This example can be built into a Cause Map, an intuitive root cause analysis format.  A Cause Map lays out cause and effect relationships and helps illustrate how all factors that contribute to an issue relate to one another and to the overall problem.  To view a high level Cause Map of this issue, click “Download PDF” above.

After scrutinizing the walks of both those who favored heels and those who didn’t, the researchers determined that habitually wearing heels changed how the women walked, even when their feet were bare.  The high heel wearers took shorter, more forceful strides and kept their feet perpetually in a flexed position with their toes pointed.

Why does this matter?  The change in walking biomechanics means that the high heel wearers primarily engaged their muscles while walking.  The control group who rarely wore heels used a combination of tendons and muscles to walk.  The use of the tendons is important because they act as springs in the body and have the capacity to store energy.  Engaging tendons while walking is more efficient.  The high heel wearers had to use more energy to cover the same amount of ground as the control group and this can cause muscle fatigue. So this means that wearing high heels causes the muscles to be engaged more while walking, greater use of the muscles increases everyday strain on muscles and this may in turn increase the chance of strain injuries.

One of the more interesting findings was that frequently wearing high heels caused shortened fibers in calf muscles so that the changes in walking biomechanics remained even after high heels were removed.   It’s also interesting to note that the volunteers who participated in the study were young (the average age was 25) meaning that the changes the researchers found are not something that takes decades to occur.

The researchers recommend limiting high heel wear to a couple of times a week if possible and removing shoes when it’s an option, such as when seated at a desk.

This study looked at nine randomized studies of aspirin use and included more than 100,000 patients.  The study only included patients who had not had a heart attack or stroke and involved giving participants either an aspirin or a placebo to see the benefits of regular doses of aspirin.

These findings have the potential to affect many people since nearly a third of middle-age Americans take a low dose aspirin regularly.  Benefits from aspirin seem to outweigh the risks for people who have a history of heart attacks, but this study calls into question the benefits for patients who are hoping to prevent their first heart attack or stroke.

This issue can be analyzed by building a Cause Map, an intuitive, visual form of root cause analysis.  In this example, the safety goal is the main goal that would be considered because of the higher risk of GI bleeding.  The higher risk of bleeding is caused by the fact that patients are taking aspirin regularly and that GI bleeding is a known side effect of aspirin.  People take aspirin because it has been shown to reduce the likelihood of blood clots.  Reducing blood clots will in turn reduce the risk of heart attacks and stroke since blood clots have the potential to block flow to the brain or heart.

The conclusion that the study draws is that there is no one size fits all solution to the question of whether patients should regularly take low dose aspirin.  The risks and potential benefits need to be determined on a case by case basis by the patient’s physician.  For an individual with a strong family history of heart disease, the benefits may very well outweigh the risk of GI bleeding, but for others the use of aspirin may not be worth the risk.

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

The study was conducted by reviewing the medical records of Medicare patients. As a condition of participating in the Medicare program, hospitals are required by federal regulations to track medical errors that harm patients and to implement solutions to protect patients from similar mistakes in the future.  All hospitals involved in the study had a method to collect information on medical errors, but all adverse events were not being efficiently captured by the systems in place.

The study found that out of 293 cases reviewed, only 40 were reported, 28 led to investigations and only five resulted in changes in the hospital’s processes.  Additionally, the inspector general estimated that more than 130,000 Medicare beneficiaries experience at least one adverse event in a hospital in one month so there is a plenty of room for improvement in patient care.

The study found a number of reasons that adverse events and medical errors were not being reported.  Confusion over requirements was one cause of the under reporting because hospital employees did not always recognize that a particular event harmed a patient and was required to be reported.  Also, there were cases where employees assumed someone else would report the incident or they considered the incident to be so common that it didn’t need to be reported.  There was also a tendency to not report things that were considered to be isolated events that were unlikely to recur.

To help combat these causes, the OIG report recommends the development of a standard list of medical errors that should be tracked and reported.  The OIG also recommends that guidance be developed and provided for the accreditors of hospitals since they do not typically investigate adverse event collection methods.  Additionally, some consumer groups are pushing for public reporting of medical errors to help pressure hospitals to improve their policies and practices.

Click on “Download PDF” above to view a high level Cause Map of this event which is an intuitive, visual root cause analysis of this issue.

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

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

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

A black box warning was placed on these drugs, but not until November 2007.  The European Medicines Agency recommended that the drug be suspended from European markets in 2010, and the drug was withdrawn from New Zealand markets in 2011.  What took so long?

We can attempt to add some clarity to this issue by viewing it in a Cause Map, or visual root cause analysis.  To begin this analysis, we look at the impact to the goals from the point of view of the manufacturer.  The patient safety goal is impacted because of the increased occurrence of stroke, heart attack, and death. The compliance goal is  impacted because – according the Senate Finance Committee – trial results that would have indicated the increased risk for cardiovascular disease were not publicly released in a timely manner.  Reduced sales as a result of the risk are estimated to be more than $2 billion (an impact to the organizational goal) and lawsuits (an impact to the patient services goal) are projected to cost more than $1 billion.

Although the actual mechanism that is causing the increased risk of cardiovascular disease is unknown, the cause of the increased occurrence of heart attack, stroke and death is due to use of the drug rosiglitazone.  Although rosiglitazone has been found to be an effective second-line treatment for Type 2 diabetes, it is unlikely that doctors would have prescribed it as readily had they known about the increased risk of heart disease.  Instead, they were likely swayed by a multi-million dollar advertising campaign, while test results that showed increased cardiovascular risk were allegedly covered up.

Unfortunately, it’s not the first (or last) time this has happened.  In early 2012, the British Medical Journal raised concern about research misconduct – including cases where poor results from clinical trials are not released to the public.  In the US, it was found that less than half of studies – including those funded by the government – are publicly released in a timely manner.  Although there are regulations that require publication of studies, they aren’t always (or even usually) followed.  Some consideration of what can be done to ensure that these regulations are effective is ongoing.

Meanwhile, rosiglitazone has been removed from Europe and New Zealand markets.  In the US, new regulations went into effect making the drug extremely difficult to come by.  A different drug – Actos – is said to have similar effects on controlling blood sugar without the increased cardiovascular risk.  However, patients should consult with their doctors.

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

Ventilator-related deaths occur when a patient who can not intake sufficient oxygen on their own (due to illness or injury) no longer receives sufficient oxygen from a ventilator.  Only a few minutes of insufficient oxygen intake can  result in brain damage or even death.  The patients do not receive sufficient oxygen from the ventilator because it stops working due to malfunction, becomes blocked with mucus, or becomes dislodged or disconnected, potentially due to patient movement.  In addition to an issue with the ventilator providing sufficient air to the patient, a death can occur when the ventilator issue is not fixed immediately. 

Normally the ventilator issue is not fixed immediately because the caregiver is unaware of the issue. (Caregiver in this instance includes not only healthcare professionals but families caring for loved ones at home who are dependent on ventilators.)  In these cases, the caregiver is unaware of an issue with the ventilator because they are dependent on listening for an alarm to indicate a problem, and they don’t notice the alarm.  Caregivers not noticing an alarm were determined to cause 65% of ventilator deaths, according to The Joint Commission. 

How do caregivers miss an alarm?  There are many possible reasons.  The ventilator alarm may not sound due to a malfunction.  Although this issue is commonly cited, the ECRI study determined that this was the case in only 2 of 119 cases it examined.  The alarm may not be sufficiently obvious to a busy caregiver.  Namely, the alarm may be set inappropriately by personnel who have insufficient training on ventilator systems.  Relatively few patients are on ventilators, and insufficient funding and time for training may mean that staff (or families) do not adequately understand how the ventilator works.   Another cause may be that some ventilators sound only once.  If you miss it, it’s done.  (As a solution, ventilator manufacturers are considering alarms that continue until reset.) 

Another issue related to lack of responding to alarms is an issue known as “alarm fatigue”.  Caregivers can become desensitized to alarms, hearing so many every day, many of which are false alarms.  Ventilators, too, can produce false alarms when a patient coughs, or rolls over.  

What can be done to reduce these deaths?  The first line of attack is frequent vacuuming and careful placement of the ventilator to reduce the risk of it becoming clogged or dislodged.  Next, an attempt to make caregivers less dependent on alarms, and more able to see problems using other indications, and more ventilator training may increase the ability of caregivers spotting issues without waiting for alarms.  As far as dealing with alarm fatigue, consideration should be taken into how alarms are presented to nurses.  Too many audible alarms may lead to ignoring even the life-threatening ones.  It may be better to have non-urgent issues presented as “alerts” rather than a one-time beeping.

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

A surgical fire, like any fire, requires the presence of three elements: a heat (or ignition) source, fuel, and an oxidizing agent.  Oxygen is necessarily present for breathing; however, additional oxygen supplied to the patient increases the risk of a fire.  Additionally, nitrous oxide produces oxygen from thermal decomposition.  An increased level of oxygen increases the risk of a surgical fire.  Like oxygen, fuel will always be present in a surgical room.  Prep agents, drapes, and even a patient’s hair are fuel sources.  Vapors from insufficiently dry prep agents are extremely flammable.  Although some drapes are advertised as flame-resistant, the ECRI has determined that all types of drapes burn in oxygen. 

Surgical equipment, such as electro-cautery devices and lasers, are believed to provide the ignition source for many surgical fires.  The increased use of such devices is believed to contribute to the increase in surgical fires.  Although these devices can provide benefits during surgery, a non-ignition source tool should be considered for surgery performed near the oxygen supply of a patient requiring oxygen. 

The best way to protect patients from surgical fires is to prevent them by reducing the use of oxygen, decreasing the flammability of potential fuel sources in the operating room (by allowing prep agents to dry and coating hair or other flammable objects with water-based lubricant) and ensuring that heat sources are monitored carefully to reduce the risk of ignition.  In addition, operating teams should be prepared in the case of fire to minimize effects on patient and staff safety by taking steps to extinguish the fire and evacuate if necessary.   

The effects and causes of surgical fires, as well as some recommended solutions, can be diagrammed in a Cause Map, a visual form of root cause analysis.  To view the Cause Map for surgical fires, please click “Download PDF” above.  Or click here to read a more detailed write-up about patient burns. 

Additional resources on surgical fires:

ECRI Institute

FDA

The Joint Commission

Anesthesia Patient Safety Foundation (APSF)

This incident can be examined in a Cause Map or visual root cause analysis. The first step is to define the problem with respect to the impacts to the organization’s goals, as described above.  The second step is to begin with the impacted goals and ask “why” questions to diagram the cause-and-effect relationships that led to the incident.  In this case, improperly cleaned tools were used on patients because the tools were cleaned with hydraulic fluid and the tools were used on patients.  The tools were used on patients because it was not immediately obvious that they had been improperly cleaned.  The tools did retain an oily feel; however, the tools are lubricated as part of the cleaning and sterilization process to avoid rust and ensure proper operation and so may retain an oily feel. 

The tools were cleaned with hydraulic cleaning fluid because the hydraulic fluid was stored in the cleaning detergent containers and delivered to system hospitals.  The containers were filled with elevator hydraulic fluid by an elevator maintenance company and left where they were picked up by the cleaning detergent provider.  The provider did not realize that the containers had been tampered with (as they were not relabeled and either had no indication of tampering or were not inspected for tampering) and so delivered them to the hospitals for use.  

Once the problem was realized, the affected tools were re-cleaned and sterilized and the detergent replaced.  Follow-up monitoring was performed and appointments offered to the affected patients, despite determination that the sterilization process was not affected and that the trace metals were not in sufficient amounts to affect patient safety.  Employees were trained in container management and a process was added to verify the status of containers delivered to and used in the hospital.  Additionally, a process to determine when product integrity has been compromised.  An external review by the Centers for Medicaid and Medicare Services has certified that the impacted hospitals are in compliance with standards based on these implemented corrective actions. 

To view the Outline, Cause Map and implemented solutions, please click “Download PDF” above.  Or click here to read information provided by the affected healthcare system.

The specific source of the contaminant has not been identified.  Investigations of previous instances of contamination with the Enterobacter sakazakii have had difficulty determining an exact source, as this bacteria is found within human  and animal guts.  However, even with limited information, we can begin a Cause Map, or visual root cause analysis, which allows us to view the areas where more data collection is needed in order to gather evidence to complete the analysis. 

We begin by capturing the basic information about the incident as well as the impacts to the goals.  The safety goal is impacted due to the risk of infection from the contamination tampons.  The environmental and customer service goals are impacted because a product was bacterially contaminated.  Additionally, the product recall impacts the production, property and labor goals.  We begin our Cause Map with the impacts to the goals.  

Both the risk for infection and the product recall were caused by the bacterial contamination of a product.  The product was contaminated because contaminated raw material was used for its manufacture.  This occurred both because the raw material was contaminated and because the quality control or testing process for the raw material was insufficient.  Whether there was no testing process for the given bacteria or whether the process did not recognize the bacteria and stop the use of the contaminated raw material is unclear.  

At this point, because the source of the raw material contamination is unknown, an open question which requires evidence-gathering is “how did the raw material get contaminated”? This will require cooperation from the raw material manufacturer.   The other necessary information is to do a detailed review of the quality control and/or testing that is used on raw materials prior to manufacturing and determine how the contaminated material was able to be used to make a final product.  Once this process is looked at in detail, specific solutions that would prevent a recurrence of this type of contamination can be implemented.  

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

A significant percentage of the US population lives without relatively easy access to a supermarket.  In a report to Congress, the USDA stated that 2.2 percent of the US population lives more than a mile from a supermarket and does not have access to a vehicle.  That’s 2.3 million people who constantly struggle with the logistics of buying groceries, even before the rising cost of food is considered.

How did food deserts come to exist?  In a country as wealthy and as industrialized as the United States, how is it that so many people don’t have access to a grocery store?

Food deserts came to exist because companies followed demand and built grocery stores where they would be most profitable, which is not typically low income urban locations or very rural areas.  Low income families typically have less money to send on groceries so more supermarkets were built in the more profitable, affluent neighborhoods than in poorer communities.  Some low income urban areas are also associated with higher crime rates so companies were hesitant to build in those areas.  People with lower incomes are also less likely to have access to a vehicle so the problem of buying food is compounded when the supermarkets are farther away from the low income communities.  Supermarkets are also less likely to be built in low population density rural areas because there are fewer potential customers and the stores aren’t as profitable.

While it’s relatively easy to identify why food deserts came to be, it’s still a tricky problem to solve.  Some groups have suggested that the government should provide subsidies to companies that build stores in food deserts.  Others are working to bring in foods to the people living in food deserts.

If you’re curious about where food deserts exist in the US, click here to view a map of the locations.  Click here to read a previous blog that discussed how food deserts are a cause of childhood obesity.

How did this horrible accident happen?

A Cause Map, or visual root cause analysis, can be built to help explain the causes that contributed to this death.  In this example, the patient needed an MRI because he had a brain tumor removed and he was hit by a magnetized oxygen tank while in the MRI machine.  This occurred because the oxygen tank was attracted by the huge magnet in the MRI and flew towards the machine at high speed. 

MRI magnets will always attract magnetic things, even when the machine is off.  Bringing a magnetic oxygen tank into a MRI examination room is a dangerous situation.  In this example, there are several reasons why the tank was brought into the MRI area.  The tank was bought into the room by a well-meaning nurse who heard the anesthesiologist calling for oxygen.

The nurse had returned to the MRI area in order to retrieve something she had left there earlier in the day when she had accompanied a patient to the space.  She heard the anesthesiologist calling for oxygen and saw the tanks nearby so she handed one to the doctor.  Contributing to this accident is the fact that the oxygen tanks were stored near the door to the MRI exam room.

The anesthesiologist was calling for oxygen because the patient had low oxygen saturation levels and needed additional oxygen.  The patient was a six year old boy so he had been sedated for the MRI procedure.  A piped in system normally supplied oxygen for use during MRIs, but the system had malfunctioned.  Both MRI techs on duty had gone to investigate the piped in oxygen system failure so nobody trained on MRI safety was around when the nurse bought in the oxygen tank.

Some simple solutions that might have helped prevent this accident, even with the oxygen system failure include storing oxygen tanks far away from the MRI exam room and not allowing unescorted non-MRI staff into the space.  It’s also always a good idea to have an acceptable back up for important systems planned in advance.  If a second safe oxygen supply was already provided, this accident could have been prevented.

The magnets in MRI machines are 200 times stronger than a refrigerator magnet and, as this example illustrates, the potential for injuries from projectiles is very real. Like most accidents, this death was caused by a number of failures that occurred at the same time.  All of the staff involved was trying to do the right thing, but the end result was the unnecessary death of a young boy.

First, the study determined that antidepressant use has increased 400% since 1988.  Eleven percent of Americans over the age of 12 are now taking antidepressants.  Any drug has risks, and more people taking a drug means that the total risk for side effects is higher.  Additionally, traces of certain kinds of antidepressants have been found in  the water supply, likely caused partially by improper disposal of these drugs.  (Don’t flush them down the toilet!)  The cost of anti-depressants is an additional issue raised with the high usage of these drugs.  

Even though talk therapy is a very useful tool for treating depression, less than 1/3 of patients who are taking antidepressants have met with a mental health professional in the last year.  Patients reportedly prefer drugs to talk therapy, potentially because reimbursement for prescriptions is generally much simpler and cheaper than reimbursement for mental health therapy, which can be capped or may not be covered at all. 

Because most antidepressants are obtained with a prescription, the higher usage of antidepressants indicates a higher rate of diagnosis of depression.  While the faltering economy can take some of the blame, hormonal changes (as middle aged women are the most frequent users of antidepressants), a decreased stigma against depression, and increased awareness of the drugs, thanks to pharmaceutical marketing, have also been listed as potential causes for the increase.  

Many agree that the decreased stigma towards depression is a positive step; however, the other side of the study found that only one third of people with severe depression symptoms are taking antidepressants.  While many with mild depression symptoms may find relief with talk therapy or other options, American Psychiatric Association guidelines recommend medication for moderate to severe depression symptoms.  This indicates that patients with severe depression may be under medicated and increases the risk for mental health problems and/or suicide.  There are many possibilities for why individuals with severe depression are not getting – or seeking – the help they need.  The high out of pocket cost for anti-depressants may be a barrier to some, as is the ability to receive screening for depression.  Although there are certainly other roadblocks along the way, making screening easier to receive may increase the treatment rate for sufferers.  The Centers for Medicare and Medicaid Services recently announced it would be covering annual screening for depression.  Hopefully this first step will result in more people getting the help they need.     

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

The company has received a large amount of negative media attention following the recall.  News articles and blogs  have claimed that CooperVision was purposely downplaying the recall, resulting in many consumers being unaware that their lenses had been recalled. Unaware of the potential danger, consumers continued to wear their lenses and continued to have eye problems as a result. The FDA publicly threatened to independently inform consumers of the risk associated with these contact lenses if the manufacturer didn’t better publicize the recall.

Following the media attention , the company has increased efforts to notify consumers about the recall.  The FDA has also posted a notice on their website of this recall, identifying it as a Class I recall, the most serious class of recall. The FDA has said that the company’s actions are now consistent with what would be expected with a Class I recall.

This example is a good illustration that the execution of a recall is a very important thing.  If consumers view a recall as slow to happen or badly executed, they will probably be less likely to trust a company in the future.  Ideally, a recall should be executed so that consumers are left with the feeling that a company did the right thing as quickly as possible.

If you are concerned that you might have recalled lenses, you can visit this website  to check.  If your lenses are recall, you are asked to remove them immediately and return them to the point of purchase.

Click on “Download PDF” above to view an outline and initial Cause Map of this example.

This study may have profound implications.  More than 12 million women in eastern and southern Africa use injectable contraceptives.  Their popularity is likely due to the cost and convenience of the once-quarterly shots, used to prevent unintended pregnancies, long an issue for maternal health in the developing world.  Although the injectable contraception is not meant to prevent transmission of HIV and other sexually transmitted diseases, the hormones (namely progestin) in the injectables appear to cause a biological change that actually increases the rate of HIV infection ABOVE that of using no contraception at all.  Previous studies have also suggested this is the case, and have found that pregnancy also increases the rate of HIV.  Birth control pills (taken once daily) may also increase the risk, though so far the increase is statistically insignificant, possibly because daily pills involve   much smaller amounts of hormone.  (Although the increased transmission risk is true for all who use injectable contraception, the focus is on sub-Saharan Africa because of the high rate of HIV.) 

The World Health Organization (WHO) will be reconsidering its contraception recommendations as a result of this study.  Woman using contraceptives are unlikely to use additional means of preventing HIV infection so wide spread use of a birth control method that doubles the risk of HIV infection creates a very real, global health risk.  However, the risk of death or serious health issues from unintended pregnancy have still not decreased, leading health officials unsure what the best path forward will be.  Removing an effective pregnancy control without other equally attractive options could leave more women at risk.  Officials at WHO will be working through this issue to see if both health risks from unintended pregnancy and HIV transmission can be minimized together.  It will be a tough job, but the lives of millions are at stake.        

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

Let’s start by focusing on just one of the recent recalls.  Listeria from contaminated cantaloupe has caused at least 15 deaths and has sickened more than 80 across the USA.  Tests have traced the listeria back to a single farm in Colorado, but the source has not yet been identified. 

Listeria is a common, but potentially deadly bacteria that can be found in soil, water, decaying plant matter and manure so the potential sources are numerous.  Another important piece of information is that Listeria can be difficult to eliminate once it has spread to distribution and processing facilities because it grows well at low temperatures, unlike most bacteria.  Listeria can continue to grow in refrigerated areas where fruit maybe stored or processed.

Finding the source of a listeria outbreak can also be difficult because it can take up to two months for an individual to become sick.  Adding to the complexity of identifying what food is causing an outbreak of listeria is the wide variety of foods that can become contaminated.  Listeria can be found in meat, dairy, fruits and vegetables.

Even once the source of contamination has been identified, it can be difficult to effectively remove the item from the food supply.  In this example, the sheer number of cantaloupes involved as well as a long supply chain made it difficult to remove all contaminated melons.  The farm recalled their entire 2011 cantaloupe crop which was more than 300,000 cases distributed from the end of July to mid-September.  The cantaloupes were shipped to 25 states and sold through many different retailers.

A recent article by CBS stated that the average cantaloupe makes four or five stops on the way to the super market shelves.  Typical cantaloupes will go to a packing house for cleaning and packing, a distributors, a retail distribution center and finally a grocery store before they make it to the consumer.   This makes it very difficult to identify where a food might have been contaminated.

Click on “Download PDF’ above to view a high level Cause Map of this issue.  A Cause Map is an intuitive form of root cause analysis that visually lays out the causes that contribute to an issue.

For example: Pap smears are frequently used to diagnose cervical cancer in wealthy countries.  But what about countries that don’t have enough doctors or labs to make this a practical solution?  Increasing the number of doctors or labs is an extremely long-term, complicated solution.  Instead, Johns Hopkins developed a new procedure that can be done in one visit by a nurse, without lab work.  You brush vinegar on the cervix, precancerous cells turn white, and they’re frozen off right then with carbon dioxide.

Another organization, Diagnostics for All, has developed paper diagnostic forms  for a whole host of diseases, which are smaller than a stamp, can be run off on a Xerox machine, cost less than a penny and can be read without training.  Although these end results are inexpensive and accessible, the path to get there may be more complicated.  Diagnostics for All is supported by grants and foundations, but that kind of support is getting harder to find as the economy continues to worsen.  Additionally, profit for items designed primary to assist developing countries are limited.

There’s also the general feeling that expensive, complicated fixes must be better.  Some of the most effective fixes for healthcare issues – washing hands, using checklists, losing weight – are still not universally used and are constantly in danger of being replaced with costly, cumbersome alternatives.  Sometimes it’s just that people don’t believe something simple can be effective.  Sometimes it’s that the people who have been seeing these problems for years believe that if a solution were that easy, it would have already worked, and something more invasive and expensive is needed.  And, sadly, a lot of it comes down to profit.  Expensive machines, diagnostics and procedures simply make everyone involved more money than using vinegar, paper, and soap.  It’s possible, and hopeful, that the changes in the economy will start turning things in a different direction.

How can you start implementing small fixes in your organization?  First, get everyone involved in the root cause analysis and solution brainstorming.  Bring in a few people who don’t appear to have anything to do with the issue.  Explain the issue to them and let them come up with a few solutions.  Their fresh voice may result in a fresh idea.  Examine all potential solutions for ease of implementation and projected effectiveness.  If you’ve got an idea that’s easy to implement, go ahead and implement it.  If it doesn’t work, or more help is still needed, go on to the more difficult-to-implement solutions.  Start an idea box.  It’s free, it’s easy, and you may be surprised what people come up with.  The New York Times has its own “Small Fixes Challenge” It posts a healthcare problem, explains the details of the issue, and invites reader ideas.  The ideas are reviewed by a healthcare professional well-versed in the topic.

Try a small fix in your organization today.  Ask someone what they see as an issue in the organization.  And then ask them what they’d do to fix it.  A great way to get a variety of responses is ask for the “money is no object” fix, a “free” fix, and then a fix somewhere in the middle.  The answers may surprise you.  And they might have a great idea with their “free” fix.  So, what are you waiting for?  Like all small fixes, it’s worth a try.

In 95% of the cases, the overdose occurred because the child self-ingested the drugs, as opposed to a labeling or dosing error. 

Why?  How are so many young children finding and consuming medication? And more importantly, what could be done to prevent these accidental overdoses?

This incident can be built into a Cause Map, an intuitive visual method for root cause analyses.  Better understanding the causes that contribute to a problem can lead to finding better solutions. 

According to the study, one of the causes contributing to the increase in accidental overdoses is that there is simply more medication in homes with small children.  As lifestyles change, the population is facing more health problems.  Obesity and metabolic syndromes are more common at younger ages than in the past and more homes of small children now contain medication associated with these illnesses as well as a variety of other medications.

Changes in drug technology have also affected the severity of overdoses, if not the number of occurrences.  More sustained-release medications are being prescribed and they can result in more severe poisoning.

The study also suggests that there is a possibility that people are being less strict about storing drugs safely, but it’s difficult to prove.  There is also the issue that people may not be aware of how dangerous their prescription and OTC medications are. 

One thing we know is that the current safety precautions are ineffective.  Children are findings ways to open child proof caps and warning labels aren’t sufficiently motivating adults to safely store medications in locked or inaccessible locations.   

Changing medication packaging is one of the potential solutions being considered for this problem.  New packaging that would be more difficult to open or would only dispense limited amounts of medication.  Bottles can be designed to dispense one pill at a time or restrict the flow of liquid.

A hospital in California recently notified 20,000 patients that their data had been published on a commercial website from September 9, 2010 to August 23, 2011.  The published data was discovered by a patient and had been used to demonstrate the use of turning data into a bar graph.  This particular data had been given to an outside contractor for billing purposes. Although it did not contain information usually used for identity theft – such as social security numbers, it did include names and diagnosis codes, meaning that extremely personal information was included.  

We can examine this issue in a Cause Map, or visual root cause analysis.  A Cause Map begins with the impacts to an organization’s goals and uses the principles of cause-and-effect to examine the causes that contributed to these impacts.  Any breach of patient privacy can be considered an impact to the patient services goals.  In fact, health care organizations may choose to add a new goal category of “Patient Privacy”.  (This is shown on the  downloadable PDF.  To view, click “Download PDF” above.)  In addition to the impacted patient services and patient privacy goals, the hospital was fined $250,000 (the maximum) by the California Department of Public Health and provided identity protection services to the affected patients.  Given the astonishingly large numbers of medical records accidentally made public, this is an issue to which all healthcare facilities should be paying attention. 

The exact method that the data made it onto a public website (which provided homework assistance) is not known, but the data had been provided to an outside contractor used for billing purposes.  The contractor is no longer being used by the hospital, and some privacy experts say that better confidentiality agreements are needed by hospitals who provide patient information to outside contractors.  What is particularly disturbing about this case is that the data remained online for nearly a year – and was discovered by a patient.  However, there does not seem to be a practical way for individual organizations to monitor the internet for misplaced patient data.  Instead, focus should be on ensuring better protection upfront for medical data, in an attempt to limit breaches of patient privacy.    

To view the Outline and Cause Map, please click “Download PDF” above.  Or view the New York Times article to learn more.

The hospital has admitted liability, possibly leaving them responsible for some or all of the patient’s specialist care and support.  Because the anesthetic needle was not removed until the patient’s body until far later than it should have been – and more than a day after the patient’s first complaints of leg numbness – it begs the question whether the procedure for administering an epidural included follow-up care, including removal.  Procedures – whether they are written down or not – exist for most complex tasks, especially medical tasks that involve risks to patient safety.  If use of the procedure results in an error, it should be re-examined.  However, many procedures only include the first part of a procedure, or the administration, ignoring follow-up that must be completed to ensure the process is a complete success.  In this case, that follow-up should have included checks to ensure that the patient was recovering from the epidural (which would have noted something amiss when she continued to feel numbness in her legs) and a schedule to remove the epidural.  Because neither of these things happened, a plan for follow-up after administering epidurals must be developed and put into practice. 

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

How did this happen? 

A Cause Map, an intuitive form of root cause analysis, can be used to analyze this incident.  As is typically the case, this is an example of multiple errors combining to cause a major issue.  The proper tests were performed.  The lab results showed that the donor was HIV positive, but the test results were never known by the right people.  The initial results were given over the phone and misheard.  One cause of this confusion is that similar words are used for negative and positive tests.  The English word “reactive” is used for a positive HIV test and “non-reactive” is used for a negative test result so a single syllable made all the difference.  But this mistake alone was not the sole cause of the HIV positive organs being transplanted. 

Standard procedure requires that surgeons take a time out prior to surgery and verify all information, including important lab test results.  If the final checks were performed as specified, the surgical team would have seen the positive HIV results.  Additionally, the transplants were performed at two separate hospitals so final checks were truncated at two different locations. 

The most poignant element of this example may be the fact that the correct information was known prior to the surgeries.  If the test results had been effectively communicated, the HIV positive organs would never have been transplanted.  This example has several lessons learned that can be applied across industries.  This issue highlights the importance of following procedures, even if they seem redundant, and using checklists, even if they seem unnecessary.  The importance of effective communication is also evident.  When using verbal communication, little steps like repeating back information to verify understanding and using words that sound distinctively different from each other can help eliminate errors. 

The investigation of this case is still ongoing and the hospitals are working to make necessary changes to ensure an incident of this type never happens again.  The five patients who received the organs are being treated with antiviral HIV medications, but doctors state it is very likely that they will contract HIV as a result of their organ transplants.

We can look at this issue in a Cause Map, a visual root cause analysis.  A Cause Map connects the impacts to the goals of an organization, or in this case, the U.S. healthcare system.  The patient safety goal is impacted because of the risk to patient health.  The organization goal is impacted because of delayed clinical trials.  The patient services goal is impacted because of the lack of needed medication.  Also, the property goal is impacted because of the replacement with more expensive medications.  We use these goals as the basis for our Cause Map, then ask “Why” questions to complete the analysis.

Insufficient supply is caused by demand greater than supply.  Both of these factors can contribute to the overall effect.  Although there are several reasons for increased demand, the most pertinent to this issue appears to be hoarding – where physicians hear of shortages and are attempting to create a stockpile for their patients.   However, increased insurance coverage and general increased need for medication for diseases such as cancer are also likely contributing.

Reduced supply is also contributing to the shortage.  Shortage of raw ingredients is considered to account for about 10% of the issue, with quality issues and insufficient production accounting for the rest.  In some cases, manufacturers are believed to be limiting their production – or ending it all together – because the drugs do not provide much profit.  Many of the limited drugs are generics, which do not provide as much profit as name brand drugs, especially as drug profits were limited by the Medicare Prescription Drug, Improvement and Modernization Act of 2003, which limited price increases in an attempt to limit Medicare spending.  The resulting drug shortage – which is sometimes resulting in paying for much more expensive drugs – is certainly an unintended consequence of this act. 

Despite best intentions, changes made to fix an identified problem may in fact cause another one – sometimes one that is far greater.  This is why follow-up to implemented solutions must occur at regular intervals, and must include a comprehensive assessment of whether the solutions are effective. 

Some of the solutions recommended to prevent the issues caused by these drug shortages are to create a national stockpile of certain kinds of drugs and requiring notification to the FDA of  supply shortages.  In the meantime, the FDA is providing guidance to patients and providers to attempt to ease the ongoing issues.

To better understand how this might work, check out this example that analyses a new treatment for leukemia that is showing excellent promise after the initial trials.  Researchers at the University of Pennsylvania recently published a study  outlining their success treating three leukemia patients with a novel treatment.  A year after treatment, two of the patients appear cancer free and the third patient’s cancer was reduced by 70%.  How did they accomplish this feat?

They drew blood from the patients and genetically modified their T cells (cells that normally serve as part of the immune system) to seek and destroy cancer cells.  Similar concepts have been tried in the past, but the previously modified T cells died out before they were able to destroy the cancer.  A different carrier, a harmless version of the HIV virus, was used to insert genes that told the T cells to multiple rapidly and target cancer cells.  A large batch of the modified T cells were grown and then injected back into the patients.  The patients endured intense flu-like symptoms while the cancers cells died out, but the other side effects have been minimal so far.

So how could a Cause Map help in this example?  It could be used in a number of ways to help others learn and apply lessons.  For somebody interested in the details of the specific cancer research performed, a detailed Cause Map could be created to better understand the intricate details of the technique so that it could be applied more efficiently to treatment for other cancers.  A person interested in how medical research is funded could create a Cause Map that details how this project was funded to learn how to fund their own work. On a larger scale, a Cause Map could be created to understand why certain areas of medical research are better funded than others and to ensure that we’re getting the biggest bang for our research bucks.  

For this specific case, a Cause Map could be used to track information and record all relevant details in a simple, intuitive format.  This treatment method will require more intensive testing before it could hope to become standard treatment and having an easily understand method to record and organize all relevant data would be very useful.  Cause Maps can be created in as much detail as needed and they can be built to focus on whatever aspect of the problem is of interest.

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

We begin with the outline, which captures the impact to the goals as well as the general information about the issue we are investigating.  In this case, we are looking at deaths of football players in the U.S.  The study determined that most deaths occur during football practice in August, in the morning, to linemen.  The impact to the goal of concern is risk of player death. 

Beginning with the impacted goal, we can ask why questions to analyze the issue.  The player deaths occur from heatstroke that is not treated immediately, whether from players and/or coaches not recognizing the signs of heatstroke, or treatment being delayed while waiting for an ambulance or other medical professional.  Heatstroke occurs when a person’s heat generation is greater than their cooling ability.  This means there are two parts to the analysis: the heat generation, and the cooling ability.  In this case, increased heat generation occurs from high ambient heat and high levels of body heat being produced, caused by practicing outside in hot weather. 

Insufficient cooling ability can occur when a player’s sweating isn’t doing enough to cool him – such as when a player isn’t producing sweat due to dehydration or when the sweat isn’t evaporating, such as in high humidity.  Additionally, players who are large (have a high BMI) tend to be more susceptible to heatstroke as their bodies tend to store more heat.  This is presumably why most deaths occur in linemen, who tend to be larger (79% of the players who died had a BMI above 30.)  Most deaths occur in August, which, in addition to being hot, tends to be the start of the season, meaning players are not accustomed to practicing in the heat. 

What can players, coaches, school districts, and parents do to limit the risk of death from heatstroke?  First, ensure that everyone involved in a sporting program recognizes the signs of heat-related illness.  There is a CDC toolkit that provides important information.  Next, make sure that a player who has signs of heat-related illness is treated immediately – while waiting for the ambulance to arrive, take the player out of the sun and spray him with water.  To try and avoid heat-related illnesses, ease into practices at the beginning of the season, limit practice time in extremely high heat and/or humidity, and provide plenty of hydration. 

 To view the outline, Cause Map, and solutions, please click on “Download PDF” above.

The first step in an incident investigation is to determine what the problem is and what the impacts to the organization’s goals are.  In this case, the problem is fairly straightforward – the resectoscope fell apart while inserted into a patient.  Although details are scant in this case, the problem statement is filled out as completely as possible to document what occurred.  The second part is to determine the impact to the organization’s goals.  An obvious impact is the potential harm to the patient, related to the hospital’s patient safety goal.  There was also the possibility of legal action, which would impact property goals.  Finally, there likely was the need to redo the procedure, taking additional time, thus impacting the organization’s labor goal.

The second step is to build a Cause Map by asking why an event occurred.   The Cause Map visually depicts what led to the young patient being exposed to harm.  In this case, the three goal impacts converge on the event where the hook electrode became uncovered.  It should be noted that multiple causes led to the patient being exposed to harm; if the resectoscope had been broken but had not been in use, then it would not have mattered.  It is crucial to include all reasons on the Cause Map because those reasons may be key to developing the optimal solution.

Facts that need to be captured about an investigation can be included in evidence boxes on the Cause Map.  They can provide the reader with important background information.  In this example, information about the hook electrode is included so that the reader knows what it is.

Reviewing the complete Cause Map, it turns out that the resectoscope was incorrectly assembled.  The third step in an incident investigation is to develop a set of solutions.  Remembering that all causes are necessary to produce an effect, the investigation team can brainstorm solutions to eliminate or counteract contributing causes.  In this case, three possible solutions were developed.  It is possible that the resectoscope could be designed differently so that the insulation would not be able to slip.  While this is a reasonable long term solution, it would not immediately remedy the problem.  Another solution would be to verify that the instrument is in working order before using on a patient.  This may have occurred, but it should be included until ruled out as a potential solution.  A final idea is to revise the assembly procedures for the resectoscope.  This is in fact what the FDA recommended.

The FDA recommends that the manufacturer’s assembly procedures always be carefully followed.  A process map is another helpful tool to determine where something went wrong.  The organization can build a process map depicting the ideal sequence of events, then compare that with what actually occurred.  The problem may not be in the instructions; the instructions might be perfect!  However, if someone doesn’t follow those instructions correctly, the process isn’t going to reach the desired outcome.

At this point, the investigation team might go back to the Cause Map to elaborate on the why the resectoscope was incorrectly assembled.  This might generate new solutions and changes to the ideal process map.  Through this iterative process, an optimum solution can be found.

This event was reported as part of the FDA’s MedWatch program.  The FDA encourages health professionals to voluntarily report problems on medical devices.  For more information on the MedWatch program, please visit their website.

This produces a highly simplified version of the Cause Map, but leads to a cause that has significant opportunity to provide improved results.  Specifically, the cause of “variable and inconsistent interpretation” suggests that guidance for more consistent interpretation may aid in reducing unnecessary surgical intervention due to false positives from EFM.  

With guidance provided from the American Family Physician, we can create a process map to aid in the use of EFM.  A process map shows the steps and decision trees involved in a process, attempting to guide practitioners towards accepted best practices. 

EFM is used continuously for high risk patients and intermittently for low risk patients  unless abnormalities occur.  There are three types of patterns produced by EFM: reassuring, non-reassuring, and ominous.  (Definitions for these patterns, as well as high risk patients are also from the American Family Physician).  Reassuring patterns generally are found to correlate with fetal health, and indicate that the delivery can continue.  Ominous patterns should lead to evaluation for immediate delivery.  Non-reassuring patterns are found between the two – and so lead to the most difficulty in interpretation.  Specific steps are outlined to be taken in the case of non-reassuring patterns which attempt to normalize the pattern.  Additionally, specific tests are recommended to attempt to determine the cause.  If the cause can be determined and corrected, continuous monitoring should accompany an attempt to continue the delivery. 

If the pattern is not normalized, evaluation for immediate delivery should occur.  There is no decision tree at this stage  because the decision on whether (and how quickly) to perform delivery must be determined based on the patient’s specific state, based on the knowledge of the practitioner.  Although some steps remain subjective, attempting to fit those that are not into a process map can improve the odds for everyone.

Gone are the metal merry-go-rounds and the ten feet tall monkey bars that many of us remember from our youth.  Modern playgrounds are populated by lower, enclosed platforms and soft ground coverings to prevent injuries and protect against lawsuits.

But are modern playgrounds better? According to a recent New York Times article , the answer isn’t the slam dunk you might expect.  There is mixed evidence about whether modern playgrounds actually reduce the number of injuries because children tend to take more risks on “safer” playgrounds.  There is also evidence that the value of playgrounds in childhood development might have been diminished by the increased focus on safety.

A recent paper by Norwegian scientists discusses the value of allowing children to face fears through “risky” play.  The concern is that children are developing more anxieties because they are losing the opportunity to face their fears by tackling challenging playground equipment. Part of the problem is also that safer playgrounds tend to be more boring which discourages children from playing at all.

There are a number of researchers asking whether the potential negative emotional impact of safer playgrounds outweigh the risk from physical injuries associated with taller, riskier playground equipment.  This is a hard question to answer because while it’s relatively easy to measure the number of bones broken on playgrounds, it’s very difficult to measure the intangible benefits of challenging playgrounds.

So can playgrounds be too safe?  It’s not clear that we have a definitive answer to that question, but what is clear is that the problem of playground safety is more complicated than originally assumed.  A Cause Map, a visual root cause analysis, can be built in cases like this to help clarify all known information.  Cause Maps are a very versatile format.  They can be created to incorporated any level of detail needed and can be added to as more information becomes available or as unexpected complications pop up.  To view a high level Cause Map of this problem, please click on “Download PDF” above.

Health concerns about the use of keratin-based hair products have been reported multiple times  over the past several years. The main issue is the formaldehyde contained in many of the products.  Formaldehyde can irritate the eyes and nose, cause skin rashes, and cause asthma-like breathing problems. Formaldehyde is also considered a carcinogen by many organizations.

These hair products contain formaldehyde because it makes the product more effective and longer lasting, but there may be a high health cost, especially to the stylists who perform the procedure.

This issue can be analyzed by building a visual root cause analysis called a Cause Map.  Click on “Download PDF” above to view a high level Cause Map for this issue. 

During the root cause analysis, it became clear that one of the causes that contributed to this issue is that many people are unaware of the potential health risk.  This in turn is caused by mislabeling of the products and a lack of safety instructions on the packaging.  Testing by the Oregon OSHA found that many keratin-based hair products labeled as “formaldehyde free” in fact contained significant levels of formaldehyde.  Another cause to consider is that these hair products are considered cosmetics and cosmetics do not require pre-approval by the FDA prior to sale, resulting in minimal government oversight of the product.

OSHA and the FDA  are both investigating the products to determine their safety, but as of right now it is perfectly legal to sell and use keratin-based products containing formaldehyde in the US.  But if you’re interested in using these products, there are several facts you should know to help keep you as safe as possible.  When reading a package, it’s good to know that formaldehyde can be listed in multiple ways, including methylene glycol, formalin, methylene oxide, paraform, formic aldehyde, methanal, oxomethane, oxymethylene, or CAS Number 50-00-0.   It’s also safer to perform this procedure in a well-ventilated area or outside.  Additionally, wearing a mask will prevent inhaling the formaldehyde and some salons now provide them to consumers and stylists to use while the keratin hair products are applied.  You should also carefully wash your hands after handling any product that contains formaldehyde.

First we begin with the impact to the goals.  The infant’s death was an impact to the patient safety goal.  A death resulting from a medication error is a “never event“, which is an impact to the compliance goals.  There is a related wrongful death lawsuit, which is an impact to the organization’s goals.  The overdose of sodium chloride delivered to the patient is an impact to the patient services goal.  

We begin the analysis with the impacts to the goals and ask why questions to fill out the Cause Map.  The infant death was caused by the sodium chloride overdose, which occurred when the infant received more than 60 times the dosage ordered by the doctor intravenously.   The infant was receiving sodium chloride intravenously to provide nutrition, as he had been born prematurely.  Although a blood test indicated abnormally high levels of sodium, it has been reported that the lab technician assumed they were inaccurate, resulting in the infant not receiving immediate care for the overdose.   

When a process – in this case, the medication delivery process – does not work correctly (such as occurs when an overdose is given), it means that the checks at every level of the process were ineffective.  The final check at the patient’s bedside was ineffective because the label on the IV bag did not match the actual contents.  It’s unclear how that occurred.  The error was made at the pharmacy, when a pharmacy technician entered an incorrect number into the compounding system.  Normally entering a too-high dose would trigger an alert with an automated system, but the alerts were turned off.  Part of the reason for the error was that the pharmacy technician had to manually enter the prescription in the first place.   A  doctor enters a prescription via the automated dispensing system.  However, the automated dispensing system, and the computerized compounding system did not communicate with each other, so for orders that required compounding, a technician had to transfer the order from one system to the other, manually.

A computerized system is no better if it’s not used properly.  If parts of the system don’t communicate with each other, and safety checks are turned of, a computerized system may actually be less safe, especially if people expect the automatic checks are being performed, and so don’t perform any of their own.  Computerized systems have a lot to offer – namely, reducing the number of medication errors relating to illegible handwriting or providing automatic checks for drug interactions.  But these systems are not fail-safe and checks used to ensure that patients

This issue can be examined within a root cause analysis captured in visual form.  To begin, we capture the impacts to the goals.  The patient safety goal is impacted because of the tissue death.  Additionally, employees and patient services are impacted because many healthcare organizations are unable to diagnose the issue.  We begin with these goals and ask “Why” questions to continue the analysis. 

Why is the tissue death occurring? Tissue death is resulting from levamisole toxicity and ineffective treatment.  The levamisole toxicity occurs from the use of cocaine contaminated with levamisole.  It’s possible that the levamisole is added to the cocaine to increase the effect of the drug.  Additionally, levamisole is cheap, so it increases the volume of the cocaine, which increases profits.  Because cocaine is an illegal drug, it’s not regulated by any government agency.  This means no quality control is in place that would detect the contamination before use. 

Ineffective treatment is generally occurring because of the previously discussed inability to diagnose the issue.  Before these reports were made widely available, most practitioners would not think to look at a no-longer-used drug as a cause of toxicity, especially when a patient is not honest about cocaine usage.  As a possible solution to improve treatment of this issue, the reports are suggesting that practitioners look to cocaine abuse when faced with tissue death, which should increase the effectiveness of the treatment for both the tissue death, and other associated issues with contaminated cocaine.  Also, increased public awareness is being attempted to try and reduce the use of cocaine.  Although previous public awareness drug use programs have been less successful than desired, perhaps the risk of skin death will get some users to quit. 

For more information, click here.

Why the spike?  Sociologist Dr. David Phillips, who conducted the study, believes it is because new doctors begin their residencies in July each year.  The phenomenon is limited to fatal medical errors, and is not evident in surgical or “general” error rates.  Consistent with the study’s “New Resident Hypothesis”, fatalities are even higher in counties with higher concentrations of teaching hospitals, in which there would be more resident doctors.  It is clear there is a link between higher rates of medication errors and the presence of brand new doctors. 

The study is one of the first to demonstrate the linkage though.  Multiple smaller studies have failed to show any correlation between time of year and death rates.  Researchers point out that the new study focused on a much longer time range and broader geographic area than any previous study however.

Although the study raises some interesting questions, it stops short of providing solutions.  Doctors already face a rigorous course of study to prepare for their residencies, which of course are designed to provide the experience needed.  New doctors are also generally well supervised.  And to some extent there will always be risk associated with inexperience when it comes to teaching hospitals. 

A Cause Map can illuminate areas that might benefit from further research.  The study narrowed down one of the contributing factors to medication administration.  Why just in that area though?  Are new residents better supervised in the OR?  Do new doctors have the capability of prescribing and administering medication during their first month?  What types of errors do they make when doing this?  Do they prescribe the wrong medication completely?  The wrong dosage?  Or do they overlook adverse interactions with other medications? 

More research is needed to accurately determine why the July Effect occurs, but patients can be prepared.  Experts agree that patients should ask plenty of questions and bring along an advocate for support.  For more information, the study, “A July Spike in Fatal Medication Errors: A Possible Effect of New Medical Residents”, is available here.

Some of the more common issues that lead to medication errors include confusion on the label of the medication.  It is estimated that almost half of Americans don’t understand the dosing instructions on their medication, leading to the potential for medication dosing errors.  It’s no wonder, when “take one pill a day,” can be written in 44 different ways according to Dr. Ruth Parker.   Additionally, many patients receive medication instructions that are either not in their primary language, or contain errors in the translation (see our previous blog about errors in translated medication instructions.) 

It’s obvious that if almost half of people receiving medication instructions don’t understand them that something should be changed.  An expert panel appointed by the US Pharmacopeial Convention (USP) has created national labeling standards in order to reduce medication errors caused by patient confusion with medication instructions.  It is hoped that a final version of these rules is published by May 2012 and will then be implemented nationally.  (Additionally, Canada is considering these standards as well.)

The proposed standards attempt to cover some of the most common errors in label decoding that lead to medication errors, including use of unfamiliar terms (such as Latin terms or jargon) and pictures instead of text (such as a picture of a crossed off alcohol bottle rather than “do not take with alcohol”).  Additionally, medication instructions would be provided in the preferred language of the patient (and hopefully national standards will reduce the translation errors currently found on many medication bottles) in clearer font, with the information important to the medication found larger and on top and other information (such as the provider and pharmacy names) below and less emphasized.

Coming up with process improvements, such as these, with an expert panel allows consideration of many issues and points of view.  When you’re looking at improvements in your organization, you already have an expert panel – it’s the people who do the work processes day in and day out.  Additionally, information released by other organizations can be leveraged to provide solutions relevant to your organization.  Take advantage of the expertise found in your organization when you are looking to improve processes – it will save time and money, and may even save lives.

Many states now mandate hearing screening at birth.  Even minor hearing loss, if not caught early, can seriously impede language and social development.  Nearly 2% of babies fail their initial screening, prompting more through testing.  Approximately 0.2% of children born in the U.S. will be diagnosed with hearing loss.  While most children with hearing loss have conductive (outer or middle ear) or sensorineural (inner ear) hearing loss, there is another type of hearing loss.  With auditory neuropathy (AN) spectrum disorder, sound enters the ear normally; but because of damage to the inner ear or hearing nerve, the brain isn’t able to understand the signal.  The sound is similar to what you might hear underwater or on radio with a lot of static. 

Little is known about AN, including what causes it and how to treat it.  Hearing aids seem to help in about half of AN cases, although sometimes children and adults grow out of it.  And some patients thrive with cochlear implants.  Until recently, most weren’t certain how many even suffered from the condition.  A recent study shows that this condition may affect up to 15% of children with born hearing loss. 

With all the confusion surrounding AN, few pediatricians and audiologists are aware of this condition or what treatment options are available.  Often the first course of treatment is a hearing aid.  Unfortunately this treatment, which amplifies sound entering the ear canal, can be exactly the wrong treatment for some types of AN.  For those with damage to the hearing nerve, blasting noise into the ear canal simply damages the external, working portions of the ear.  Infants have very sensitive hearing, and just a week of continuous hearing aid use can be enough to cause permanent damage.  Unwitting parents, worried about their children and eager to follow the doctor’s orders, may not realize their children are capable of “hearing”, albeit distortedly, until it’s too late. 

A Cause Map can help sort out the factors contributing to this problem.  The top of the Cause Map shows the desired outcome.  Mandatory or recommended screening in infancy results in earlier diagnoses of hearing loss, which limits developmental delays further down the road.  However the bottom portion of the Cause Map shows how current screening practices can often lead to misdiagnosis and the wrong treatment.  By focusing on this area of the Cause Map, solutions can be identified to eliminate the unintended effect.  

Two such potential solutions have been identified.  First, changes to the screening process might identify AN early on.  Considering that up to 15% of hearing loss may be caused by AN, this may be a more feasible solution than previously thought.  Second, an awareness campaign may help doctors and audiologists become more aware of AN and how to properly treat it.  

With more research and greater awareness, there is hope that those with auditory neuropathy spectrum disorder will not accidently suffer more.  For more information on AN, please visit the National Institute on Deafness and Other Communications Disorders website.

In 2007, a director at a medical center in Brooklyn, New York discovered that premature babies were routinely being over-radiated during x-rays.  Full body x-rays of babies, known as “babygrams” were being done when not medically necessary. When a simple chest x-ray was ordered, as is common for premature babies with lung issues, the entire body was being x-rayed without any shielding.  Additionally, the CT scanners had been set too high for infants in some cases.  There were also issues of poor body positioning that made it difficult for doctors to accurately read the x-rays. 

The end result was that many young babies were being habitually exposed to unnecessary radiation at this facility.  This is especially troubling when you consider the fact that children are particularly vulnerable to radiation exposure because their cells divide more quickly because they are still growing. 

The causes in this example aren’t well known, but a basic Cause Map can be started and could be expanded if more information becomes available.  Click on “Download PDF” above to view the Cause Map.

What is clear is that this is more than a case where one person made a single error.  The culture and training in the department didn’t recognize the importance of limiting radiation exposure.  The radiation field as a whole is also minimally regulated.  Standards and regulations are decided at the state level and many states choose not to regulate all occupations working with radiation.  In 15 states radiation therapists are unregulated, 11 states don’t regulate imaging technologists and medical physicist are unregulated in 18 states. For the past 12 years, the American Society of Radiologic Technologists has lobbied for a bill to set education and certification requirements for people working in medical imaging and radiation therapy, but as of yet no bill has been passed.

After the improper radiation techniques were discovered, the hospital instituted many changes to their procedures.  No more full body x-rays were performed and shielding was used to minimize radiation exposure for children as well as adult patients. An investigation is also underway by the New York state health department.

A six-year-old boy in the Netherlands was receiving pooled platelets when he suffered from an allergic reaction.  The staff was able to prevent potential death or serious injury with an immediate injection of adrenaline.  As a follow-up, the staff tested the boy and ruled out many other potential causes.  The lab tests and testimony from the boy’s mother confirmed an allergy to a peptide, which is a protein that is left in the blood after ingesting peanuts. The peptide, known as Ara h2, is resistant to digestion, as evidenced by studies that have found levels in the blood 24 hours after ingestion. 

Because this case demonstrates a newly discovered phenomenon, evidence to support the causes is particularly important.  Evidence supporting the placement of a cause related to a root cause analysis can be placed in a box directly below the cause box on a Cause Map.  (To see the Cause Map, click on “Download PDF” above.)  The allergy to the peanut peptide causing the allergic reaction and the peptides being present were verified by testing and interviews with the donors and the patient’s family.  

The immediate solution, to inject adrenaline to prevent the patient’s death from the allergic reaction, was taken immediately but does not do anything to solve the broader problem of potential allergens in the blood supply.  One of the potential solutions is to screen the blood supply for dietary contributions, but considering the large amount of donors and recipients, this is considered to be prohibitively expensive and difficult.  Because there is not a viable alternative blood transplant source, and blood transfusions are still needed by patients with allergies, it seems that the solution must be to figure out a way to remove the proteins, at least from blood transfusions going to people with allergies.  However, another case, from 2003 resulted in a blood product recipient developing allergies when receiving a blood transfusion from a donor who had peanut allergies, so screening the blood supply prior to transfusing people with allergies may not be sufficient.

In this health care scenario, patient safety is the foremost concern.  So the most basic Cause Map would show that the Patient Safety Goal is impacted by preventable bloodstream infections, and that those infections come from pathogens introduced by a central line.  The next step is to elaborate on how pathogens enter the bloodstream, and then determine what appropriate solutions might be. 

Preventable bloodstream infections happen because pathogens access the bloodstream and also because the infections aren’t treated early on.  This suggests that by treating infections early on, and vigilantly watching for signs of infection, more serious infections can be prevented.  

Pathogens can access the bloodstream because a central line provides a direct conduit to the bloodstream and because pathogens are present.  Again, while these are obvious statements, they allow the opportunity to develop potential solutions.  First, the CDC recommends not using a CVC unless absolutely necessary.  Additionally, CVCs shouldn’t be placed in the femoral artery in adults because it is associated with greater infection rates and secondary problems such as deep venous thrombosis. 

Assuming a central line is necessary; more analysis leads to further solutions that might reduce the presence of pathogens.  Pathogens generally come from two sources – the line was improperly put in or somehow the line became contaminated during use.  Using antimicrobial materials is one potential way of minimizing contamination. 

Looking closer at the uppermost branch , how the line was put in, leads to some insightful solutions.  One simple solution recommended by the CDC is to use a checklist and follow their guidance.  Checklists are a simple but highly effective way of reducing errors in repetitive processes.  There are two major causes in this branch, dirty hands/gloves from the nurse or doctor putting the CVC in the patient and the patient having dirty skin at the site of the CVC.  CDC guidance also recommends using maximal barriers such as masks and gloves and washing your hands.  Cleaning the patient’s skin with a chlorhexidine-based solution is another important step that can reduce these infections. 

With so many possible solutions, it is important to identify where changes need to occur in your own processes.  This is fairly simplistic Cause Map and there are many other solutions suggested by the CDC and other government health agencies.  For more information on steps to reduce CLASBIs, see the U.S. Department of Health and Human Services Guideline.

Gout occurs when there are high levels of uric acid in the blood stream.  Excessive uric acid forms crystals that collect in joints and soft tissues, causing acute pain and inflammation.  Uric acid is produced when the body processes purines.  Purines are found naturally within the body and are also found in many types of food, including meat (especially organ meat), anchovies, herring, asparagus and mushrooms. 

Why are more people suffering from gout? This issue can be investigated by creating a Cause Map and performing a root cause analysis to determine what causes contribute to the problem. (Click on the “Download PDF” button above to view a high level Cause Map of this issue.)

Digging through some of the data available, it becomes clear that the modern diet is one cause, but there are a number of other causes that contribute to gout including higher life expectancy, higher weights, and modern medications.  Risk of gout is also higher for people who suffer from a number of illnesses, including hypertension, diabetes, high cholesterol and congestive heart failure; all diseases which are more common now than they were in the past thanks to advances in modern medicine and increased life expectancy.  Obesity also makes gout more likely and today’s population is heavier on average.  There are also several medications that have been shown to increase the risk of gout, including medicines commonly used to treat high blood pressure and low-dose aspirin. 

Gout has typically been considered a man’s disease, but now more women are suffering from it. Prior to menopause, woman naturally have lower levels of uric acid in their blood, but as women live longer more cases of gout are developing in women.

Looking at the risk factors associated with gout, it’s clear why more and more people are suffering from it.  Some risk factors can’t be changed, such as gender or age, but staying healthy overall can reduce the likelihood of suffering from gout.

On April 13, 2011, a surgeon performing a routine procedure to correct a wandering eye mistakenly operated on the wrong eye of a four year old boy.  In this case, the wandering eye was caused by a muscle that was too strong so the surgery was performed to weaken the muscle.  It’s unclear at this point whether the wrong site surgery will have any lasting impact on the patient’s vision, but the patient’s mother has stated that the previously healthy eye is now wandering.  A specialist who examined the boy post-surgery stated that the eye needs to completely heal (about 5 weeks) until any determination can be made about long term consequences.

How did this happen?  How does a surgeon perform a procedure on the wrong part of the body? And most importantly, how do we prevent these types of errors in the future?

The investigation of this incident is still ongoing, but a Cause Map of the incident can be started and then expanded as more information becomes available.  A Cause Map is a visual root cause analysis that lays out the causes of an incident in an intuitive format.  Once the Cause Map is complete, it can be used to develop solutions to help prevent future problems. Click on “Download PDF” above to see an Outline of this incident and the initial Cause Map.

In this example, it isn’t clear yet how the mistake was made.  Findings from the investigation so far have determined that the correct eye was marked before surgery, but statements by the surgeon indicate that the mark may have been accidentally covered by a nurse. The hospital has protocols in place that require checking and double checking the surgery site, but it’s not clear why they weren’t followed.  Once the investigation is complete, the hospital will determine what solutions need to be implemented to ensure that this doesn’t happen again.

Modern surgical techniques, including laparoscopic surgery, require great manual dexterity and control as well as sustained mental focus.  It is common knowledge that both of these skills are impaired while intoxicated.  What is unknown is how these skills are impaired after one is no longer intoxicated, but obviously still affected.  In all but one test subject, their blood alcohol content (BAC) had returned to 0.00%.  Initial testing done in the morning showed no significant difference between test and control subjects, however later in the day there was a perceptible decline.  While the study was only a preliminary one, it indicates that more research is needed in this area. 

A Cause Map can be especially helpful in a research environment because it helps define causal relationships.  In this case, the researchers focused on the effects of drinking the night previous.  But perhaps there are other reasons at play, such as fatigue, which contribute to the effect.  When searching for causes it is important not to focus in on one aspect, ignoring others, since all causes are required to produce an effect.

It is expected that surgeons wouldn’t actually drink while at work.  However, there are surprisingly no guidelines about when they should stop drinking beforehand.  Pilots are federally mandated not to drink at least 8 hours prior to flying or fly with a blood alcohol content (BAC) of .04% or greater.  Perhaps this study will generate an overdue discussion on the need for abstention prior to surgery.  Potential solutions, such as training or regulations, can be displayed directly on the Cause Map above the appropriate cause.

The information provided by this comprehensive series can be summarized visually within a Cause Map.  A thorough root cause analysis built as a Cause Map can capture all of the causes in a simple, intuitive format that   fits on one page.  We begin the Cause Map much as the series begins – with a focus on the impacts of stillbirth, beginning with the 2.6 million deaths per year.  We can consider this an impact to the public safety goal.  A related impact is an impact to the public safety goal – lack of access to quality care.  Starting with these two goals, we can begin an analysis of the problems contributing to stillbirth. 

Although the data collection for stillbirth lacks consistency, there are five major causes of stillbirth that we’ll address here: fetal growth restriction, childbirth complications, maternal infection, maternal disorders, and congenital abnormalities.  At a very, very high level, we can discuss some of the causes of these issues, which the Lancet series hopes to address in order to halve the number of stillbirths by 2020. 

Fetal growth restriction can be caused by inadequate prenatal care.  Increased fetal growth restriction detection and management is expected to reduce the number of stillbirths by 107,000 per year.  Childbirth complications can be caused by lack of quality obstetric care and/or labor past 41 weeks.  Comprehensive emergency obstetric care is expected to reduce yearly stillbirths by 696,000 and  identification/induction of women who are past 41 weeks gestation is expected to reduce another 52,000.

 The main maternal infections of concern are malaria and syphilis.  Additional malaria prevention (such as insecticide treated nets) would reduce annual stillbirths by 35,000 and syphilis detection/treatment another 136,000.  Maternal disorders of concern are mainly diabetes and hypertension. Detection and management of maternal diabetes and hypertension would prevent 24,000 and 57,000 stillbirths per year, respectively.  Congenital abnormalities can be caused by insufficient folic acid intake at and after conception.  Increased access to folic acid supplementation would save 27,000 lives. 

 If all of these recommendations can be fully implemented, more than 1 million stillbirths could be prevented each year.   Far more detail can be added to this Cause Map, depending of the level of analysis required. As with any investigation the level of detail in the analysis is based on the impact of the incident on the organization’s overall   goals.  To see the outline, Cause Map, and solutions, please click “Download PDF” above.  To learn more about stillbirth, and the goals, please see the Lancet series.

Concern about availability and quality of this compounded drug helped lead to development and expedited U.S. Food and Drug Administration (FDA) approval of a name brand version.  The name brand version was approved on February 3, 2011 and was granted 7 years of market exclusivity under the “Orphan Drug Act”, an FDA incentive to develop products.  The name brand version of the drug was priced at $1,500 an injection.  Concern over the price increase, which could total nearly $30,000 a pregnancy, led to concerns of increases in preterm labor due to the unaffordable drug.  This on turn led to concerns about patient safety and patient services.  Additionally, there has been general outrage over the increase in cost, leading to a request for a Federal Trade Commission (FTC) investigation into the pricing of the drug and a loss of market share for the manufacturer.

To attempt to alleviate the concerns regarding access to the drug, the manufacturer has lowered the price to $690 an injection and has developed a host of other programs to increase affordability of the drug.  The price drop and other programs were announced on April 1, 2011.  The FDA announced on March 30, 2011, that it will not stop pharmacies from continuing to compound 17P, in a rare move to ensure drug availability.  However, some doctors are concerned that prescribing a pharmacy-compounded drug. when there is a brand name drug available, will leave them open to legal action if safety concerns arise. 

The impact of this issue on the future of preterm labor and drug pricing is unclear at this point.  It appears that more action may be required to reduce the risk of preterm labor, either by the manufacturer or the FDA, or both.  View the analysis of this issue, including a timeline, problem outline, Cause Map and solutions, by clicking “Download PDF” above

Although the first infection occurred in January, 2011, a pattern was not established until March, 2011, after nineteen patients were infected with serratia marcescens bacteria.  Patient infection is an impact to the patient safety goal. 

The infections occurred as a result of the patients being given contaminated product – in this case, the IV bags.  The bags were recalled, and are no longer in production.  Ten of the patients died.  Investigators have said they won’t be able to determine whether the infection caused the deaths because the patients were already very ill (TNP is used for patients who are too ill to eat on their own). 

The IV bags were compounded at a local pharmacy.  There was a potential for contamination in the raw material used for compounding, during the compounding at the pharmacy, or at the hospital.  Because six different hospitals experienced the same rare bacterial contamination, it is unlikely that the contamination occurred at the hospital.  

According to Dr. Alexander J. Kallen, a medical officer with the Centers for Disease Control and Prevention, “Historically, what we’ve seen is a breakdown in the manufacturing process.”  The investigation is underway to determine if the contamination was caused by an issue with the manufacturing process, an issue with the sterility of equipment, or a contamination of the raw material.  As the investigation continues, more detail can be added to the Cause Map.  As with any investigation the level of detail in the analysis is based on the impact of the incident on the organization’s overall goals. 

While investigating an issue, it can also be helpful to look at the process for identifying and isolating issues, and implementing improvements.  In this case, after patients receive or use products, they are monitored for certain reactions.  If those reactions occur (such as those that indicate a bacterial infection), they are reported to the State Health Department, then the CDC.  The CDC investigates to determine the source of the infection and then pulls the affected products off the market.  Currently, the CDC has identified the product that is contaminated, though not the source of the contamination. 

A thorough root cause analysis built as a Cause Map can capture all of the causes in a simple, intuitive format that fits on one page.  To view the Cause and Process maps, click “Download PDF” above.

Some physicians have recommended removal of the affected areas.  The choice between that, or living with the risk of tungsten particles, whose long-term effect has not been thoroughly studied, is an impact to the patient safety goal.  In addition the particles will look like calcium deposits, which can be an indication of cancer, in future mammograms, resulting in an impact to the patient services goal.  The device has since been recalled, which is an impact to the property goal, and at least one suit has been filed against the manufacturer of the device and the hospital performing the trial.  It is believed that 30 women are affected.

The health issue of leaving the tungsten within the patient’s body is caused by a particle of unknown long-term safety being deposited in the body.  The tungsten appears to have been shed by a device used during radiation treatment to prevent radiation from reaching other parts of the body.  It’s still unknown how a device that would shed particles into a patient’s body made it into a human clinical trial.  What is known is that the device went through the accelerated FDA approval process known as 510(k) for devices that are similar to devices that have already been approved.  It’s unclear which device was considered similar enough to allow for the approval of this one, but there have been many concerns that the FDA’s approval process is insufficient. 

An in-depth look at the approval process of the FDA is currently underway to determine where changes in the process may result in a more thorough review and , most importantly, prevent an issue like this one from reoccurring.

The problem is that such a “decrease in capabilities” is highly subjective and difficult to measure.  Surgeons rely on a variety of cognitive and tactile skills in their craft – steady hands, learning new techniques, composure under stress, communication skills, and so on.  As highly trained professionals, it is sometimes difficult to decide when it is time to call it quits.  

Furthermore, in the United States, age-based discrimination is outlawed in most industries except where regulated.  For instance, airline pilots and air traffic controllers are both subject to earlier-than-average retirements due to public safety concerns.  Many federal and state public workers, such as corrections officers and firefighters, are similarly limited. It’s difficult to argue that some physicians don’t make similar split-second, life-and-death decisions – especially surgeons.

The associated Cause Map visually lays out the dilemma.  Surgeons who aren’t performing adequately do so for two reasons.  First, they have a medical condition precluding them from performing to standards.  (Note that to keep this Cause Map simple, other issues such as mental health problems, addiction, and failure to maintain their continuing education were not examined.)  Second, they are allowed to continue practicing. 

Such physicians continue after their abilities are impacted for a number of reasons.  Some might be unaware of their condition or unwilling to accept it, both stemming from a belief that they are still competent to practice.  Additionally, current processes at most hospital are slow to identify such physicians.  Most hospitals rely on co-workers to identify such doctors, clearly a highly subjective and ethically complex system.  Age-based screening is not common at many hospitals, partly because of resistance from hospital staff.  In fact, only 5-10% of hospitals have directly addressed this issue.  Labeling doctors as “unfit to practice” isn’t necessarily a bad thing.  If such doctors are identified early, patient safety is enhanced.  Additionally, early identification can sometimes allow those doctors to continue practicing in a controlled and safe environment.

Now that the problem has been laid out, the next step is to look for possible solutions.  It’s clear that little can be done about age-related deterioration.  So the focus moves to the other branch of the Cause Map.  Here there are a number of possibilities.  While age-based screening is certainly an option, it’s not the only one.  For instance, including hospital staff in making decisions might also help decrease resistance to identifying deficient physicians.  Additional training on the impacts of age might make co-workers more willing to discuss their concerns.  Or doctors might be more willing to adapt to their limitations if regular screening can identify possible health problems. 

While more research is needed to determine how extensive this issue is, it is clear that at most hospitals current procedures to identify deficient physicians are lacking.

Why?

Why would pills protect against radiation?  The first part of the answer lies in the thyroid gland.  The thyroid contains some of the only cells in the body that can absorb iodine.  The thyroid needs iodine in order to produce thyroid hormones which are used by nearly every cell in the body and help regulate important functions such as metabolism.  The second part of the answer is that iodine-131 is a common isotope produced by the fission of uranium atoms during the operation of nuclear reactors.  When fission products are released into the environment and consumed by humans, the thyroid can absorb radioactive iodine, just like it absorbs stable iodine.  Exposure from radioactive iodine can lead to thyroid cancer.

When exposure to radiation is possible, potassium iodide is used because the thyroid has a limit to how much iodine it needs.  If the thyroid has been flooded by stable iodine, it decreases the chance that radioactive iodine will be absorbed.  Any unneeded iodine should be passed through the body relatively quickly, limiting the amount of exposure to the radiation emitted by the iodine-131.

History has shown us that the threat of thyroid cancer is very real following a nuclear reactor accident.  There has been an epidemic of thyroid cancer in the area affected by the Chernobyl accident in 1986.  Experts believe that distribution of iodide potassium could have largely prevented this long term health consequence.  Additionally, the majority of iodine exposure came from drinking milk produced by cows living in the area contaminated by the accident.  If people had avoided drinking contaminated milk in the months following the accident, the effects of radioactive iodine would have greatly been diminished.  Another possible solution that could be applied to help prevent thyroid cancer following a reactor accident would be to test all food and drink for contamination.

There are a few other important facts to consider about potassium iodide.  It is not recommend for low levels of radiation.  The U.S. Nuclear Regulatory Committee has stated that very low levels of radiation may reach the United Stations, but that the amount is well below any harmful limit.  Officials have repeatedly stated that there while use of the potassium iodide is an appropriate precaution for individuals near the accident site in Japan, there is no need for people within the US to take potassium iodide to protect against the effects of radiation.  There are also a number of unpleasant side effects associated with potassium iodide and it is recommended that you speak to your doctor before taking the supplement.  

Click on the “Download PDF” button above to view a Process Map of how the body absorbs iodine and a high level Cause Map of the thyroid epidemic following Chernobyl.

On January 5, 2011, The Triad Group, one of the nation’s largest medical product suppliers, announced a massive recall of alcohol wipes, swabs and pads because of contamination from the same rare bacteria, Bacillus cerus.  Products by this manufacturer were used to care for the boy during his hospital stay.  Although, a definitive link between the death of the boy and the recalled pads has yet to be established, there is a lawsuit pending.

Since the time of the recall, other people have come forward with possible cases of infection from Bacillus cerus from using the recalled products.  The FDA has launched an investigation.

Even through the investigation is not completed, this example can be built into a Cause Map based on the information that is available.  A Cause Map is an intuitive, visual method of performing a Root Cause Analysis. Any additional information can be added to the Cause Map as it becomes available and any necessary changes made. 

When beginning a Cause Map, the first step is to determine the impact to the organizational goals and document them in an Outline.  In this case, the Safety Goal was impacted because a boy died and there is potential that more people were infected by the same harmful bacteria.  Once the impact to the goals is completed, Causes are added to the map by asking “why” questions. In this case, the boy died from bacterial meningitis because he was exposed to Bacillus cerus.  Next, we would ask “why” he was exposed to the bacteria. 

Because the link between the recalled wipes and the death of the patient has not been officially determined, a question mark is included with that information when it’s added.  It’s important that all evidence or lack of evidence is documented on the Cause Map so that it is clear which Causes are agreed upon, known facts and which still need to be proven. Click on the “Download PDF” button above to see a high level Cause Map of this example.

The recall is a short term solution to this problem, but at least all products known to be contaminated should be removed from shelves and hospital storerooms.  It isn’t clear yet what steps are needed at the manufacturer to ensure safety of consumers, but the affected products will not be sold again until they are tested and deemed safe.

 To try and help figure out what went wrong, we begin with the impacted goal and ask “Why” questions to fill out the analysis. We discover that there were two kidneys that arrived at the hospital simultaneously.  In order for the kidneys to be switched, the kidneys must have been mislabeled, or miss-identified once at the hospital.  The coordinating agency for transplants states that the packaging and labeling of the organs was correct.  We then turn our focus to the identification steps of the organ once at the transplant center. 

To aid in determining where process improvements can be made, first we need to define the process.  We can do this with a process map – a step by step instruction of how a process is performed.  In this case, the steps for transplants have been developed by an outside agency – the United Network for Organ Sharing (UNOS).  We can outline these steps in our Process Map.  Because of the high risk for consequence should an error occur, the process is well-defined and consists of checks to ensure that mismatches do not occur.  The last highly publicized incident of a transplant error was in 2003 (see more about that incident here). 

The hospital involved has not released details about what might have occurred in the process; however, it’s certain that they’re looking at the process with a fine-tooth comb and trying to implement improvements.  The transplant program has closed down while they’re doing so.

Mareena Silva had just found out she was expecting.  Six weeks pregnant and a bit under the weather, her doctor prescribed Mareena antibiotics to clear up an infection.  She filled the prescription at the local Safeway, and after taking the medicine as directed, became nauseous.  Upon checking the medication label, she made the horrifying discovery that she had been given the wrong medicine. 

Instead of the antibiotics she had been prescribed, Mareena had taken a dose of methotrexate.  Methotrexate is a chemotherapy drug which targets rapidly dividing cells, like cancer…or embryos.  Her doctor urged her to vomit whatever medicine she could.  Then an ambulance rushed her to the hospital where she was given charcoal to absorb any medication remaining in her stomach.  Unfortunately, at this point all she can do is wait to see if her unborn child was affected by the unintended medication.  Methotrexate can cause serious birth defects, especially during the critical formative period during the first trimester, and even miscarriage.  Reports state that the baby faces 50-50 odds of developing abnormalities.

How did Mareena end up with a drug sometimes used to abort ectopic pregnancies?  The pharmacy staff dispensing the medication accidentally handed her one intended for patient in her late 50’s with a very similar name.  According to statements released by Safeway, pharmacy staff failed to repeat Silva’s name to her twice and verify her birth date – standard company policy.  The company has said that they are conducting an investigation to see why their procedure was not followed.  They will not be the only ones looking into the incident; the Colorado Pharmacy Board will also be reviewing the case. 

Unfortunately mistakes like this are far too common.  No national agency tracks how many prescriptions are incorrectly distributed, and few states track such information either.  However, a 2003 study by Auburn University indicates that the dispensing error rate could conservatively be estimated at 1%.  That’s astonishing considering billions of prescriptions are filled each year.  How might those errors be prevented?  Dispensing medication is more complex than meets the eye, and there are a number of places a mistake can happen.  In this instance, Safeway’s pharmaceutical staff did not follow proper procedures for dispensing medication.  18.3% of dispensing errors were caused by procedures not followed according to U.S. Pharmacopeia’s 2003 study of medication error reports.

While the investigation will unearth further information about what happened behind the counter that day, a detailed Cause Map pictorially lays out how the incident occurred and why.  As the investigation unfolds, more information can be added and solutions can be developed to prevent future incidents like this one from happening.

How did Vancouver do it?  And can it be done elsewhere?

In order to understand how Vancouver has been successful in fighting the AIDS epidemic, we first need to understand why there were such high infection rates to begin with.  This problem can be approached by building a Cause Map, an intuitive visual root cause analysis method that lays out the Causes to a problem.  (Click on the “Download PDF button” to see a high level Cause Map of this example.)

A little research shows that one of the major contributors to this problem is that a significant percentage of the population in this area is engaged in high risk behavior.  The Downtown Eastside area has been called the center of the injection drug epidemic.  Along with rampant drug problems, this area is also home to a thriving sex trade.  Shared needles and unprotected sex significantly contributed to the fast growing rate of new infections in the area.

As many cities have found out, it is difficult to change behavior.  Drug addicts are typically one of the hardest to reach populations.

Vancouver’s approach has been to create a “safe injection site”, called Insite.  At Insite, addicts can inject drugs they bought on the street under the supervisor of nurses.  They are provided clean needles and a safe location.  To make this work, Insite currently has a special exemption from narcotics laws.

Insite also tests for HIV and provides aggressive treatment for those infected.  Aggressive treatment seems to be one of the main factors that has slowed the infection rate in Vancouver.  Antiretroviral medications lower the amount of virus in the blood, which in turn makes a person 90 percent less infective. 

Research has shown that the rate at which the AIDS virus is transmitted can be lowered by treating infected people even if they still engage in high risk behavior. 

Unfortunately, treatment can be expensive.  One of the reasons that aggressive treatment works in Canada is that the government provides free healthcare.  In the US, the fastest growing epidemics are typically in low income areas where health insurance is limited.

The antiretroviral medication can also have some unpleasant side effects so many doctors don’t prescribe it until there are signs that their patient’s immune system is compromised. 

Vancouver’s approach is also obviously controversial.  Using government funds to provide a place for individuals to inject illegal drugs is going to raise a lot of questions.  Insite was created under a more liberal government and the issue is due to be reviewed by the Canadian supreme court this year.

Although rising healthcare costs is a national issue, some of the problems you face at an organization may seem just as insurmountable.  What can be done when an issue appears too big to fix?

First, ensure that you limit your analysis and potential solutions to your own sphere of influence.  Although patients individually reducing obesity and taking their medications properly and on time would certainly reduce healthcare risks, those steps must be taken by the individuals.  As a healthcare organization though, it is possible to take steps to increase the probability that individuals will take these steps.  Generally patient education, automated reminders, and making it easier to do the right thing – by including clearer instructions on prescriptions or offering more fresh fruit in the hospital cafeteria – are steps that can be taken that are within the realm of an organization’s sphere of influence.  Attempting to control solutions outside your sphere of influence is an exercise in frustration!

Next, focus on a piece of the pie.  Not all the causes identified during a root cause analysis have to be tackled at once.  A great way to get started: find a solution that is nearly free and can be implemented fairly transparently to staff.  For example, ask providers to hand out a healthy eating brochure to patients as they leave their appointment.  Is this going to make a big impact? Probably not, but it’s somewhere to start.  And even a little impact can help.

Or, take a note from Camden, New Jersey. In Camden, 1% of patients are responsible for 30% of medical costs. Jeffrey Brenner, a local physician, is making a difference reducing costs by focusing on those few patients.  This is the big “bang for your buck” solution.  And, the solutions that work for this 1% will probably help reduce costs for the other 99% as well.  By focusing on a small number of patients – determining the causes specific to them and tailor-making solutions – headway is being made against an extremely difficult problem.  (Read more at: http://www.newyorker.com/online/blogs/newsdesk/2011/01/atul-gawande-super-utilizers.html)

If you’re feeling overwhelmed, try taking one step at a time.  If healthcare costs can be tackled by looking at a small part of the problem, what can your organization do with a focused look at solutions?

The medical examiner determined that it was likely that a fat embolism, a rare complication of liposuction, had prevented blood flow to her brain, causing her death. Because the patient had declined liposuction, it’s unclear how she ended up having the procedure.  It appears that the patient may not have known that she had liposuction, and hence, was not aware of the potential complications including fat embolisms, from liposuction.  The nurse who presented the surgical consent form to the patient said she hadn’t brought up liposuction because it was “implied” as part of a tummy tuck. 

It is unclear if the outcome would have been different had the patient received treatment more quickly.  The patient was released to her husband the day of the surgery, as it was considered an outpatient procedure, even though there were complications related to low oxygen.  She was not taken to the emergency room until more than 24 hours after the surgery, possibly because of her and her husband’s insufficient understanding of the risks of liposuction. 

The public inquiry into improvements to the healthcare system that might reduce the risks of similar incidents occurring (though the risks for fat embolisms causing brain blood flow blockage are very low) ended last week.  When the results of the public inquiry are released, our initial Cause Map can be updated and the potential action items resulting can be added.

Malyia, bruised, feverish and weak, waited with her family in her local hospital’s emergency room for five hours.  Originally assessed as sick with only a virus and a rash, her parents suspected something more.  Once again a triage nurse reassessed Malyia as non-urgent, with just a virus and rash.  Finally as her small body went limp, her frantic father barged past the ER nurses’ station to demand a second opinion.  That move is probably what saved her life, as blood tests soon confirmed liver failure due to group A streptococcus (GAS).  Two hospital transfers later, Malyia was on life support and blood pressure medication which kept her heart beating and ultimately saved her life.  The lack of oxygen to her limbs however forced doctors to amputate her left hand, fingers on her right hand and both of her lower legs three weeks after her initial infection.

According to the Center for Disease Control, “severe, sometimes life-threatening, GAS disease may occur when bacteria get into parts of the body where bacteria usually are not found, such as the blood, muscle, or the lungs…Streptococcal toxic shock syndrome (STSS) results in a rapid drop in blood pressure and organs (e.g., kidney, liver, lungs) to fail. While 10%-15% of patients with invasive group A streptococcal disease die from their infection, more than 35% with STSS die.”  Doctors know that early diagnosis and treatment are critical with aggressive bacteria such as GAS.  Would Malyia have fared better had she been seen sooner?

Emergency room waiting times have exploded in recent years.  If you were to ask someone on the street why, you might guess that the biggest contributing factor is the growing number of uninsured patients.  Not so, according to an extensive 2009 government report.  Long wait times are actually a symptom of a complex problem.  Vacant hospital beds, specialist availability and access to primary care all play a part in why emergency rooms, especially metropolitan ones, are constantly full.  Using a Cause Map, it is easier to see exactly why. 

While Cause Mapping might help us see why ER wait times are a complex issue, it doesn’t alleviate the suffering the Jeffers family has and will face in the months and years to come.   Unfortunately it is tempting to point fingers and place blame.  Yet the reasons behind this tragic cause are not so simple.  Hopefully, process improvements will alleviate the suffering of those stuck waiting in the ER. 

More information on the story can be found in the Sacramento Bee.  A 2009 GAO report also provided helpful information on the nation-wide issue of emergency room waiting times.

Measles, once considered conquered in most of the developed world, is now making resurgence in the United Kingdom.  Why?  Parents fear vaccinating their children.  The Measles, Mumps, and Rubella (MMR) vaccination rate nationwide dropped as low as 84% during the last decade.  Following the drop, measles became more prevalent, infecting thousands after a decade of steep declines.  In fact, measles infection rates are at their highest rates in well over a decade.  Unfortunately, this also coincided with multiple deaths stemming from measles – deaths that were all preventable.

Why the drop in vaccinations?  In this instance, there is clear reason.  A widely-publicized study in 1998 found a correlation between the MMR vaccination, autism and bowel disease.  Any rational parent would fear causing autism in their child, especially when the perceived risk of catching measles was at an all-time low. 

What makes this especially disturbing is that the chance of developing autism from receiving an MMR vaccination is…none.  The original study was recently deemed fraudulent and formally retracted.  To create this “study” the lead researcher, Andrew Wakefield, is accused of grossly manipulating data.  One of the longest medical board investigations in UK history found that all 12 cases included in the original study were altered.  Multiple studies which followed showed absolutely no link between the MMR vaccination and autism.  In short, he fabricated the story completely.

Why do such a thing?  To start, Wakefield accepted over £435,000 in compensation.  This pay, provided by a national legal aid fund for the poor, came at the behest of litigators looking to build a case against the makers of the MMR vaccine.  Moreover, Wakefield had various business ventures which would benefit greatly from such a linkage, to the tune of at least £28M per year.

Yet despite overwhelming evidence that the MMR vaccine doesn’t cause autism, perpetually low vaccination rates remain in the UK.  Performing a root cause analysis of the measles epidemic in the UK and building a Cause Map reveals the causes contributing to the problem, including the role Wakefield’s bogus study played.   Medical studies are complex and rely on the integrity and analytic skills of the researchers involved.  Inaccurate conclusions, sensationalism and fraud all can lead to unintended and dangerous consequences.

Click on “Download PDF” to see the Cause Map detailing the drop in UK vaccination rates due to the Wakefield Autism & MMR Study.

 (Details of this case were recently published in the British Medical Journal.)

The vaccine that was previously available in Africa was a polysaccharide vaccine, which did not prevent transmission of the disease. Understanding that the current situation was dire, the Meningitis Vaccine Project was formed.  With funding from various donors including The Gates Foundation and money raised in Africa, a vaccine that protects against the group A meningitis strain – responsible for more than eight out of ten infections in Africa – has been developed at a cost of less than $.50 (US) a dose.  More funding is still needed to meet the goal of vaccinating 300 million people across 25 nations.    However, the steps that have already been made are remarkable and represent a huge step forward in helping fight this dreadful disease.  

 Click on “Download PDF” to see the outline and Cause Map of the 1996-1997 meningitis epidemic and the timeline of the progress of the Meningitis Vaccine Project.  To learn more, see the Meningitis Vaccine Project.

The specific steps identified that didn’t go well, or weren’t performed, from the process map now become causes on our Cause Map.  Instead of the causes or errors being grouped chronologically or by type (as they are on a fishbone diagram), the causes are grouped by their contribution to the incident.  The Cause Map reads from left to right by asking “Why” questions, beginning with the impacts to the goals. 

For example, the patient safety goal was impacted because a patient received the wrong surgery.  Why?  Because the physician performed the wrong type of surgery. Why? Because the surgical site was not clearly marked.  Why? It was marked on the correct arm, though not the correct site (the wrong surgery was performed on the correct hand) and the mark was washed off during patient preparations.  These are both issues identified in the process map that did not follow the universal protocol for surgical preparations.  Both of these issues contributed to the wrong surgery.  In addition, the surgeon was thinking about carpal tunnel surgery, since most of his day, especially just prior to the surgery, had been spent on carpal tunnel surgery, either performing it, or doing pre- or post-surgery briefs with other patients. 

Neither the patient nor the operating room staff stopped the surgeon from performing the incorrect surgery.  The patient spoke only Spanish, which may have contributed to her not speaking up.  The operating room staff did not include the nurse that had done the patient assessment, due to a last-minute operating room and staff switch due to other delays.  There was no time-out prior to the procedure, which may have alerted the staff about the wrong  procedure, or may have helped the surgeon switch from thinking about carpal tunnel surgery.

Once the analysis is complete, possible solutions are identified on the Cause Map.  Many of the solutions in this case are to ensure that the universal protocol procedures are being followed.  Had they been followed in this case, the risk of performing the wrong surgery would have been reduced.  Many facilities are already using the universal protocol; however, this case study shouldn’t be ignored by them.  The operating surgeon made this case public and added the following comment: “I hope that none of you ever have to go through what my patient and I went through. I no longer see these protocols as a burden. That is the lesson.” 

This surgeon has learned his lesson and will likely be more diligent about following these protocols in the future.  However, there’s no need to wait until you, or your staff members, have their own incidents to learn from.  Use this case study to emphasize the needs for these protocols, in hopes that your facility can reduce its own risk. 

(Details of this incident were recently published in the New England Journal of Medicine.)

We will be analyzing this issue in two parts.  This week, we’ll be looking at the timeline of events and a process map of the universal protocol developed to reduce the incidence of surgical errors.  (The timeline and process map can be seen by clicking “Download PDF” above.)  Next week, we’ll perform a root cause analysis of the issue.

The timeline of events shows a harried day where the surgeon in question performed a carpal tunnel release surgery with a patient who became upset about the use of anesthetic, then briefed the patient who would later receive the wrong surgery, then performed another carpal tunnel release surgery on a second patient.  Then the first patient became very agitated, resulting in an emotional conversation for the surgeon.  Delays resulted in a change of operating room and operating staff for the third patient, so the nurse who had performed the pre-procedure assessment was no longer participating in the procedure.

The  procedure was further delayed when the circulating nurse had to leave to find a tourniquet, since there wasn’t one in the operating room.  The surgeon spoke to the patient in Spanish (she did not speak English), which the nurse took as the time-out, so a real surgical time-out did not occur.  As per hospital protocol, the patient’s arm, but not the specific surgical site, was marked, but it washed off while her arm was being prepped for surgery.

It’s easy to see how this sets the scene for mistakes. Unfortunately, these kind of things happen, and so it is important that there are procedures in place to minimize errors.  The procedures here are the universal protocol, which are shown on the PDF.  Additionally, the parts of the process that were not performed, or were performed improperly, are noted in red.

Although the U.S. Food and Drug Administration (FDA) requires manufacturers to notify them when there are drug shortages that have no alternatives, there are no sanctions if they do not.  Because many of these drugs have alternatives, the manufacturers are not required to notify the FDA, and healthcare providers are oftentimes not aware of shortages until they run out of needed medication, causing last-minute scrambles and potentially leading to medication errors, such as when an alternative drug has a lower dosage than the drug being replaced.  Because healthcare providers are so accustomed to the dose of the replaced drug, medication errors can result amidst the confusion. 

The FDA estimates that approximately 40% of the shortages are due to manufacturing problems, including safety issues identified in inspections, 20% of the shortages are due to production delays, and another 20% occur when manufacturers stop making drugs.  Although drug manufacturers will not confirm, it is assumed that as insurance companies start covering fewer and fewer brand names and generic prices continue to undercut brand-name prices, it isn’t profitable to make some medications.  The FDA does not have authority to require manufacturers to make medication.  Also contributing to the shortages are increased demand, and shortages of parts and raw materials required to manufacture the medications.

Trying to address these issues and come up with some solutions to the drug shortages is going to take more work than just identifying the issues.  To that end, groups representing doctors, anesthesiologists, pharmacists and safety advocates have invited the FDA, health experts, supply chain representatives and drug manufacturers to attempt to work through a solution earlier this month.  Hopefully they’re able to come up with some actions that will prevent further deaths and medication errors due to this shortage

Additionally, a third child died after a medication error in September 2010, but it has not been determined if the medication error contributed to the death and an adult patient was given the wrong medication but recovered at around the same time.

In response to these errors, Seattle Children’s is performing a root cause analysis by independent experts to determine the causes.  In the meantime, Seattle Children’s is making specific process improvements, such as allowing only pharmacists and anesthesiologists to administer calcium chloride (an overdose of which led to one of the deaths), as well as general training and reminders for staff.  The hospital held a patient safety day on Saturday, October 30th, 2010, where over 550 staff members participated in training and simulations designed to improve patient safety, with a focus on medication safety.

Although the root cause analysis of the various medication errors has not been completed, Seattle Children’s has identified some specific causes that may contribute to medication errors and is launching improvements to try and reduce the impact of these causes.  For example, interruptions to nurses when they are in the process of ordering, preparing or administering medications can lead to medication errors.  During the training, the staff discussed the types of interruptions that occur and what can be done to reduce them.

Medication errors are estimated to kill 1.5 million people per year, so Seattle Children’s is not the only medical facility that will find itself reeling after the deaths of several patients.  These other facilities should take Seattle Children’s lead and begin a serious attempt to reduce these errors, and deaths.

Want to learn more?  See our webpage about medication errors in medical facilities or watch the video.

 We can do a closer examination of the causes contributing to this issue in a Cause Map, or visual root cause analysis.  The first step to the analysis is to capture information about the issue and define the problem with respect to an organization’s goals.  The problem can be defined as a cholera epidemic with a high death rate.  It was first discovered, or at least reported, in November of 2010 at makeshift camps in Haiti.  We’ll use the goals of the Haitian government to determine impacts.  At least 284 people have died and 3,600 people have been infected with cholera. This is an impact to the population safety goal.   The high death rate indicates a failure of population services from the government.  The environmental goal is impacted by the epidemic spread of the disease, and  the financial goal is impacted by the cost of treatment of those afflicted. 

The second step of the analysis is to determine the causes that led to the impacted goals.  The high number of deaths results from the high number of infections and the high death rate.  Infections are caused by ingestion of contaminated food and water.  The bacteria that causes cholera is spreading due to heavy rains and the large number of people living in the unsanitary conditions.  The overcrowding in the camps is due to the earthquake that hit Haiti on January 12, 2010.  As previously mentioned, it’s unclear how the  bacteria got there in the first place, but not surprising that it did.  The high death rate is due to untreated dehydration.  Severe diarrhea is a symptom of a cholera infection, and with inadequate medical care and lack of access to clean water, the dehydration can quickly become severe enough to lead to death.

 Support organizations like the WHO are desperately trying to stop the spread of the epidemic and reduce the rate of death.  However, it’s clear they have their work cut out for them, given the current circumstances.

The process for establishing goals and implementing process improvements to meet those goals is the same process that is used for Cause Mapping.  I’d like to highlight some of the tips from Holland Hospital’s success.  (You can read the whole case study at http://www.whynotthebest.org/contents/view/61.)

Establish a team to develop and work towards goals:  The hospital’s “core measures leadership team” contains physicians, clinical directors and other leaders to ensure buy-in from those closest to the work and management.  The team meets to review noncompliant cases (called “opportunities for improvement”) on a monthly basis.  Additionally, the hospital created a respiratory disease core measure team which developed improvement strategies specific to the pneumonia core measures.

Focus on the system, not on blame: According to the hospital’s director of quality and risk: “the hospital’s patient safety culture means being blame-free. Unless the case is egregious, we assume mistakes occurred because the established care process failed our staff and/or physicians.”  Rather than focusing energy on assigning blame, the team focuses on improving systems to reduce the occurrence of similar incidents, improving the core measures performance for all staff members, not just the ones involved in the noncompliant cases.  As an example, the hospital increased screening for the pneumonia vaccine by reprogramming the electronic nursing record to require an answer to 

Get everyone involved: If performance goals are met, and money is available, a bonus pool is established for all full-time employees (even those not directly involved in patient care), except hospital executives.  If the performance goals are not met, no bonus money is distributed.

Adjust responsibilities when necessary: The hospital discovered some difficulties with one measure – taking a blood culture prior to giving antibiotics.  The team discovered that there was a delay in taking the blood culture because a phlebotomist had to be called into the emergency room.  The team also discovered delays in administering antibiotics when a patient was transferred to another unit from the emergency department. A process change resolved these difficulties.  Emergency room nurses now take the blood culture (contacting a phlebotomist assigned to the emergency department if necessary) and administer the first dose of antibiotics before the patient leaves the emergency department.

Sepsis is a whole-body inflammatory state that occurs in the presence of an infection, and was previously known as a blood infection. The exact causes of sepsis are unclear. However, new research from Portugal’s Instituto Gulbenkian de Cienci has shown that during sepsis, red blood cells may be injured and leak a substance called heme. In combination with inflammation that is present during an infection, the high levels of heme become toxic to the body’s organs, causing organ failure.

The body produces a substance called hemopexin that cleans up the leaking heme. However, as levels of heme rise, levels of hemopexin fall, increasing the amount of heme in the body. The Instituto Gulbenkian de Cienci researchers have had success injecting mice with hemopexin to aid their body in reducing levels of heme. We can show the results of their research in Cause Mapping form, which can be viewed by clicking “Download PDF” above.

This potential solution to reduce the impact of sepsis still requires more research before it can be applied to humans, but may indicate a first step towards reducing the high impact of sepsis on mortality.

There are several  impacts to the goals of the medical center; namely, the impact to patient safety resulting from the injury to the child, the impact to the organizational goals from the settlement, the impact to patient services from the delay to the birth, and the impact to the time and labor goal for additional work required as a result of the issues with the child.  Our analysis begins with these impacts to the goals.

The injury to the child was caused by a lack of oxygen, caused in part from insufficient oxygen before the birth and in part because of insufficient oxygen after the birth.  The baby did not have sufficient oxygen before birth because the umbilical cord was wrapped around her neck and her birth was delayed, due to a “lack of communication” between the second-year resident and her supervisor who were charged with the mother’s care.  More detail on this lack of communication is not currently available; however, from the perspective of the  medical center involved, this is a key place where more detail needs to be added to the Cause Map once it is available.

The baby had insufficient oxygen after birth because the oxygen tube placed to increase her oxygen levels was feeding into her stomach rather than her lungs.  The tube was misplaced by a first-year intern who was being insufficiently supervised.  (Note that the reports don’t say this anywhere, but if you have an intern under supervision who places a tube incorrectly, you can conclude that the supervision was insufficient.)  Note this is another area that requires more detail for the investigation to be complete in order to find effective solutions.  As with any investigation the level of detail in the analysis is based on the impact of the incident on the organization’s overall goals.  Because of the extremely high impact on patient safety, the analysis for this issue should be quite detailed.

“DVIC has concluded that the facts of this case meet the statutory criteria for demonstrating that the vaccinations CHILD received on July 19, 2000, significantly aggravated an underlying mitochondrial disorder, which predisposed her to deficits in cellular energy metabolism, and manifested as a regressive encephalopathy with features of autism spectrum disorder.”

With a very careful reading of the court’s decision, we can put what the court determined was applicable to the case in a Cause Map, or visual root cause analysis.  (I’ve also recorded the chronological information in a timeline, used to assist with our understanding of the issue.  The information from the timeline is also from the ruling.)     

First we can enter the impacts to the goals in the outline.  The patient safety goal was impacted because a child wound up brain-damaged (or with encephalopathy).  The resulting payment of over $1.5M is an impact to the financial goals of the vaccine injury board.  Based on the ruling, the vaccines aggravated an underlying condition, which can be considered an impact to the patient services and environmental goals.   Additionally, in this particular circumstance the child received vaccines not on schedule.  This could be considered an impact to the compliance goal. 

Beginning with the most important goal – patient safety – we build the Cause Map.  The patient’s encephalopathy was determined to have been caused by an underlying condition that was aggravated by the receipt of vaccines against 9 diseases all at once.  However, the link between this and the encephalopathy isn’t yet clear.  Rather than just stopping our Cause Map, we can add a “?” in the middle of the cause-and-effect relationship, and highlight this unclear relationship.  This allows us to focus our attention.  Even with this question mark in the middle of the map, we can still do a lot to clarify the cause-and-effect causes.

For example, based on the child’s physicians’ diagnoses, we know that the underlying condition was a  mitochondrial disorder.  We also know that the child received vaccines against 9 diseases at once because she was behind on vaccines, having skipped some doses while she was ill. 

Even with the uncertainty surrounding this analysis, the Cause Map can still provide clarity to the issue. It can also help lead to possible solutions (though adding more detail will allow for even more).  For example, doctors may adjust catch-up vaccination schedules based on this incident, resulting in fewer vaccines being given at once.

 Exposure to infants is generally from parents or school-age siblings, who may themselves not know they are infected because of the mild symptoms.  Because the protection from the vaccine that protects against whooping cough lasts only about 5 years, many adults may find they’re no longer properly immunized against the disease.  Some children have never been immunized against whooping cough because their parents have chosen not to vaccinate their children.  Because of the lack of immunity of some members of the community, and the difficulty of diagnosing whooping cough, the problem may continue unless steps are taken.

 Some of the solutions being considered are to not allow unvaccinated children to school.  The responsibility of this would fall to school or state officials.   Recommendations are made to keep vaccines for children and adults up to date, but this responsibility ultimately lies with the individual and/or parent.  This may make healthcare providers feel somewhat helpless.  But a recommendation for them has been given – children less than six months old who present breathing difficulties should be given lab tests that would show whooping cough.  This would not prevent infants from getting whooping cough, but would ensure that the disease is discovered, and so can be treated, as soon as possible, hopefully reducing deaths.

We will look at the causes of this event in a Cause Map, or visual root cause analysis.  The information used to put together this analysis is from the legal filing.

On June 23, 2010, a man (who we’ll call “the patient”) was in a serious car accident and was airlifted to a Maryland Hospital.  He woke up the next day, after receiving treatment for blunt torso trauma and chest pain and asked for something to eat.  After some confusion, the patient realized that his identification bracelet was not his – it identified a female patient 13 years his junior.  At this point, he decided to leave the hospital and was stopped with a verbal and physical exchange with several security guards.  He eventually was able to leave successfully, and was treated at a second hospital for broken ribs, a sprained shoulder, a ruptured spleen, and a concussion. 

As mentioned before, physical abuse of a patient is a “Never event”, and is an impact to the compliance goal.   More importantly, there was injury to the patient, resulting in an impact to the safety goal.   Because the patient was wrongly identified as needing surgery to remove a cancerous mass, there was the potential for the patient receiving unnecessary surgery, also an impact to the safety goal.  The patient has taken legal action against the employees involved (Employee Impact goal) and has filed a lawsuit against the hospital for more than $12 million (an impact to the organizational goal).   The misidentification of the patient can be considered an impact to the patient services goal. 

We begin our Cause Map with these impacted goals.  The patient was beaten because employees were trying to restrain the patient to keep him from leaving, and restrained him in an inappropriate manner.  The employees were trying to get the patient to stay because they believed he needed surgery because he was misidentified.  At this point, the hospital involved should be asking “Where did our identification procedure go wrong?”  The next step in the investigation should be to look at the identification procedure to determine specifically which steps allowed the misidentification to happen.  Only once this is determined can appropriate corrective actions be taken to prevent future misidentifications.

Another area that requires more analysis is the patient restraint procedure.  The security guards in this instance were attempting to restrain the patient to prevent him from leaving.  However, they did this in an inappropriate manner.  The question is, why?  Were the guards not following the existing restraint procedure? If not, why not?  Or, is there no procedure for restraint?  Were the restraint expectations not clearly provided to the guards?  Again, until the specific breakdowns leading to this incident are uncovered, corrective actions will be generic and may not be effective.  To view a one-page PDF showing the investigation at this point, click on “Download PDF” above.

In this case, a pregnant woman was prescribed a feeding tube to ensure that she and her baby were getting adequate nourishment.  The feeding tube was improperly connected to the intravenous (IV) line, causing liquid food to enter her veins, causing sepsis which killed her and her fetus. 

One issue (cause) is that medical personnel made an incorrect connection.  Although there was no information given in the article, this would certainly be an area for the responsible organization to look at in more detail and determine if there are steps that can be taken to reduce the risk of these types of errors.  (Some organizations have found success with color coding the tubes, for example.)

However, another issue is that the tubes COULD be incorrectly connected in the first place.  The number of errors in feeding tube connections (discussed in an article from The Joint Commission Journal on Quality and Patient Safety) has led the U.S. Food and Drug Administration (FDA) to consider declaring these products unsafe. 

The tubes become compatible with other tubing connections (such as IV) when needle-free connectors were adopted, to increase caregiver safety (by limiting exposure to needles).  Since then, there have been issues with the compatible tubing.  (A history of tubing issues is found on the PDF, which can be downloaded by clicking “Download PDF” above.)   And, feeding tube connections that are incompatible with other tubing lines are difficult to find.  There are many causes given for the delay of developing incompatible tubing, including resistance from the medical industry, difficulties with the FDA approval process, and a delay in forwarding requirements for incompatible tubing.  This delay is mainly attributed to waiting for an international group to develop a recommendation regarding tubing, which is expected to take several years. 

The FDA has an expedited review process which allows approval of a device if it works like an already approved device, regardless of whether that device is safe, or has been recalled.  Because compatible tubing devices have already been approved, new devices that use the same – compatible – connection can go through this expedited process, whereas incompatible connections can not.  Without federal agencies requiring change, it’s been difficult getting manufacturers to update their products.

View the problem outline, Cause Map, and timeline of tubing issues by clicking “Download PDF” above.

Because a patient suffered cardiac arrest, there was an impact to the patient safety goal.  We begin this impacted goal and ask “Why” questions to add more causes to the Cause Map.  The cardiac arrest was caused by suffocation.  The suffocation was a result of undetected excessive carbon dioxide (CO2) levels.  The levels were undetected because the child was under anesthesia (thus making it difficult to judge the breathing air quality) and because there was no device to detect high CO2 levels.  The CO2 levels were high due to rebreathing.  (The high CO2 levels were an impact to the patient services  and environmental goals as well.) 

The rebreathing occurred because of a lower than normal fresh gas (breathing oxygen) flow.  With a breathing system of this type, the rebreathing (or taking in exhaled CO2) is inversely proportional to the fresh gas flow.  As the gas flow decreases, the rebreathing increases.  The reduced fresh gas flow was caused by a leaky humidifier.  (The leaky humidifier can be considered an impact to the property goal.)  The leaky humidifier was caused by an unrepaired pressure drop through the gas flow passages.  The pressure drop was caused by an inadequate seal on those passages due to two (of four) loose screws that were apparently not noticed.

The leak had been detected during the pre-use test of the equipment.  The leak was believed to be repaired, but instead of performing another pre-use test of the equipment, the system was put together, and a test was done on the whole system.  The system has a higher allowed leak rate than each individual piece of equipment, so the fact that the leak was not in fact repaired was not noticed.

Some of the suggestions given by ECRI Institute to prevent this kind of incident from recurring are to install a CO2 detector on the breathing circuit, ensure the anesthesia equipment is on a regular inspection and maintenance program, and to redo individual equipment tests after repairs.

In order to shed some light on the issues surrounding this most recent death, we can begin sifting through the facts in a root cause analysis.  First, we enter the necessary information into the outline, including the impact to the goals (to view the outline, timeline and Cause Map, please click on download PDF above).  The impacts to the organization’s goals begin the Cause Map, or visual root cause analysis.  We can continue to add more detail to the Cause Map by asking “Why” questions. 

We will then discover that the patient died of suffocation.  An early concern was that the patient’s airway was blocked by gum, but the doctor determined that was not the case.  (We can leave this cause on the Cause Map but can cross it out once it has been determined that it did not contribute to the incident.)  The patient suffocated when she was left facedown on a beanbag chair, after being given a sedative that slowed her breathing, and was not properly monitored for breathing or a pulse.    The patient had been restrained and sedated after threatening and assaulting the hospital staff.  The patient was not constantly supervised, as suggested, possibly due to a lack of staff. 

When the charge nurse arrived several minutes later and determined the patient was not breathing, resuscitation was not immediately begun (either mouth-to-mouth or CPR). She first left to get a light, then a stethoscope, then to find the patient’s nurse.  After the patient’s nurse returned, she left to call a “Code Blue”.  The first aide that arrived was told not to begin CPR or mouth-to-mouth because there was no breathing mask.  She did anyway.  Nine minutes later, the doctor inserted a breathing tube.  The staff attempted to restart the patient’s heart but were unsuccessful and she was pronounced dead.

To determine what actions can be taken so that this never happens again, first we have to do a little more research into a few specific areas.  First there needs to be a thorough investigation on the restraint procedure at this hospital.  Because a patient died in restraints, some aspect(s) of the restraint procedure must be improved.  To improve the procedure, however, first we have to know what the hospital staff  actually did, step by step, in this case (and others).  Then we should look at expectations and/or requirements for supervision of patients who are being restrained, or given sedatives, or who, based on their behavior, require constant supervision.  For example, patients who are held facedown need extra supervision to make sure their breathing is not constricted.  Additionally, it may be appropriate to turn the patient back face up once the sedatives begin to work.

The patient’s death was caused in part by the delay in resuscitation.  Beyond the delay in recognizing the patient’s respiratory distress, the expectations for staff in this situation need to be addressed.  Because the charge nurse was fired, it seems that the hospital did not think she properly performed her expected duties, but why?  Perhaps the staff does not understand what they should do in this case, or doesn’t have the necessary equipment (such as a breathing mask) readily available.  Although refresher training might be in order, we don’t stop there.  We need to figure out all the things that are keeping our staff from being able to do what they need to for their jobs and remove those obstacles – BEFORE this happens again.

To view the outline, timeline and Cause Map, click on “Download PDF” above.  To learn more about this incident, please see the news story.

The radiation overdoses were caused by delivery of the high-powered electron beam without attenuation. In order for this to happen, the high-powered beam was delivered, and the attenuation was not present. The lower-powered beam did not require attenuation provided by the beam spreader, so it was possible to operate the machine without it. The machine did register an error when the high-powered beam was turned on without attenuation. However, it was possible to operate the the beam with the error and the warning was overridden by the operators.

The Therac-25 had two different responses to errors. One was to pause the treatment, which allowed the operators to resume without any changes to settings, and another was to reset the machine settings. The error resulting in this case, having the high-power beam without attenuation, resulted only in a treatment pause, allowing the operator to resume treatment with an override, without changing any of the settings. Researchers talking to the operators found that the Therac-25 frequently resulted in errors and so operators were accustomed to overriding them. In this case, the error that resulted (“Malfunction 54″) was ambiguous and not defined in any of the operating manuals. (This code was apparently only to be used for the manufacturing company, not healthcare users.)

The Therac-25 allowed the beam to be turned on without error (minus the overridden warning) in this circumstance. The Therac-25 had no hardware protective circuits and depended solely on software for protection. The safety analysis of the Therac-25 considered only hardware failures, not software errors, and thus did not discover the need for any sort of hardware protection. The reasoning given for not including software errors was the “extensive testing” of the Therac-25, the fact that software, unlike hardware, does not degrade, and the general assumption that software is error-proof. Software errors were assumed to be caused by hardware errors, and residual software errors were not included in the analysis.

Unfortunately the coding used in the Therac-25 was in part borrowed from a previous machine and contained a residual error. This error was not noticed in previous versions because hardware protective circuits prevented a similar error from occurring. The residual error was a software error known as a “race condition”. In short, the output of the coding was dependent on the order the variables were entered. If an operator were to enter the variables for the treatment very quickly and not in the normal order (such as going back to correct a mistake), the machine would accept the settings before the change from the default setting had registered. In some of these cases, it resulted in the error described here. This error was not caught before the overdoses happened because software failures were not considered in the safety analysis (as described above), the code was reused from a previous system that had hardware interlocks (and so had not had these problems) and the review of the software was inadequate. The coding was not independently reviewed, the design of the software did not include failure modes and the software was not tested with the hardware until installation.

This incident can teach us a lot about over-reliance on one part of a system and re-using designs in a new way with inadequate testing and verification (as well as many other issues). If we can learn from the mistakes of others, we are less likely to make those mistakes ourselves. For more detail on this (extremely complicated) issue, please see Nancy Leverson and Clark Turner’s “An Investigation of the Therac-25 Incidents.”

Investigations by the lab determined that no patients were harmed from the impurities, but this is still a significant issue in a nationally renown laboratory.

How did this happen?

This issue can be investigated by building a root cause analysis as a Cause Map. To start a Cause Map, the impact to the organization goals is determined. In this example, this issue is obviously an impact to safety because there was potential to harm patients. It is also an impact to the production-schedule goal because research has been suspended. Additionally, this problem is an impact to the customer service goal because this issue raises questions about the validity of research results.

To build a Cause Map, select one goal and start asking “why” questions to add causes. In this case, the first goal considered will be the safety goal. There was a potential for injury. Why? Because impure injections were given to patients. Why? Because the injections are necessary for research, because the labs typically prepare the compounds themselves and because the lab prepared the compounds incorrectly. When there is more than one causes that contributed, the causes are added vertically with an “and” between them.

Each impacted goal needs to eventually connect to the same Cause Map. If they do not, the impacted goal may not be caused by the same problem and the goals should be revisited.

To continue building the Cause Map, keep asking “why” questions for each added cause until the level of detail is sufficient.

A Cause Map can be as high level or as detailed as needed. The more significant the impact to the goals, the more likely a detailed Cause Map will be warranted. Once the Cause Map is completed, it can be used to develop solutions to help prevent the problem from reoccurring.

In this example, the lab is currently changing management and reorganizing procedures to help prevent the similar problems in the future.

To view an initial Cause Map for this issue, please click the “Download PDF” button above.

Then the question is: is this a bad thing (a problem) or a good thing (a success)?  Like a lot of things, it doesn’t necessarily have to be one or the other.  There’s an aspect of success – swine flu did NOT turn out to be a deadly global epidemic, as was predicted – and an aspect of failure – up to $450 million of vaccines were tossed out.

 The question that remains for the analysis is: how do we maximize the successes (preventing epidemics) and minimize the not-so-good stuff (wasting vaccines and money)?  A detailed root cause analysis can draw out the successes and problems associated with any event, including this one.  We can use it to look at the planning process used for an epidemic to look for places where the estimation of the need for vaccines can be improved.  We can even look at the use of and expiration dates of the vaccine to determine if, in the future, a backup plan might allow us to get some secondary use out of the vaccines.  Opportunities for improvement are limited only by the brainstorming capability of your organization!

 A very basic Cause Map shows that the potential for maternal and infant injury occurs from difficulty delivering the baby.  The difficulty is caused by a combination of shoulder dystocia (which occurs during vaginal delivery when the fetal shoulder width is greater than the pelvic opening) and improper management of the delivery.  Based on this very simplified Cause Map, two solutions are to plan for a cesarean section (C-section) when there is the potential for shoulder dystocia, and to define the process for delivery when shoulder dystocia occurs. 

We can define a very basic process map for delivery management. First, the patient should be evaluated for the potential for shoulder dystocia.  Then, the labor team prepares for the potential for shoulder dystocia.  If shoulder dystocia is diagnosed, the team should perform the appropriate response, deliver the baby and then administer post-partum follow-up.  The key to this, of course, is to define the appropriate response.

 We can add more detail to part of this process map.  Specifically, the additional detail outlines the “HELPERRZ” process used by some medical facilities for the management of  shoulder dystocia.  (To view the Outline, Cause Map and Process Map, click on “Download PDF” above).

Based on the changes to procedure made by this facility, as well as the recommendations from The Journal of Family Practice and the Annals of Surgery, we can put together a sample procedure for sponge counts during an operative procedure which is shown on the downloadable PDF (click “Download PDF” above).

In our sample procedure, a sponge count is required before the surgical site is opened, each time sponges are added to the surgical field, an incision or body cavity is closed, and if a scrub or circulating nurse is replaced (such as at a shift change).   Once the procedure is complete, a sponge count, as well exploration of  the surgical area is performed before skin closure.  In addition, if the procedure indicates a high risk for retained sponge (examples are shown below), a radiograph of the surgical area is taken.  Because only sponges with radio-opaque markers are used, this creates another layer of assurance.

The procedure shown above may be more comprehensive than the sponge counting procedure used in some facilities.  As such, it requires more time, dedication and resources.  Is it really worth it?  The effort required to implement changes to a procedure have to be balanced with the risk of what the procedure attempts to prevent.  In this case, the sponge count procedure attempts to reduce the risk of object retention after surgery.  The risks of retaining an object after surgery include severe injury, possibly even death.  The retention of surgical sponges is a fairly common surgical complication, estimated to occur once for every thousand to five thousand surgeries.  Additionally, the financial and legal consequences for a facility and operating team for a retained foreign object can be severe.  Each organization must consider its own risks and available resources while determining the appropriate level of effort for a procedure.  However, because of the high level of risk of a retained foreign object, the procedure in this case should involve significant effort.

First we define the problem in an outline.  Within the outline we capture the basic information about the incident – the what, when and where.  We also capture the impacts to the organization’s goals.  In this case, there was a risk of death or serious injury to the patient, which is an impact to the patient services goal.  Two of the employees involved received disciplinary action, which impacts the employee impact goal.  The compliance goal was impacted because hospital policy/procedure was not followed.  The organization goal was impacted because of the $50,000 fine levied by the CDPH.   The patient services goal was impacted because the lap band was left inside the patient.  The property and labor goals were impacted due to the second surgery performed to remove the lap band.

Once we have defined the what, when, where and impact to the goals, we can look at the “why”.  First, we begin with the impacted goals and asking “why” questions, fill out the Cause Map to the right.  In this case, the risk of death or serious injury was caused by an intestinal obstruction caused by the lap band being left within the  patient’s abdomen post-surgery.  The lap tape was used within the abdomen to aid in the Cesarean section.  The lap band could not be seen visually and the sponge count (used to prevent objects from being left within patients) was performed incorrectly.  There were 20 sponges opened in the operating room (OR).  The hospital’s procedures required that each sponge be placed in its own “easy count” bag.  Then, the OR staff could ensure that the number of bags matched the number of sponges used in the surgery.  Of the 15 sponges that were used in the surgery, 14 were placed into bags and counted.  Of the remaining sponges, 5 were not used, and were not placed in bags (but were counted), and one was left within the patient.  The staff believed that the sponge was within the surgical field and the surgeon did not report placing the lap band within the patient.

As a response to this incident, the hospital updated its procedures and re-trained its staff.  Frequent audits of surgeries were also implemented. Since the changes were updated, there have been no cases of objects retained after surgery. 

Check back next week as we look at the sponge counting procedure developed by this facility in response to this incident.

We can perform a proactive root cause analysis to determine what causes these illnesses.  Essentially, a person consumes germs by ingesting pool water that contains germs.  Pool water becomes contaminated when germs enter the pool from fecal matter.  (Easier said than done. Did you know that the average person is wearing 0.14 grams of fecal matter?)  So please, keep fecal matter out of the pool.  Take a shower before you get in and make sure your kids are using the bathroom regularly elsewhere.  (Not surprisingly, kiddie pools are the ‘germiest’.)    

Now, pools are treated to prevent these germs from proliferating.  However, some combinations of pool chemicals and germs take much too long to work to be effective.  (For example, cryptosporidium takes 7 days to be killed in chlorine.)  Some pools aren’t getting enough chemicals due to inadequate maintenance.  And, there’s some stuff you can put in the pool – namely urine, sunscreen, and sweat – that interacts with chlorine and reduces the effective volume in the pool. So, even though urine itself doesn’t contain germs, don’t pee in the pool.  And again, take a shower.

Our solutions to RWI – take a shower, don’t perform any bodily functions in the pool, and don’t swallow the pool water.  However, that works for you and your family, but what about the unwashed masses in the pool?  The CDC recommends you buy your own water testing kit and test the pool water before you get in.  Make sure there’s a pool treatment plan and that it’s being followed, and that all ‘accidents’ are reported immediately.  (Yep, even if   they’re your fault.)  Then lay back, relax, and enjoy your swim.

There is the potential (although believed to be remote) for an impact to consumer health, which is an impact to the safety goal.  Additionally, the drugs were recalled for not meeting required quality standards, which can also be  considered an impact to the safety goal.  The product recall, which encompassed 1,500 lots of 43 products, is an impact to both the customer service and property goal.  The cost of this recall has not yet been estimated.  The  manufacturing facility is on hold, which is an impact to the production goal.  Lastly, the time and costs associated with the investigation to determine what went wrong is an impact to the labor goal.  We can record these impacts to the goals in the outline (Step 1). 

Once we’ve completed the first step, we move on to the root cause analysis, or Step 2.  We begin the analysis with the impacts to the goals and ask “Why” questions to complete the Cause Map.  Because the FDA’s investigation report has not yet been released, the Cause Map we have so far is very basic.  Essentially, the recalls occurred because unacceptable product was released to consumers.  It was released because the finished product met testing requirements.  However, it was unacceptable because it did not meet quality standards, because of contamination in the raw materials that were used.  At this point in the map, we run into more questions.  More detail can be added to this Cause Map as the analysis continues and more information is released. As with any investigation the level of detail in the analysis is based on the impact of the incident on the organization’s overall goals. 

A thorough root cause analysis built as a Cause Map can capture all of the causes in a simple, intuitive format that fits on one page.  View the investigation by clicking on “Download PDF” above.

The patient death was caused by cardiac arrest, caused by insufficient oxygen.  The patient had insufficient oxygen and insufficient supervision.  Had the patient been properly supervised (as required), a medical staffer should have noticed the issue before it came to this point.  The patient was unable to breath on his own because of the pneumonia and so was placed on oxygen.  The patient was placed on portable oxygen in order to be transported to the radiology department for an ultrasound.  Although there was the capability within the radiology department for the patient to be hooked up to the wall oxygen supply, there was no policy to do so, and the patient remained on the portable oxygen supply.  

According to hospital procedures, when a patient is being transported, the responsibility for the safety of that patient lies with the transporter.  A hospital policy allows for patients to be transported by untrained personnel in the case that a patient is stable, and this is indicated on the Transport Communication Form.  This patient was transported by an untrained person; however, no Transport Communication Form was completed or signed.  Whether or not the patient was considered ‘stable’ is unknown.  For reasons that are unclear, the transport person left the patient in the radiology department and did not return.  Eventually, the Ultrasound Technician returned the patient to his room.   It was then realized that the patient was not breathing and the patient was connected to the wall supply.  However, it was too late and the patient was unable to be revived.  Although the Ultrasound Technician was trying to aid the patient, she did not verify that the patient was breathing, either because it was not her responsibility or she was unaware of the patient’s oxygen requirements.  The transport person was both not around, and not trained for this type of work.  Although the hospital policy required an RN or a Respiratory Therapist to regulate the oxygen flow rate, none were around.

Shortly after this incident, the hospital implemented new and clarified policies regarding patients on oxygen, and how they were to be transported.  These solutions, along with the rest of the information from the investigation, can be seen by clicking “Download PDF” above.    

Information used for this investigation was found in the report by the California Department of Public Health.

 One of the five patients who received a transfusion died, but as he was in hospice care for terminal cancer, it’s unclear whether the contaminated transfusion was responsible.  Three of the four remaining patients had yellow fever antibodies in their system, but have not demonstrated any symptoms of yellow fever.  The potential transmission of yellow fever to these patients is an impact to the patient safety goal.  Additionally, the transfusion of contaminated blood impacts the compliance, organization, and patient services goals.   The cost of the disposal of 83 contaminated units of blood is an impact to the materials goal, and the required investigation is an impact to the labor goal. 

 The contaminated transfusions occurred because of the medical need for blood, and the use of contaminated donor blood.  The donor blood was contaminated because the recall did not occur for several weeks (although it happened immediately after the contamination became known) and because the blood contained yellow fever antibodies.  The yellow fever antibodies were present due to donors who had recently received vaccines, and donated, though ineligible.  Because of the large number of trainees who donated blood despite being ineligible, it’s apparent that there was a disconnect in providing the information of a required two-week deferral from donation after vaccination.

 Although the Red Cross does make its eligibility criteria known, it’s clear from this incident that this was insufficient in this case.  The military has agreed to provide vaccination records for its members to ensure that blood is not donated during the deferral time after live virus vaccines.  Additionally, the Red Cross has added specific, individual questioning about recent vaccinations.  (The previous process used for screening with respect to recent vaccines was not discussed.)  A recommendation is being made to have healthcare providers discuss eligibility for blood donation after vaccines are provided, though this is not currently being specifically required.  These solutions should reduce the risk of providing contaminated blood. 

To view the one-page PDF containing the outline, Cause Map, timeline and action items, please click “Download PDF” above.  The information for this investigation was provided by the Centers for Disease Control and Prevention (CDC)’s Morbidity and Mortality Weekly Report (MMWR).

A recent study published in the American Academy of Pediatrics Journal “evaluated the accuracy of translated Spanish-language medicine labels among pharmacies in a borough with a large Spanish-speaking population. ^“  The study found significant issues with label accuracy with a popular language in an area with a large population of speakers of that language.  You can imagine how these results could get even worse for an area that had a smaller number of Spanish speakers, or for patients who speak a less common language.

One of the most striking examples was a man who received heart medication that was to be taken once daily.  The instructions were only partially translated and “once” (which means 11 in Spanish) was left on the instructions.  The patient took 11 pills (instead of 1) a day.

The study found an overall error rate of the prescription instructions that had been translated into Spanish by computer of 50%.  (86% of the pharmacies surveyed translated their prescriptions with a computer program.)  It is likely that patients with the incorrectly translated prescription instructions took the medicine incorrectly, resulting in the potential for serious harm, or even death.  This is an impact to the patient safety goal.  The rate of errors made by the computer means more work for pharmacists and translators due to the corrections that must be (or should be) made.  (Obviously this is not always happening.)  Patients receiving instructions they do not understand can be considered an impact to the patient services, compliance, and organizational goals.  (The study was performed in the Bronx, New York.  It is a law in New York City for pharmacy chains to provide translated labels for the top seven foreign languages in the area.)       

Patients do not understand the directions because the patients do not speak English and the instructions are either not translated, or are translated incorrectly.  The instructions may be translated incorrectly because the computer program translates them incorrectly and there is an inadequate verification of the computer translation, because the pharmacist does not speak the language and/or there is no translator available (likely due to lack of funds or an uncommon language).   The instructions may not be translated if the pharmacy has no translating capabilities, also likely due to cost or an uncommon language.

An obvious suggestion is to improve the accuracy of the computer programs that do the translating, perhaps standardizing the translations among the different programs that do the job.  Pharmacists could also be provided with a guidebook of translations for standard pharmacy terms (such as take orally).  Additionally, translation software could be added to the computer programs currently used by pharmacists.   

I have a simpler suggestion that I borrowed from the aviation industry.  I noticed the last time I flew that instead of having translations of the safety instructions in a dozen different languages, there were practically no words at all.  Instead, the airline used picture instructions.  I suggest doing something similar with medications.  (See my example of a picture for “take orally” on the PDF.  View the root cause analysis investigation and my picture by clicking “Download PDF” above.) 

Because of the risk involved, it’s clear something needs to be done.  Prescription instructions are hard enough to understand in English, much less poorly translated into another language.  I’m sure suggestions will keep coming in, and surely some smart folks out there will come up with a way to reduce the potential for confusion and injury.

The facility is working through the impacts of these errors, the causes of the error, and what needs to be done to keep an issue like this from ever happening again.

First let’s examine the impacts to the goals resulting from this error.  There’s an impact to the patient safety goal due to potential for deaths and injuries. (Because these patients  were already sick – sometimes very sick – the facility is still determining what impact the overdoses may have had.)  There has not yet been mention of an employee impact – the physicist who set up the machine is no longer at the facility – so we’ll just put a “?” after Employee Impact.  The event was reported to The Joint Commission (no reports were required by law), which can be considered an impact to the compliance goal.   The organizational goal was impacted due to potential lawsuits against the hospital.   The patient services goal was impacted because 76 patients received an average overdose of 50% (other patients received overdoses that were considered within the acceptable range for treatment).  Because radiation was involved, there is the potential for an environmental impact.  However, there is no evidence that any radiation leaked to the environment, we’ll put a “?” by the environmental goal as well.  Lastly, the property and labor/time goals were impacted because of the additional follow-up exams, testing, support, and treatment, which the facility will provide for all those affected by the issue.

Once we’ve determined the impact of the event, we can begin an analysis of how it happened.  Or, what were the causes?  The goals were impacted due to the overdose to several patients.  The overdose occurred because the radiation therapy machine was miscalibrated and the miscalibration was not discovered for five years.  The machine was miscalibrated because the incorrect chamber was installed and the chamber installation was not verified.  The physicist chose the wrong chamber and the equipment representative (who was on hand for the installation) did not notice the error.  At this point, it’s unclear why the physicist chose the wrong chamber and why the equipment representative did not notice the error.

The miscalibration was not noticed for five years because any re-calibration of the machine depended on the chamber which was incorrectly installed.  So although the machine was not delivering the correct amount of  radiation, the problem was with the calibration itself, resulting in a propagating error.  According to the facility, none of the patients showed any unusual side effects that would indicate they were getting too much radiation. However, some of the symptoms may take years to develop.  Additionally, no other staff members were trained on the equipment for five years.  It was a second staff member who was trained on the equipment who finally noticed the error.

Even though there are some questions still remaining in our Cause Map, we can develop some solutions, as the facility in question (as well as other stakeholders) is doing.   One suggestion is to do an external calibration of the machine – i.e., use a calibration method that is completely separate from the machine to determine if the correct amount of radiation is being delivered.  Also, have an independent verification that each piece of the equipment was installed correctly.   Require the equipment representative to sign off on the installation.  Last but not least, train other staff members to operate the equipment as backup.   The facility is working with the FDA to assist in its efforts to increase the safety of radiation use in healthcare settings.  (See our previous blog about this topic.) 

Step 4 to avoid radiation therapy errors: verify HOW MUCH – how much radiation therapy is required, and how much is the patient actually getting.

To address these concerns, the clinic has installed iris scanners to identify the patients.  The scanner pulls up a patient’s electronic medical records with an extremely low error rate.  An additional benefit is that an iris scanner does not require the patient to physically touch it, so it is much less likely to spread germs than a fingerprint or palm scanner. 

The clinic has been extremely pleased with the iris scanner, noting that it has also helped fight benefits fraud and won the clinic recognition from the Healthcare Information and Management Systems Society.   The downside is that the system is expensive.  (The Bronx clinic purchased their scanner with a grant from the New York Department of Health.)  However, considering the high prevalence and cost of medical errors, it seems to be a worthwhile expense.

Although there was no damage to the patient’s health, this incident impacted the facility’s patient safety goal, because of the potential for injury to a patient when radiation is delivered unnecessarily.  Additionally, it impacted the patient service goal because the radiation treatment was misdirected to the wrong body part.  The organization and compliance goals were impacted because of this reportable error.  Lastly, there are impact to the materials and labor goals due to the additional treatments that were required to deliver radiation to the upper spine. 

The situation was complicated by the software error that brought up an old picture, indicating that the therapy should treat the esophagus.  To add to the confusion, there was a tattoo on the esophagus designating it as the site of the therapy.  There was nothing in the set-up notes to indicate that the patient had had a previous round of radiation therapy.  It is unclear whether the therapist had access to the patient’s chart, which would have designated the area to be irradiated and would mention the previous therapy.

The facility involved introduced measures to solve the software problems which resulted in the old photograph being downloaded.  Second therapy sites are now marked with double tattoos.  Information such as the therapy location and any previous radiation therapy sites are now included in the set-up notes.  Additionally, ensuring that the therapist has access to a patient’s medical chart will help allow the therapist to ensure a patient’s therapy is delivered properly.  

Step 3 to avoid radiation therapy errors: verify the WHERE – which body part requires the radiation therapy

This incident impacted the facility’s patient safety goal, because the patient died of cancer, possibly because the radiation dose to her lungs was too low to effectively fight the cancer.  Additionally, it  impacted the patient service goal because the patient received the wrong radiation treatment.  The organization and compliance goals were also impacted because of this reportable error. 

How did this happen?  The patient had a complex radiation therapy program, involving two different treatments to two different parts of her body simultaneously (radiation was delivered to different body parts on alternating days). Obviously some confusion on the part of the staff was involved, and because only one therapist was present for administering the therapy, there was no oversight, or anyone else to catch the error.

Based on the causes of this incident, we can develop action items to be taken by the facility to reduce the risk of this type of incident happening again.  Unless it is medically necessary, avoiding administering two different therapies at one time would reduce the risk of this type of confusion.  The treatment a patient is receiving should always be verified before the treatment is administered.  Also, because of the high level of risk to patients, more than one therapist should be present.  (The facility involved in this particular incident has implemented a rule that more than one therapist be present for complex treatments.  Although it’s not clear exactly what’s meant by complex, surely this would qualify.)   Hopefully these steps, when taken by facilities who deliver radiation therapy to patients, will reduce the risk of radiation errors.

Step 2 to avoid radiation therapy errors: verify the WHAT – the type of treatment the patient is receiving.

This incident impacted the facility’s patient safety goal, because of the risk of injury to Patient A.  Additionally, it  impacted the patient service goal, because Patient A received unnecessary radiation.  The organization and compliance goals were also impacted because of this reportable error. 

How did this happen?  Patient A was at risk for injury because of the delivery of unnecessary radiation.  She was given radiation meant for another patient because the therapist delivered the radiation and Patient A, not knowing that her own treatment was complete, didn’t know to stop it.  The therapist did not effectively verify the identity of Patient A, instead going off the chart that had been opened by the previous therapist, for unknown reasons.  Had the first therapist told Patient A that her therapy was complete, or had the first therapist not opened another patient’s chart, or had the second therapist verified the identity of Patient A, this error would probably not have occurred.

Based on the causes of this incident, we can develop action items to be taken by the facility to reduce the risk of this type of incident happening again.  Therapists should not open charts until they have verified the identity of a patient.  They should verify a patient’s identity before treatment, and they should review the outcome of a treatment with the patient.  After all, had any of these steps occurred, Patient A would have been able to properly celebrate the end of her radiation therapy, rather than worry about a risk to her health.

Step 1 to avoid radiation therapy errors: verify the WHO – the identity of the patient.

Sepsis is a bloodstream infection.  The study found that nearly 20% of patients who contract sepsis after invasive surgery at a hospital will die from it.  On average, a patient who contracts sepsis can expect 11 additional days at the hospital, at a cost of $32,900.  Sepsis contracted in hospitals is generally a bacterial infection, caused by bacteria in the bloodstream (known as bacteremia).  A patient must be exposed to bacteria in order for the bacteria to access the bloodstream.  Bacterial access to a patient can be caused by ineffective infectious control procedures.

Nosocomia (or hospital-acquired) pneumonia is an infection of the lungs.  Like sepsis, in a hospital setting it is generally caused by a bacterial infection when bacteria enter the lungs.  Also like sepsis, this requires bacterial access to the patient.  More than 11% of patients who contract nosocomial pneumonia after invasive surgery will die.  On average, a patient with nosocomial pneumonia will spend 14 extra days in the hospital, at a cost of $46,400.

To prevent these types of bacterial infections, every employee in a hospital must practice effective infectious disease control.  Each hospital must develop infection control procedures to aid in preventing the spread of disease.  As an example, here we’ll look at the infection control procedure for  pre-surgery.  This extremely simple procedure was developed based on the CDC’s Surgical Site Infection FAQs.  If a patient has hair in the surgical area, it should be clipped, not shaved, to avoid infection.  If a patient is high risk, he or she may receive antibiotics before the surgery.  The patient’s skin will be cleaned at the surgical site to avoid introducing the patient’s skin bacteria into the surgical wound.  Before the providers begin surgery, they will wash their hands and arms up to the elbows thoroughly and don protective wear.  This helps prevent bacteria carried by the providers (including bacteria from the providers’ previous patients) from infecting the patient.

This is just one example of a process that demonstrates infection control to protect patients from hospital-acquired infections.  More can be developed, based on a hospital’s best practices.  What’s important is the focus on infection control to protect patients.

We will look at one of our previous blogs – the intensity modulated radiation therapy overdose – and discuss how the initiatives proposed by the FDA may have prevented the death of Scott Jerome-Parks.  There are two radiation protection concepts for the initiatives – justification for use of radiation-related procedures, and optimization of the dose during the procedures. 

The justification portion of the initiative aims to ensure medical justification and informed decision-making by patients and their doctors.  In order for the decisions to be informed, the FDA notes that patients must have comprehensive understanding of both the risks and benefits of the use of radiation.  If patients were more aware of the risks of the use of radiation, it’s possible that Jerome-Parks and others would have chosen alternative approaches or would have selected facilities based on their experience or safety rating.  Currently, because reporting requirements for errors involving radiation are inconsistent (or there are none at all), it’s nearly impossible for patients to make these sorts of comparisons.

Another issue raised by the Jerome-Parks case is the lack of safeguards on the radiation equipment itself.  Jerome-Parks received seven times the radiation dose on three occasions, and nobody noticed.  The FDA proposes that equipment designed to deliver radiation be equipped with safeguards that optimize radiation doses and/or provide alerts when radiation exceeds a reference level or range.  These safeguards would alert providers when radiation doses are higher than expected, giving them another chance to verify that the settings are correct.  Hopefully this will prevent many occurrences of radiation overdose.

The FDA has also noted the lack of training and quality assurance practices for some radiation delivery practitioners.  Several medical organizations are attempting to create standardized training and quality assurance methods to provide practitioners with the information they need to properly use radiation delivery equipment.  The FDA is also planning to partner with the Center for Medicare and Medicaid Services (CMS) to incorporate appropriate quality assurance practices into accreditation and participation criteria for medical facilities, further
supporting the safe use of radiation delivery equipment.

Looking at the two previous radiation overdose cases, we can see the detrimental effect of radiation therapy when not used properly.  Because of the great potential impact to patient safety, all involved parties MUST work together to ensure less patient risk from radiation therapy.

Any adverse event that occurs during patient care or patient death is investigated by the National Naval Medical Center. We can look at the beginnings of what such an investigation would look like in a root cause analysis. (To see the root cause analysis investigation, click on “Download PDF” above.)

We begin by recording relevant basic problem information in the outline, or problem definition. We record the “what, when and where” of the incident. Because more than one date and facility is involved, it may be helpful to create a timeline of events to aid in the investigation. Once we’ve recorded this information, we can define the problem with respect to the organization’s goals. A patient death is our primary concern, and is an impact to the patient safety goal. An adverse event that occurs during patient care can be considered an impact to the compliance, organization, and patient services goal. Additionally, there were certainly additional costs incurred due to the additional care required, which are impacts to the materials and labor goals.

Once we’ve completed our outline, we begin with our Cause Map. We begin with the impacts to the goals on the left, then ask “why” questions and fill in causes to the right. The patient death was caused by an infection believed to be caused by a nicked intestine from laparoscopic gallbladder surgery. Because not all laparoscopic gallbladder surgeries result in nicked intestines, there has to be an additional cause, but we don’t know what it is. We’ll just put “Surgical error ?” as a cause, and we can add more detail as more information is released.

The National Naval Medical Center has released its basic process for a quality assurance review, which is performed in the event of a patient death or adverse event during patient care. Because this process is going to be part of the solution to this issue, we can record the information we know about this process in a Process Map. Unlike a Cause Map, the Process Map flows from left to right in the direction of time to show the order of steps that should be taken. We can add this Process Map to the investigation sheet as well, for reference.

Although we don’t have a lot of detail on what exactly happened, we can get a lot of information about our investigation onto one sheet of paper (see “Download PDF”). We’ll add more information to the investigation as more information is released.

The circumstances of this case are very similar to those of the previous radiation therapy overdose.  The patient, Alexandra Jn-Charles, was receiving radiation therapy as a follow-up to surgery for an aggressive form of breast cancer.  Instead of using the type of linear accelerator with a beam frequency modulator discussed in the last case, the radiation therapy used on Ms. Jn-Charles was from a linear accelerator that was modulated with a metallic block known as a wedge.  However, for her radiation therapy, the wedge was mistakenly left out of the machine, resulting in 3.5 times the desired amount of radiation reaching the patient.  The error was not noticed throughout her 27 days of radiation treatment.

As we did with the last case, we can look at this issue in Cause Mapping form.    First we can record the basic information of the issue in the problem outline.  We capture the what, when, and where in the top part of the outline, then capture the impact to the goals.  Here, the patient was killed, which is an impact to the patient safety goal.  The error resulted in a fine from the city, which is an impact to the organizational goal.  The patient received an overdose on 27 occasions, which is an impact to the patient services goal.  Additionally, there was a radiation overexposure, which we will consider an impact to the environmental goal. 

We begin our Cause Map with these impacts to the goals.  The patient received an overdose of radiation therapy because the patient was receiving radiation therapy to treat her aggressive breast cancer.  (This treatment was following surgery and chemotherapy.)  The overdose occurred when the radiation was ineffectively filtered.  The wedge that filters radiation from the linear accelerator was left out of the machine.  The machine was programmed for ‘wedge out’ instead of ‘wedge in’ and the error was not noticed by either other therapists or physicists who did a weekly check of the machine.

The error was not noticed for 27 days.  Obviously the safeguards were inadequate, because they allowed a patient to be over-irradiated on 27 occasions.  However, it’s unclear whether there were no required over-checks which would have caught the error or whether these over-checks were not performed. 

Because we are still lacking somewhat in information on what exactly occurred and what procedures exist, we would need to ask some more questions to complete this Cause Map before we are able to find effective solutions.  However, I’m sure that the healthcare facility involved, as well as New York State, is doing this right now and ensuring that this sort of error will never happen again.  

To view the beginnings of this root cause analysis investigation, click on “Download PDF” above.

In IMRT, the radiation beam comes down through a collimator, which has programmable leaves (that look like metal teeth) that open and close to direct and modulate the beam.  If the collimator leaves are completely closed, no radiation gets through.  If the collimator leaves are completely open, the dose of radiation will be too high, and the beam will not be properly directed to the desired radiation site (here, Jerome-Parks’ tongue) but will rather hit a larger part of the body. 

In this case, the collimator settings were lost, which resulted in the collimator being wide open, delivering seven times the desired dose to Jerome-Parks.  The error was not noticed until 3 days – and 3 treatments – later, when the physicist performed a test to verify the programming and discovered the overdose.  It was apparently customary, though not required, that the therapist verified the settings after reprogramming.  On this day, the hospital was apparently short-staffed due to therapist training, so the verification test was delayed. 

Jerome-Parks eventually died of his injuries.  He hoped that his death would lead to fewer radiation errors like the one that killed him.  Some progress is being made, but there’s still a way to go.

The company who manufactured the IMRT equipment released a new version of the software which contains a fail-safe to reduce the risk of the modulator being left wide open.  Although the details aren’t clear, it appears that the default setting for the equipment was to have the collimator wide-open, resulting in an overdose, rather than closed, which would result in no radiation at all.  It also was difficult for the therapists to determine which of their changes had been saved when the computer crashed, which apparently happened frequently.

It’s unclear what changes the hospital involved is making to its procedures to reduce the risk of this type of error.  However, there were several opportunities for the error to be caught, so there are some effective changes that could be made.  The State of NY, concerned with the number of radiation errors, especially high-profile ones like that of Jerome-Parks, has released several alerts to draw attention towards the problem of radiation errors.  It’s also attempting to increase reporting requirements (now practically non-existent) for these types of errors to increase accountability.  Let’s hope that it works and nobody has to suffer like Jerome Parks again.

If you’d like to learn more about Jerome-Parks and radiation errors, check out the article by the New York Times.  For more on radiation errors, check back at our blog next week!

This gives an argument towards greater specialization – based on this research, a medical professional who spends all day looking for breast cancer in mammograms would be more effective at finding it than a general practitioner who may only see a few cases of breast cancer throughout his or her career. 

However, another recommended solution is to make sure that the people doing the screening see many examples of what they’re looking for.  Not only could this be done during medical training, but some facilities have found success in “booster exercises”.  Essentially, before a worker spends time screening for rare occurrences, such as indications of cancer, look at results that include a number of positive (i.e. cancerous) screenings.  This helps focus the worker’s attention, leading to quicker and more accurate screening results.

For these reasons, it is important to work on reducing the occurrence of mediastinitis in medical facilities. A tool we can use to help reduce the occurence is a visual root cause analysis, presented as a Cause Map. A thorough root cause analysis built as a Cause Map can capture all of the causes in a simple, intuitive format that fits on one page. We develop a Cause Map in three steps.

First, define the problem. Here, the problem is mediastinitis, which occurs in the mediastinum, as a result of the process of CABG surgery. After we capture this relevant information regarding the problem, we look at the impact to the organization’s goals. An increased risk of patient death is an impact to the patient safety and patient services goals. The compliance and organizational goals are impacted by the contraction of a hospital-acquired infection. Additionally, the non-reimbursable cost to the hospital is an impact to the materials and labor goal.

Now that the problem has been defined related to the organization’s goals, we perform our root cause analysis, or make our Cause Map. First we put down the impacts to the goals, then by asking “Why” questions we add causes to the map. Here, the impacts to the goals are caused by a patient contracting mediastinitis. The causes of a patient contracting mediastinitis are bacterial colonization of the mediastinum and the bacteria not being destroyed (possibly due to inadequate levels of antibiotics in tissue because of perioperative antibiotics not being administered). The bacterial colonization is caused by bacterial contamination, and/or an environment susceptible to colonization, possibly due to impaired wound healing, such as caused by elevated blood glucose levels. Bacterial contamination is caused by bacteria in the area of an open chest (which is open for the purposes of performing a CABG). The bacteria in the area can be caused by a number of things, including a non-sterile atmosphere, bacterial infection of the skin, insufficient sanitization of the skin, and bacteria on the operative staff hands or gloves.

The root cause analysis can be viewed by clicking “Download PDF” above. The root cause analysis we show here is highly simplified. Even more detail can be added to this Cause Map as the analysis continues. As with any investigation the level of detail in the analysis is based on the impact of the incident on the organization’s overall goals.

Once the Cause Map is completed, we look for solutions. The solutions are attached to the cause they control. For example, a solution to elevated blood glucose levels is to use a continuous IV infusion of insulin for diabetic patients during surgery. Other solutions are shown on the Cause Map. Individual medical facilities can evaluate these solutions based on the impact to the organization’s goals to determine which solution(s) will be most effective in reducing their risk.

Click on “Download PDF” above to download a PDF showing the Cause Map.

Using the information presented in this report, it’s possible to make a Cause Map outlining the causes of hepatitis B and C infections.  First we begin with the impact to the goals.  First, the report estimates that there are approximately 15,000 deaths per year associated with chronic HBV and HCV.  Additionally, 3-5 million people are estimated to be living with chronic HBV and HCV.  These are both impacts to the patient safety goal.  In many cases, these infections are not treated.  This is an impact to the patient services goal.

Once we’ve defined the incident in respect to the goals, we can begin our Cause Map.  We begin with an impact to the goals and ask “why” questions until all the causes are on the Cause Map.  In this case, the deaths are caused by chronic HBV and HCV, which are caused when a person is infected and not treated.  Infections can result from being born to an infected mother, infected blood transfusions (before blood was tested for HCV), sexual contact with an infected partner, sharing needles with an infected person, or needlesticks with an infected needle.

Most typically, people who are infected with HBV or HCV do not seek treatment because they are unaware they are infected due to the asymptomatic nature of hepatitis.  Persons may not be screened even in high risk situations because either they or their healthcare providers do not realize the risk, or they do not have adequate access to healthcare.

The infection rate of HBV is decreasing thanks to a vaccine for hepatitis B.  However, a vaccine is not yet available for hepatitis C. This is certainly a priority in the national fight against hepatitis infections, as well as increased education and awareness programs.

This thorough root cause analysis built as a Cause Map can capture all of the causes in a simple, intuitive format   that fits on one page.  To view the one-page downloadable PDF, please click on “Download PDF” above.

Researchers have verified that the contaminant in the recalled heparin is oversulfated chondroitin sulfate (OSCS) and that they have discovered a mechanism by which the contaminant can cause the adverse effects (falling blood pressure and severe allergic reactions). Additionally, the researchers have provided a test for regulators to screen heparin for this contaminant.

They have determined that the OSCS was present at the active ingredient supplier plant in China. Because OSCS does not occur in nature and mimics the chemical structure of heparin so closely, it is believed that the (mostly unregulated) crude heparin suppliers in China added OSCS to increase their profit, as OSCS is many times less expensive than heparin. The OSCS was not detected by standard impurity tests, due to its similarity with heparin. In Congressional hearings since the event, the Food and Drug Adminstration (FDA) has said that the inspections of the Chinese plant (as well as those of most foreign plants) were inadequate due to lack of funding for the FDA mission.

The Cause Map shows that the heparin got into the drug supply after being placed in the raw ingredients. It was not discovered by regulators, due to the lack of a commonly used, effective test. A thorough root cause analysis built as a Cause Map can capture all of the causes in a simple, intuitive format that fits on one page. As more information is released about the failings of the supply chain in this instance, we can add more details to the Cause Map.

Click on “Download PDF” above to download a PDF showing the Cause Map.

See a more detailed root cause analysis of the heparin contamination.

First, the hospital needed to determine what was at stake. Over 18 months, it was estimated that more than 1500 patients would die from infections. This is an impact to the patient safety goal. There was non-compliance with procedures, which is an impact to the compliance and organization goals. Infections result in a longer intensive care unit (ICU) stay, which is an impact to the patient services goal. Lastly, the hospital estimated that, over the 18 months, it would spend $175 million in additional costs from these infections.

Next, the stakeholders in the central line insertion process (doctors and nurses) were asked to help determine why these infections were occurring. Bloodstream infections resulting from intravenous catheters result when a catheter is inserted (for vascular access) with bacteria on it. Generally, the bacteria is on the catheter from a missed step in the catheter process which prevents contamination. The steps that were not always being followed were: doctors washing their hands and donning protective wear, patients not being washed with antiseptic or fully draped, and insertion sites not being covered with sterile dressing after the catheter is inserted.

As a solution, a checklist was created that outlined the six steps of catheter insertion. (The outline, Cause Map, process map, solutions, and checklist are shown on the downloadable PDF. To view it, click on “Download PDF” above.) The six steps included the cleanliness steps discussed above. Additionally, the medical professionals noticed that sometimes the procedures weren’t being followed because the necessary equipment was not available in the ICUs. Senior executives from the hospital were assigned to each unit, and were able to properly stock the ICUs. Additionally, the executives got Arrow International to manufacture central line kits that contained the necessary antiseptic and patient drapes.

The progress at Sinai-Grace has been remarkable, by joining all the necessary parties to an effective root cause analysis. Click on “Download PDF” to see what they did. (Read more in The New Yorker Annals of Medicine.)

Luckily, we don’t have to wait until an incident happens to us. We can instead perform a proactive root cause analysis, where we consider what COULD go wrong to result in an infant being discharged to the wrong person. A thorough root cause analysis built as a Cause Map can capture all of the causes in a simple, intuitive format that fits on one page.

For our very basic Cause Map, we can consider that two things have to happen in order for a infant to go home with the wrong family. First, the wrong baby has to be given to a family, and second, the matching system has to be ineffective. We’ll break each of these causes down into more detail.

The matching system may be ineffective because it isn’t being used. If a facility doesn’t have a matching system, it obviously won’t be effective. Additionally, if a computerized system is in use there is always the possibility that it won’t be working. Or the staff may not know how to use the system, possibly due to lack of training or insufficient staffing.

If the system is being used but not being checked, it won’t be effective. Again, this could be because the staff doesn’t know how to use the system, or it could just be that the discharge personnel forget.

The wrong baby could be given to a family if the matching system is on the wrong infant. (This is only likely to happen if the matching system is put on outside the delivery room.) Or, the wrong baby could be in a bassinet. This could happen if the baby is kept in an nursery and a nurse is transporting more than one baby..

It’s possible to add even more detail to this Cause Map as the analysis continues. As with any investigation the level of detail in the analysis is based on the impact of the incident on the organization’s overall goals. Once the Cause Map is complete, solutions can be brainstormed that match up with causes. The solutions are shown on the downloadable PDF.

Click on “Download PDF” above to download a PDF showing the Cause Map and Solutions.

Auto-programming provides an additional layer of safety than the stand-alone technologies and by streamlining the IV medication administration process, the potential for error would be reduced.

Lancaster identified a problem – in this case the problem is medication errors, of which 56% are estimated to be from improperly inserted intravenously (I.V.) medications.  Because of the potential for serious adverse patient health outcomes due to medication errors, Lancaster knew something had to be done.  Lancaster looked at the infusion pump programming process, and discovered it had 17 steps, many of them manually performed.  At each manually-controlled step in a process is an opportunity for human error, no matter how careful people are. 

By reducing the number of steps in a process, and by reducing the amount of human input required, the opportunity for human error is reduced.  In order to reduce this risk, Lancaster has implemented “fully auto-programmed smart infusion systems” .  The implementation of these systems has reduced the number of steps in the infusion pump programming process to 7 (from 17).  As a result, they have seen a greater than 90% reduction in reprogramming (or errors that were noticed and fixed).  This has surely led to a great reduction in I.V. medication administration errors.  In addition to the patient safety improvements, it has the added bonus of reducing the amount of time spent programming the pumps by 24.8%.  This also contributes to patient safety because it frees up nurses’ valuable time. 

Read more about the new infusion pump system.   Lancaster’s solution is just one way to solve the problem of medication errors.  However, by removing steps from a process, not only does it require less time of your most valuable asset (employees), it can reduce the possibility for error.

However, sometimes a combination of oversights can result in these checks being ineffective. This is especially true when there are patients of similar names, as happened in this particular case.

A patient (patient 1) was scheduled for a procedure in the EP lab. The EP lab called up to Patient 1′s floor, and were directed (incorrectly) to another floor by a person on the telephone. Although Patient 1 was on that floor, another patient with a similar name (patient 2) had been moved to another floor. The EP lab then directed Patient 2′s nurse to bring Patient 2 to the lab. The nurse brought Patient 2 to the lab, over her objections, despite the lack of information in Patient 2′s chart, or a signed consent form.

The various staff members at the EP lab did not verify the identity of the patient, either. However, they did notice the lack of consent form, and convinced Patient 2 to sign a consent form, for a procedure she did not need, was not scheduled for, and had opposed throughout the process.

Although the procedure was stopped partway through, when the true identity was realized, and there was no lasting injury to Patient 2, any procedure performed on the wrong patient has huge risk for patient safety.

On the downloadable PDF page, a simplified version of the process for taking patients to procedures is shown. The individual causes of the incident are identified in the Cause Map, and, where applicable, the process map. This example shows how a process map can be used to identify the various causes that led to an event.

A thorough root cause analysis built as a Cause Map can capture all of the causes in a simple, intuitive format that fits on one page. Even more detail can be added to this Cause Map as the analysis continues. As with any investigation the level of detail in the analysis is based on the impact of the incident on the organization’s overall goals.

Click on “Download PDF” above to download a PDF showing the Cause Map and Process Map.

To define your organization’s goals, try to imagine a perfect day for your organization.  For the healthcare industry, that perfect day doesn’t include anyone getting hurt or killed due to the actions (or lack of action) of the organization’s employees.  This is the patient safety goal.  Additionally, a perfect day would not include any injuries or deaths of employees.  This is the employee safety goal.

Additionally, most industries have a goal of not impacting the environment.  However, a healthcare industry may have a base level of environmental impact, such as a standard amount of hazardous waste disposal or an appropriate number of x-rays.  In this case, your goal might be to not surpass that level rather than having no impact.  This is the environmental goal.  Environmental impacts usually result from leaks or spills of any material other than water, but may also result from improper storage or disposal of hazardous material.  Misuse of diagnostic equipment such as radiographs may result in an environmental impact. 

The medical and insurance industries have defined some events that should not happen on a perfect day.  The Joint Commission has its list of “never events” which are events that should never happen, and Medicare has a list of “hospital acquired conditions” which are conditions caused or worsened by medical provider actions for which Medicare will no longer reimburse.  This is the regulatory or compliance goal.

A healthcare organization exists to provide services to its patients.  If patients are not receiving appropriate services in a reasonable amount of time, this impacts the patient services goal. 

Another area of concern for almost all organizations is cost.  An incident that results in additional costs to the organization impacts the material and labor goal.  If an incident results in many costs, it’s possible to itemize them within the problem outline.  Quantifying all the costs associated with an incident can help prioritize which incidents require the most immediate attention.  It also provides a bound for the cost of solutions – installing a $100,000 machine to solve an infrequent $20,000 problem doesn’t make sense.  (Of course, for incidents that involve impacts that can’t be easily quantified – human safety, regulatory requirements, patient services, etc.  – these impacts must be considered above and beyond the “cost” of the incident.)

Once you’ve determined all of the goals that are meaningful to your organization, you’re ready to make an outline for the first step of the Cause Mapping method of root cause analysis – define the problem.  But what order do you put the goals in?  Generally, the goals go in order from most to least important.  The safety goal is almost always at the top.  Your organization’s mission statement is an excellent resource to determine the order of the goals.  Ideally, they’ll follow along with your mission statement, with any goals not specifically called out (such as the “material and labor” goal) listed below.  It’s also possible to use a different order so that the biggest impacts from an incident are listed at the top.  However, your organization may prefer to always use the same order for consistency. 

If an incident resulted in no impact to one of your organization’s goals, don’t delete the goal from the problem outline.  Instead, write “N/A” next to the goal.  That way, it’s clear that the goal was considered but it was determined that there was no impact.  Deleting the goal may lead others to believe that it’s no longer a goal of the organization!  Shown below is a standard outline for a healthcare organization. 

ThinkReliability has specialists who can solve all types of problems. We investigate errors, defects, failures, losses, outages and incidents in a wide variety of industries.  Visit our website to find out more about our investigation services and root cause analysis training.

Although there was no risk of patient death due to this medical error, it is the fifth wrong site surgery to happen at this teaching hospital in two years. Rhode Island Hospital was previously fined $50,000 for three prior wrong-site surgeries. The Rhode Island Health Department fined the hospital $150,000 for the latest incident and is requiring the hospital to install cameras in its operating room.

Although some of the details of the surgical error are unknown, it is known that rather than marking the individual fingers that were supposed to be operated on, the patient’s wrists were marked. Additionally, it was not the operating surgeon who did the markings. The operating team also did not hold a “timeout”, which is used to make sure the operating team has the right patient, right location and right surgery, before performing the second surgery. (In particularly disturbing news, after the error was noticed and the family consented to performing the operation on the correct finger, there was again no “timeout”.)

The downloadable PDF shows the outline of the problem and a very basic Cause Map. (Click on “Download PDF” above.) As more details emerge during the investigation, they can be added to the Cause Map. Once the Cause Map is completed to a level of detail commensurate with the impact to the organization’s goals, solutions can be found to mitigate the future risk.

Want to learn more?

See how else wrong-site surgeries could occur in our proactive Cause Map.

Read the news article.

However, in other circumstances where a woman has discovered she is carrying a stranger’s baby, the baby has been aborted.  Although very few women have been implanted with stranger’s embryos, the consequences of such a mistake are drastic.  Because of these consequences, fertility clinics must ensure that their procedures involve checks, double checks, and are followed by every employee in a clinic. 

All people make mistakes, which is why oversight is so necessary for procedures that can lead to disastrous consequences.  In the medical field, this is why effective procedures that are followed to the letter are so important.  There have been no details released in what exactly went wrong to lead to a woman being implanted with another family’s embryo.  However, it’s certain that the fertility clinic will be forced to review its procedures, to make sure that this never happens again.

So, here we have two potential impacts to the goals. First, the public safety goal is impacted because of the potential that the public won’t be able to be effectively treated. This might occur if medical facilities are overwhelmed, by both patients who require treatment and patients who do not require treatment coming to the facilities. Patients who do not require treatment may come to the facilities because they are not certain if they require care.

The patient safety goal is impacted because patients might contract the swine flu. This could occur when patients go to a medical facility and there are patients there who have swine flu. The patients might go to the medical facility if they believe they have swine flu and are uncertain if they require medical care.

These causes are shown in the Cause Map above. Any cause on the cause map can have a solution; however, in this case there is one cause common to both impacts to the goals. Thus, mitigating this cause reduces the impacts to both goals. But how do we help patients determine whether or not they need medical care? Microsoft Corporation, along with doctors from Emory University, have developed a swine flu on-line questionnaire that can help you determine whether you require medical treatment. Hopefully this tool can help keep some patients who don’t require treatment out of medical facilities, and from contracting swine flu if they didn’t already have it.

Databases that track these sorts of prescriptions have been implemented in most states to curb access to large amounts of the most frequently abused drugs.  However, since the programs are state-run, patients could still get multiple prescriptions by crossing state lines.  Also, in some states it may take as long as two weeks before a new prescription shows up in a database, creating extra time for addicts to collect prescriptions. 

This is an example of a case where a solution has been implemented, but it  hasn’t reduced the risk to an acceptable level (as evidenced by the thousands of people still dying from prescription drug overdoses).  So, the solution is being tweaked.  The federal government has provided funding to states to upgrade their databases.  It’s hoped that this will start to decrease the number of deaths from prescription drug abuse.  If it doesn’t, even more drastic action will be needed.

In our case, a patient was prepped for a surgery he didn’t need, even receiving spinal anesthesia. He was prepped for a procedure based on the advice of an orthopedist, who believed the patient to have an ankle trimalleolar fracture, which he did not.

Why did the orthopedist believe the patient to have a fracture? The radiologist who had reviewed the patient’s radiographs diagnosed the fracture. The orthopedist did not review the radiographs. The orthopedist did examine the patient’s ankle, but gained no new insight into the diagnosis. Additionally, the family/patient did not mention the previous diagnosis, possibly because they weren’t told of it, or didn’t understand it..

The radiologist diagnosed the fracture because there was a fracture shown on the radiographs, which were labeled with the patient’s name. However, it was later determined that the radiographs were actually of a previous imaging client. The radiographs were taken because the patient’s previous radiographs did not arrive in time.

Given no more information about this case, our analysis stops here. However, the next step for the medical facility involved would be to examine the radiography procedures to ensure that mislabeling incidents do not occur. Other causes listed in the map can also be examined, to determine where other improvements can be made.

Even more detail can be added to this Cause Map as the analysis continues. As with any investigation the level of detail in the analysis is based on the impact of the incident on the organization’s overall goals..

1)  a heat source – typically in the operating room the heat source is provided by electrical surgical equipment. 

2) oxygen - patients under anesthesia may be receiving 100% oxygen, providing an extremely oxygen-rich environment for fires. 

3) fuel – the disposable synthetic fabrics primarily used now are more flammable than cloth drapes.

Since all three of these causes are required for a fire, removing any one of the causes will prevent a fire.  However, in an operating room environment it’s not practical to remove any one of these causes, so instead we can work on reducing the risk by mitigating the effect of each of these causes.  To reduce the risk from the heat source, surgeons are warned to leave electrical tools in standby mode, or turned off, whenever they are not in use.  To reduce the concentration of oxygen in the air, anesthetists may be asked to provide only as much oxygen as needed for the patient, and avoid creating places that oxygen may concentrate, such as under the drapes.  More flame-resistant material is being considered for use in some operating rooms.  Additionally, more and more operating room teams are providing training in preventing and extinguishing surgical fires, because although only an extremely small percentage of surgeries result in fire, the results can be catastrophic.

Obesity can result in a greater risk of disease (more than 90% of overweight children have at least one avoidable factor for heart disease.) This is an impact to the health goal of a community, and the nation. Obesity is the result of sustained weight gain. Weight gain is a simple balance problem. If calories consumed are greater than calories expended, as a result of too many calories consumed, too few expended, or both, weight gain will result. Usually obesity is caused by both.

First we’ll look at the causes of consuming too many calories. Too many calories are consumed when children eat high-calorie, low-satisfaction foods. In many cases, this is because a child has access to these types of foods and because healthy choices are not available. This is true with family, and at school, which generally contribute equally to caloric intake. A high proportion of foods consumed at school may be unhealthy; schools must offer healthier choices. Some schools have done away with soda and candy, but more healthy choices must also be offered. Students bringing their own lunches may suffer doubly from healthy food not being available at home, due to a lack of access or affordability. The all-too-many areas in the country that do not have access to healthy food at supermarkets or farmer’s markets are known as “nutritional deserts”, most frequently found in low-income and/or rural areas. Communities must improve access to healthy food, at school and at home.

The other part of the equation is calories consumed, otherwise known as exercise. However, children don’t need time on the treadmill; they need safe places to play outdoors or a safe route to walk or bike to school in order to get exercise. They also need physical education (PE) at school, and they need to see the importance of physical activity (something their parents may not be modeling at home, based on adult obesity rates, which are extremely high as well). Low-income and/or rural areas are less likely to have safe places to play outdoors, or a safe way for children to bike/walk to school, so these children are disproportionately affected by obesity. Communities must provide an outlet for physical activity for children.

On the downloadable PDF (download by clicking “Download PDF” above), we show the causes and solutions in a Cause Map, a simple intuitive format that fits on one page. The causes are solutions shown here are from the perspective of the community – causes and solutions that can be controlled by a community. If communities began implementing these solutions, the childhood obesity epidemic would be a thing of the past.

Want to learn more? See the Institute of Medicine report, issued in 2007.

“We have to also make promises that this won’t happen again and get patients and families engaged in the effort to improve our performance.”

The University of Illinois Medical Center, along with other medical facilities, has made great efforts to communicated with grieving family members after medical mistakes, and getting those family members involved with helping prevent future mistakes.

One of the changes implemented requires an x-ray of patients at risk for foreign objects retained after surgery. So far, the x-rays have found 8 foreign objects found left in patients , despite a manual count that claimed all the sponges were accounted for.

Some experts worry that the “increased candor” with families may increase the number of lawsuits. Dr. McDonald says that, though the number of procedures at the University of Illinois Medical Center have increased 23% since the program was implemented, the number of lawsuits has decreased 40%.

To many family members of victims of medical errors, it’s not about the money; it’s about making sure nobody else will suffer from the same mistake. Allowing these family members (or the victims themselves) to help improve the processes that led to the errors may ease their concerns. (View the news article in the Wall Street Journal.)

We can look at impacts to the goals to determine why a solution that’s successfully implemented to solve a problem at one location or organization may not be the right solution for another organization. In a hospital, a loss of power could impact the goals pretty severely – the risk of death to the patients impacts the safety goal, the loss of life-saving equipment impacts the customer service goal. Additionally, the production goal may be impacted because the facility is unable to enter new patients. Last but not least, an additional cost (impact to the materials/labor goal) may be incurred transferring patients to a new facility. Obviously the risk of death means a HUGE impact to the organization’s goals, demanding comprehensive reliability solutions.

Compare this to an office building, such as where our administrative offices would be. If a loss of power occurred, the goals would be impacted – employees could get injured leaving the building if the lights went out. This is an impact to the safety goal. We may lose our business function during the outage, which would be an impact to the customer service and production goals. Additionally, we may have to pay our employees for a non-work day. The goals are impacted, but the severity of the impacts pales compared to the impacts of a hospital or medical facility losing power.

If we create a Cause Map based on these impacts to the goals, it shows that all the impacts to the goals tie back to a loss of electrical power, caused by both a power outage AND a lack of back-up electricity source. (The Outline and Cause Map are shown on the downloadable PDF.)

When determining solutions, there are a few that come to mind, including transferring patients to another healthcare facility (which becomes an impact to the goals) and installing battery backups in equipment. However, because of the severe impacts to the goals, a hospital will likely decide that the whole problem can be solved by installing an emergency generator. Problem solved; we have been able to find the best solution.

The administrative offices may feel differently. The cost of installing an emergency generator is large, and if we compare that cost to the costs that would be incurred due to a loss of power without backup, it’s probably not worth it. Instead, the office building may implement solutions further to the left on the Cause Map, such as installing emergency lighting, or using battery backups, that would mitigate (but not prevent) the impacts to the goals. So, just because a solution was the “right” solution in one case, it may not be in every case.

View the Outlines and Cause Maps for both the hospital and office building by clicking “Download PDF” above.

View the Joint Commission’s article on Power System Failures.

Performing surgery on the wrong body part or wrong-site surgery is a “never event” as defined by the National Qualify Forum (NQF), and can have serious health consequences for a patient.

We can use a Cause Map to determine some ways to prevent wrong-site surgery. Some of the common errors leading to wrong site surgeries are presented in the Cause Map found on the downloadable PDF. They include: time pressure, lack of paperwork, misreading radiography, not marking or incorrectly marking the surgical site, and marking the wrong site.

Once the root cause analysis is complete, solutions are brainstormed and placed with the cause they control. In this example, we use the solutions to create a basic Process Map for the surgical preparation procedure to prevent wrong site surgeries. The solutions are numbered based on the order they appear on the Process Map. It’s clear that consistent adherence to this Process Map would result in fewer wrong-site surgeries.

Click on “Download PDF” above to download a PDF showing the Cause Map and Process Map.

Go to Root Cause Analysis Healthcare Home Page

In order to work at preventing these conditions, first we must examine how they occur. We’ll do this by looking at Catheter-Associated Urinary Tract Infections in a visual root cause analysis (or Cause Map).

A UTI is an impact to our patient safety goal. A UTI is caused by pathogens accessing the urinary tract and not being removed. We will look at each of these causes in more detail. Pathogens access the urinary tract when a urinary catheter is inserted. The catheter may be used for obtaining urine, because a patient is incontinent, or to permit urinary drainage.

In order for pathogens to access the urinary tract on a catheter, there must be pathogens on or in the catheter. These can be pathogens already in the body, contamination from the drainage system, or pathogens transferred on the hands of medical personnel, or by a non-sterile insertion.

The pathogens are not removed from the body either because of an insufficient immune response caused by damage to the urinary tract by improper insertion or improper securing of the catheter. Or, the pathogens are not excreted due to an obstructed urinary flow.

Once we have determined the basic causes of a UTI from our simple root cause analysis, we can consider solutions associated with the causes. For example, if a cause is “Pathogens on hands of medical personnel”, a solution may be to require “Handwashing before and after manipulation of catheter site or apparatus.”

Click on “Download PDF” below to see the Cause Map and possible solutions. If facilities began implementing some or all of these solutions, the incidence of Catheter-Associated UTIs would decrease, and patient health and satisfaction would increase.

“Experts estimate that a staggering 98,000 people die from preventable medical errors each year”

“A federal Centers for Disease Control and Prevention study concluded that 99,000 patients a year succumb to hospital-acquired infections. Almost all of those deaths, experts say, also are preventable.”

Not only do almost 200,000 people a year die from preventable errors or infections acquired in hospitals, but, according to expert federal analysts, the rate of these deaths may actually be increasing.  Part of the problem is that the recommendations provided by experts, federal and private studies and various other resources are not being implemented quickly – or at all.

Some people think that the root cause analysis investigation process ends when solutions are recommended.  In fact, the hardest part may be just beginning.  There’s a reason we refer to solutions as “action items” – they require action.  They also require follow-up.

Proper follow-up will determine if solutions are being effectively implemented, i.e. the problem is being solved.  In this case, that would be the number of medical errors are decreasing.  Since that’s not happening, the next step is to determine why the action items were ineffective.  Right now, the recommended action items aren’t effective because they aren’t being implemented.

An organization can only effectively implement solutions that are within its sphere of influence.  Medicare, for example, is attempting to influence medical errors by using its most effective weapon – its pocketbook.  Medicare is no longer reimbursing for certain medical errors, and hopes to add to the list.  As many private insurers follow suit, more healthcare facilities will find it necessary to change the way they do business . . . and then hopefully the medical error rate will begin to decrease.

Learn more about finding solutions.

Since there are currently no equally effective replacement drugs or a vaccine for malaria, an increase in the drug-resistance of malaria may increase the number of deaths from malaria. In 2006, malaria was responsible for nearly 1 million deaths, according to the World Health Organization (WHO).

A Cause Map built using a root cause analysis template can visually explain the causes leading to drug-resistant malaria in a simple, intuitive format that fits on one page. (To view the Cause Map, click on “Download PDF” above.)

A risk in the increase in deaths from malaria is caused by people being infected by malaria, and ineffective malaria treatment. Nearly 250 million people a year are infected with malaria, due to exposure to mosquitoes in an endemic area, no vaccine and no preventive drugs (which are expensive and can have side effects with long-term use). Ineffective malaria treatment can be due to counterfeit drugs, which are estimated by WHO to comprise up to 40% of the drug supply. Counterfeit drug distribution is increasing due to a lack of security of the drug supply.

Additionally, the increase in drug-resistant malaria means that existing treatments are less effective. (Counterfeit medicines are a double whammy in that they also contribute to drug resistance.) Drug resistance generally occurs when an infected person takes a not-quite-whole course of treatment. The treatment kills off most of the bugs, leaving only those strong enough to resist. When these “super” bugs then reproduce, the resulting generations are more likely to be drug resistant. (This is what’s been happening in the U.S. with some antibiotics.)

The most effective (and WHO recommended) course for malaria is the combination therapy discussed above. Unfortunately, the mefloquine class of drugs have severe adverse side effects, including nausea, vomiting, and nightmares. When the two medications are given separately, some people chose not to take all (or any) of the mefloquine to avoid these side effects. A possible solution is to only offer the two together, in a combination pill.

The WHO and other organizations continue to work on this problem. An experiment in Europe recently used weakened mosquitoes