Root Cause Analysis

Drug Shortages in the US

By Kim Smiley

The FDA has reported a record number of drug shortages in 2010 that is continuing to increase into 2011.  Some of the drugs included in this shortage are chemotherapy drugs.  Providers across the U.S. are reporting that the shortages may endanger patients if they are unable to receive the necessary drugs.  In some cases, drugs that are more expensive, less effective, or both are being used.  Or, patients are turning to the “grey market”, buying drugs of questionable safety that have, in most cases, been significantly marked up.  Additionally, because already approved drugs are needed for clinical trials, some clinical trials have been delayed, limiting the addition of new medications.

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.

Root Cause Analysis

Promising New Leukemia Treatment

By Kim Smiley

One of the best things about the Cause Mapping method of root cause analysis is its flexibility.  For instance, root cause analysis is often associated with fixing problems, but Cause Mapping is also well suited for use when something positive happens.  Why would you bother to analyze something that isn’t a “problem”? Understanding why positive outcomes occurred might help you reproduce the success in other situations.

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.

Root Cause Analysis

Heatstroke Deaths of Football Players

By Kim Smiley

A study released in 2010 shed some light on what seems like a high number of football players dying of heat-related deaths.  The study determined that the number of heat-related deaths have actually increased in recent years from less than two per year in the early 90s to nearly 3 currently.  The study outlined some of the causes for the increase.  We can look at these causes in a thorough root cause analysis built as a Cause Map.

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.

Root Cause Analysis

Working to Ensure Safe Assembly of Surgical Tools

By ThinkReliability Staff

A 2-month old was undergoing a cystoscopy to incise a ureterocele in the bladder.  During the endoscopic procedure, a resectoscope was used to remove the unwanted tissue.  However, during the operation part of the resectoscope slipped off, exposing a hook-shaped internal piece of the instrument.  Fortunately the patient was not injured; however the potential for injury was very real.  How did the medical instrument come apart?

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.

Root Cause

Interpretation of Electronic Fetal Heart Rate Monitoring

By ThinkReliability Staff

Electronic fetal heart rate monitoring (EFM) is used to determine fetal distress.  When fetal distress is indicated, intervention and/or early delivery are generally performed.  Because of this, EFM is performed frequently, even in low risk births.  However, EFM has a high rate of false positives, resulting in unnecessary surgical intervention, which can impact both patient safety and an organization’s goals, especially as the rate of cesarean sections continue to increase.  One of the causes for these high rates of false positives is the variable and inconsistent interpretation of EFM data.  This is in itself an impact to the patient services goal.

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.

Root Cause

Can Safety be Taken Too Far?

By Kim Smiley

Sometimes, what seems like a very simple, easy solution turns out to be much more complicated.  Unless a system is very well understood, implementing a solution can have unintended consequences.  Take for example, the changes made to playgrounds over the past couple of decades.  There was concern that children were being injured while playing, especially from falls from high playground equipment.  Removing any playground equipment that was deemed dangerous seemed like an obvious solution to this problem.

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.

Root Cause Analysis

The Price of Beauty?

By Kim Smiley

In recent years, keratin-based hair products have become increasingly popular.  They smooth hair and many rave over their effective de-frizzing abilities.  These products are expensive, but are consumers paying an even higher price for beautiful hair?

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.

Never Event

Infant Death Due to Sodium Chloride Overdose

By ThinkReliability Staff

On October 15, 2010, a 40-day old prematurely born infant died from a sodium chloride overdose at an Illinois hospital.  Because a computerized system was involved, this case has been noted as a harbinger for possible issues resulting from the use of computerized systems.  To learn more about what happened, we can look at the case in a visual root cause analysis, or Cause Map, to examine all the causes.

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

Root Cause Analysis

Skin Death Associated with Contaminated Cocaine

By Kim Smiley

Recently, increasing amounts of information has been released regarding patients suffering from tissue death (purpura) associated with use of cocaine “cut” (contaminated) with levamisole.  Levamisole is a veterinary anti-worming drug no longer used in humans because of adverse side effects (such as the tissue death described above and also its interference with the blood marrow’s ability to produce white blood cells, known as agranulocytosis).  The US Drug Enforcement Agency (DEA) reported in 2009 that 69% of cocaine was contaminated, a significant increase from previous years.

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.

Root Cause Analysis

The July Effect

By ThinkReliability Staff

No one ever looks forward to a trip to the hospital, and a new study suggests that you might be particularly wary during the coming weeks.  A new study shows a 10% spike in patient fatalities during the month of July.  Many in the medical profession have been aware of “the July Effect” anecdotally for years, but researchers in the University of California at San Diego study combed through over 62 million death certificates dating back to 1976 to prove its existence.

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.