Monthly Archives: August 2012

Root Cause Analysis

Donated Kidney Trashed

By ThinkReliability Staff

On August 10, 2012, a living donor’s kidney was thrown out, instead of being transplanted as planned.  The incident was chalked up to “human error”, which is almost certainly part of the problem . . . but definitely not all of it.

This extremely rare, but serious, event is being analyzed by several oversight agencies, as well as a contractor hired by the medical center in Ohio where the event took place, to ensure that needed improvements are identified and put into place so this type of incident doesn’t happen again.  We can examine the currently known information in a visual root cause analysis, or Cause Map.  To do so, we begin with the impacted goals.

There are many goals that were impacted as a result of this error.  Firstly, the patient safety goal was impacted because the patient did not receive the transplanted kidney.  This can also be considered an impact to the patient services goal.  Three personnel from the hospital were placed on administrative leave as a result of the incident.  This results in an impact to employees.  The compliance goal is impacted because this event has resulted in a review by several oversight agencies.  The living kidney donor program is currently shut down for review, which can be considered an impact to the organization goal.  The kidney was disposed of improperly, which is an impact to the environmental goal.  (Medical waste has strict requirements for disposal.)   The loss of the donated kidney can be considered an impact to the property goal.  Personnel time was taken both to attempt to resuscitate the kidney and to participate in an independent review of the donor program.  These can both be considered impacts to the labor/time goal.

Once we have determined the impacts to the goals, we can ask “Why” questions to develop the cause-and-effect relationships that led to these impacts.  In this case, the patient did not receive a kidney transplant because the kidney was thrown out and because of concern about the kidney’s viability.  Part of this concern was the delay in actually finding the kidney, likely due to the fact that it was disposed of improperly.  The reason given by the medical center for the disposal of the kidney is “human error”.  However, there is ordinarily a support system involved in organ transplants that would minimize these types of errors.  Certainly the fact that the program has been stopped and three employees – at least one of whom was not directly involved in the transplant operation – were placed on administrative leave suggest that the organization is looking at more than just a screw-up by one person acting alone.

Specifically, the investigation should look at communication – was the nurse who disposed of the organ told it was destined for transplant?  Was there a surgical time-out immediately prior to the removal with the entire operating team that discussed the plan for the kidney?  Also the training and preparation of the surgical team should be investigated.  Had the team been properly trained and prepped for this type of surgery?  The fact that it was done frequently at this facility doesn’t mean that adequate training was in place.  What about the procedure for treatment and supervision of donated organs?  Donated organs have to be treated in a very particular way to ensure their viability for the transplant patient.  Who, if anyone, was responsible for ensuring that the organ was prepared in a proper way for transplant?  Were they involved in the surgical time-out?  Lastly, because an error was made with the disposal procedure, the procedure, training and communication regarding disposal of medical waste needs to be analyzed to ensure it is adequate. The hope is that by doing a thorough review – and improvement – of policies, procedures, training and communication at the facility, it will not only reduce the risk of this type of error, but provide improvement in many other aspects of the care provided as well.

To view the Outline and Cause Map, please click “Download PDF” above.

Root Cause Analysis

Possible Link Between Antibiotics and Obesity

By Kim Smiley

A study recently published in the International Journal of Obesity found that infants given antibiotics before six months of age were 22 % more likely to be overweight between the ages of 10 months and 3 years.  Researchers believe this may be because the natural balance of bacteria in their digestive tracts is altered by the antibiotics.

Obesity has long been assumed to be a matter of too much food into the body while too few calories are burned, but new studies. including the recent one finding a link between use of antibiotics early in life and body weight later in childhood,  are suggesting that the issue may be more complicated than it appears on the surface.

Scientists are still studying how bacteria in human digestive tracts affect how the body processes food, but many researchers believe that the balance of bacteria plays a role in how the body absorbs calories.  The amount of calories that a body absorbs from the same amount of identical food may not be a constant.  More studies are needed to understand the relationship between bacteria in the gut and body weight, but studies done so far are intriguing.

The link between antibiotics and higher body mass remained even when researchers controlled for factors such as what the baby ate, the weight of a baby’s parents, whether the mother smoked while pregnant, and the family’s socioeconomic status.  Researchers did note that the study found an association and not a cause-effect link and that further studies are needed, but there seems to be a relationship between how antibiotics affect the body and body mass.

More research is needed to fully understand this issue, but this study is an interesting step to better understanding the causes of childhood obesity.  On the downloadable PDF, we have created a Cause Map, or visual root cause analysis, to show the possible cause-and-effect relationships between use of antibotics in early enfancy and childhood obesity.

In this specific study used to build this example, the researchers were quick to point out that infants should be given antibiotics if they are needed, but it’s important to understand how the medication may be affecting bodies, especially very young bodies.

To view a Cause Map of this issue, click on “Download PDF”.

Root Cause Analysis

At Least 31 Patients Contracted Hepatitis C

by Kim Smiley

Testing is still ongoing, but at least 31 people have contracted hepatitis C from contaminated syringes at a New Hampshire cardiac catheterization lab.  A previous blog discussed the outbreak when it was initially announced that four patients who had used the same cardiac catheterization lab had tested positive for the same strain of hepatitis C, but more information has been released and the Cause Map should be updated to incorporate all the relevant details.  One of the strengths of a Cause Map, a visual root cause analysis, is that it can be updated relatively quickly to document important information as it becomes available.  In this example, investigators are continuing to work to understand the issues involved, but two new significant pieces of information should be added to the Cause Map.

The source of the hepatitis C has been determined by investigators.  Investigators found that a medical technician with hepatitis C contaminated syringes that were then used on patients.  The medical technician is a drug addict who used the syringes because they were filled with Fentanyl, an anesthetic far more powerful than morphine.  Hepatitis C is spread through blood to blood contact so syringes contained with hepatitis C are a major health hazard that are capable of spreading the disease. The syringes were not secured so he was able to attain them.  He then used them, refilled them with saline or another liquid and replaced them without any other member of the staff noticing.

Investigators have also learned that the medical technician responsible for the contamination has worked in 18 hospitals in seven other states during the last 10 years.  It’s not known when the medical technician contracted hepatitis C, but investigators believe he had a positive test for hepatitis C in June 2010.  This means that the investigation needs to be expanded and that many more people may need to be tested.

This article contains information about what facilities the medical technician worked at and the timeline for his employment.  To view an updated high level “Cause Map”, click here.

Root Cause Analysis

Consumption of Small Cigars Increases

By Kim Smiley

A study by the CDC has found a decrease in cigarette smoking, but a corresponding increase in the use of other tobacco products.  Cigarette smoking declined 33% between 2000 and 2011 which would be cause for celebration except for the fact that use of other kinds of tobacco grew by 123%.  This seems to be an example of unintended consequences where the attempt to control one problem changed behavior in an unexpected way.

A Cause Map, or visual root cause analysis, can be used to help explain this situation.  Building a Cause Map can illuminate the cause-and-effect relationships between the different factors that contributed to an incident.  To begin a Cause Map, the impacts to organizational goals are determined and then “why” questions are asked to add Causes.  In this example, we’ll focus on the increase in the use of small cigars since they are the tobacco alternative most similar to cigarettes.  We’ll also focus on the Safety Goal since public health is affected by the increasing use of small cigars, although there are certainly other issues such as missed tax revenue worth considering in a more detailed Cause map.

Why is the risk to public health increasing?  This occurs because more people are using small cigars and they have similar health risks to cigarettes because they contain the same toxic chemicals.  Why are more people using small cigars?  Small cigars smoke similarly to cigarettes, are far cheaper than cigarettes and can taste better.

Small cigars are slightly larger than cigarettes, but are similar enough in size to provide a similar smoking experience.  They are far less expensive than cigarettes because they are in a different tax category because of their slightly larger size and the fact that not all tobacco products are equally taxed.  The price difference is significant; small cigars may cost as little as $1.40 a pack while cigarettes sell for $4 or $5 a pack since they are highly taxed to discourage smoking.

Cigars can also taste better because manufacturers are allowed to add flavorings such as grape and chocolate to small cigars, but they are not allowed to add them to cigarettes.  The Food and Drug Administration has regulations that bar adding flavoring to tobacco, but these do not apply to cigars and pipe tobacco.

From 2010 to 2011, the overall use of smoked-tobacco decreased by less than 1%.
It appears that attempts to discourage smoking cigarettes with high taxes just pushed some people into buying cheaper alternatives.  One potential solution to this issue would be to equalize the taxes and regulations on all types of tobacco.

To view a high level Cause Map of this example, click on “Download PDF” above.

Root Cause Analysis

DC Searches for Solutions to Slow the HIV Epidemic

By Kim Smiley

Washington DC is trying some new methods to help fight the AIDS epidemic.  DC has long had one of the highest rates of HIV infection in the United States, but there is hope that these new techniques might change that fact.

This issue can be built into a Cause Map, a visual root cause analysis.  A Cause Map shows the relationship because the causes that contribute to an issue and can also show how potential solutions would impact those causes.  To view a high level Cause Map of this issue, click on “Download PDF” above.

The focus of DC’s fight against HIV is treatment, which seems to be the key to controlling the HIV infection rate.  While researchers are still searching for a cure, simply treating people infected with HIV has the potential to dramatically slow down the epidemic.  HIV positive patients who consistently take their drugs lower their chances of infecting others by 96% because the amount of virus in their bloodstream is significantly lower.

The first step in treating infected people is to identify who is infected.  Testing is also important because the earlier patients can be identified; the more effective treatment is typically.  Washington DC has increased testing efforts in order to identify the estimated 5,000 people who live in the DC area and are unaware that they are infected.  People are now being paid to get tested and HIV tests are being offered in a number of new locations such as grocery stores, high schools, on corners where addicts gather, and at the DMV.  There are also efforts to focus testing on the highest risk populations by paying for referrals and social network tracing.

The next area of difficulty is getting patients consistent treatment.  Only 29% of people diagnosed in DC take their drugs every day, which is about average for an American city.  Washington DC is working to track HIV patients, who are typically more transient than the rest of the population and to help get treatment to as many people as possible.

Another cause of the AIDS epidemic that Washington DC is working to improve is to slow the spread of the virus itself.  Typical transmission routes for HIV are unprotected sex and use of dirty needles.  Last year, five million male and female condoms were given away in the DC area.  There were also more than 300,000 clean needles given away.

These innovative new programs seem to be having a positive impact on the epidemic. New cases have fallen to 835 from 1,103 in 2006.  The number of AIDS test administered has greatly increased.  Only time will tell how effective these solutions have been at slowing down the HIV epidemic in the nation’s capital.