class 2 substances, the same as cocaine and morphine, and the sale of them carries severe penalties.

This issue is just beginning to come to light and more information is needed to fully understand how many students are involved and the best way to stop the abuse of the prescription stimulants.  As more information is available it can easily be added to the Cause Map.

To view a high level Cause Map of this issue, click on “Download PDF” above.

Root Cause Analysis

Four Patients Contracted Hepatitis C

By Kim Smiley

A cardiac catheterization lab was temporarily shutdown after four patients tested positive for hepatitis C.  All four patients have the same strain of hepatitis C which means they contracted the virus from the same source.  The investigation into this incident is ongoing, but no other connection other than the cardiac lab has been found between the four patients.

This issue can be analyzed by building a Cause Map, an intuitive root cause analysis that visually lays out the cause-and-effect relationships between the factors that contribute to an incident. The first step in building a Cause Map is to determine the impact to the overall organizational goals.  The basic information about an incident and the impacts to the goals are documented in an Outline.  In this example, the safety goal was impacted because four patients contracted hepatitis C and there is potential that more people were also infected.  The customer service goal is also impacted because hundreds of people need to be tested to ensure that they are not also infected.  Once the impact to the goals are determined, “why” questions are asked to find the causes that belong on the Cause Map.

Testing is necessarily because hepatitis C is often asymptomatic for many years so many infected individuals will not know unless they are tested.  Hepatitis C can be treated with medication and cured in 50–80% of cases, but there cases that cause severe liver issues. Hepatitis C is the leading cause of liver transplants.

651 patients had used the cardiac catheterization lab since August 2011 and all are being tested along with 30 staff members.  Test results take up to 10 days to process so the final results on how many people were infected aren’t available yet.

New Hampshire Division of Public Health and hospital officials are still investigating to determine the source of the hepatitis C.  It was likely medical equipment of some type since hepatitis C is spread through blood to blood contact.  Once the investigation is complete, any additional information can be easily added to the Cause Map so that it documents all relevant information for the issue.

Once the investigation is completed, the lab will be able to make whatever changes are necessary to ensure that all equipment is properly sterilized and this type of event doesn’t occur again.

Root Cause Analysis

Study Finds that Diabetics are at Risk of Medication Errors

By Kim Smiley

A new study found that nearly a third of diabetic hospital patients experienced a medication error in a one week period.  The study examined bedside data for 12,800 patients and 6,600 patient questionnaires for hospitals in England and Wales.  Medication errors when treating diabetics can have severe consequences because many diabetics require medication to maintain healthy blood sugar levels.  Blood sugar levels that are either too high or too low can result in significant illness and even death if untreated.

The two most common errors found by the study were failing to properly adjust medication when a patient’s blood sugar level was high (23.9%) and failing to sign off on the patient’s bedside information chart when insulin was given (11.1%).

This issue can be examined by building a Cause Map, an intuitive, visual root cause analysis format.  The first step to building a Cause Map is to determine the impact to the overall organizational goals.  In this example, the risk to diabetic patients is an impact to the safety goal.  The next step is to ask “why” questions and add the cause boxes to the Cause Map to illustrate the cause and effect relationships between all the factors that contributed to the issue.

In this example, the risk to the diabetic patients occurred because medication errors occurred and the patients required medication to maintain healthy blood sugar levels.  The study did not provide details on why the medication errors were made by hospital staff, but that information could be added to the Cause Map if it becomes known.  A Cause Map can be still be useful when only a high level map can be built because it can help identify an at risk population and a common problem, the diabetic patients and the medication errors, which could help identify where more research is needed or where resources could be directed.  To view a high level Cause Map of this issue, click on “Download PDF” above.

A potential solution that has been suggested for this problem is to improve training for hospital staff on how to properly treat diabetic patients.  A more detailed look at understanding exactly why the staff is making errors could help direct the training plan to the most needed areas.

Root Cause Analysis

More Children are Swallowing Batteries

By Kim Smiley

A new study has found that the number of children going to the emergency room because of batteries that have been swallowed or placed in the mouth, ears or nose has nearly doubled during the past 20 years.  The study determined that a child visits an emergency room in the United States every three hours for issues involving a battery.  Most of the cases involve children under 5 and batteries that were swallowed.

These findings are relevant because a swallowed battery can result in severe injury and even death in extreme cases.  This issue can be examined by building a Cause Map, a visual format for performing a root cause analysis.  In this example, there is the potential for serious injury or death because children are swallowing batteries and batteries can cause serious injuries. More children are swallowing batteries in part because of the increasing popularity of button batteries, which account for 84% of all battery-related ingestions.  Button batteries are shiny, circle batteries that are used in a number of modern gadgets and there are far more of them in the typical house today than 20 years ago.  They are used to power toys, games, hearing aids, remotes and any number of small things common in the modern household.

Button batteries are more likely to be swallowed than traditional batteries because they are much smaller.  It’s also easy to see how the shiny appearance of button batteries would be tempting to small children.  Some devices use screws or other restraints on their battery compartments so that children can’t remove the batteries, but many devices do not, especially those intended for adult use.

Button batteries can cause serious injuries because they can get stuck in the esophagus, a moist environment where the battery can form a microcell that erodes the tissue.  In the worst cases, the battery can eat though the throat and into the aorta, causing a child to bled to death.  Damage can also occur very quickly, in less than two hours and the child may not show any symptoms at first.

The best way to protect children is to tape the battery compartment or securely store all devices that use button batteries if the battery compartment does not have a screw.  It is also essential to take children to the emergency room immediately if there is any suspicion that they might have swallowed a battery.  A simple x-ray can determine if a battery was swallowed and quick removal of the battery can prevent significant damage if the battery is caught in their esophagus.

Click “Download PDF” above to view a high level Cause Map of this issue.

Root Cause Analysis

Amish have few allergies

By Kim Smiley

A new study has found that Amish children living in Indiana have far fewer allergies than the general population and even significantly fewer allergies than other children living on farms.  As high as 50 percent of the general population has evidence of allergic sensitivity when tested and only seven percent of the Amish children had allergic sensitivity.  The study also looked at Swiss children living on farms and found that they had half the allergic sensitivity of the general population, but still more than Amish children.

Why is this finding significant?  Scientists hope that studying the Amish will help them understand what factors are causing the large increase in allergies in the general population in Western Countries over the past few decades.

This issue can be built into a Cause Map, an intuitive, visual root cause analysis, to help illustrate the-cause-and-effect relationship between the factors involved.  As more research is done and more information on this issue becomes available, it can easily be added to the Cause Map.  In this example, researchers aren’t sure why the Amish have such low levels of allergic sensitivities, but there are a few factors that are likely involved.  These factors could be documented on the Cause Map, but a question mark would be added to note that more information is needed to verify the accuracy of the cause and to ensure proper placement on the Cause Map.  To view a high level Cause Map of this issue, click “Download PDF” above.

One fact worth adding to the Cause Map is that Amish are exposed to a wide variety of animals and the germs that go along with them from a young age. Many Amish live on farms and nearly all own horses for transportation.  Additionally, Amish children help care for the animals from a young age.  Pregnant Amish women are also typically around large animals and the prenatal exposure may play a role.  Many Amish also consume unpasteurized milk and the impact of this on development of allergies is an ongoing debate.

In addition to environmental factors, some researchers also think that genetic plays a role in allergies so it is also worth noting that the Amish are relatively isolated genetically with limited mixing with the general population.

Understanding the factors that contribute to the low allergy rates of Amish children would hopefully help scientists both understand why allergies in the general population are increasing so dramatically and the best actions to take to treat them, maybe even before they develop.

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.

Never Event, Root Cause Analysis

Patient Deaths Caused by Defective Defibrillator Wires

By Kim Smiley

A recent study determined that at least 20 patients have died as a result of defective defibrillator wires.  The wires, also called leads, connect the defibrillator to the heart to both monitor heart rhythms and deliver electric shock if needed.  Defective defibrillator wires have the potential to affect many people since more than 79,000 in the United States and 49,000 abroad have the implants.

This issue can be explored by building a Cause Map, an intuitive, visual root cause analysis method.  To begin a Cause Map, the first step is to determine what the impacts have been on the overall organizational goals.  In this example, the safety goal will be focused on since the study determined at least 20 patients have died as a result of this issue.  Once the impact to goals is found, the Cause Map is built by asking “why” questions and adding the information.

In this case, the patients died because their heart stopped.  The heart stopped because the patients were at risk of heart issues, had defibrillators implanted and the defibrillators malfunctioned.  Implanting defibrillators is a common treatment for certain heart conditions and many people have them.

The defibrillators malfunctioned because the wires used to connect the defibrillator to the hearts weren’t properly insulated and a short circuit developed, preventing the defibrillator from shocking the heart when it was needed.  The wires aren’t properly insulated because the silicone coating on the wires is breaking down over time.  The defibrillators are also malfunctioning because the issue with the wires isn’t one that can be found by routine monitoring so the problem isn’t identified until it’s too late.

The company that makes the wires is questioning the findings of the study and says that the information used was incomplete.

It’s also not clear at this time what the best course of action is at this time beyond continuing to monitor patients.  Removing the wires is considered to be a risky operation.

To view a high level Cause Map of this issue, click “Download PDF”.

Root Cause Analysis

Counterfeit Drugs Bought by US Oncology Practices

By Kim Smiley

Counterfeit Avastin, a cancer treatment drug, was purchased by as many as 19 U.S. oncology practices last year.  The counterfeit drug did not contain anything that would harm patients, but there were no active cancer fighting ingredients in it. There have been no reported cases of patients being given the fake drug, but there was a very real risk that this could happen.

How did this happen?  How could so many medical facilities fall for a counterfeit drug?

This example can be analyzed by building a Cause Map, a visual root cause analysis format that intuitively shows the cause-and-effect relationships between the many Causes that contribute to an issue.   In this case, many factors led to the oncology practices purchasing the fake Avastin.  The supplier offered the lowest price for the drug, about $400 less than the manufacturer’s price.  Additionally, the supplier appeared to be legitimate and had a very convincing salesman working for them.  The supplier appeared to have both US phone number and offices in the US.  In reality, the US number phones were being automatically routed to an overseas number, but this process was transparent to the medical practices.  The counterfeit drugs themselves also appeared to be authentic.  As technology improves it is becoming more difficult to spot the fakes.

At this point in the investigation it’s not clear whether the supplier knew the drugs were fakes.  The company claims it had no knowledge that the counterfeit product.  One thing that is clear is why counterfeit drugs appear in the supply.  There is a lot of money to be made. Some prescription drugs are extremely expensive and selling fakes can be very profitable.  The drug in this case, Avastin, sells for more than $2,000 for a 400-milligram vial.  There are also generally less severe punishments for crimes associated with prescription drugs compared with the illegal drug trade.

It is estimated that less than one percent of the drug supply is counterfeit in developed nations, but counterfeit drugs are a huge issue in developing countries.  Even a small amount of counterfeit prescription drugs  has the potential for a large impact on peoples’ health.  There are a number of solutions to this issue that have been suggested.  The US Senate has recently passed a bill that pushes for stronger punishments for counterfeit drug trafficking and calls for a universal system to track prescription drugs, but it’s unclear how this might be adopted into law.

To view a high level Cause Map of this issue, click “Download PDF” above.