Tag Archives: Root Cause Analysis

Root Cause Analysis

Counterfeit Drugs Bought by US Oncology Practices

By Kim Smiley

Counterfeit Avastin, a cancer treatment drug, was purchased by as many as 19 U.S. oncology practices last year.  The counterfeit drug did not contain anything that would harm patients, but there were no active cancer fighting ingredients in it. There have been no reported cases of patients being given the fake drug, but there was a very real risk that this could happen.

How did this happen?  How could so many medical facilities fall for a counterfeit drug?

This example can be analyzed by building a Cause Map, a visual root cause analysis format that intuitively shows the cause-and-effect relationships between the many Causes that contribute to an issue.   In this case, many factors led to the oncology practices purchasing the fake Avastin.  The supplier offered the lowest price for the drug, about $400 less than the manufacturer’s price.  Additionally, the supplier appeared to be legitimate and had a very convincing salesman working for them.  The supplier appeared to have both US phone number and offices in the US.  In reality, the US number phones were being automatically routed to an overseas number, but this process was transparent to the medical practices.  The counterfeit drugs themselves also appeared to be authentic.  As technology improves it is becoming more difficult to spot the fakes.

At this point in the investigation it’s not clear whether the supplier knew the drugs were fakes.  The company claims it had no knowledge that the counterfeit product.  One thing that is clear is why counterfeit drugs appear in the supply.  There is a lot of money to be made. Some prescription drugs are extremely expensive and selling fakes can be very profitable.  The drug in this case, Avastin, sells for more than $2,000 for a 400-milligram vial.  There are also generally less severe punishments for crimes associated with prescription drugs compared with the illegal drug trade.

It is estimated that less than one percent of the drug supply is counterfeit in developed nations, but counterfeit drugs are a huge issue in developing countries.  Even a small amount of counterfeit prescription drugs  has the potential for a large impact on peoples’ health.  There are a number of solutions to this issue that have been suggested.  The US Senate has recently passed a bill that pushes for stronger punishments for counterfeit drug trafficking and calls for a universal system to track prescription drugs, but it’s unclear how this might be adopted into law.

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

Root Cause Analysis

Mercury in Cosmetics

By Kim Smiley

The toxic metal mercury has been found in cosmetics in at least 7 states in the US. Some products contain hundreds or thousands of times the allowable level.  Even small amounts of mercury are a concern as it accumulates in the body.

The use of products containing mercury can result in risk of illness or even death due to mercury poisoning.  Mercury accumulates in the body, increasing the risk with each application.  Additionally, family members can also be exposed, even if they aren’t using the product.

The Food and Drug Administration (FDA) does not allow mercury in cosmetics, whether manufactured in or imported into the US.  These mercury containing products are generally manufactured outside the US and are brought in by non-regulated channels, such as personal mail or luggage.   The FDA is constantly adding products found to contain mercury to the seizure list.  If found, the products are taken and the importers or sellers can face legal action.

Mercury is added to cosmetic products in an attempt to aid in skin lightening, anti-aging or blemish control.  However, it seems unlikely that any effectiveness the product may have is worth the possible side effects of mercury poisoning, which include damage to the kidneys and nervous system, tremors, depression, memory problems, and even death.  It can also interfere with the development of the brain in the unborn and very young.  Because mercury is sometimes listed under different names on the ingredient list (or imported products contain no ingredient list or the ingredient list is in a different language), it’s likely that users of these products are unaware they contain mercury.

The FDA recommends that you check the labels of any products advertised as face-lightening, anti-aging or blemish treatments.  If the label contains mercury, mercurous chloride, calomel, mercuric or mercurio, stop use immediately.  Additionally, if there is no ingredient label or the label is not in English, stop use immediately.  Store in a sealed bag and contact Poison Control or your healthcare provider.

We can investigate the issue of mercury in cosmetics in a Cause Map, or visual root cause analysis, in order to show the cause-and-effect relationships that lead to the potential for health effects.  To view the Outline and Cause Map, please click “Download PDF” above.  Or click here to read more.

Root Cause Analysis

Technique Increases Availability of Donor Kidneys

By ThinkReliability Staff

Transplanted donor kidneys save lives, but availability does not meet demand.  Contributing to the problem is that some people who are willing to be donors have organs that are considered unsuitable for transplant.  A new procedure has been successful in making some of these previously rejected kidneys usable again.

The procedure involves flushing donated kidneys, which would previously have been rejected as unsuitable for transplant, with oxygenated blood (normothermic perfusion).  This can allow use of some damaged kidneys, such as those from the elderly or those with high blood pressure or diabetes.  It decreases the risk of a marginal organ being rejected.  It is believed that this could increase the availability of organs by about 500 a year in the United Kingdom, reducing the number of people on transplant waiting lists by about 10%.   (There are more than 6,400 kidney patients waiting for a transplant in the UK.)

So far, 17 organs that have been through the procedure have been successfully transplanted, between November 2010 and November 2011.  They are all functioning well.  The success of this procedure can be examined in a Cause Map, or visual root cause analysis.   Positive impacts to the goals can be examined in the same way that negative impacts are – by identifying the impacts and asking “why” questions to identify the causes.  Due to this procedure, the patient safety goal has been impacted by reducing the risk of rejected transplanted organs.  The patient services and material goal has been impacted by increasing the availability of donor kidneys.  And, the “labor” goal has been impacted by reducing the amount of time people wait for donor kidneys.

Beginning with these impacts and asking “why” questions, we can identify that the procedure is allowing the use of previously marginal organs by allowing treatment outside the recipient body and  reducing the risk of rejection.  This increases the number of organs that can be used, and since there are still more organs needed than available, this reduces the amount of time on the waiting list.

Although this procedure should increase the number of organs available and reduce time on the waiting list, it still will not provide enough organs for everyone who needs one.  Donor outreach to increase donors and family understanding of the life-saving organ donation process is still needed.

To view the Outline and Cause Map, please click “Download PDF” above.  Or click here to read more.

Root Cause Analysis

Potential Dangers of Unpasteurized Dairy Products

By Kim Smiley

A new study by the Centers for Disease Control and Prevention (CDC) found that unpasteurized milk is 150 times more likely to cause food-borne illness outbreaks than pasteurized dairy.  The CDC found that there were 73 disease outbreaks, two deaths and many permanent disabilities caused by the consumption of unpasteurized dairy products from 1993 to 2006.  Pasteurized dairy products aren’t perfect either.  According to the same report there were 48 disease outbreaks from contaminated pasteurized milk and cheese resulting in thousands of illnesses and one death during the same time period.  But the CDC determined that unpasteurized milk is a far greater risk since more illnesses were caused by it and it is estimated that only about one percent of the population consumed unpasteurized dairy products.

This issue can be analyzed by building a Cause Map, an intuitive, visual format for performing a root cause analysis.  In this example, the safety goal was obviously impacted since hundreds got sick from consuming unpasteurized milk.  The Cause Map is built by asking “why” questions and adding the information onto the Cause Map in order to show the cause and effect relationships between all the factors that contributed to the issue.  In this example, people got sick because they were exposed to harmful microorganisms.  This occurred because unpasteurized milk is more likely to be contaminated with harmful microorganisms and consumers drank unpasteurized milk.

Unpasteurized milk is more likely to be contaminated because by definition it isn’t heated to kill microorganisms.  During the pasteurization process, milk is heated to 161 degrees and held there for about 20 seconds to kill anything harmful that might be in the milk.  There is the potential for all milk to get contaminated because cow manure is a potential source of contamination and it’s a constant in the environment where milk is produced.

People drink unpasteurized milk because they prefer it and it’s legal to buy in many states.  Some consumers prefer unpasteurized milk for a number of reasons.  Unpasteurized milk has a distinct taste some people like.  There is also a general trend of people moving towards less processed foods.  The pasteurization processes decreases the amount of a few nutrients in milk so some people think that unpasteurized milk is healthier for them.  There are also a number of people who believe that unpasteurized milk has healing properties.  There are testimonies that unpasteurized dairy products have reversed a number of health issues, including allergies, asthma, digestive disorders, arthritis and behavior problems in children.

There are some who believe the sale of all unpasteurized diary should be banned because of the risk of contamination and the resulting illnesses, but unpasteurized dairy has very active, vocal advocates that believe strongly that its sale and consumption should be legal.  Both the CDC and the Food and Drug Administration urge consumers to avoid unpasteurized dairy products because of the potential health risks.

Root Cause Analysis

High Heels May Increase Risk of Strains

By Kim Smiley

A new study found that habitually wearing high heels changes the biomechanics of how a woman walks and may increase the likelihood of strains, even when the heels are off.  The research compared young women who had worn high heels at least 40 hours a week for a minimum of two years with women who never or rarely wore heels.  Their walks were studied by using motion-capture reflective markers and electrodes to track leg-muscle activity.  The lengths of the muscle fibers in their legs were measured by ultrasound probes.

This example can be built into a Cause Map, an intuitive root cause analysis format.  A Cause Map lays out cause and effect relationships and helps illustrate how all factors that contribute to an issue relate to one another and to the overall problem.  To view a high level Cause Map of this issue, click “Download PDF” above.

After scrutinizing the walks of both those who favored heels and those who didn’t, the researchers determined that habitually wearing heels changed how the women walked, even when their feet were bare.  The high heel wearers took shorter, more forceful strides and kept their feet perpetually in a flexed position with their toes pointed.

Why does this matter?  The change in walking biomechanics means that the high heel wearers primarily engaged their muscles while walking.  The control group who rarely wore heels used a combination of tendons and muscles to walk.  The use of the tendons is important because they act as springs in the body and have the capacity to store energy.  Engaging tendons while walking is more efficient.  The high heel wearers had to use more energy to cover the same amount of ground as the control group and this can cause muscle fatigue. So this means that wearing high heels causes the muscles to be engaged more while walking, greater use of the muscles increases everyday strain on muscles and this may in turn increase the chance of strain injuries.

One of the more interesting findings was that frequently wearing high heels caused shortened fibers in calf muscles so that the changes in walking biomechanics remained even after high heels were removed.   It’s also interesting to note that the volunteers who participated in the study were young (the average age was 25) meaning that the changes the researchers found are not something that takes decades to occur.

The researchers recommend limiting high heel wear to a couple of times a week if possible and removing shoes when it’s an option, such as when seated at a desk.

Root Cause Analysis

Serious Side Effects From Low Dose Aspirin

By Kim Smiley

A recent study determined that the risks associated with regular use of low dose aspirin may outweigh the benefits for many patients. The researchers determined that regular aspirin users were 10 percent less likely to have a heart event and 20 percent less likely to have a nonfatal heart attack.  These statistics sound good except that regular aspirin users are also around 30 percent more likely to have serious gastrointestinal (GI) bleeding.  The overall risk of death was the same for both patients who regularly used aspirin and those who did not.

This study looked at nine randomized studies of aspirin use and included more than 100,000 patients.  The study only included patients who had not had a heart attack or stroke and involved giving participants either an aspirin or a placebo to see the benefits of regular doses of aspirin.

These findings have the potential to affect many people since nearly a third of middle-age Americans take a low dose aspirin regularly.  Benefits from aspirin seem to outweigh the risks for people who have a history of heart attacks, but this study calls into question the benefits for patients who are hoping to prevent their first heart attack or stroke.

This issue can be analyzed by building a Cause Map, an intuitive, visual form of root cause analysis.  In this example, the safety goal is the main goal that would be considered because of the higher risk of GI bleeding.  The higher risk of bleeding is caused by the fact that patients are taking aspirin regularly and that GI bleeding is a known side effect of aspirin.  People take aspirin because it has been shown to reduce the likelihood of blood clots.  Reducing blood clots will in turn reduce the risk of heart attacks and stroke since blood clots have the potential to block flow to the brain or heart.

The conclusion that the study draws is that there is no one size fits all solution to the question of whether patients should regularly take low dose aspirin.  The risks and potential benefits need to be determined on a case by case basis by the patient’s physician.  For an individual with a strong family history of heart disease, the benefits may very well outweigh the risk of GI bleeding, but for others the use of aspirin may not be worth the risk.

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

Root Cause Analysis

Study Finds Only 1 in 7 medical errors reported

By ThinkReliability Staff

A study by the Office of the Inspector General (OIG) of the Department of Health and Human Services found that hospital employees are only reporting fourteen percent of all medical errors.  Additionally, the study determined that processes are rarely changed to help prevent similar errors in the future.

The study was conducted by reviewing the medical records of Medicare patients. As a condition of participating in the Medicare program, hospitals are required by federal regulations to track medical errors that harm patients and to implement solutions to protect patients from similar mistakes in the future.  All hospitals involved in the study had a method to collect information on medical errors, but all adverse events were not being efficiently captured by the systems in place.

The study found that out of 293 cases reviewed, only 40 were reported, 28 led to investigations and only five resulted in changes in the hospital’s processes.  Additionally, the inspector general estimated that more than 130,000 Medicare beneficiaries experience at least one adverse event in a hospital in one month so there is a plenty of room for improvement in patient care.

The study found a number of reasons that adverse events and medical errors were not being reported.  Confusion over requirements was one cause of the under reporting because hospital employees did not always recognize that a particular event harmed a patient and was required to be reported.  Also, there were cases where employees assumed someone else would report the incident or they considered the incident to be so common that it didn’t need to be reported.  There was also a tendency to not report things that were considered to be isolated events that were unlikely to recur.

To help combat these causes, the OIG report recommends the development of a standard list of medical errors that should be tracked and reported.  The OIG also recommends that guidance be developed and provided for the accreditors of hospitals since they do not typically investigate adverse event collection methods.  Additionally, some consumer groups are pushing for public reporting of medical errors to help pressure hospitals to improve their policies and practices.

Click on “Download PDF” above to view a high level Cause Map of this event which is an intuitive, visual root cause analysis of this issue.

Root Cause Analysis

Drug Used to Treat Diabetes May Increase Risk of Heart Disease

By ThinkReliability Staff

Since rosiglitazone was approved for use in controlling blood sugar in Type 2 diabetics who did not have success with front line treatments in 1999, studies have shown that this drug (included in trade name drugs Avandia, Avandamet and Avaglim) increases the risk of heart disease in users.  This is of particular concern because most Type 2 diabetics die from heart disease.  It is estimated that 60,000 to 200,000 people have suffered from heart disease due to these drugs.

A black box warning was placed on these drugs, but not until November 2007.  The European Medicines Agency recommended that the drug be suspended from European markets in 2010, and the drug was withdrawn from New Zealand markets in 2011.  What took so long?

We can attempt to add some clarity to this issue by viewing it in a Cause Map, or visual root cause analysis.  To begin this analysis, we look at the impact to the goals from the point of view of the manufacturer.  The patient safety goal is impacted because of the increased occurrence of stroke, heart attack, and death. The compliance goal is  impacted because – according the Senate Finance Committee – trial results that would have indicated the increased risk for cardiovascular disease were not publicly released in a timely manner.  Reduced sales as a result of the risk are estimated to be more than $2 billion (an impact to the organizational goal) and lawsuits (an impact to the patient services goal) are projected to cost more than $1 billion.

Although the actual mechanism that is causing the increased risk of cardiovascular disease is unknown, the cause of the increased occurrence of heart attack, stroke and death is due to use of the drug rosiglitazone.  Although rosiglitazone has been found to be an effective second-line treatment for Type 2 diabetes, it is unlikely that doctors would have prescribed it as readily had they known about the increased risk of heart disease.  Instead, they were likely swayed by a multi-million dollar advertising campaign, while test results that showed increased cardiovascular risk were allegedly covered up.

Unfortunately, it’s not the first (or last) time this has happened.  In early 2012, the British Medical Journal raised concern about research misconduct – including cases where poor results from clinical trials are not released to the public.  In the US, it was found that less than half of studies – including those funded by the government – are publicly released in a timely manner.  Although there are regulations that require publication of studies, they aren’t always (or even usually) followed.  Some consideration of what can be done to ensure that these regulations are effective is ongoing.

Meanwhile, rosiglitazone has been removed from Europe and New Zealand markets.  In the US, new regulations went into effect making the drug extremely difficult to come by.  A different drug – Actos – is said to have similar effects on controlling blood sugar without the increased cardiovascular risk.  However, patients should consult with their doctors.

To view the Outline, Cause Map, Solutions and Timeline, please click “Download PDF” above.  Or click here to read more.

Root Cause Analysis

Bacterial Contamination of Tampons

By ThinkReliability Staff

On November 9, 2011, the FDA announced a recall of a certain subset of tampons for contamination with the bacteria Enterobacter sakazakii.  The recall is for certain products delivered to certain stores, mainly in the central U.S. Region.  For a full list of the product  recalls, check the FDA recall site.

The specific source of the contaminant has not been identified.  Investigations of previous instances of contamination with the Enterobacter sakazakii have had difficulty determining an exact source, as this bacteria is found within human  and animal guts.  However, even with limited information, we can begin a Cause Map, or visual root cause analysis, which allows us to view the areas where more data collection is needed in order to gather evidence to complete the analysis.

We begin by capturing the basic information about the incident as well as the impacts to the goals.  The safety goal is impacted due to the risk of infection from the contamination tampons.  The environmental and customer service goals are impacted because a product was bacterially contaminated.  Additionally, the product recall impacts the production, property and labor goals.  We begin our Cause Map with the impacts to the goals.

Both the risk for infection and the product recall were caused by the bacterial contamination of a product.  The product was contaminated because contaminated raw material was used for its manufacture.  This occurred both because the raw material was contaminated and because the quality control or testing process for the raw material was insufficient.  Whether there was no testing process for the given bacteria or whether the process did not recognize the bacteria and stop the use of the contaminated raw material is unclear.

At this point, because the source of the raw material contamination is unknown, an open question which requires evidence-gathering is “how did the raw material get contaminated”? This will require cooperation from the raw material manufacturer.   The other necessary information is to do a detailed review of the quality control and/or testing that is used on raw materials prior to manufacturing and determine how the contaminated material was able to be used to make a final product.  Once this process is looked at in detail, specific solutions that would prevent a recurrence of this type of contamination can be implemented.

To view the Outline and Cause Map, please click “Download PDF” above.  Or click here to read more.

Root Cause Analysis

America’s Food Deserts

By Kim Smiley

A food desert is a community that lacks adequate access to healthy, nutritious food because they don’t have sufficient stores that sell these items at an affordable price, such as a supermarket. Both isolated rural areas and low income urban neighborhoods are typical locations where a food desert might exist in the United States.  In these locations, residents typically must rely on the food that is available nearby, usually small convenience stores and fast food restaurants.  Smaller convenience type stores generally don’t offer a variety of fresh food and vegetables and the prices are typically higher.  Many times the result is a less healthy diet and the potential health problems that go along with it.

A significant percentage of the US population lives without relatively easy access to a supermarket.  In a report to Congress, the USDA stated that 2.2 percent of the US population lives more than a mile from a supermarket and does not have access to a vehicle.  That’s 2.3 million people who constantly struggle with the logistics of buying groceries, even before the rising cost of food is considered.

How did food deserts come to exist?  In a country as wealthy and as industrialized as the United States, how is it that so many people don’t have access to a grocery store?

Food deserts came to exist because companies followed demand and built grocery stores where they would be most profitable, which is not typically low income urban locations or very rural areas.  Low income families typically have less money to send on groceries so more supermarkets were built in the more profitable, affluent neighborhoods than in poorer communities.  Some low income urban areas are also associated with higher crime rates so companies were hesitant to build in those areas.  People with lower incomes are also less likely to have access to a vehicle so the problem of buying food is compounded when the supermarkets are farther away from the low income communities.  Supermarkets are also less likely to be built in low population density rural areas because there are fewer potential customers and the stores aren’t as profitable.

While it’s relatively easy to identify why food deserts came to be, it’s still a tricky problem to solve.  Some groups have suggested that the government should provide subsidies to companies that build stores in food deserts.  Others are working to bring in foods to the people living in food deserts.

If you’re curious about where food deserts exist in the US, click here to view a map of the locations.  Click here to read a previous blog that discussed how food deserts are a cause of childhood obesity.