Category Archives: Root Cause Analysis

Root Cause Analysis

Donated Blood Contaminated By Yellow Fever Vaccines

By ThinkReliability Staff

On March 27, 2009, 89 active duty military trainees donated blood at a local blood center.  Unfortunately, the trainees had received yellow fever vaccines (which contain live virus) only four days earlier.  The Red Cross blood donation eligibility criteria requires a two-week wait after a yellow fever vaccine.  The Red Cross does not test donated blood for yellow fever virus antibodies and the ineligible donations were not realized until the blood bank was preparing for another blood drive several weeks later.  The contaminated blood was immediately recalled, tracked down and destroyed, but only after six units had been transfused into five patients.

One of the five patients who received a transfusion died, but as he was in hospice care for terminal cancer, it’s unclear whether the contaminated transfusion was responsible.  Three of the four remaining patients had yellow fever antibodies in their system, but have not demonstrated any symptoms of yellow fever.  The potential transmission of yellow fever to these patients is an impact to the patient safety goal.  Additionally, the transfusion of contaminated blood impacts the compliance, organization, and patient services goals.   The cost of the disposal of 83 contaminated units of blood is an impact to the materials goal, and the required investigation is an impact to the labor goal.

The contaminated transfusions occurred because of the medical need for blood, and the use of contaminated donor blood.  The donor blood was contaminated because the recall did not occur for several weeks (although it happened immediately after the contamination became known) and because the blood contained yellow fever antibodies.  The yellow fever antibodies were present due to donors who had recently received vaccines, and donated, though ineligible.  Because of the large number of trainees who donated blood despite being ineligible, it’s apparent that there was a disconnect in providing the information of a required two-week deferral from donation after vaccination.

Although the Red Cross does make its eligibility criteria known, it’s clear from this incident that this was insufficient in this case.  The military has agreed to provide vaccination records for its members to ensure that blood is not donated during the deferral time after live virus vaccines.  Additionally, the Red Cross has added specific, individual questioning about recent vaccinations.  (The previous process used for screening with respect to recent vaccines was not discussed.)  A recommendation is being made to have healthcare providers discuss eligibility for blood donation after vaccines are provided, though this is not currently being specifically required.  These solutions should reduce the risk of providing contaminated blood.

To view the one-page PDF containing the outline, Cause Map, timeline and action items, please click “Download PDF” above.  The information for this investigation was provided by the Centers for Disease Control and Prevention (CDC)’s Morbidity and Mortality Weekly Report (MMWR).

Root Cause Analysis

Iris Scanners Used to Identify Patients

By ThinkReliability Staff

The Bronx, New York medical clinic had a potential problem.  It serves a large population (over 37,000 patients) that sometimes speaks limited English and has little identification.  Of the 37,000 patients served, the clinic had a high number of repeated names, including 103 Jose Rodriguezes.  The clinic was concerned that these issues would lead to potential safety issues if a patient was mistaken for another patient with the same or a similar name.

To address these concerns, the clinic has installed iris scanners to identify the patients.  The scanner pulls up a patient’s electronic medical records with an extremely low error rate.  An additional benefit is that an iris scanner does not require the patient to physically touch it, so it is much less likely to spread germs than a fingerprint or palm scanner.

The clinic has been extremely pleased with the iris scanner, noting that it has also helped fight benefits fraud and won the clinic recognition from the Healthcare Information and Management Systems Society.   The downside is that the system is expensive.  (The Bronx clinic purchased their scanner with a grant from the New York Department of Health.)  However, considering the high prevalence and cost of medical errors, it seems to be a worthwhile expense.

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 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 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 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.