Tag Archives: cause mapping

Root Cause Analysis

Impure Injections Used

By Kim Smiley

Research is been suspended at a prominent brain-imaging center associated with Columbia University. Food and Drug Administration investigations found that the Kreitchman PET (positron emission tomography) Center has injected mental patients with drugs that contained potentially harmful impurities repeatedly over the past four years.

Investigations by the lab determined that no patients were harmed from the impurities, but this is still a significant issue in a nationally renown laboratory.

How did this happen?

This issue can be investigated by building a root cause analysis as a Cause Map. To start a Cause Map, the impact to the organization goals is determined. In this example, this issue is obviously an impact to safety because there was potential to harm patients. It is also an impact to the production-schedule goal because research has been suspended. Additionally, this problem is an impact to the customer service goal because this issue raises questions about the validity of research results.

To build a Cause Map, select one goal and start asking “why” questions to add causes. In this case, the first goal considered will be the safety goal. There was a potential for injury. Why? Because impure injections were given to patients. Why? Because the injections are necessary for research, because the labs typically prepare the compounds themselves and because the lab prepared the compounds incorrectly. When there is more than one causes that contributed, the causes are added vertically with an “and” between them.

Each impacted goal needs to eventually connect to the same Cause Map. If they do not, the impacted goal may not be caused by the same problem and the goals should be revisited.

To continue building the Cause Map, keep asking “why” questions for each added cause until the level of detail is sufficient.

A Cause Map can be as high level or as detailed as needed. The more significant the impact to the goals, the more likely a detailed Cause Map will be warranted. Once the Cause Map is completed, it can be used to develop solutions to help prevent the problem from reoccurring.

In this example, the lab is currently changing management and reorganizing procedures to help prevent the similar problems in the future.

To view an initial Cause Map for this issue, please click the “Download PDF” button above.

Root Cause Analysis

The Downside of Preparedness?

By Kim Smiley

The U.S. Government has announced that 40 million doses of swine flu vaccine have expired and must be disposed of.   In addition, 30 million more doses are about to expire and will also be disposed of (unless there is a sudden need for swine flu vaccine).  The vaccine doses are worth $260-$450 million.  We can capture this information in a problem definition outline.

Then the question is: is this a bad thing (a problem) or a good thing (a success)?  Like a lot of things, it doesn’t necessarily have to be one or the other.  There’s an aspect of success – swine flu did NOT turn out to be a deadly global epidemic, as was predicted – and an aspect of failure – up to $450 million of vaccines were tossed out.

The question that remains for the analysis is: how do we maximize the successes (preventing epidemics) and minimize the not-so-good stuff (wasting vaccines and money)?  A detailed root cause analysis can draw out the successes and problems associated with any event, including this one.  We can use it to look at the planning process used for an epidemic to look for places where the estimation of the need for vaccines can be improved.  We can even look at the use of and expiration dates of the vaccine to determine if, in the future, a backup plan might allow us to get some secondary use out of the vaccines.  Opportunities for improvement are limited only by the brainstorming capability of your organization!

Root Cause

Recreational Water Illnesses

By ThinkReliability Staff

Last year we wrote a blog about preventing pool injuries, specifically slipping and drowning.  However, there’s a lesser known risk from a pool – getting sick from swimming.  This is officially known as “recreational water illness” or RWI, and normally involves diarrhea. RWI is estimated to affect approximately 1,000 people a year (according to WebMD) and can cause death, especially in immune-compromised people.

We can perform a proactive root cause analysis to determine what causes these illnesses.  Essentially, a person consumes germs by ingesting pool water that contains germs.  Pool water becomes contaminated when germs enter the pool from fecal matter.  (Easier said than done. Did you know that the average person is wearing 0.14 grams of fecal matter?)  So please, keep fecal matter out of the pool.  Take a shower before you get in and make sure your kids are using the bathroom regularly elsewhere.  (Not surprisingly, kiddie pools are the ‘germiest’.)

Now, pools are treated to prevent these germs from proliferating.  However, some combinations of pool chemicals and germs take much too long to work to be effective.  (For example, cryptosporidium takes 7 days to be killed in chlorine.)  Some pools aren’t getting enough chemicals due to inadequate maintenance.  And, there’s some stuff you can put in the pool – namely urine, sunscreen, and sweat – that interacts with chlorine and reduces the effective volume in the pool. So, even though urine itself doesn’t contain germs, don’t pee in the pool.  And again, take a shower.

Our solutions to RWI – take a shower, don’t perform any bodily functions in the pool, and don’t swallow the pool water.  However, that works for you and your family, but what about the unwashed masses in the pool?  The CDC recommends you buy your own water testing kit and test the pool water before you get in.  Make sure there’s a pool treatment plan and that it’s being followed, and that all ‘accidents’ are reported immediately.  (Yep, even if   they’re your fault.)  Then lay back, relax, and enjoy your swim.

Root Cause

Over-the-counter Medications Recalled

By ThinkReliability Staff

On April 30, 2010, following a 10-day FDA inspection of a U.S. manufacturing facility, 43 name-brand over-the-counter (OTC) children’s’ liquid medications were voluntarily recalled.  Although there have not yet been any reported adverse events associated with the recalled medication, the impact of the issue has been far-reaching.

There is the potential (although believed to be remote) for an impact to consumer health, which is an impact to the safety goal.  Additionally, the drugs were recalled for not meeting required quality standards, which can also be  considered an impact to the safety goal.  The product recall, which encompassed 1,500 lots of 43 products, is an impact to both the customer service and property goal.  The cost of this recall has not yet been estimated.  The  manufacturing facility is on hold, which is an impact to the production goal.  Lastly, the time and costs associated with the investigation to determine what went wrong is an impact to the labor goal.  We can record these impacts to the goals in the outline (Step 1).

Once we’ve completed the first step, we move on to the root cause analysis, or Step 2.  We begin the analysis with the impacts to the goals and ask “Why” questions to complete the Cause Map.  Because the FDA’s investigation report has not yet been released, the Cause Map we have so far is very basic.  Essentially, the recalls occurred because unacceptable product was released to consumers.  It was released because the finished product met testing requirements.  However, it was unacceptable because it did not meet quality standards, because of contamination in the raw materials that were used.  At this point in the map, we run into more questions.  More detail can be added to this Cause Map as the analysis continues and more information is released. 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.

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.  View the investigation by clicking on “Download PDF” above.

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

Therapy Equipment Delivers Radiation Overdoses for Years

By ThinkReliability Staff

In September of last year, a physicist at a healthcare facility was trained on use of the BrainLAB stereotactic radiation therapy system.  During this training, the physicist realized that the system had been incorrectly calibrated, as the wrong chamber had been inserted into the machine.  The facility realized that the chamber had been incorrectly inserted at installation in 2004, and that patients who used the portion of the machine calibrated by that chamber had received radiation overdoses over those five years.

The facility is working through the impacts of these errors, the causes of the error, and what needs to be done to keep an issue like this from ever happening again.

First let’s examine the impacts to the goals resulting from this error.  There’s an impact to the patient safety goal due to potential for deaths and injuries. (Because these patients  were already sick – sometimes very sick – the facility is still determining what impact the overdoses may have had.)  There has not yet been mention of an employee impact – the physicist who set up the machine is no longer at the facility – so we’ll just put a “?” after Employee Impact.  The event was reported to The Joint Commission (no reports were required by law), which can be considered an impact to the compliance goal.   The organizational goal was impacted due to potential lawsuits against the hospital.   The patient services goal was impacted because 76 patients received an average overdose of 50% (other patients received overdoses that were considered within the acceptable range for treatment).  Because radiation was involved, there is the potential for an environmental impact.  However, there is no evidence that any radiation leaked to the environment, we’ll put a “?” by the environmental goal as well.  Lastly, the property and labor/time goals were impacted because of the additional follow-up exams, testing, support, and treatment, which the facility will provide for all those affected by the issue.

Once we’ve determined the impact of the event, we can begin an analysis of how it happened.  Or, what were the causes?  The goals were impacted due to the overdose to several patients.  The overdose occurred because the radiation therapy machine was miscalibrated and the miscalibration was not discovered for five years.  The machine was miscalibrated because the incorrect chamber was installed and the chamber installation was not verified.  The physicist chose the wrong chamber and the equipment representative (who was on hand for the installation) did not notice the error.  At this point, it’s unclear why the physicist chose the wrong chamber and why the equipment representative did not notice the error.

The miscalibration was not noticed for five years because any re-calibration of the machine depended on the chamber which was incorrectly installed.  So although the machine was not delivering the correct amount of  radiation, the problem was with the calibration itself, resulting in a propagating error.  According to the facility, none of the patients showed any unusual side effects that would indicate they were getting too much radiation. However, some of the symptoms may take years to develop.  Additionally, no other staff members were trained on the equipment for five years.  It was a second staff member who was trained on the equipment who finally noticed the error.

Even though there are some questions still remaining in our Cause Map, we can develop some solutions, as the facility in question (as well as other stakeholders) is doing.   One suggestion is to do an external calibration of the machine – i.e., use a calibration method that is completely separate from the machine to determine if the correct amount of radiation is being delivered.  Also, have an independent verification that each piece of the equipment was installed correctly.   Require the equipment representative to sign off on the installation.  Last but not least, train other staff members to operate the equipment as backup.   The facility is working with the FDA to assist in its efforts to increase the safety of radiation use in healthcare settings.  (See our previous blog about this topic.)

Step 4 to avoid radiation therapy errors: verify HOW MUCH – how much radiation therapy is required, and how much is the patient actually getting.

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

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.