All posts by ThinkReliability Staff

ThinkReliability are specialists in applying root cause analysis to solve all types of problems. We investigate errors, defects, failures, losses, outages and incidents in a wide variety of industries. Our Cause Mapping analysis method of root causes, captures the complete investigation with the best solutions all in an easy to understand format. ThinkReliability provides investigation services and root cause analysis training to clients around the world and is considered the trusted authority on the subject.
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

Teen Dies From Peanut Reaction Despite Epinephrine Injections

By ThinkReliability Staff

Even with the best medical treatment known provided quickly after an anaphylactic reaction, a teen died after taking a bite of a snack containing peanuts, to which she was severely allergic. It is important to note that the snack was not clearly marked to contain peanuts and it was a style of treat (Rice Krispies) that would not ordinarily contain peanuts.

In a situation requiring emergency response, it is important to ensure that all the prescribed steps were taken.  The required steps can be diagrammed visually within a Process Map.  In this case, all available actions were taken to attempt to reverse the allergic reaction. (View the Process Map of the appropriate food allergy response by clicking “Download PDF” above.)

For reasons as yet unknown, food allergies have been increasing over recent years.  This has resulted in a greater risk for anaphylactic reactions, which can result in serious injury and even death, usually from throat closure from swelling (known as severe laryngeal edema).

According to John Lehr, the Chief Executive Officer of  Food Allergy Research & Education:  “Avoidance is the only way to avoid a reaction, but we know accidents happen.  That’s the insidious nature of food allergies.”

Because avoidance is the only way to avoid an anaphylactic reaction, many schools and other public facilities have stopped offering any food containing peanuts.  Others have designated peanut-free zones to help those with allergies avoid contact with peanuts.  (Although peanut allergies are not the most prevalent, they are the most dangerous, both from reaction severity and likelihood of contact.)  Certainly, snacks containing peanuts must be clearly marked as such.

Because of the high risk of serious injury or even death from food allergies,  please pass the word about food allergies.  If you are an allergy sufferer, ensure that you have multiple epinephrine auto-injectors that have not expired.  It may save your life.  (Although up to 40% of anaphylaxis victims require two or three epinephrine injections, death after receiving injections is extremely rare.)   Also note, from John Lehr:  “We tell people that their last reaction is not an indication of their next reaction.  Don’t think because you have not had a severe reaction that you can’t have one.”  If you provide food to the public or children, consider removing peanuts from your  kitchen and at the very least, clearly mark anything that does contain peanuts.   Remember, the risk from food allergies is very real, and can be very severe.

You can see the cause-and-effect relationships that led to this tragedy, as well as the Process Map discussing anaphylactic response, in visual form, by clicking “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

Heart-Lung Transplant Blood Type Mismatch

By ThinkReliability Staff

On February 22nd, 2003, a patient at Duke University Medical Center died after receiving her second heart-lung transplant.  The first transplant she received was rejected by her body due to a blood type incompatibility (she was Type O, the organs were Type A).  The loss of her life was tragic enough, but it was compounded by the fact that the two rare heart-lung block donations she received could have saved the lives of others as well.

We can perform a thorough root cause analysis built as a Cause Map that can capture all of the causes in a simple, intuitive format that fits on one page.  First we determine the impacts on the organization’s goals as a result of this incident.  The death of a patient was an impact to the hospital’s patient safety goal.   The surgeon, who knew the patient well, was devastated. The loss of the organs was an impact to the patient services goal.  The compliance goal is impacted because patient death due to blood incompatibility is considered a “Never Event” and a “Hospital-Acquired Condition”.  These types of events may require reporting by the accrediting agency and also may impact reimbursement to the hospital for costs incurred as a result of these errors.

Once we’ve determined the impacts to the goals, we can ask “Why” questions to determine the cause-and-effect relationships that resulted in those impacts.  The patient died because her health condition deteriorated after a second transplant surgery was performed.  Her body rejected the first set of organs because the blood type of the first transplanted organs was incompatible with the patient’s blood type.

The mismatched blood type organs were transplanted because the procuring surgeon (sent to pick up the organs) was not told of the blood type, so he could not perform an effective blood matching.  Donor services offered organs with the incorrect blood type because they didn’t ask what that was, possibly because the surgeon had specifically asked for the organs for this patient, and they assumed that a surgeon wouldn’t ask unless the blood type was correct.  The surgeon didn’t verify the blood type of the organs because he assumed that donor services wouldn’t offer an organ of the wrong blood type (which is normally the case, per their regulations).  The mismatch was discovered in the laboratory, but not until too late in the procedure, because the surgery must begin while the organs are en-route, due to limited viability of the organs.

In a previous blog, we discussed the process that is generally used to ensure appropriate blood type matching for blood transfusions.  A similar process to ensure that organ donations are also blood-type compatible.

This tragic incident demonstrates the problem in making assumptions, and it shows us some areas where transplant safety can be improved.  Although this was a very rare case, both hospitals and the donor services are making improvements to their systems to ensure this never happens again.

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.