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.

Root Cause Analysis

Number of Gout Cases Continues to Increase

By Kim Smiley

Gout was historically known as “the disease of kings” or “rich man’s disease” and has long been associated with rich food and excessive alcohol, but recently gout has become a common problem across all socio-economic classes.  More than six million adults in the US have gout and the number will likely keep rising in the future.

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

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

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

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

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

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.

Root Cause Analysis

Hungover Surgeons More Likely to Err

By ThinkReliability Staff

The headline probably isn’t shocking to anyone who’s woken up the next morning with a pounding headache and dry mouth.  Clearly one’s performance at work is going to be impacted by a night of unabated drinking.  However a recent Irish study, published this month in the Archives of Surgery, show surprising results regarding the lingering effect of alcohol consumption.  Their findings show that well into the day surgeons are more likely to make mistakes.

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

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

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

Root Cause Analysis

Reducing Stillbirth Rates Worldwide

By ThinkReliability Staff

Stillbirth is the loss of a pregnancy after 22 weeks gestation.  Around 2.6 million stillbirths occur every year around the world, primarily in developing countries.  However, the kind of attention being addressed to other issues in the developing world has not been focused on stillbirth, leading the rates of stillbirth to decrease more slowly than other death rates.  In an attempt to draw more attention to this issue – with its profound impact on the family and community – the Lancet has published a series of articles on stillbirth, addressing some of the impacts, causes, and a plan to reduce the number of stillbirths in half by 2020.

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

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

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

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

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

Root Cause Analysis

Increased Cost of Drug May Increase Potential for Pre-Term Labor

By Kim Smiley

In 2003, a study by the National Institutes of Health determined that administering hydroxyprogesterone caproate (also known as17P) could reduce the risk of preterm delivery.  Preterm delivery can cause many health issues for infants.  However, there was no commercial source of 17P, so pharmacies compounded it upon request for $10-$20 an injection.  Injections are generally taken starting at weeks 16-24 of pregnancy for up to 20 weeks.

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

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

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