Root Cause Analysis

ER Wait Leads to Amputation

By ThinkReliability Staff

In some cases, it’s easy to equate “cause” with “blame”.  Sadly that seems to be the case for the family of a 2-year old triple amputee from Sacramento, where a near-certain malpractice suit looms.  The fundamental question in this story is whether or not Malyia Jeffers would have come so close to death had she been diagnosed and treated sooner, upon arriving at the emergency room.

Malyia, bruised, feverish and weak, waited with her family in her local hospital’s emergency room for five hours.  Originally assessed as sick with only a virus and a rash, her parents suspected something more.  Once again a triage nurse reassessed Malyia as non-urgent, with just a virus and rash.  Finally as her small body went limp, her frantic father barged past the ER nurses’ station to demand a second opinion.  That move is probably what saved her life, as blood tests soon confirmed liver failure due to group A streptococcus (GAS).  Two hospital transfers later, Malyia was on life support and blood pressure medication which kept her heart beating and ultimately saved her life.  The lack of oxygen to her limbs however forced doctors to amputate her left hand, fingers on her right hand and both of her lower legs three weeks after her initial infection.

According to the Center for Disease Control, “severe, sometimes life-threatening, GAS disease may occur when bacteria get into parts of the body where bacteria usually are not found, such as the blood, muscle, or the lungs…Streptococcal toxic shock syndrome (STSS) results in a rapid drop in blood pressure and organs (e.g., kidney, liver, lungs) to fail. While 10%-15% of patients with invasive group A streptococcal disease die from their infection, more than 35% with STSS die.”  Doctors know that early diagnosis and treatment are critical with aggressive bacteria such as GAS.  Would Malyia have fared better had she been seen sooner?

Emergency room waiting times have exploded in recent years.  If you were to ask someone on the street why, you might guess that the biggest contributing factor is the growing number of uninsured patients.  Not so, according to an extensive 2009 government report.  Long wait times are actually a symptom of a complex problem.  Vacant hospital beds, specialist availability and access to primary care all play a part in why emergency rooms, especially metropolitan ones, are constantly full.  Using a Cause Map, it is easier to see exactly why.

While Cause Mapping might help us see why ER wait times are a complex issue, it doesn’t alleviate the suffering the Jeffers family has and will face in the months and years to come.   Unfortunately it is tempting to point fingers and place blame.  Yet the reasons behind this tragic cause are not so simple.  Hopefully, process improvements will alleviate the suffering of those stuck waiting in the ER.

More information on the story can be found in the Sacramento Bee.  A 2009 GAO report also provided helpful information on the nation-wide issue of emergency room waiting times.

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

Developing a Meningitis Vaccine Program to Prevent Epidemics in Africa

By ThinkReliability Staff

Meningitis epidemics occur on a regular basis in Africa. Last year, there were more than 88,000 reported cases.  In 1996-1997, during the largest reported epidemic, more than 250,000 cases were reported.  Meningitis is highly contagious and approximately one in ten cases are fatal.  Disability occurs in approximately one in five cases.

The vaccine that was previously available in Africa was a polysaccharide vaccine, which did not prevent transmission of the disease. Understanding that the current situation was dire, the Meningitis Vaccine Project was formed.  With funding from various donors including The Gates Foundation and money raised in Africa, a vaccine that protects against the group A meningitis strain – responsible for more than eight out of ten infections in Africa – has been developed at a cost of less than $.50 (US) a dose.  More funding is still needed to meet the goal of vaccinating 300 million people across 25 nations.    However, the steps that have already been made are remarkable and represent a huge step forward in helping fight this dreadful disease.

Click on “Download PDF” to see the outline and Cause Map of the 1996-1997 meningitis epidemic and the timeline of the progress of the Meningitis Vaccine Project.  To learn more, see the Meningitis Vaccine Project.

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

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

Using Root Cause Analysis to Achieve Organizational Goals

By Kim Smiley

The Commonwealth Fund’s healthcare improvement website (www.whynotthebest.org) provides case studies of medical facilities that have been improving various performance measures.   One of these cases involves Holland Hospital, in Michigan, which has improved its pneumonia process-of-care over the last five years and is now in the top three percent of hospitals in the U.S. for these core measures.

The process for establishing goals and implementing process improvements to meet those goals is the same process that is used for Cause Mapping.  I’d like to highlight some of the tips from Holland Hospital’s success.  (You can read the whole case study at http://www.whynotthebest.org/contents/view/61.)

Establish a team to develop and work towards goals:  The hospital’s “core measures leadership team” contains physicians, clinical directors and other leaders to ensure buy-in from those closest to the work and management.  The team meets to review noncompliant cases (called “opportunities for improvement”) on a monthly basis.  Additionally, the hospital created a respiratory disease core measure team which developed improvement strategies specific to the pneumonia core measures.

Focus on the system, not on blame: According to the hospital’s director of quality and risk: “the hospital’s patient safety culture means being blame-free. Unless the case is egregious, we assume mistakes occurred because the established care process failed our staff and/or physicians.”  Rather than focusing energy on assigning blame, the team focuses on improving systems to reduce the occurrence of similar incidents, improving the core measures performance for all staff members, not just the ones involved in the noncompliant cases.  As an example, the hospital increased screening for the pneumonia vaccine by reprogramming the electronic nursing record to require an answer to

Get everyone involved: If performance goals are met, and money is available, a bonus pool is established for all full-time employees (even those not directly involved in patient care), except hospital executives.  If the performance goals are not met, no bonus money is distributed.

Adjust responsibilities when necessary: The hospital discovered some difficulties with one measure – taking a blood culture prior to giving antibiotics.  The team discovered that there was a delay in taking the blood culture because a phlebotomist had to be called into the emergency room.  The team also discovered delays in administering antibiotics when a patient was transferred to another unit from the emergency department. A process change resolved these difficulties.  Emergency room nurses now take the blood culture (contacting a phlebotomist assigned to the emergency department if necessary) and administer the first dose of antibiotics before the patient leaves the emergency department.

Root Cause

New Research May Lead to Reduced Deaths from Sepsis

By ThinkReliability Staff

Sepsis kills about 200,000 people in the U.S. every year, about 30% of those afflicted. Millions die every year from sepsis worldwide.

Sepsis is a whole-body inflammatory state that occurs in the presence of an infection, and was previously known as a blood infection. The exact causes of sepsis are unclear. However, new research from Portugal’s Instituto Gulbenkian de Cienci has shown that during sepsis, red blood cells may be injured and leak a substance called heme. In combination with inflammation that is present during an infection, the high levels of heme become toxic to the body’s organs, causing organ failure.

The body produces a substance called hemopexin that cleans up the leaking heme. However, as levels of heme rise, levels of hemopexin fall, increasing the amount of heme in the body. The Instituto Gulbenkian de Cienci researchers have had success injecting mice with hemopexin to aid their body in reducing levels of heme. We can show the results of their research in Cause Mapping form, which can be viewed by clicking “Download PDF” above.

This potential solution to reduce the impact of sepsis still requires more research before it can be applied to humans, but may indicate a first step towards reducing the high impact of sepsis on mortality.