All posts by Kim Smiley

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

Toxic Algae Bloom Makes Toledo’s Water Unsafe

By Kim Smiley

On the evening of August 1, 2014, 400,000 people living in the Toledo, Ohio region were told not to use or consume tap water.  The water ban was imposed after higher levels of a toxin,  microcystin, than were deemed safe were detected in the water supply.   The water ban was lifted on the morning of August 4, but the issue may not be over since many of the factors that lead to the problem are still present.

This issue can be analyzed by building a Cause Map, or visual root cause analysis.  A Cause Map intuitively lays out the cause-and-effect relationships that contributed to an issue.   In order to build the Cause Map, “why” questions are asked and the answers are documented on the Cause Map.

So why were people told not to use their tap water?  Microcystin is a toxin that can cause vomiting, cramps, rashes and even significant liver damage, and it was detected in the water supply at levels officials deemed unsafe.  (No illnesses have been reported as a result of the toxin.)  The investigation is still ongoing, but many scientists believe the microcystin came from a recent algae bloom in Lake Erie, where the area draws their water.  Algae blooms in Lake Erie are relatively common, but recent weather patterns meant that this particular bloom occurred near  the water treatment plants’ inlets.

Algae are always present in Lake Erie; they can reproduce rapidly and may form a bloom when conditions are conducive to growth and there is high nutrient availability.  Scientists are still working to understand more about the algae blooms, but many believe that phosphorus in agricultural runoff is the main source feeding them.  Phosphorus is commonly used in fertilizer and rain washes it into the lake where it may be consumed by algae.  There are also other possible sources of phosphates such as cattle feedlots and leaky septic systems that need to be investigated.

While it’s tempting to over simplify this issue, it really is very complicated.  There is research showing that an invasive species, the zebra mussel, may be adding to the problem by selectively consuming the non-toxic algae so that any blooms that form are more likely to be toxic. There is still debate about what exactly is causing the algae blooms to form. There are limited federal regulations in place to limit or monitor agriculture runoff and there isn’t agreement on what, if anything, should be done.  There are not even federal limits on the allowable levels of microcystin in drinking water.  Toledo officials used the limits set by the World Health Organization because there isn’t a federal standard.

There are many open questions and not enough answers.  One of the things that we do know is that this particular algae bloom wasn’t particularly bigger or more intense than what has been normal in recent history.  Its main distinguishing characteristic was the location near the water plant inlets.  Scientists are predicting that blooms will peak in September this year so the impacts on the water supply may not be over for the year.

Root Cause

Scientists Moving a Lab Find Forgotten Smallpox

By Kim Smiley

On July 1, 2014, vials marked “variola”, the virus that causes smallpox, were found when a fridge was being cleaned out as part of the effort to move a National Institutes of Health campus to a new location. The vials were immediately secured and a CDC team was dispatched to retrieve the vials. No exposure to smallpox is suspected, but the discovery is still alarming. There are only two heavily secured locations where smallpox is supposed to exist in the world so the fact that vials of a dangerous virus were just sitting forgotten in a fridge has raised many issues that that should be investigated.

This issue can be analyzed by building a Cause Map, a visual root cause analysis method.  To build a Cause Map, the problem is first defined by identifying impacts to the overall goals and then “why” questions are asked to lay out all the causes that contributed to an issue to show the cause-and-effect relationships.  For this example, the safety goal was impacted because there was potential for a smallpox outbreak.  This would be the first box on the Cause Map and more boxes would be added by asking “why”.

So “why” was there potential for a smallpox outbreak?  This occurred because there was a potential for people to be exposed to the smallpox virus and the population has little to no immunity to smallpox.  There was potential for exposure to smallpox because “lost” vials of smallpox were in a fridge in an unsecured lab.  The vials, which were created in 1954, appear to have been in the fridge a long time and somewhere along the way, their presence was forgotten.  Smallpox can survive in refrigeration for a long time and testing has shown that the virus was still viable.  The general population has little immunity to smallpox.  The last smallpox case in the United States was in 1949 and the US stopped vaccinating for smallpox in 1972.

The final step of the Cause Mapping process is to use the Cause Map to develop and implement solutions to  reduce the risk of a similar problem occurring in the future.  In this example, the immediate problem was addressed by moving the vials to a secured lab.  Once scientists are done studying the vials, the contents and all traces of the virus will be destroyed.  Longer-term solutions will likely include ensuring that all  government laboratory storerooms are inventoried to ensure that no other potentially dangerous vials have been “lost”.  Inventory procedures should also be reviewed to ensure they are adequate.

To me, the most worrisome part of this issue is that the vials were only discovered because workers were moving the lab to a new location. It naturally raises questions about what else might be out there and how frequently inventory is happening, or not happening as the case may be.   Investigation into this incident has already uncovered a number of other vials filled with potentially dangerous specimens in the same storage facility.   If any other potentially dangerous vials are “lost” in other locations, I hope we find them before 60 years have passed.

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

Root Cause

“Artificial Pancreas” May Dramatically Improve Management of Type 1 Diabetes

By Kim Smiley

As many as 3 million Americans have type 1 diabetes and for many managing the autoimmune disease requires constant vigilance.  Patients have to carefully monitor what they eat and their blood sugar levels, often pricking their fingers and injecting insulin multiple times a day.  The number of people diagnosed with type 1 diabetes has been increasing, but there is some good news.  There is no cure for type 1 diabetes, but a new device, an artificial pancreas, may make managing the disease significantly simpler.

Type 1 diabetes is caused when the immune systems attacks insulin-producing cells in the pancreas so the body can no longer produce adequate insulin.  Insulin is needed because it works to allow sugar to enter cells where it is used for energy, reducing the levels of sugar in the blood stream.  Sugar builds up in the blood when food is consumed and from natural processes in the body.  Without enough insulin, blood sugar levels will continue to increase.  High blood sugar can damage major organs and can have significant impacts on long-term health.  Low blood sugar is also dangerous and can quickly become a life-threatening emergency so patients with type 1 diabetes are constantly working to keep blood sugar within acceptable levels.

The artificial pancreas works by monitoring blood sugar levels every 5 minutes and using two pumps to deliver two different hormones (insulin to lower blood sugar levels and glucagon to raise blood sugar) as needed with minimum intervention required by the user.  The current version of the artificial pancreas consists of three parts (two small pumps and iPhone contacted to a continuous glucose monitor) but there are plans to simplify the device in the future.  The components connect to three small needles that are inserted in the patient to allow blood sugar levels to be monitored.  Insulin pumps currently used by many type 1 diabetics can only inject insulin and require more input from the user, so the artificial pancreas is a significant improvement over currently available technology.

The artificial pancreas is still in the development stage and needs additional testing and modification prior to becoming widely available for patient use.  The first test was done using about 50 patients (20 adults and 32 teenagers) who wore the new device for 5 days.  The results were very promising, but more testing will need to be done. During the 5-day test, the patients had lower blood sugar levels overall and the device simplified management of the disease.  Researchers reported that the patients didn’t want to return the devices because they worked so well. The next step is to have patients use the device for a longer time period.  It’s essential to ensure that the device is very robust, because the consequences can be dire if it fails.  Once the design is finalized, the hope is to seek FDA approval and have the artificial pancreas available in about 3 years.

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

Root Cause

5.5 Million Cases of Norovirus are Spread Via Food Each Year

By Kim Smiley

Norovirus outbreaks on cruise ships may make exciting headlines, but the reality is that only one percent of norovirus outbreaks occur on the high seas.  About 20 million people in the US are sickened by noroviruses in the US each year and one of the most common transmission paths is via food.  Food-borne norovirus is estimated to be responsible for 5.5 million cases of norovirus annually in the US.

A Cause Map, a visual method for performing a root cause analysis, can be used to analyze this issue.  The first step in the Cause Mapping process is to determine how an issue impacts the overall goals and then the Cause Map is built by asking “why” questions to visually lay out the cause-and-effect relationships.  In this example, we’ll focus on the safety goal since it is clearly impacted by 5.5 million cases of norovirus transmitted via food.

So why are people getting norovirus from food?  This is happening because they are consuming contaminated food, predominantly at restaurants or catered events.  The food becomes contaminated when a food worker’s hands are contaminated by norovirus and they touch food, particularly food that is ready to serve and won’t be cooked prior to consumption.  (Disclaimer: You may want to stop reading here if you are eating or thinking about going to out to eat soon.)

For those unfamiliar with the illness, norovirus is basically a gastrointestinal nightmare that can cause the human body to do very messy things.  If a food service worker is ill, the virus can get on their hands, especially after using the bathroom.  According to a Centers for Disease Control and Prevention (CDC) report, the transmission of food-borne norovirus is “primarily via the fecal-oral route.”  And that is more than enough said about that.

It is also worth asking why food workers are at work if they are under the weather.  In the US, few food service workers get paid sick leave so they may show up at work sick because they are concerned about the loss of income and the impact on their jobs.  It’s also important to ensure that workers understand the importance of good hygiene and have access to both water and soap and time to effectively wash their hands.

The final step in the Cause Mapping process is to develop solutions to reduce the risk of the problem recurring.  The solutions to this problem are both simple in concept and difficult to effectively implement.  Ideally, food workers should stay home when they are ill and for at least 48 hours afterwards, but this is much easier said than done for many people.  Food workers should also wash their hands after using the bathroom and before handling any food, but it can be difficult to enforce the policy because employers and managers aren’t (and shouldn’t be) closely monitoring what happens during bathroom breaks.

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

Root Cause

Study Finds Bacteria Can Live on Airplane Surfaces for Days

By Kim Smiley

With many bodies packed into a tight space and seemingly stale air, airplanes tend to bring out the inner germaphobe in many of us.  And the latest research, especially if you just read the headlines, isn’t going to help. Researchers at the University of Auburn found that Methicillin-resistant Staphylococcus aureus (commonly known as MRSA) and E. Coli can live for days on airplane surfaces.

The experiment involved sterilizing six surfaces found on airplanes (seat pocket, arm rest, leather seat, window shade, tray table and toilet handle), introducing MRSA and E. Coli bacteria to them and then measuring how long the bacteria survived.  Typical conditions inside an airplane were stimulated and the bacteria were suspended in three different solutions (saline, simulated seat and simulated saliva) to replicated the environment inside an airplane. The survival times ranged from 8 to 2 days.  This is a little scary, especially since an estimated 1-2 percent of people in the US may be carriers of these dangerous bacteria.

The good news, and there is good news, is that the surfaces where the bacteria lived the longest, the more porous surfaces such as the seat pocket, are the least likely surfaces to actually spread the contamination.  The study also didn’t look into how much bacteria remained after the typical cleaning  by airlines between flights, but the researchers plan to look into this in the future.

So what can you do to reduce the risk of illness if you have plans to travel on an airplane soon?  The simplest thing you can do to protect yourself is to frequently wash your hands with soap or use hand sanitizer as well as avoid touching your face as much as possible.  If you feel the need to take additional precautions, you can clean the areas around your seat with a disinfectant when you board the plane.

Airline cleaning procedures can also significantly impact the spread of illness.  So the question is, how much do you trust the thoroughness of the cleaning performed by the airline?  I think I may invest in a travel-size hand sanitizer before my next flight.

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

Root Cause

The Future Is Now?: Building a Neurobridge

By Kim Smiley

A chip was recently inserted into the brain of a man paralyzed from the chest down with the goal of allowing him to move his hand.  The tiny microchip is part of a system, called a Neurobridge, which uses a computer and a sleeve that fits around the patient’s arm in addition to the chip to allow the patient to communicate with his limb by bypassing his damaged spinal cord.  If the procedure works, the patient will be the first paralyzed person who has used his own thoughts to control a limb.  It will be a few weeks before the success of the procedure can be verified, but this is already an exciting development with the promise of amazing future applications of this type of technology.

So how does this Neurobridge work?  An article by The Washington Post “Ohio surgeons hope chip in man’s brain lets him control paralyzed hand with thoughts” by Jim Tankersley discussed the procedure in detail.  The patient’s brain was mapped prior to the surgery using a functional magnetic resonance imaging (MRI) machine.  The patient was shown pictures of hands moving and the areas of his brain that showed activity while he imagined moving his hand were recorded.  Once the surgery began, a portion of the patient’s skull was removed to allow access to his brain.  Electric pulses were fired into the area of the brain believed to control hand movement.  The patient was unable to move his hands, but did have movement of his upper arms so the team watched for a response in his upper arms to verify that the correct location was identified to insert the chip.

Once the chip was inserted into the brain, it was connected by wire to a transmitter port at the skull.  This transmitter port is connected by cable to a computer.  The signal from the brain then travels through the cable into the computer where it is run through an algorithm that mirrors the brainwaves that are present when a person is thinking about moving.  The signal now mimics brainwaves and is sent to a sleeve wrapped around the arm.  The sleeve has tiny electrodes that are used to stimulate the muscles to make the hand move.

It’s an ambitious project that if successful could help not only paralyzed patients, but others with limited motor function like stroke victims.   And as amazing as a Neurobridge sounds, it’s just one of many types of brain implants being actively researched and some of the ideas sound more like science fiction than plain old science.

The Neurobridge process can be illustrated by building a Process Map.  A Process Map visually shows the steps and is generally easier to read than the same information written in paragraph form.  To see a high level Process Map of this procedure, click on “Download” PDF above.

Root Cause

New Federal Rule Limits Level of Coal Dust Allowed

By Kim Smiley

On April 23, 2014, federal officials announced changes to the regulations governing dust-control practices in coal mines.  These changes are the most significant since the Coal Mine Health and Safety Act of 1969 and are intended to curb the increasing number of black lung cases.

Black lung is a potentially deadly disease that occurs when coal dust accumulates in a person’s lungs.  The coal dust slowly destroys parts of the lungs and blood vessels resulting in breathing problems, coughing and even death if the lungs are unable to adequately function.  As discussed in a previous blog, there is evidence that the number of black lung cases has been increasing in recent years.  Many believe that changes to the mining industry, such as modern high-speed mining equipment that produces high levels of dust and longer shifts, are increasing the risks to miners, in at least some mines.

The bad news is that there is no way to remove the dust once it has settled into the lungs and black lung disease is irreversible, but the good news is that it can be prevented by limiting the coal dust a person inhales and this is exactly what the new federal regulations are hoping to do.

The new regulations attempt to reduce the number of black lung cases by reducing the amount of coal dust exposure that is allowed during a shift by 25% (1.5 milligrams per cubic meter from 2.0).  Better monitoring of dust levels will also be required.  Miners regularly exposed to high levels of coal dust will be required to wear monitors that continuously track coal dust levels.  If dust levels are found to be above the limit, immediate actions to lower the dust limits will be required (such as slowing production) and respirators will be required to be available to miners working in the high dust areas.

The changes, first proposed in 2010, have been a long time coming and many in the mining industry have opposed them.  Some plan to continue fighting against the new regulations like Murray Energy Corp who have stated their intention to file a lawsuit against the U.S. Department of Labor saying the new rules are flawed, have no scientific support and are unachievable. As with any new regulation, only time will tell how smoothly the new changes can be implemented and how effective a solution they will be.

Root Cause

Concern Over Rising Costs of Specialty Drugs

By Kim Smiley

The good news is that more and more specialty drugs that show promise for treating serious medical conditions are becoming available.  The bad news is that some of these drugs are really expensive, both for insurance companies and individuals.

The new issues swirling around specialty drugs are illustrated well by the new drug for treating hepatitis C from Gilead Sciences.  The new drug is a significant improvement over previous treatment with a higher cure rate, a shorter duration and fewer reported side effects, but it carries an equally significant price tag.  The pills cost $1,000 each with a typical course of treatment costing $84,000.  The pills are in high demand and Gilead has reported a record breaking $2.3 billion in sales of their new hepatitis C drug during its first full quarter on the market.  But on the flip side, UnitedHealth Group, one of the largest US insurers, has reported it has spent $100 million to cover the hepatitis C drug and had their stock prices decrease.

An insurance company losing money may not seem like a source of concern, but more of the burden of the cost of specialty drugs is being passed along to patients as insurance companies figure out how to deal with the high price of specialty drugs.  Some insurance plans require patients to cover twenty percent of the cost of specialty drugs and 20 percent of $84,000 is beyond the means of many patients.  And some specialty drugs are even more expensive.  Also, financially healthy insurance companies are also vital if they are going to provide medical insurance at prices people can afford.

So why are these drugs so expensive? There are a number of factors that make specialty drugs so expensive.  One of them is that they generally treat a condition that relatively few people suffer from.  When more people take a particular drug, the development costs of the drug can be spread out and recouped over a larger population making the overall cost less for each individual.  The opposite occurs when there are fewer people who will take a particular medication: the development costs are more concentrated, making drugs for less common conditions more expensive in general.

There is also not usually a generic alternative available for specialty medication.  Many of the expensive specialty medications are newer and still protected by patents so that generics can’t be manufactured.  Most specialty medications are also biologics, meaning they are derived from living organizations, and they can’t be duplicated.  Medications with generic versions available tend to be chemically-based and easier to replicate.

Only time will tell how specialty medications will continue to shape the healthcare system, but their presence is only likely to grow as more drugs are developed.  Solutions will need to be developed to allow patients reasonable, affordable access to specialty medications, but also keep insurance and drug companies in business.

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

Root Cause

CDC Finds that 1 in 25 Patients Acquire an Infection While in the Hospital

By Kim Smiley

A recent headline from the New York Times reads “Infections at Hospitals Are Falling, CDC Says”.  That sounds like fantastic news right?  Well, what about this one from the same day from the Washington Post: “One in 25 patients has an infection acquired during hospital stay, CDC says.”  One in 25 doesn’t seem like great odds to me.  The two headlines give very different impressions of the problem, so which one is right?

The truth is that both statements are accurate, but neither tells the complete story.  To really understand the situation, you need to read a lot more than just the headlines. This is a good analogy for what happens in meetings every day.  Something goes wrong and everybody thinks they know what THE problem is or what is THE root cause.  Many times when people argue they aren’t really in disagreement, they are just focused on different parts of the same puzzle.

Building a Cause Map, a visual format for performing a root cause analysis, can help reduce miscommunication.  The first step in the Cause Mapping process is to fill in an Outline.  The top of the Outline lists the basic background information.  At the bottom of the Outline, there is space for listing the specific impacts to the overall goals.  People may argue about what THE problem is, but it’s hard to argue when specifically listing how the problem impacts goals.  For example, most people would agree that increased cost of healthcare is an impact to the overall economic goal of a hospital.  It may sound counterintuitive, but adding detail helps clarify the situation, when defining the problem and when actually determining what went wrong.

In the case of those headlines listed above, both refer to a recent study by the Center for Disease Control and Prevention that found that about 1 in 25 patients in US hospitals in 2011 acquired at least one infection based on data from 11,282 patients treated at 183 hospitals in 10 states.   (The total number of patients who acquired at least one infection is over 700,000.) The study estimated that around 75,000 of these patients died, but didn’t provide information on whether the deaths directly resulted from the infections.  The study also didn’t include nursing homes, emergency departments, rehabilitation hospitals and outpatient treatment centers.  Previous estimates put the number of infections each year at 2.1 million in the 1970s and 1.7 million from 1990 through 2002. The rate of infections also varies widely from hospital to hospital.  There is uncertainty in the data available, but the trend seems to be going in the right direction, even though the problem of hospital-acquired infections remains significant.  Before working to reduce the risk of a problem, it’s important to lay out all the facts and understand what exactly the problem is.  That generally requires more than a simple statement, which is why the Cause Mapping uses a formal Outline to define a problem.

After the Outline is completed, the next step is to analyze the issue by building a Cause Map by asking “why” questions starting with one of the impacted goals.  Hospital acquired infections are an impact to the patient safety goal so we could begin by asking “Why are patients getting infections in hospitals?”  This occurs because they are exposed to a pathogen.  Why?  There are pathogens at the hospital because many sick people are there for treatment.  Inadequate cleanliness also plays a role.  Additionally, the pathogen is able to infect the patient.  You would continue asking questions to determine why patients are being infected until you reach the desired level of detail.  Generally, the bigger the problem, the greater level of detail is needed.

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

Root Cause

US Doctors Issue Statement That Mothers Should Avoid Water Births

By Kim Smiley

The number of water births in the United States has been increasing in recent years and controversy over their safety continues to rage.  The latest development is that the American Academy of Pediatrics and the American College of Obstetricians and Gynecologists recently issued a joint statement saying that water births are not recommended and should be avoided, but some midwives and mothers disagree and adamantly defend the benefits of birthing in water.  The doctors agree that soaking in water during early labor may make the experience more pleasant for mothers, but feel that actual birth should be outside of the birthing tub.

One of the issues is that the benefits of water birthing are difficult to prove and the potential risks are difficult to quantify .  Some mothers believe that birthing in water helps relieve pain and can aid in a drug-free delivery.  Supporters of the practice also think that birthing in water can shorten labors, which reduces stress on the mother and the baby.  Some midwives have also expressed a belief that water births are gentler on babies, saying that many do not cry when they are born.  It’s difficult to definitively study the impacts of water births because birth outcomes depend on so many factors and you can’t do a double-blind study because it’s pretty much impossible to have a placebo for a water birth.

There have been reports of individual cases where something went wrong during a water birth, but there is little information on how often this occurs.  There is general agreement that complications are rare, but the doctors  releasing the statement feel the risk of complications outweighs the benefits.  The most serious concern is the baby drawing its first breath underwater, which could lead to breathing issues and even drowning.  There is also a risk of umbilical cord ruptures since the baby must be brought to the surface relatively quickly and the cord may be too short.  There is also increased risk of infection for the mother and baby since they are both exposed to potentially contaminated water because birth can get messy.

Until now, there has been little formal guidance provided about water births.  Providing more information for expectant mothers is a great first step, but disagreement between medical professionals about birthing methods can add confusion to an already stressful time.  Until more studies are done to provide a better understanding of the risks involved, women will have to rely on their own judgment and the guidance of their healthcare provider.

To view an Outline and Cause Map of this issue, please click “Download PDF” above.