Root Cause Analysis

Wrong Body Part Irradiated

By ThinkReliability Staff

In October of 2005 a therapist was preparing a patient for radiation therapy.  The therapist used a tattoo on the patient’s body to guide the radiation therapy.  Additionally the therapist brought up a photo of the area to be irradiated.  Unfortunately in this instance the tattoo and the photographs both indicated the patient’s esophagus – which was the site of previously delivered radiation therapy – instead of his upper spine, where the new radiation treatments were to be delivered.

Although there was no damage to the patient’s health, this incident impacted the facility’s patient safety goal, because of the potential for injury to a patient when radiation is delivered unnecessarily.  Additionally, it impacted the patient service goal because the radiation treatment was misdirected to the wrong body part.  The organization and compliance goals were impacted because of this reportable error.  Lastly, there are impact to the materials and labor goals due to the additional treatments that were required to deliver radiation to the upper spine.

The situation was complicated by the software error that brought up an old picture, indicating that the therapy should treat the esophagus.  To add to the confusion, there was a tattoo on the esophagus designating it as the site of the therapy.  There was nothing in the set-up notes to indicate that the patient had had a previous round of radiation therapy.  It is unclear whether the therapist had access to the patient’s chart, which would have designated the area to be irradiated and would mention the previous therapy.

The facility involved introduced measures to solve the software problems which resulted in the old photograph being downloaded.  Second therapy sites are now marked with double tattoos.  Information such as the therapy location and any previous radiation therapy sites are now included in the set-up notes.  Additionally, ensuring that the therapist has access to a patient’s medical chart will help allow the therapist to ensure a patient’s therapy is delivered properly.

Step 3 to avoid radiation therapy errors: verify the WHERE – which body part requires the radiation therapy

Root Cause Analysis

Wrong Radiation Treatment Delivered to Patient

by ThinkReliability Staff

A cancer patient was scheduled to receive two radiation therapy treatments – radiation to her upper lung every day, and radiation to her mediastinum on alternating days.  However, a mix-up resulted in her receiving the program for her lungs to her mediastinum (which resulted in ten times the prescribed dose) and receiving the program for her mediastinum to her lungs (which resulted in one-tenth the prescribed dose).  The patient died of cancer later in the year.

This incident impacted the facility’s patient safety goal, because the patient died of cancer, possibly because the radiation dose to her lungs was too low to effectively fight the cancer.  Additionally, it impacted the patient service goal because the patient received the wrong radiation treatment.  The organization and compliance goals were also impacted because of this reportable error.

How did this happen?  The patient had a complex radiation therapy program, involving two different treatments to two different parts of her body simultaneously (radiation was delivered to different body parts on alternating days). Obviously some confusion on the part of the staff was involved, and because only one therapist was present for administering the therapy, there was no oversight, or anyone else to catch the error.

Based on the causes of this incident, we can develop action items to be taken by the facility to reduce the risk of this type of incident happening again.  Unless it is medically necessary, avoiding administering two different therapies at one time would reduce the risk of this type of confusion.  The treatment a patient is receiving should always be verified before the treatment is administered.  Also, because of the high level of risk to patients, more than one therapist should be present.  (The facility involved in this particular incident has implemented a rule that more than one therapist be present for complex treatments.  Although it’s not clear exactly what’s meant by complex, surely this would qualify.)   Hopefully these steps, when taken by facilities who deliver radiation therapy to patients, will reduce the risk of radiation errors.

Step 2 to avoid radiation therapy errors: verify the WHAT – the type of treatment the patient is receiving.

Root Cause Analysis

Radiation Therapy Delivered to Wrong Patient

By ThinkReliability Staff

In March 2006 a patient (who we’ll call Patient A) reached an exciting milestone. She had just completed radiation treatment for a brain tumor.  However, she was not told that her radiation therapy was complete.  Instead, the therapist opened the medical chart of another patient (Patient B) and left.  Another therapist came in, saw the chart for Patient B, and noticed that Patient B required radiation treatment for breast cancer.  The therapist then delivered that radiation to Patient A.

This incident impacted the facility’s patient safety goal, because of the risk of injury to Patient A.  Additionally, it  impacted the patient service goal, because Patient A received unnecessary radiation.  The organization and compliance goals were also impacted because of this reportable error.

How did this happen?  Patient A was at risk for injury because of the delivery of unnecessary radiation.  She was given radiation meant for another patient because the therapist delivered the radiation and Patient A, not knowing that her own treatment was complete, didn’t know to stop it.  The therapist did not effectively verify the identity of Patient A, instead going off the chart that had been opened by the previous therapist, for unknown reasons.  Had the first therapist told Patient A that her therapy was complete, or had the first therapist not opened another patient’s chart, or had the second therapist verified the identity of Patient A, this error would probably not have occurred.

Based on the causes of this incident, we can develop action items to be taken by the facility to reduce the risk of this type of incident happening again.  Therapists should not open charts until they have verified the identity of a patient.  They should verify a patient’s identity before treatment, and they should review the outcome of a treatment with the patient.  After all, had any of these steps occurred, Patient A would have been able to properly celebrate the end of her radiation therapy, rather than worry about a risk to her health.

Step 1 to avoid radiation therapy errors: verify the WHO – the identity of the patient.

Root Cause

Hospital-Acquired Infections Sepsis and Pneumonia

By ThinkReliability Staff

Infections of any kind acquired in a hospital are undesirable from the perspective of both the hospital and the patient.  After all, patients go to a hospital to get better, not sicker.  Until recently, the incidence of these sorts of infections has been difficult to determine, with inconsistent reporting requirements across the country and difficulty determining the sources of such infections.  However, a recent study in the Archives of Internal Medicine has determined some staggering numbers related to two hospital-acquired infections, sepsis and pneumonia.  Together, these two infections result in 48,000 deaths and $8.1 billion in additional costs per year.  A total of 1.7 million patients contract infections at hospitals every year.

Sepsis is a bloodstream infection.  The study found that nearly 20% of patients who contract sepsis after invasive surgery at a hospital will die from it.  On average, a patient who contracts sepsis can expect 11 additional days at the hospital, at a cost of $32,900.  Sepsis contracted in hospitals is generally a bacterial infection, caused by bacteria in the bloodstream (known as bacteremia).  A patient must be exposed to bacteria in order for the bacteria to access the bloodstream.  Bacterial access to a patient can be caused by ineffective infectious control procedures.

Nosocomia (or hospital-acquired) pneumonia is an infection of the lungs.  Like sepsis, in a hospital setting it is generally caused by a bacterial infection when bacteria enter the lungs.  Also like sepsis, this requires bacterial access to the patient.  More than 11% of patients who contract nosocomial pneumonia after invasive surgery will die.  On average, a patient with nosocomial pneumonia will spend 14 extra days in the hospital, at a cost of $46,400.

To prevent these types of bacterial infections, every employee in a hospital must practice effective infectious disease control.  Each hospital must develop infection control procedures to aid in preventing the spread of disease.  As an example, here we’ll look at the infection control procedure for  pre-surgery.  This extremely simple procedure was developed based on the CDC’s Surgical Site Infection FAQs.  If a patient has hair in the surgical area, it should be clipped, not shaved, to avoid infection.  If a patient is high risk, he or she may receive antibiotics before the surgery.  The patient’s skin will be cleaned at the surgical site to avoid introducing the patient’s skin bacteria into the surgical wound.  Before the providers begin surgery, they will wash their hands and arms up to the elbows thoroughly and don protective wear.  This helps prevent bacteria carried by the providers (including bacteria from the providers’ previous patients) from infecting the patient.

This is just one example of a process that demonstrates infection control to protect patients from hospital-acquired infections.  More can be developed, based on a hospital’s best practices.  What’s important is the focus on infection control to protect patients.

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

Representative John Murtha: Killed by a Surgical Error?

By ThinkReliability Staff

On February 8, 2010, Representative John Murtha died at the Virginia Medical Center. His cause of death was complications from gallbladder surgery. He received laparoscopic gallbladder surgery at the National Naval Medical Center in Bethesda, Maryland on January 28, 2010. It is believed that his intestine was nicked during that surgery, causing an infection which would eventually kill him.

Any adverse event that occurs during patient care or patient death is investigated by the National Naval Medical Center. We can look at the beginnings of what such an investigation would look like in a root cause analysis. (To see the root cause analysis investigation, click on “Download PDF” above.)

We begin by recording relevant basic problem information in the outline, or problem definition. We record the “what, when and where” of the incident. Because more than one date and facility is involved, it may be helpful to create a timeline of events to aid in the investigation. Once we’ve recorded this information, we can define the problem with respect to the organization’s goals. A patient death is our primary concern, and is an impact to the patient safety goal. An adverse event that occurs during patient care can be considered an impact to the compliance, organization, and patient services goal. Additionally, there were certainly additional costs incurred due to the additional care required, which are impacts to the materials and labor goals.

Once we’ve completed our outline, we begin with our Cause Map. We begin with the impacts to the goals on the left, then ask “why” questions and fill in causes to the right. The patient death was caused by an infection believed to be caused by a nicked intestine from laparoscopic gallbladder surgery. Because not all laparoscopic gallbladder surgeries result in nicked intestines, there has to be an additional cause, but we don’t know what it is. We’ll just put “Surgical error ?” as a cause, and we can add more detail as more information is released.

The National Naval Medical Center has released its basic process for a quality assurance review, which is performed in the event of a patient death or adverse event during patient care. Because this process is going to be part of the solution to this issue, we can record the information we know about this process in a Process Map. Unlike a Cause Map, the Process Map flows from left to right in the direction of time to show the order of steps that should be taken. We can add this Process Map to the investigation sheet as well, for reference.

Although we don’t have a lot of detail on what exactly happened, we can get a lot of information about our investigation onto one sheet of paper (see “Download PDF”). We’ll add more information to the investigation as more information is released.

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.

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!

Root Cause Analysis

Positive cancer screenings: the needle in the haystack?

By ThinkReliability Staff

Recent research from the journal Current Biology has determined that workers in all industries, including healthcare, are less likely to find rare items.  Says lead author Jeremy Wolfe of Harvard Medical School, “If you don’t find it often, you often don’t find it.”   The research may help explain some of the difficulty in finding rare cancers.  Simply put, if a medical professional hasn’t seen very many examples of what cancer looks like in screening tests, it’s more difficult for that professional to find it.

This gives an argument towards greater specialization – based on this research, a medical professional who spends all day looking for breast cancer in mammograms would be more effective at finding it than a general practitioner who may only see a few cases of breast cancer throughout his or her career.

However, another recommended solution is to make sure that the people doing the screening see many examples of what they’re looking for.  Not only could this be done during medical training, but some facilities have found success in “booster exercises”.  Essentially, before a worker spends time screening for rare occurrences, such as indications of cancer, look at results that include a number of positive (i.e. cancerous) screenings.  This helps focus the worker’s attention, leading to quicker and more accurate screening results.

Root Cause

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.