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.

Root Cause

Whooping Cough Deaths

By ThinkReliability Staff

Amidst an epidemic of whooping cough (or pertussis) in California, which is the worst since 1958, eight infants have died of the disease.  Infants are prone to catching whooping cough when they are exposed to it, as they have not completed their first round of inoculations and have weak immune systems.  Because the symptoms of early sickness are so mild, whooping cough is very difficult to diagnose based on symptoms alone.   In each of the cases of the eight deaths, the infants had been seen by multiple care providers before an appropriate diagnosis was made.

 Exposure to infants is generally from parents or school-age siblings, who may themselves not know they are infected because of the mild symptoms.  Because the protection from the vaccine that protects against whooping cough lasts only about 5 years, many adults may find they’re no longer properly immunized against the disease.  Some children have never been immunized against whooping cough because their parents have chosen not to vaccinate their children.  Because of the lack of immunity of some members of the community, and the difficulty of diagnosing whooping cough, the problem may continue unless steps are taken.

Some of the solutions being considered are to not allow unvaccinated children to school.  The responsibility of this would fall to school or state officials.   Recommendations are made to keep vaccines for children and adults up to date, but this responsibility ultimately lies with the individual and/or parent.  This may make healthcare providers feel somewhat helpless.  But a recommendation for them has been given – children less than six months old who present breathing difficulties should be given lab tests that would show whooping cough.  This would not prevent infants from getting whooping cough, but would ensure that the disease is discovered, and so can be treated, as soon as possible, hopefully reducing deaths.

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.

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!