Category Archives: Root Cause Analysis

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 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.

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.

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

Hospital Acquired Condition, Root Cause Analysis

Tackling a Seemingly Insurmountable Problem

By ThinkReliability Staff

The goal of any root cause analysis is to uncover causes and, most importantly, solutions that will reduce the risk or mitigate the effects of the problem being studied. However, sometimes a problem seems insurmountable. Take rising health care costs. There are myriad causes that contribute to increasing health care costs. Many of the solutions that have been identified are costly, difficult, or both. Additionally, some solutions place the onus on patients, which can limit the effectiveness. Although patients presumably would love to reduce their health care costs, most don’t have the resources to do so.

Although rising healthcare costs is a national issue, some of the problems you face at an organization may seem just as insurmountable. What can be done when an issue appears too big to fix?

First, ensure that you limit your analysis and potential solutions to your own sphere of influence. Although patients individually reducing obesity and taking their medications properly and on time would certainly reduce healthcare risks, those steps must be taken by the individuals. As a healthcare organization though, it is possible to take steps to increase the probability that individuals will take these steps. Generally patient education, automated reminders, and making it easier to do the right thing – by including clearer instructions on prescriptions or offering more fresh fruit in the hospital cafeteria – are steps that can be taken that are within the realm of an organization’s sphere of influence. Attempting to control solutions outside your sphere of influence is an exercise in frustration!

Next, focus on a single piece of the pie. Not all the causes identified during a root cause analysis have to be tackled at once. A great way to get started: find a solution that is nearly free and can be implemented fairly transparently to staff. For example, ask providers to hand out a healthy eating brochure to patients as they leave their appointment. Is this going to make a big impact? Probably not, but it’s somewhere to start. And even a little impact can help.

Or, take a note from Camden, New Jersey. In Camden, 1% of patients are responsible for 30% of medical costs. Jeffrey Brenner, a local physician, is making a difference reducing costs by focusing on those few patients. This is the big “bang for your buck” solution. And, the solutions that work for this 1% will probably help reduce costs for the other 99% as well. By focusing on a small number of patients – determining the causes specific to them and tailor-making solutions – headway is being made against an extremely difficult problem. (Read more at: http://www.newyorker.com/online/blogs/newsdesk/2011/01/atul-gawande-super-utilizers.html)

If you’re feeling overwhelmed, try taking one step at a time. If healthcare costs can be tackled by looking at a small part of the problem, what can your organization do with a focused look at solutions?

Root Cause Analysis

Contaminated IV Bags Sicken 19

By Kim Smiley

With the aid of the State Health Department and the Centers for Disease Control and Prevention (CDC), six hospitals have traced back recent patient infections to contamination in total parenteral nutrition (TNP) delivered via intravenous (IV) bags.

Although the first infection occurred in January, 2011, a pattern was not established until March, 2011, after nineteen patients were infected with serratia marcescens bacteria.  Patient infection is an impact to the patient safety goal.

The infections occurred as a result of the patients being given contaminated product – in this case, the IV bags.  The bags were recalled, and are no longer in production.  Ten of the patients died.  Investigators have said they won’t be able to determine whether the infection caused the deaths because the patients were already very ill (TNP is used for patients who are too ill to eat on their own).

The IV bags were compounded at a local pharmacy.  There was a potential for contamination in the raw material used for compounding, during the compounding at the pharmacy, or at the hospital.  Because six different hospitals experienced the same rare bacterial contamination, it is unlikely that the contamination occurred at the hospital.

According to Dr. Alexander J. Kallen, a medical officer with the Centers for Disease Control and Prevention, “Historically, what we’ve seen is a breakdown in the manufacturing process.”  The investigation is underway to determine if the contamination was caused by an issue with the manufacturing process, an issue with the sterility of equipment, or a contamination of the raw material.  As the investigation continues, more detail can be added to the Cause Map.  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.

While investigating an issue, it can also be helpful to look at the process for identifying and isolating issues, and implementing improvements.  In this case, after patients receive or use products, they are monitored for certain reactions.  If those reactions occur (such as those that indicate a bacterial infection), they are reported to the State Health Department, then the CDC.  The CDC investigates to determine the source of the infection and then pulls the affected products off the market.  Currently, the CDC has identified the product that is contaminated, though not the source of the contamination.

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.  To view the Cause and Process maps, click “Download PDF” above.