All posts by Kim Smiley

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

Are Medical Residents Dangerously Fatigued?

By Kim Smiley

Medical residents work extremely long, tiring schedules on their arduous path to becoming physicians.  Possible consequences of this demanding schedule have long been debated.  Many wonder if it’s safe to have someone who has been on duty for 24 hours straight treating patients.

This issue can be explored by building a Cause Map, or visual root cause analysis.  A Cause Map is built by asking “why” questions and laying out the different causes that contributed to an issue to the cause-and-effect relationships.  In this example, there is potential risk to patients and to the medical residents themselves.  Patients may be at risk because fatigued medical residents are treating patients and fatigued people are more likely to make mistakes, increasing the chance of a medical error that affects patient safety.  Residents are fatigued because they work long hours and the current regulations allow 80 hour work weeks.

Additionally, the health of the residents themselves may be at risk.  A poll by the Mayo clinic found that 11 percent of medical residents had been in an auto accident.  The poll also found that 8 percent of residents reported having at least one blood or body fluid exposure due to fatigue or stress, potentially exposing them to any number of diseases.  Sleep deprivation itself can also have long term health consequences increasing the likelihood of a number of illness including heart disease and gastrointestinal problems.

While there is ongoing debate on whether residents are still working too many hours, there have been changes made to reduce resident fatigue. In 2003, residents were limited to 80 hours per week by the Accreditation Council for Graduate Medical Education.  Prior to this move, there was essentially no limit to the hours a resident could log.  This issue isn’t black and white and there are also many who argue that the limits have had negative unintended consequences.  Fewer hours in the hospital mean that residents see fewer patients and have less experience when they become independent physicians.  Limiting shifts also increases the potential for each patient to be seen by more doctors and for essential information to be lost during turnovers.  This isn’t an issue with a clear answer and any additional restrictions in the hours a resident is allowed to work will need to be mitigated with effective methods of turning over patient care and assurances that residents are getting adequate training.

This is a good example to demonstrate the important of taking an investigation past determining that the problem is caused by “human error”.  Medical errors are caused by human errors, but the most useful part of the investigation usually comes from asking why the error was made.  Was the person overly fatigued?  Was the procedure confusing?  Would the process go smoother with a phase to verify information or a checklist?  An investigation shouldn’t be stopped at “human error”; it should be taken a few steps farther to see what may have contributed to the error and what changes may help prevent a similar error in the future.

Root Cause

Is the NFL Getting More Dangerous?

By Kim Smiley

Player injuries in the National Football League (NFL) have been making headlines for years now.  One of the questions that have been asked is whether increases in players’ weight and speed have been making the game more dangerous.

A Cause Map, an intuitive method for performing a root cause analysis, can be used to analyze this issue.  The first step when building a Cause Map is to determine how the overall goals are impacted.  In this example, the main focus will be player safety, but there are factors worth considering such as the negative publicity this issue has generated for the NFL.  There is also a whole lot of money in play with a lawsuit that more than 4000 players have filed against the NFL for allegedly covering up life-altering brain injuries.

The Cause Map is built by taking one of the impacted goals and asking “why” questions.  Why is there a safety concern?  There is the potential for severe neurological trauma because players are suffering brain injuries on the field.  The obvious reason this happens is because it’s football.  Players are hit and hit hard as part of perfectly legal and allowed tackles.  It’s how the game is played.    Players may also be hurt during illegal plays, such as a helmet-to-helmet contact, which are more likely to cause brain damage.  One extremely hard hit can end a career, but more and more evidence is showing that milder, repeated hits may also cause life-altering brain injuries.  Another potential cause that might be worth exploring is the protection that players wear.  They are still getting hurt despite wearing helmets and pads.  Maybe different equipment could help prevent some of these injuries.

The protective gear has improved and the tackling rules have been modified, but the basic game has remained the same since 1920 when the NFL began with one notable expectation.  The players themselves have changed radically over the decades.  In the 1920, the average lineman was 190 pounds.  The average lineman these days weighs 300 pounds.  Despite the extra 100 plus pounds, the average lineman has also gotten faster.  A faster, heavier player hits with more force and slamming into another body with more force probably isn’t healthier for anybody involved.

Continuing the Cause Map, it makes sense to ask why today’s players are so much bigger and quicker.  Specialization of training and nutrition programs surely play a role in the evolution of the player’s body.  There is also speculation that performance enhancing drugs are being used and complaints about the lack of the effective testing for substances such as human growth hormone.

This is an issue that still needs research.  A better understanding of how impacts are affecting brains is needed so that the full scope of the issue is known.  If the problem is as large as it is suspected, better ways of protecting these players need to be found.

Root Cause

FDA Recommends Lower Doses of Sleep Aids

By Kim Smiley

On January 10, 2013, the Federal Drug Administration (FDA) announced a new requirement to dramatically decrease the normally prescribed doses of sleep aids containing zolpidem, which includes Ambien, Edluar and Zolpimist.    Products containing zolpidem are the most commonly prescribed sleep aids with about 40 million dispensed in 2011.

A Cause Map, or visual root cause analysis, can be used to help understand this issue.  The first step in the Cause Mapping process is to fill in an outline with the background information for a problem, such as the date and location.  The bottom half of an outline is filled in with the impacts to an organization’s goals.  In this example, the safety goal is impacted because there is a risk of car accidents after patients used prescriptions containing zolpidem and drove a car.  There have been about 700 reports of car accidents after people used products contain zolpidem. The customer service goal is also impacted because this issue has generated some bad publicity for the companies that manufacture these drugs.

After the outline is completed, the next step is to use the impacts to the goals to ask “why” questions and add the answers to the Cause Map to show the cause-and-effect relationships.  Why is there a risk of car accidents? People may be driving while impaired because zolpidem makes you drowsy and they may have zolpidem in their systems.  Zolpidem is a sedative; it’s the active ingredient in a number of sleep aids.  People may still have zolpidem in their systems because millions of people take prescription sleep aids containing it and it stays in the body longer than was known.    Originally it was believed that it was safe to drive 8 hours after taking zolpidem, but the FDA determined that enough of the drug may be present to impair driving after 8 hours.  Women are especially at risk of impaired driving because they metabolize the drug slower.

The final step in the Cause Mapping process is to determine possible solutions that would prevent a problem from reoccurring.  In this example, the FDA determined that taking a lower dose of sleeping aids containing zolpidem would help reduce the risk of impaired driving and the potential for car accidents.  The new FDA requirements would lower the dose for women from 10 milligrams to 5 milligrams for immediate-release products and from 12.5 milligrams to 6.25 milligrams for the extended-release product. The safest option is always to take the lowest dose of any sleep aid that is effective.

If you use a sleep aid containing 10 mg or 12.5 mg dose zolpidem, the FDA recommends that you continue taking your medication as prescribed until you can contact your healthcare professional.

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

 

 

Root Cause

NYC Hospital Unexpectedly Evacuated During Sandy

By Kim Smiley

On October 30, 2012, power outages forced evacuation of a New York City hospital amidst the onslaught of Hurricane Sandy.   All 217 patients in the hospital to had moved, including 20 infants staying in the neonatal intensive care unit.

This incident can be analyzed by building a Cause Map, an intuitive format for performing a root cause analysis.  The first step in the process is to fill in an Outline that lays out the basic background information and also identifies the impact to the goals.  In this example, the safety goal is clearly impacted because it is risky to evacuate patients during a hurricane.  Although the potential for injury was very real, no one was hurt during the evacuation and the hospital staff did an amazing job of carrying patients down darkened stairwells and ensuring basic life support remained stable.  The customer service goal is also worth considering since the unexpected evacuation received a large amount of negative publicity.

After the Outline is completed, the next step is to ask “why” questions to add Causes to the Cause Map.  Why were patients at risk?  This occurred because the hospital had to be evacuated because it lost power and the backup power generators failed.  Why the generators failed hasn’t been identified yet, but there is speculation that the age of the equipment may have played a role. It’s also possible that the location of the generators might be factor since a number of hospital building were flooded by ten feet of water.  Electrical service was lost because New York City was hit hard by Hurricane Sandy and saw unprecedented flooding and strong winds.  This wasn’t an unexpected impact of the storm, but the hospital did not expect the generators to fail, especially so quickly.  The patients were also at risk because the hospital had many patients in critical care units that required life support systems and the patients were evacuated under dangerous conditions, both inside and outside the hospital.  At the time of the evacuation the hospital had lost power and patients were being carried down stairs lit by flashlights.  Some patients were bought down 16 flights of stairs.  The evacuation also occurred during the hurricane so the conditions during the drive to a new faculty were potentially dangerous.  The evacuation occurred during the hurricane, as opposed to before the storm hit, because the hospital assured the city that it was prepared and could ride out the hurricane.

This issue is still being investigated, but once all the facts are known solutions can be developed and implemented to help ensure that patients aren’t forced to evacuate under similar adverse conditions.

Click on “Download PDF” above to see a high level Cause Map of this issue.

Root Cause Analysis

Teen Impersonates a Physician’s Assistant

By Kim Smiley

A teen, who was 17 at the time, was arrested on September 2, 2012 for impersonating a physician’s assistant in a Florida hospital.  The young man worked at a hospital, treating patients and performing duties typical of a physician’s assistant, for about a week before anyone became suspicious of his lack of credentials.  Investigation into the case found that he examined patients, removed an IV and even performed CPR without any medical training.

How could this possibly happen?  A Cause Map, or visual root cause analysis, of this situation can be built to help understand the different causes that contributed to a young man successful impersonating a medical professional.  The first step in building a Cause Map is to determine how the issue impacted the overall organization goals.  In this example, the safety goal is clearly impacted since an unlicensed individual treated patients.  The customer service goal was also impacted because of the negative publicity for the hospital involved in the scandal.

Causes are added to the Cause Map by asking “why” questions.  Why did this happen?  How did a teen end up performing the duties of a physician’s assistant?  Statements by the teen indicated that he was interested in learning more about the profession so he decided to work at the hospital.  He was able to pull this off because he was incorrectly given a physician’s assistant identification badge and nobody initially questioned his credentials because he acted the part well.

The teen worked as a clerk in a doctor’s office near the hospital and when he went to the ID office to get a badge, he was somehow given the wrong one.  His credentials were never checked and personnel at the ID office have stated that this was because the office was very busy at the time.  The teen also never told anybody he had the wrong badge and decided to use it.

The masquerade was also successful for a time because the teen played the role of physician’s assistant well.  He wore scrubs and a stethoscope and used the correct terminology.

This case went to trial in August 2012.  The teen was found guilty on two counts of impersonating a physician assistant and two counts of practicing medicine without a license.  His sentencing is scheduled for November 14 and he faces up to 25 years in prisons.

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

Root Cause Analysis

Working to Eradicate A Painful Parasite

By Kim Smiley

The lifecycle of the Guinea worm is the stuff of nightmares.  This parasite is ingested by a host as larvae, mate and mature inside the host and then the adult female painfully emerges to lay her eggs. The adult female is between two to three feet long and the thickness of a spaghetti noodle.  The only way to get rid of the parasite is to wrap it around a stick and slowly pull it out, a process that takes several weeks or even months.

Individuals who are infected by this parasite can suffer for months, making it difficult to work and feed their families.  There is no immunity to Guinea worms so it’s possible for people to suffer year after year if they continue to ingest the larvae of the Guinea worms.  There is also no drug to treat Guinea worm disease and there is no vaccine that prevents infections.

But there is hope in the fight against this excruciating disease.  The number of cases of Guinea worm disease has decreased dramatically.  In 1986 there were an estimated 3.5 million cases of Guinea worm disease spread across 21 countries in Asia and Africa.  In 2011, there were only 1,058 reported cases of Guinea worm disease in four African countries.

How was this possible?  The first step in answering that question is to understand more about the disease.  The problem of Guinea worm disease can be illustrated by building a Cause Map, an intuitive root cause analysis format.  By asking “Why” questions, causes can be added to the Cause Map and the problem can be analyzed.    Why are people getting the disease?  People are drinking water that is contaminated with copepods, also called water fleas, which are infested with larvae of Guinea worms.  There is also typically no other supply of safe drinking water and the water wasn’t treated or filtered prior to consumption.

Painful blisters form when the female Guinea worm emerges from the body and people put their sores into the same water used for drinking (because it is usually the only water available) to help relieve the burning sensation.   The female Guinea worm then releases hundreds of thousands of guinea worm larvae once she senses water.  Guinea worm larvae is eaten by the water fleas.  The infected water fleas are small and ingested along with the water, which restarts the whole process.

This process had been going on for thousands of years, affecting millions and millions of people.  Its remains have even been found in Egyptian mummies.  But simple changes have nearly eliminated the disease.  In fact, Guinea worm disease is predicted to be the first human disease ever eradicated without a vaccine and only human disease to be eradicated other than small-pox.

Relatively simple changes have made all the difference in the world.  People were educated about how to prevent the disease.  Millions of straws with filters were handed out to villagers to strain out the infected water fleas and prevent the parasite from entering the body.  Efforts were also made to treat water with larvicide and provide access to uncontaminated drinking water.

Without new hosts, the Guinea worm larvae died.  Once the lifecycle was broken, the disease disappeared from many regions.  There are now only four countries that reported any cases of the disease last year, the vast number being in war torn South Sudan where public health efforts have been difficult to sustain.

Click on “Download PDF” above to view a high level Cause Map of this issue

Root Cause Analysis

Possible Link Between Antibiotics and Obesity

By Kim Smiley

A study recently published in the International Journal of Obesity found that infants given antibiotics before six months of age were 22 % more likely to be overweight between the ages of 10 months and 3 years.  Researchers believe this may be because the natural balance of bacteria in their digestive tracts is altered by the antibiotics.

Obesity has long been assumed to be a matter of too much food into the body while too few calories are burned, but new studies. including the recent one finding a link between use of antibiotics early in life and body weight later in childhood,  are suggesting that the issue may be more complicated than it appears on the surface.

Scientists are still studying how bacteria in human digestive tracts affect how the body processes food, but many researchers believe that the balance of bacteria plays a role in how the body absorbs calories.  The amount of calories that a body absorbs from the same amount of identical food may not be a constant.  More studies are needed to understand the relationship between bacteria in the gut and body weight, but studies done so far are intriguing.

The link between antibiotics and higher body mass remained even when researchers controlled for factors such as what the baby ate, the weight of a baby’s parents, whether the mother smoked while pregnant, and the family’s socioeconomic status.  Researchers did note that the study found an association and not a cause-effect link and that further studies are needed, but there seems to be a relationship between how antibiotics affect the body and body mass.

More research is needed to fully understand this issue, but this study is an interesting step to better understanding the causes of childhood obesity.  On the downloadable PDF, we have created a Cause Map, or visual root cause analysis, to show the possible cause-and-effect relationships between use of antibotics in early enfancy and childhood obesity.

In this specific study used to build this example, the researchers were quick to point out that infants should be given antibiotics if they are needed, but it’s important to understand how the medication may be affecting bodies, especially very young bodies.

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

Root Cause Analysis

At Least 31 Patients Contracted Hepatitis C

by Kim Smiley

Testing is still ongoing, but at least 31 people have contracted hepatitis C from contaminated syringes at a New Hampshire cardiac catheterization lab.  A previous blog discussed the outbreak when it was initially announced that four patients who had used the same cardiac catheterization lab had tested positive for the same strain of hepatitis C, but more information has been released and the Cause Map should be updated to incorporate all the relevant details.  One of the strengths of a Cause Map, a visual root cause analysis, is that it can be updated relatively quickly to document important information as it becomes available.  In this example, investigators are continuing to work to understand the issues involved, but two new significant pieces of information should be added to the Cause Map.

The source of the hepatitis C has been determined by investigators.  Investigators found that a medical technician with hepatitis C contaminated syringes that were then used on patients.  The medical technician is a drug addict who used the syringes because they were filled with Fentanyl, an anesthetic far more powerful than morphine.  Hepatitis C is spread through blood to blood contact so syringes contained with hepatitis C are a major health hazard that are capable of spreading the disease. The syringes were not secured so he was able to attain them.  He then used them, refilled them with saline or another liquid and replaced them without any other member of the staff noticing.

Investigators have also learned that the medical technician responsible for the contamination has worked in 18 hospitals in seven other states during the last 10 years.  It’s not known when the medical technician contracted hepatitis C, but investigators believe he had a positive test for hepatitis C in June 2010.  This means that the investigation needs to be expanded and that many more people may need to be tested.

This article contains information about what facilities the medical technician worked at and the timeline for his employment.  To view an updated high level “Cause Map”, click here.

Root Cause Analysis

Consumption of Small Cigars Increases

By Kim Smiley

A study by the CDC has found a decrease in cigarette smoking, but a corresponding increase in the use of other tobacco products.  Cigarette smoking declined 33% between 2000 and 2011 which would be cause for celebration except for the fact that use of other kinds of tobacco grew by 123%.  This seems to be an example of unintended consequences where the attempt to control one problem changed behavior in an unexpected way.

A Cause Map, or visual root cause analysis, can be used to help explain this situation.  Building a Cause Map can illuminate the cause-and-effect relationships between the different factors that contributed to an incident.  To begin a Cause Map, the impacts to organizational goals are determined and then “why” questions are asked to add Causes.  In this example, we’ll focus on the increase in the use of small cigars since they are the tobacco alternative most similar to cigarettes.  We’ll also focus on the Safety Goal since public health is affected by the increasing use of small cigars, although there are certainly other issues such as missed tax revenue worth considering in a more detailed Cause map.

Why is the risk to public health increasing?  This occurs because more people are using small cigars and they have similar health risks to cigarettes because they contain the same toxic chemicals.  Why are more people using small cigars?  Small cigars smoke similarly to cigarettes, are far cheaper than cigarettes and can taste better.

Small cigars are slightly larger than cigarettes, but are similar enough in size to provide a similar smoking experience.  They are far less expensive than cigarettes because they are in a different tax category because of their slightly larger size and the fact that not all tobacco products are equally taxed.  The price difference is significant; small cigars may cost as little as $1.40 a pack while cigarettes sell for $4 or $5 a pack since they are highly taxed to discourage smoking.

Cigars can also taste better because manufacturers are allowed to add flavorings such as grape and chocolate to small cigars, but they are not allowed to add them to cigarettes.  The Food and Drug Administration has regulations that bar adding flavoring to tobacco, but these do not apply to cigars and pipe tobacco.

From 2010 to 2011, the overall use of smoked-tobacco decreased by less than 1%.
It appears that attempts to discourage smoking cigarettes with high taxes just pushed some people into buying cheaper alternatives.  One potential solution to this issue would be to equalize the taxes and regulations on all types of tobacco.

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

Root Cause Analysis

DC Searches for Solutions to Slow the HIV Epidemic

By Kim Smiley

Washington DC is trying some new methods to help fight the AIDS epidemic.  DC has long had one of the highest rates of HIV infection in the United States, but there is hope that these new techniques might change that fact.

This issue can be built into a Cause Map, a visual root cause analysis.  A Cause Map shows the relationship because the causes that contribute to an issue and can also show how potential solutions would impact those causes.  To view a high level Cause Map of this issue, click on “Download PDF” above.

The focus of DC’s fight against HIV is treatment, which seems to be the key to controlling the HIV infection rate.  While researchers are still searching for a cure, simply treating people infected with HIV has the potential to dramatically slow down the epidemic.  HIV positive patients who consistently take their drugs lower their chances of infecting others by 96% because the amount of virus in their bloodstream is significantly lower.

The first step in treating infected people is to identify who is infected.  Testing is also important because the earlier patients can be identified; the more effective treatment is typically.  Washington DC has increased testing efforts in order to identify the estimated 5,000 people who live in the DC area and are unaware that they are infected.  People are now being paid to get tested and HIV tests are being offered in a number of new locations such as grocery stores, high schools, on corners where addicts gather, and at the DMV.  There are also efforts to focus testing on the highest risk populations by paying for referrals and social network tracing.

The next area of difficulty is getting patients consistent treatment.  Only 29% of people diagnosed in DC take their drugs every day, which is about average for an American city.  Washington DC is working to track HIV patients, who are typically more transient than the rest of the population and to help get treatment to as many people as possible.

Another cause of the AIDS epidemic that Washington DC is working to improve is to slow the spread of the virus itself.  Typical transmission routes for HIV are unprotected sex and use of dirty needles.  Last year, five million male and female condoms were given away in the DC area.  There were also more than 300,000 clean needles given away.

These innovative new programs seem to be having a positive impact on the epidemic. New cases have fallen to 835 from 1,103 in 2006.  The number of AIDS test administered has greatly increased.  Only time will tell how effective these solutions have been at slowing down the HIV epidemic in the nation’s capital.