Tag Archives: cause mapping

Root Cause Analysis

Autism & the MMR Vaccine

By ThinkReliability Staff

During most of human history, families and communities feared diseases such as small pox, influenza, tuberculosis.  And rightly so – these scourges were responsible for the deaths of millions.  So with the advent of vaccinations, humanity should have finally been relieved from the worries of these horrible, yet now preventable, diseases.  Unfortunately, despite the widespread acceptance of vaccinations, notable events have set back progress against one particular disease – measles.

Measles, once considered conquered in most of the developed world, is now making resurgence in the United Kingdom.  Why?  Parents fear vaccinating their children.  The Measles, Mumps, and Rubella (MMR) vaccination rate nationwide dropped as low as 84% during the last decade.  Following the drop, measles became more prevalent, infecting thousands after a decade of steep declines.  In fact, measles infection rates are at their highest rates in well over a decade.  Unfortunately, this also coincided with multiple deaths stemming from measles – deaths that were all preventable.

Why the drop in vaccinations?  In this instance, there is clear reason.  A widely-publicized study in 1998 found a correlation between the MMR vaccination, autism and bowel disease.  Any rational parent would fear causing autism in their child, especially when the perceived risk of catching measles was at an all-time low.

What makes this especially disturbing is that the chance of developing autism from receiving an MMR vaccination is…none.  The original study was recently deemed fraudulent and formally retracted.  To create this “study” the lead researcher, Andrew Wakefield, is accused of grossly manipulating data.  One of the longest medical board investigations in UK history found that all 12 cases included in the original study were altered.  Multiple studies which followed showed absolutely no link between the MMR vaccination and autism.  In short, he fabricated the story completely.

Why do such a thing?  To start, Wakefield accepted over £435,000 in compensation.  This pay, provided by a national legal aid fund for the poor, came at the behest of litigators looking to build a case against the makers of the MMR vaccine.  Moreover, Wakefield had various business ventures which would benefit greatly from such a linkage, to the tune of at least £28M per year.

Yet despite overwhelming evidence that the MMR vaccine doesn’t cause autism, perpetually low vaccination rates remain in the UK.  Performing a root cause analysis of the measles epidemic in the UK and building a Cause Map reveals the causes contributing to the problem, including the role Wakefield’s bogus study played.   Medical studies are complex and rely on the integrity and analytic skills of the researchers involved.  Inaccurate conclusions, sensationalism and fraud all can lead to unintended and dangerous consequences.

Click on “Download PDF” to see the Cause Map detailing the drop in UK vaccination rates due to the Wakefield Autism & MMR Study.

(Details of this case were recently published in the British Medical Journal.)

Root Cause Analysis

Wrong Surgery Performed on Patient (Part 2)

By ThinkReliability Staff

This week, we will continue our discussion of an incident where the wrong surgery was performed on a patient.  Last week, we looked at the timeline of events and a process map of the universal protocol developed to reduce the incidence of surgical errors.  This week, we’ll perform a root cause analysis of the issue.

The specific steps identified that didn’t go well, or weren’t performed, from the process map now become causes on our Cause Map.  Instead of the causes or errors being grouped chronologically or by type (as they are on a fishbone diagram), the causes are grouped by their contribution to the incident.  The Cause Map reads from left to right by asking “Why” questions, beginning with the impacts to the goals.

For example, the patient safety goal was impacted because a patient received the wrong surgery.  Why?  Because the physician performed the wrong type of surgery. Why? Because the surgical site was not clearly marked.  Why? It was marked on the correct arm, though not the correct site (the wrong surgery was performed on the correct hand) and the mark was washed off during patient preparations.  These are both issues identified in the process map that did not follow the universal protocol for surgical preparations.  Both of these issues contributed to the wrong surgery.  In addition, the surgeon was thinking about carpal tunnel surgery, since most of his day, especially just prior to the surgery, had been spent on carpal tunnel surgery, either performing it, or doing pre- or post-surgery briefs with other patients.

Neither the patient nor the operating room staff stopped the surgeon from performing the incorrect surgery.  The patient spoke only Spanish, which may have contributed to her not speaking up.  The operating room staff did not include the nurse that had done the patient assessment, due to a last-minute operating room and staff switch due to other delays.  There was no time-out prior to the procedure, which may have alerted the staff about the wrong  procedure, or may have helped the surgeon switch from thinking about carpal tunnel surgery.

Once the analysis is complete, possible solutions are identified on the Cause Map.  Many of the solutions in this case are to ensure that the universal protocol procedures are being followed.  Had they been followed in this case, the risk of performing the wrong surgery would have been reduced.  Many facilities are already using the universal protocol; however, this case study shouldn’t be ignored by them.  The operating surgeon made this case public and added the following comment: “I hope that none of you ever have to go through what my patient and I went through. I no longer see these protocols as a burden. That is the lesson.”

This surgeon has learned his lesson and will likely be more diligent about following these protocols in the future.  However, there’s no need to wait until you, or your staff members, have their own incidents to learn from.  Use this case study to emphasize the needs for these protocols, in hopes that your facility can reduce its own risk.

(Details of this incident were recently published in the New England Journal of Medicine.)

Root Cause Analysis

Drug Shortages

By ThinkReliability Staff

Shortages of commonly used medications are beginning to impact patient safety.  The Institute for Safe Medicine  Practices (ISMP)recently asked healthcare workers to participate in a survey regarding drug shortages.  One out of three respondents said that shortages caused medication errors that could have caused harm to patients.  One out of four respondents said mistakes with medication reached patients, and one in five said that patients were harmed by the medication errors.  In addition, patient care has been impacted by the unavailability of some commonly used medications.  There have been reports of patients who woke up during surgery because sedative was being conserved.

Although the U.S. Food and Drug Administration (FDA) requires manufacturers to notify them when there are drug shortages that have no alternatives, there are no sanctions if they do not.  Because many of these drugs have alternatives, the manufacturers are not required to notify the FDA, and healthcare providers are oftentimes not aware of shortages until they run out of needed medication, causing last-minute scrambles and potentially leading to medication errors, such as when an alternative drug has a lower dosage than the drug being replaced.  Because healthcare providers are so accustomed to the dose of the replaced drug, medication errors can result amidst the confusion.

The FDA estimates that approximately 40% of the shortages are due to manufacturing problems, including safety issues identified in inspections, 20% of the shortages are due to production delays, and another 20% occur when manufacturers stop making drugs.  Although drug manufacturers will not confirm, it is assumed that as insurance companies start covering fewer and fewer brand names and generic prices continue to undercut brand-name prices, it isn’t profitable to make some medications.  The FDA does not have authority to require manufacturers to make medication.  Also contributing to the shortages are increased demand, and shortages of parts and raw materials required to manufacture the medications.

Trying to address these issues and come up with some solutions to the drug shortages is going to take more work than just identifying the issues.  To that end, groups representing doctors, anesthesiologists, pharmacists and safety advocates have invited the FDA, health experts, supply chain representatives and drug manufacturers to attempt to work through a solution earlier this month.  Hopefully they’re able to come up with some actions that will prevent further deaths and medication errors due to this shortage

Root Cause Analysis

Cholera Outbreak in Haiti

By ThinkReliability Staff

Although the World Health Organization (WHO) has never seen cholera in Haiti before, it’s not a great surprise that an epidemic has spread through crowded makeshift camps where people have been living since the earthquake in January.  Unsanitary conditions frequently lead to outbreaks of the disease and in situations where there is very limited access to healthcare and clean water, death rates are often high.   The death rate in Haiti was nearly 10% at the beginning of the outbreak. It’s now decreased to 7.7% which is still well above the 1% death rate threshold accepted by the United Nations (UN).

We can do a closer examination of the causes contributing to this issue in a Cause Map, or visual root cause analysis.  The first step to the analysis is to capture information about the issue and define the problem with respect to an organization’s goals.  The problem can be defined as a cholera epidemic with a high death rate.  It was first discovered, or at least reported, in November of 2010 at makeshift camps in Haiti.  We’ll use the goals of the Haitian government to determine impacts.  At least 284 people have died and 3,600 people have been infected with cholera. This is an impact to the population safety goal.   The high death rate indicates a failure of population services from the government.  The environmental goal is impacted by the epidemic spread of the disease, and  the financial goal is impacted by the cost of treatment of those afflicted.

The second step of the analysis is to determine the causes that led to the impacted goals.  The high number of deaths results from the high number of infections and the high death rate.  Infections are caused by ingestion of contaminated food and water.  The bacteria that causes cholera is spreading due to heavy rains and the large number of people living in the unsanitary conditions.  The overcrowding in the camps is due to the earthquake that hit Haiti on January 12, 2010.  As previously mentioned, it’s unclear how the  bacteria got there in the first place, but not surprising that it did.  The high death rate is due to untreated dehydration.  Severe diarrhea is a symptom of a cholera infection, and with inadequate medical care and lack of access to clean water, the dehydration can quickly become severe enough to lead to death.

Support organizations like the WHO are desperately trying to stop the spread of the epidemic and reduce the rate of death.  However, it’s clear they have their work cut out for them, given the current circumstances.

Root Cause Analysis

Severe Injury to Baby at Birth

By ThinkReliability Staff

In November 11, 2005, a woman in labor checked in to an Army Medical Center in Hawaii.  The mother was placed in the care of a second-year medical resident.  The fetus showed signs of distress throughout the day, and “took a turn for the worse” at approximately 5:00 p.m.  However, the child was not delivered until nearly 6:00 p.m. when the fetus was “almost dead”.  The baby was born with the umbilical cord wrapped around her neck and was turned over to another team.  On this team, a first-year intern placed an oxygen tube incorrectly, resulting in oxygen being delivered to the baby’s stomach instead of her lungs for approximately 40 minutes.  The child now has severe brain damage and the family was awarded a $11 M settlement for her care.   This is the fourth large settlement this hospital has made relating to errors made from 2003-2007, with an average of $11M per year to settle the lawsuits.

There are several  impacts to the goals of the medical center; namely, the impact to patient safety resulting from the injury to the child, the impact to the organizational goals from the settlement, the impact to patient services from the delay to the birth, and the impact to the time and labor goal for additional work required as a result of the issues with the child.  Our analysis begins with these impacts to the goals.

The injury to the child was caused by a lack of oxygen, caused in part from insufficient oxygen before the birth and in part because of insufficient oxygen after the birth.  The baby did not have sufficient oxygen before birth because the umbilical cord was wrapped around her neck and her birth was delayed, due to a “lack of communication” between the second-year resident and her supervisor who were charged with the mother’s care.  More detail on this lack of communication is not currently available; however, from the perspective of the  medical center involved, this is a key place where more detail needs to be added to the Cause Map once it is available.

The baby had insufficient oxygen after birth because the oxygen tube placed to increase her oxygen levels was feeding into her stomach rather than her lungs.  The tube was misplaced by a first-year intern who was being insufficiently supervised.  (Note that the reports don’t say this anywhere, but if you have an intern under supervision who places a tube incorrectly, you can conclude that the supervision was insufficient.)  Note this is another area that requires more detail for the investigation to be complete in order to find effective solutions.  As with any investigation the level of detail in the analysis is based on the impact of the incident on the organization’s overall goals.  Because of the extremely high impact on patient safety, the analysis for this issue should be quite detailed.

Root Cause Analysis

Brain Damage Resulting from Aggravation of Underlying Mitochondrial Disorder by Childhood Vaccinations

By ThinkReliability Staff

The Federal Court Division of Vaccine Injury Compensation (DVIC) ruled on November 9, 2007 that a child’s parents would receive compensation due to a vaccine injury.  Recently the amount of compensation was named – $1.5 million plus $500,000 a year for treatment.  There has been much discussion about what the award means.  With a charged issue such as this one, wording is very important.  The court’s wording in this case is as follows:

“DVIC has concluded that the facts of this case meet the statutory criteria for demonstrating that the vaccinations CHILD received on July 19, 2000, significantly aggravated an underlying mitochondrial disorder, which predisposed her to deficits in cellular energy metabolism, and manifested as a regressive encephalopathy with features of autism spectrum disorder.”

With a very careful reading of the court’s decision, we can put what the court determined was applicable to the case in a Cause Map, or visual root cause analysis.  (I’ve also recorded the chronological information in a timeline, used to assist with our understanding of the issue.  The information from the timeline is also from the ruling.)

First we can enter the impacts to the goals in the outline.  The patient safety goal was impacted because a child wound up brain-damaged (or with encephalopathy).  The resulting payment of over $1.5M is an impact to the financial goals of the vaccine injury board.  Based on the ruling, the vaccines aggravated an underlying condition, which can be considered an impact to the patient services and environmental goals.   Additionally, in this particular circumstance the child received vaccines not on schedule.  This could be considered an impact to the compliance goal.

Beginning with the most important goal – patient safety – we build the Cause Map.  The patient’s encephalopathy was determined to have been caused by an underlying condition that was aggravated by the receipt of vaccines against 9 diseases all at once.  However, the link between this and the encephalopathy isn’t yet clear.  Rather than just stopping our Cause Map, we can add a “?” in the middle of the cause-and-effect relationship, and highlight this unclear relationship.  This allows us to focus our attention.  Even with this question mark in the middle of the map, we can still do a lot to clarify the cause-and-effect causes.

For example, based on the child’s physicians’ diagnoses, we know that the underlying condition was a  mitochondrial disorder.  We also know that the child received vaccines against 9 diseases at once because she was behind on vaccines, having skipped some doses while she was ill.

Even with the uncertainty surrounding this analysis, the Cause Map can still provide clarity to the issue. It can also help lead to possible solutions (though adding more detail will allow for even more).  For example, doctors may adjust catch-up vaccination schedules based on this incident, resulting in fewer vaccines being given at once.

Never Event

Patient Physically Assaulted

By ThinkReliability Staff

On June 24, 2010, a patient at a Maryland Hospital was physically assaulted by security guards after trying to leave the hospital.  A patient who is injured or killed due to physical assault is one of the ‘Never events’, i.e. medical events/errors that should never happen.

We will look at the causes of this event in a Cause Map, or visual root cause analysis.  The information used to put together this analysis is from the legal filing.

On June 23, 2010, a man (who we’ll call “the patient”) was in a serious car accident and was airlifted to a Maryland Hospital.  He woke up the next day, after receiving treatment for blunt torso trauma and chest pain and asked for something to eat.  After some confusion, the patient realized that his identification bracelet was not his – it identified a female patient 13 years his junior.  At this point, he decided to leave the hospital and was stopped with a verbal and physical exchange with several security guards.  He eventually was able to leave successfully, and was treated at a second hospital for broken ribs, a sprained shoulder, a ruptured spleen, and a concussion.

As mentioned before, physical abuse of a patient is a “Never event”, and is an impact to the compliance goal.   More importantly, there was injury to the patient, resulting in an impact to the safety goal.   Because the patient was wrongly identified as needing surgery to remove a cancerous mass, there was the potential for the patient receiving unnecessary surgery, also an impact to the safety goal.  The patient has taken legal action against the employees involved (Employee Impact goal) and has filed a lawsuit against the hospital for more than $12 million (an impact to the organizational goal).   The misidentification of the patient can be considered an impact to the patient services goal.

We begin our Cause Map with these impacted goals.  The patient was beaten because employees were trying to restrain the patient to keep him from leaving, and restrained him in an inappropriate manner.  The employees were trying to get the patient to stay because they believed he needed surgery because he was misidentified.  At this point, the hospital involved should be asking “Where did our identification procedure go wrong?”  The next step in the investigation should be to look at the identification procedure to determine specifically which steps allowed the misidentification to happen.  Only once this is determined can appropriate corrective actions be taken to prevent future misidentifications.

Another area that requires more analysis is the patient restraint procedure.  The security guards in this instance were attempting to restrain the patient to prevent him from leaving.  However, they did this in an inappropriate manner.  The question is, why?  Were the guards not following the existing restraint procedure? If not, why not?  Or, is there no procedure for restraint?  Were the restraint expectations not clearly provided to the guards?  Again, until the specific breakdowns leading to this incident are uncovered, corrective actions will be generic and may not be effective.  To view a one-page PDF showing the investigation at this point, click on “Download PDF” above.

Never Event

Feeding Tube Misconnection Results in Patient, Fetus Death

By ThinkReliability Staff

Recent articles have related several stories of patients being injured or even killed by medical tubing mix-ups.  A product used other than intended that results in a patient death is one of the “Never Events” – events that should never happen at healthcare facilities.   An article in The New York Times discusses injuries and deaths caused by accidentally connecting food meant for a feeding tube through an intravenous (IV) line.    A specific incident mentioned in the article can be analyzed in a Cause Map to capture all of the causes in a simple, intuitive format that fits on one page.

In this case, a pregnant woman was prescribed a feeding tube to ensure that she and her baby were getting adequate nourishment.  The feeding tube was improperly connected to the intravenous (IV) line, causing liquid food to enter her veins, causing sepsis which killed her and her fetus.

One issue (cause) is that medical personnel made an incorrect connection.  Although there was no information given in the article, this would certainly be an area for the responsible organization to look at in more detail and determine if there are steps that can be taken to reduce the risk of these types of errors.  (Some organizations have found success with color coding the tubes, for example.)

However, another issue is that the tubes COULD be incorrectly connected in the first place.  The number of errors in feeding tube connections (discussed in an article from The Joint Commission Journal on Quality and Patient Safety) has led the U.S. Food and Drug Administration (FDA) to consider declaring these products unsafe.

The tubes become compatible with other tubing connections (such as IV) when needle-free connectors were adopted, to increase caregiver safety (by limiting exposure to needles).  Since then, there have been issues with the compatible tubing.  (A history of tubing issues is found on the PDF, which can be downloaded by clicking “Download PDF” above.)   And, feeding tube connections that are incompatible with other tubing lines are difficult to find.  There are many causes given for the delay of developing incompatible tubing, including resistance from the medical industry, difficulties with the FDA approval process, and a delay in forwarding requirements for incompatible tubing.  This delay is mainly attributed to waiting for an international group to develop a recommendation regarding tubing, which is expected to take several years.

The FDA has an expedited review process which allows approval of a device if it works like an already approved device, regardless of whether that device is safe, or has been recalled.  Because compatible tubing devices have already been approved, new devices that use the same – compatible – connection can go through this expedited process, whereas incompatible connections can not.  Without federal agencies requiring change, it’s been difficult getting manufacturers to update their products.

View the problem outline, Cause Map, and timeline of tubing issues by clicking “Download PDF” above.

Never Event

Cardiac Arrest Due to Leaky Equipment

By ThinkReliability Staff

A patient death associated with equipment that does not perform properly is one of the “Never Events” (i.e. events that should never happen).  A case where a leaking piece of equipment caused the cardiac arrest of a child is described by the ECRI Institute.  We can record this information in a Cause Map, or visual root cause analysis in order to show the relationships between the causes and suggested solutions.  The root cause analysis investigation can be seen by clicking on “Download PDF”.

Because a patient suffered cardiac arrest, there was an impact to the patient safety goal.  We begin this impacted goal and ask “Why” questions to add more causes to the Cause Map.  The cardiac arrest was caused by suffocation.  The suffocation was a result of undetected excessive carbon dioxide (CO2) levels.  The levels were undetected because the child was under anesthesia (thus making it difficult to judge the breathing air quality) and because there was no device to detect high CO2 levels.  The CO2 levels were high due to rebreathing.  (The high CO2 levels were an impact to the patient services  and environmental goals as well.)

The rebreathing occurred because of a lower than normal fresh gas (breathing oxygen) flow.  With a breathing system of this type, the rebreathing (or taking in exhaled CO2) is inversely proportional to the fresh gas flow.  As the gas flow decreases, the rebreathing increases.  The reduced fresh gas flow was caused by a leaky humidifier.  (The leaky humidifier can be considered an impact to the property goal.)  The leaky humidifier was caused by an unrepaired pressure drop through the gas flow passages.  The pressure drop was caused by an inadequate seal on those passages due to two (of four) loose screws that were apparently not noticed.

The leak had been detected during the pre-use test of the equipment.  The leak was believed to be repaired, but instead of performing another pre-use test of the equipment, the system was put together, and a test was done on the whole system.  The system has a higher allowed leak rate than each individual piece of equipment, so the fact that the leak was not in fact repaired was not noticed.

Some of the suggestions given by ECRI Institute to prevent this kind of incident from recurring are to install a CO2 detector on the breathing circuit, ensure the anesthesia equipment is on a regular inspection and maintenance program, and to redo individual equipment tests after repairs.

Never Event, Root Cause Analysis

Patient Death from Restraint

By ThinkReliability Staff

A patient death associated with the use of restraints is a “never event” as defined by the National Quality Forum (NQF).  A recent death at a St. Louis, Missouri hospital has placed the hospital at risk of being terminated from the Medicare program after two other recent patient deaths associated with restraints and inappropriate patient seclusion.

In order to shed some light on the issues surrounding this most recent death, we can begin sifting through the facts in a root cause analysis.  First, we enter the necessary information into the outline, including the impact to the goals (to view the outline, timeline and Cause Map, please click on download PDF above).  The impacts to the organization’s goals begin the Cause Map, or visual root cause analysis.  We can continue to add more detail to the Cause Map by asking “Why” questions.

We will then discover that the patient died of suffocation.  An early concern was that the patient’s airway was blocked by gum, but the doctor determined that was not the case.  (We can leave this cause on the Cause Map but can cross it out once it has been determined that it did not contribute to the incident.)  The patient suffocated when she was left facedown on a beanbag chair, after being given a sedative that slowed her breathing, and was not properly monitored for breathing or a pulse.    The patient had been restrained and sedated after threatening and assaulting the hospital staff.  The patient was not constantly supervised, as suggested, possibly due to a lack of staff.

When the charge nurse arrived several minutes later and determined the patient was not breathing, resuscitation was not immediately begun (either mouth-to-mouth or CPR). She first left to get a light, then a stethoscope, then to find the patient’s nurse.  After the patient’s nurse returned, she left to call a “Code Blue”.  The first aide that arrived was told not to begin CPR or mouth-to-mouth because there was no breathing mask.  She did anyway.  Nine minutes later, the doctor inserted a breathing tube.  The staff attempted to restart the patient’s heart but were unsuccessful and she was pronounced dead.

To determine what actions can be taken so that this never happens again, first we have to do a little more research into a few specific areas.  First there needs to be a thorough investigation on the restraint procedure at this hospital.  Because a patient died in restraints, some aspect(s) of the restraint procedure must be improved.  To improve the procedure, however, first we have to know what the hospital staff  actually did, step by step, in this case (and others).  Then we should look at expectations and/or requirements for supervision of patients who are being restrained, or given sedatives, or who, based on their behavior, require constant supervision.  For example, patients who are held facedown need extra supervision to make sure their breathing is not constricted.  Additionally, it may be appropriate to turn the patient back face up once the sedatives begin to work.

The patient’s death was caused in part by the delay in resuscitation.  Beyond the delay in recognizing the patient’s respiratory distress, the expectations for staff in this situation need to be addressed.  Because the charge nurse was fired, it seems that the hospital did not think she properly performed her expected duties, but why?  Perhaps the staff does not understand what they should do in this case, or doesn’t have the necessary equipment (such as a breathing mask) readily available.  Although refresher training might be in order, we don’t stop there.  We need to figure out all the things that are keeping our staff from being able to do what they need to for their jobs and remove those obstacles – BEFORE this happens again.

To view the outline, timeline and Cause Map, click on “Download PDF” above.  To learn more about this incident, please see the news story.