All posts by Kim Smiley

Mechanical engineer, consultant and blogger for ThinkReliability, obsessive reader and big believer in lifelong learning
Root Cause Analysis

Impure Injections Used

By Kim Smiley

Research is been suspended at a prominent brain-imaging center associated with Columbia University. Food and Drug Administration investigations found that the Kreitchman PET (positron emission tomography) Center has injected mental patients with drugs that contained potentially harmful impurities repeatedly over the past four years.

Investigations by the lab determined that no patients were harmed from the impurities, but this is still a significant issue in a nationally renown laboratory.

How did this happen?

This issue can be investigated by building a root cause analysis as a Cause Map. To start a Cause Map, the impact to the organization goals is determined. In this example, this issue is obviously an impact to safety because there was potential to harm patients. It is also an impact to the production-schedule goal because research has been suspended. Additionally, this problem is an impact to the customer service goal because this issue raises questions about the validity of research results.

To build a Cause Map, select one goal and start asking “why” questions to add causes. In this case, the first goal considered will be the safety goal. There was a potential for injury. Why? Because impure injections were given to patients. Why? Because the injections are necessary for research, because the labs typically prepare the compounds themselves and because the lab prepared the compounds incorrectly. When there is more than one causes that contributed, the causes are added vertically with an “and” between them.

Each impacted goal needs to eventually connect to the same Cause Map. If they do not, the impacted goal may not be caused by the same problem and the goals should be revisited.

To continue building the Cause Map, keep asking “why” questions for each added cause until the level of detail is sufficient.

A Cause Map can be as high level or as detailed as needed. The more significant the impact to the goals, the more likely a detailed Cause Map will be warranted. Once the Cause Map is completed, it can be used to develop solutions to help prevent the problem from reoccurring.

In this example, the lab is currently changing management and reorganizing procedures to help prevent the similar problems in the future.

To view an initial Cause Map for this issue, please click the “Download PDF” button above.

Root Cause Analysis

The Downside of Preparedness?

By Kim Smiley

The U.S. Government has announced that 40 million doses of swine flu vaccine have expired and must be disposed of.   In addition, 30 million more doses are about to expire and will also be disposed of (unless there is a sudden need for swine flu vaccine).  The vaccine doses are worth $260-$450 million.  We can capture this information in a problem definition outline.

Then the question is: is this a bad thing (a problem) or a good thing (a success)?  Like a lot of things, it doesn’t necessarily have to be one or the other.  There’s an aspect of success – swine flu did NOT turn out to be a deadly global epidemic, as was predicted – and an aspect of failure – up to $450 million of vaccines were tossed out.

The question that remains for the analysis is: how do we maximize the successes (preventing epidemics) and minimize the not-so-good stuff (wasting vaccines and money)?  A detailed root cause analysis can draw out the successes and problems associated with any event, including this one.  We can use it to look at the planning process used for an epidemic to look for places where the estimation of the need for vaccines can be improved.  We can even look at the use of and expiration dates of the vaccine to determine if, in the future, a backup plan might allow us to get some secondary use out of the vaccines.  Opportunities for improvement are limited only by the brainstorming capability of your organization!

Root Cause

Woman Gives Birth to Stranger’s Baby!

By Kim Smiley

Unfortunately, this isn’t a tabloid story.  On September 24, 2009, a woman named Carolyn Savage gave birth to a healthy baby boy.  However, the baby boy was not biologically hers.  The fertility clinic that the Savages had used had implanted a stranger’s embryo.  The Savages decided to carry the baby to term and then give him up to his biological parents.  (See the news story.)

However, in other circumstances where a woman has discovered she is carrying a stranger’s baby, the baby has been aborted.  Although very few women have been implanted with stranger’s embryos, the consequences of such a mistake are drastic.  Because of these consequences, fertility clinics must ensure that their procedures involve checks, double checks, and are followed by every employee in a clinic.

All people make mistakes, which is why oversight is so necessary for procedures that can lead to disastrous consequences.  In the medical field, this is why effective procedures that are followed to the letter are so important.  There have been no details released in what exactly went wrong to lead to a woman being implanted with another family’s embryo.  However, it’s certain that the fertility clinic will be forced to review its procedures, to make sure that this never happens again.

Root Cause

A prescription to end unintentional drug poisoning

By Kim Smiley

According to the CDC, drug poisoning is now the second leading cause of unintentional death, after car crashes.  Most of the drug poisoning deaths result from the abuse of illegal and prescription drugs.  If we look at an extremely basic cause-and-effect for overdose of prescription drugs, we note that a patient overdoses (takes too many pills) for some situationally-dependent reason (such as increasing the amount of medication to provide additional benefit, as can occur with painkiller addiction) AND access to an increased amount of the medication.  Many times the access to the medication is provided by “doctor-shopping”, where a patient sees multiple doctors for painkiller prescriptions. 

Databases that track these sorts of prescriptions have been implemented in most states to curb access to large amounts of the most frequently abused drugs.  However, since the programs are state-run, patients could still get multiple prescriptions by crossing state lines.  Also, in some states it may take as long as two weeks before a new prescription shows up in a database, creating extra time for addicts to collect prescriptions.

This is an example of a case where a solution has been implemented, but it  hasn’t reduced the risk to an acceptable level (as evidenced by the thousands of people still dying from prescription drug overdoses).  So, the solution is being tweaked.  The federal government has provided funding to states to upgrade their databases.  It’s hoped that this will start to decrease the number of deaths from prescription drug abuse.  If it doesn’t, even more drastic action will be needed.

Root Cause Analysis

Childhood Obesity – A Community Problem

By Kim Smiley

It takes a village to raise a child . . .and to keep one from becoming obese. Childhood obesity is now being recognized as, at least partially, a community problem with community-based solutions. At the peak of the “obesity epidemic”, 32% of children in the U.S. were classified as overweight and 16% were classified as obese.

Obesity can result in a greater risk of disease (more than 90% of overweight children have at least one avoidable factor for heart disease.) This is an impact to the health goal of a community, and the nation. Obesity is the result of sustained weight gain. Weight gain is a simple balance problem. If calories consumed are greater than calories expended, as a result of too many calories consumed, too few expended, or both, weight gain will result. Usually obesity is caused by both.

First we’ll look at the causes of consuming too many calories. Too many calories are consumed when children eat high-calorie, low-satisfaction foods. In many cases, this is because a child has access to these types of foods and because healthy choices are not available. This is true with family, and at school, which generally contribute equally to caloric intake. A high proportion of foods consumed at school may be unhealthy; schools must offer healthier choices. Some schools have done away with soda and candy, but more healthy choices must also be offered. Students bringing their own lunches may suffer doubly from healthy food not being available at home, due to a lack of access or affordability. The all-too-many areas in the country that do not have access to healthy food at supermarkets or farmer’s markets are known as “nutritional deserts”, most frequently found in low-income and/or rural areas. Communities must improve access to healthy food, at school and at home.

The other part of the equation is calories consumed, otherwise known as exercise. However, children don’t need time on the treadmill; they need safe places to play outdoors or a safe route to walk or bike to school in order to get exercise. They also need physical education (PE) at school, and they need to see the importance of physical activity (something their parents may not be modeling at home, based on adult obesity rates, which are extremely high as well). Low-income and/or rural areas are less likely to have safe places to play outdoors, or a safe way for children to bike/walk to school, so these children are disproportionately affected by obesity. Communities must provide an outlet for physical activity for children.

On the downloadable PDF (download by clicking “Download PDF” above), we show the causes and solutions in a Cause Map, a simple intuitive format that fits on one page. The causes are solutions shown here are from the perspective of the community – causes and solutions that can be controlled by a community. If communities began implementing these solutions, the childhood obesity epidemic would be a thing of the past.

Want to learn more? See the Institute of Medicine report, issued in 2007.