Tag Archives: cause mapping

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

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

Medical Information from 20,000 Patients Posted Online

By ThinkReliability Staff

Unfortunately, privacy of health records has become an increasingly frustrating issue.  The Department of Health and Human Services revealed that records for 11 million people were potentially made public for over two years.  A recent medical records privacy breach has made the news for the length of time the records were publicly exposed.

A hospital in California recently notified 20,000 patients that their data had been published on a commercial website from September 9, 2010 to August 23, 2011.  The published data was discovered by a patient and had been used to demonstrate the use of turning data into a bar graph.  This particular data had been given to an outside contractor for billing purposes. Although it did not contain information usually used for identity theft – such as social security numbers, it did include names and diagnosis codes, meaning that extremely personal information was included.

We can examine this issue in a Cause Map, or visual root cause analysis.  A Cause Map begins with the impacts to an organization’s goals and uses the principles of cause-and-effect to examine the causes that contributed to these impacts.  Any breach of patient privacy can be considered an impact to the patient services goals.  In fact, health care organizations may choose to add a new goal category of “Patient Privacy”.  (This is shown on the  downloadable PDF.  To view, click “Download PDF” above.)  In addition to the impacted patient services and patient privacy goals, the hospital was fined $250,000 (the maximum) by the California Department of Public Health and provided identity protection services to the affected patients.  Given the astonishingly large numbers of medical records accidentally made public, this is an issue to which all healthcare facilities should be paying attention.

The exact method that the data made it onto a public website (which provided homework assistance) is not known, but the data had been provided to an outside contractor used for billing purposes.  The contractor is no longer being used by the hospital, and some privacy experts say that better confidentiality agreements are needed by hospitals who provide patient information to outside contractors.  What is particularly disturbing about this case is that the data remained online for nearly a year – and was discovered by a patient.  However, there does not seem to be a practical way for individual organizations to monitor the internet for misplaced patient data.  Instead, focus should be on ensuring better protection upfront for medical data, in an attempt to limit breaches of patient privacy.

To view the Outline and Cause Map, please click “Download PDF” above.  Or view the New York Times article to learn more.

Hospital Acquired Condition, Root Cause Analysis

Teenager Paralyzed After Epidural Not Removed

By ThinkReliability Staff

In May 2008, a fourteen-year-old entered an English Children’s Hospital for a routine surgery to remove gallstones.  The recovery, however, was anything but routine.  The patient was given a spinal epidural to reduce pain during the operation; however, the epidural was not removed until two days later. By then, permanent damage of the spinal cord caused the patient to be paralyzed from the waist down.

The hospital has admitted liability, possibly leaving them responsible for some or all of the patient’s specialist care and support.  Because the anesthetic needle was not removed until the patient’s body until far later than it should have been – and more than a day after the patient’s first complaints of leg numbness – it begs the question whether the procedure for administering an epidural included follow-up care, including removal.  Procedures – whether they are written down or not – exist for most complex tasks, especially medical tasks that involve risks to patient safety.  If use of the procedure results in an error, it should be re-examined.  However, many procedures only include the first part of a procedure, or the administration, ignoring follow-up that must be completed to ensure the process is a complete success.  In this case, that follow-up should have included checks to ensure that the patient was recovering from the epidural (which would have noted something amiss when she continued to feel numbness in her legs) and a schedule to remove the epidural.  Because neither of these things happened, a plan for follow-up after administering epidurals must be developed and put into practice.

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

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 Analysis

Working to Ensure Safe Assembly of Surgical Tools

By ThinkReliability Staff

A 2-month old was undergoing a cystoscopy to incise a ureterocele in the bladder.  During the endoscopic procedure, a resectoscope was used to remove the unwanted tissue.  However, during the operation part of the resectoscope slipped off, exposing a hook-shaped internal piece of the instrument.  Fortunately the patient was not injured; however the potential for injury was very real.  How did the medical instrument come apart?

The first step in an incident investigation is to determine what the problem is and what the impacts to the organization’s goals are.  In this case, the problem is fairly straightforward – the resectoscope fell apart while inserted into a patient.  Although details are scant in this case, the problem statement is filled out as completely as possible to document what occurred.  The second part is to determine the impact to the organization’s goals.  An obvious impact is the potential harm to the patient, related to the hospital’s patient safety goal.  There was also the possibility of legal action, which would impact property goals.  Finally, there likely was the need to redo the procedure, taking additional time, thus impacting the organization’s labor goal.

The second step is to build a Cause Map by asking why an event occurred.   The Cause Map visually depicts what led to the young patient being exposed to harm.  In this case, the three goal impacts converge on the event where the hook electrode became uncovered.  It should be noted that multiple causes led to the patient being exposed to harm; if the resectoscope had been broken but had not been in use, then it would not have mattered.  It is crucial to include all reasons on the Cause Map because those reasons may be key to developing the optimal solution.

Facts that need to be captured about an investigation can be included in evidence boxes on the Cause Map.  They can provide the reader with important background information.  In this example, information about the hook electrode is included so that the reader knows what it is.

Reviewing the complete Cause Map, it turns out that the resectoscope was incorrectly assembled.  The third step in an incident investigation is to develop a set of solutions.  Remembering that all causes are necessary to produce an effect, the investigation team can brainstorm solutions to eliminate or counteract contributing causes.  In this case, three possible solutions were developed.  It is possible that the resectoscope could be designed differently so that the insulation would not be able to slip.  While this is a reasonable long term solution, it would not immediately remedy the problem.  Another solution would be to verify that the instrument is in working order before using on a patient.  This may have occurred, but it should be included until ruled out as a potential solution.  A final idea is to revise the assembly procedures for the resectoscope.  This is in fact what the FDA recommended.

The FDA recommends that the manufacturer’s assembly procedures always be carefully followed.  A process map is another helpful tool to determine where something went wrong.  The organization can build a process map depicting the ideal sequence of events, then compare that with what actually occurred.  The problem may not be in the instructions; the instructions might be perfect!  However, if someone doesn’t follow those instructions correctly, the process isn’t going to reach the desired outcome.

At this point, the investigation team might go back to the Cause Map to elaborate on the why the resectoscope was incorrectly assembled.  This might generate new solutions and changes to the ideal process map.  Through this iterative process, an optimum solution can be found.

This event was reported as part of the FDA’s MedWatch program.  The FDA encourages health professionals to voluntarily report problems on medical devices.  For more information on the MedWatch program, please visit their website.