Root Cause Analysis

Living Donor Dies During Liver Transplant

by ThinkReliability Staff

In May 2010, a living liver donor died on the operating table.  Investigation showed that there were multiple issues related to the patient’s death.  The clinic was cleared of any wrongdoing in the death – and the surgeons there don’t believe that the surgical issues contributed to the death – but the clinic was cited for  violating rules designed to inform and protect donors.

We can look at all the related issues and see the cause-and-effect relationships in a Cause Map, or visual root cause analysis.  We begin with the impacts to the goals.  The patient death is an impact to the patient safety goal.  Patient deaths also cause impacts to related employees, which is an impact to the goals.  The citation for the violation of donor protection rules can be considered an impact to the compliance goals.  As a result of this incident, the clinic voluntarily stopped operations on living donors for 4 months, which can be considered impacts to the schedule and customer service goals.  Once the impacts to the goals are determined, we can begin with an impact and ask “why” questions to add detail to the Cause Map.

The patient death was determined to be due to a combination of cardiac arrest and excessive bleeding.  The cardiac arrest occurred because the patient’s heart was too weak to withstand surgery, and the patient was undergoing surgery.  The patient was donating a portion of his liver as a “living donor”.  Because the patient was not properly informed prior to his surgery, it’s unclear whether he would have continued if proper processes had been followed.  Donors are required to be given outcomes from both the site performing the surgery and national results.  The information the donor received was not up-to-date, as the paperwork had not been updated.   Additionally, because the donor’s needs may be opposite of the recipient’s needs, the donor’s advocate is required to be involved only in the donor’s care.  In this case, the advocate was also involved in the recipient’s care. Lastly, the patient received an abnormal EKG (which indicated that he may have had a prior heart attack) during his operation prep.  Although later testing showed that there was no reduction in blood flow to the heart, it’s unclear whether the patient was aware of these results or in a cardiologist was consulted.  The patient did not request a second opinion to determine whether or not he was healthy enough to handle the surgery.

Excessive bleeding occurred during the surgery and was thought to also have contributed to the patient’s death.  Bleeding occurred because the patient was in surgery.  Because the type of surgery the patient was doing is relatively new, it’s also possible that the surgeon’s lack of familiarity with the surgery may have contributed to the bleeding.  The bleeding wasn’t able to be stopped because it was difficult to find the multiple sources.  The patient was having laparasopically assisted surgery, which results in a quicker recovery time for the patient but also means that the bleeding source needs to be found through small holes, rather than one large incision.  Although the surgeons say it was not related to the patient death, a high speed blood pump was not used, though it was available, and the procedure for massive bleeding was not followed.

Whether or not these issues contributed directly to the patient’s death, they should still be reviewed as sources of improvement for the facility.  Other facilities as well can use this incident to examiner their own procedures and look for opportunities to increase patient safety.

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

Never Event, Root Cause Analysis

Patient Deaths Caused by Defective Defibrillator Wires

By Kim Smiley

A recent study determined that at least 20 patients have died as a result of defective defibrillator wires.  The wires, also called leads, connect the defibrillator to the heart to both monitor heart rhythms and deliver electric shock if needed.  Defective defibrillator wires have the potential to affect many people since more than 79,000 in the United States and 49,000 abroad have the implants.

This issue can be explored by building a Cause Map, an intuitive, visual root cause analysis method.  To begin a Cause Map, the first step is to determine what the impacts have been on the overall organizational goals.  In this example, the safety goal will be focused on since the study determined at least 20 patients have died as a result of this issue.  Once the impact to goals is found, the Cause Map is built by asking “why” questions and adding the information.

In this case, the patients died because their heart stopped.  The heart stopped because the patients were at risk of heart issues, had defibrillators implanted and the defibrillators malfunctioned.  Implanting defibrillators is a common treatment for certain heart conditions and many people have them.

The defibrillators malfunctioned because the wires used to connect the defibrillator to the hearts weren’t properly insulated and a short circuit developed, preventing the defibrillator from shocking the heart when it was needed.  The wires aren’t properly insulated because the silicone coating on the wires is breaking down over time.  The defibrillators are also malfunctioning because the issue with the wires isn’t one that can be found by routine monitoring so the problem isn’t identified until it’s too late.

The company that makes the wires is questioning the findings of the study and says that the information used was incomplete.

It’s also not clear at this time what the best course of action is at this time beyond continuing to monitor patients.  Removing the wires is considered to be a risky operation.

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

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

New Use for Old Drug May Save Lives

By ThinkReliability Staff

An off-label use for an existing drug, tranexamic acid, has been shown in recent studies to reduce bleeding – and so risk of death – from trauma.  The drug is believed to slow bleeding by slowing the dissolution of blood clots  by  blocking plasmin, which aids in the dissolution of blood clots.  A recent trial shows that 128,000 lives could be saved thanks to the use of tranexamic acid, an existing, cheap generic.  The drug slows bleeding in trauma patients and is being used on the battlefield, in Britain . . . and just about nowhere else.

How does the drug help trauma patients and why isn’t it being used? We can look at both of these issues in a Cause Map, or visual root cause analysis.  We begin the Cause Map with the outline, which captures the basic information about the issue and the impacts to the goals.  Here, we are looking at the use of tranexamic acid to slow bleeding in trauma patients.  Currently, it’s being used primarily on battlefields and in trauma centers, mainly by Britain.  Use of the drug impacts the patient safety goal by potentially reducing the risk of death from trauma, and the patient services goal by slowing bleeding.

We begin with these impacted goals and ask “Why” questions to add detail to the Cause Map.  In this case, the potential for the reduced risk of death  results from having 400,000 people die of trauma in hospitals every year, and  the potential for slowed bleeding.    The potential for slowed bleeding is due to a drug that has been shown to slow bleeding, and the fact that that drug is not commonly used for trauma.  The drug is believed to slow bleeding by  blocking plasmin, which aids in the dissolution of blood clots.  The drug is not commonly used  for trauma, in part because it has not been FDA approved for this use.  (It can still be prescribed “off label” by doctors.)  The leader of the trial showing the potential benefits of the drug in trauma believes that the lack of use is due to inertia.  Because the drug is inexpensive, it doesn’t provide a large profit for drug companies, and so they are less likely to advertise the benefits.  Additionally, since the FDA hasn’t approved it for trauma, the drug companies aren’t allowed to advertise the drug for this use.

It’s unclear if manufacturers are attempting to  obtain FDA approval for trauma use.  However, publication of these studies, and sharing information between healthcare facilities may help increase the use of this drug, potentially saving lives.   It’s been added to the World Health Organization’s essential drugs, and is finding use on battlefields aiding wounded soldiers.  Hopefully in time, it will be used in healthcare facilities as well.

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

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.