Tag Archives: patient safety

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.

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.

Root Cause Analysis

Working Towards Solutions for Medication Errors

By ThinkReliability Staff

It’s no surprise that we’ve written frequently about medication errors.  It is estimated that medication errors harm approximately 1.5 million people annually in the U.S.  We’ve outlined some of the many causes that contribute to medical errors at medical facilities, as well as some of the things that the public can do to reduce their risk of medication errors.

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.

Root Cause

Diagnosing Hearing Loss in Babies

By ThinkReliability Staff

All new parents wait to hear that first wail in the delivery room, followed by a quick counting of fingers and toes.  Satisfied with their healthy new baby and exhausted from delivery, few notice the battery of tests newborns face in their first few days of life.  Thanks to these tests, many serious problems can be detected and treated before they become life-threatening.

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.

Root Cause Analysis

Infants Exposed to Unnecessary Radiation

By ThinkReliability Staff

A recent New York Times article, X-Rays and Unshielded Infants, used an example of poor x-ray technique issues to highlight problems with the operation of radiation equipment in the medical industry.

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.

Root Cause Analysis

Protein in Donated Blood Causes Life-Threatening Allergy

By ThinkReliability Staff

Blood transfusions are fairly common, with 25 million blood component transfusions occurring per year.  Blood transfusions are also very safe. The risk of health concerns from blood component transfusions is extremely low.  Until recently, it was believed that all the concerns from transfused blood were being tested for and rooted out.  However, a new case presented in the New England Journal of Medicine has presented a new concern.

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.

Hospital Acquired Condition, Never Event

Preventing Central Line Infections

By ThinkReliability Staff

Central line infections, also called central line-associated bloodstream infections (CLASBI), can occur when a large tube is placed in a large vein in the neck, chest, groin or arms to give fluids, blood, or medications or to do certain medical tests quickly.  While they allow exceptional access to internal systems, Central Venous Catheters (CVC) also can cause thousands of patient deaths a year and add billions of dollars in healthcare costs.  However, these infections are entirely preventable.

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.

Never Event

Surgery Performed on Wrong Eye

By Kim Smiley

There are few medical errors scarier than a wrong site surgery.  The idea that you could go to sleep and wake up having had a procedure performed on the wrong body part is terrifying.  Unfortunately, this is exactly what happened to a family in Washington recently.

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.