Category Archives: Root Cause

Fatal Radiation Overdose from Cancer Treatment

By ThinkReliability Staff

Beginning on March 14, 2005, Scott Jerome-Parks received intensity modulated radiation therapy (IMRT) as a treatment for his tongue cancer.  (As Jerome-Parks did not fit the typical profile of a tongue cancer sufferer, it is thought that perhaps exposure to the dust from the World Trade Center collapse on 9/11 may have contributed to the disease.)  He had received these treatments before, but this time something was different.  The therapist had reprogrammed the machine at the request of Jerome-Parks’ doctor to minimize damage to his teeth (an unfortunate side effect of radiation therapy near the mouth).  During the reprogramming, the computer had crashed and although the therapist was asked if she would like her changes saved, some of the programming was lost – specifically, the collimator settings.

In IMRT, the radiation beam comes down through a collimator, which has programmable leaves (that look like metal teeth) that open and close to direct and modulate the beam.  If the collimator leaves are completely closed, no radiation gets through.  If the collimator leaves are completely open, the dose of radiation will be too high, and the beam will not be properly directed to the desired radiation site (here, Jerome-Parks’ tongue) but will rather hit a larger part of the body.

In this case, the collimator settings were lost, which resulted in the collimator being wide open, delivering seven times the desired dose to Jerome-Parks.  The error was not noticed until 3 days – and 3 treatments – later, when the physicist performed a test to verify the programming and discovered the overdose.  It was apparently customary, though not required, that the therapist verified the settings after reprogramming.  On this day, the hospital was apparently short-staffed due to therapist training, so the verification test was delayed.

Jerome-Parks eventually died of his injuries.  He hoped that his death would lead to fewer radiation errors like the one that killed him.  Some progress is being made, but there’s still a way to go.

The company who manufactured the IMRT equipment released a new version of the software which contains a fail-safe to reduce the risk of the modulator being left wide open.  Although the details aren’t clear, it appears that the default setting for the equipment was to have the collimator wide-open, resulting in an overdose, rather than closed, which would result in no radiation at all.  It also was difficult for the therapists to determine which of their changes had been saved when the computer crashed, which apparently happened frequently.

It’s unclear what changes the hospital involved is making to its procedures to reduce the risk of this type of error.  However, there were several opportunities for the error to be caught, so there are some effective changes that could be made.  The State of NY, concerned with the number of radiation errors, especially high-profile ones like that of Jerome-Parks, has released several alerts to draw attention towards the problem of radiation errors.  It’s also attempting to increase reporting requirements (now practically non-existent) for these types of errors to increase accountability.  Let’s hope that it works and nobody has to suffer like Jerome Parks again.

If you’d like to learn more about Jerome-Parks and radiation errors, check out the article by the New York Times.  For more on radiation errors, check back at our blog next week!

Nobody wants bacteria colonizing their chest!

By ThinkReliability Staff

Mediastinitis (deep sternal wound infection) acquired as a surgical complication of coronary artery bypass graft (CABG) surgery is now considered by Medicare as a hospital-acquired condition for which reimbursement will not be given. It is a serious complication that results in an increased risk of death and, from Medicare data, adds almost $300,000 to the cost of a hospital stay.

For these reasons, it is important to work on reducing the occurrence of mediastinitis in medical facilities. A tool we can use to help reduce the occurence is a visual root cause analysis, presented as a Cause Map. A thorough root cause analysis built as a Cause Map can capture all of the causes in a simple, intuitive format that fits on one page. We develop a Cause Map in three steps.

First, define the problem. Here, the problem is mediastinitis, which occurs in the mediastinum, as a result of the process of CABG surgery. After we capture this relevant information regarding the problem, we look at the impact to the organization’s goals. An increased risk of patient death is an impact to the patient safety and patient services goals. The compliance and organizational goals are impacted by the contraction of a hospital-acquired infection. Additionally, the non-reimbursable cost to the hospital is an impact to the materials and labor goal.

Now that the problem has been defined related to the organization’s goals, we perform our root cause analysis, or make our Cause Map. First we put down the impacts to the goals, then by asking “Why” questions we add causes to the map. Here, the impacts to the goals are caused by a patient contracting mediastinitis. The causes of a patient contracting mediastinitis are bacterial colonization of the mediastinum and the bacteria not being destroyed (possibly due to inadequate levels of antibiotics in tissue because of perioperative antibiotics not being administered). The bacterial colonization is caused by bacterial contamination, and/or an environment susceptible to colonization, possibly due to impaired wound healing, such as caused by elevated blood glucose levels. Bacterial contamination is caused by bacteria in the area of an open chest (which is open for the purposes of performing a CABG). The bacteria in the area can be caused by a number of things, including a non-sterile atmosphere, bacterial infection of the skin, insufficient sanitization of the skin, and bacteria on the operative staff hands or gloves.

The root cause analysis can be viewed by clicking “Download PDF” above. The root cause analysis we show here is highly simplified. Even more detail can be added to this Cause Map as the analysis continues. 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.

Once the Cause Map is completed, we look for solutions. The solutions are attached to the cause they control. For example, a solution to elevated blood glucose levels is to use a continuous IV infusion of insulin for diabetic patients during surgery. Other solutions are shown on the Cause Map. Individual medical facilities can evaluate these solutions based on the impact to the organization’s goals to determine which solution(s) will be most effective in reducing their risk.

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

Woman Gives Birth to Stranger’s Baby!

By Kim Smiley

Unfortunately, this isn’t a tabloid story.  On September 24, 2009, a woman named Carolyn Savage gave birth to a healthy baby boy.  However, the baby boy was not biologically hers.  The fertility clinic that the Savages had used had implanted a stranger’s embryo.  The Savages decided to carry the baby to term and then give him up to his biological parents.  (See the news story.)

However, in other circumstances where a woman has discovered she is carrying a stranger’s baby, the baby has been aborted.  Although very few women have been implanted with stranger’s embryos, the consequences of such a mistake are drastic.  Because of these consequences, fertility clinics must ensure that their procedures involve checks, double checks, and are followed by every employee in a clinic.

All people make mistakes, which is why oversight is so necessary for procedures that can lead to disastrous consequences.  In the medical field, this is why effective procedures that are followed to the letter are so important.  There have been no details released in what exactly went wrong to lead to a woman being implanted with another family’s embryo.  However, it’s certain that the fertility clinic will be forced to review its procedures, to make sure that this never happens again.

Seeking Treatment for Swine Flu: To go, or not to go?

By ThinkReliability Staff

Think you (or a family member) might have the swine flu? Conventional wisdom might say to get to the doctor, stat. However, that may not be the recommended action. Public health officials and other medical experts are concerned that if the swine flu reaches epidemic proportions, the health system may be overwhelmed. Additionally, there is a concern that a person who has seasonal flu or a cold might go to the doctor believing it’s swine flu . . . and catch swine flu in the doctor’s office from the ill people there.

So, here we have two potential impacts to the goals. First, the public safety goal is impacted because of the potential that the public won’t be able to be effectively treated. This might occur if medical facilities are overwhelmed, by both patients who require treatment and patients who do not require treatment coming to the facilities. Patients who do not require treatment may come to the facilities because they are not certain if they require care.

The patient safety goal is impacted because patients might contract the swine flu. This could occur when patients go to a medical facility and there are patients there who have swine flu. The patients might go to the medical facility if they believe they have swine flu and are uncertain if they require medical care.

These causes are shown in the Cause Map above. Any cause on the cause map can have a solution; however, in this case there is one cause common to both impacts to the goals. Thus, mitigating this cause reduces the impacts to both goals. But how do we help patients determine whether or not they need medical care? Microsoft Corporation, along with doctors from Emory University, have developed a swine flu on-line questionnaire that can help you determine whether you require medical treatment. Hopefully this tool can help keep some patients who don’t require treatment out of medical facilities, and from contracting swine flu if they didn’t already have it.

A prescription to end unintentional drug poisoning

By Kim Smiley

According to the CDC, drug poisoning is now the second leading cause of unintentional death, after car crashes.  Most of the drug poisoning deaths result from the abuse of illegal and prescription drugs.  If we look at an extremely basic cause-and-effect for overdose of prescription drugs, we note that a patient overdoses (takes too many pills) for some situationally-dependent reason (such as increasing the amount of medication to provide additional benefit, as can occur with painkiller addiction) AND access to an increased amount of the medication.  Many times the access to the medication is provided by “doctor-shopping”, where a patient sees multiple doctors for painkiller prescriptions. 

Databases that track these sorts of prescriptions have been implemented in most states to curb access to large amounts of the most frequently abused drugs.  However, since the programs are state-run, patients could still get multiple prescriptions by crossing state lines.  Also, in some states it may take as long as two weeks before a new prescription shows up in a database, creating extra time for addicts to collect prescriptions.

This is an example of a case where a solution has been implemented, but it  hasn’t reduced the risk to an acceptable level (as evidenced by the thousands of people still dying from prescription drug overdoses).  So, the solution is being tweaked.  The federal government has provided funding to states to upgrade their databases.  It’s hoped that this will start to decrease the number of deaths from prescription drug abuse.  If it doesn’t, even more drastic action will be needed.

Which ankle needs surgery? Neither? Oops . . . (Wrong Procedure)

By ThinkReliability Staff

A patient receiving the wrong procedure is a very serious event. It has been named a “never event” by The Joint Commission. For organizations that are trying to prevent these kinds of serious events from happening, there is value in looking at near misses, such as the case we’ll examine here in a root cause analysis. A thorough root cause analysis built as a Cause Map can capture all of the causes in a simple, intuitive format that fits on one page.

In our case, a patient was prepped for a surgery he didn’t need, even receiving spinal anesthesia. He was prepped for a procedure based on the advice of an orthopedist, who believed the patient to have an ankle trimalleolar fracture, which he did not.

Why did the orthopedist believe the patient to have a fracture? The radiologist who had reviewed the patient’s radiographs diagnosed the fracture. The orthopedist did not review the radiographs. The orthopedist did examine the patient’s ankle, but gained no new insight into the diagnosis. Additionally, the family/patient did not mention the previous diagnosis, possibly because they weren’t told of it, or didn’t understand it..

The radiologist diagnosed the fracture because there was a fracture shown on the radiographs, which were labeled with the patient’s name. However, it was later determined that the radiographs were actually of a previous imaging client. The radiographs were taken because the patient’s previous radiographs did not arrive in time.

Given no more information about this case, our analysis stops here. However, the next step for the medical facility involved would be to examine the radiography procedures to ensure that mislabeling incidents do not occur. Other causes listed in the map can also be examined, to determine where other improvements can be made.

Even more detail can be added to this Cause Map as the analysis continues. 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..

Patient Killed By Operating Room Fire

By ThinkReliability Staff

In a previous blog, we looked at possible causes of patient burns, including operating room fires.  Sadly, on September 8th, a patient passed away, six days after being burned during surgery.  (See the news article.)  Due to patient safety laws and ongoing investigations, there is no information suggesting what could have been the causes of the fire.  However, as with any fire, an operating room flash fire, like the one suspected in this case, requires 3 things:

1)  a heat source – typically in the operating room the heat source is provided by electrical surgical equipment.

2) oxygen – patients under anesthesia may be receiving 100% oxygen, providing an extremely oxygen-rich environment for fires.

3) fuel – the disposable synthetic fabrics primarily used now are more flammable than cloth drapes.

Since all three of these causes are required for a fire, removing any one of the causes will prevent a fire.  However, in an operating room environment it’s not practical to remove any one of these causes, so instead we can work on reducing the risk by mitigating the effect of each of these causes.  To reduce the risk from the heat source, surgeons are warned to leave electrical tools in standby mode, or turned off, whenever they are not in use.  To reduce the concentration of oxygen in the air, anesthetists may be asked to provide only as much oxygen as needed for the patient, and avoid creating places that oxygen may concentrate, such as under the drapes.  More flame-resistant material is being considered for use in some operating rooms.  Additionally, more and more operating room teams are providing training in preventing and extinguishing surgical fires, because although only an extremely small percentage of surgeries result in fire, the results can be catastrophic.

Sorry alone doesn’t work unless we learn from our mistakes.

By ThinkReliability Staff

The title is a quote from Timothy McDonald, a pediatric anesthesiologist and the chief safety officer of the University of Illinois Medical Center, discussing medical errors, which are now estimated to kill as many as 98,000 Americans a year.

“We have to also make promises that this won’t happen again and get patients and families engaged in the effort to improve our performance.”

The University of Illinois Medical Center, along with other medical facilities, has made great efforts to communicated with grieving family members after medical mistakes, and getting those family members involved with helping prevent future mistakes.

One of the changes implemented requires an x-ray of patients at risk for foreign objects retained after surgery. So far, the x-rays have found 8 foreign objects found left in patients , despite a manual count that claimed all the sponges were accounted for.

Some experts worry that the “increased candor” with families may increase the number of lawsuits. Dr. McDonald says that, though the number of procedures at the University of Illinois Medical Center have increased 23% since the program was implemented, the number of lawsuits has decreased 40%.

To many family members of victims of medical errors, it’s not about the money; it’s about making sure nobody else will suffer from the same mistake. Allowing these family members (or the victims themselves) to help improve the processes that led to the errors may ease their concerns. (View the news article in the Wall Street Journal.)

Implement Solutions Within Your Sphere of Influence

By ThinkReliability Staff

The Houston Chronicle reports disturbing news on the state of healthcare safety and reform.    They reported that:

“Experts estimate that a staggering 98,000 people die from preventable medical errors each year”

“A federal Centers for Disease Control and Prevention study concluded that 99,000 patients a year succumb to hospital-acquired infections. Almost all of those deaths, experts say, also are preventable.”

Not only do almost 200,000 people a year die from preventable errors or infections acquired in hospitals, but, according to expert federal analysts, the rate of these deaths may actually be increasing.  Part of the problem is that the recommendations provided by experts, federal and private studies and various other resources are not being implemented quickly – or at all.

Some people think that the root cause analysis investigation process ends when solutions are recommended.  In fact, the hardest part may be just beginning.  There’s a reason we refer to solutions as “action items” – they require action.  They also require follow-up.

Proper follow-up will determine if solutions are being effectively implemented, i.e. the problem is being solved.  In this case, that would be the number of medical errors are decreasing.  Since that’s not happening, the next step is to determine why the action items were ineffective.  Right now, the recommended action items aren’t effective because they aren’t being implemented.

An organization can only effectively implement solutions that are within its sphere of influence.  Medicare, for example, is attempting to influence medical errors by using its most effective weapon – its pocketbook.  Medicare is no longer reimbursing for certain medical errors, and hopes to add to the list.  As many private insurers follow suit, more healthcare facilities will find it necessary to change the way they do business . . . and then hopefully the medical error rate will begin to decrease.

Learn more about finding solutions.