All posts by ThinkReliability Staff

ThinkReliability are specialists in applying root cause analysis to solve all types of problems. We investigate errors, defects, failures, losses, outages and incidents in a wide variety of industries. Our Cause Mapping analysis method of root causes, captures the complete investigation with the best solutions all in an easy to understand format. ThinkReliability provides investigation services and root cause analysis training to clients around the world and is considered the trusted authority on the subject.
Root Cause Analysis

Hungover Surgeons More Likely to Err

By ThinkReliability Staff

The headline probably isn’t shocking to anyone who’s woken up the next morning with a pounding headache and dry mouth.  Clearly one’s performance at work is going to be impacted by a night of unabated drinking.  However a recent Irish study, published this month in the Archives of Surgery, show surprising results regarding the lingering effect of alcohol consumption.  Their findings show that well into the day surgeons are more likely to make mistakes.

Modern surgical techniques, including laparoscopic surgery, require great manual dexterity and control as well as sustained mental focus.  It is common knowledge that both of these skills are impaired while intoxicated.  What is unknown is how these skills are impaired after one is no longer intoxicated, but obviously still affected.  In all but one test subject, their blood alcohol content (BAC) had returned to 0.00%.  Initial testing done in the morning showed no significant difference between test and control subjects, however later in the day there was a perceptible decline.  While the study was only a preliminary one, it indicates that more research is needed in this area.

A Cause Map can be especially helpful in a research environment because it helps define causal relationships.  In this case, the researchers focused on the effects of drinking the night previous.  But perhaps there are other reasons at play, such as fatigue, which contribute to the effect.  When searching for causes it is important not to focus in on one aspect, ignoring others, since all causes are required to produce an effect.

It is expected that surgeons wouldn’t actually drink while at work.  However, there are surprisingly no guidelines about when they should stop drinking beforehand.  Pilots are federally mandated not to drink at least 8 hours prior to flying or fly with a blood alcohol content (BAC) of .04% or greater.  Perhaps this study will generate an overdue discussion on the need for abstention prior to surgery.  Potential solutions, such as training or regulations, can be displayed directly on the Cause Map above the appropriate cause.

Hospital Acquired Condition, Root Cause Analysis

Tackling a Seemingly Insurmountable Problem

By ThinkReliability Staff

The goal of any root cause analysis is to uncover causes and, most importantly, solutions that will reduce the risk or mitigate the effects of the problem being studied. However, sometimes a problem seems insurmountable. Take rising health care costs. There are myriad causes that contribute to increasing health care costs. Many of the solutions that have been identified are costly, difficult, or both. Additionally, some solutions place the onus on patients, which can limit the effectiveness. Although patients presumably would love to reduce their health care costs, most don’t have the resources to do so.

Although rising healthcare costs is a national issue, some of the problems you face at an organization may seem just as insurmountable. What can be done when an issue appears too big to fix?

First, ensure that you limit your analysis and potential solutions to your own sphere of influence. Although patients individually reducing obesity and taking their medications properly and on time would certainly reduce healthcare risks, those steps must be taken by the individuals. As a healthcare organization though, it is possible to take steps to increase the probability that individuals will take these steps. Generally patient education, automated reminders, and making it easier to do the right thing – by including clearer instructions on prescriptions or offering more fresh fruit in the hospital cafeteria – are steps that can be taken that are within the realm of an organization’s sphere of influence. Attempting to control solutions outside your sphere of influence is an exercise in frustration!

Next, focus on a single piece of the pie. Not all the causes identified during a root cause analysis have to be tackled at once. A great way to get started: find a solution that is nearly free and can be implemented fairly transparently to staff. For example, ask providers to hand out a healthy eating brochure to patients as they leave their appointment. Is this going to make a big impact? Probably not, but it’s somewhere to start. And even a little impact can help.

Or, take a note from Camden, New Jersey. In Camden, 1% of patients are responsible for 30% of medical costs. Jeffrey Brenner, a local physician, is making a difference reducing costs by focusing on those few patients. This is the big “bang for your buck” solution. And, the solutions that work for this 1% will probably help reduce costs for the other 99% as well. By focusing on a small number of patients – determining the causes specific to them and tailor-making solutions – headway is being made against an extremely difficult problem. (Read more at: http://www.newyorker.com/online/blogs/newsdesk/2011/01/atul-gawande-super-utilizers.html)

If you’re feeling overwhelmed, try taking one step at a time. If healthcare costs can be tackled by looking at a small part of the problem, what can your organization do with a focused look at solutions?

Root Cause Analysis

Aging Surgeons

By ThinkReliability Staff

Over 20% of today’s physicians are over the age of 65.  Should this be cause for concern?  After all, we rely on our doctors to take care of us when we are often at our most vulnerable.  While increased age means increased experience, there are also down sides.  Age can bring with it a decrease in physical and mental capabilities, as well as a reluctance to adopt newer technologies.  At least this is what multiple studies have hinted at over the past few years.

The problem is that such a “decrease in capabilities” is highly subjective and difficult to measure.  Surgeons rely on a variety of cognitive and tactile skills in their craft – steady hands, learning new techniques, composure under stress, communication skills, and so on.  As highly trained professionals, it is sometimes difficult to decide when it is time to call it quits.

Furthermore, in the United States, age-based discrimination is outlawed in most industries except where regulated.  For instance, airline pilots and air traffic controllers are both subject to earlier-than-average retirements due to public safety concerns.  Many federal and state public workers, such as corrections officers and firefighters, are similarly limited. It’s difficult to argue that some physicians don’t make similar split-second, life-and-death decisions – especially surgeons.

The associated Cause Map visually lays out the dilemma.  Surgeons who aren’t performing adequately do so for two reasons.  First, they have a medical condition precluding them from performing to standards.  (Note that to keep this Cause Map simple, other issues such as mental health problems, addiction, and failure to maintain their continuing education were not examined.)  Second, they are allowed to continue practicing.

Such physicians continue after their abilities are impacted for a number of reasons.  Some might be unaware of their condition or unwilling to accept it, both stemming from a belief that they are still competent to practice.  Additionally, current processes at most hospital are slow to identify such physicians.  Most hospitals rely on co-workers to identify such doctors, clearly a highly subjective and ethically complex system.  Age-based screening is not common at many hospitals, partly because of resistance from hospital staff.  In fact, only 5-10% of hospitals have directly addressed this issue.  Labeling doctors as “unfit to practice” isn’t necessarily a bad thing.  If such doctors are identified early, patient safety is enhanced.  Additionally, early identification can sometimes allow those doctors to continue practicing in a controlled and safe environment.

Now that the problem has been laid out, the next step is to look for possible solutions.  It’s clear that little can be done about age-related deterioration.  So the focus moves to the other branch of the Cause Map.  Here there are a number of possibilities.  While age-based screening is certainly an option, it’s not the only one.  For instance, including hospital staff in making decisions might also help decrease resistance to identifying deficient physicians.  Additional training on the impacts of age might make co-workers more willing to discuss their concerns.  Or doctors might be more willing to adapt to their limitations if regular screening can identify possible health problems.

While more research is needed to determine how extensive this issue is, it is clear that at most hospitals current procedures to identify deficient physicians are lacking.

Root Cause Analysis

Pregnant Woman Receives Wrong Medication

By ThinkReliability Staff

One of the most exciting moments in a young couples’ relationship is finding out that they are about to start a family.  New moms-to-be will take extra precautions to make sure their child has the best possible start in life – a healthier diet, a regimen on prenatal vitamins, limitations on coffee and so on.  However, that excitement is sometimes tempered with worry about the new baby’s health.

Mareena Silva had just found out she was expecting.  Six weeks pregnant and a bit under the weather, her doctor prescribed Mareena antibiotics to clear up an infection.  She filled the prescription at the local Safeway, and after taking the medicine as directed, became nauseous.  Upon checking the medication label, she made the horrifying discovery that she had been given the wrong medicine.

Instead of the antibiotics she had been prescribed, Mareena had taken a dose of methotrexate.  Methotrexate is a chemotherapy drug which targets rapidly dividing cells, like cancer…or embryos.  Her doctor urged her to vomit whatever medicine she could.  Then an ambulance rushed her to the hospital where she was given charcoal to absorb any medication remaining in her stomach.  Unfortunately, at this point all she can do is wait to see if her unborn child was affected by the unintended medication.  Methotrexate can cause serious birth defects, especially during the critical formative period during the first trimester, and even miscarriage.  Reports state that the baby faces 50-50 odds of developing abnormalities.

How did Mareena end up with a drug sometimes used to abort ectopic pregnancies?  The pharmacy staff dispensing the medication accidentally handed her one intended for patient in her late 50’s with a very similar name.  According to statements released by Safeway, pharmacy staff failed to repeat Silva’s name to her twice and verify her birth date – standard company policy.  The company has said that they are conducting an investigation to see why their procedure was not followed.  They will not be the only ones looking into the incident; the Colorado Pharmacy Board will also be reviewing the case.

Unfortunately mistakes like this are far too common.  No national agency tracks how many prescriptions are incorrectly distributed, and few states track such information either.  However, a 2003 study by Auburn University indicates that the dispensing error rate could conservatively be estimated at 1%.  That’s astonishing considering billions of prescriptions are filled each year.  How might those errors be prevented?  Dispensing medication is more complex than meets the eye, and there are a number of places a mistake can happen.  In this instance, Safeway’s pharmaceutical staff did not follow proper procedures for dispensing medication.  18.3% of dispensing errors were caused by procedures not followed according to U.S. Pharmacopeia’s 2003 study of medication error reports.

While the investigation will unearth further information about what happened behind the counter that day, a detailed Cause Map pictorially lays out how the incident occurred and why.  As the investigation unfolds, more information can be added and solutions can be developed to prevent future incidents like this one from happening.

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.

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

Shoulder Dystocia

By ThinkReliability Staff

Shoulder dystocia (SD) happens during childbirth when a baby’s shoulder gets stuck in the pelvic opening.  Shoulder dystocia can cause injury to or death of the baby and maternal injury.  These are impacts to the patient safety goals.

A very basic Cause Map shows that the potential for maternal and infant injury occurs from difficulty delivering the baby.  The difficulty is caused by a combination of shoulder dystocia (which occurs during vaginal delivery when the fetal shoulder width is greater than the pelvic opening) and improper management of the delivery.  Based on this very simplified Cause Map, two solutions are to plan for a cesarean section (C-section) when there is the potential for shoulder dystocia, and to define the process for delivery when shoulder dystocia occurs.

We can define a very basic process map for delivery management. First, the patient should be evaluated for the potential for shoulder dystocia.  Then, the labor team prepares for the potential for shoulder dystocia.  If shoulder dystocia is diagnosed, the team should perform the appropriate response, deliver the baby and then administer post-partum follow-up.  The key to this, of course, is to define the appropriate response.

We can add more detail to part of this process map.  Specifically, the additional detail outlines the “HELPERRZ” process used by some medical facilities for the management of  shoulder dystocia.  (To view the Outline, Cause Map and Process Map, click on “Download PDF” above).