Tag Archives: Root Cause Analysis

Root Cause Analysis

Contaminated Cantaloupes Cause Deaths

By Kim Smiley

The number of food recalls in the news lately is enough to make you lose your appetite.

Let’s start by focusing on just one of the recent recalls.  Listeria from contaminated cantaloupe has caused at least 15 deaths and has sickened more than 80 across the USA.  Tests have traced the listeria back to a single farm in Colorado, but the source has not yet been identified.

Listeria is a common, but potentially deadly bacteria that can be found in soil, water, decaying plant matter and manure so the potential sources are numerous.  Another important piece of information is that Listeria can be difficult to eliminate once it has spread to distribution and processing facilities because it grows well at low temperatures, unlike most bacteria.  Listeria can continue to grow in refrigerated areas where fruit maybe stored or processed.

Finding the source of a listeria outbreak can also be difficult because it can take up to two months for an individual to become sick.  Adding to the complexity of identifying what food is causing an outbreak of listeria is the wide variety of foods that can become contaminated.  Listeria can be found in meat, dairy, fruits and vegetables.

Even once the source of contamination has been identified, it can be difficult to effectively remove the item from the food supply.  In this example, the sheer number of cantaloupes involved as well as a long supply chain made it difficult to remove all contaminated melons.  The farm recalled their entire 2011 cantaloupe crop which was more than 300,000 cases distributed from the end of July to mid-September.  The cantaloupes were shipped to 25 states and sold through many different retailers.

A recent article by CBS stated that the average cantaloupe makes four or five stops on the way to the super market shelves.  Typical cantaloupes will go to a packing house for cleaning and packing, a distributors, a retail distribution center and finally a grocery store before they make it to the consumer.   This makes it very difficult to identify where a food might have been contaminated.

Click on “Download PDF’ above to view a high level Cause Map of this issue.  A Cause Map is an intuitive form of root cause analysis that visually lays out the causes that contribute to an issue.

Root Cause Analysis

Fixes Don’t Have to be Complicated

By Kim Smiley

The main goal of doing root cause analysis is to get to the solutions at the end.  The actual analysis portion serves to provide a comprehensive, orderly way to get to those solutions.  The best way to get solutions is brainstorming by all the personnel who have a stake in the issue – and maybe some who don’t.  The New York Times recent series on “small fixes” has highlighted some amazing developments that are helping to mitigate a large number of healthcare issues, in extremely easy ways.

For example: Pap smears are frequently used to diagnose cervical cancer in wealthy countries.  But what about countries that don’t have enough doctors or labs to make this a practical solution?  Increasing the number of doctors or labs is an extremely long-term, complicated solution.  Instead, Johns Hopkins developed a new procedure that can be done in one visit by a nurse, without lab work.  You brush vinegar on the cervix, precancerous cells turn white, and they’re frozen off right then with carbon dioxide.

Another organization, Diagnostics for All, has developed paper diagnostic forms  for a whole host of diseases, which are smaller than a stamp, can be run off on a Xerox machine, cost less than a penny and can be read without training.  Although these end results are inexpensive and accessible, the path to get there may be more complicated.  Diagnostics for All is supported by grants and foundations, but that kind of support is getting harder to find as the economy continues to worsen.  Additionally, profit for items designed primary to assist developing countries are limited.

There’s also the general feeling that expensive, complicated fixes must be better.  Some of the most effective fixes for healthcare issues – washing hands, using checklists, losing weight – are still not universally used and are constantly in danger of being replaced with costly, cumbersome alternatives.  Sometimes it’s just that people don’t believe something simple can be effective.  Sometimes it’s that the people who have been seeing these problems for years believe that if a solution were that easy, it would have already worked, and something more invasive and expensive is needed.  And, sadly, a lot of it comes down to profit.  Expensive machines, diagnostics and procedures simply make everyone involved more money than using vinegar, paper, and soap.  It’s possible, and hopeful, that the changes in the economy will start turning things in a different direction.

How can you start implementing small fixes in your organization?  First, get everyone involved in the root cause analysis and solution brainstorming.  Bring in a few people who don’t appear to have anything to do with the issue.  Explain the issue to them and let them come up with a few solutions.  Their fresh voice may result in a fresh idea.  Examine all potential solutions for ease of implementation and projected effectiveness.  If you’ve got an idea that’s easy to implement, go ahead and implement it.  If it doesn’t work, or more help is still needed, go on to the more difficult-to-implement solutions.  Start an idea box.  It’s free, it’s easy, and you may be surprised what people come up with.  The New York Times has its own “Small Fixes Challenge” It posts a healthcare problem, explains the details of the issue, and invites reader ideas.  The ideas are reviewed by a healthcare professional well-versed in the topic.

Try a small fix in your organization today.  Ask someone what they see as an issue in the organization.  And then ask them what they’d do to fix it.  A great way to get a variety of responses is ask for the “money is no object” fix, a “free” fix, and then a fix somewhere in the middle.  The answers may surprise you.  And they might have a great idea with their “free” fix.  So, what are you waiting for?  Like all small fixes, it’s worth a try.

Root Cause Analysis

The Number of Accidental Child Poisoning from Medication is Increasing

By Kim Smiley

A recent study in The Journal of Pediatrics revealed that the number of accidental drug overdoses by children is increasing in the United States.  An investigation of hundreds of thousands of patient records showed that the number of accidental drug poisonings among children under 5 years of age increased 22% from 2001 to 2008.

In 95% of the cases, the overdose occurred because the child self-ingested the drugs, as opposed to a labeling or dosing error.

Why?  How are so many young children finding and consuming medication? And more importantly, what could be done to prevent these accidental overdoses?

This incident can be built into a Cause Map, an intuitive visual method for root cause analyses.  Better understanding the causes that contribute to a problem can lead to finding better solutions.

According to the study, one of the causes contributing to the increase in accidental overdoses is that there is simply more medication in homes with small children.  As lifestyles change, the population is facing more health problems.  Obesity and metabolic syndromes are more common at younger ages than in the past and more homes of small children now contain medication associated with these illnesses as well as a variety of other medications.

Changes in drug technology have also affected the severity of overdoses, if not the number of occurrences.  More sustained-release medications are being prescribed and they can result in more severe poisoning.

The study also suggests that there is a possibility that people are being less strict about storing drugs safely, but it’s difficult to prove.  There is also the issue that people may not be aware of how dangerous their prescription and OTC medications are.

One thing we know is that the current safety precautions are ineffective.  Children are findings ways to open child proof caps and warning labels aren’t sufficiently motivating adults to safely store medications in locked or inaccessible locations.

Changing medication packaging is one of the potential solutions being considered for this problem.  New packaging that would be more difficult to open or would only dispense limited amounts of medication.  Bottles can be designed to dispense one pill at a time or restrict the flow of liquid.

Root Cause Analysis

Drug Shortages in the US

By Kim Smiley

The FDA has reported a record number of drug shortages in 2010 that is continuing to increase into 2011.  Some of the drugs included in this shortage are chemotherapy drugs.  Providers across the U.S. are reporting that the shortages may endanger patients if they are unable to receive the necessary drugs.  In some cases, drugs that are more expensive, less effective, or both are being used.  Or, patients are turning to the “grey market”, buying drugs of questionable safety that have, in most cases, been significantly marked up.  Additionally, because already approved drugs are needed for clinical trials, some clinical trials have been delayed, limiting the addition of new medications.

We can look at this issue in a Cause Map, a visual root cause analysis.  A Cause Map connects the impacts to the goals of an organization, or in this case, the U.S. healthcare system.  The patient safety goal is impacted because of the risk to patient health.  The organization goal is impacted because of delayed clinical trials.  The patient services goal is impacted because of the lack of needed medication.  Also, the property goal is impacted because of the replacement with more expensive medications.  We use these goals as the basis for our Cause Map, then ask “Why” questions to complete the analysis.

Insufficient supply is caused by demand greater than supply.  Both of these factors can contribute to the overall effect.  Although there are several reasons for increased demand, the most pertinent to this issue appears to be hoarding – where physicians hear of shortages and are attempting to create a stockpile for their patients.   However, increased insurance coverage and general increased need for medication for diseases such as cancer are also likely contributing.

Reduced supply is also contributing to the shortage.  Shortage of raw ingredients is considered to account for about 10% of the issue, with quality issues and insufficient production accounting for the rest.  In some cases, manufacturers are believed to be limiting their production – or ending it all together – because the drugs do not provide much profit.  Many of the limited drugs are generics, which do not provide as much profit as name brand drugs, especially as drug profits were limited by the Medicare Prescription Drug, Improvement and Modernization Act of 2003, which limited price increases in an attempt to limit Medicare spending.  The resulting drug shortage – which is sometimes resulting in paying for much more expensive drugs – is certainly an unintended consequence of this act.

Despite best intentions, changes made to fix an identified problem may in fact cause another one – sometimes one that is far greater.  This is why follow-up to implemented solutions must occur at regular intervals, and must include a comprehensive assessment of whether the solutions are effective.

Some of the solutions recommended to prevent the issues caused by these drug shortages are to create a national stockpile of certain kinds of drugs and requiring notification to the FDA of  supply shortages.  In the meantime, the FDA is providing guidance to patients and providers to attempt to ease the ongoing issues.

Root Cause Analysis

Promising New Leukemia Treatment

By Kim Smiley

One of the best things about the Cause Mapping method of root cause analysis is its flexibility.  For instance, root cause analysis is often associated with fixing problems, but Cause Mapping is also well suited for use when something positive happens.  Why would you bother to analyze something that isn’t a “problem”? Understanding why positive outcomes occurred might help you reproduce the success in other situations.

To better understand how this might work, check out this example that analyses a new treatment for leukemia that is showing excellent promise after the initial trials.  Researchers at the University of Pennsylvania recently published a study  outlining their success treating three leukemia patients with a novel treatment.  A year after treatment, two of the patients appear cancer free and the third patient’s cancer was reduced by 70%.  How did they accomplish this feat?

They drew blood from the patients and genetically modified their T cells (cells that normally serve as part of the immune system) to seek and destroy cancer cells.  Similar concepts have been tried in the past, but the previously modified T cells died out before they were able to destroy the cancer.  A different carrier, a harmless version of the HIV virus, was used to insert genes that told the T cells to multiple rapidly and target cancer cells.  A large batch of the modified T cells were grown and then injected back into the patients.  The patients endured intense flu-like symptoms while the cancers cells died out, but the other side effects have been minimal so far.

So how could a Cause Map help in this example?  It could be used in a number of ways to help others learn and apply lessons.  For somebody interested in the details of the specific cancer research performed, a detailed Cause Map could be created to better understand the intricate details of the technique so that it could be applied more efficiently to treatment for other cancers.  A person interested in how medical research is funded could create a Cause Map that details how this project was funded to learn how to fund their own work. On a larger scale, a Cause Map could be created to understand why certain areas of medical research are better funded than others and to ensure that we’re getting the biggest bang for our research bucks.

For this specific case, a Cause Map could be used to track information and record all relevant details in a simple, intuitive format.  This treatment method will require more intensive testing before it could hope to become standard treatment and having an easily understand method to record and organize all relevant data would be very useful.  Cause Maps can be created in as much detail as needed and they can be built to focus on whatever aspect of the problem is of interest.

To a high level Cause Map of this example, click “Download PDF” above.

Root Cause Analysis

The July Effect

By ThinkReliability Staff

No one ever looks forward to a trip to the hospital, and a new study suggests that you might be particularly wary during the coming weeks.  A new study shows a 10% spike in patient fatalities during the month of July.  Many in the medical profession have been aware of “the July Effect” anecdotally for years, but researchers in the University of California at San Diego study combed through over 62 million death certificates dating back to 1976 to prove its existence.

Why the spike?  Sociologist Dr. David Phillips, who conducted the study, believes it is because new doctors begin their residencies in July each year.  The phenomenon is limited to fatal medical errors, and is not evident in surgical or “general” error rates.  Consistent with the study’s “New Resident Hypothesis”, fatalities are even higher in counties with higher concentrations of teaching hospitals, in which there would be more resident doctors.  It is clear there is a link between higher rates of medication errors and the presence of brand new doctors.

The study is one of the first to demonstrate the linkage though.  Multiple smaller studies have failed to show any correlation between time of year and death rates.  Researchers point out that the new study focused on a much longer time range and broader geographic area than any previous study however.

Although the study raises some interesting questions, it stops short of providing solutions.  Doctors already face a rigorous course of study to prepare for their residencies, which of course are designed to provide the experience needed.  New doctors are also generally well supervised.  And to some extent there will always be risk associated with inexperience when it comes to teaching hospitals.

A Cause Map can illuminate areas that might benefit from further research.  The study narrowed down one of the contributing factors to medication administration.  Why just in that area though?  Are new residents better supervised in the OR?  Do new doctors have the capability of prescribing and administering medication during their first month?  What types of errors do they make when doing this?  Do they prescribe the wrong medication completely?  The wrong dosage?  Or do they overlook adverse interactions with other medications?

More research is needed to accurately determine why the July Effect occurs, but patients can be prepared.  Experts agree that patients should ask plenty of questions and bring along an advocate for support.  For more information, the study, “A July Spike in Fatal Medication Errors: A Possible Effect of New Medical Residents”, is available here.

Root Cause

Diagnosing Hearing Loss in Babies

By ThinkReliability Staff

All new parents wait to hear that first wail in the delivery room, followed by a quick counting of fingers and toes.  Satisfied with their healthy new baby and exhausted from delivery, few notice the battery of tests newborns face in their first few days of life.  Thanks to these tests, many serious problems can be detected and treated before they become life-threatening.

Many states now mandate hearing screening at birth.  Even minor hearing loss, if not caught early, can seriously impede language and social development.  Nearly 2% of babies fail their initial screening, prompting more through testing.  Approximately 0.2% of children born in the U.S. will be diagnosed with hearing loss.  While most children with hearing loss have conductive (outer or middle ear) or sensorineural (inner ear) hearing loss, there is another type of hearing loss.  With auditory neuropathy (AN) spectrum disorder, sound enters the ear normally; but because of damage to the inner ear or hearing nerve, the brain isn’t able to understand the signal.  The sound is similar to what you might hear underwater or on radio with a lot of static.

Little is known about AN, including what causes it and how to treat it.  Hearing aids seem to help in about half of AN cases, although sometimes children and adults grow out of it.  And some patients thrive with cochlear implants.  Until recently, most weren’t certain how many even suffered from the condition.  A recent study shows that this condition may affect up to 15% of children with born hearing loss.

With all the confusion surrounding AN, few pediatricians and audiologists are aware of this condition or what treatment options are available.  Often the first course of treatment is a hearing aid.  Unfortunately this treatment, which amplifies sound entering the ear canal, can be exactly the wrong treatment for some types of AN.  For those with damage to the hearing nerve, blasting noise into the ear canal simply damages the external, working portions of the ear.  Infants have very sensitive hearing, and just a week of continuous hearing aid use can be enough to cause permanent damage.  Unwitting parents, worried about their children and eager to follow the doctor’s orders, may not realize their children are capable of “hearing”, albeit distortedly, until it’s too late.

A Cause Map can help sort out the factors contributing to this problem.  The top of the Cause Map shows the desired outcome.  Mandatory or recommended screening in infancy results in earlier diagnoses of hearing loss, which limits developmental delays further down the road.  However the bottom portion of the Cause Map shows how current screening practices can often lead to misdiagnosis and the wrong treatment.  By focusing on this area of the Cause Map, solutions can be identified to eliminate the unintended effect.

Two such potential solutions have been identified.  First, changes to the screening process might identify AN early on.  Considering that up to 15% of hearing loss may be caused by AN, this may be a more feasible solution than previously thought.  Second, an awareness campaign may help doctors and audiologists become more aware of AN and how to properly treat it.

With more research and greater awareness, there is hope that those with auditory neuropathy spectrum disorder will not accidently suffer more.  For more information on AN, please visit the National Institute on Deafness and Other Communications Disorders website.

Root Cause Analysis

Protein in Donated Blood Causes Life-Threatening Allergy

By ThinkReliability Staff

Blood transfusions are fairly common, with 25 million blood component transfusions occurring per year.  Blood transfusions are also very safe. The risk of health concerns from blood component transfusions is extremely low.  Until recently, it was believed that all the concerns from transfused blood were being tested for and rooted out.  However, a new case presented in the New England Journal of Medicine has presented a new concern.

A six-year-old boy in the Netherlands was receiving pooled platelets when he suffered from an allergic reaction.  The staff was able to prevent potential death or serious injury with an immediate injection of adrenaline.  As a follow-up, the staff tested the boy and ruled out many other potential causes.  The lab tests and testimony from the boy’s mother confirmed an allergy to a peptide, which is a protein that is left in the blood after ingesting peanuts. The peptide, known as Ara h2, is resistant to digestion, as evidenced by studies that have found levels in the blood 24 hours after ingestion.

Because this case demonstrates a newly discovered phenomenon, evidence to support the causes is particularly important.  Evidence supporting the placement of a cause related to a root cause analysis can be placed in a box directly below the cause box on a Cause Map.  (To see the Cause Map, click on “Download PDF” above.)  The allergy to the peanut peptide causing the allergic reaction and the peptides being present were verified by testing and interviews with the donors and the patient’s family.

The immediate solution, to inject adrenaline to prevent the patient’s death from the allergic reaction, was taken immediately but does not do anything to solve the broader problem of potential allergens in the blood supply.  One of the potential solutions is to screen the blood supply for dietary contributions, but considering the large amount of donors and recipients, this is considered to be prohibitively expensive and difficult.  Because there is not a viable alternative blood transplant source, and blood transfusions are still needed by patients with allergies, it seems that the solution must be to figure out a way to remove the proteins, at least from blood transfusions going to people with allergies.  However, another case, from 2003 resulted in a blood product recipient developing allergies when receiving a blood transfusion from a donor who had peanut allergies, so screening the blood supply prior to transfusing people with allergies may not be sufficient.

Root Cause Analysis

Number of Gout Cases Continues to Increase

By Kim Smiley

Gout was historically known as “the disease of kings” or “rich man’s disease” and has long been associated with rich food and excessive alcohol, but recently gout has become a common problem across all socio-economic classes.  More than six million adults in the US have gout and the number will likely keep rising in the future.

Gout occurs when there are high levels of uric acid in the blood stream.  Excessive uric acid forms crystals that collect in joints and soft tissues, causing acute pain and inflammation.  Uric acid is produced when the body processes purines.  Purines are found naturally within the body and are also found in many types of food, including meat (especially organ meat), anchovies, herring, asparagus and mushrooms.

Why are more people suffering from gout? This issue can be investigated by creating a Cause Map and performing a root cause analysis to determine what causes contribute to the problem. (Click on the “Download PDF” button above to view a high level Cause Map of this issue.)

Digging through some of the data available, it becomes clear that the modern diet is one cause, but there are a number of other causes that contribute to gout including higher life expectancy, higher weights, and modern medications.  Risk of gout is also higher for people who suffer from a number of illnesses, including hypertension, diabetes, high cholesterol and congestive heart failure; all diseases which are more common now than they were in the past thanks to advances in modern medicine and increased life expectancy.  Obesity also makes gout more likely and today’s population is heavier on average.  There are also several medications that have been shown to increase the risk of gout, including medicines commonly used to treat high blood pressure and low-dose aspirin.

Gout has typically been considered a man’s disease, but now more women are suffering from it. Prior to menopause, woman naturally have lower levels of uric acid in their blood, but as women live longer more cases of gout are developing in women.

Looking at the risk factors associated with gout, it’s clear why more and more people are suffering from it.  Some risk factors can’t be changed, such as gender or age, but staying healthy overall can reduce the likelihood of suffering from gout.

Never Event

Surgery Performed on Wrong Eye

By Kim Smiley

There are few medical errors scarier than a wrong site surgery.  The idea that you could go to sleep and wake up having had a procedure performed on the wrong body part is terrifying.  Unfortunately, this is exactly what happened to a family in Washington recently.

On April 13, 2011, a surgeon performing a routine procedure to correct a wandering eye mistakenly operated on the wrong eye of a four year old boy.  In this case, the wandering eye was caused by a muscle that was too strong so the surgery was performed to weaken the muscle.  It’s unclear at this point whether the wrong site surgery will have any lasting impact on the patient’s vision, but the patient’s mother has stated that the previously healthy eye is now wandering.  A specialist who examined the boy post-surgery stated that the eye needs to completely heal (about 5 weeks) until any determination can be made about long term consequences.

How did this happen?  How does a surgeon perform a procedure on the wrong part of the body? And most importantly, how do we prevent these types of errors in the future?

The investigation of this incident is still ongoing, but a Cause Map of the incident can be started and then expanded as more information becomes available.  A Cause Map is a visual root cause analysis that lays out the causes of an incident in an intuitive format.  Once the Cause Map is complete, it can be used to develop solutions to help prevent future problems. Click on “Download PDF” above to see an Outline of this incident and the initial Cause Map.

In this example, it isn’t clear yet how the mistake was made.  Findings from the investigation so far have determined that the correct eye was marked before surgery, but statements by the surgeon indicate that the mark may have been accidentally covered by a nurse. The hospital has protocols in place that require checking and double checking the surgery site, but it’s not clear why they weren’t followed.  Once the investigation is complete, the hospital will determine what solutions need to be implemented to ensure that this doesn’t happen again.