Tag Archives: cause mapping

Root Cause Analysis

Price of Daraprim jumped ~5,000%

By Kim Smiley

The cost of prescription drugs have been in the news the last several years as the United States struggles to deal with rising health care costs, but few stories have come close to generating as much outrage as the recent massive price increase of Daraprim.  As new specialty drugs hit the market, they are often expensive as drug companies recoup the costs of development and maximize profits while the drug is covered by patents, which may be frustrating but is understandable.  That is not what happened in the case of Daraprim, a lifesaving drug used as an antimalarial drug and to treat toxoplasmosis.  The medication has been around since the 1950s and isn’t covered by any patents.

So why has the price of Daraprim suddenly increased about 5,000 percent?  A Cause Map, or visual root cause analysis, can be used to intuitively show the causes that contributed to the issue.  (To view an outline and a High Level Cause Map, click on “Download PDF” above.) This is one of those issues where it may be tempting to identify the “root cause” or focus on a single cause that contributed to the issue, but there are many factors that need to be considered.  The piece of the puzzle that is probably the easiest to focus on is the fact that a new company bought the only company with regulatory approval to sell the drug in the United States and significantly raised the price.  Basically, there is demand for the drug and the company which has a monopoly on the supply in the US took advantage of it by increasing the price per pill from $13.50 to about $750.

The CEO of the company has been widely villainized for what many consider a predatory price increase, but it is important to remember that the Daraprim price increase was legal.  Many find the price increase distasteful, but there are currently no laws or regulations that prevent huge medication price increases, which is another cause that contributed to the issue.

While a generic version of the drug is available in many other countries for less than a dollar a pill, it cannot be sold in the US without going through a lengthy and expensive approval process. Possible solutions to prevent similar price increases in the future could be to create laws that limit price increases on drugs without patents on them or to increase the supply of medications sold in the US by allowing some sort of reciprocal approvals with countries that have strong regulatory systems in place.  A senate committee is requesting documents and information relating to the pricing of Daraprim and several other medications and there are lawmakers pushing to create legislation that would limit price hikes.

Another enterprising company seems to have found their own solution to the problem of the high cost of Daraprim – creating a cheaper alternative. Imprimis Pharmaceuticals has stated that they will produce a substitute drug that will be priced as low as $99 for a 100 pills.  The alternative drug isn’t a generic version of Daraprim, but rather a compounded drug that combines two FDA approved drugs (pyrimethamine, the only ingredient in Daraprim, and leucovorin) that are often used together.  The compounded drug would not be FDA approved, but doctors can prescribe it specifically for a patient based on the rules governing compounded medications.

It isn’t as elegant as having another FDA-approved supplier of Daraprim, but it seems like a viable work-around for many patients.  It also seems like satisfactory justice for the price of 60-year-old pyrimethamine drugs to end up cheaper in the US after they were hiked up to such high levels.

Root Cause Analysis

Lethal-Injection Drug Mix-up

By ThinkReliability Staff

On January 15, 2015, a prisoner was executed by lethal injection in Oklahoma. On October 8, the autopsy report, showed that prisoner had been injected with potassium acetate instead of potassium chloride as intended.

This was the first injection to take place in the state since a prisoner took 43 minutes to die after the drugs were administered in April 2014 (see our previous blog about this execution).  After that, further executions were stayed.

Just hours prior to the first execution scheduled since January, Department of Corrections personnel realized they were sent potassium acetate instead of potassium chloride and that execution was called off.  Shortly afterwards, an Oklahoma court granted an indefinite stay for the prisoners who were scheduled for execution.

While there is ongoing debate about whether the change adversely impacted the speed or humaneness of the execution, it certainly caused great concern about the ability of the state of Oklahoma to correctly perform an execution.  Says an attorney, “The state’s disclosure that it used potassium acetate instead of potassium chloride during the execution of Charles Warner yet again raises serious questions about the ability of the Oklahoma Department of Corrections to carry out executions.”

Along with the concern for ability to perform future executions, there is potential safety impact regarding the prisoner’s suffering, as well as the production impact resulting from the delay in future executions.  The ongoing investigation will also impact goals because of the resources required.  This investigation will attempt to determine how the wrong drugs were used in the execution.

In case of the execution scheduled for September, the wrong drug was placed in the syringe used to inject the prisoner, and there was an ineffective verification of the drugs.  It’s unclear whether there was an attempt at verification that the drugs being used were correct.  If there was such a check, verification may have been difficult because records show that the syringe was labeled potassium chloride (the desired drug).

Department of Corrections records also show that the state received potassium acetate instead of the desired potassium chloride.  It seems that the potassium acetate was accidentally delivered from the supplier (there doesn’t appear to be a need for potassium acetate).  According to the prisons director, the supplier believed that the drugs were interchangeable.  In general, the oversight of suppliers who provide lethal injection drugs is limited – many states refuse to disclose their suppliers and many suppliers are compounding pharmacies, which are subject to less regulation.

Oklahoma does have several different combinations and substitutions of drugs allowable for executions, but there is no approved substitute for potassium chloride.  This, and recent changes to suppliers because so many refuse to supply drugs for lethal injection, may have led to some confusion.

It’s likely that solutions, or changes to the execution protocol may not be discussed until after the investigation is complete.  A completely different type of execution may be considered: in April 2014 Oklahoma approved nitrogen gas the backup method for executions if lethal injection could not be used.  Based on all the recent issues and concerns, that new method may be under consideration.

Root Cause Analysis

Why You Will Experience a Diagnostic Error

By ThinkReliability Staff

On September 22, 2015, the Institute of Medicine released a report entitled “Improving Diagnosis in Health Care“. The report was the result of a request in 2013 by the Society to Improve Diagnosis in Medicine to the Institute of Medicine (IOM) to undertake a study on diagnostic error. The tasking to the committee formed by the IOM matched the three step problem-solving process: first, to define the problem by examining “the burden of harm and economic costs associated with diagnostic error”; second, to analyze the issue by evaluating diagnostic error; third, to provide recommendations as “action items for key stakeholders”.

The burden of harm determined to result from diagnostic errors is significant. Diagnostic errors are estimated to contribute to about 10% of hospital deaths, and 6-17% of hospital adverse events, clearly impacting patient safety. Not only patient safety is impacted, however. Diagnostic errors are the leading type of paid malpractice claims. They also impact patient services, leading to ineffective, delayed, or unnecessary treatment. This then impacts schedule and labor as additional treatment is typically required. The report found that, in a “conservative” estimate, 5% of adults who seek outpatient care in the United States experience a diagnostic error each year and determined that it is likely that everyone in the US will likely experience a meaningful diagnostic error in their lifetime.

The report also provided an analysis of issues within the diagnostic process (to learn more about the diagnostic process, see our previous blog) that can lead to diagnostic errors. Errors that occur at any step of the diagnostic process can lead to diagnostic errors. If a provider receives inaccurate or incomplete patient information, due to inadequate time or communication with a patient, compatibility issues with health information technology, or an ineffective physical exam, making a correct diagnosis will be difficult. Ineffective diagnostic testing or imaging, which can be caused by numerous errors during the process (detailed in the report). Diagnostic uncertainty or biases can also result in errors. However, not all errors are due to “human error”. The report asserts that diagnostic errors often occur because of errors in the health care system, including both systemic and communication errors.

When diagnostic errors do occur, they can be difficult to identify. The data on diagnostic errors is sparse due to both liability concerns as well as a lack of focus historically on diagnostic errors. In addition, there are few reliable measures for measuring diagnostic errors, and diagnostic errors can frequently only be definitely determined in retrospect.

The report identifies eight goals for improving diagnosis and reducing diagnostic errors that address these potential causes of diagnostic errors. These goals are presented as a call to action to health care professionals, organizations, patients and their families, as well as researchers and policy makers.

To view a high-level overview of the impacts to the goals, potential causes and recommendations related to diagnostic error presented in a Cause Map, or visual root cause analysis, click on “Download PDF” above. To learn more:

To read the report, click here.

For an overview of the diagnostic process, click here.

For an example of a diagnostic error with extensive public health impacts, click here.

Root Cause

Medical Device Vulnerable to Hacking

By Kim Smiley

The Food and Drug Administration (FDA) made headlines when they issued a warning that a computerized pump used for infusion therapy, Hospira Symbiq Infusion System, has cybersecurity vulnerabilities. Hacking is scary enough when talking about a laptop, but the stakes are much higher if someone had the ability to alter the dosage of critical medication.

A Cause Map, a visual format for performing root cause analysis, can be used to analyze this issue.  The first step in the Cause Mapping process is to fill in an Outline with the basic background information, including how the issue impacts the overall goals.  Defining the impacts to the goals helps define the scope of an issue.  Once the Outline is completed, one of the impacted goals is used as the starting point to building the Cause Map itself.  For example, the potential risk of serious injury or death is an impact to the patient safety goal and would be the first cause box on the Cause Map.  The rest of the Cause Map is built by asking “why” questions and documenting the answers in cause boxes to intuitively lay out the cause-and-effect relationships.

So why is there potential for injury or death with the use of the Hospira Symbiq Infusion System?  It is possible for a patient to receive the incorrect dosage of medication because the system could be accessed remotely by an unauthorized user who could theoretically change the settings.  There have been no reported cases where this infusion pump system has been hacked, but both Hospira and an independent researcher have confirmed that it is possible.

This system is vulnerable to hacking because it is designed to communicate with hospital networks and the design has a software bug that could allow it to be accessed remotely via a hospital’s network.  The infusion system was designed to interface with hospital networks to help reduce medication dosage errors because the dosage information wouldn’t need to be entered multiple times.

The final step in the Cause Mapping process is to develop solutions to help reduce the risk of similar errors in the future.  In this specific example, the FDA has strongly encouraged healthcare facilities to transition to alternative infusion systems as soon as possible.  Hospira discontinued this specific design of infusion system in 2013, reportedly due to unrelated issues, but it is still available for sale by third-party companies and used by many healthcare facilities. There will not be a software patch provided or any other means to make the Hospira Symbiq Infusion System less vulnerable to hacking so the only option going forward will be to switch to a different infusion system. During the time required to transition to new equipment, the FDA has provided specific steps that can be taken to reduce the risk of unauthorized system access that can be read here.

Root Cause

Attack on Hospital Staff Indicates Systematic Safety Issues

By ThinkReliability Staff

On July 13, 2015, a security counselor at a Minnesota psychiatric hospital was attacked and seriously injured by a patient. Even one injury to an employee is highly undesirable and should initiate a root cause analysis in order to reduce the risk of these types of events recurring. In the case of this hospital, this employee injury is one in a long line. In 2014, 101 staff injuries were reported at the hospital. From January to June of 2015, 68 staff injuries were reported. Clearly this is an extensive – and growing – problem at the site. According to Jennifer Munt, a spokeswoman for a union which represents 790 workers, “Workers at the security hospital feel like getting hurt has become part of the job description.”

An incident like this one can be captured within a Cause Map, or visual root cause analysis. The first step in the method is to define the problem in a problem outline. The problem outline captures the what, when and where of an incident, as well as the impact to the goals. Another important piece of information that is included is the frequency of similar events. Capturing the frequency helps provide the scope of the problem.

Understanding the details for one specific incident will likely reveal systematic issues that are impacting other similar incidents. That is definitely true in this case. Beginning with an impacted goal and asking “why” questions results in developing cause-and-effect relationships. Each cause that is determined to have contributed to an issue can lead to a possible solution. Each cause added to the Cause Map provides additional possible solutions, which, when implemented, can reduce the risk of future similar incidents.

In this case, we begin with the employee safety goal. An employee was seriously injured because of an assault by a patient at the hospital. The assault resulted from two causes, which were both required and so are joined with an “AND”. First, violent patients are housed at the facility. There were no other facilities available for the patient and the hospital is required to admit mentally ill county jail inmates because of a Minnesota law (known as the “48 hour rule” because of the time limit on admissions).

Second, clearly there was inadequate control of the patient. According to the union, limitations on the use of restraints, which are only allowed when a patient poses an “imminent risk”, mean that staff members feel that they cannot restrain patients until after they’ve been threatened – or assaulted. The union also says that inadequate staffing is leading to the increase in assaults. Specifically, union officials say at least 54 more staff members are required for the facility to be fully staffed.

The issues have caught the attention of state safety regulators and government. Multiple solutions have already been incorporated, including use of cameras, a separate admissions unit for new patients and protective equipment for staff. Additional staff is also being hired. The patient involved in the attack is isolated and under constant supervision. There’s no word yet on whether the use of mobile restraints, as requested by the union, will be allowed.

Says Jaime Tincher, Chief of Staff for Minnesota Governor Mark Dayton, “These are important first steps; however we will continue to assess what additional resources are needed to improve safety and treatment at this facility.” No less would be expected for ongoing issues that have such a significant impact on employee safety.

Root Cause

Cuba Eliminates Transmission of HIV from Mother to Child

By ThinkReliability Staff

On June 30, 2015, the World Health Organization (WHO) declared mother-to-child transmission (MTCT) of HIV in Cuba eliminated. Clearly, this is fantastic news. Says Dr. Margaret Chen, WHO Director-General, “Eliminating transmission of a virus is one of the greatest public health achievements possible. This is a major victory in our long fight against HIV and sexually transmitted infections, and an important step towards having an AIDS-free generation.” The fight against HIV continues, with a global target of less than 40,000 new child infections per year by 2015.   (In 2013, there were 240,000 children born with HIV worldwide.) It’s hoped that the progress made in Cuba can be extended to the rest of the world.

How did Cuba do it? Root cause analysis can be used to determine causes of positive impacts as well as negatives. Here we will use a Cause Map, or visual root cause analysis, to determine the causes that resulted in Cuba being declared free of MTCT of HIV. Instead of defining the “problem” in a problem outline, we will define the success using the same format. In this case, the elimination of transmission of HIV from mother to child is the success we’ll be looking at. This success impacts goals as well, though positively. The child safety goal is impacted because it is now very rare (only 2 in 2013) for children to receive HIV from their mothers. The maternal safety goal is impacted because mothers are receiving effective treatment for HIV. Other goals are impacted because of the decreased need for services for children who might otherwise have been infected with HIV.

Beginning with an impacted goal, we can ask Why questions. Why is it rare for children to receive HIV from their mothers? Because the risk of passing HIV from mother to child has been lessened. Why? Because when children are born to HIV-infected mothers, there is decreased exposure to infants from their mother’s bodily fluids, and both mothers and children are being treated effectively for HIV. Decreased exposure to bodily fluids has been accomplished by the use of Cesarean sections and substitution for breastfeeding. Effective HIV treatment results from awareness of the presence of HIV infection from testing performed by healthcare providers, seen as part of a five-year initiative that gave universal healthcare coverage and access. That same access allowed treatment for infected moms and their children with antiretrovirals.

Although this Cause Map is presented as a positive impact to the goals, it could also be presented as an analysis of the problem of HIV transmission from mother to child. The causes would be baby’s exposure to mom’s body fluids, and lack of effective treatment due to lack of knowledge of infection and/or lack of access. The solutions to that Cause Map are the causes presented here in the positive Cause Map. (For example, use of Cesarean sections and substitutions for breastfeeding are solutions to the cause of baby being exposed to mom’s body fluids.)

In order to receive validation from WHO of the elimination of MTCT of HIV, Cuba had to meet very specific indicators for a defined period of time. These indicators do not just measure the overall success of the program (impact indicators), but also measure the success of the initiatives meant to achieve those goals (process indicators). Impact indicators included reducing MTCT of HIV to less than 50 cases per 100,000 live births, less than 5% in breastfeeding populations, and less than 2% in non-breastfeeding populations for at least 1 year. Process indicators included more than 95% of all pregnant women receiving at least one antenatal visit, more than 95% of pregnant women knowing their HIV status, and more than 95% of HIV-positive pregnant women receiving antiretroviral drugs for at least 2 years.

With implementation of similar initiatives across the world, it is hoped that MTCT of HIV will continue to decrease rapidly.

To view the outline, Cause Map, and indicators, click on “Download PDF” above. Click here to read the release from the WHO.

Root Cause

U.S. Teen Dies from Plague

By Kim Smiley

Few people think of the plague as a present-day problem, but a teen boy died of the plague on June 8, 2015 in Colorado.  Officials believe he was bitten by a flea carrying the disease on his family’s farm although the exact source of exposure isn’t known. According to the Centers for Disease Control and Prevention, there are an average of seven cases of plague in the United States a year and a small percentage of these cases result in death.

A Cause Map, a visual root cause analysis, can be built to analyze this case and better understand how a patient died of the plague.  The first step in building a Cause Map is to fill in an Outline with the basic background information to define the issue.  The Outline includes a place to list the impacts to the goals resulting from an issue to help define the scope of the problem.  Focusing on the safety goal for this example, a death would be an obvious impact.  Next, “why” questions are used to build the Cause Map.

So why did the teen die from the plague?  There are two causes that contributed to his death; first, he was infected with the plague and second, he wasn’t treated for the plague.  When there are two causes that both contribute to an issue, both are listed vertically on the Cause Map and separated by an “and”.  So why was the patient exposed to the plague?  Officials believe that he was bitten by an infected flea.  The bacteria that causes plague lives in rodents and their fleas.  Investigators haven’t been able to identify which species of rodent was the culprit.

The teen wasn’t treated for plague because it wasn’t identified that he had the plague until it was too late.  All forms of plague can be successfully treated with antibiotics, but the window for treating the illness before it becomes life-threatening can be relatively short and plague can be difficult to identify.  It is suspected that this patient had septicemic plague which occurs when the plague bacteria enter the bloodstream directly.  Septicemic plague is caused by the same bacteria as the more common Bubonic plague, but the symptoms are different and more difficult to identify.  Rather than the telltale presence of swollen, discolored lymph nodes (also known as buboes) caused by the Bubonic plague, the main symptoms of the septicemic plague are fever, chills and abdominal pain which are very similar to the flu and other common illnesses.  In this heart-breaking case, the family of the teen understandably believed he had the flu and he wasn’t treated for the plague in time to prevent his death.

As alarming as this case is, it is important to note that plague cases in the United States are very rare and occur primarily in two regions – northern New Mexico, northern Arizona, and southern Colorado and California, southern Oregon and far western Nevada. If you are planning to enjoy the outdoors in one of these areas, just remember that the best way to prevent plague is to prevent flea bites.

Click on “Download PDF” above to see a Cause Map and Outline for this example.

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.