Monthly Archives: June 2014

Root Cause

Alleged Radiology Misreading Results in Removal of Cancer Patient’s Healthy Kidney

By ThinkReliability Staff

On January 17, 2013, a radiologist discussed the results of a CT scan with an urologist.  The CT scans identified cancer in the kidney of an urologist’s patient.  Two months later, the patient underwent surgery to remove the kidney.  The kidney was examined by a pathologist, who declared it cancer-free.  The wrong kidney had been removed, allegedly due to a misidentification by the radiologist.

Wrong-site surgeries like this one can lead to severe patient safety consequences, as well as severe financial and regulatory consequences for the doctors and healthcare facilities involved.  This is why surgery performed on the wrong body part has been identified as a “never event“, or an event that should never occur in a healthcare facility.

Even with this designation and the known seriousness of the issues, wrong-site surgeries continue to occur.  The Joint Commission estimates that the prevalence of wrong-site surgeries in the United States is as high as 40 per week.

Clearly, action must be taken to reduce the risk of wrong-site surgeries.  To identify areas of potential improvement, it can help to look at an example of an actual case of wrong-site surgery to determine lessons learned.  We will examine the case of the wrong kidney being removed as an example of issues that can lead to wrong-site surgeries using the Cause Mapping method of root cause analysis.

It’s important to identify the impacts to the goals as a result of an incident.  In this case, the patient safety goal was clearly impacted as the patient now has only 3/4 of a kidney remaining, with the potential to cause serious health impacts.  (A portion of the cancerous kidney was removed in a later operation.)  The compliance goal is impacted because of the occurrence of a “never event” as discussed above.  The patient services goal is impacted due to the removal of the wrong (healthy) kidney.  The radiologist and urologist involved in the issue have been sued for more than $1 million as a result of the issue.  If all these issues received similar lawsuits, the costs to the health system would be over $2B a year.

Once the impacts to the goals are identified, asking “why” questions develops the cause-and-effect relationships that led to the issue.  In this case, the removal of the wrong kidney is alleged to have resulted from the radiologist misreading the CT scan that identified the kidney with cancer and passing that information on to the urologist who performed the surgery.  Clearly the urologist’s physical exam (if any) did not adequately determine the site of the cancer.

To better understand the steps that led to the surgery, they can be diagrammed in a Process Map.  A Process Map lays out a process in much the same way that a Cause Map visually lays out cause-and-effect relationships.  A very high level overview of the process used in this case is shown on the downloadable PDF.  What’s important to note is that an incorrect reading of a CT scan or other diagnostic tool propagates through the process.  With no second opinions or double checks built in, the diagnosis of cancer in the left kidney was the only information the urologist had to determine the operating site.

There are of course other errors in the surgical preparation procedure that can also cause wrong-site surgeries.  (Many of these errors are identified in our proactive write-up on wrong-site surgeries.)  As stated by Mark R. Chassin, M.D., President of The Joint Commission, “Wrong site surgery events occur basically because none of the processes that we use in taking care of patients is perfect.”  Equally important is that the people performing the processes are not perfect.  Although both processes and people’s performance can be improved, it will never reach perfection.  For this reason, adding double checks and second opinions into processes is essential to reduce the risk of the one mistake resulting in a devastating patient safety impact.  In this case, having a second opinion on the CT scan, or having the physician re-identify the area with a physical exam prior to surgery (if possible) may have identified the error prior to removal of a healthy kidney.

View the Cause Map and process map by clicking on “Download PDF” above.

Root Cause

“Artificial Pancreas” May Dramatically Improve Management of Type 1 Diabetes

By Kim Smiley

As many as 3 million Americans have type 1 diabetes and for many managing the autoimmune disease requires constant vigilance.  Patients have to carefully monitor what they eat and their blood sugar levels, often pricking their fingers and injecting insulin multiple times a day.  The number of people diagnosed with type 1 diabetes has been increasing, but there is some good news.  There is no cure for type 1 diabetes, but a new device, an artificial pancreas, may make managing the disease significantly simpler.

Type 1 diabetes is caused when the immune systems attacks insulin-producing cells in the pancreas so the body can no longer produce adequate insulin.  Insulin is needed because it works to allow sugar to enter cells where it is used for energy, reducing the levels of sugar in the blood stream.  Sugar builds up in the blood when food is consumed and from natural processes in the body.  Without enough insulin, blood sugar levels will continue to increase.  High blood sugar can damage major organs and can have significant impacts on long-term health.  Low blood sugar is also dangerous and can quickly become a life-threatening emergency so patients with type 1 diabetes are constantly working to keep blood sugar within acceptable levels.

The artificial pancreas works by monitoring blood sugar levels every 5 minutes and using two pumps to deliver two different hormones (insulin to lower blood sugar levels and glucagon to raise blood sugar) as needed with minimum intervention required by the user.  The current version of the artificial pancreas consists of three parts (two small pumps and iPhone contacted to a continuous glucose monitor) but there are plans to simplify the device in the future.  The components connect to three small needles that are inserted in the patient to allow blood sugar levels to be monitored.  Insulin pumps currently used by many type 1 diabetics can only inject insulin and require more input from the user, so the artificial pancreas is a significant improvement over currently available technology.

The artificial pancreas is still in the development stage and needs additional testing and modification prior to becoming widely available for patient use.  The first test was done using about 50 patients (20 adults and 32 teenagers) who wore the new device for 5 days.  The results were very promising, but more testing will need to be done. During the 5-day test, the patients had lower blood sugar levels overall and the device simplified management of the disease.  Researchers reported that the patients didn’t want to return the devices because they worked so well. The next step is to have patients use the device for a longer time period.  It’s essential to ensure that the device is very robust, because the consequences can be dire if it fails.  Once the design is finalized, the hope is to seek FDA approval and have the artificial pancreas available in about 3 years.

To view a Cause Map of this issue, click on “Download PDF” above.

Root Cause

5.5 Million Cases of Norovirus are Spread Via Food Each Year

By Kim Smiley

Norovirus outbreaks on cruise ships may make exciting headlines, but the reality is that only one percent of norovirus outbreaks occur on the high seas.  About 20 million people in the US are sickened by noroviruses in the US each year and one of the most common transmission paths is via food.  Food-borne norovirus is estimated to be responsible for 5.5 million cases of norovirus annually in the US.

A Cause Map, a visual method for performing a root cause analysis, can be used to analyze this issue.  The first step in the Cause Mapping process is to determine how an issue impacts the overall goals and then the Cause Map is built by asking “why” questions to visually lay out the cause-and-effect relationships.  In this example, we’ll focus on the safety goal since it is clearly impacted by 5.5 million cases of norovirus transmitted via food.

So why are people getting norovirus from food?  This is happening because they are consuming contaminated food, predominantly at restaurants or catered events.  The food becomes contaminated when a food worker’s hands are contaminated by norovirus and they touch food, particularly food that is ready to serve and won’t be cooked prior to consumption.  (Disclaimer: You may want to stop reading here if you are eating or thinking about going to out to eat soon.)

For those unfamiliar with the illness, norovirus is basically a gastrointestinal nightmare that can cause the human body to do very messy things.  If a food service worker is ill, the virus can get on their hands, especially after using the bathroom.  According to a Centers for Disease Control and Prevention (CDC) report, the transmission of food-borne norovirus is “primarily via the fecal-oral route.”  And that is more than enough said about that.

It is also worth asking why food workers are at work if they are under the weather.  In the US, few food service workers get paid sick leave so they may show up at work sick because they are concerned about the loss of income and the impact on their jobs.  It’s also important to ensure that workers understand the importance of good hygiene and have access to both water and soap and time to effectively wash their hands.

The final step in the Cause Mapping process is to develop solutions to reduce the risk of the problem recurring.  The solutions to this problem are both simple in concept and difficult to effectively implement.  Ideally, food workers should stay home when they are ill and for at least 48 hours afterwards, but this is much easier said than done for many people.  Food workers should also wash their hands after using the bathroom and before handling any food, but it can be difficult to enforce the policy because employers and managers aren’t (and shouldn’t be) closely monitoring what happens during bathroom breaks.

To view a high level Cause Map of this issue, click on “Download PDF” above.

Root Cause

Gamma Camera Collapse Kills Patient

By ThinkReliability Staff

On June 5, 2013, a nuclear medicine scanner was being used for a diagnostic procedure at a New York Veterans Affairs (VA) medical center when the gamma camera collapsed on a patient, causing his death.  This issue can be examined in a Cause Map, or visual root cause analysis, in order to determine both the impact to the organization’s goals as well as the causes of the incident.

In this case, multiple goals were impacted, the first and foremost of which is the death of a patient.  This is an impact to the patient safety goal.  Had the camera collapsed at a different time, it could have also injured an employee, causing an impact to the employee safety goal as well.  The death of a patient due to a medical device that functions other than designed is a “Never Event“, or an event that should never happen in a medical facility.  The scanner collapse on a patient clearly does not meet the goals for patient services.  The property goal is impacted due to potential damage to the scanner. (None of the publicly released reports specified how much damage, if any, was caused to the scanner and camera.)  The scanners of this type from this manufacturer were recalled shortly after this incident, impacting the operations goal and necessitating inspection and/or maintenance activities provided by the manufacturer, an impact to the labor time goal.

Investigation conducted shortly after this patient’s death determined the collapse was caused by loose bolts.  The machines were quickly subject to a Class 1 recall with the FDA.  Sites with the recalled equipment were told to discontinue use until inspections and, if needed, preventive maintenance could be performed by the manufacturer.  Said the manufacturer’s spokesperson, “If no issue is found with the support mechanism fasteners, the site can resume use of the device. If an issue with the support mechanism fasteners is found on a system, the GEHC Field Engineer will coordinate the replacement of impacted parts, and ensure that the system is operating appropriately and meets all specifications.”

Publicly released information about the incident has not specified who was responsible for the preventive maintenance that may have determined the need for tightening the bolts.  However, inspection and maintenance costs were covered by the manufacturer of the devices.

Sites that are using the affected models should have been notified and should stop use until the recommendations of the recall are met.  Although details of broader solutions were not available, both the manufacturer of the devices and the healthcare facilities using them will surely take a look at the preventive maintenance schedule to decrease the risk of patient injury from this type of event.

To view the Outline and Cause Map, please click “Download PDF” above.  Or click here to read more.