All posts by Kim Smiley

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

Safely using a treadmill is not quite as simple as it seems

By Kim Smiley

Did you know that treadmills are the riskiest exercise machines?  I sure didn’t, but I have to admit that I have fallen off one before.  (Based on conversations with my coworkers, this isn’t all that uncommon.)  As recent headlines have made clear, using a treadmill safely may not be quite as simple as it seems.

According to data from the National Electronic Injury Surveillance System, about 19,000 people went to the emergency room (ER) because of treadmill injuries in 2009, which is about triple the number of injuries reported in 1991.  More and more people are using treadmills and the number of accidents has increased as well. Although only a small percentage of the injuries are serious, about 30 deaths related to treadmill use were reported between 2003 and 2011.

Understandably, the details surrounding Dave Goldberg’s death have not been released to the public, but it is believed that he slipped while using a treadmill and hit his head when he fell.  Falls off treadmills that result in serious injury are rare, but they have the potential to cause significant injury and even death. More common injuries associated with treadmill use are less serious overuse injuries, such as strains and sprains.

Children are at particular risk of being injured by treadmills.  A motor propels the belt on treadmills and children can get their extremities caught in the moving belt or suffer burns if they accidently turn a treadmill on or one is left running while unattended.  Of the 19,000 ER visits associated with treadmills in 2009, nearly a third were for children under age 9.

So how do you stay safe while using a treadmill?  The number one rule is to limit distractions.  Using a phone or watching TV puts you at a much higher risk of accidently misplacing a foot and falling.  (Trying to write an email while I walked on a treadmill is what resulted in my own fall.  Luckily, only my pride was injured, but I have learned my lesson.)

Treadmills have also risen in complexity and all the buttons and options can be distracting, especially if you are unfamiliar with the specific equipment.  Make sure you understand how to use the treadmill prior to starting the belt.  If you have balance issues or are elderly, you should also check with a doctor prior to using a treadmill.  And lastly, start by walking slowly and gradually increase the pace of the treadmill so that you aren’t caught unaware by how quickly the belt is moving.

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

Root Cause

What Caused an HIV Outbreak in Rural Indiana?

By Kim Smiley

A public health emergency has been declared after 79 cases of HIV were confirmed in rural Indiana, the worst outbreak of HIV the state has ever seen.  Individuals potentially at risk have been encouraged to get tested and the number of cases is expected to rise as more cases are identified. The epidemic has been tied to intravenous drug use, although other risky behaviors may also have spread the disease.

In order to effectively fight this HIV epidemic and hopefully reduce the risk of outbreaks in the future, the factors that have led to these HIV cases needs to be understood. This region has been struggling with the use of Opana, a powerful opioid painkiller, for years.  Opana is commonly injected and health officials believe that the use of dirty needles has been the primary driver of HIV infections although unprotected sex was also a potential pathway for infection for some.  Needle exchange programs are illegal in Indiana and access to clean needles is limited so needles are being shared.  In an environment where needle sharing is common, it takes only one individual infected with HIV to rapidly spread the virus to many other drug users.

HIV is also more likely to be spread if infected individuals are unaware that they are infected and are not being treated.   Identifying an individual who has contracted HIV as early as possible and providing treatment helps prevent the disease from spreading because an HIV-positive person who receives sustained treatment is drastically less infectious, even if they continue to engage in high risk behaviors. Access to healthcare and HIV testing is limited in this region where many residents are uninsured and may lack transportation. Heroin use has long been tied to HIV, but users of Opana (a licensed pharmaceutical) may not have been fully aware of the potential risk from sharing needles.

Now that the HIV epidemic has been identified, healthcare officials are working to reduce the risk of more infections by providing testing and treatment.  One physician is even driving door to door, offering free HIV testing and trying to educate residents on drug addiction and HIV treatment.  Austin, Indiana has established its first ever HIV clinic to provide testing, counseling and treatment.  Targeted resources to help educate residents on drug use and to assist addicts seeking to get clean are also being provided.  The governor of Indiana has approved a short term needle exchange program.  Indiana has also created a public awareness campaign to help inform people about the risks of intravenous drug use.  Drug addiction is a notoriously difficult problem to battle, but the additional resources should help reduce the rate of future HIV cases.

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

Root Cause

Hospital reduces neonatal fatalities by 50%

By Kim Smiley

Infant mortality rate is often used as an indication of a nation’s health and social condition.  When reviewing the data for different countries, it becomes obvious that for a wealthy, developed country, the United States has a high infant mortality rate. According to the CIA World Factbook, the US infant mortality rate is 6.2 deaths per 1,000 births, which is nearly twice that of France, Italy and Spain. Additionally, the US ranked 60 for maternal deaths in a study for the Institute for Health Metrics and Evaluation.

The good news is that healthcare providers are working to improve care and help reduce preventable injuries and deaths during childbirth.  Obviously, access to prenatal care, overall health of the mother and other factors play a role in birth outcomes, but some relatively simple solutions targeting labor and delivery care have proven to dramatically increase birth outcomes.  A new report “Solutions in Sight” by the nonprofit Public Citizen lists some of the successes in improving birth outcomes.

One particularly impressive case is that of Ascensions Health, which reduced its neonatal fatality rate by 50% across its 43 hospitals by implementing relatively cheap, common-sense solutions.  Ascension did a number of things to help improve birth outcomes such as improving training and communications.  Drills were done to practice how staff should respond in a variety of emergency situations to help medical personnel identify and quickly respond to potentially dangerous scenarios.  There was also focus on communication between personnel to help ensure there were no misunderstandings in high pressure situations and to encourage all staff members to speak up if they perceived a dangerous situation.

Additionally, they worked to develop “bundles” of services, which are packages of procedures that have been shown to produce the best results.  Bundles are essentially guidelines for how staff should respond in a variety of situations.  There was also an emphasis on reducing C-section deliveries that weren’t medically necessary because these types of births are associated with a higher rate of complications. None of these solutions were earth-shattering, but they have proven effective when consistently implemented.

In additional to the clear benefit of saving lives and reducing the number of potentially life-long injuries, improving birth outcomes has economic benefits.  Better birth outcomes reduce the likelihood of expensive lawsuits. This example is a classic win-win where doing the right thing actually saves money in the long run as well.

Many of us do not spend our days delivering babies, but this example has many lessons that can be applied across industries.  Learning how to provide effective, realistic training can dramatically improve performance.  Empowering employees at all levels to speak up when something doesn’t look right can save lives, whether it’s in a factory or a hospital.  Formally documenting and using best practices so employees can benefit from others’ experience can streamline many processes and reduce preventable errors.  Sometimes the simple solutions really are the most effective.

Typically, a Cause Map is built when something has gone wrong, but it can also be used as a proactive tool to help understand why something has gone right.  To view a high level Cause Map of this example, click on “Download PDF” above.  Another example of a proactive, positive Cause Map is the Miracle on the Hudson, where all passengers survived a plane landing on a river.

Root Cause

This year’s flu vaccine only about 23% effective

By Kim Smiley

According to the Centers for Disease Control and Prevention (CDC), the flu vaccine for the 2014-2015 flu season is only about 23% effective among people of all ages.  While the flu vaccine is not perfect, the effectiveness is generally closer to 60% percent.

So what made this year different?  Why is the flu vaccine so much less effective than what has been previously observed?  The short answer is that creating a flu vaccine is not an exact science and that the experts’ best guess of which flu strains would be the most common wasn’t as good this year.

One of the reasons that a flu vaccine is needed each year while many vaccines (like the MMR vaccine) aren’t is that the flu virus changes relatively quickly.  The strains of flu that are circulating generally morph from year to year and a new vaccine is needed to protect against them.  The lag time inherent in developing a new vaccine also makes attacking this moving target  difficult.  It just takes time to develop a new vaccine that needs to be tested, manufactured and distributed to millions of people.  Companies need about six months to manufacture vaccines in the quantities required so the process of developing a new flu vaccine begins long before the predicted start of the flu season.

Every year there are hundreds of different strains of flu circulating and flu vaccines contain antigens for only 3 or 4 specific strains. Deciding which strains to include in the vaccine each year is not a simple cut and dry decision. Scientists monitor which strains of flu are circulating worldwide and use that data to select which strains to include in the vaccine, but it is difficult to predict how the virus will change months out.  The button line is that sometimes the flu virus changes unexpectedly and the vaccine ends up being less effective, as it did this year when the specific type of H3N2 virus included in the vaccine morphed after the development of the vaccine.

The question of how to prevent a similar problem in the future is tricky and doesn’t have simple answers.  There are scientists working to develop antigens that would respond to a part of the flu virus that doesn’t change, which could potentially lead to a longer lasting flu vaccine.  Until then the best way you can protect yourself is to get the flu vaccine each year. The CDC still recommends people receive the vaccine this year, even with the lower effectiveness, because it does offer some protection against the flu.

And wash your hands often with soap…that is always the simplest way to reduce the spread of disease.

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

Root Cause

Patient zero believed to have gotten Ebola from bats

By Kim Smiley

Scientists believe they have identified the origin of the ongoing Ebola outbreak.  The first person believed to have contracted Ebola was a two-year-old boy named Emile Ouamouno from a village called Meliandou in Guinea.  The fact that patient zero was a small child is unusual since he is too young to have been a hunter or travel far from the village alone.  His exposure to bushmeat, which has been identified as a likely culprit for transmission to humans in previous Ebola outbreaks, was also limited.

So how did a young boy contract Ebola?  A Cause Map, a form of visual root cause analysis, can be built to help analyze this issue.  A Cause Map intuitively lays out the causes that contributed to a problem to show the cause-and-effect relationships.  (Click on “Download PDF” above to view a high level Cause Map.)  As the Cause Map shows, researchers believe the boy was exposed to bats that carried Ebola.

Children from the village liked to play in a nearby hollow tree filled with Angolan free-tailed bats. Researchers believe that the boy may have come into contact with either bats infected with Ebola or their feces.   Unfortunately, the tree burned in the time since the Ebola epidemic started and researchers were unable to take samples from it, so it cannot be confirmed conclusively that the bats in the tree spread Ebola.  This information would have been particularly useful because this species of bats has not been previously linked to Ebola and Angolan free-tailed bats commonly live near people.  The scientists were able to rule out larger mammals such as chimpanzees and antelopes as the source of the current outbreak.

Tracking the origins of Ebola has proved difficult, in part because Ebola is a zoonotic disease, meaning that it can be transmitted between species.  Bats have long been suspected of being carriers of Ebola, but scientists have never been able to conclusively prove which animals are responsible for human Ebola outbreaks.  Ebola outbreaks tend to occur in remote areas where it’s difficult to gather data in a timely manner, especially in the midst of an Ebola outbreak.  Cultural differences can also make research difficult because local populations are often suspicious of the researchers, many of who are foreigners.

The current Ebola outbreak has killed nearly 8,000 people and is still spreading.  As populations grow and people are exposed to more animals, outbreaks like this may become more common.  If the species responsible for spreading Ebola could be identified, researchers would be better able to prevent future Ebola cases and possibly prevent outbreaks from occurring.

If you are curious, here are some interesting articles on lessons learned during the Ebola Outbreak –

Malaria killing thousands more than Ebola in West Africa

Ebola’s lessons, painfully learned at great cost in dollars and human lives

Root Cause

Anesthesia Without Electricity or Oxygen Tanks

By Kim Smiley

Almost 32 million surgeries are performed globally each year without a proper supply of oxygen and anesthesia, predominantly in developing nations.  Many more surgeries are canceled or delayed because anesthesia isn’t available.  One of the issues that plague hospitals in low income countries is that traditional anesthesia machines need electricity and oxygen tanks to function, both of which can be in short supply. A new design, called the Universal Anesthesia Machine (UAM), can operate without electricity or oxygen if necessary and is proving to be a practical solution to this difficult problem.

The UAM was invented by a doctor, Dr. Paul Fenton, who worked as an anesthesiologist at Queen Elizabeth Central Hospital in Blantyre, Malawi where he saw the problems with providing adequate anesthesia first-hand.  He designed his machine to use electricity when it is available, but to continue to function if power is lost by using a hand-powered pump on top. A digital display of oxygen levels switches to a 10 hour battery when power is lost so that the patient can continue to be monitored.  It also uses a compressor and air from the room so oxygen tanks aren’t required.

In an effort to make the UAM as practical to use as possible, it doesn’t use specialized parts.  Parts needed to maintain the machine should be available through a typical auto supply shop.  It’s also a flexible design that is compatible with all standard adult and pediatric breathing systems.

Honestly, this invention sounds too good to be true, but the UAM seems to be functioning as promised.   The number of UAMs in use is still relatively small (100 have been distributed to 18 countries), but they have already provided oxygen for over 30,000 surgeries.  Inadequate anesthesia is a huge issue, but this new machine may very well prove to be an important step in working towards a solution.

Click on “Download PDF” above to see a Cause Map of the problem of inadequate anesthesia.  You can also learn more about how the Universal Anesthesia Machine works by clicking here.

Root Cause

The Race to Develop an Ebola Vaccine

By Kim Smiley

Traditional public health methods have not been able to stop the Ebola epidemic raging in West Africa and some experts are speculating that a vaccine may be necessary to quash the outbreak.  The only problem is an approved vaccine against Ebola doesn’t exist.

A Cause Map, a visual root cause analysis, can be built to analyze this issue by intuitively laying out the causes that contribute to the problem.  A Cause Map is built by asking “why” questions and documenting the answers on the Cause Map to show the cause-and-effect relationships.

So why isn’t there an approved Ebola vaccine?  There are several promising vaccines in development, but some of them are newer efforts that haven’t had time to go through the lengthy approval process.  A few potential vaccines have been around for years, but development stalled prior to the necessary human trials.  Prior to this year, there was limited potential revenue from an Ebola vaccine because of the limited demand so it has never been a high-priority product. Demand for, and interest in, producing an Ebola vaccine, has of course skyrocketed as a result of the ongoing epidemic in West Africa and Ebola cases popping up in other countries.

Now that companies are putting significant resources in the race to produce an Ebola vaccine there are still huge logistical obstacles that must be overcome.  At least two different vaccines should be ready for large-scale human trials early next year, but actually distributing the vaccine and tracking volunteers will require significant resources.  The vaccine must be kept at a constant temperature which can be difficult in regions of West Africa without reliability electricity.  Keeping track of thousands of volunteers is always a massive undertaking, but will be even more challenging in the middle of an epidemic in a region where the medical systems are overtaxed.  There is also a chance for significant political fallout if the vaccine created by Western countries and given to poor African nations turns out to have harmful side effects.

This topic raises some really difficult ethical issues.  How much do you fast-track a vaccine?  People are dying and an effective vaccine would save lives, but distributing a vaccine prior to the normally required testing could also result in significant human suffering if there is an unexpected side effect.  When has a vaccine been tested “enough” to justify giving it to people in a high-risk environment?  Even designing the human trials requires some hard decisions.  Do you conduct a blind study with a control group, knowing that some of that group is statistically likely to be infected with a deadly disease? There is a lot of gray area and it’s difficult to know what the right answer is.  Thousands of lives may hang in the balance and there isn’t a lot precedence in how best to respond to the challenge of this Ebola outbreak.

If you’d like to learn more about this epidemic, you can read our previous blogs:

Patient With Ebola Sent Home From ER

Ebola Outbreak Claiming Lives of Medical Staff

Hundreds Affected in ‘Unprecedented’ Ebola Outbreak

 

Root Cause

Patient With Ebola Sent Home From ER

By Kim Smiley

If you have been paying any attention to the news lately you have heard that a patient was diagnosed with Ebola in the United States for the first time.  The fact that the patient sought treatment at an emergency room (ER) and was sent home is particularly alarming and people are naturally very interested in how such a thing could happen.

The media has been flooded with breaking news about this case. In situations like this, keeping track of what information is current and reliable and what is already outdated or has been determined to be inaccurate can be a moving target.  A Cause Map, a visual format for performing a root cause analysis, can be useful in these situations as a way to document the available information.  A Cause Map visually lays out the causes that contributed to an issue in an intuitive format.  It is relatively easy to quickly expand a Cause Map as more information becomes available.

Generally, a Cause Map is built in an Excel workbook so old versions of the Cause Map can be easily saved as different tabs and that the evolution of the investigation isn’t lost.  Additionally, it’s easy to add evidence supporting each individual cause onto the Cause Map itself so that all relevant information is documented in one location and easily referenced.  There are often things that are being considered that may have played a role in a problem, but lack evidence to determine whether or not they are actually relevant to the investigation.  This situation can be documented on a Cause Map by listing the potential cause and adding a question mark to show that a cause is being considered, but that it needs more evidence.  If that cause is later determined to not have been a factor it can be crossed out to document that it has been considered so that no work is duplicated.

So what information is known at this point about the patient with Ebola who was sent home from the ER?  A man has been diagnosed with Ebola in Dallas, Texas.  Statements by friends and family indicate that he helped transport a sick woman prior to traveling to the US.  It’s not clear whether he knew that she had Ebola or not.  After being exposed to Ebola, he passed through the airport screening because he did not have a fever at that time and he did not indicate possible exposure on the required questionnaire.   He arrived in Dallas, Texas on September 20, 2014.

His family has stated that he started feeling ill on the 24th and he sought treatment at a hospital on September 26.  He was released with a prescription for antibiotics.  Ebola can be difficult to diagnose because the early symptoms, such as fever and muscle pains, are very nonspecific.  The only information the hospital would have had to indicate that patient might have Ebola is his travel history.  Statements by the hospital indicate that the patient told the nurse he had recently been in Liberia.  The travel history information doesn’t seem to have been known by physicians that treated the patient.  Initial statements by the hospital indicated that issues with electronic health records may have played a role in the confusion, but later released more information that modified their position.  Exactly how the risk of Ebola was missed isn’t clear and this portion of the Cause Map will need to be expanded as more information is available.

It is not shocking that an Ebola case would be diagnosed in the US with travelers still arriving from West Africa and the long incubation period.  As long as Ebola is still a problem in Africa, US hospitals could see more patients with Ebola and need to be prepared for the possibility.  But it is concerning that someone who had recently traveled from West Africa with a fever wouldn’t trigger any alarms at an ER.   Individuals with Ebola must be quickly identified and isolated In order to prevent the spread of the deadly disease and hospitals in the US need to ensure that no other potential Ebola patients fall through the cracks.

Click on “Download PDF” above to see an initial intermediate level Cause Map for this example.

Root Cause

Wrong Dye Injected into Spine During Surgery

By Kim Smiley

In the high stress, fast paced operating room environment, high consequence errors can and do happen, but the risk can be reduced by analyzing medical errors and improving standard work processes.  A recent case where a woman died unexpectedly after a routine procedure to insert a pump underneath her skin to administer medication offers many potentially useful lessons.  The wrong dye was injected into her spine during the surgery, which is the type of error that should be entirely preventable.

A Cause Map, or visual root cause analysis, can be used to analyze this issue.  To build a Cause Map, all causes that contribute to the issue are visually laid out to show the cause-and-effect relationships.  The general idea is to ask “why” questions to determine ALL the causes (plural) that contributed to the problem, and not focus the investigation on a single root cause because this allows a wider range of solutions to be considered.

So why did the wrong dye get injected into the patient?  The dye was injected because it was used during the surgery to verify the location of tubing that was threaded into the patient’s spine and the wrong dye was used.  The surgeon needed the dye to verify the location because the tubing was inserted during the surgery and it was difficult to see. The tubing was part of a pump that was being stitched under the patient’s skin to administer medication directly to the spine to treat symptoms from a back injury.  The patient had broken several vertebrae during a fall.

And now on to the meatier part of the discussion in regard to medical error prevention – why was the wrong dye used? The request for medication (dye) was given orally by the doctor to the nurse who passed it along to the pharmacy so it is possible that the pharmacist missed that the dye was intended for use in the spine.  The exact point where the work process breakdown occurred wasn’t clear in the media reports, but it is known that there were several checks in the process that failed for this type of error to occur.

Following this incident, the hospital did make changes in their work process to help reduce the likelihood of a similar error occurring.  The hospital now uses detailed written orders for medications except in emergencies when that isn’t possible.  The written order includes information about how the medication will be administered, which would have clarified that the dye was intended for use in the spine in this case.

Root Cause

The Hand is Quicker Than the Sneeze

By Kim Smiley

A new study, simply titled “How Quickly Viruses Can Contaminate Buildings and How to Stop Them”, found that a single source of contamination can spread to 40 to 60 percent of people and commonly touched objects within 2 to 4 hours.  As stated by Charles Gerba, a researcher at University of Arizona who worked on the study, “what we really learned was the hand is quicker than the sneeze in the spread of disease.”

To study the spread of viruses within a building, researchers contaminated a variety of surfaces in several different buildings with a benign virus that lives and multiplies within bacteria to use as a tracer.  The particular virus used was bacteriophage MS-2, which is similar to noroviruses which are a common cause of the stomach flu.

After some time had passed, researchers sampled surfaces that can harbor infectious organisms, such a light switches and faucet handles, to see how far the planted virus had spread. What they found was that the virus had spread to a majority of commonly touched surfaces after just two to four hours.  They also found that the bathroom wasn’t the worst offender; the break room was the most contaminated location.  (Just think how many people touch the coffee pot handle!)

The study also included an intervention phase where cleaning personal and employees were provided with quaternary ammonium compounds (QUATS) disinfectant containing wipes and instructed on proper use (at least once daily). After the use of the wipes, researchers retested the surfaces and found that the number of places where the virus was detected was reduced by 80% and the concentration of the virus was drastically reduced.

The recommended solutions that can be used to limit the spread of disease are relatively cheap and easy.  Washing hands with soap and water or using alcohol-based hand sanitizer is still the best way to reduce the spread of infectious organisms.  This study also showed that the use of wipes containing QUATS just once a day can prevent the spread of illness.  For most circumstances, neither of these practices should be cost nor time prohibitive.

This study didn’t exactly reach shocking conclusions –  all of us know we should be washing our hands after using the bathroom and before preparing food or eating – but it’s still a good reminder.  Flu and cold season is coming soon and some simple precautions can keep everybody healthier.

To view the Cause Map, a visual root cause analysis, of the results of this study – click on “Download PDF” above.