Monthly Archives: June 2011

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.