Category Archives: Root Cause Analysis

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.

Root Cause Analysis

Theft at Healthcare Facilities Puts Patient Data at Risk

By ThinkReliability Staff

There have been many reported cases of thefts at healthcare facilities that resulted in patient data being at risk.  Loss of medical equipment or patient safety data is a big issue for the involved healthcare facility, and it’s all too common.  More than half of healthcare facilities have reported at least one health data breach since 2009.  It is   estimated that 66% of reported breaches are due to theft.  (For an example of a patient privacy breach not related to theft, read our previous blog.)

Some notable thefts: more than $1 million worth of equipment (including some that contained patient information) was stolen over a two-year period from a VA Hospital in Florida.  A health insurance provider lost nine server drives, including patient and provider information  for 1.9 million people.  The theft was not reported until two months later and followed a theft two years prior of a portable disk drive which contained personal data for 1.5 million members.  We can look at the issue of theft of equipment in a proactive root cause analysis performed as a Cause Map, which allows us to visually map causes that could results in impacts to the goals.

In this case, there is the risk of impact to the patient safety goal if patient medical records are impacted.  The loss of property can be considered an impact to employees, the organization, and the property goal.  The loss of patient data can be considered an impact to the patient services and compliance goal (as compliance with privacy regulations may be affected).  In this case, we look specifically at loss of equipment and data due to theft.

Beginning with the impacted goals, we can ask “Why” questions to add detail to the Cause Map.  Loss of property can result from theft, and insufficient inventory records can contribute.  (This was noted in the case of the VA loss.)  Theft can occur within or outside a healthcare facility.   Within a facility, property can be stolen by either employees, or non-employees.  If it is determined that property was only accessed by employees, more intense background checks may be in order.  In either case, security needs to be considered.  The levels of security depend on the type of facility, type of property and data contained in various spaces, and various other factors, and should be considered for each facility individually.

Property that is stolen outside the facility is generally stolen from an employee who works off-site or has taken data off-site, and insufficiently protects the data.  If employees are allowed to have sensitive information or expensive equipment off-site, sufficient precautions must be taken, which are also dependent on the sensitivity of data, value of property, and needs of the facility.

To view the Outline and Cause Map, please click “Download PDF” above.

Hospital Acquired Condition, Root Cause Analysis

New Research on the Impact of Hospital-Acquired Infections

By ThinkReliability Staff

Recent research has shown that in-hospital mortality for patients who acquire an infection in the hospital increases from 4.5% to 18.5%.  Hospital-acquired infections are infections obtained while a patient is hospitalized.  The three main hospital-acquired infections (or HAIs) are bloodstream infections (28% of HAIs), pneumonia (21%) and urinary tract infections (15%).

Not only does an HAI increase the mortality rate, it has other impacts as well.  We can look at these impacts, and their causes, in a root cause analysis demonstrated visually as a Cause Map.  For the purpose of this root cause analysis, we will limit our investigation to HAIs that occur during hospitalization in an intensive care unit (ICU).  We begin with determining the other impacts to the goals.  The patient safety goal is impacted due to the increase in mortality.  The organization goal is impacted because many insurers (including Medicare and Medicaid) will not reimburse for some infections obtained during hospitalization.   Additional treatment is required to treat the infection, resulting in an impact to the patient services goal.  The treatment for these infections normally results in an increased stay in the ICU (from an average of 8.1 days to 15.8 days), at a cost of $16,000.  It is estimated that 26.7% of all ICU stays result in at least one HAI.

Beginning with the impacted patient safety goal, we can ask “Why” questions to demonstrate the cause-and-effect relationships leading to the increase in mortality.  Increased mortality is due to the acquiring of an HAI.  HAIs result from the exposure to a pathogen and frequently occur in the ICU partially due to the increased risk of infection due to the underlying condition for which the patient is in the ICU.  There are two types of pathogens to which patients can be exposed: endogenous (essentially, from the patient’s own body) and exogenous (from visitors, healthcare providers, equipment, the environment, etc).  HAIs are highly related to the use of invasive support measures, which provide a path for either kind of pathogen directly into the patient’s body.  Specifically, the use of a central intravenous line is cited in 91% of bloodstream infections, mechanical ventilation is cited in 95% of hospital-acquired pneumonias, and urinary catheters are cited in 77% of urinary tract infection.

Because these invasive support measures are generally required for patient care, it’s difficult to see how these infections can be reduced.  However, some programs have been shown to substantially reduce HAIs – and the cost associated with them – by improving the culture of safety and compliance with preventive methods.  One such program in Michigan has reduced the rate of bloodstream infections associated with central lines from 7.7 to 1.3 per 1,000 catheter days.  Even without a dedicated safety program, insisting on hand washing and proper cleanliness procedures during the insertion, checking, and removal of invasive support measures can reduce the risk of HAIs.  Additionally, because the use of invasive support measures is so strongly correlated to HAIs, removal of these measures as soon as possible can also reduce the risk.

To view the Outline and Cause Map, please click “Download PDF” above.  Click here to read more about hospital-acquired conditions.  Or click here to read more about the latest research.

Root Cause Analysis

Living Donor Dies During Liver Transplant

by ThinkReliability Staff

In May 2010, a living liver donor died on the operating table.  Investigation showed that there were multiple issues related to the patient’s death.  The clinic was cleared of any wrongdoing in the death – and the surgeons there don’t believe that the surgical issues contributed to the death – but the clinic was cited for  violating rules designed to inform and protect donors.

We can look at all the related issues and see the cause-and-effect relationships in a Cause Map, or visual root cause analysis.  We begin with the impacts to the goals.  The patient death is an impact to the patient safety goal.  Patient deaths also cause impacts to related employees, which is an impact to the goals.  The citation for the violation of donor protection rules can be considered an impact to the compliance goals.  As a result of this incident, the clinic voluntarily stopped operations on living donors for 4 months, which can be considered impacts to the schedule and customer service goals.  Once the impacts to the goals are determined, we can begin with an impact and ask “why” questions to add detail to the Cause Map.

The patient death was determined to be due to a combination of cardiac arrest and excessive bleeding.  The cardiac arrest occurred because the patient’s heart was too weak to withstand surgery, and the patient was undergoing surgery.  The patient was donating a portion of his liver as a “living donor”.  Because the patient was not properly informed prior to his surgery, it’s unclear whether he would have continued if proper processes had been followed.  Donors are required to be given outcomes from both the site performing the surgery and national results.  The information the donor received was not up-to-date, as the paperwork had not been updated.   Additionally, because the donor’s needs may be opposite of the recipient’s needs, the donor’s advocate is required to be involved only in the donor’s care.  In this case, the advocate was also involved in the recipient’s care. Lastly, the patient received an abnormal EKG (which indicated that he may have had a prior heart attack) during his operation prep.  Although later testing showed that there was no reduction in blood flow to the heart, it’s unclear whether the patient was aware of these results or in a cardiologist was consulted.  The patient did not request a second opinion to determine whether or not he was healthy enough to handle the surgery.

Excessive bleeding occurred during the surgery and was thought to also have contributed to the patient’s death.  Bleeding occurred because the patient was in surgery.  Because the type of surgery the patient was doing is relatively new, it’s also possible that the surgeon’s lack of familiarity with the surgery may have contributed to the bleeding.  The bleeding wasn’t able to be stopped because it was difficult to find the multiple sources.  The patient was having laparasopically assisted surgery, which results in a quicker recovery time for the patient but also means that the bleeding source needs to be found through small holes, rather than one large incision.  Although the surgeons say it was not related to the patient death, a high speed blood pump was not used, though it was available, and the procedure for massive bleeding was not followed.

Whether or not these issues contributed directly to the patient’s death, they should still be reviewed as sources of improvement for the facility.  Other facilities as well can use this incident to examiner their own procedures and look for opportunities to increase patient safety.

To view the Outline and Cause Map, please click “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.

Root Cause Analysis

New Use for Old Drug May Save Lives

By ThinkReliability Staff

An off-label use for an existing drug, tranexamic acid, has been shown in recent studies to reduce bleeding – and so risk of death – from trauma.  The drug is believed to slow bleeding by slowing the dissolution of blood clots  by  blocking plasmin, which aids in the dissolution of blood clots.  A recent trial shows that 128,000 lives could be saved thanks to the use of tranexamic acid, an existing, cheap generic.  The drug slows bleeding in trauma patients and is being used on the battlefield, in Britain . . . and just about nowhere else.

How does the drug help trauma patients and why isn’t it being used? We can look at both of these issues in a Cause Map, or visual root cause analysis.  We begin the Cause Map with the outline, which captures the basic information about the issue and the impacts to the goals.  Here, we are looking at the use of tranexamic acid to slow bleeding in trauma patients.  Currently, it’s being used primarily on battlefields and in trauma centers, mainly by Britain.  Use of the drug impacts the patient safety goal by potentially reducing the risk of death from trauma, and the patient services goal by slowing bleeding.

We begin with these impacted goals and ask “Why” questions to add detail to the Cause Map.  In this case, the potential for the reduced risk of death  results from having 400,000 people die of trauma in hospitals every year, and  the potential for slowed bleeding.    The potential for slowed bleeding is due to a drug that has been shown to slow bleeding, and the fact that that drug is not commonly used for trauma.  The drug is believed to slow bleeding by  blocking plasmin, which aids in the dissolution of blood clots.  The drug is not commonly used  for trauma, in part because it has not been FDA approved for this use.  (It can still be prescribed “off label” by doctors.)  The leader of the trial showing the potential benefits of the drug in trauma believes that the lack of use is due to inertia.  Because the drug is inexpensive, it doesn’t provide a large profit for drug companies, and so they are less likely to advertise the benefits.  Additionally, since the FDA hasn’t approved it for trauma, the drug companies aren’t allowed to advertise the drug for this use.

It’s unclear if manufacturers are attempting to  obtain FDA approval for trauma use.  However, publication of these studies, and sharing information between healthcare facilities may help increase the use of this drug, potentially saving lives.   It’s been added to the World Health Organization’s essential drugs, and is finding use on battlefields aiding wounded soldiers.  Hopefully in time, it will be used in healthcare facilities as well.

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