All posts by Kim Smiley

Mechanical engineer, consultant and blogger for ThinkReliability, obsessive reader and big believer in lifelong learning
Root Cause Analysis

A Stealth Contact Lens Recall?

By Kim Smiley

Avaira Toric contact lenses, manufactured by CooperVision Inc, were voluntary recalled on August 19, 2011.  The recall occurred after dozens of consumers complained about eye problems including impaired vision, eye pain and torn corneas.  According to a company statement, a manufacturing error resulted in a silicone oil residue on some contacts.  More than 8 million lenses were affected worldwide by the recall, but only about 780,000 of these contact lenses were distributed in the USA.

The company has received a large amount of negative media attention following the recall.  News articles and blogs  have claimed that CooperVision was purposely downplaying the recall, resulting in many consumers being unaware that their lenses had been recalled. Unaware of the potential danger, consumers continued to wear their lenses and continued to have eye problems as a result. The FDA publicly threatened to independently inform consumers of the risk associated with these contact lenses if the manufacturer didn’t better publicize the recall.

Following the media attention , the company has increased efforts to notify consumers about the recall.  The FDA has also posted a notice on their website of this recall, identifying it as a Class I recall, the most serious class of recall. The FDA has said that the company’s actions are now consistent with what would be expected with a Class I recall.

This example is a good illustration that the execution of a recall is a very important thing.  If consumers view a recall as slow to happen or badly executed, they will probably be less likely to trust a company in the future.  Ideally, a recall should be executed so that consumers are left with the feeling that a company did the right thing as quickly as possible.

If you are concerned that you might have recalled lenses, you can visit this website  to check.  If your lenses are recall, you are asked to remove them immediately and return them to the point of purchase.

Click on “Download PDF” above to view an outline and initial Cause Map of this example.

Root Cause Analysis

Increased Risk of HIV Transmission with Injectable Contraceptives

By Kim Smiley

A recent study has brought to light some disturbing news for women using injectable contraceptives.  The study, published October 4, 2011, has discovered that the transmission rate of HIV is nearly doubled for both women who use injectable hormones for contraception and their partners.  Specifically, the rate of HIV transmission for women is 6.61 per 100 people per year when using injectable contraceptives, compared to 3.78 for those who do not.  For men whose partners use injectable contraceptives, the rate is 2.61, compared to 1.51 whose partners do not use injectable contraception.

This study may have profound implications.  More than 12 million women in eastern and southern Africa use injectable contraceptives.  Their popularity is likely due to the cost and convenience of the once-quarterly shots, used to prevent unintended pregnancies, long an issue for maternal health in the developing world.  Although the injectable contraception is not meant to prevent transmission of HIV and other sexually transmitted diseases, the hormones (namely progestin) in the injectables appear to cause a biological change that actually increases the rate of HIV infection ABOVE that of using no contraception at all.  Previous studies have also suggested this is the case, and have found that pregnancy also increases the rate of HIV.  Birth control pills (taken once daily) may also increase the risk, though so far the increase is statistically insignificant, possibly because daily pills involve   much smaller amounts of hormone.  (Although the increased transmission risk is true for all who use injectable contraception, the focus is on sub-Saharan Africa because of the high rate of HIV.)

The World Health Organization (WHO) will be reconsidering its contraception recommendations as a result of this study.  Woman using contraceptives are unlikely to use additional means of preventing HIV infection so wide spread use of a birth control method that doubles the risk of HIV infection creates a very real, global health risk.  However, the risk of death or serious health issues from unintended pregnancy have still not decreased, leading health officials unsure what the best path forward will be.  Removing an effective pregnancy control without other equally attractive options could leave more women at risk.  Officials at WHO will be working through this issue to see if both health risks from unintended pregnancy and HIV transmission can be minimized together.  It will be a tough job, but the lives of millions are at stake.

To view the Outline and Cause Map, please click “Download PDF” above.

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

Five Receive HIV Postive Organs

By Kim Smiley

Waiting on a transplant list must be a nerve racking, intensely stressful time.  But what if the problems only get more complicated once the long awaited organ is transplanted?  In a terrible case of miscommunication, two respected hospitals in Taiwan recently performed five transplants using organs from a HIV positive donor.

How did this happen?

A Cause Map, an intuitive form of root cause analysis, can be used to analyze this incident.  As is typically the case, this is an example of multiple errors combining to cause a major issue.  The proper tests were performed.  The lab results showed that the donor was HIV positive, but the test results were never known by the right people.  The initial results were given over the phone and misheard.  One cause of this confusion is that similar words are used for negative and positive tests.  The English word “reactive” is used for a positive HIV test and “non-reactive” is used for a negative test result so a single syllable made all the difference.  But this mistake alone was not the sole cause of the HIV positive organs being transplanted.

Standard procedure requires that surgeons take a time out prior to surgery and verify all information, including important lab test results.  If the final checks were performed as specified, the surgical team would have seen the positive HIV results.  Additionally, the transplants were performed at two separate hospitals so final checks were truncated at two different locations.

The most poignant element of this example may be the fact that the correct information was known prior to the surgeries.  If the test results had been effectively communicated, the HIV positive organs would never have been transplanted.  This example has several lessons learned that can be applied across industries.  This issue highlights the importance of following procedures, even if they seem redundant, and using checklists, even if they seem unnecessary.  The importance of effective communication is also evident.  When using verbal communication, little steps like repeating back information to verify understanding and using words that sound distinctively different from each other can help eliminate errors.

The investigation of this case is still ongoing and the hospitals are working to make necessary changes to ensure an incident of this type never happens again.  The five patients who received the organs are being treated with antiviral HIV medications, but doctors state it is very likely that they will contract HIV as a result of their organ transplants.

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

Heatstroke Deaths of Football Players

By Kim Smiley

A study released in 2010 shed some light on what seems like a high number of football players dying of heat-related deaths.  The study determined that the number of heat-related deaths have actually increased in recent years from less than two per year in the early 90s to nearly 3 currently.  The study outlined some of the causes for the increase.  We can look at these causes in a thorough root cause analysis built as a Cause Map.

We begin with the outline, which captures the impact to the goals as well as the general information about the issue we are investigating.  In this case, we are looking at deaths of football players in the U.S.  The study determined that most deaths occur during football practice in August, in the morning, to linemen.  The impact to the goal of concern is risk of player death.

Beginning with the impacted goal, we can ask why questions to analyze the issue.  The player deaths occur from heatstroke that is not treated immediately, whether from players and/or coaches not recognizing the signs of heatstroke, or treatment being delayed while waiting for an ambulance or other medical professional.  Heatstroke occurs when a person’s heat generation is greater than their cooling ability.  This means there are two parts to the analysis: the heat generation, and the cooling ability.  In this case, increased heat generation occurs from high ambient heat and high levels of body heat being produced, caused by practicing outside in hot weather.

Insufficient cooling ability can occur when a player’s sweating isn’t doing enough to cool him – such as when a player isn’t producing sweat due to dehydration or when the sweat isn’t evaporating, such as in high humidity.  Additionally, players who are large (have a high BMI) tend to be more susceptible to heatstroke as their bodies tend to store more heat.  This is presumably why most deaths occur in linemen, who tend to be larger (79% of the players who died had a BMI above 30.)  Most deaths occur in August, which, in addition to being hot, tends to be the start of the season, meaning players are not accustomed to practicing in the heat.

What can players, coaches, school districts, and parents do to limit the risk of death from heatstroke?  First, ensure that everyone involved in a sporting program recognizes the signs of heat-related illness.  There is a CDC toolkit that provides important information.  Next, make sure that a player who has signs of heat-related illness is treated immediately – while waiting for the ambulance to arrive, take the player out of the sun and spray him with water.  To try and avoid heat-related illnesses, ease into practices at the beginning of the season, limit practice time in extremely high heat and/or humidity, and provide plenty of hydration.

To view the outline, Cause Map, and solutions, please click on “Download PDF” above.

Root Cause

Can Safety be Taken Too Far?

By Kim Smiley

Sometimes, what seems like a very simple, easy solution turns out to be much more complicated.  Unless a system is very well understood, implementing a solution can have unintended consequences.  Take for example, the changes made to playgrounds over the past couple of decades.  There was concern that children were being injured while playing, especially from falls from high playground equipment.  Removing any playground equipment that was deemed dangerous seemed like an obvious solution to this problem.

Gone are the metal merry-go-rounds and the ten feet tall monkey bars that many of us remember from our youth.  Modern playgrounds are populated by lower, enclosed platforms and soft ground coverings to prevent injuries and protect against lawsuits.

But are modern playgrounds better? According to a recent New York Times article , the answer isn’t the slam dunk you might expect.  There is mixed evidence about whether modern playgrounds actually reduce the number of injuries because children tend to take more risks on “safer” playgrounds.  There is also evidence that the value of playgrounds in childhood development might have been diminished by the increased focus on safety.

A recent paper by Norwegian scientists discusses the value of allowing children to face fears through “risky” play.  The concern is that children are developing more anxieties because they are losing the opportunity to face their fears by tackling challenging playground equipment. Part of the problem is also that safer playgrounds tend to be more boring which discourages children from playing at all.

There are a number of researchers asking whether the potential negative emotional impact of safer playgrounds outweigh the risk from physical injuries associated with taller, riskier playground equipment.  This is a hard question to answer because while it’s relatively easy to measure the number of bones broken on playgrounds, it’s very difficult to measure the intangible benefits of challenging playgrounds.

So can playgrounds be too safe?  It’s not clear that we have a definitive answer to that question, but what is clear is that the problem of playground safety is more complicated than originally assumed.  A Cause Map, a visual root cause analysis, can be built in cases like this to help clarify all known information.  Cause Maps are a very versatile format.  They can be created to incorporated any level of detail needed and can be added to as more information becomes available or as unexpected complications pop up.  To view a high level Cause Map of this problem, please click on “Download PDF” above.