Category Archives: Root Cause Analysis

Root Cause Analysis

Wrong Surgery Performed on Patient (Part 1)

By ThinkReliability Staff

A case study of an incident where the wrong surgery was performed on a patient was recently published in the New England Journal of Medicine.  Surprisingly, the study was published by the surgeon who performed the operation, because, in his words, ” hope that none of you ever have to go through what my patient and I went through.”  The surgeon also provided full disclosure to the patient – who requested that he also perform the correct surgery.

We will be analyzing this issue in two parts.  This week, we’ll be looking at the timeline of events and a process map of the universal protocol developed to reduce the incidence of surgical errors.  (The timeline and process map can be seen by clicking “Download PDF” above.)  Next week, we’ll perform a root cause analysis of the issue.

The timeline of events shows a harried day where the surgeon in question performed a carpal tunnel release surgery with a patient who became upset about the use of anesthetic, then briefed the patient who would later receive the wrong surgery, then performed another carpal tunnel release surgery on a second patient.  Then the first patient became very agitated, resulting in an emotional conversation for the surgeon.  Delays resulted in a change of operating room and operating staff for the third patient, so the nurse who had performed the pre-procedure assessment was no longer participating in the procedure.

The  procedure was further delayed when the circulating nurse had to leave to find a tourniquet, since there wasn’t one in the operating room.  The surgeon spoke to the patient in Spanish (she did not speak English), which the nurse took as the time-out, so a real surgical time-out did not occur.  As per hospital protocol, the patient’s arm, but not the specific surgical site, was marked, but it washed off while her arm was being prepped for surgery.

It’s easy to see how this sets the scene for mistakes. Unfortunately, these kind of things happen, and so it is important that there are procedures in place to minimize errors.  The procedures here are the universal protocol, which are shown on the PDF.  Additionally, the parts of the process that were not performed, or were performed improperly, are noted in red.

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

Hospital Working Hard to Prevent Recurrence of Medication Errors

By ThinkReliability Staff

Experts believe that most medical errors go unreported, due to a combination of lax reporting laws, strict patient privacy laws, and ambiguous definitions of these medical errors.  However, Seattle Children’s Hospital is making an attempt to be forthright and accountable with not only its mistakes, but its plan for improvements.  Seattle Children’s made the news recently when it published the serious reportable events that had occurred there from 2004-2010, including two deaths resulting from medication errors.

Additionally, a third child died after a medication error in September 2010, but it has not been determined if the medication error contributed to the death and an adult patient was given the wrong medication but recovered at around the same time.

In response to these errors, Seattle Children’s is performing a root cause analysis by independent experts to determine the causes.  In the meantime, Seattle Children’s is making specific process improvements, such as allowing only pharmacists and anesthesiologists to administer calcium chloride (an overdose of which led to one of the deaths), as well as general training and reminders for staff.  The hospital held a patient safety day on Saturday, October 30th, 2010, where over 550 staff members participated in training and simulations designed to improve patient safety, with a focus on medication safety.

Although the root cause analysis of the various medication errors has not been completed, Seattle Children’s has identified some specific causes that may contribute to medication errors and is launching improvements to try and reduce the impact of these causes.  For example, interruptions to nurses when they are in the process of ordering, preparing or administering medications can lead to medication errors.  During the training, the staff discussed the types of interruptions that occur and what can be done to reduce them.

Medication errors are estimated to kill 1.5 million people per year, so Seattle Children’s is not the only medical facility that will find itself reeling after the deaths of several patients.  These other facilities should take Seattle Children’s lead and begin a serious attempt to reduce these errors, and deaths.

Want to learn more?  See our webpage about medication errors in medical facilities or watch the video.

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, 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.

Root Cause Analysis

Therac-25 Radiation Overdoses

By ThinkReliability Staff

The Therac-25 is a radiation therapy machine used during the mid-80s. It delivered two types of radiation beams, a low-power electron beam and a high-power x-ray. This provided the economic advantage of delivering two kinds of therapeutic radiation with one machine. From June 1985 to January 1987, the Therac-25 delivered massive radiation overdoses to 6 people around the country. We can look at the causes of these overdoses in a root cause analysis performed as a Cause Map.

The radiation overdoses were caused by delivery of the high-powered electron beam without attenuation. In order for this to happen, the high-powered beam was delivered, and the attenuation was not present. The lower-powered beam did not require attenuation provided by the beam spreader, so it was possible to operate the machine without it. The machine did register an error when the high-powered beam was turned on without attenuation. However, it was possible to operate the the beam with the error and the warning was overridden by the operators.

The Therac-25 had two different responses to errors. One was to pause the treatment, which allowed the operators to resume without any changes to settings, and another was to reset the machine settings. The error resulting in this case, having the high-power beam without attenuation, resulted only in a treatment pause, allowing the operator to resume treatment with an override, without changing any of the settings. Researchers talking to the operators found that the Therac-25 frequently resulted in errors and so operators were accustomed to overriding them. In this case, the error that resulted (“Malfunction 54”) was ambiguous and not defined in any of the operating manuals. (This code was apparently only to be used for the manufacturing company, not healthcare users.)

The Therac-25 allowed the beam to be turned on without error (minus the overridden warning) in this circumstance. The Therac-25 had no hardware protective circuits and depended solely on software for protection. The safety analysis of the Therac-25 considered only hardware failures, not software errors, and thus did not discover the need for any sort of hardware protection. The reasoning given for not including software errors was the “extensive testing” of the Therac-25, the fact that software, unlike hardware, does not degrade, and the general assumption that software is error-proof. Software errors were assumed to be caused by hardware errors, and residual software errors were not included in the analysis.

Unfortunately the coding used in the Therac-25 was in part borrowed from a previous machine and contained a residual error. This error was not noticed in previous versions because hardware protective circuits prevented a similar error from occurring. The residual error was a software error known as a “race condition”. In short, the output of the coding was dependent on the order the variables were entered. If an operator were to enter the variables for the treatment very quickly and not in the normal order (such as going back to correct a mistake), the machine would accept the settings before the change from the default setting had registered. In some of these cases, it resulted in the error described here. This error was not caught before the overdoses happened because software failures were not considered in the safety analysis (as described above), the code was reused from a previous system that had hardware interlocks (and so had not had these problems) and the review of the software was inadequate. The coding was not independently reviewed, the design of the software did not include failure modes and the software was not tested with the hardware until installation.

This incident can teach us a lot about over-reliance on one part of a system and re-using designs in a new way with inadequate testing and verification (as well as many other issues). If we can learn from the mistakes of others, we are less likely to make those mistakes ourselves. For more detail on this (extremely complicated) issue, please see Nancy Leverson and Clark Turner’s “An Investigation of the Therac-25 Incidents.”

Root Cause Analysis

Impure Injections Used

By Kim Smiley

Research is been suspended at a prominent brain-imaging center associated with Columbia University. Food and Drug Administration investigations found that the Kreitchman PET (positron emission tomography) Center has injected mental patients with drugs that contained potentially harmful impurities repeatedly over the past four years.

Investigations by the lab determined that no patients were harmed from the impurities, but this is still a significant issue in a nationally renown laboratory.

How did this happen?

This issue can be investigated by building a root cause analysis as a Cause Map. To start a Cause Map, the impact to the organization goals is determined. In this example, this issue is obviously an impact to safety because there was potential to harm patients. It is also an impact to the production-schedule goal because research has been suspended. Additionally, this problem is an impact to the customer service goal because this issue raises questions about the validity of research results.

To build a Cause Map, select one goal and start asking “why” questions to add causes. In this case, the first goal considered will be the safety goal. There was a potential for injury. Why? Because impure injections were given to patients. Why? Because the injections are necessary for research, because the labs typically prepare the compounds themselves and because the lab prepared the compounds incorrectly. When there is more than one causes that contributed, the causes are added vertically with an “and” between them.

Each impacted goal needs to eventually connect to the same Cause Map. If they do not, the impacted goal may not be caused by the same problem and the goals should be revisited.

To continue building the Cause Map, keep asking “why” questions for each added cause until the level of detail is sufficient.

A Cause Map can be as high level or as detailed as needed. The more significant the impact to the goals, the more likely a detailed Cause Map will be warranted. Once the Cause Map is completed, it can be used to develop solutions to help prevent the problem from reoccurring.

In this example, the lab is currently changing management and reorganizing procedures to help prevent the similar problems in the future.

To view an initial Cause Map for this issue, please click the “Download PDF” button above.

Root Cause Analysis

The Downside of Preparedness?

By Kim Smiley

The U.S. Government has announced that 40 million doses of swine flu vaccine have expired and must be disposed of.   In addition, 30 million more doses are about to expire and will also be disposed of (unless there is a sudden need for swine flu vaccine).  The vaccine doses are worth $260-$450 million.  We can capture this information in a problem definition outline.

Then the question is: is this a bad thing (a problem) or a good thing (a success)?  Like a lot of things, it doesn’t necessarily have to be one or the other.  There’s an aspect of success – swine flu did NOT turn out to be a deadly global epidemic, as was predicted – and an aspect of failure – up to $450 million of vaccines were tossed out.

The question that remains for the analysis is: how do we maximize the successes (preventing epidemics) and minimize the not-so-good stuff (wasting vaccines and money)?  A detailed root cause analysis can draw out the successes and problems associated with any event, including this one.  We can use it to look at the planning process used for an epidemic to look for places where the estimation of the need for vaccines can be improved.  We can even look at the use of and expiration dates of the vaccine to determine if, in the future, a backup plan might allow us to get some secondary use out of the vaccines.  Opportunities for improvement are limited only by the brainstorming capability of your organization!