Tag Archives: Root Cause Analysis

Never Event

Feeding Tube Misconnection Results in Patient, Fetus Death

By ThinkReliability Staff

Recent articles have related several stories of patients being injured or even killed by medical tubing mix-ups.  A product used other than intended that results in a patient death is one of the “Never Events” – events that should never happen at healthcare facilities.   An article in The New York Times discusses injuries and deaths caused by accidentally connecting food meant for a feeding tube through an intravenous (IV) line.    A specific incident mentioned in the article can be analyzed in a Cause Map to capture all of the causes in a simple, intuitive format that fits on one page.

In this case, a pregnant woman was prescribed a feeding tube to ensure that she and her baby were getting adequate nourishment.  The feeding tube was improperly connected to the intravenous (IV) line, causing liquid food to enter her veins, causing sepsis which killed her and her fetus.

One issue (cause) is that medical personnel made an incorrect connection.  Although there was no information given in the article, this would certainly be an area for the responsible organization to look at in more detail and determine if there are steps that can be taken to reduce the risk of these types of errors.  (Some organizations have found success with color coding the tubes, for example.)

However, another issue is that the tubes COULD be incorrectly connected in the first place.  The number of errors in feeding tube connections (discussed in an article from The Joint Commission Journal on Quality and Patient Safety) has led the U.S. Food and Drug Administration (FDA) to consider declaring these products unsafe.

The tubes become compatible with other tubing connections (such as IV) when needle-free connectors were adopted, to increase caregiver safety (by limiting exposure to needles).  Since then, there have been issues with the compatible tubing.  (A history of tubing issues is found on the PDF, which can be downloaded by clicking “Download PDF” above.)   And, feeding tube connections that are incompatible with other tubing lines are difficult to find.  There are many causes given for the delay of developing incompatible tubing, including resistance from the medical industry, difficulties with the FDA approval process, and a delay in forwarding requirements for incompatible tubing.  This delay is mainly attributed to waiting for an international group to develop a recommendation regarding tubing, which is expected to take several years.

The FDA has an expedited review process which allows approval of a device if it works like an already approved device, regardless of whether that device is safe, or has been recalled.  Because compatible tubing devices have already been approved, new devices that use the same – compatible – connection can go through this expedited process, whereas incompatible connections can not.  Without federal agencies requiring change, it’s been difficult getting manufacturers to update their products.

View the problem outline, Cause Map, and timeline of tubing issues by clicking “Download PDF” above.

Never Event, Root Cause Analysis

Patient Death from Restraint

By ThinkReliability Staff

A patient death associated with the use of restraints is a “never event” as defined by the National Quality Forum (NQF).  A recent death at a St. Louis, Missouri hospital has placed the hospital at risk of being terminated from the Medicare program after two other recent patient deaths associated with restraints and inappropriate patient seclusion.

In order to shed some light on the issues surrounding this most recent death, we can begin sifting through the facts in a root cause analysis.  First, we enter the necessary information into the outline, including the impact to the goals (to view the outline, timeline and Cause Map, please click on download PDF above).  The impacts to the organization’s goals begin the Cause Map, or visual root cause analysis.  We can continue to add more detail to the Cause Map by asking “Why” questions.

We will then discover that the patient died of suffocation.  An early concern was that the patient’s airway was blocked by gum, but the doctor determined that was not the case.  (We can leave this cause on the Cause Map but can cross it out once it has been determined that it did not contribute to the incident.)  The patient suffocated when she was left facedown on a beanbag chair, after being given a sedative that slowed her breathing, and was not properly monitored for breathing or a pulse.    The patient had been restrained and sedated after threatening and assaulting the hospital staff.  The patient was not constantly supervised, as suggested, possibly due to a lack of staff.

When the charge nurse arrived several minutes later and determined the patient was not breathing, resuscitation was not immediately begun (either mouth-to-mouth or CPR). She first left to get a light, then a stethoscope, then to find the patient’s nurse.  After the patient’s nurse returned, she left to call a “Code Blue”.  The first aide that arrived was told not to begin CPR or mouth-to-mouth because there was no breathing mask.  She did anyway.  Nine minutes later, the doctor inserted a breathing tube.  The staff attempted to restart the patient’s heart but were unsuccessful and she was pronounced dead.

To determine what actions can be taken so that this never happens again, first we have to do a little more research into a few specific areas.  First there needs to be a thorough investigation on the restraint procedure at this hospital.  Because a patient died in restraints, some aspect(s) of the restraint procedure must be improved.  To improve the procedure, however, first we have to know what the hospital staff  actually did, step by step, in this case (and others).  Then we should look at expectations and/or requirements for supervision of patients who are being restrained, or given sedatives, or who, based on their behavior, require constant supervision.  For example, patients who are held facedown need extra supervision to make sure their breathing is not constricted.  Additionally, it may be appropriate to turn the patient back face up once the sedatives begin to work.

The patient’s death was caused in part by the delay in resuscitation.  Beyond the delay in recognizing the patient’s respiratory distress, the expectations for staff in this situation need to be addressed.  Because the charge nurse was fired, it seems that the hospital did not think she properly performed her expected duties, but why?  Perhaps the staff does not understand what they should do in this case, or doesn’t have the necessary equipment (such as a breathing mask) readily available.  Although refresher training might be in order, we don’t stop there.  We need to figure out all the things that are keeping our staff from being able to do what they need to for their jobs and remove those obstacles – BEFORE this happens again.

To view the outline, timeline and Cause Map, click on “Download PDF” above.  To learn more about this incident, please see the news story.

Root Cause Analysis

Therac-25 Radiation Overdoses

By ThinkReliability Staff

The Therac-25 is a radiation therapy machine used during the mid-80s. It delivered two types of radiation beams, a low-power electron beam and a high-power x-ray. This provided the economic advantage of delivering two kinds of therapeutic radiation with one machine. From June 1985 to January 1987, the Therac-25 delivered massive radiation overdoses to 6 people around the country. We can look at the causes of these overdoses in a root cause analysis performed as a Cause Map.

The radiation overdoses were caused by delivery of the high-powered electron beam without attenuation. In order for this to happen, the high-powered beam was delivered, and the attenuation was not present. The lower-powered beam did not require attenuation provided by the beam spreader, so it was possible to operate the machine without it. The machine did register an error when the high-powered beam was turned on without attenuation. However, it was possible to operate the the beam with the error and the warning was overridden by the operators.

The Therac-25 had two different responses to errors. One was to pause the treatment, which allowed the operators to resume without any changes to settings, and another was to reset the machine settings. The error resulting in this case, having the high-power beam without attenuation, resulted only in a treatment pause, allowing the operator to resume treatment with an override, without changing any of the settings. Researchers talking to the operators found that the Therac-25 frequently resulted in errors and so operators were accustomed to overriding them. In this case, the error that resulted (“Malfunction 54”) was ambiguous and not defined in any of the operating manuals. (This code was apparently only to be used for the manufacturing company, not healthcare users.)

The Therac-25 allowed the beam to be turned on without error (minus the overridden warning) in this circumstance. The Therac-25 had no hardware protective circuits and depended solely on software for protection. The safety analysis of the Therac-25 considered only hardware failures, not software errors, and thus did not discover the need for any sort of hardware protection. The reasoning given for not including software errors was the “extensive testing” of the Therac-25, the fact that software, unlike hardware, does not degrade, and the general assumption that software is error-proof. Software errors were assumed to be caused by hardware errors, and residual software errors were not included in the analysis.

Unfortunately the coding used in the Therac-25 was in part borrowed from a previous machine and contained a residual error. This error was not noticed in previous versions because hardware protective circuits prevented a similar error from occurring. The residual error was a software error known as a “race condition”. In short, the output of the coding was dependent on the order the variables were entered. If an operator were to enter the variables for the treatment very quickly and not in the normal order (such as going back to correct a mistake), the machine would accept the settings before the change from the default setting had registered. In some of these cases, it resulted in the error described here. This error was not caught before the overdoses happened because software failures were not considered in the safety analysis (as described above), the code was reused from a previous system that had hardware interlocks (and so had not had these problems) and the review of the software was inadequate. The coding was not independently reviewed, the design of the software did not include failure modes and the software was not tested with the hardware until installation.

This incident can teach us a lot about over-reliance on one part of a system and re-using designs in a new way with inadequate testing and verification (as well as many other issues). If we can learn from the mistakes of others, we are less likely to make those mistakes ourselves. For more detail on this (extremely complicated) issue, please see Nancy Leverson and Clark Turner’s “An Investigation of the Therac-25 Incidents.”

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

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 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

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.