Category Archives: Root Cause Analysis

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

Shortage of Life Saving Cancer Drug

By Kim Smiley

Shortage of a lifesaving cancer drug, methotrexate, has hospitals scrambling to find enough drugs to treat patients. Methotrexate has long been a treatment for acute lymphoblastic leukemia, or ALL, and a type of bone cancer called osteogenic sarcoma.  A particular form of methotrexate without alcohol-based preservatives is needed to treat ALL because a high dose must be injected directly into the spines of patients and preservatives can be toxic and cause paralysi at such a high dose.  With treatment, ALL can be cured more than 90 percent of the time.  What makes this drug storage particularly heart breaking is that ALL most often strikes between ages 2 to 5.  If hospitals don’t have adequate supplies of preservative free methotrexate, children will die from a disease that is largely curable.

This issue can be analyzed by building a Cause Map, an intuitive, visual root cause analysis.  A Cause Map is built by determining the impact to the overall goals and then asking “why” questions to add causes that contributed to the issue and show the cause-and-effect relationships between the causes.  In this example, the safety goal is clearly impacted because there is a risk of patient death.

To begin adding causes to the Cause Map, we could ask why that is true.  Patients may die because they have cancer, the doctors may not be able to treat the cancer and the cancer is fatal if untreated.  Why might the doctors be unable to treat the cancer?  There is a shortage of the required medication because the plant that was the primary supplier for US is shut down.  The plant is voluntarily shut down so that significant manufacturing and quality issues can be addressed.  In order to understand the issues, it is also worth asking why one plant manufactured so much of the supply of methotrexate.  As much detail as necessary can be added to the Cause Map.  Once the Cause Map is built, the information can be used to brain storm solutions and determine which should be implemented.  To view a high level Cause Map of this issue, click on “Download PDF” above.

In this example, the FDA is currently negotiating with five plants that are approved to manufacture methotrexate to increase their production of the drug.  In the meantime, the plant that was shut down has worked with the FDA to allow distribution of some of the methotrexate that was manufactured, but not shipped prior to the shutdown.  Hospitals still have a smaller supply of methotrexate than would be desired, but all patients’ needs are currently being met.

 

Root Cause Analysis

Patient Brain Damaged Due to Malpractice and Surgeon Inexperience

By ThinkReliability Staff

When complications occur during surgery, an experienced surgeon and surgical team can help ensure a positive outcome for the patient.  Inexperience can lead to problems – in this case, brain damage.  A special concern in this case is that hospital documentation advertised that the surgeon was accredited when he did not meet the requirements.  They were convicted of fraud.

When a patient suffers brain damage, the patient safety goal is impacted.  Any time the patient safety goal is impacted, an investigation  should be performed.  In this case, we can look at the issue in a Cause Map, or visual root cause analysis.

With the Cause Mapping approach, we begin with the impacts to the organization’s goals.  In addition to the brain damage, the patient also suffered from  loss of eyesight, another impact to the patient safety goal.   The  doctor was convicted of malpractice, which is an impact to the employee.   Additionally, the hospital was convicted of fraud, which can be considered an impact to the compliance goal.  The hospital was assigned $178 million in compensatory damage and $10 million in punitive damages.    Last but not least, the patient services goal was impacted due to the uncorrected leakage in the patient’s abdomen.

We can begin with the first patient safety goal and ask “why” questions to add more detail to the map.   In this case, the patient suffered brain damage as a result of a stroke.  The patient suffered a stroke because of uncorrected leakage in the abdomen.  The leakage occurred as a result of bariatric surgery, potentially due to the inexperience of the surgeon.  In addition,  the leakage was not treated for 8 days.  Again, it is believed that the inexperience of the surgeon contributed to insufficient patient care.

The fact that the leakage was untreated for 8 days was considered reason for malpractice.  While the patient was on a respirator due to his stroke, he was not treated with eye drops, resulting in a retinal burn that left him blind.  The hospital was convicted of fraud because it used documentation with the accreditation seal from the American Society Bariatric Surgery’s Center of Excellence referencing the surgeon who performed this surgery.  However, the surgeon did not meet the requirements for accreditation.  He had performed an insufficient number of surgeries and had not taken an adequate number of bariatric education courses to meet accreditation  requirements.  The use of the seal in hospital documentation was determined to be fraud.

This case reinforces the necessity for patients to be active in their own care in selecting their physicians.  Specifically, patients should perform  their own investigation of their surgeon’s qualifications.  However, in this case accurately determining those qualifications would have been difficult due to the associated fraud.  If the patient had asked how many surgeries the surgeon had performed, he may have decided to go elsewhere.

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

Root Cause Analysis

Patient Death over the Holidays

By ThinkReliability Staff

On December 31, 2010, a patient entered St. James’s Hospital in Leeds for a urinary tract infection.  Unfortunately for the patient, the hospital was experiencing nursing shortages due to the holiday and the patient died 3 days later.  The death of the patient is an impact to the patient safety goal.  We can look at this incident in more detail, based on the information available, in a root cause analysis presented in a visual Cause Map format.

Besides the impact to the patient safety goal, there was an employee impact due to the staffing shortage.  The patient’s son noted mistakes in the patient notes and charts (an impact to the compliance goal) and received a settlement from the National Health Service (NHS).  Last but certainly not least, the patient services goal was impacted due to the delay in appropriate treatment that the patient experienced.

To add more detail to the Cause Map, we can ask “why” questions.  The patient’s death was due to the combination of a urinary tract infection and the delay in appropriate treatment.  The urinary tract infection was caused by a catheter in place as the patient was bed-bound due to a previous stroke.   The delay in treatment was two-fold: first, the patient was not given another dose of antibiotics for 24 hours after the initial dose administered in the emergency room.  Second, the medication that was eventually given was not effective as the infection was resistant to that particular antibiotic.  The junior doctor who prescribed the medication failed to notice the antibiotic resistance and there was no over check of the prescription, likely due to the staffing shortage.

The patient was not monitored for 15 hours during the first 24 hours she was in the hospital.  Neither the nurses (again, likely due to the shortage) nor the consultant who performed morning rounds monitored her during this time.  This likely also led to mistakes in the patient’s notes and chart (which her son says number 140) and contributed to the patient’s death.  The NHS and hospital involved have developed an action plan to ensure that lessons are learned from this incident.

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

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

Concerns over Faulty Implants

By Kim Smiley

Thousands of women received faulty breast implants between 2001 and 2010.  These implants contain substandard silicone, not approved for medical use, and are also rupturing at a usually high rate.  It isn’t clear at this time what the long term health risks associated with these implants might be.  The faulty implants were manufactured in France, but eighty percent were exported so the wide spread nature of the problem also complicates the implementation of any possible solutions. (These implants were not sold in the US.)

This issue can be investigated by building a Cause Map, an intuitive, visual root cause analysis.  A Cause Map is built by asking “why” questions to determine what causes contributed to an issue.  In this example, women are facing health risks because they received faulty breast implants.  The implants are considered faulty because they are filled with substandard, non-medical grade silicone and they are rupturing at twice the industrial average.

The implants were filled with industrial grade silicone, instead of medical grade, because industrial grade silicon is far less expensive and the company was trying to cut costs.  Hundreds of thousands of these implants were manufactured before any quality issues were raised so inadequate oversight should also be considered as a potential cause.  It isn’t clear why the implants are rupturing at an unusually high rate at this time, but that information can be added to the Cause Map once it is available.

The long term health consequences of this issue also aren’t clear yet.  The substandard silicone used may have impurities in it that could pose a health risk in addition to any health effects that result from the ruptured implants in general.  There are concerns that the implants are increasing the risk of breast cancer, but there isn’t any hard evidence that this is the case at this point.  All the countries involved are struggling to weigh the known risks of removing the implants with the unknown risks of leaving them in place.  There is also the question of costs and who will pay for removal or replacement of the faulty implants. Ongoing monitoring for signs of leakage and ruptures are recommended for any woman who chooses to keep the implants.