Tag Archives: cause mapping

Root Cause

New Prostate Cancer Tests Look Promising

By Kim Smiley

One in six American men will be affected by prostate cancer during their life making prostate cancer the most common non-skin cancer.  Despite the number of people impacted by this disease, screening and treating prostate cancer remains problematic and even controversial at times.

This issue can be analyzed by building a Cause Map, an intuitive format for performing a root cause analysis.  The first step in the Cause Mapping process is to fill in an Outline with the basic background information.  How the issue impacts the overall goals is also documented in the Outline.  In this example, there are several significant impacts that need to be considered.  The first is that it’s estimated that about 30,000 men will die from prostate cancer in the US in 2013.  The second major issue is that many men are treated unnecessarily for prostate cancer.  Unnecessary treatments are a waste of resources and the side effects cause significant suffering.  The next step of the Cause Mapping process is to build the actual Cause Map by asking “why” questions and laying out the causes visually to show the cause-and-effect relationships.  (To see a high level Cause Map for this issue, click on “Download PDF” above.)

One of the factors that leads to so many deaths from prostate cancer is that it is generally found at later stages.  Most patients have few symptoms with early stage prostate cancer and current screening methods for prostate cancer are far from perfect.  Conditions other than prostate cancer, such as enlarged prostates, can result in positives during blood tests for prostate cancer.   The positive indications of cancer then trigger needle biopsies in areas of the body no one wants biopsied.  Less than half of these follow up biopsies find cancer cells. Physical exams for prostate cancer are uncomfortable and usually only find larger cancers.  Additionally, many prostate cancers grow so slowly that they will not impact a patient’s life span and do not require treatment, but there is currently no test that can accurately determine whether a prostate cancer is dangerous.

This inability to distinguish between types of prostate cancer is what leads to so many being treated unnecessarily for prostate cancer.  Many patients opt for treatment once prostate cancer is found because they have no way of really knowing whether it’s safe to leave the cancer untreated.   But treatment is not without significant costs, both financially and in suffering.  Many of the prostate cancer treatments, such as radiation or surgery, can cause major side effects such as  incontinence or sexual dysfunction.  Most patients will willingly undergo treatment for life threatening cancers, but it’s terrible that some patients endure cancer treatments without need.

The final step in the Cause Mapping process is to find solutions.  In this example, the good news is that many researchers are working to develop better prostate cancer tests, which would rapidly lead to better patient care.   Better tests could save lives by finding prostate cancers earlier and could help reduce unnecessary treatment by identifying the more dangerous cancers.  A urine test for prostate cancer is now available that has been found to be more accurate than current screening methods.  Other research groups are working to develop other urine prostate tests with a focus on developing accurate, low cost tests that can be performed at home.  None of these tests are perfect yet, but they are a significant step in the right direction.

 

Root Cause

How Best to Prevent Patient Falls?

By ThinkReliability Staff

Though there is consensus that improvement must be made in the area of injury due to patient falls, how to reduce patient injury due to falls has raised questions about effective solutions to this problem.

According to the Agency for Healthcare Research and Quality, accidental falls contribute to patient complications in 2% of hospital stays.  Specifically in the state of Washington, where potential legislation aims to reduce the risk of patient falls, falls are found to kill or injure a few dozen patients per year.  The American Nurses Association said in a statement: “Falls are a leading driver of healthcare costs, especially for the elderly.  What’s more, Medicare and Medicaid do not reimburse hospitals for costs associated with injuries from inpatient falls, essentially increasing unreimbursed hospital healthcare costs.”  Obviously, patient falls cause an impact to both patient safety and quality of care, and may affect hospital reimbursement.

A recent fall case in Washington raised some of the concerns at the forefront of the falls prevention debate.  A patient was badly injured after he fell while being medicated with a sleeping pill (zolpidem).  A study has found that hospital patients taking zolpidem are four times more likely to fall. Some hospitals have begun phasing out zolpidem as a sleeping pill because it makes patients more likely to fall.

Most hospitals rely on a fall risk assessment for their patients to determine the level of fall prevention care required.  However, changes in patient status – such as the use of medication that increases fatigue or confusion – must cause a re-evaluation of a patient’s risk.  For hospitals that continue to offer zolpidem, its use may lead to a patient that was previously classified as a low fall risk becoming a high fall risk, leading to additional protocols or care depending on the hospital’s fall prevention plan.

Studies show that more nurses result in fewer patients falling.  Nurses in Washington have supported legislation requiring higher staffing levels.  But hospital management is concerned about the cost of this requirement, although the hospital did add 29 more nurses at the hospital where this fall occurred.   Additionally, that hospital’s Chief Nursing Officer says “What we have found is it has much less to do with staffing ratios than with having good solid reliable processes in place and following those every single time.”

Many of these processes involve bed alarms – which some studies have shown to be ineffective at preventing falls.  Additionally, as a nurse states, “You still need a person to be close enough nearby to be able to respond to the alarm.”

When looking at the causes that result in an issue impacting the organization’s goals, the analysis step may seem like the most difficult part to get through.  However, in many cases, especially where patient safety, staffing, funding and reimbursement come into play, it can be even more difficult to determine which solutions should be implemented to reduce the risk of the issue recurring, especially when studies may offer conflicting or confusing evidence about the effectiveness of various interventions.  In this case, it is particularly important that organizations determine the required reduction in risk (in this case, most hospitals are attempting to end patient injury due to falls) and the solutions (interventions) that will result in that reduction based on the needs and available resources of the organization.

Most importantly, after a specified time period, the solutions need to be evaluated for effectiveness, based on carefully determined criteria.  In this case, whatever intervention is selected to reduce injury from patient falls should be evaluated against the number of injuries due to falls at that facility.  If the risk has not been reduced as desired, additional interventions are in order.

To view the fall issue discussed here in a Cause Map, with notes about solutions under consideration for reducing fall risk, please click “Download PDF” above.  Or click here to read more.

Root Cause

Increase in Resistant Bacteria and Fungus Threatens Public Health

By ThinkReliability Staff

On September 16, 2013, the Centers for Disease Control and Prevention (CDC) issued a report “Antibiotic Resistance Threats in the United States, 2013”.  This report detailed the impacts, causes and recommended solutions related to antibiotic resistance within the US (although the concerns are similar worldwide).

The report takes the form of an incident investigation.  Specifically, the report addresses the impacts to the goals of the CDC, the cause-and-effect relationships resulting in these impacts, and what is recommended to reduce the risk of these impacts continuing. The information presented in their report can be captured in a Cause Map, or visual root cause analysis, which allows a demonstration of the interaction of the various causes presented in the report.

The report begins with the goals being impacted by the problem of antibiotic resistance.  Specifically, the CDC conservatively estimates that more than 2 million people are sickened in the US every year by antibiotic-resistant infections.  More than 23,000 are estimated to die as a result.  The risk is not just for the general public, but healthcare providers as well, who are implicated in the report as having resistant strains on their hands, which causes a health risk for them as well as patients.  The report identifies not only person-to-person spreading of infection, but also spreading from environmental causes, such as food.  The presence of these strains impacts the environmental goal as well.

The cost of these infections is staggering.  It is estimated that up to $20 billion per year is spent on direct excess healthcare costs as a result of these infections in the US alone.  The productivity cost (loss of productivity across industries due to employees being out sick) is estimated to be as high as $35 billion per year.  (While the causes discussed in the report are of concern globally, the impacts to the population are specific to the US.)

Increased illness from resistant infections results from exposure to resistant infections, decreased protection from infection, and a shortage of drugs available to treat these infections.  Exposure to antibiotic-resistant infections results from either person-to-person or environmental spread.  Spread can pass from anybody who has antibiotic resistant bacteria or fungus, but a primary source is healthcare providers, who can easily pass the infection with improper hand washing (or none at all).  Environmental causes include surfaces (again, healthcare providers are a frequent source here) but also food.  Food animals are given antibiotics to control disease, but also sometimes are given antibiotics without a diagnosis to prevent infection or promote growth.  These antibiotics kill off non-resistant bacteria but not resistant bacteria, which remains in the meat and feces.  If meat is improperly cooked, the bacteria can be passed on to humans.  But the issue is not just with improperly cooked meat.  Other foods can be contaminated with animal feces, which can also contain the resistant bacteria.

When a person is taking antibiotics, they have a decreased protection from infection.  This is because antibiotics kill all bacteria – including “good” bacteria that helps prevent infection.  While antibiotics are used to treat disease,  the CDC estimates that 50% of prescriptions are unnecessary or not optimally effective.  The use of antibiotics has been identified as the single most important factor leading to antibiotic resistance.

The increase of antibiotic-resistant bacteria (and fungi) means that more and more drugs are becoming ineffective in treating these infections, increasing the risk of death when infections occur.  Additionally, research and development into antibiotics is slowing, compounding the problem of effective drug availability.

As part of the report, the CDC provides wide-ranging recommendations to limit antibiotic-resistant infections.  The recommendations are for healthcare providers, communities and individuals.  They aim to first prevent the spread of infection by ensuring that antibiotics are prescribed and used properly, as well as by better tracking the spread of antibiotic resistant pathogens.  This includes stopping the use of antibiotics in feed animals for growth promotion.  Additionally, better cleanliness control for healthcare providers, food preparers and the general population will reduce the spread of disease.  Secondly, the CDC aims to provide better treatment for these infections by investing in research and development to provide new antibiotic treatment options.  It is also hoped that surveillance data can provide more effective diagnostic tools and use of the treatments currently available.

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

Want to learn more?
Read the CDC report.
Read our previous blog on Carbapenem-Resistant Enterobacteriacae (one of the “Urgent” threats identified in the CDC report).

Root Cause

RISK: Vaccines vs. Disease

By ThinkReliability Staff

Although endemic transmission of measles has been considered “interrupted by vaccination” in the United States, a recent measles outbreak has brought to the forefront the risks of not getting vaccinated.  A member of a church in Texas, who had not received the full measles vaccination, traveled to Indonesia, an area where measles is still endemic.  The disease, which is easily spread in close contact, then infected at least 20 other members of his church, which has concerns about the risks of vaccination, especially bundled vaccinations like the MMR (measles/ mumps/ rubella) vaccine.

In recent years, people have been increasingly concerned about the risks of vaccination.  One of the main concerns with the MMR vaccine is its purported link to autism (which was first mentioned in a 1998 study that has been mostly discredited).  There are, of course, risks to vaccination for any disease.  According to the CDC, risks from the MMR vaccine include mild problems, such as fever (up to 1 person out of 6), mild rash (up to 1 person out of 20) and very rare severe problems, such as allergic reactions (which occur in less than 1 out of a million doses).

However, as the CDC notes “The risk of the MMR vaccine causing serious harm, or death, is extremely small.  Getting the MMR vaccine is much safer than getting measles, mumps or rubella.”  This brings us to the other side of the equation.  People who do not get vaccinated for these diseases face the risks of getting the disease.  According to Dr. Paul Offit, Chief of the Division of Infectious Diseases and Director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, “There are only two ways you can develop specific immunity, either be infected by the natural virus or be immunized.  A choice not to get a vaccine is not a risk-free choice, It’s a choice to take a different and more serious risk.”

Because transmission of measles had been considered effectively stopped in the US, not vaccinating may have seemed like a minor risk.  After all, there are some people who cannot receive the vaccine.  This includes young children, pregnant women, and those who may be suffering from other health concerns.  These people have generally been protected by “herd immunity”.   This refers to the unlikelihood of getting measles when a very high percentage of the population is vaccinated against it.

However, in recent years, the number of people choosing not to get vaccinated has been increasing.  Sometimes these people are clustered geographically, such as within a church that has expressed its concerns about vaccinations (as in the recent outbreak in Texas).  When unvaccinated persons travel to an area that has not made as much progress towards eradicating disease, the likelihood of disease spreading is much higher.

This is true for other diseases as well.  The Texas Department of State Health Services has recently released a health alert regarding vaccination against pertussis (whooping cough) after more than 2,000 cases this year, including two deaths of infants too young to be vaccinated..  Says Dr. Lisa Cornelius, the Department’s infectious diseases medical officer, “This is extremely concerning.  If cases continue to be diagnosed at the current rate, we will see the most Texas cases since the 1950s.”

Although the potential risk of a vaccine may seem frightening, it is important to ensure that everyone in your family is fully vaccinated.  Not only will this provide the best protection for each of you, it will also provide protection to those members of your community who cannot be vaccinated, and limit the spread of these diseases.  Some communities are experiencing this the hard way. The Texas church involved in the outbreak has begun offering vaccination clinics for its members to attempt and stop the outbreak and protect against another one.

You can view the Outline and Cause Map discussing this issue by clicking “Download PDF” above.

Root Cause

Patient Receives Unneeded Mastectomy

By ThinkReliability Staff

Information about a lab mix-up that resulted in a patient receiving an unnecessary mastectomy was recently released by a health authority in Nova Scotia, Canada.  The authority has conducted an investigation into the error and how it occurred.  We can look at some of the information that will need to be considered in order to reduce the risk of a similar issue recurring.

First, we capture the “What”, “When”, and “Where” of the incident.  In this case, a switch of pathology results occurred in late April, 2013 at a cancer center in Nova Scotia.  The error was caught as a result of oversight analysis of tissue samples.

We can capture the goals impacted as the result of the issue.  In this case, the patient safety goal was impacted because a patient (Patient 1) received an unnecessary surgery (mastectomy).  In addition, the patient safety goal was impacted because another patient (Patient 2) did not receive a necessary surgery.  The staff employees are impacted because they are reportedly devastated, as frequently happens in cases like these.  The organization goal is impacted due to the apology given to the public as a result of this issue.  The patient services goal is impacted due to a switch of the tissue samples.  The property goal is impacted because an unnecessary procedure was performed, and the labor goal is impacted due to the extensive investigation that is taking place.

Asking “Why” questions can help determine the cause-and-effect relationships that led to the impacted goals.  In this case, the patient safety impacts are due to the switching of the patient’s sampling.  This occurred due to the results being recorded into the wrong records.

While trying to solve a problem, it can be helpful to examine the related processes.  In this case, we look at the tissue sampling process.  Any process is meant to get from point A to point B. In this case, the process ideally takes us from a tissue sample being taken (point A) to a diagnosis (point B).  We know that we did not get to point B in this case (i.e. the diagnosis was incorrect).  Looking at the steps in more detail can help us determine which specific part of the process did not go as intended, which will allow us to identify process-specific solutions.

A sample is taken from a patient, labeled, and sent to the lab.  The lab tests the sample, obtains the results, then delivers them to the patient’s physician or care center.  At that point, the results are recorded in the patient’s records and then used to make a diagnosis.  The error reportedly occurred at the point where the results were entered into the patients’ records.

Once we’ve identified the specific point where the error occurred, we can identify potential solutions.  In this case, the facility involved is implementing bar-coding and moving towards an automated system.  Although there is still the potential for error, it is reduced with automated systems and bar codes because the data has to be transcribed fewer times. As the Premier of Nova Scotia stated, “Human error is always a possibility. But one of the things we strive for is to ensure there are appropriate controls in place to ensure that the risk of these things is absolutely minimized.”

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

Root Cause

Woman Dies After Neck Trapped Between Mattress and Bed Rail

By ThinkReliability Staff

On January 26, 2013, a nursing home resident died of positional asphyxiation after her neck became trapped between her bed’s mattress and a bed rail.  The nursing home was cited for neglect by the state for not evaluating whether or not the use of a bed rail is appropriate.

The cause-and-effect relationships that led to the resident’s death can be diagrammed in a Cause Map, or visual root cause analysis.  This allows all the issues related to the incident to be examined so that as many potential solutions as possible can be considered, increasing healthcare reliability.

The first step in the Cause Mapping method is to capture the what, when, and where of the incident, as well as the impacts to the organization’s goals.  A nursing home’s goals include ensuring residents’ safety,  employees’ safety, residents’ quality of life, and compliance with regulatory and other accrediting agencies.  In this case, the resident safety goal was impacted because of the resident death.  The resident quality of life was impacted because there was no assessment performed to ensure the use of bed rails was appropriate.  Because that assessment was not performed, the facility was fined by the state Health Department.  Additionally, the compliance goal was impacted because both the Centers for Medicare and Medicaid (CMS) and The Joint Commission prohibit the use of bed rails when used as restraints.  CMS also will not reimburse for treatment for injuries related to the use of bed rails.

Beginning with an impacted goal, asking “Why” questions aids in developing the cause-and-effect relationships that resulted in the impact to the goal.  In this case, the resident death was caused by positional asphyxiation because the resident’s neck was caught between her bed rail and mattress.  The asphyxiation also resulted from the resident not being found immediately.  In this case, there were forty minutes between the last nursing check and when the resident was discovered.

The resident’s neck was caught because she was unable to free herself due to limited mobility and dementia and the use of bed rails.  In this case, as previously noted, an assessment to determine whether the use of the bed rail was appropriate had not been performed.   Presumably the bed rail was used because of the resident’s history of falls. Despite research that the risks outweigh the benefits when using bed rails as restraints (as opposed to mobility aids for residents who are cognitively and physically able), the FDA has stopped short of requiring a safety label on bed rails.

The nursing home involved in this incident has provided an approved plan to reduce the risks of this type of incident recurring.  Beyond that particular facility, states Minnesota Commissioner of Health Dr. Ed Ehlinger,  “As a result of this death, we want all health settings where bed rails are used to take immediate steps to make sure they are following the correct guidelines around bed rails, grab bars and other devices.”

To view the Outline and Cause Map, please click “Download PDF” above.  Or click here to read more about the use of bed rails and associated risks.

Root Cause

New Limits Proposed for Arsenic in Apple Juice

By Kim Smiley

The FDA recently proposed a new limit for the amount of arsenic allowed in apple juice.  The proposed limit would match what has already been established for bottled water.  This marks the first time that the FDA has established an arsenic limit for food or drinks other than water.

This issue can be analyzed by building a Cause Map, or visual root cause analysis.  A Cause Map lays out the causes that contribute to an issue in an intuitive, visual format so that the cause-and-effect relationships are obvious.  The first step of the process is to fill in an Outline with the basic background information for an issue.  The Outline also documents the impacts that the issue is having on the organizational goals so that the full effect of the issue can be clearly understood.  In this example, the concern that consumers may be exposed to arsenic, a known carcinogen, is an impact to the safety goal.  The media hype surrounding this issue is also important to consider because consumer concern could impact sales.

After the Outline is complete, the next step is to ask “why” questions and use the answers to build the Cause Map.  So why is there arsenic in apple juice?  Arsenic is a naturally occurring substance that is found in the environment.  There are also places that have been contaminated by arsenic, primarily the result of arsenic-based pesticides.  Use of arsenic-based pesticides in the US ended by 1970, but parts of the world still use them.

To understand this issue, it’s also important to understand the public relationships portion of  the puzzle. The concern over arsenic in apple juice exploded after the issue was featured on the “The Dr. Oz Show” in 2011.  Outcry after the segment was well covered by major media outlets and the issue has repeatedly made headlines over the past two years. Consumer Reports has also issued a report about samples of apple juice that test above the limit for drinking water.  None of this can possibly be good for the apple juice business.

The final step of the Cause Mapping process is to use the Cause Map to develop solutions.  A limit for arsenic in apple juice should go a long way to easing concerns if it is established.  The proposal is to set the limit for arsenic in apple juice to match that for drinking water, which should be conservative since consistent consumption of more apple juice than water seems unlikely.   Producers of apple juice that is found to contain arsenic above the limit could face legal action and the juice could be removed from the market.  How much the new limit will actually impact the products on the shelf is unclear because different sources have reported widely different sample results, but at least action could be taken if any juice is found to have arsenic levels above the limit.

 

Root Cause

Patient Wakes While Being Prepped for Organ Harvesting

By ThinkReliability Staff

An extremely rare but tragic case has been recently brought to light.  On October 16, 2009, a patient was brought to a hospital center in Syracuse, New York after suffering a drug overdose.  Over the next several days, the patient was in a deep coma, though she did not meet the requirements for brain death based on scans performed at the hospital.   The family was notified and agreed to donate her organs.  The patient, after being sedated, was prepped for donation after cardiac death (DCD).  The organ harvesting stopped prior to any organs being removed when the patient opened her eyes on the operating table.

The hospital was cited not only for the error, but for the inadequate response and investigation after the error was made by the state Department of Health and the Centers for Medicare & Medicaid Services (CMS).  Specifically, the CMS report states “The hospital’s Quality Assurance Performance Improvement program did not conduct thorough reviews of an adverse occurrence involving a patient who was being considered for withdrawal of life-sustaining treatment when she regained consciousness.”

We can examine the error using a Cause Map, or visual root cause analysis, to determine the issues related to the incident.  This provides a starting point for developing solutions to reduce the risk of such an incident recurring, and improving healthcare reliability at this site.

It’s important to frame the issue with respect to an organization’s goals.  In this case, the patient safety goal was impacted due to the risk of patient death from having organs removed.  The accidental removal of organs can also be considered an impact to the patient services goal.  The compliance goal is impacted because of the sanction and fine (though a minimal $6,000) from the Health Department.  Negative press and public opinion as a result of this incident – which was uncovered and reported to the Health Department by the press – is an impact to the Organizational goal.

Beginning with an impacted goal – in this case the Patient Safety goal – asking “Why” questions allows us to develop the cause-and-effect relationships that led to the issue.  In this case, the risk for patient death was due to risk of removing her organs.  The risk for removing organs is because the organ harvesting process had begun.  (The investigation did find that there were no concerns with the organ donation process itself, indicating that errors were prior to the donation prep process.)  The process began because the family agreed to donate organs after the patient was (incorrectly) determined to have suffered cardiac death.

There were a combination of errors that resulted in the patient being incorrectly declared “dead”.  Because all of these factors acted together to result in the impact to the goals, it is important to capture and fully investigate all of them to be able to improve processes at the organization.  In this case, the patient was injected with a sedative, which was not recorded in the doctor’s notes.  It is unclear who ordered the sedative and why.  (It’s also unclear why you would sedate a dead patient, as another doctor stated “If you have to sedate them . . .they’re not brain dead.”)  The patient had previously been in a deep coma due to the drug overdose.  It is possible the coma went on longer than usual because the patient was not given activated charcoal to inhibit absorption of the drugs by the body after the staff was unable to  unable to place a tube.  There appears to have been no additional effort – another area that should be investigated to ensure that protocol is sufficient for patient safety.

The hospital’s evaluation of the patient’s condition before a diagnosis of cardiac death was insufficient.  Specifically, it has been noted that the staff performed an inadequate number of brain scans, inadequate testing to determine the drug levels remaining in the body, and ignored signs that the patient was regaining consciousness prior to preparing her for organ donation.  Because details of these issues were not thoroughly investigated, it’s impossible to know whether the protocols in place at the organization were inadequate for determining cardiac death or whether the protocols were adequate and weren’t followed by staff.

Determining if changes need to be made to protocols as a result of this tragic (though I do want to emphasize rare – the state was unable to find any similar cases in its records) incident is of utmost importance to reduce the risk of an incident like this happening again.  Hopefully the additional scrutiny from the state and CMS will ensure improved patient safety in the future.

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

Root Cause

Is a Doctor onboard? Management of inflight medical emergencies depends on other passengers

By ThinkReliability Staff

In a recent article, Pierre M. Barker, M.D. describes a terrifying situation – a passenger stops breathing on a plane over the Atlantic Ocean.  Turns out inflight medical emergencies are not that uncommon.  A study published in the New England Journal of Medicine says that about 1 in 600 flights has an inflight medical emergency – for a total of about 44,000 a year, worldwide.  Although the number of people who die as a result of these emergencies is fairly low, the incident that Dr. Barker was involved in indicates there is much room for improvement.

Taking the information from Dr. Barker’s article, we can perform a visual root cause analysis, or Cause Map, of the medical emergency on his flight.  Information gleaned from performing an analysis of one particular incident can provide valuable insight to improving outcomes for similar incidents – in this case, all inflight medical emergencies.

After recording the what, when, and where of the incident (here it’s inflight over the Atlantic Ocean), we capture the incidents to the goals.  Based on Dr. Barker’s description, this situation is aptly described as a “near miss” for patient safety.  What this means is that, had a lot of luck not headed this passenger’s way, he may very well have died on this flight.  We’ll discuss exactly what it is that made it a near miss – and not a fatality – later.   In this situation – and many other inflight emergencies – it seems that the employees are inadequately prepared for medical emergencies.  This is an impact to them – certainly it must be very stressful to have this sort of situation happen on their watch while feeling like there’s not much they can do.   In this case (and occasionally other, similar inflight emergencies), the flight was diverted, an impact to the organization’s goals.  Considering the sick passenger as a “patient” (and this is how I’ll refer to him going forward), the patient services were impacted because the ventilation bag did not connect to the oxygen tank.  Lastly, other passengers were called on to treat the “patient”, which was found to be very typical from the study.  This is an impact to the labor/time goal.

Once we’ve determined which goals were impacted, we can ask “Why” questions to determine which cause-and-effect relationships led to the impacted goals.  In this case there’s a combination of negative impacts and positive impacts – which is how the situation ended up as a “near miss”.  On the negative side, the patient stopped breathing and suffered cardiac arrest.  Because the conditions on a plane are hardly ideal for health, this may contribute to inflight medical emergencies.  There was difficulty in giving the patient oxygen, because the ventilation bag did not connect to the oxygen tank.  Additionally, there was a lack of patient medical history.  The patient was unconscious and there was no health information available which may have aided in his treatment.

The situation described above could have gone very, very badly.  There are some positive causes that contributed as well to make this a near miss.  First, the fact that the patient had stopped breathing was noticed very quickly, because he happened to have Dr. Barker – a pediatric lung specialist – two rows behind him who noticed his difficulty breathing, and then when it stopped altogether.  Because this was not by design but rather a stroke of rather good luck, this is how we get a “near miss”.  After all, you certainly can’t count on a lung specialist tracking the breathing of every person on a plane to stop inflight emergencies.  Not only was the issue noticed quickly it was treated quickly, by Dr. Barker as well as two ER nurses, a surgeon and an infectious disease doctor, as well as a flight attendant who performed a cardiac massage.  This ad-hoc medical team managed to do a heroic job of stabilizing the patient – including use of an AED, which was on the flight, an IV with fluids and glucose, and administration of an aspirin donated by another patient (though according to the study, aspirin should be included in the emergency medical kit on each flight as well).

The flight was diverted – as quickly as possible – to Miami.  This took about two and a half hours, during which time the medical team kept the patient stable until he was transferred off-plane.  This patient was extremely lucky to have these medical personnel aboard.  According to the NEJM study, doctors are present about 50% of time on flights, and the responsibility for treatment of inflight medical emergencies – as well as the decision whether to divert a plane – is generally left up to them.  When an inflight medical emergency occurs and a doctor is not present, the plane is more likely to divert.

As a result of this incident, Dr. Barker has some recommendations on how to make flying safer.  The NEJM study also makes some recommendations.  These solutions are placed directly on the Cause Map, and evaluated for effectiveness.  In this case, creating a standard emergency kit (there is an FAA-mandated emergency medical kit but as seen in this incident, the pieces may or may not work together properly and the kit may be different on different flights) for all flights should be developed.  This kit should ensure that all necessary equipment and medication for the most common and dangerous inflight medical conditions is included and that all flight attendants know where to find and how to put together the necessary pieces of equipment in the kit.  If, as seems to be the case, medical professionals on flights are expected to be responsible for other sick passengers in the case of an emergency, they should be notified as such.  If this occurred, flight attendants would also be aware of where to find these medical professionals.  This could involve a briefing similar to that received by personnel who sit in exit rows.  Where easy diversion is not possible (such as flights over oceans or uninhabited areas), at least one flight attendant should receive EMT training which includes in-depth instruction on how to use the medication and equipment available in the medical kit.  Coordination with onground medical staff should continue, with a focus on trying to make medical history available when possible.

The aviation industry has made flying incredibly safe.  Although inflight medical emergencies are rare and usually non-fatal, the industry now has the opportunity to make experiencing a medical emergency onboard a flight even safer.

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

Root Cause

Common Birth Control Pills Have Increased Risk of Blood Clots

By Kim Smiley

Deaths of 24 Canadian women associated with the use of Yaz and Yasmin birth control pills have been making headlines in recent weeks.  South of the border in the US, more than $1 billion has already been paid out to settle thousands of lawsuits over alleged side effects.  Yaz and Yasmin are drospirenone-based birth control pills that are the most widely prescribed birth control pills worldwide so any concerns with the safety of the medication are alarming.

This issue can be analyzed by building a Cause Map, or visual root cause analysis.  A Cause Map lays out the many causes that contribute to an issue in an intuitive way that illustrates the cause-and-effect relationships.  The first step in the Cause Mapping process is to fill in an Outline with basic background information and to determine how the problem is affecting the overall goals of the organization.  In this example, side effects from the pills have been reported to have caused deaths and injuries.    Lawsuits associated with the side effects, specifically blood clots, have cost the drug manufacturer huge amounts of money as well as generated significant negative publicity, neither of which are outcomes a company is hoping for.

The complaints about severe and potentially deadly side effects have been focused on blood clots.  Blood clots are a known potential side effect of using any birth control pills.  It is believed that the estrogen used in birth control pills increases the clotting factors in blood making blood clots more likely.  The reason these specific pills are making headlines is that researchers have found that drospirenone-based birth control pills have a higher risk of blood clots than other birth control pills.  Researchers have estimated that the risk of blood cloths is 1.5 to 3 times higher with drospirenone-containing pills than with some other birth control pills.

For perspective, the FDA has stated that if 10,000 women who are not pregnant and do not use birth control pills are followed for one year, between 1 and 5 of these women will develop a blood clot and for women using birth control pills the range is 3 to 9.  But, and in my opinion this is a pretty big but, it’s worth knowing that the risk of blood clots during pregnancy is estimated to be 5 to 20 out of 10,000 and it’s even higher during first 12 weeks postpartum; estimated to be 40 to 65.

Please talk to your doctor if you have any concerns about blood clots or questions about whether a particular birth control pill is safe for you, especially if you think you may have other risk factors for blood clots.  If you’re curious about the symptoms of a blood clot or about other risk factors you can get more information here.

Please click on “Download PDF” above to see a high level Cause Map of this issue.