All posts by Angela Griffith

I lead comprehensive investigations by collecting and organizing all related information into a coherent record of the issue. Let me solve a problem for you!
Root Cause

Amputated Leg Cremated by Hospital Against Patient’s Wishes

By ThinkReliability Staff

When a patient at a Chicago-area hospital had to have a portion of his leg amputated, he requested that it be returned to him for burial in accordance with his religious beliefs.  The hospital cremated it instead, and the patient has sued the hospital and the hospital rabbi, whom the patient informed of his desires.  The lawsuit was dismissed but an appeals court sent the case back for trial.

More information is sure to come out at the trial, but we can begin documenting the information that is known in a Cause Map, or a visual root cause analysis.  The Cause Mapping method begins by determining the problem in a problem outline.  The what, when and where is captured, as well as the impacts to the goals.  This is especially important in a case like this.  The patient might claim that the “problem” is that his leg was cremated, while the hospital would probably consider this to be the normal practice of disposed limbs.  Instead phrasing the problem as an impact to the organization’s goals (in this case, the hospital’s) agreement can be met.  In this case, the compliance goal is impacted because of a lawsuit against the hospital.  The patient services goal is impacted because a patient’s requests were not heeded, and because a patient did not understand the release forms presented to him prior to the surgery.

Beginning with an impacted goal, asking why questions will develop cause-and-effect relationships.  For example, asking the question “Why were the patient’s requests not heeded?” results in the cause “Patient’s leg was cremated.”  The patient’s leg was cremated because there appears to be no procedure for ensuring limbs are saved if requested because typical practice is to dispose of removed limbs.  Additionally, the patient signed two release forms which stated the hospital could dispose of the removed portion of the leg.

Clearly the patient did not understand the release forms, as he wanted the leg to be saved, not disposed of.  This is another impact to the patient services goal.  The patient is legally blind, and so was unable to effectively read the release forms himself.  In the lawsuit, the patient claims that the nurse who presented him with the forms explained them as consent forms for surgery and did not discuss that the forms also addressed disposal of the limb that would be removed.

Because the request for the leg was unusual, if the nurse who described the release forms was unaware of the request, it seems understandable that the portion discussing the disposal of the removed limbs (as was done in almost all cases), would not have stood out as something that the patient needed to have summarized.  However, this case has raised an issue with summarizing release forms to patients who are not able to read them.

The hospital has not discussed what steps it will take to reduce the likelihood of this type of issue recurring in the future.  However, some steps that may reduce the risk are to develop a procedure that would ensure special requests for removed body parts in surgery are followed.  Additionally, having release forms read out loud completely for patients who are unable to read the forms themselves would allow those patients to know all of what they are signing.

Root Cause

Epidural of Cleaning Fluid Results in Lasting Pain

By ThinkReliability Staff

A woman in labor was given an epidural of the skin antiseptic chlorhexidine after the container was accidentally switched with that of the epidural drug.  According to a neurologist, the lasting permanent damage was small, but the woman was hospitalized for two weeks, reportedly in severe pain.

The incident can be examined in a Cause Map, or visual root cause analysis, which begins by determining the impact to the goals.  In this case, the patient safety goal is impacted because of the risk of lasting damage.  (The risk is considered small because of the amount that was administered.)  This is a “never event”, or event that should never happen in a healthcare facility.  The patient services goal is impacted because of the cleaning fluid being administered instead of a proper epidural.  The labor/ time goal is also impacted by the investigation and hospital care for two weeks while the woman remained for treatment.

The next step is to perform an analysis, beginning with an impacted goal and asking ‘why’ questions.  In this case, the details that have been released show that the epidural was given with a cleaning fluid when the usual drug was confused with the chlorhexidine and administered when the patient requested an epidural.  The bottles of the two drugs were apparently switched, though at what point is unclear.  Obviously the check of the drugs was ineffective as the result was the wrong drug being administered to a patient.

More detail can be added to the Cause Map as it is discovered during an investigation.  The hospital involved is addressing the cause of the cleaning fluid being present in the same area as the medication by removing the cleaning chemical.  Said Anders Rehn, acting director of the hospital, “We consider this extremely serious.  Obviously this shouldn’t happen.  We have removed the containers so they cannot be switched. The chemical is no longer in the birthing clinic.”

Though this will strongly reduce the risk of this particular chemical being mistaken for a medication, the medication administration process should still be examined for improvement to reduce the risk of other medication errors.

Other chemical mix-ups have been in the news recently.  A restaurant mixed an odorless cleaning-compound lye used for de-greasing the deep fryer into iced tea after mistaking it for sugar.   The only woman who drank the tea received burns in her esophagus but is making a ‘miraculous’ recovery.  Long-term effects will be determined by ongoing tests and procedures.  It was also determined that an employee was burned by the chemical which had been placed in a sugar container.

Two weeks later, a boy drinking a milkshake complained it didn’t taste right.  The milkshake had been contaminated with cleaning product after a worker picked the cleaning product container out of the sink, thinking it had been washed, and filled it with vanilla syrup.  At least two other customers apparently drank the milkshake and were treated at hospital.  Clearly it’s not only medical facilities that need to ensure that there is a high level of protection between items meant for human internal use.  Lessons learned from this incident can be applied to all types of industries to ensure customer safety.

Root Cause

What You Need to Know About Caffeine Powder

By ThinkReliability Staff

1. It can kill you

A teenager died of a caffeine overdose in LaGrange, Ohio on May 27, 2014 after taking caffeine powder.  Regarding caffeine powder, Loraine County Coroner Dr. Stephen Evans says, “What it does is it leads into cardiac arrhythmias, which is speeding heart and it leads into seizures. Those two things are what took his life.”

2. It only takes a little bit

The caffeine in two large cups of coffee (a pretty typical amount for adults) is found in just 1/16th of a teaspoon of caffeine powder.  That’s because caffeine powder is just about all caffeine.  One teaspoon of the powder has the caffeine of about 25 cups of coffee.  The teenager who died from an overdose had 70 mg/mL caffeine in his blood, or about 23 times that of a typical coffee drinker, said Dr. Evans. According to Jennifer Dooren, a spokesperson for the FDA, “The difference between a safe amount and a lethal dose of caffeine in these powdered products is very small.”

3. It’s not regulated

Caffeine powder is sold as a supplement, so you can get it in bulk online.  Because of this, the dose isn’t controlled.  Because such small amounts can be lethal, this means that caffeine powder isn’t safe for anyone.  In a recent warning, the FDA “advises consumers to avoid powdered pure caffeine.”

4. Its use is increasing

Caffeine powder is increasing in popularity for weight loss and energy supplementation.  Other caffeinated products are as well.  Recently, sales of caffeinated gum and alcoholic beverages have been removed from the market.  However, energy drinks remain and are also leading to issues.  As we reported in an earlier blog, emergency room visits from energy drinks more than doubled from 2007 to 2011.  However, because of the concentration, caffeine powder poses the most immediate health risk.  Dr. Henry Spiller, the director of a poison control center at Nationwide Children’s Hospital in Columbus, Ohio says there have been multiple calls in a week that resulted in hospitalization due to caffeine powder use.  He says, “I can’t believe you can buy this,” Spiller said. “Honestly, I mean, it’s frightening. It makes no sense to me.”

5. The risks are not well-known

Three weeks before the young man’s death, his school held an assembly on heroin and painkiller abuse.  Caffeine powder wasn’t covered.  “I don’t think any of us really knew that this stuff was out there,” said Jay Arbaugh, the Keystone Local Schools superintendent. This isn’t surprising.  Caffeine has long been considered the drug with the least potential of abuse.  Cautions Dr. Bob Hoffman, a medical toxicologist at the New York University, “The thing about caffeine is just because you see it every day, just because it’s naturally occurring … doesn’t mean that it’s safe.”  The school will be adding caffeine powder to its drug and alcohol awareness programs.  The FDA is considering regulatory action against these powders.

The FDA recommends seeking medical care immediately and reporting to the FDA adverse events associated with caffeine powder.  You can view a visual diagram of the cause-and-effect relationships that led to the teenagers death by clicking on “Download PDF” above.  Or, read the FDA warning to learn more.

Root Cause

Ebola Outbreak Claiming Lives of Medical Staff

By ThinkReliability Staff

On July 29, 2014, the ongoing Ebola epidemic in west Africa was hit a hard blow when Dr. Sheik Humarr Khan, a leading doctor who treated Ebola patients and  national hero in Sierra Leone, died from the deadly virus.  The outbreak, which began this spring, has now infected thousands and killed nearly 900 people across Sierra Leone, Liberia, Guinea and Nigeria, including more than 90 healthcare workers who were treating victims.  It’s the most widespread and deadliest yet, due to the relative ease of travel and an apparently new strain of the disease.  (Read our previous blog about the outbreak.)

Because of the deadly and quick-spreading nature of the Ebola virus, many precautions are taken to protect healthcare workers from the disease.  Says Marie-Christine Ferir, the Emergency Coordinator of Médecins Sans Frontières/ Doctors Without Borders, “As well as the personal protective equipment that our staff wears, we have a series of strict procedures and protocols.  Our treatment centers are designed to ensure the safest possible working environment for our staff.”  Adds Dr. Tom Frieden, the Director of The Centers for Disease Control and Prevention (CDC), “We work actively to educate American health-care workers on how to isolate patients and how to protect themselves against infection.”

Yet workers are still getting sick – and dying.  In an interview with Armand Sprecher, the medical advisor to Doctors Without Borders, he noted that, though the suits worn by healthcare workers when dealing with infected patients are impervious to fluid, procedures and protocols still have to be followed.  For example, wearing or taking off the suit improperly can cause fluid transfer to the face, or hands, which then may touch the face.  An accidental needle stick can also result in a transfer of fluids that can lead to infection.

Now people in other countries are concerned Ebola may spread further.   In order to give stricken healthcare workers the best shot possible, they are generally returned to their home countries for treatment, raising concerns that their presence will allow the virus to take root there.  An American doctor and nurse were returned to the United States for treatment on August 2nd and August 4th, respectively.  Officials note that every precaution is being taken to isolate the patients and that Ebola can be spread only by bodily fluids, which requires very close contact.

Though there are no vaccines or currently approved treatment for Ebola, the infected American personnel received experimental treatment while still in Liberia. The treatment attempts to use antibodies produced by animals exposed to Ebola to help the immune system fight off the virus.  Dr. Brantly received a blood transfusion from a boy who survived Ebola under his care (surviving Ebola appears to provide immunity against re-infection).  Both vaccines and treatments are in development, but funding is difficult given the relative rarity of Ebola.

In the ongoing attempt to contain the spread of the virus, Sierra Leone has quarantined neighborhoods, cancelled public meetings and overseas trips, while Liberia has closed schools, most borders, and put state employees on leave.  The CDC has issued a Level 3 Travel Warning to Guinea, Liberia and Sierra Leone.  The World Health Organization has launched a $100 million campaign with the aim of bringing the epidemic under control, partially by providing new doctors.

To view the impacts this disease is having on the public as well as healthcare professionals, the causes of these impacts and what is being done to reduce the risk of these impacts, please click on “Download PDF” above.  Or read our previous blog to learn more about the outbreak.

 

Root Cause

Surgical Tool May Spread Cancer

By ThinkReliability Staff

Women who suffer from painful uterine fibroids may have their uterus removed for relief.  The most common hysterectomy procedure involves a 3-to-7-inch incision through which the entire uterus is removed intact.  Surgeries that can be performed laparoscopically through a smaller incision offer less scarring, fewer complications and shorter recovery time.  In order to remove the uterus through a smaller incision, it first has to be cut up into pieces.  This is performed using a laparoscopic power morcellator.  The device can also be used to remove fibroids only (called myomectomy) in a laparoscopic procedure.

On April 17, 2014, the Food and Drug Administration (FDA) issued a statement saying it “discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids.” An advisory panel then provided a variety of recommendations, some going so far as to recommend completely banning the use of the device.

The issues surrounding the use of the morcellator can be examined in a Cause Map.  The Cause Map allows a visual diagram of cause-and-effect relationships that include the impacts associated with a particular issue.  In this case, the use of the power morcellator is found to increase the risk of spreading cancer, a clear impact to the patient safety goal.  Concerns about the delay in determining the safety risk (morcellators have been used since the 1990s) can be considered an impact to the patient services goal.  Sales of morcellators have been stopped, and as discussed above, the use of morcellators is being questioned by the FDA.

Beginning with the impacted goals, we can ask “Why” questions to determine the cause-and-effect relationships.  The risk for spreading cancer results from undetected cancer in tissues that are then cut up inside the body.  Uterine cancer is difficult to detect with available testing and can be difficult to distinguish from fibroids.  Additionally, cases have been found where cancer was missed in testing prior to surgical treatment.  Recent studies have shown that women who seek such surgeries have a higher incidence rate of uterine cancer (1 in 368 post-hysterectomy patients were found to have uterine cancer versus 1 in 10,000 for the general population).

The morcellator cuts up tissue so it can be removed laparoscopically in a minimally invasive hysterectomy or myomectomy for fibroids.  Until recently, there was no data or warning indicating that morcellators weren’t safe to use.  The device did not provide clinical trial data, which is not required for new products considered “substantially similar” to existing products that are already marketed.  The FDA does not believe that the cancer risk would have been discovered even with a higher level of scrutiny.  The FDA depends on a database of medical-device problems reported by doctors.  However, doctors are not required to report issues.  In addition, it’s not clear that many made the link from the spread of cancer after the use of the morcellator.  Or, some healthcare professionals say they didn’t report it because they believed the undetected cancer – not the use of a device – was to blame.

The link over spreading cancer has now clearly been established.  (Data is still being examined to see if the device worsens cancer as well.)  The FDA is working to determine what – if any – restrictions will be placed on morcellator use.  It’s pretty clear to some, especially given that this treatment for fibroids is considered elective and there are alternatives, including a traditional hysterectomy.  Says Dr. Craig Shriver, surgical oncologist at Walter Reed National Military Medical Center, “There is at present no safe way to offer laparoscopic power morcellation as part of any minimally invasive surgery.”

However, others think the tool still has a place for minimally invasive surgery and that patients should be able to determine for themselves if the risk is worth taking.  According to Dr. Jason D. Wright, the lead author of a study regarding morcellators published in the Journal of the American Medical Association study, “I don’t know that necessarily morcellation should be banned. But this data is important to allow people to make decisions.”

In the meantime, some facilities are attempting to enclose the uterus in a protective bag before morcellation to minimize the risk of tissue remaining in the body, but there is no evidence that this reduces the risk of cancer spread.  Until the FDA’s final decision, each patient and healthcare facility will have to do their own risk assessment to determine whether or not the tool should be used.

 

Root Cause

Solving the Problem of Organ Donation

By ThinkReliability Staff

6,570 Americans die every year waiting for a donor organ.  Says Johns Hopkins surgeon Dr. Andrew Cameron, “There just aren’t enough organ donors to go around.  That’s not a medical problem.  That’s a social problem.”  Though 95% of people support organ donation, only 40% are registered organ donors.  For the over 123,000 people on the waiting list, there just aren’t enough donor organs to go around.

This issue can be addressed within a Cause Map, a visual root cause analysis.  The first step is to capture the “what”, “when”, and “where of the incident, as well as the impact to the goals.  In this case, the problem is lack of donor organs available, causing patient deaths.  Though the problem exists everywhere, the focus of this blog will be on ongoing organ shortage in the United States.  Important differences in the United States related to organ donation are that only 40% of Americans are registered organ donors (despite widespread public support), and that there is no central registry of organ donors within the United States.  (Organ registries are typically state-run.)

The large number of deaths resulting from inadequate donor organs is an impact to the patient safety goal.  The delay in receipt of organs can be considered both an impact to the patient services and schedule/operations goal.  The lack of available organs can be considered an impact to the property goal.

To develop the cause-and-effect relationships that led to the impacted goals, we ask “why” questions.  In this case, the patient deaths result from the need for donor organs due to disease or injury, and the delay in receipt of organs.  The delay in receipt of organs is due to a lack of available organs.  Millions of Americans die every year, and while not all organs are acceptable for transplant, more than one organ can often be used from donors, resulting in multiple lives saved from each donor.

In an interesting cause-and-effect result, increased traffic safety has resulted in fewer fatal traffic accidents of young, healthy people, which has led to a decrease in available donor organs.  Of course there is no effort to try and increase organ donation by stopping the decrease of deaths of young people.

The shortage of donors from people who are eligible (upon death or brain death) result from not signing up for the organ donation registry and/or from a family not choosing to donate organs.  There are multiple reasons suggested for people not choosing to register or donate organs.  To solve the problem, companies are working on increasing the number of donors.  Dr. Cameron coordinated with Facebook to allow users to register as organ donors and saw the number of organ donors go up “22 fold”.  Says Dr. Cameron, “That’s proof that we can move the needle.”  The startup Organize is “building a portfolio of technology that makes it easier for people to demonstrate their desire to be an organ donor.”  The company hopes that it will improve organ donation to the point that it puts itself out of business in five years.

To view the overview of the organ donation problem and solutions, click on “Download PDF” above.  As discussed in a previous blog, work is also being done to increase the number of organs that are acceptable for donation (in this case with kidneys).

Root Cause

Fire Door Falls on Dementia Patient

By ThinkReliability Staff

On November 7, 2013, during renovation taking place at a care home in Moston, Great Britain, staff responded to a cry for help, finding a resident underneath a fire door that had been removed and leaned against a wardrobe during the remodeling work.  The resident suffered a broken hip and died on December 2nd.  The management trust that operated the care home and the renovating firm were both fined under the Health and Safety at Work Act after a Health and Safety Executive (HSE) investigation found that the renovation area, which contained multiple hazards, had been left unlocked the night before.

According to HSE Inspector Laura Moran, “Both firms clearly knew there were vulnerable residents living at the care home but they still allowed the door to what was essentially a building site to be left unlocked on numerous occasions.”  Clearly multiple failures led to the resident’s death.  Diagramming the cause-and-effect relationships related to this issue can help clarify what happened, and offer areas for improvement.

We can perform an analysis of this incident in a Cause Map, or visual root cause analysis.  We begin with the impacted goals.  The patient safety goal was impacted due to the death of the patient.  In addition, the employee safety goal was impacted due to the potential for employee injury.  The fines can be considered an impact to the compliance goal and the patient services goal is impacted due to the insufficient protection provided for residents.

Beginning with an impacted goal and asking “why” questions develops the cause-and-effect relationships.  In this case, the patient death resulted from a broken hip.  The broken hip resulted from the patient being crushed under a fire door.  (It took 3 people to lift the fire door off the patient.)  The patient was crushed under the fire door because the fire door fell and the patient was in the renovation area where the fire door was located.  Both of these causes are required – had the fire door not fallen, the patient would not have been crushed, even if she was in the renovation area.  If the fire door fell but the patient was not present, the patient also would not have been crushed.  When both causes are required to produce an effect, the causes are joined by and “and” on the Cause Map.

The fire door fell as it was leaning against a wardrobe due to the renovation.  The patient, who suffered from dementia, was prone to wandering and was able to access the area under renovation because it had not been locked.  Neither the renovation firm nor the care home staff locked the area, or checked to verify that it was locked.

Other goals can be added as effects in the appropriate locations of the analysis.  For example, the patient services goal was impacted due to the insufficient protection of patients.  This occurred because the renovation area was unlocked and because the hazards in the renovation area.  (Beyond the fire door, the care home staff found exposed wiring, loose boards, and other potential safety hazards.)  The insufficient protection of patients resulted in the fine.  The impact to the employee safety goal was impacted due to the renovation area hazards as well.

Some amount of hazard always exists in construction sites – this is why hard hats are generally required.  It’s also why access to these sites is controlled.  In this case, limiting access to only those that need it was determined to be the best way to protect patients.  Because the previous process for ensuring the area was locked had failed, according to Inspector Moran, “Following the incident, the companies introduced a new procedure which meant workers had to collect and return a key at the start and end of each day, and lock the door when there was no one inside.”

The lessons learned from this tragedy are applicable not only to the specific situation of care homes undergoing renovation but to all those who have a need to protect a vulnerable population or limit access to a hazardous site to ensure safety.  Simple things like making sure doors are locked at the end of the day may save a life.

 

Root Cause

Heavy Metal Toxicity Professor Killed by Mercury Exposure

By ThinkReliability Staff

Professor Karen Wetterhahn knew firsthand how dangerous heavy metals could be.  Her research involved determining the biologic toxicity of heavy metals.  The chemical she was working with on August 14, 1996, was particularly dangerous.  Dimethylmercury, used as a reference standard, is lethal at about 400 mg, a few drops.  This classifies it as “supertoxic”.  When she spilled a few drops on her gloved hand, she assumed the precautions she had taken (the use of disposable latex gloves and a ventilated hood) were adequate.  She was incorrect, but would not know it for quite a while.

It took 149 days before Professor Wetterhahn began to exhibit neurological symptoms, 154 days before she sought care, and 168 days before chelation therapy began.  Chelation therapy involves the use of agents that form chemical bonds with metal ions to form a water-soluble complex, allowing the heavy metal to be excreted from the body.  However, according to a report on Professor Wetterhahn’s death in the New England Journal of Medicine (NEJM), chelation treatment delayed after exposure “is of little or no clinical benefit”.

Professor Wetterhahn became unresponsive on February 12, 1997 and died on June 8.  As a result of her poisoning, more research has been done to better determine the causes that led to her death, as well as determining actions that can reduce the risk of more deaths from mercury poisoning.  We can look at these causes in a Cause Map, or visual root cause analysis.

The death of Professor Wetterhahn was due to accidental dimethylmercury poisoning, which is lethal in just a few drops, and ineffective chelation therapy (which may have been able to reduce the impact had it been administered immediately after exposure).  Due to the latency of neurological symptoms and the belief that protections taken while working with dimethylmercury were adequate, this did not occur.

Based on later research and testing, it was determined that Professor Wetterhahn was exposed through her skin when she dropped a few drops of dimethylmercury on her glove.  The disposable latex gloves she was wearing were later found to result in permeation to the skin in a matter of seconds.    The Material Safety Data Sheet (MSDS), which defines necessary personal protection for working with various chemicals, specified only “wear appropriate chemical-resistant gloves”.  The use of a plastic-laminate chemically-resistant glove was found to result in no permeation after four hours and should be used rather than disposable latex while working with this chemical.

It is also possible that mercury exposure occurred via inhalation. Although Professor Wetterhahn was using a ventilated hood, dimethylmercury is extremely volatile and could have created an inhalation hazard when it was spilled.

Many organizations would be tempted to identify the spill of the dimethylmercury as the root cause and end the investigation there.   However, basing personnel safety solely on attempting to prevent spills does not provide adequate protection.  In this case, the risks of using dimethylmercury were found to be so high that an alternative is recommended unless absolutely necessary.  If the use of the supertoxic compound is found to be essential, very specific personal protection equipment is called for as well as seeking treatment immediately after possible exposure.

In the NEJM report, the authors state “Before she lapsed into a vegetative state, the patient requested that her case be presented to the general medical community, to scientists working with mercury, and to toxicologists, in the hope of improving the recognition, treatment, and prevention of future cases of mercury poisoning.”   By examining all the causes and possible solutions, it is hoped that all chemical work can be made safer, in honor of Professor Wetterhahn.

To view the Outline, Cause Map and timeline of this issue, please click on “Download PDF” above.

Root Cause

Alleged Radiology Misreading Results in Removal of Cancer Patient’s Healthy Kidney

By ThinkReliability Staff

On January 17, 2013, a radiologist discussed the results of a CT scan with an urologist.  The CT scans identified cancer in the kidney of an urologist’s patient.  Two months later, the patient underwent surgery to remove the kidney.  The kidney was examined by a pathologist, who declared it cancer-free.  The wrong kidney had been removed, allegedly due to a misidentification by the radiologist.

Wrong-site surgeries like this one can lead to severe patient safety consequences, as well as severe financial and regulatory consequences for the doctors and healthcare facilities involved.  This is why surgery performed on the wrong body part has been identified as a “never event“, or an event that should never occur in a healthcare facility.

Even with this designation and the known seriousness of the issues, wrong-site surgeries continue to occur.  The Joint Commission estimates that the prevalence of wrong-site surgeries in the United States is as high as 40 per week.

Clearly, action must be taken to reduce the risk of wrong-site surgeries.  To identify areas of potential improvement, it can help to look at an example of an actual case of wrong-site surgery to determine lessons learned.  We will examine the case of the wrong kidney being removed as an example of issues that can lead to wrong-site surgeries using the Cause Mapping method of root cause analysis.

It’s important to identify the impacts to the goals as a result of an incident.  In this case, the patient safety goal was clearly impacted as the patient now has only 3/4 of a kidney remaining, with the potential to cause serious health impacts.  (A portion of the cancerous kidney was removed in a later operation.)  The compliance goal is impacted because of the occurrence of a “never event” as discussed above.  The patient services goal is impacted due to the removal of the wrong (healthy) kidney.  The radiologist and urologist involved in the issue have been sued for more than $1 million as a result of the issue.  If all these issues received similar lawsuits, the costs to the health system would be over $2B a year.

Once the impacts to the goals are identified, asking “why” questions develops the cause-and-effect relationships that led to the issue.  In this case, the removal of the wrong kidney is alleged to have resulted from the radiologist misreading the CT scan that identified the kidney with cancer and passing that information on to the urologist who performed the surgery.  Clearly the urologist’s physical exam (if any) did not adequately determine the site of the cancer.

To better understand the steps that led to the surgery, they can be diagrammed in a Process Map.  A Process Map lays out a process in much the same way that a Cause Map visually lays out cause-and-effect relationships.  A very high level overview of the process used in this case is shown on the downloadable PDF.  What’s important to note is that an incorrect reading of a CT scan or other diagnostic tool propagates through the process.  With no second opinions or double checks built in, the diagnosis of cancer in the left kidney was the only information the urologist had to determine the operating site.

There are of course other errors in the surgical preparation procedure that can also cause wrong-site surgeries.  (Many of these errors are identified in our proactive write-up on wrong-site surgeries.)  As stated by Mark R. Chassin, M.D., President of The Joint Commission, “Wrong site surgery events occur basically because none of the processes that we use in taking care of patients is perfect.”  Equally important is that the people performing the processes are not perfect.  Although both processes and people’s performance can be improved, it will never reach perfection.  For this reason, adding double checks and second opinions into processes is essential to reduce the risk of the one mistake resulting in a devastating patient safety impact.  In this case, having a second opinion on the CT scan, or having the physician re-identify the area with a physical exam prior to surgery (if possible) may have identified the error prior to removal of a healthy kidney.

View the Cause Map and process map by clicking on “Download PDF” above.

Root Cause

Gamma Camera Collapse Kills Patient

By ThinkReliability Staff

On June 5, 2013, a nuclear medicine scanner was being used for a diagnostic procedure at a New York Veterans Affairs (VA) medical center when the gamma camera collapsed on a patient, causing his death.  This issue can be examined in a Cause Map, or visual root cause analysis, in order to determine both the impact to the organization’s goals as well as the causes of the incident.

In this case, multiple goals were impacted, the first and foremost of which is the death of a patient.  This is an impact to the patient safety goal.  Had the camera collapsed at a different time, it could have also injured an employee, causing an impact to the employee safety goal as well.  The death of a patient due to a medical device that functions other than designed is a “Never Event“, or an event that should never happen in a medical facility.  The scanner collapse on a patient clearly does not meet the goals for patient services.  The property goal is impacted due to potential damage to the scanner. (None of the publicly released reports specified how much damage, if any, was caused to the scanner and camera.)  The scanners of this type from this manufacturer were recalled shortly after this incident, impacting the operations goal and necessitating inspection and/or maintenance activities provided by the manufacturer, an impact to the labor time goal.

Investigation conducted shortly after this patient’s death determined the collapse was caused by loose bolts.  The machines were quickly subject to a Class 1 recall with the FDA.  Sites with the recalled equipment were told to discontinue use until inspections and, if needed, preventive maintenance could be performed by the manufacturer.  Said the manufacturer’s spokesperson, “If no issue is found with the support mechanism fasteners, the site can resume use of the device. If an issue with the support mechanism fasteners is found on a system, the GEHC Field Engineer will coordinate the replacement of impacted parts, and ensure that the system is operating appropriately and meets all specifications.”

Publicly released information about the incident has not specified who was responsible for the preventive maintenance that may have determined the need for tightening the bolts.  However, inspection and maintenance costs were covered by the manufacturer of the devices.

Sites that are using the affected models should have been notified and should stop use until the recommendations of the recall are met.  Although details of broader solutions were not available, both the manufacturer of the devices and the healthcare facilities using them will surely take a look at the preventive maintenance schedule to decrease the risk of patient injury from this type of event.

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