Tag Archives: patient safety

Root Cause

Patient Gets MRI (and a Diagnosis) Only After 24 Visits to 13 Doctors

By ThinkReliability Staff

In a tragic case of incorrect diagnosis, a 16-year-old patient died January 24, 2013, eleven months after being diagnosed with “migraines”.  In fact, the patient had a rare brain tumor (known as a disseminated oligodendroglioma-like leptomeningeal tumor).  She died eight days after receiving an MRI that finally properly diagnosed the causes of her headaches, numbness, nausea and eyesight problems.

It’s unclear if earlier diagnosis would have saved the life of the patient.  Though the prognosis is poor for a leptomeningeal tumor, a oligodendroglioma that is treated before it is disseminated gives a long-term survival chance to 80-100%.  The tumor had disseminated once it was found on the MRI, eleven months after the patient was diagnosed with migraines.  However, even if her prognosis was poor, the patient could have spent the last eleven months of her short life enjoying time with her family and friends, instead of making 24 trips to 13 different doctors and, in one particularly devastating appointment, being accused of “putting the symptoms on”.

Although the coroner at the inquest said there was no need to make a formal recommendation for changes at the hospital that failed to diagnose the patient, a spokesperson for that hospital said “In the next few weeks, many of the clinicians who looked after Natasha will be meeting to discuss this sad case and ensure that any opportunities for learning are not missed.”

It is hoped that these opportunities for learning can reduce the possibility of another patient suffering as this patient did, due to a misdiagnosis.  Misdiagnosis is a common source of medical error.  According to an article by Michael Astion, MD, PhD, “Available data suggests that misdiagnoses occur in 15% or more of clinical cases, but overall there is very limited data on the frequency of misdiagnosis in medicine.”  Especially in rare clinical cases such as this one, sharing details of the disease and diagnosis may help other clinicians in the same position.

In order to effectively determine lessons learned and improvements that can be made, the details of a case need to be presented clearly and concisely.  I’ve put together the details of the case in a Cause Map, which uses cause-and-effect to demonstrate the linkage of the issues that led to the tragedy discussed here.

In a blog discussing the cases and possible responses, Suzanne Leigh suggests that if an MRI was denied, other cheaper alternatives, such as a CT scan, be considered.  She also suggests a much more thorough review to “ensure that in the future, scans are  not withheld from patients with potentially life-threatening conditions”  and that the hospital involved should “study the flaws in the system and human errors that led to the failure of 13 doctors to order a diagnostic MRI that would have resulted in emergency treatment earlier in the disease’s progression”.  Given the tragedy of this case, the suggestions seem far more appropriate than the treatment of the patient over the last year of her life.

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

Root Cause

Students Will Receive a Meningitis Vaccine Not Yet Approved in the US

By ThinkReliability Staff

In an unusual move, on November 16, 2013 the US Food and Drug Administration (FDA) approved the importation and use of a vaccine not yet approved in the US to attempt to minimize the spread of a rarer – and more difficult to prevent – strain of meningitis on a college campus.

Information about the outbreak, including the effects, causes, and recommended solutions, can be captured in a Cause Map, or visual form of root cause analysis.  This method of problem-solving begins by capturing the background information on the event, then determining the impact of the event on the organization’s goals.

The outbreak began at Princeton University in March of this year.  Meningitis outbreaks can be more common at college campuses because of the close living quarters.  The specific strain involved is known as serogroup, or type B, which has been more difficult to create a vaccine against because the coating on the bacteria is different than that from other types, for which a vaccine was developed in 2005.  Since that vaccine, the number of cases of meningitis on college campuses has declined, though there were 160 cases of B strain meningitis in the US last year.  (In the US, B strain is rarer than other types.)  This is the first outbreak of B strain meningitis in the world since the vaccine was approved.

This outbreak has impacted the safety goal, as the potential for serious injuries and fatalities is high.  The spread of meningitis can be considered an impact to the environmental goal, and the customer service goal is impacted by students being sickened by meningitis.  Treatment and vaccination are an impact to the labor/time goal.

Beginning with the impacted goals and asking “why” questions develops the cause-and-effect relationships related to the incident.  In this case, the outbreak resulted from the spread of meningitis due to coughing or contact among the close quarters common on a college campus, and the fact that students were not vaccinated against this particular strain of meningitis.  A vaccine for the B strain of meningitis has not yet been approved in the US as it was recently developed, although it was approved for use in Europe and Australia earlier this year.  Developing a vaccine for the B strain was difficult (it took over 20 years) because of the differences in bacteria coating from other strains.

Though the vaccine has not been approved for general use in the US, the FDA and Princeton University officials determined that the prevention benefits outweigh the risk of its use.  Specifically, students at Princeton will be offered two doses of the vaccine, paid for by the university.  The vaccines are not mandatory.  In addition, students are being reminded to wash their hands, cover their mouths while coughing, and not to share personal items.  It’s also hoped that holiday travels will end the outbreak as students disperse, though it’s also possible that the travel could spread the disease, though this is considered highly unlikely by health officials.   Time will tell if these actions are adequate to stop the spread on campus.

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

Root Cause

After Hurricane Sandy, Medical Centers Work to Prevent Future Issues

By ThinkReliability Staff

As a result of both infrastructure damage and power failures due to Hurricane Sandy, five major hospitals in the New York City area had to be evacuated (see our previous blog about one hospital’s evacuation).  Medical centers in the impacted areas are still recovering, while trying to determine what should be done to prevent future risk – and who should be responsible.

Historically, it’s been difficult to tell whether or not a hospital’s emergency plan is adequate until it’s tested.   In May of 2011 (less than 6 months before Sandy hit), the U.S. Department of Health and Human Services announced that a majority (over 76%) of hospitals that were part of the National Hospital Preparedness Program “met 90% or more of all program measures for all-hazards preparedness in 2009”.  Many of the hospitals that were evacuated had earned accreditation by the Joint Commission – which includes criteria for emergency preparedness and backup power capacity.   In fact, according to the Joint Commission, the hospitals that were forced to evacuate would still be accredited based on the existing codes.  Says George Mills, the director of the Joint Commission’s Department of Engineering, “Yes, we would accredit them. We have no standards that say get your generator out of the basement.”

But that is exactly what many hospitals that have been affected by storm surges are doing.   NYU Langone Medical Center has upgraded its infrastructure and purchased flood barriers which can be deployed in the case of flooding. The hospital was reimbursed $150 million for rebuilding costs by the federal government shortly after the storm.  Bellevue Hospital Center, where the basement flooded in 45 minutes and took 5 days to pump out, also installed flood barriers and will be raising its backup generator’s fuel pumps from the basement.  Coney Island Hospital has elevated its outside electrical equipment and installed temporary barriers, but is looking at the elevation of its emergency department, which is on the first floor.  (In addition, the Manhattan Veterans Affairs Medical Center evacuated before the storm and experienced complete flooding of the basement and ground floor, resulting in power failures.  Also evacuated were 200 patients from the Henry I. Carter Specialty Hospital and Nursing Facility.)

The city’s Health and Hospitals Corporation President Alan Aviles says the cost of repairs, response and long-term protection from floods will be more than $800 million.  The projects will not be started until the city ensures that the Federal Emergency Management Agency (FEMA) will cover the costs.

According to Al Berman, the head of disaster recovery organization DRI International, the city won’t know how effective these measures have been unless much more rigorous testing is done . . . or until the next storm hits.  In his words, “A disaster is a terrible time to test your plan.”

The information related to the impacted goals as a result of the evacuations from Hurricane Sandy are captured in an Outline, the causal relationships leading to the evacuations and the proposed solutions are captured in a Cause Map, which can be viewed by clicking “Download PDF” above.  The Cause Map allows us to visually capture the cause-and-effect relationships in a logical, organized manner that clearly demonstrates the impact of various causes and the benefit of proposed solutions.

What about the hospitals that managed to weather the storm?  The Shorefront Center for Rehabilitation and Nursing Care in Brooklyn, just a few yards from the Atlantic Ocean, was praised for its handling of the storm – and assistance it provided to other healthcare facilities.  Says their administrator, Loyola Princivil-Barnett, “Our executive team have been taking, and are taking, emergencies very seriously.  It’s a matter of life and death.”

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

Patient Dies After Fall During Transfer

By ThinkReliability Staff

A medical center in California received a fine for an adverse event in which a patient’s fall at the facility resulted in his death.  As a part of the investigation into these types of events, a plan of action to mitigate the risk of similar events occurring in the future.  In order to best determine which events will be helpful in decreasing future risk, a full accounting of the cause-and-effect relationships that led to the incident being investigated can be helpful.  We can develop a visual map of the causes that resulted in this incident in a Cause Map, a visual form of root cause analysis which determines all relevant causes in order to offer the most possible solutions.

We begin our analysis with a summary of the “what, when and where” of the event, as well as determining which of the organization’s goals were impacted.  In this case, the patient safety goal was impacted due to the patient death.  The compliance goal is impacted because the facility was found to be noncompliant with requirements for licensure as a result of this event.  The fine from the state health department can be considered an impact to the organizational goal.  The patient services goal was impacted due to the improper transport of a patient.  Lastly, it was found that equipment was missing necessary safety features.  This can be considered an impact to the property/ equipment goal.

Once we have determined the impacts to the goals, we can begin with one impacted goal and ask “Why” questions to  determine the cause-and-effect relationship that led to the impacted goals.  In this case, we begin with the patient safety goal.  Why was the patient safety goal impacted? Because of a patient’s death.  Why did the patient die? His death was due to rib fractures and internal bleeding.  Why? Because of blunt force trauma.  Why? Because the patient fell out of a geri/bed chair (a device that can be used as a stretcher semi recliner or chair).

To ensure that the causes we include in our analysis are accurate, we include evidence wherever possible.  Evidence allows validation of the inclusion of causes on the Cause Map.  In this case, the evidence for the cause of death is provided by the autopsy report.

In addition to continuing to ask “Why” questions to add more detail to the Cause Map, we can also add additional impacted goals to the Cause Map.  For example, the patient fall out of the geri/bed chair was what caused the noncompliance with licensure that is an impact to the compliance goal.  This noncompliance caused the fine to the facility.   The patient fell out of the geri/bed chair due to inadequate transport, which impacted the patient services goal.

In some cases, more than one cause is necessary to result in the effect.  The inadequate transport was caused by the patient – who had been assessed as a high fall risk – being both left unattended and not secured in the geri/bed chair.  The patient was not secured on the geri/bed chair because it did not have straps.  It’s also possible he was not secured, and was left unattended, because the transport team, who took him to the radiology department to get an X-ray, was not aware of his high fall risk.  Although a transfer form is used to turn the care of a patient over to another team in cases such as this, there was no record on the transfer form that indicated a report being made to the transfer team that would have included information about the patient, including his fall risk.

As part of the investigation, corrective actions are required.  As is typical in these cases, many of the solutions included additional training and education to staff to reduce the risk of these events happening again.  Although usually included as part of the corrective actions for adverse events, training (or re-training) and continued education are some of the least effective solutions in terms of error recurrence.  (After all, presumably the staff had already been trained on the policies and requirements that were already in place at the time of the accident.)  More effective solutions include changes in policy that result in increased patient safety.  For example, in this case the transport policy has been updated to ensure that patients are left in locations where they can easily be monitored.  This of course will not prevent all falls, but may prevent some, and will certainly lead to staff noticing falls quickly.  Even more effective are changes in equipment to make following policies easier.  In this case, the geri/bed chair that was used for patient transport did not have a strap, even though its use was required.  It is unreasonable to expect busy staff to spend their time searching for equipment that has the proper safety equipment.  Rather, ensure that all geri/bed chairs or other transport devices have the required safety devices.  I’m sure you can imagine that it is much more likely for staff to comply with a policy requiring use of safety devices when the devices are available and by doing so, will reduce the risk of patient falls, and patient deaths.

To view the Outline, Cause Map, and recommended solutions please click “Download PDF” above.  Or click here to read the state department of health report.

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

Adult Dose of Heparin Delivered to Premature Infants

By ThinkReliability Staff

On September 16, 2006 6 premature newborns in Indianapolis were given adult doses of the blood thinner heparin, used to prevent blood clots that could clog intravenous (IV) tubes.  Adult doses are 1000x more concentrated than infant doses.  Three of the babies died and the other three were in critical condition.  In 2007, in Los Angeles, an overdose was given to three more babies due to the same error.  Luckily none of those babies died.  (Up to 17 babies in Texas also received heparin overdoses in 2008, but these were caused by a mixing error at the hospital pharmacy.)

We can examine this issue in a visual root cause analysis, or Cause Map.  Fully investigating the errors that occurred for these overdoses to happen can lead us to solutions to increase healthcare reliability by decreasing the risk of the same situation recurring.

We begin with the outline, where we capture the what, when and where of the incident, as well as the impact to the organization’s goals.  These medication overdoses impacted the patient safety goal because they resulted in fatalities and serious injury to the babies who received the medications.  Additionally, employees involved in the issue can be affected as a second victim.  Death or serious disability due to a medication error is a “Never Event“, which is an impact to the organization’s compliance goals.  Patient services are impacted due to the incorrect drug dose delivery.

Once we’ve determined the impacts to the goals, we can ask “Why” questions to determine the cause-and-effect relationships that led to the incident.  In this case, 5 opportunities for double-checking the dosage were missed.  The wrong dosage was missed as 1) the bottle was removed from the pharmacy, 2) the bottle was placed in the cabinet, 3) the bottle remained in the cabinet, 4) the bottle was taken from the cabinet, and 5) the drug was administered to the babies.  Some of the reasons that it was missed: there was no effective double check by another staff member, there was no check by a computer and of course due to human error, which was aided by the issue that the adult dosage bottle and the infant dosage bottle looked practically identical (this has since been remedied).

An article in The Journal of Pediatric Pharmacology and Therapeutics states, “As frequently occurs, all of these heparin-associated medication errors happened when a number of system failures occurred simultaneously. System failures included: 1) failure to carefully and accurately read the label on the medication vial prior to administering the drug to the patient; 2) inaccurate filling of automated drug-dispensing cabinets; 3) non-distinct “look-alike” labels on the heparin vials; 4) similar size of the heparin vials as both were 1-mL vials; and 5) “factor of ten” dosing errors.”

Many solutions to this type of error (such as requiring double checks by staff members and using a computerized prescription dispensation system) were suggested as a result of this and other heparin overdoses over the past several years and are already being implemented at hospitals across the nation.

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

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

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.