Rabies From Donated Kidney Kills Recipient

By ThinkReliability Staff

A kidney donation recipient died in February, 2013.  It was determined that his death was due to rabies – specifically rabies that had been transferred with the donated kidney during the transplant in September 2011.  Although infectious disease transmission through transplant – especially rabies – is rare, there is benefit in visually diagramming a root cause analysis of this event in a Cause Map.   A Cause Map begins with the specific impacts to an organization’s goals resulting from an incident, and shows the cause-and-effect relationships that led to those impacts.

In this case, the patient safety goal was impacted due to the recipient death.  The receipt of organs infected with a disease such as rabies is an impact to the patient services goal.  Three other recipients also received organs from the same donor but have not shown symptoms of rabies.    Their treatment is an impact to the property and labor goals, due to the cost, time and inconvenience of those treatments.

The impacted goals form the first cause-and-effect relationship in our Cause Map.  We ask “Why” questions to determine other cause-and-effect relationships.  In this case, the donor death was due to rabies.  The donor was infected with rabies from an infected transplanted organ, and was not treated for rabies.  The recipient was not treated for rabies as the symptoms did not emerge until a year after the transplant (rabies can have a long incubation period).  The donor organs were infected with rabies from an unknown cause, though rabies usually results from contact with wild animals (specifically, this strain of rabies appears to be from a raccoon).   The transplant medical team was unaware that the donor had rabies.

Though the donor had encephalitis, it was thought that it was due to a food-borne illness.  (Detail on how the diagnosis was obtained has not been released.)  While there is testing for certain diseases performed on donor organs, due to the time constraints on the viability of the organ, testing for rabies is not generally performed.  However, new guidance from the Disease Transmission Advisory Committee (put out after this donation occurred) urges caution in use of organs from donors with encephalitis, perhaps including more robust testing for specific illnesses, or using only certain organs.

Due to an acute shortage of viable donated organs, some believe that organs from disease-positive donors should be used, and treatment started immediately.  With many in need of transplants dying on the waiting list, this may be a more practical approach, though there are certainly concerns about transmitting diseased organs to those who are already very ill, and who will be taking immune suppressing drugs to prevent rejection of transplanted organs, making them more susceptible to such diseases.

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

Read our previous blog about a recipient who died of lung cancer after receiving the lungs of a heavy smoker

US Stockpiles Smallpox Medicine, Fear of Bioterrorism

By Kim Smiley

The last case of smallpox in the United States occurred in 1949, but the government recently made headlines for spending $463 million on enough medicine to treat two million people infected with the disease.  It is feared that the deadly and disfiguring disease could be used by bioterrorists and the government wanted to be prepared in the event of an attack.

The concern that smallpox could be used for bioterrorism can be analyzed by building a Cause Map, a visual root cause analysis.  The first step is to fill in an Outline with the background information for the problem and determine which goals are impacted.  In this example, the safety goal is impacted because there is a chance of many deaths if smallpox is released, the financial goal is impacted because hundreds of millions of dollars were spent on treatment for smallpox and the customer service goal is impacted because people are nervous about the potential for smallpox bioterrorism.  Once the impacts to the goals are determined, the Cause Map is built by asking “why” questions.

Why is there a potential for many deaths?  This is true because there is the potential that a smallpox outbreak could happen, many are unprotected against smallpox, and smallpox is a very deadly, highly contagious disease.  An outbreak could occur if bioterrorists released smallpox because the virus still exists in research labs in the US and Russia.  Advances in the genetic field have also opened the possibility that the smallpox virus could be  re-engineered and essentially created in a lab anywhere in the world.   Many people are unprotected against smallpox because the vaccination program ended in 1980 when it was eradicated.  People vaccinated prior to 1980 likely maintain some level of protection from smallpox, but the effectiveness of the vaccine degrades over time and they are no longer fully protected.  Smallpox is a very dangerous disease because it has fatality rate of about 30% and many survivors are left blind or disfigured.  It’s also very contagious and can be spread without direct contact because it can be transmitted via aerosolized droplets from saliva and other body fluids.

The financial goal is also worth considering.  Hundreds of millions of dollars have been spent to prepare for a potential smallpox attack.  The government has long stockpiled smallpox vaccines in the event they were needed, but the move to buy medicine to treat the disease is fairly recent and substantially more expensive than just buying vaccines.  This option has only recently been a possibility because there was no treatment for smallpox until now.  A private company developed antiviral medicine to treat smallpox in the hope that it would be profitable.

Developing solutions to problems that might occur is always tricky and likely to cause debate.  There are many reasons why a smallpox bioterrorism attack is frightening, but how much money should the US government spend to prepare for an attack?    How much preparation is enough?  There is no simple answer, but it’s important to understand these types of problems to the best of our ability to help make well thought out and reasonable decisions.

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




Cases of Deadly ‘Superbugs’ on the Rise in US

By Kim Smiley

A new antibiotic resistant strain of bacteria is causing deaths and raising flags in US healthcare facilities. The bacteria is called Carbapenem-Resistant Enterobacteriaceae, often shortened to CRE, and is named for its ability to resist carbapenem antibiotics, the last resort treatment for antibiotic resistant bacteria. The fatality rate for those infected may be as high as 50 percent. In 2012, 4 percent of hospitals reported cases of CRE, up from about 1 percent a decade ago. The situation at long-term care hospitals is significantly worse, with 18 percent reporting cases last year.

The issue of CRE can be analyzed by building a Cause Map, a visual method for performing a root cause analysis. The first step is to create an Outline that documents all the background information for an issue. How the problem impacts the overall organization goals is also listed on the bottom of the Outline. In this example, the safety goal is obviously impacted since there have been patient deaths. After the Outline is completed, the second step is to build the Cause Map. The Cause Map is built by asking “why” questions to determine what causes contributed to the issue and then arranging the causes visually to show cause-and-effect relationships. Why have there been patient deaths?  This has occurred because they were infected with CRE and CRE infections are dangerous.

People are being exposed to CRE primarily in healthcare settings. CRE is being passed between patients within the same facility and between healthcare facilities as infected patients are transferred to different healthcare settings. Exposure is occurring between patients because infected patients may not be identified or adequately isolated. Many healthcare facilities do not have the capability to test for CRE and it’s also difficult to identify who should be tested since some patients who carry the bacteria are not symptomatic. CRE also tends to infect individuals who have other health issues and weakened immune systems. Treatment of the other issues may involve invasive medical devices, such as catheters, that can provide a pathway for infection into the body.

CRE infections are dangerous because they have a high rate of fatality, up to 50 percent according to the CDC, and they are difficult to treat. CRE are resistant to virtually all antibiotics. This strain of bacteria is also particularly worrying because they can transfer their resistance to other bacteria within their family, compounding the problem. Antibiotic resistant bacteria have developed over the years because of the wide use of antibiotics. Each time antibiotics are used, bacteria have a chance to evolve and they have over the years.

The final step in the Cause Mapping process is to find solutions that would reduce the risk of the problem in the future. In this example, there isn’t an easy solution. There are no promising new antibiotics in development at this time that would likely be able to treat CRE infections so the best hope is to prevent the bacteria from spreading. The CDC has recommended steps such as identifying and isolating infected patients.

This example also show important it is to track the effectiveness of solutions after they are implemented because there can be unintended consequences that show up later on. Antibiotics have saved thousands of lives, but they are becoming less effective as bacteria develop resistance to them. New solutions will be needed to prevent or fight these types of infections in the future. Cause Mapping is a useful tool to document evolving issues because they can easily be adjusted and added to as new information is available.

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