Monthly Archives: June 2015

Root Cause

Multiple Potential Causes for Avian Flu Outbreak

By ThinkReliability Staff

An outbreak of avian influenza (flu) H5N2 centered around Iowa in the United States has resulted in nearly 47 million birds being killed in 21 states. There is a low risk that this outbreak could spread to humans as the 1996 avian flu did. The impacts on the poultry industry have been significant: the number of birds being killed has led to an increase in poultry prices. Says Phil Lempert, “We’ve lost 10 to 13 percent of the laying hens in this country, so we’re going to have this period of time where we have less birds and less eggs. That means higher prices.”

The financial impact isn’t limited to consumers. The United States Department of Agriculture (USDA) estimates it will spend more than $500 million fighting the outbreak. The impact on poultry producers is expected to be even higher. The USDA Animal and Plant Health Inspection Service (APHIS) is studying the outbreak and attempting to put into place measures that will reduce the spread of the outbreak. Finding the causes leading to the outbreak has proven to be challenging.

We can capture the information that is known in cause-and-effect relationships using a Cause Map to better understand what caused this outbreak. The first step in the Cause Mapping process is to fill in an Outline with basic background information, which includes listing how the overall goals are impacted by the issue. The Cause Map is than built by asking “why” questions to lay out the cause-and-effect relationships. In this example, the animal safety goal is impacted due to the deaths of nearly 47 million birds. These birds were killed because of an outbreak of avian flu. An outbreak results from an initial infection (believed to have been transmitted in this case to domestic flocks by wild birds) and the spread of the disease. Based on genetic analyses from APHIS, this outbreak appears to have multiple independent introductions within the outbreak area (i.e. the transmission from wild birds to domestic flocks happened in multiple locations).

According to their Epidemiologic and Other Analysis of HPAI-Affected Poultry Flocks: June 15, 2015 Report: “APHIS concludes that at present, there is not substantial or significant enough evidence to point to a specific pathway or pathways for the current spread of the virus. We have collected data on the characteristics and biosecurity measures of infected farms and studied wind and airborne viruses as possible causes of viral spread, and conducted a genetic analysis of the viruses detected in the United States.” This means that the cause or causes of the spread of the avian flu cannot be definitively determined due to lack of evidence. When an investigation has a lack of evidence, potential causes are included in the analysis with a question mark, indicating insufficient evidence.

In this case, avian flu was potentially spread by air, by wild birds, and by human movement. Data from APHIS research indicates that the virus has been able to spread on windy days up to a half mile. A solution under consideration is more advanced ventilation systems for poultry farms that would prevent transmission of disease from farm to farm. Previous outbreaks have indicated that wild birds can not only cause an initial infection, but can continue to spread the disease from flock to flock. This evidence supports this cause, but is not strong enough to rule out other causes so all should still be included on the Cause Map. Lastly, APHIS found inadequate biosecurity (primarily cleaning and disinfecting) measures on equipment and personnel that traveled from farm to farm, which could also potentially spread the disease.

The issues found with biosecurity are a particular concern. Says Michael T. Osterholm, the director of the Center for Infectious Disease Research and Policy at the University of Minnesota, “We used to think we had outstanding biosecurity in poultry. But, except for the outbreak in 1983, which was stopped quickly, we have never been tested before.”

Osterholm and other researchers say more research is needed to screen for viruses, and develop drugs and vaccines to ensure public safety. Although the virus has not yet been shown to infect humans, the Centers for Disease Control and Prevention has developed interim guidelines on testing and treatment. APHIS continues research on how to limit the spread and the USDA, in order to offer some relief on prices, has recently allowed poultry imports from the Netherlands.

To view a Cause Map, or root cause analysis presented in a visual cause-and-effect diagram, of the ongoing outbreak, please click “Download PDF” above.

Root Cause

Contamination found in NIH pharmacy

By Kim Smiley

The National Institutes of Health (NIH) has announced that production of drugs for use in clinical studies has been suspended after fungal contamination was found in two vials of product.  The exact source of the contamination has not been identified, but a recent Food and Drug Administration (FDA) inspection of the facility that prepares the contaminated product found multiple deficiencies, including issues with both the facility and work practices.

This issue can be analyzed by building a Cause Map, a visual root cause analysis that intuitively lays out the cause-and-effect relationships that contribute to an issue. The first step of the Cause Mapping process is to determine how an issue impacted the overall goals.  In this example, the safety goal is impacted because 6 patients were unknowingly given potentially contaminated drugs.  These patients received vials of product from the same batch as the 2 vials found to be contaminated prior to the contamination being identified.  None of the patients have shown signs of illnesses, but they will continue to be monitored. Additionally, the safety goal is impacted because some patients will knowingly be given potentially contaminated drugs.  These patients are due for treatment imminently with no alternative available and the risk of delayed treatment has been determined to be greater than the risk of using the products.  The schedule goal is also impacted as clinical trials are being delayed because the necessary medications aren’t available.

The next step is building the actual Cause Map by starting at one of the impacted goals and asking “why” questions.  So why were the drugs contaminated? It hasn’t been released what specifically lead to the fungal contamination and it may never be known, but the FDA found deficiencies within the facility that could lead to contamination. The inspectors observed workers working with sterile products with protective gear worn inappropriately so that skin and facial hair were exposed.  Issues with the facility itself was also noted, both in the design of sterile work spaces and in the cleanliness of the spaces.  Inspectors determined that the air handling system for the clean rooms wasn’t adequately designed to ensure physical separation from the other spaces.  Additionally, a filter was missing on the air handling system.  The problems with cleanliness of clean rooms included insects found in 2 of 5 clean room ceiling light bays.

The investigation into these issues is ongoing and officials are working to ensure the safety of all products.  As more information becomes available, it can easily be added to the Cause Map.  Once the specific problems with the work processes and facility have been determined, specific solutions can be implemented to address the many issues found by investigators. This problem is one that clearly doesn’t have “one root cause”, but rather many causes that contributed to the problem and more than one solution will be needed to reduce the risk of contamination to an acceptable level.

Root Cause

Care Home Residents Unable to Escape Fire

By ThinkReliability Staff

A tragic fire at a care home for residents dependent on caregivers occurred in Pingdingshan, China on the night of May 25, 2015. Of the 51 residents housed at the 130-bed care home, 38 were killed and 6 injured.

It is tempting to declare the fire as the “root cause” of the tragedy. However, doing so limits the analysis (and thus potential solutions) to only prevention of fires. While many potential improvements in fire prevention at this and other structures with high-risk occupants can be identified, it’s also important to identify solutions that increase the probability of occupants being able to successfully escape a fire.

To ensure that the investigation develops the broadest possible range of solutions, begin with the impact to the goals. In this case, the primary goal impacted was that of resident safety – 38 residents died and 6 were injured. Most residents were unable to escape, impacting the resident services goal. The care home was completely destroyed, impacting the property goal, and it was found to not meet standards, impacting the compliance goal.

Once we’ve determined the impact to the goals, we can develop a Cause Map, or a visual diagram of cause-and-effect relationships that led to the impacted goals. Beginning with one of the impacted goals (in this case the deaths and injuries), and asking “Why” questions develops the cause-and-effect relationships. In this case, the deaths were due to the severe fire at the care home. But that isn’t the only cause. After all, the fire occurred in a facility where 51 residents were (presumably) sleeping, and there were a few residents who were able to escape with their lives.

This means that the cause-and-effect relationship of “fire kills resident” is accurate, but not complete. The effect of the deaths resulted not only from the fire, but from the residents being unable to escape. This gives us two different lines of questioning and possible solutions.

A severe fire results from a fire being initiated and spreading. Heat, fuel and oxygen are required in order to initiate a fire. Oxygen is present in the atmosphere. As in most fires due to destruction of evidence, the heat (or ignition) source has not been identified, but the national work safety agency investigation did find “irregularities” in the electrical system, which could be a potential source. While the initial fuel source is not clear, the care home was constructed with highly flammable materials, which allowed the spread of the fire.

The residents in the care home were dependent on caregivers and so were generally unable to escape without help. Unfortunately help was in short supply. Although residents complained of a shortage of caregivers, it’s not clear how many caregivers were on duty at the time of the fire. Shortage of caregivers is a huge problem in China due to the large percentage of the population that is older, which resulted from the one child policy of previous generations. It’s estimated there are 200,000 caregivers for the elderly in China, and 10 million are needed. In addition, the national work safety agency investigation found that the escape routes in the care home were poorly designed, making it difficult for anyone to escape.

After the tragedy, Chinese Premier Li Keqiang called on others to “draw lessons from the accident, checking all potential safety hazards to avoid similar incidents.” To avoid deaths from fire, that involves not only reducing the risk of fire, but making sure all people, regardless of ability, are able to escape.

To view the analysis of this issue, click on “Download PDF” above. To read about an arson at a care home in Australia that killed 11 and spurred a law requiring installation of automatic sprinkler systems, click here.