Tag Archives: patient safety

Root Cause Analysis

Severe Injury to Baby at Birth

By ThinkReliability Staff

In November 11, 2005, a woman in labor checked in to an Army Medical Center in Hawaii.  The mother was placed in the care of a second-year medical resident.  The fetus showed signs of distress throughout the day, and “took a turn for the worse” at approximately 5:00 p.m.  However, the child was not delivered until nearly 6:00 p.m. when the fetus was “almost dead”.  The baby was born with the umbilical cord wrapped around her neck and was turned over to another team.  On this team, a first-year intern placed an oxygen tube incorrectly, resulting in oxygen being delivered to the baby’s stomach instead of her lungs for approximately 40 minutes.  The child now has severe brain damage and the family was awarded a $11 M settlement for her care.   This is the fourth large settlement this hospital has made relating to errors made from 2003-2007, with an average of $11M per year to settle the lawsuits.

There are several  impacts to the goals of the medical center; namely, the impact to patient safety resulting from the injury to the child, the impact to the organizational goals from the settlement, the impact to patient services from the delay to the birth, and the impact to the time and labor goal for additional work required as a result of the issues with the child.  Our analysis begins with these impacts to the goals.

The injury to the child was caused by a lack of oxygen, caused in part from insufficient oxygen before the birth and in part because of insufficient oxygen after the birth.  The baby did not have sufficient oxygen before birth because the umbilical cord was wrapped around her neck and her birth was delayed, due to a “lack of communication” between the second-year resident and her supervisor who were charged with the mother’s care.  More detail on this lack of communication is not currently available; however, from the perspective of the  medical center involved, this is a key place where more detail needs to be added to the Cause Map once it is available.

The baby had insufficient oxygen after birth because the oxygen tube placed to increase her oxygen levels was feeding into her stomach rather than her lungs.  The tube was misplaced by a first-year intern who was being insufficiently supervised.  (Note that the reports don’t say this anywhere, but if you have an intern under supervision who places a tube incorrectly, you can conclude that the supervision was insufficient.)  Note this is another area that requires more detail for the investigation to be complete in order to find effective solutions.  As with any investigation the level of detail in the analysis is based on the impact of the incident on the organization’s overall goals.  Because of the extremely high impact on patient safety, the analysis for this issue should be quite detailed.

Root Cause Analysis

Brain Damage Resulting from Aggravation of Underlying Mitochondrial Disorder by Childhood Vaccinations

By ThinkReliability Staff

The Federal Court Division of Vaccine Injury Compensation (DVIC) ruled on November 9, 2007 that a child’s parents would receive compensation due to a vaccine injury.  Recently the amount of compensation was named – $1.5 million plus $500,000 a year for treatment.  There has been much discussion about what the award means.  With a charged issue such as this one, wording is very important.  The court’s wording in this case is as follows:

“DVIC has concluded that the facts of this case meet the statutory criteria for demonstrating that the vaccinations CHILD received on July 19, 2000, significantly aggravated an underlying mitochondrial disorder, which predisposed her to deficits in cellular energy metabolism, and manifested as a regressive encephalopathy with features of autism spectrum disorder.”

With a very careful reading of the court’s decision, we can put what the court determined was applicable to the case in a Cause Map, or visual root cause analysis.  (I’ve also recorded the chronological information in a timeline, used to assist with our understanding of the issue.  The information from the timeline is also from the ruling.)

First we can enter the impacts to the goals in the outline.  The patient safety goal was impacted because a child wound up brain-damaged (or with encephalopathy).  The resulting payment of over $1.5M is an impact to the financial goals of the vaccine injury board.  Based on the ruling, the vaccines aggravated an underlying condition, which can be considered an impact to the patient services and environmental goals.   Additionally, in this particular circumstance the child received vaccines not on schedule.  This could be considered an impact to the compliance goal.

Beginning with the most important goal – patient safety – we build the Cause Map.  The patient’s encephalopathy was determined to have been caused by an underlying condition that was aggravated by the receipt of vaccines against 9 diseases all at once.  However, the link between this and the encephalopathy isn’t yet clear.  Rather than just stopping our Cause Map, we can add a “?” in the middle of the cause-and-effect relationship, and highlight this unclear relationship.  This allows us to focus our attention.  Even with this question mark in the middle of the map, we can still do a lot to clarify the cause-and-effect causes.

For example, based on the child’s physicians’ diagnoses, we know that the underlying condition was a  mitochondrial disorder.  We also know that the child received vaccines against 9 diseases at once because she was behind on vaccines, having skipped some doses while she was ill.

Even with the uncertainty surrounding this analysis, the Cause Map can still provide clarity to the issue. It can also help lead to possible solutions (though adding more detail will allow for even more).  For example, doctors may adjust catch-up vaccination schedules based on this incident, resulting in fewer vaccines being given at once.

Never Event

Patient Physically Assaulted

By ThinkReliability Staff

On June 24, 2010, a patient at a Maryland Hospital was physically assaulted by security guards after trying to leave the hospital.  A patient who is injured or killed due to physical assault is one of the ‘Never events’, i.e. medical events/errors that should never happen.

We will look at the causes of this event in a Cause Map, or visual root cause analysis.  The information used to put together this analysis is from the legal filing.

On June 23, 2010, a man (who we’ll call “the patient”) was in a serious car accident and was airlifted to a Maryland Hospital.  He woke up the next day, after receiving treatment for blunt torso trauma and chest pain and asked for something to eat.  After some confusion, the patient realized that his identification bracelet was not his – it identified a female patient 13 years his junior.  At this point, he decided to leave the hospital and was stopped with a verbal and physical exchange with several security guards.  He eventually was able to leave successfully, and was treated at a second hospital for broken ribs, a sprained shoulder, a ruptured spleen, and a concussion.

As mentioned before, physical abuse of a patient is a “Never event”, and is an impact to the compliance goal.   More importantly, there was injury to the patient, resulting in an impact to the safety goal.   Because the patient was wrongly identified as needing surgery to remove a cancerous mass, there was the potential for the patient receiving unnecessary surgery, also an impact to the safety goal.  The patient has taken legal action against the employees involved (Employee Impact goal) and has filed a lawsuit against the hospital for more than $12 million (an impact to the organizational goal).   The misidentification of the patient can be considered an impact to the patient services goal.

We begin our Cause Map with these impacted goals.  The patient was beaten because employees were trying to restrain the patient to keep him from leaving, and restrained him in an inappropriate manner.  The employees were trying to get the patient to stay because they believed he needed surgery because he was misidentified.  At this point, the hospital involved should be asking “Where did our identification procedure go wrong?”  The next step in the investigation should be to look at the identification procedure to determine specifically which steps allowed the misidentification to happen.  Only once this is determined can appropriate corrective actions be taken to prevent future misidentifications.

Another area that requires more analysis is the patient restraint procedure.  The security guards in this instance were attempting to restrain the patient to prevent him from leaving.  However, they did this in an inappropriate manner.  The question is, why?  Were the guards not following the existing restraint procedure? If not, why not?  Or, is there no procedure for restraint?  Were the restraint expectations not clearly provided to the guards?  Again, until the specific breakdowns leading to this incident are uncovered, corrective actions will be generic and may not be effective.  To view a one-page PDF showing the investigation at this point, click on “Download PDF” above.

Never Event

Feeding Tube Misconnection Results in Patient, Fetus Death

By ThinkReliability Staff

Recent articles have related several stories of patients being injured or even killed by medical tubing mix-ups.  A product used other than intended that results in a patient death is one of the “Never Events” – events that should never happen at healthcare facilities.   An article in The New York Times discusses injuries and deaths caused by accidentally connecting food meant for a feeding tube through an intravenous (IV) line.    A specific incident mentioned in the article can be analyzed in a Cause Map to capture all of the causes in a simple, intuitive format that fits on one page.

In this case, a pregnant woman was prescribed a feeding tube to ensure that she and her baby were getting adequate nourishment.  The feeding tube was improperly connected to the intravenous (IV) line, causing liquid food to enter her veins, causing sepsis which killed her and her fetus.

One issue (cause) is that medical personnel made an incorrect connection.  Although there was no information given in the article, this would certainly be an area for the responsible organization to look at in more detail and determine if there are steps that can be taken to reduce the risk of these types of errors.  (Some organizations have found success with color coding the tubes, for example.)

However, another issue is that the tubes COULD be incorrectly connected in the first place.  The number of errors in feeding tube connections (discussed in an article from The Joint Commission Journal on Quality and Patient Safety) has led the U.S. Food and Drug Administration (FDA) to consider declaring these products unsafe.

The tubes become compatible with other tubing connections (such as IV) when needle-free connectors were adopted, to increase caregiver safety (by limiting exposure to needles).  Since then, there have been issues with the compatible tubing.  (A history of tubing issues is found on the PDF, which can be downloaded by clicking “Download PDF” above.)   And, feeding tube connections that are incompatible with other tubing lines are difficult to find.  There are many causes given for the delay of developing incompatible tubing, including resistance from the medical industry, difficulties with the FDA approval process, and a delay in forwarding requirements for incompatible tubing.  This delay is mainly attributed to waiting for an international group to develop a recommendation regarding tubing, which is expected to take several years.

The FDA has an expedited review process which allows approval of a device if it works like an already approved device, regardless of whether that device is safe, or has been recalled.  Because compatible tubing devices have already been approved, new devices that use the same – compatible – connection can go through this expedited process, whereas incompatible connections can not.  Without federal agencies requiring change, it’s been difficult getting manufacturers to update their products.

View the problem outline, Cause Map, and timeline of tubing issues by clicking “Download PDF” above.

Never Event

Cardiac Arrest Due to Leaky Equipment

By ThinkReliability Staff

A patient death associated with equipment that does not perform properly is one of the “Never Events” (i.e. events that should never happen).  A case where a leaking piece of equipment caused the cardiac arrest of a child is described by the ECRI Institute.  We can record this information in a Cause Map, or visual root cause analysis in order to show the relationships between the causes and suggested solutions.  The root cause analysis investigation can be seen by clicking on “Download PDF”.

Because a patient suffered cardiac arrest, there was an impact to the patient safety goal.  We begin this impacted goal and ask “Why” questions to add more causes to the Cause Map.  The cardiac arrest was caused by suffocation.  The suffocation was a result of undetected excessive carbon dioxide (CO2) levels.  The levels were undetected because the child was under anesthesia (thus making it difficult to judge the breathing air quality) and because there was no device to detect high CO2 levels.  The CO2 levels were high due to rebreathing.  (The high CO2 levels were an impact to the patient services  and environmental goals as well.)

The rebreathing occurred because of a lower than normal fresh gas (breathing oxygen) flow.  With a breathing system of this type, the rebreathing (or taking in exhaled CO2) is inversely proportional to the fresh gas flow.  As the gas flow decreases, the rebreathing increases.  The reduced fresh gas flow was caused by a leaky humidifier.  (The leaky humidifier can be considered an impact to the property goal.)  The leaky humidifier was caused by an unrepaired pressure drop through the gas flow passages.  The pressure drop was caused by an inadequate seal on those passages due to two (of four) loose screws that were apparently not noticed.

The leak had been detected during the pre-use test of the equipment.  The leak was believed to be repaired, but instead of performing another pre-use test of the equipment, the system was put together, and a test was done on the whole system.  The system has a higher allowed leak rate than each individual piece of equipment, so the fact that the leak was not in fact repaired was not noticed.

Some of the suggestions given by ECRI Institute to prevent this kind of incident from recurring are to install a CO2 detector on the breathing circuit, ensure the anesthesia equipment is on a regular inspection and maintenance program, and to redo individual equipment tests after repairs.

Never Event, Root Cause Analysis

Patient Death from Restraint

By ThinkReliability Staff

A patient death associated with the use of restraints is a “never event” as defined by the National Quality Forum (NQF).  A recent death at a St. Louis, Missouri hospital has placed the hospital at risk of being terminated from the Medicare program after two other recent patient deaths associated with restraints and inappropriate patient seclusion.

In order to shed some light on the issues surrounding this most recent death, we can begin sifting through the facts in a root cause analysis.  First, we enter the necessary information into the outline, including the impact to the goals (to view the outline, timeline and Cause Map, please click on download PDF above).  The impacts to the organization’s goals begin the Cause Map, or visual root cause analysis.  We can continue to add more detail to the Cause Map by asking “Why” questions.

We will then discover that the patient died of suffocation.  An early concern was that the patient’s airway was blocked by gum, but the doctor determined that was not the case.  (We can leave this cause on the Cause Map but can cross it out once it has been determined that it did not contribute to the incident.)  The patient suffocated when she was left facedown on a beanbag chair, after being given a sedative that slowed her breathing, and was not properly monitored for breathing or a pulse.    The patient had been restrained and sedated after threatening and assaulting the hospital staff.  The patient was not constantly supervised, as suggested, possibly due to a lack of staff.

When the charge nurse arrived several minutes later and determined the patient was not breathing, resuscitation was not immediately begun (either mouth-to-mouth or CPR). She first left to get a light, then a stethoscope, then to find the patient’s nurse.  After the patient’s nurse returned, she left to call a “Code Blue”.  The first aide that arrived was told not to begin CPR or mouth-to-mouth because there was no breathing mask.  She did anyway.  Nine minutes later, the doctor inserted a breathing tube.  The staff attempted to restart the patient’s heart but were unsuccessful and she was pronounced dead.

To determine what actions can be taken so that this never happens again, first we have to do a little more research into a few specific areas.  First there needs to be a thorough investigation on the restraint procedure at this hospital.  Because a patient died in restraints, some aspect(s) of the restraint procedure must be improved.  To improve the procedure, however, first we have to know what the hospital staff  actually did, step by step, in this case (and others).  Then we should look at expectations and/or requirements for supervision of patients who are being restrained, or given sedatives, or who, based on their behavior, require constant supervision.  For example, patients who are held facedown need extra supervision to make sure their breathing is not constricted.  Additionally, it may be appropriate to turn the patient back face up once the sedatives begin to work.

The patient’s death was caused in part by the delay in resuscitation.  Beyond the delay in recognizing the patient’s respiratory distress, the expectations for staff in this situation need to be addressed.  Because the charge nurse was fired, it seems that the hospital did not think she properly performed her expected duties, but why?  Perhaps the staff does not understand what they should do in this case, or doesn’t have the necessary equipment (such as a breathing mask) readily available.  Although refresher training might be in order, we don’t stop there.  We need to figure out all the things that are keeping our staff from being able to do what they need to for their jobs and remove those obstacles – BEFORE this happens again.

To view the outline, timeline and Cause Map, click on “Download PDF” above.  To learn more about this incident, please see the news story.

Root Cause

Errors in Translated Medication Instructions

By ThinkReliability Staff

It’s well known that instructions on medication (both prescription and otherwise) can be confusing and lead to potentially lethal consequences.  (See our previous blog on the topic.)  Now imagine how much more danger there is if you don’t speak the language in which the instructions are printed.

A recent study published in the American Academy of Pediatrics Journal “evaluated the accuracy of translated Spanish-language medicine labels among pharmacies in a borough with a large Spanish-speaking population. ”  The study found significant issues with label accuracy with a popular language in an area with a large population of speakers of that language.  You can imagine how these results could get even worse for an area that had a smaller number of Spanish speakers, or for patients who speak a less common language.

One of the most striking examples was a man who received heart medication that was to be taken once daily.  The instructions were only partially translated and “once” (which means 11 in Spanish) was left on the instructions.  The patient took 11 pills (instead of 1) a day.

The study found an overall error rate of the prescription instructions that had been translated into Spanish by computer of 50%.  (86% of the pharmacies surveyed translated their prescriptions with a computer program.)  It is likely that patients with the incorrectly translated prescription instructions took the medicine incorrectly, resulting in the potential for serious harm, or even death.  This is an impact to the patient safety goal.  The rate of errors made by the computer means more work for pharmacists and translators due to the corrections that must be (or should be) made.  (Obviously this is not always happening.)  Patients receiving instructions they do not understand can be considered an impact to the patient services, compliance, and organizational goals.  (The study was performed in the Bronx, New York.  It is a law in New York City for pharmacy chains to provide translated labels for the top seven foreign languages in the area.)

Patients do not understand the directions because the patients do not speak English and the instructions are either not translated, or are translated incorrectly.  The instructions may be translated incorrectly because the computer program translates them incorrectly and there is an inadequate verification of the computer translation, because the pharmacist does not speak the language and/or there is no translator available (likely due to lack of funds or an uncommon language).   The instructions may not be translated if the pharmacy has no translating capabilities, also likely due to cost or an uncommon language.

An obvious suggestion is to improve the accuracy of the computer programs that do the translating, perhaps standardizing the translations among the different programs that do the job.  Pharmacists could also be provided with a guidebook of translations for standard pharmacy terms (such as take orally).  Additionally, translation software could be added to the computer programs currently used by pharmacists.

I have a simpler suggestion that I borrowed from the aviation industry.  I noticed the last time I flew that instead of having translations of the safety instructions in a dozen different languages, there were practically no words at all.  Instead, the airline used picture instructions.  I suggest doing something similar with medications.  (See my example of a picture for “take orally” on the PDF.  View the root cause analysis investigation and my picture by clicking “Download PDF” above.)

Because of the risk involved, it’s clear something needs to be done.  Prescription instructions are hard enough to understand in English, much less poorly translated into another language.  I’m sure suggestions will keep coming in, and surely some smart folks out there will come up with a way to reduce the potential for confusion and injury.

Root Cause Analysis

Applying the Proposed FDA Initiatives to Fatal Radiation Overdose

By ThinkReliability Staff

Recently, we posted two blogs about medical radiation overdoses resulting from cancer overdoses –  a patient who overdosed on radiation therapy for breast cancer, and a second patient who overdosed on intensity modulated radiation therapy for tongue cancer.  Because of the risk of these types of incidents, proper control of radiation in medical settings has become a high priority for several investigations.  Recently, the U.S. Food and Drug Administration (FDA) released an initiative to control unnecessary radiation exposure from medical imaging.  Many of the initiatives to reduce exposure from medical imaging can also be applied to reduce exposure from
radiation therapy.

We will look at one of our previous blogs – the intensity modulated radiation therapy overdose – and discuss how the initiatives proposed by the FDA may have prevented the death of Scott Jerome-Parks.  There are two radiation protection concepts for the initiatives – justification for use of radiation-related procedures, and optimization of the dose during the procedures.

The justification portion of the initiative aims to ensure medical justification and informed decision-making by patients and their doctors.  In order for the decisions to be informed, the FDA notes that patients must have comprehensive understanding of both the risks and benefits of the use of radiation.  If patients were more aware of the risks of the use of radiation, it’s possible that Jerome-Parks and others would have chosen alternative approaches or would have selected facilities based on their experience or safety rating.  Currently, because reporting requirements for errors involving radiation are inconsistent (or there are none at all), it’s nearly impossible for patients to make these sorts of comparisons.

Another issue raised by the Jerome-Parks case is the lack of safeguards on the radiation equipment itself.  Jerome-Parks received seven times the radiation dose on three occasions, and nobody noticed.  The FDA proposes that equipment designed to deliver radiation be equipped with safeguards that optimize radiation doses and/or provide alerts when radiation exceeds a reference level or range.  These safeguards would alert providers when radiation doses are higher than expected, giving them another chance to verify that the settings are correct.  Hopefully this will prevent many occurrences of radiation overdose.

The FDA has also noted the lack of training and quality assurance practices for some radiation delivery practitioners.  Several medical organizations are attempting to create standardized training and quality assurance methods to provide practitioners with the information they need to properly use radiation delivery equipment.  The FDA is also planning to partner with the Center for Medicare and Medicaid Services (CMS) to incorporate appropriate quality assurance practices into accreditation and participation criteria for medical facilities, further
supporting the safe use of radiation delivery equipment.

Looking at the two previous radiation overdose cases, we can see the detrimental effect of radiation therapy when not used properly.  Because of the great potential impact to patient safety, all involved parties MUST work together to ensure less patient risk from radiation therapy.

Root Cause Analysis

Another Fatal Radiation Overdose from Cancer Treatment

By ThinkReliability Staff

Last week’s blog was about a fatal radiation error that killed a patient.  After this radiation overdose, New York State health officials issued a warning to healthcare facilities to be careful with linear accelerators used to deliver radiation therapy.  However, on the day of this warning, another patient at a different facility in New York was beginning radiation treatment that would eventually cost her life.

The circumstances of this case are very similar to those of the previous radiation therapy overdose.  The patient, Alexandra Jn-Charles, was receiving radiation therapy as a follow-up to surgery for an aggressive form of breast cancer.  Instead of using the type of linear accelerator with a beam frequency modulator discussed in the last case, the radiation therapy used on Ms. Jn-Charles was from a linear accelerator that was modulated with a metallic block known as a wedge.  However, for her radiation therapy, the wedge was mistakenly left out of the machine, resulting in 3.5 times the desired amount of radiation reaching the patient.  The error was not noticed throughout her 27 days of radiation treatment.

As we did with the last case, we can look at this issue in Cause Mapping form.    First we can record the basic information of the issue in the problem outline.  We capture the what, when, and where in the top part of the outline, then capture the impact to the goals.  Here, the patient was killed, which is an impact to the patient safety goal.  The error resulted in a fine from the city, which is an impact to the organizational goal.  The patient received an overdose on 27 occasions, which is an impact to the patient services goal.  Additionally, there was a radiation overexposure, which we will consider an impact to the environmental goal.

We begin our Cause Map with these impacts to the goals.  The patient received an overdose of radiation therapy because the patient was receiving radiation therapy to treat her aggressive breast cancer.  (This treatment was following surgery and chemotherapy.)  The overdose occurred when the radiation was ineffectively filtered.  The wedge that filters radiation from the linear accelerator was left out of the machine.  The machine was programmed for ‘wedge out’ instead of ‘wedge in’ and the error was not noticed by either other therapists or physicists who did a weekly check of the machine.

The error was not noticed for 27 days.  Obviously the safeguards were inadequate, because they allowed a patient to be over-irradiated on 27 occasions.  However, it’s unclear whether there were no required over-checks which would have caught the error or whether these over-checks were not performed.

Because we are still lacking somewhat in information on what exactly occurred and what procedures exist, we would need to ask some more questions to complete this Cause Map before we are able to find effective solutions.  However, I’m sure that the healthcare facility involved, as well as New York State, is doing this right now and ensuring that this sort of error will never happen again.

To view the beginnings of this root cause analysis investigation, click on “Download PDF” above.

Never Event, Root Cause Analysis

We Regret to Inform You We’ve Removed the Wrong Leg . . .

By ThinkReliability Staff

Performing surgery on the wrong body part or wrong-site surgery is a “never event” as defined by the National Qualify Forum (NQF), and can have serious health consequences for a patient.

We can use a Cause Map to determine some ways to prevent wrong-site surgery. Some of the common errors leading to wrong site surgeries are presented in the Cause Map found on the downloadable PDF. They include: time pressure, lack of paperwork, misreading radiography, not marking or incorrectly marking the surgical site, and marking the wrong site.

Once the root cause analysis is complete, solutions are brainstormed and placed with the cause they control. In this example, we use the solutions to create a basic Process Map for the surgical preparation procedure to prevent wrong site surgeries. The solutions are numbered based on the order they appear on the Process Map. It’s clear that consistent adherence to this Process Map would result in fewer wrong-site surgeries.

Click on “Download PDF” above to download a PDF showing the Cause Map and Process Map.

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