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.

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.

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.

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!