Tag Archives: surgery

Root Cause Analysis

Accidentally Ingested Wire Bristles

By Kim Smiley

There have been a number of documented cases of people accidentally swallowing wire bristles from the brushes commonly used to clean grills.  If ingested, the bristles can cause significant pain and have the potential to puncture organs, including the intestine which can lead to dangerous infections.  There isn’t a lot of data available to determine how often this occurs, but a recent report discussing six cases of ingested wire bristles at a single hospital in a one year period hint that this may be more common than many realize.

This issue can be analyzed by building a Cause Map or visual root cause analysis.  The first step in creating a Cause Map is to determine how the issue impacts the overall goals of an organization.  In this example, we’ll consider the organization the general public and the main impacted goal is the safety goal since there is a risk of serious health issues.  Causes are now added to the Cause Map by asking “why” questions.  Why is there a risk of serious health issues?  Because there is the potential to swallow a wire bristle and the wire bristle can do a lot of damage within the body.   (To view a high level Cause Map of this issue, click “Download PDF” above.)

Continuing the “why” questions, we would now ask “why” is there a potential to swallow a wire bristle?  This possibilities exists because people may inadvertently swallow the bristles without realizing it, the bristles come from wire brushes that are often used to clean residential grills and the bristles sometimes fall out of the brushes and stick to the grill.  People may inadvertently ingest the bristles because the bristles can stick to meat and the texture can hide the presence of the bristle.  Many people are also unaware of the potential danger of eating a wire bristle so they aren’t looking to find bristles.  Investigation into this issue has not found any defects that are causing bristles to fall out.  No one brand or type of grill brushes has been singled out as the culprit in these causes, but a worn grill brush is more likely to shed bristles than a new brush.

All six patients in the report did make full recoveries after treatment.  In three of the cases, the wire bristles were stuck in the throat and required only laryngoscopic removal; the other three cases required more invasive surgery to remove the object.

The best way to protect yourself from the possibility of this occurring is to inspect the grill after using a wire grill brush or to find another method to clean your grill.  The Consumer Product Safety Commission has asked that medical professions or consumers report any incidents of swallow grill brush bristles to http://www.saferproducts.gov to help monitor this issue.

Root Cause

Airman Loses Both Legs After Gallbladder Surgery

By ThinkReliability Staff

A former member of the US Air Force lost both legs after a routine gallbladder surgery and was medically retired.  During the surgery, his aorta was lacerated.  Subsequent delays meant his legs were without blood flow for hours.

After the damage to the aortic laceration was repaired, still more time passed before the patient was transferred to a civilian hospital for treatment.  The Air Force Medical Center did not have a vascular surgeon on-site.  By the time the legs were removed, the patient had lost more than 2/3 of his blood volume.

Multiple issues contributed to the injuries received by the airman.  We can examine these issues in a visual root cause analysis presented as a Cause Map.  First we determine the impacts to the goals.  The patient safety goal was impacted due to the potential for patient death during the surgery and aftermath.  Although there was no disciplinary action taken by the Air Force, a $54.8 million lawsuit has been filed that claims negligence.  Last but certainly not least, the loss of both of the patient’s legs can be considered an impact to the patient services goal.

We begin with the impacted goals and ask “Why” questions to determine the cause-and-effect relationships that led to the impacted goals.  In this case, the patient’s legs had to be removed after they were without blood flow for several hours.  The blood loss was caused by a laceration to the aorta, made during the gallbladder surgery, and the subsequent accidental suturing of the aorta during the repair.  The repair to the aorta was delayed as it was not immediately recognized.  A surgical resident was performing the operation, and it is likely inexperience and lack of supervisor from the supervising surgeon contributed to this delay.  Additionally, although the operating room staff was unable to get a blood pressure reading from the patient, it was assumed that the machine was malfunctioning. After the aorta repair, there was further delay in recognizing and treating the loss of blood flow to the legs.  As there was no vascular surgeon on-site, the patient was eventually transferred to a civilian facility, where both legs were amputated.

The facility has not commented on the case and so it is unclear what actions might be taken to protect patients.  There have been several charges of negligence at the facility in recent years.

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

Root Cause Analysis

Patient Brain Damaged Due to Malpractice and Surgeon Inexperience

By ThinkReliability Staff

When complications occur during surgery, an experienced surgeon and surgical team can help ensure a positive outcome for the patient.  Inexperience can lead to problems – in this case, brain damage.  A special concern in this case is that hospital documentation advertised that the surgeon was accredited when he did not meet the requirements.  They were convicted of fraud.

When a patient suffers brain damage, the patient safety goal is impacted.  Any time the patient safety goal is impacted, an investigation  should be performed.  In this case, we can look at the issue in a Cause Map, or visual root cause analysis.

With the Cause Mapping approach, we begin with the impacts to the organization’s goals.  In addition to the brain damage, the patient also suffered from  loss of eyesight, another impact to the patient safety goal.   The  doctor was convicted of malpractice, which is an impact to the employee.   Additionally, the hospital was convicted of fraud, which can be considered an impact to the compliance goal.  The hospital was assigned $178 million in compensatory damage and $10 million in punitive damages.    Last but not least, the patient services goal was impacted due to the uncorrected leakage in the patient’s abdomen.

We can begin with the first patient safety goal and ask “why” questions to add more detail to the map.   In this case, the patient suffered brain damage as a result of a stroke.  The patient suffered a stroke because of uncorrected leakage in the abdomen.  The leakage occurred as a result of bariatric surgery, potentially due to the inexperience of the surgeon.  In addition,  the leakage was not treated for 8 days.  Again, it is believed that the inexperience of the surgeon contributed to insufficient patient care.

The fact that the leakage was untreated for 8 days was considered reason for malpractice.  While the patient was on a respirator due to his stroke, he was not treated with eye drops, resulting in a retinal burn that left him blind.  The hospital was convicted of fraud because it used documentation with the accreditation seal from the American Society Bariatric Surgery’s Center of Excellence referencing the surgeon who performed this surgery.  However, the surgeon did not meet the requirements for accreditation.  He had performed an insufficient number of surgeries and had not taken an adequate number of bariatric education courses to meet accreditation  requirements.  The use of the seal in hospital documentation was determined to be fraud.

This case reinforces the necessity for patients to be active in their own care in selecting their physicians.  Specifically, patients should perform  their own investigation of their surgeon’s qualifications.  However, in this case accurately determining those qualifications would have been difficult due to the associated fraud.  If the patient had asked how many surgeries the surgeon had performed, he may have decided to go elsewhere.

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

Root Cause Analysis

Surgical Tools Cleaned with Hydraulic Fluid

By Kim Smiley

In late 2004, a healthcare system in North Carolina realized that it had been using elevator hydraulic fluid instead of cleaning detergent when cleaning its surgical tools.  Before the problem was realized, the improperly cleaned tools were used on 3,650 patients.  An analysis by infection control, material and toxicology experts determined that the sterilization process of the tools was not affected and that trace metals left on the tools from the hydraulic fluid were in too small of amounts to cause risk to patients.  Nonetheless, the potential for these safety risks is an impact to the patient safety goal.  Additionally, the fact that improperly cleaned tools were used on patients is an impact to the patient services goal.  Lastly, the re-cleaning and sterilization required for the tools is an impact to the labor goal.

This incident can be examined in a Cause Map or visual root cause analysis. The first step is to define the problem with respect to the impacts to the organization’s goals, as described above.  The second step is to begin with the impacted goals and ask “why” questions to diagram the cause-and-effect relationships that led to the incident.  In this case, improperly cleaned tools were used on patients because the tools were cleaned with hydraulic fluid and the tools were used on patients.  The tools were used on patients because it was not immediately obvious that they had been improperly cleaned.  The tools did retain an oily feel; however, the tools are lubricated as part of the cleaning and sterilization process to avoid rust and ensure proper operation and so may retain an oily feel.

The tools were cleaned with hydraulic cleaning fluid because the hydraulic fluid was stored in the cleaning detergent containers and delivered to system hospitals.  The containers were filled with elevator hydraulic fluid by an elevator maintenance company and left where they were picked up by the cleaning detergent provider.  The provider did not realize that the containers had been tampered with (as they were not relabeled and either had no indication of tampering or were not inspected for tampering) and so delivered them to the hospitals for use.

Once the problem was realized, the affected tools were re-cleaned and sterilized and the detergent replaced.  Follow-up monitoring was performed and appointments offered to the affected patients, despite determination that the sterilization process was not affected and that the trace metals were not in sufficient amounts to affect patient safety.  Employees were trained in container management and a process was added to verify the status of containers delivered to and used in the hospital.  Additionally, a process to determine when product integrity has been compromised.  An external review by the Centers for Medicaid and Medicare Services has certified that the impacted hospitals are in compliance with standards based on these implemented corrective actions.

To view the Outline, Cause Map and implemented solutions, please click “Download PDF” above.  Or click here to read information provided by the affected healthcare system.

Root Cause Analysis

Working to Ensure Safe Assembly of Surgical Tools

By ThinkReliability Staff

A 2-month old was undergoing a cystoscopy to incise a ureterocele in the bladder.  During the endoscopic procedure, a resectoscope was used to remove the unwanted tissue.  However, during the operation part of the resectoscope slipped off, exposing a hook-shaped internal piece of the instrument.  Fortunately the patient was not injured; however the potential for injury was very real.  How did the medical instrument come apart?

The first step in an incident investigation is to determine what the problem is and what the impacts to the organization’s goals are.  In this case, the problem is fairly straightforward – the resectoscope fell apart while inserted into a patient.  Although details are scant in this case, the problem statement is filled out as completely as possible to document what occurred.  The second part is to determine the impact to the organization’s goals.  An obvious impact is the potential harm to the patient, related to the hospital’s patient safety goal.  There was also the possibility of legal action, which would impact property goals.  Finally, there likely was the need to redo the procedure, taking additional time, thus impacting the organization’s labor goal.

The second step is to build a Cause Map by asking why an event occurred.   The Cause Map visually depicts what led to the young patient being exposed to harm.  In this case, the three goal impacts converge on the event where the hook electrode became uncovered.  It should be noted that multiple causes led to the patient being exposed to harm; if the resectoscope had been broken but had not been in use, then it would not have mattered.  It is crucial to include all reasons on the Cause Map because those reasons may be key to developing the optimal solution.

Facts that need to be captured about an investigation can be included in evidence boxes on the Cause Map.  They can provide the reader with important background information.  In this example, information about the hook electrode is included so that the reader knows what it is.

Reviewing the complete Cause Map, it turns out that the resectoscope was incorrectly assembled.  The third step in an incident investigation is to develop a set of solutions.  Remembering that all causes are necessary to produce an effect, the investigation team can brainstorm solutions to eliminate or counteract contributing causes.  In this case, three possible solutions were developed.  It is possible that the resectoscope could be designed differently so that the insulation would not be able to slip.  While this is a reasonable long term solution, it would not immediately remedy the problem.  Another solution would be to verify that the instrument is in working order before using on a patient.  This may have occurred, but it should be included until ruled out as a potential solution.  A final idea is to revise the assembly procedures for the resectoscope.  This is in fact what the FDA recommended.

The FDA recommends that the manufacturer’s assembly procedures always be carefully followed.  A process map is another helpful tool to determine where something went wrong.  The organization can build a process map depicting the ideal sequence of events, then compare that with what actually occurred.  The problem may not be in the instructions; the instructions might be perfect!  However, if someone doesn’t follow those instructions correctly, the process isn’t going to reach the desired outcome.

At this point, the investigation team might go back to the Cause Map to elaborate on the why the resectoscope was incorrectly assembled.  This might generate new solutions and changes to the ideal process map.  Through this iterative process, an optimum solution can be found.

This event was reported as part of the FDA’s MedWatch program.  The FDA encourages health professionals to voluntarily report problems on medical devices.  For more information on the MedWatch program, please visit their website.

Never Event

Surgery Performed on Wrong Eye

By Kim Smiley

There are few medical errors scarier than a wrong site surgery.  The idea that you could go to sleep and wake up having had a procedure performed on the wrong body part is terrifying.  Unfortunately, this is exactly what happened to a family in Washington recently.

On April 13, 2011, a surgeon performing a routine procedure to correct a wandering eye mistakenly operated on the wrong eye of a four year old boy.  In this case, the wandering eye was caused by a muscle that was too strong so the surgery was performed to weaken the muscle.  It’s unclear at this point whether the wrong site surgery will have any lasting impact on the patient’s vision, but the patient’s mother has stated that the previously healthy eye is now wandering.  A specialist who examined the boy post-surgery stated that the eye needs to completely heal (about 5 weeks) until any determination can be made about long term consequences.

How did this happen?  How does a surgeon perform a procedure on the wrong part of the body? And most importantly, how do we prevent these types of errors in the future?

The investigation of this incident is still ongoing, but a Cause Map of the incident can be started and then expanded as more information becomes available.  A Cause Map is a visual root cause analysis that lays out the causes of an incident in an intuitive format.  Once the Cause Map is complete, it can be used to develop solutions to help prevent future problems. Click on “Download PDF” above to see an Outline of this incident and the initial Cause Map.

In this example, it isn’t clear yet how the mistake was made.  Findings from the investigation so far have determined that the correct eye was marked before surgery, but statements by the surgeon indicate that the mark may have been accidentally covered by a nurse. The hospital has protocols in place that require checking and double checking the surgery site, but it’s not clear why they weren’t followed.  Once the investigation is complete, the hospital will determine what solutions need to be implemented to ensure that this doesn’t happen again.

Root Cause Analysis

Aging Surgeons

By ThinkReliability Staff

Over 20% of today’s physicians are over the age of 65.  Should this be cause for concern?  After all, we rely on our doctors to take care of us when we are often at our most vulnerable.  While increased age means increased experience, there are also down sides.  Age can bring with it a decrease in physical and mental capabilities, as well as a reluctance to adopt newer technologies.  At least this is what multiple studies have hinted at over the past few years.

The problem is that such a “decrease in capabilities” is highly subjective and difficult to measure.  Surgeons rely on a variety of cognitive and tactile skills in their craft – steady hands, learning new techniques, composure under stress, communication skills, and so on.  As highly trained professionals, it is sometimes difficult to decide when it is time to call it quits.

Furthermore, in the United States, age-based discrimination is outlawed in most industries except where regulated.  For instance, airline pilots and air traffic controllers are both subject to earlier-than-average retirements due to public safety concerns.  Many federal and state public workers, such as corrections officers and firefighters, are similarly limited. It’s difficult to argue that some physicians don’t make similar split-second, life-and-death decisions – especially surgeons.

The associated Cause Map visually lays out the dilemma.  Surgeons who aren’t performing adequately do so for two reasons.  First, they have a medical condition precluding them from performing to standards.  (Note that to keep this Cause Map simple, other issues such as mental health problems, addiction, and failure to maintain their continuing education were not examined.)  Second, they are allowed to continue practicing.

Such physicians continue after their abilities are impacted for a number of reasons.  Some might be unaware of their condition or unwilling to accept it, both stemming from a belief that they are still competent to practice.  Additionally, current processes at most hospital are slow to identify such physicians.  Most hospitals rely on co-workers to identify such doctors, clearly a highly subjective and ethically complex system.  Age-based screening is not common at many hospitals, partly because of resistance from hospital staff.  In fact, only 5-10% of hospitals have directly addressed this issue.  Labeling doctors as “unfit to practice” isn’t necessarily a bad thing.  If such doctors are identified early, patient safety is enhanced.  Additionally, early identification can sometimes allow those doctors to continue practicing in a controlled and safe environment.

Now that the problem has been laid out, the next step is to look for possible solutions.  It’s clear that little can be done about age-related deterioration.  So the focus moves to the other branch of the Cause Map.  Here there are a number of possibilities.  While age-based screening is certainly an option, it’s not the only one.  For instance, including hospital staff in making decisions might also help decrease resistance to identifying deficient physicians.  Additional training on the impacts of age might make co-workers more willing to discuss their concerns.  Or doctors might be more willing to adapt to their limitations if regular screening can identify possible health problems.

While more research is needed to determine how extensive this issue is, it is clear that at most hospitals current procedures to identify deficient physicians are lacking.

Root Cause Analysis

Kidney Transplant Mix-up

By ThinkReliability Staff

On January 29, 2011, a kidney was transplanted into the wrong patient.  No one was injured, but this was known as a “near miss” – had things gone slightly differently, it could have resulted in severe consequences.  Namely, the patient who received the incorrect kidney could have been killed or seriously injured, had the kidney not happened to be compatible with that patient also.  (The kidney donor had Type O blood, known as the universal donor, which aided in the compatibility.)  The patient who was supposed to receive the kidney could have had a long wait back  on the transplant list.  Luckily, a new donor was found for the second kidney and a new kidney was found for the second donor fairly quickly.  Although there were no injuries, the high potential for injury results in an impact to the patient safety goal.

To try and help figure out what went wrong, we begin with the impacted goal and ask “Why” questions to fill out the analysis. We discover that there were two kidneys that arrived at the hospital simultaneously.  In order for the kidneys to be switched, the kidneys must have been mislabeled, or miss-identified once at the hospital.  The coordinating agency for transplants states that the packaging and labeling of the organs was correct.  We then turn our focus to the identification steps of the organ once at the transplant center.

To aid in determining where process improvements can be made, first we need to define the process.  We can do this with a process map – a step by step instruction of how a process is performed.  In this case, the steps for transplants have been developed by an outside agency – the United Network for Organ Sharing (UNOS).  We can outline these steps in our Process Map.  Because of the high risk for consequence should an error occur, the process is well-defined and consists of checks to ensure that mismatches do not occur.  The last highly publicized incident of a transplant error was in 2003 (see more about that incident here).

The hospital involved has not released details about what might have occurred in the process; however, it’s certain that they’re looking at the process with a fine-tooth comb and trying to implement improvements.  The transplant program has closed down while they’re doing so.

Root Cause

Patient Death from Complications of Liposuction

By ThinkReliability Staff

On July 18, 2008, a young mother of two went in for a routine tummy tuck (abdominoplasty).  Although liposuction was frequently performed along with the surgery, the patient had declined the liposuction option.  Although there were some complications related to low oxygen during the procedure, the patient was released to her husband that evening.  She was sick the remainder of the evening but assumed it was reaction from the anesthesia.  The next morning she woke with a severe headache that worsened until she asked her husband to call an ambulance.  The paramedic consulted with the attending physician and gave the patient morphine for her pain. The patient then went into convulsions and stopped breathing.  The patient was put into a chemically reduced coma to relieve swelling on her brain.  She never recovered and was taken off life support on July 31, 2008.

The medical examiner determined that it was likely that a fat embolism, a rare complication of liposuction, had prevented blood flow to her brain, causing her death. Because the patient had declined liposuction, it’s unclear how she ended up having the procedure.  It appears that the patient may not have known that she had liposuction, and hence, was not aware of the potential complications including fat embolisms, from liposuction.  The nurse who presented the surgical consent form to the patient said she hadn’t brought up liposuction because it was “implied” as part of a tummy tuck.

It is unclear if the outcome would have been different had the patient received treatment more quickly.  The patient was released to her husband the day of the surgery, as it was considered an outpatient procedure, even though there were complications related to low oxygen.  She was not taken to the emergency room until more than 24 hours after the surgery, possibly because of her and her husband’s insufficient understanding of the risks of liposuction.

The public inquiry into improvements to the healthcare system that might reduce the risks of similar incidents occurring (though the risks for fat embolisms causing brain blood flow blockage are very low) ended last week.  When the results of the public inquiry are released, our initial Cause Map can be updated and the potential action items resulting can be added.