Root Cause Analysis

High Heels May Increase Risk of Strains

By Kim Smiley

A new study found that habitually wearing high heels changes the biomechanics of how a woman walks and may increase the likelihood of strains, even when the heels are off.  The research compared young women who had worn high heels at least 40 hours a week for a minimum of two years with women who never or rarely wore heels.  Their walks were studied by using motion-capture reflective markers and electrodes to track leg-muscle activity.  The lengths of the muscle fibers in their legs were measured by ultrasound probes.

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.

Root Cause Analysis

Serious Side Effects From Low Dose Aspirin

By Kim Smiley

A recent study determined that the risks associated with regular use of low dose aspirin may outweigh the benefits for many patients. The researchers determined that regular aspirin users were 10 percent less likely to have a heart event and 20 percent less likely to have a nonfatal heart attack.  These statistics sound good except that regular aspirin users are also around 30 percent more likely to have serious gastrointestinal (GI) bleeding.  The overall risk of death was the same for both patients who regularly used aspirin and those who did not.

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.

Root Cause Analysis

Study Finds Only 1 in 7 medical errors reported

By ThinkReliability Staff

A study by the Office of the Inspector General (OIG) of the Department of Health and Human Services found that hospital employees are only reporting fourteen percent of all medical errors.  Additionally, the study determined that processes are rarely changed to help prevent similar errors in the future.

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.

Root Cause Analysis

Concerns over Faulty Implants

By Kim Smiley

Thousands of women received faulty breast implants between 2001 and 2010.  These implants contain substandard silicone, not approved for medical use, and are also rupturing at a usually high rate.  It isn’t clear at this time what the long term health risks associated with these implants might be.  The faulty implants were manufactured in France, but eighty percent were exported so the wide spread nature of the problem also complicates the implementation of any possible solutions. (These implants were not sold in the US.)

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.

Root Cause Analysis

Drug Used to Treat Diabetes May Increase Risk of Heart Disease

By ThinkReliability Staff

Since rosiglitazone was approved for use in controlling blood sugar in Type 2 diabetics who did not have success with front line treatments in 1999, studies have shown that this drug (included in trade name drugs Avandia, Avandamet and Avaglim) increases the risk of heart disease in users.  This is of particular concern because most Type 2 diabetics die from heart disease.  It is estimated that 60,000 to 200,000 people have suffered from heart disease due to these drugs.

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.

Root Cause Analysis

Alarm-Related Ventilator Deaths

By ThinkReliability Staff

Although The Joint Commission dropped alarm safety as a patient safety goal in 2005 (a year after setting it as a goal), recent reviews by the US Food and Drug Administration and the ECRI Institute have noted concerns with alarm-associated ventilator deaths.  We can look at the issue of alarm-related ventilator deaths in a Cause Map, or visual root cause analysis, to see some of the causes related to these deaths, and some plans to reduce them.

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.

Hospital Acquired Condition

Facial Burns from Surgical Fires

By ThinkReliability Staff

At least two patients received burns to the face from surgical fires in early December 2011.  Surgical fires are becoming an increasing risk to patients (and staff) in the operating room.  Although the 550-650 surgical fires a year that are estimated to occur by the ECRI Institute is a small percentage of patients undergoing surgery, this doesn’t make surgical fires seem “rare” to those who are affected.

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)

Root Cause Analysis

Surgical Tools Cleaned with Hydraulic Fluid

By Kim Smiley

In late 2004, a healthcare system in North Carolina realized that it had been using elevator hydraulic fluid instead of cleaning detergent when cleaning its surgical tools.  Before the problem was realized, the improperly cleaned tools were used on 3,650 patients.  An analysis by infection control, material and toxicology experts determined that the sterilization process of the tools was not affected and that trace metals left on the tools from the hydraulic fluid were in too small of amounts to cause risk to patients.  Nonetheless, the potential for these safety risks is an impact to the patient safety goal.  Additionally, the fact that improperly cleaned tools were used on patients is an impact to the patient services goal.  Lastly, the re-cleaning and sterilization required for the tools is an impact to the labor goal.

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.

Root Cause Analysis

Bacterial Contamination of Tampons

By ThinkReliability Staff

On November 9, 2011, the FDA announced a recall of a certain subset of tampons for contamination with the bacteria Enterobacter sakazakii.  The recall is for certain products delivered to certain stores, mainly in the central U.S. Region.  For a full list of the product  recalls, check the FDA recall site.

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.

Root Cause Analysis

America’s Food Deserts

By Kim Smiley

A food desert is a community that lacks adequate access to healthy, nutritious food because they don’t have sufficient stores that sell these items at an affordable price, such as a supermarket. Both isolated rural areas and low income urban neighborhoods are typical locations where a food desert might exist in the United States.  In these locations, residents typically must rely on the food that is available nearby, usually small convenience stores and fast food restaurants.  Smaller convenience type stores generally don’t offer a variety of fresh food and vegetables and the prices are typically higher.  Many times the result is a less healthy diet and the potential health problems that go along with it.

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.