Tag Archives: cause mapping

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

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 Analysis

The Causes and Effects of Hepatitis B & C

By ThinkReliability Staff

As well as medical errors and industrial accidents, the Cause Mapping method of root cause analysis can be used to research the causes and solutions to disease epidemics.  Take the case of hepatitis B and C.  A report recently released by the Insitute of Medicine states that the infection rates of chronic hepatitis B and C viruses (HBV and HCV) is 3-5 times that of HIV (human immunodeficiency virus).  The report also outlines some of the problem associated with lowering the infection rates of hepatitis B and C.

Using the information presented in this report, it’s possible to make a Cause Map outlining the causes of hepatitis B and C infections.  First we begin with the impact to the goals.  First, the report estimates that there are approximately 15,000 deaths per year associated with chronic HBV and HCV.  Additionally, 3-5 million people are estimated to be living with chronic HBV and HCV.  These are both impacts to the patient safety goal.  In many cases, these infections are not treated.  This is an impact to the patient services goal.

Once we’ve defined the incident in respect to the goals, we can begin our Cause Map.  We begin with an impact to the goals and ask “why” questions until all the causes are on the Cause Map.  In this case, the deaths are caused by chronic HBV and HCV, which are caused when a person is infected and not treated.  Infections can result from being born to an infected mother, infected blood transfusions (before blood was tested for HCV), sexual contact with an infected partner, sharing needles with an infected person, or needlesticks with an infected needle.

Most typically, people who are infected with HBV or HCV do not seek treatment because they are unaware they are infected due to the asymptomatic nature of hepatitis.  Persons may not be screened even in high risk situations because either they or their healthcare providers do not realize the risk, or they do not have adequate access to healthcare.

The infection rate of HBV is decreasing thanks to a vaccine for hepatitis B.  However, a vaccine is not yet available for hepatitis C. This is certainly a priority in the national fight against hepatitis infections, as well as increased education and awareness programs.

This 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.  To view the one-page downloadable PDF, please click on “Download PDF” above.