Tag Archives: patient safety

FDA To Device Maker: Complaints Not Properly Investigated

By ThinkReliability Staff

The Food and Drug Administration (FDA) issued a warning letter – a possible precursor to regulatory action – to a manufacturer of pulse oximeters challenging its response to violations identified during a facility inspection in 2013.  Specifically it found that:

1) Complaints of device failures were not adequately investigated,

2) Investigation records did not include required information,

3) Procedures did not identify all potentially affected product, and

4) Causes of failures were not investigated.

The company’s response to the initial violations found during the FDA inspection was found to be unacceptable.  Some of the comments to the FDA regarding the violations were: “The reported event poses no risk to user or patient safety, therefore, no Corrective and Preventive Action required”, “The cable and sensor that were returned with the instrument were also investigated and no problem was found”, “Through the investigation process, it was determined that Masimo’s product did not malfunction”. To each of the violations, the company claimed that either no problem was found, or that the problem did not involve any failures of the pulse oximeters identified in the complaints.

This doesn’t ring true to Diana Zuckerman, the president of the National Center for Health Research.  She says, “It may well be that it’s a user error. But you have to investigate that and show that it’s a user error and not a device error… When a company refuses to respond in any way to the FDA other than to say that the FDA is wrong on every issue, that’s not very credible.  Especially when users made complaints that the company’s product put patients at risk.”

Included in the complaints are that the manufacturer’s pulse oximeters failed to alarm in a patient that died and that they resulted in burns on both an 11-month old and 33-year-old and a skin tear on another patient.  Complaints also indicated issues with consistency of readings and exposed wires at the connection points.  The failures are getting attention not only because FDA warning letters are fairly rare – this is the first such letter to the company in its 25-year history – but also because of the company head’s views on medical errors and funding of the nonprofit Patient Safety Movement Foundation.

Pulse oximeters are used to monitor a patient’s pulse and blood oxygen.  Abnormal readings can indicate a change in a patient’s condition which may require medical intervention.  If the device fails to function, it can lead to patient injury or even death.  Because the devices are intended for use in diagnosis, they are regulated by the FDA and have to conform with FDA practices.  If the violations identified by the FDA in the warning letter are not corrected, the company may face regulatory action.

For now, the company has not released its plans to ensure compliance with the FDA requirements.  The FDA is clearly looking at updates to the investigation process used to respond to customer complaints and ensuring that causes identified as part of those reviews result in changes to other processes, such as manufacturing and quality control.

To view an outline and analysis (in the form of a Cause Map, a visual form of root cause analysis) of the FDA’s findings, click on “Download PDF” above.

Patient With Ebola Sent Home From ER

By Kim Smiley

If you have been paying any attention to the news lately you have heard that a patient was diagnosed with Ebola in the United States for the first time.  The fact that the patient sought treatment at an emergency room (ER) and was sent home is particularly alarming and people are naturally very interested in how such a thing could happen.

The media has been flooded with breaking news about this case. In situations like this, keeping track of what information is current and reliable and what is already outdated or has been determined to be inaccurate can be a moving target.  A Cause Map, a visual format for performing a root cause analysis, can be useful in these situations as a way to document the available information.  A Cause Map visually lays out the causes that contributed to an issue in an intuitive format.  It is relatively easy to quickly expand a Cause Map as more information becomes available.

Generally, a Cause Map is built in an Excel workbook so old versions of the Cause Map can be easily saved as different tabs and that the evolution of the investigation isn’t lost.  Additionally, it’s easy to add evidence supporting each individual cause onto the Cause Map itself so that all relevant information is documented in one location and easily referenced.  There are often things that are being considered that may have played a role in a problem, but lack evidence to determine whether or not they are actually relevant to the investigation.  This situation can be documented on a Cause Map by listing the potential cause and adding a question mark to show that a cause is being considered, but that it needs more evidence.  If that cause is later determined to not have been a factor it can be crossed out to document that it has been considered so that no work is duplicated.

So what information is known at this point about the patient with Ebola who was sent home from the ER?  A man has been diagnosed with Ebola in Dallas, Texas.  Statements by friends and family indicate that he helped transport a sick woman prior to traveling to the US.  It’s not clear whether he knew that she had Ebola or not.  After being exposed to Ebola, he passed through the airport screening because he did not have a fever at that time and he did not indicate possible exposure on the required questionnaire.   He arrived in Dallas, Texas on September 20, 2014.

His family has stated that he started feeling ill on the 24th and he sought treatment at a hospital on September 26.  He was released with a prescription for antibiotics.  Ebola can be difficult to diagnose because the early symptoms, such as fever and muscle pains, are very nonspecific.  The only information the hospital would have had to indicate that patient might have Ebola is his travel history.  Statements by the hospital indicate that the patient told the nurse he had recently been in Liberia.  The travel history information doesn’t seem to have been known by physicians that treated the patient.  Initial statements by the hospital indicated that issues with electronic health records may have played a role in the confusion, but later released more information that modified their position.  Exactly how the risk of Ebola was missed isn’t clear and this portion of the Cause Map will need to be expanded as more information is available.

It is not shocking that an Ebola case would be diagnosed in the US with travelers still arriving from West Africa and the long incubation period.  As long as Ebola is still a problem in Africa, US hospitals could see more patients with Ebola and need to be prepared for the possibility.  But it is concerning that someone who had recently traveled from West Africa with a fever wouldn’t trigger any alarms at an ER.   Individuals with Ebola must be quickly identified and isolated In order to prevent the spread of the deadly disease and hospitals in the US need to ensure that no other potential Ebola patients fall through the cracks.

Click on “Download PDF” above to see an initial intermediate level Cause Map for this example.

Healthcare Worker with Active TB May Have Infected Infants

By ThinkReliability Staff

A healthcare worker may have exposed more than 751 infants and 55 coworkers to tuberculosis (TB), a potentially deadly disease, during the 11.5 months she worked with newborns in the nursery and post-partum unit.  The employee was found to have symptoms of active TB (the only kind that is contagious) in July 2014 and was tested on August 21, 2014.  Infants and coworkers who were in those units between September 1, 2013 and August 16, 2014 are potentially affected.

The impacts of the potential exposure are significant.  The goal of ensuring patient safety has been impacted because of the potential exposure of 751 infants (so far identified).  Additionally, the goal of ensuring employee safety has also been impacted as 55 coworkers are also potentially impacted (those already screened have not shown any signs of infectious tuberculosis).  Because of the close contact required to spread TB, the issue has not been identified as a public health threat.  Regulatory agencies are still interested – the hospital has been cited by the Department of State Health Services for issues relating at least in part to infection control that are “an immediate jeopardy to patient safety”.  (It wasn’t clear how or if these issues are directly related to the TB exposure but were found in an inspection that occurred as a result of it.) All the patients who have been exposed may potentially require a course of antibiotics, typically six to nine months.  Infants under six months are being given the course as a preventive measure.  This impacts the patient services goal.  All the screening and treatment is being provided by the hospital free of charge, which is an impact to the hospital’s labor and time goal.

Developing the cause-and-effect relationships that led to the goals that were impacted can provide clarity to the investigation and potential solutions.  Exposure to TB occurred when an employee with an active infection came to work and was potentially aided by the hospital’s infection control policies or procedures, which may not have been effective in preventing the spread of the disease.  It’s unclear how the employee contracted tuberculosis, but she was likely not vaccinated. Although a vaccine against tuberculosis exists, it’s rarely used in US.

A question raised by this issue is why the long period of time during which there was a potential exposure?  Tuberculosis can remain latent in the body for months or even years before turning into an active case.  (It is only contagious when active.)  The employee appears to have passed a routine annual health screening in July 2013 and started showing symptoms at or near her next annual health screening in July 2014.  However, she was not tested for the disease until August 21st and appears to have continued work until August 16th.  It’s unclear why the delay occurred, and the hospital will surely be looking to ways to minimize patient exposure to workers who may be sick.

The hospital is working with the Texas Department of State Health Services and the Centers for Disease Control and Prevention to screen and treat patients and other healthcare workers that came into contact with the infected worker based on employment and medical records in an extensive outreach campaign.  The employee has been placed on leave and is being treated.  The hospital is required to submit a corrective action plan to the Texas Department of State Health Services, which should identify corrective actions to issues raised as a result of the state’s inspection and by the Centers for Medicare & Medicaid Services.

To view the impacted goals, cause-and-effect relationships and potential solutions in a Cause Map, or visual root cause analysis, please click “Download PDF” above.  Or, click here to learn more.

Wrong Dye Injected into Spine During Surgery

By Kim Smiley

In the high stress, fast paced operating room environment, high consequence errors can and do happen, but the risk can be reduced by analyzing medical errors and improving standard work processes.  A recent case where a woman died unexpectedly after a routine procedure to insert a pump underneath her skin to administer medication offers many potentially useful lessons.  The wrong dye was injected into her spine during the surgery, which is the type of error that should be entirely preventable.

A Cause Map, or visual root cause analysis, can be used to analyze this issue.  To build a Cause Map, all causes that contribute to the issue are visually laid out to show the cause-and-effect relationships.  The general idea is to ask “why” questions to determine ALL the causes (plural) that contributed to the problem, and not focus the investigation on a single root cause because this allows a wider range of solutions to be considered.

So why did the wrong dye get injected into the patient?  The dye was injected because it was used during the surgery to verify the location of tubing that was threaded into the patient’s spine and the wrong dye was used.  The surgeon needed the dye to verify the location because the tubing was inserted during the surgery and it was difficult to see. The tubing was part of a pump that was being stitched under the patient’s skin to administer medication directly to the spine to treat symptoms from a back injury.  The patient had broken several vertebrae during a fall.

And now on to the meatier part of the discussion in regard to medical error prevention – why was the wrong dye used? The request for medication (dye) was given orally by the doctor to the nurse who passed it along to the pharmacy so it is possible that the pharmacist missed that the dye was intended for use in the spine.  The exact point where the work process breakdown occurred wasn’t clear in the media reports, but it is known that there were several checks in the process that failed for this type of error to occur.

Following this incident, the hospital did make changes in their work process to help reduce the likelihood of a similar error occurring.  The hospital now uses detailed written orders for medications except in emergencies when that isn’t possible.  The written order includes information about how the medication will be administered, which would have clarified that the dye was intended for use in the spine in this case.

Health Declines as Veterans Wait for VA Care

By ThinkReliability Staff

On September 5, 2014, a tragic story was released of a man who lost most of his nose due to spreading cancer.   When diagnosing cancer, it’s generally acknowledged that the earlier the cancer is caught, the less the risk of the cancer spreading.  In this case, the veteran waited over two years for a biopsy.  He is one of thousands of patients who have had to wait unreasonable amounts of time for care through the Veterans Administration (VA) system.

Although the issues with delay of veterans care appear to be nationwide, looking at one particular incident can help shed some light on not only what went wrong, but possibilities for reducing the risk of it happening in the future.  The Inspector General examined dozens of cases of patients who died while waiting for care at the Phoenix VA hospital in order to determine the impacts of the delayed care, the causes related to it, and recommendations for fixing the problem.  We can also examine the impact, causes and potential solutions for the care issue by performing a root cause analysis based on the story of this particular patient.  (His case was not covered in the IG report, which primarily examined deaths of veterans while waiting to be seen at VA facilities.)

We can capture the analysis in a Cause Map, which visually lays out the cause-and-effect relationships that resulted in an incident in order to provide the maximum opportunities for improvement.  After the what, when and where of the incident are captured, it’s important to determine the impacts to the goals resulting from a particular issue.  In this case, the patient’s safety was endangered because of the spread of cancer.  The patient services goal was impacted because the patient lost most of his nose as a result of inadequate treatment at the healthcare facility.  The schedule/operations goal is impacted due to the delay in treatment of the patient.  In order to better quantify the effects of an overarching issue such as this one, a frequency of events is essential.  In this case, the Inspector General found that delayed treatment was clinically significant for at least 28 other veterans at the same VA hospital.  (The Inspector General also found that 40 veterans died while waiting for appointments but was unable to determine if the deaths were due to the delays.)

Beginning with an impacted goal, asking “Why” questions adds detail to the Cause Map.  The spread of the patient’s cancer was caused by a delay of treatment.  Treatment was delayed due to the exceptionally long wait for a biopsy (two and a half years) as well as the wait between the diagnosis and treatment (surgical removal).  Insufficient capacity and large numbers of veterans seeking care at the VA hospital resulted in veterans waiting months or even years for care.  Because (as described by a whistleblower physician from the site) the site used “secret” waiting lists (where patients were effectively put on a non-official waiting list for the waiting list so that the reported wait was within an acceptable time frame), oversight of the facility was minimal.  As in this case, many veterans prefer to get care at a VA facility and/or don’t have another type of insurance that would cover the costs incurred for healthcare needs.

As expected, the results of these investigations have resulted in a number of personnel being removed from their positions in the VA.  The “secret” waiting lists were used to hide the fact that the VA hospitals don’t appear to have the capacity for the number of veterans that need treatment.  Significant additional funding is being directed towards the VA in order to build more hospitals and hire additional medical staff.   In the meantime (and possibly continuing into the future if capacity continues to be inadequate), arrangements for veterans to receive covered care at other facilities are being made.

In light of these highly publicized issues, hopefully the VA will receive the funding and oversight it needs so that the nation’s veterans can receive the care they deserve.

Solving the Problem of Organ Donation

By ThinkReliability Staff

6,570 Americans die every year waiting for a donor organ.  Says Johns Hopkins surgeon Dr. Andrew Cameron, “There just aren’t enough organ donors to go around.  That’s not a medical problem.  That’s a social problem.”  Though 95% of people support organ donation, only 40% are registered organ donors.  For the over 123,000 people on the waiting list, there just aren’t enough donor organs to go around.

This issue can be addressed within a Cause Map, a visual root cause analysis.  The first step is to capture the “what”, “when”, and “where of the incident, as well as the impact to the goals.  In this case, the problem is lack of donor organs available, causing patient deaths.  Though the problem exists everywhere, the focus of this blog will be on ongoing organ shortage in the United States.  Important differences in the United States related to organ donation are that only 40% of Americans are registered organ donors (despite widespread public support), and that there is no central registry of organ donors within the United States.  (Organ registries are typically state-run.)

The large number of deaths resulting from inadequate donor organs is an impact to the patient safety goal.  The delay in receipt of organs can be considered both an impact to the patient services and schedule/operations goal.  The lack of available organs can be considered an impact to the property goal.

To develop the cause-and-effect relationships that led to the impacted goals, we ask “why” questions.  In this case, the patient deaths result from the need for donor organs due to disease or injury, and the delay in receipt of organs.  The delay in receipt of organs is due to a lack of available organs.  Millions of Americans die every year, and while not all organs are acceptable for transplant, more than one organ can often be used from donors, resulting in multiple lives saved from each donor.

In an interesting cause-and-effect result, increased traffic safety has resulted in fewer fatal traffic accidents of young, healthy people, which has led to a decrease in available donor organs.  Of course there is no effort to try and increase organ donation by stopping the decrease of deaths of young people.

The shortage of donors from people who are eligible (upon death or brain death) result from not signing up for the organ donation registry and/or from a family not choosing to donate organs.  There are multiple reasons suggested for people not choosing to register or donate organs.  To solve the problem, companies are working on increasing the number of donors.  Dr. Cameron coordinated with Facebook to allow users to register as organ donors and saw the number of organ donors go up “22 fold”.  Says Dr. Cameron, “That’s proof that we can move the needle.”  The startup Organize is “building a portfolio of technology that makes it easier for people to demonstrate their desire to be an organ donor.”  The company hopes that it will improve organ donation to the point that it puts itself out of business in five years.

To view the overview of the organ donation problem and solutions, click on “Download PDF” above.  As discussed in a previous blog, work is also being done to increase the number of organs that are acceptable for donation (in this case with kidneys).

Fire Door Falls on Dementia Patient

By ThinkReliability Staff

On November 7, 2013, during renovation taking place at a care home in Moston, Great Britain, staff responded to a cry for help, finding a resident underneath a fire door that had been removed and leaned against a wardrobe during the remodeling work.  The resident suffered a broken hip and died on December 2nd.  The management trust that operated the care home and the renovating firm were both fined under the Health and Safety at Work Act after a Health and Safety Executive (HSE) investigation found that the renovation area, which contained multiple hazards, had been left unlocked the night before.

According to HSE Inspector Laura Moran, “Both firms clearly knew there were vulnerable residents living at the care home but they still allowed the door to what was essentially a building site to be left unlocked on numerous occasions.”  Clearly multiple failures led to the resident’s death.  Diagramming the cause-and-effect relationships related to this issue can help clarify what happened, and offer areas for improvement.

We can perform an analysis of this incident in a Cause Map, or visual root cause analysis.  We begin with the impacted goals.  The patient safety goal was impacted due to the death of the patient.  In addition, the employee safety goal was impacted due to the potential for employee injury.  The fines can be considered an impact to the compliance goal and the patient services goal is impacted due to the insufficient protection provided for residents.

Beginning with an impacted goal and asking “why” questions develops the cause-and-effect relationships.  In this case, the patient death resulted from a broken hip.  The broken hip resulted from the patient being crushed under a fire door.  (It took 3 people to lift the fire door off the patient.)  The patient was crushed under the fire door because the fire door fell and the patient was in the renovation area where the fire door was located.  Both of these causes are required – had the fire door not fallen, the patient would not have been crushed, even if she was in the renovation area.  If the fire door fell but the patient was not present, the patient also would not have been crushed.  When both causes are required to produce an effect, the causes are joined by and “and” on the Cause Map.

The fire door fell as it was leaning against a wardrobe due to the renovation.  The patient, who suffered from dementia, was prone to wandering and was able to access the area under renovation because it had not been locked.  Neither the renovation firm nor the care home staff locked the area, or checked to verify that it was locked.

Other goals can be added as effects in the appropriate locations of the analysis.  For example, the patient services goal was impacted due to the insufficient protection of patients.  This occurred because the renovation area was unlocked and because the hazards in the renovation area.  (Beyond the fire door, the care home staff found exposed wiring, loose boards, and other potential safety hazards.)  The insufficient protection of patients resulted in the fine.  The impact to the employee safety goal was impacted due to the renovation area hazards as well.

Some amount of hazard always exists in construction sites – this is why hard hats are generally required.  It’s also why access to these sites is controlled.  In this case, limiting access to only those that need it was determined to be the best way to protect patients.  Because the previous process for ensuring the area was locked had failed, according to Inspector Moran, “Following the incident, the companies introduced a new procedure which meant workers had to collect and return a key at the start and end of each day, and lock the door when there was no one inside.”

The lessons learned from this tragedy are applicable not only to the specific situation of care homes undergoing renovation but to all those who have a need to protect a vulnerable population or limit access to a hazardous site to ensure safety.  Simple things like making sure doors are locked at the end of the day may save a life.

 

Alleged Radiology Misreading Results in Removal of Cancer Patient’s Healthy Kidney

By ThinkReliability Staff

On January 17, 2013, a radiologist discussed the results of a CT scan with an urologist.  The CT scans identified cancer in the kidney of an urologist’s patient.  Two months later, the patient underwent surgery to remove the kidney.  The kidney was examined by a pathologist, who declared it cancer-free.  The wrong kidney had been removed, allegedly due to a misidentification by the radiologist.

Wrong-site surgeries like this one can lead to severe patient safety consequences, as well as severe financial and regulatory consequences for the doctors and healthcare facilities involved.  This is why surgery performed on the wrong body part has been identified as a “never event“, or an event that should never occur in a healthcare facility.

Even with this designation and the known seriousness of the issues, wrong-site surgeries continue to occur.  The Joint Commission estimates that the prevalence of wrong-site surgeries in the United States is as high as 40 per week.

Clearly, action must be taken to reduce the risk of wrong-site surgeries.  To identify areas of potential improvement, it can help to look at an example of an actual case of wrong-site surgery to determine lessons learned.  We will examine the case of the wrong kidney being removed as an example of issues that can lead to wrong-site surgeries using the Cause Mapping method of root cause analysis.

It’s important to identify the impacts to the goals as a result of an incident.  In this case, the patient safety goal was clearly impacted as the patient now has only 3/4 of a kidney remaining, with the potential to cause serious health impacts.  (A portion of the cancerous kidney was removed in a later operation.)  The compliance goal is impacted because of the occurrence of a “never event” as discussed above.  The patient services goal is impacted due to the removal of the wrong (healthy) kidney.  The radiologist and urologist involved in the issue have been sued for more than $1 million as a result of the issue.  If all these issues received similar lawsuits, the costs to the health system would be over $2B a year.

Once the impacts to the goals are identified, asking “why” questions develops the cause-and-effect relationships that led to the issue.  In this case, the removal of the wrong kidney is alleged to have resulted from the radiologist misreading the CT scan that identified the kidney with cancer and passing that information on to the urologist who performed the surgery.  Clearly the urologist’s physical exam (if any) did not adequately determine the site of the cancer.

To better understand the steps that led to the surgery, they can be diagrammed in a Process Map.  A Process Map lays out a process in much the same way that a Cause Map visually lays out cause-and-effect relationships.  A very high level overview of the process used in this case is shown on the downloadable PDF.  What’s important to note is that an incorrect reading of a CT scan or other diagnostic tool propagates through the process.  With no second opinions or double checks built in, the diagnosis of cancer in the left kidney was the only information the urologist had to determine the operating site.

There are of course other errors in the surgical preparation procedure that can also cause wrong-site surgeries.  (Many of these errors are identified in our proactive write-up on wrong-site surgeries.)  As stated by Mark R. Chassin, M.D., President of The Joint Commission, “Wrong site surgery events occur basically because none of the processes that we use in taking care of patients is perfect.”  Equally important is that the people performing the processes are not perfect.  Although both processes and people’s performance can be improved, it will never reach perfection.  For this reason, adding double checks and second opinions into processes is essential to reduce the risk of the one mistake resulting in a devastating patient safety impact.  In this case, having a second opinion on the CT scan, or having the physician re-identify the area with a physical exam prior to surgery (if possible) may have identified the error prior to removal of a healthy kidney.

View the Cause Map and process map by clicking on “Download PDF” above.

Gamma Camera Collapse Kills Patient

By ThinkReliability Staff

On June 5, 2013, a nuclear medicine scanner was being used for a diagnostic procedure at a New York Veterans Affairs (VA) medical center when the gamma camera collapsed on a patient, causing his death.  This issue can be examined in a Cause Map, or visual root cause analysis, in order to determine both the impact to the organization’s goals as well as the causes of the incident.

In this case, multiple goals were impacted, the first and foremost of which is the death of a patient.  This is an impact to the patient safety goal.  Had the camera collapsed at a different time, it could have also injured an employee, causing an impact to the employee safety goal as well.  The death of a patient due to a medical device that functions other than designed is a “Never Event“, or an event that should never happen in a medical facility.  The scanner collapse on a patient clearly does not meet the goals for patient services.  The property goal is impacted due to potential damage to the scanner. (None of the publicly released reports specified how much damage, if any, was caused to the scanner and camera.)  The scanners of this type from this manufacturer were recalled shortly after this incident, impacting the operations goal and necessitating inspection and/or maintenance activities provided by the manufacturer, an impact to the labor time goal.

Investigation conducted shortly after this patient’s death determined the collapse was caused by loose bolts.  The machines were quickly subject to a Class 1 recall with the FDA.  Sites with the recalled equipment were told to discontinue use until inspections and, if needed, preventive maintenance could be performed by the manufacturer.  Said the manufacturer’s spokesperson, “If no issue is found with the support mechanism fasteners, the site can resume use of the device. If an issue with the support mechanism fasteners is found on a system, the GEHC Field Engineer will coordinate the replacement of impacted parts, and ensure that the system is operating appropriately and meets all specifications.”

Publicly released information about the incident has not specified who was responsible for the preventive maintenance that may have determined the need for tightening the bolts.  However, inspection and maintenance costs were covered by the manufacturer of the devices.

Sites that are using the affected models should have been notified and should stop use until the recommendations of the recall are met.  Although details of broader solutions were not available, both the manufacturer of the devices and the healthcare facilities using them will surely take a look at the preventive maintenance schedule to decrease the risk of patient injury from this type of event.

To view the Outline and Cause Map, please click “Download PDF” above.  Or click here to read more.

Hundreds Affected in ‘Unprecedented’ Ebola Outbreak

By ThinkReliability Staff

The ongoing Ebola epidemic in Africa is “unprecedented” due to its high mortality rate (up to 90%), geographic spread (at least 5 countries have reported cases of the disease, which has spread to urban areas as well), and difficulty enforcing quarantines that would reduce the spread.  As with many outbreaks, the factors involved are complex and wide-ranging.

We can address the issues contributing to the outbreak by capturing them in a Cause Map, or visual root cause analysis. This intuitive method ties impacted goals to cause-and-effect relationships, allowing development of solutions to all aspects of an issue.

First we begin with the impacts to the goals.  The outbreak began in Guinea at some point in early 2014, but was reported to the World Health Organization (WHO) on March 23, 2014.  The outbreak is still ongoing and has impacted Guinea the most, but has also spread to neighboring countries.  The strain involved is the Zaire Ebola virus, which is spread by bodily fluids.

At the date of publication, the virus has killed at least 101 out of 157 infected in Guinea alone.  The infections and deaths, as well as the spread of the disease, can be considered impacts to the public safety goal.  This is the first outbreak to have impacted urban Guinea, though there have been dozens of outbreaks in Africa over the past 40 years.

“Why” questions are used to determine the cause-and-effect relationships that resulted in the impacted goals.  Death typically results from bleeding or shock, which occurs due to infection with the virus and insufficient treatment. Infection results from the initial transmission (caused by eating raw infected meat), and the spread of the disease.  The spread in this case has resulted from the unusual migratory pattern, both because of the easy and frequent travel between countries but also due to an as-yet-unknown factor.  Normal outbreaks involve a much smaller geographic area.) Victims are contagious for a long time, meaning the disease is easily spread, and it has been difficult to enforce quarantine, because of mistrust of local authorities and foreign aid workers.  According to Stéphane Hugonnet  of WHO, “The mortality rate is extremely important.  Nine out of ten patients will die.  If we look at this from the population’s perspective, why would you go to a hospital if you have almost zero chance of getting out of it.”  However, with effective care, there is a chance of surviving Ebola.

However, providing that care is another challenge.  There is no cure for Ebola, possibly because financial incentives to develop a cure for a rare disease that primarily strikes poor African villages isn’t there. Care essentially involves keeping a person alive long enough for their body to be able to fight back, difficult in a country that has 0.1 physicians for every 1,000 people fighting a disease that rapidly replicates and – through an unknown mechanism – disables the immune system.

So what’s being done to end this outbreak?  Medical teams from Doctors without Borders (or Médecins Sans Frontières) and WHO have been dispatched to the area.   These medical teams may include anthropologists, to better address local concerns regarding the disease.  WHO has also recommended limiting personal contact and a on raw bush meat.  Meanwhile, researchers are working on a vaccine to prevent  transmission of Ebola.  It is hoped that these steps together will end this outbreak – and prevent future outbreaks as well.

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