Tag Archives: wrong-site surgery

Never Event, Root Cause Analysis

Healthy kidney removed by mistake

By Kim Smiley

The Patient Safety Network presented a case study where a patient with suspected kidney cancer had the wrong kidney removed.  Instead of the right kidney that showed suspected renal cell carcinoma in a CT scan, the healthy left kidney was removed. A second surgery was then performed to remove the right kidney and the patient was left dependent on dialysis after losing both kidneys.  The patient wasn’t a candidate for a kidney transplant because of the cancer.

Reviewing and understanding case studies such as this one is important because wrong-site surgeries are one of the more common serious medical errors.  A Cause Map, a visual root cause analysis, can be used to better understand the many causes that contributed to this wrong-site surgery, and better understanding the causes of an incident leads to development of better solutions.  The first step in building a Cause Map is to fill in an Outline with the basic background information.  These details are often not published for medical errors to protect patient privacy, but the information should be recorded if available.  The bottom of the Outline also includes space to list how the issue impacts the overall organizational goals. The Cause Map itself is built by starting at one of the impacted goals and asking “why” questions.

Focusing on the patient safety goal as a starting point, the investigation could be started by asking “why was a healthy left kidney removed instead of the right?” The surgeon who performed the surgery believed the tumor was in the left kidney because all patient information readily available stated the tumor was in the left kidney.  The case study didn’t include details on how this error in the patient’s record occurred, but it is known that a CT scan was initially performed at a different hospital than the one that performed the surgery.  The patient sought treatment at the first hospital after suffering from abdominal pain and hematuria and a CT scan was performed.  He was transferred to a second hospital for the surgery after the CT scan revealed suspected renal cell carcinoma.  An image of the CT scan was not included with the patient records at the time of transfer and the records noted that there was a tumor in the incorrect (left) kidney.

The stage was essentially set for a wrong-site surgery and the surgeon missed the opportunity to prevent it.  The surgeon chose to perform the surgery based on the records without either verifying the original CT (because it was not available) or requesting an additional CT scan to be performed to confirm the diagnosis.  It does not appear that the surgeon was required to review the CT scan, but the decision on whether to do so was left up to the surgeon’s judgement. The error was only identified after the pathologist who examined the left kidney found no evidence of cancer and informed the surgeon who then reviewed the original CT scan and realized the wrong kidney had been removed.

Once the causes that contributed to an issue have been identified, the final step in the Cause Mapping process is to identify and implement solutions to prevent a problem from reoccurring.  One way to prevent similar errors is to require labeled radiology images to be available to the surgeon prior to any surgery.  Requiring a review of images prior to the surgery would build in a double check to ensure the surgery is performed at the correct site.  Building in a double check of medical records may also reduce errors like the wrong kidney being listed as potentially cancerous or a patient being transferred with medical files missing important radiology images.

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

The Willie King Case: Wrong Foot Amputated

By Kim Smiley

In one of the most notorious medical error examples in US history, the wrong foot was amputated on a patient named Willie King on February 20, 1995.  Both the hospital and surgeon involved paid hefty fines and the media had a feeding frenzy covering the dramatic and alarming mistake.

So how did a doctor remove the wrong foot?  Such a mistake seems difficult to comprehend, but was it really as mind boggling as it looks at first glance?

The bottom line is that the doctor honestly believed he was removing the correct foot when he began the surgery. The blackboard in the operating room and the operating room schedule all listed the wrong foot because the scheduler had accidentally listed the wrong foot.  After reading the incorrect paperwork, the nurse prepped the wrong foot.  When the doctor entered the operating room, the wrong foot was prepped and the most obvious documentation listed the wrong foot.  Basically, the stage was set for a medical error to occur.

The foot itself also looked the part.  The patient was suffering from complications of diabetes and both of his feet were in bad shape.  The “good” foot that was incorrectly removed looked like a candidate for amputation so there were no obvious visual clues it wasn’t the intended surgery site. Other doctors had testified in defense of the doctor saying the majority of other surgeons would have made the same mistake given the same set of circumstances.

There was some paperwork that listed the correct foot to be amputated, such as patient’s consent form and medical history.  This paperwork was available in the operating room, but no procedures in place at the time required the doctor to check these forms and these forms were far less visual than the documents where the incorrect information was listed.  Additionally, the doctor never spoke directly with the patient prior to the surgery which was another missed opportunity for the mistake to be caught.

Clearly the procedures needed to be changed to prevent future wrong site surgeries from occurring and a number of changes have been incorporated in the time since this case occurred to help reduce the risk of this type of medical error.  Surgeons in Florida are now required to take a timeout prior to beginning a surgery.  During the time out they are required to confirm that they have the right patient, right procedure and right surgical site.  This rule has been in place since 2004.

Mistakes will always happen, such as numbers being transposed or misheard words over the phone, but small mistakes need to be caught before they become big problems. Procedures like a timeout can significantly reduce the likelihood of an error going uncorrected.  In an ideal world, the simple mistake by the scheduler would have been caught long before it culminated in a surgery on the wrong body part.

A visual root cause analysis, called a Cause Map, can be built to illustrate the facts of this case.  A Cause Map intuitively lays out the cause-and-effect relationships including all the causes that contributed to an issue.  To view a Cause Map of this example, click on “Download PDF” above.

Root Cause

Pregnant Patient Dies After Wrong Organ is Removed

By ThinkReliability Staff

A series of errors resulted of the death of a young mother in Romford of the United Kingdom on November 11, 2011.  Details of the patient’s condition and care provided by a  local hospital during a bout of appendicitis were recently released.  We can look at the causes that led to her death – and the death of her unborn baby – in a Cause Map, or visual root cause analysis.

With a complex issue taking place over several days like this one, it can be helpful to develop a timeline to aid in understanding.  In October, 2011, the 5-months pregnant patient entered the hospital and was diagnosed with appendicitis.  Surgery to remove her appendix occurred on October 23rd.  On the 29th, the patient was discharged from the hospital.  The pathology results became available on October 31st. These tests indicated that it was not the appendix that had been removed, but an ovary.  However, the results were not read by any hospital staff at this time.

The patient returned to the hospital on November 7, still in pain.  On the 9th, she suffered a miscarriage, at which point the pathology tests were read.  The patient underwent surgery to remove septic fluid from the diseased appendix, which had not been removed.  Two days later, on the 11th, the patient underwent a second surgery to remove her appendix, and died during the operation.

Before beginning an analysis it’s important to determine which organizational goals were impacted as a result of any issue being analyzed.  In this case, the patient death and miscarriage are both impacts to the patient safety goal.  (Both the mom and baby can be considered patients.)  As a result of the issues related to the patient’s death, eight hospital staff are being investigated, an impact on the hospital’s employees.  The death of a patient related to the wrong procedure being performed – in this case, the wrong organ was removed during her appendectomy – is a “Never event”, which is an impact to the compliance goal.  The Hospital Trust has accepted liability for her death, an impact to the organization.  The wrong organ being removed is an impact to the patient services goal. Additional required surgeries are an impact to the labor goal.

To perform our root cause analysis, we begin with an impacted goal and ask “Why” questions.  In this case, the patient death was due to multiple organ failure.  The multiple organ failure occurred because the patient had sepsis, and the sepsis was not immediately recognized.  (Although it appears that nothing was done to deal with sepsis until two days after the patient returned to the hospital, details on what was done have not been released.)  The sepsis resulted from the patient having appendicitis, and the appendix not being removed for 19 days.  Why was the appendix not removed for 19 days?  Instead of removing the appendix during surgery, the patient’s ovary was removed.  The results of the pathology report (which would have identified that the organ sent was not an appendix) was not read when available.  It is also not clear what the process was for reading these reports at the hospital, and how that process is being fixed.  It is known that the pathologist did not do any special reporting of the adverse results.

Now we get to the question, why was the wrong organ removed in the first place?  The surgeons were attempting to remove the appendix, which was inflamed as the patient was suffering from appendicitis.  Because they were performing open surgery, rather than laparoscopic, and the uterus was in the way of the appendix (due to the pregnancy), the surgery was being performed by feel, rather than sight.  (As you can imagine, this makes the surgery more difficult.)  During the surgery by feel, the ovary was mistaken for the appendix.  The ovary was possibly inflamed, due to the pregnancy, but another important issue is that the surgery was performed with overall inadequate expertise – specifically by trainees with no senior medical staff present.  (Senior medical staff were not required to be present, but due to the admitted difficulty of this type of surgery, that may have been a good move.)

As with many medical mishaps, any number of staff members could have improved the patient’s outcome.  Specifically, though the pathologist was only tangentially involved in the patient’s case, had she or he called the patient’s team immediately upon noticing that what was labeled an appendix was actually an ovary, the patient’s (and baby’s) life would likely have been saved.  Patient safety depends on everyone.

To view the Outline and Cause Map, please click “Download PDF” above.

Root Cause

A Tongue Tie Release Wrongly Performed in Case of Tongue Lesion Resection

By ThinkReliability Staff

A California hospital has been fined $50,000 – its fifth administrative penalty from the State since 2009 – for performing the wrong procedure on a 6-year-old boy.  The boy was supposed to receive a tongue lesion resection, but instead a tongue tie release was performed.

We can examine the issues that resulted in this incident within a Cause Map, or visual root cause analysis.  The first step in any analysis is to define what you are analyzing.  We begin with impacts to the organization’s goals.  In this case, we look at the impacted goals from the respect of the hospital.  First, the patient safety goal  was impacted due to an increased risk of bleeding, infection, and complications from anesthesia.  The compliance goal is impacted because performing the wrong surgical procedure on a patient is a “Never Event” (events that should never happen).  The organizational goal is impacted because of the $50,000 fine levied by the State of California.  The patient services goal is impacted because the wrong procedure was performed and the labor goal was impacted due to the additional procedure that was required to be performed.

The second step of our analysis is to develop the cause-and-effect relationships that describe how the incident occurred.  We can develop these relationships by beginning with the Impacted Goals and asking “why” questions.  For example, the patient safety goal was impacted because of the additional risk to the patient. The patient received additional risk because of the performance of an additional procedure.  An additional procedure was necessary because the wrong procedure was initially performed.

There are many causes that contributed to the wrong surgery being performed.  These causes are outlined in the  report provided by the California Department of Public Health.  In this case, there were several causes that likely resulted in the wrong procedure.  The Operative Report had the incorrect diagnosis – tongue tie – which would suggest that a release would be the appropriate procedure.  Additionally, the Anesthesia Record contained the wrong procedure (tongue tie release), possibly because the Pre-Anesthesia Evaluation originally noted that a tongue tie release was to be performed and was later corrected (by crossing out the incorrect procedure and writing in the actual procedure).

The type and site of surgery was not verified.  The surgeon who performed the surgery could not remember if a time-out had been performed, although there was a record of a time-out performed immediately prior to the surgical procedure.  Since the time-out was performed immediately prior to the procedure and the surgeon was unable to remember the proper procedure, the time-out was obviously ineffective.

The surgeon stated after the surgery that he believed that the tongue tie release surgery which was performed was indicated based on scar tissue that was found under the tongue.  The surgeon did not notice the lesion on the tongue during the surgery and no pre-surgical exam was performed by the surgeon.  Additionally, the surgical site was not marked (as the site of the correct, as well as the incorrect, surgeries were both within the patient’s mouth).

During the procedure, none of the other staff stopped the surgery as it was occurring.  However, given the proximity of the “correct” site to the “incorrect” site, it may have been difficult for the other staff to see what was going on.  The surgeon did note that the lesion removal should have created a sample, the lack of which was not noted by staff.

The surgeon involved in this case has indicated that he will be examining his patients prior to surgery in the future. Hopefully this incident will also serve as a reminder to all medical staff that in the case of a site that cannot be marked as per procedure, extra care should be taken to ensure the correct site is operated on and the correct procedure is performed.

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

Never Event

Surgery Performed on Wrong Eye

By Kim Smiley

There are few medical errors scarier than a wrong site surgery.  The idea that you could go to sleep and wake up having had a procedure performed on the wrong body part is terrifying.  Unfortunately, this is exactly what happened to a family in Washington recently.

On April 13, 2011, a surgeon performing a routine procedure to correct a wandering eye mistakenly operated on the wrong eye of a four year old boy.  In this case, the wandering eye was caused by a muscle that was too strong so the surgery was performed to weaken the muscle.  It’s unclear at this point whether the wrong site surgery will have any lasting impact on the patient’s vision, but the patient’s mother has stated that the previously healthy eye is now wandering.  A specialist who examined the boy post-surgery stated that the eye needs to completely heal (about 5 weeks) until any determination can be made about long term consequences.

How did this happen?  How does a surgeon perform a procedure on the wrong part of the body? And most importantly, how do we prevent these types of errors in the future?

The investigation of this incident is still ongoing, but a Cause Map of the incident can be started and then expanded as more information becomes available.  A Cause Map is a visual root cause analysis that lays out the causes of an incident in an intuitive format.  Once the Cause Map is complete, it can be used to develop solutions to help prevent future problems. Click on “Download PDF” above to see an Outline of this incident and the initial Cause Map.

In this example, it isn’t clear yet how the mistake was made.  Findings from the investigation so far have determined that the correct eye was marked before surgery, but statements by the surgeon indicate that the mark may have been accidentally covered by a nurse. The hospital has protocols in place that require checking and double checking the surgery site, but it’s not clear why they weren’t followed.  Once the investigation is complete, the hospital will determine what solutions need to be implemented to ensure that this doesn’t happen again.

Root Cause Analysis

Wrong Surgery Performed on Patient (Part 1)

By ThinkReliability Staff

A case study of an incident where the wrong surgery was performed on a patient was recently published in the New England Journal of Medicine.  Surprisingly, the study was published by the surgeon who performed the operation, because, in his words, ” hope that none of you ever have to go through what my patient and I went through.”  The surgeon also provided full disclosure to the patient – who requested that he also perform the correct surgery.

We will be analyzing this issue in two parts.  This week, we’ll be looking at the timeline of events and a process map of the universal protocol developed to reduce the incidence of surgical errors.  (The timeline and process map can be seen by clicking “Download PDF” above.)  Next week, we’ll perform a root cause analysis of the issue.

The timeline of events shows a harried day where the surgeon in question performed a carpal tunnel release surgery with a patient who became upset about the use of anesthetic, then briefed the patient who would later receive the wrong surgery, then performed another carpal tunnel release surgery on a second patient.  Then the first patient became very agitated, resulting in an emotional conversation for the surgeon.  Delays resulted in a change of operating room and operating staff for the third patient, so the nurse who had performed the pre-procedure assessment was no longer participating in the procedure.

The  procedure was further delayed when the circulating nurse had to leave to find a tourniquet, since there wasn’t one in the operating room.  The surgeon spoke to the patient in Spanish (she did not speak English), which the nurse took as the time-out, so a real surgical time-out did not occur.  As per hospital protocol, the patient’s arm, but not the specific surgical site, was marked, but it washed off while her arm was being prepped for surgery.

It’s easy to see how this sets the scene for mistakes. Unfortunately, these kind of things happen, and so it is important that there are procedures in place to minimize errors.  The procedures here are the universal protocol, which are shown on the PDF.  Additionally, the parts of the process that were not performed, or were performed improperly, are noted in red.

Never Event, Root Cause Analysis

Fifth Wrong-Site Surgery in Two Years Results in Fine for Hospital

By ThinkReliability Staff

Last month a patient at Rhode Island Hospital received surgery on his fingers. The surgery was supposed to be on two separate fingers (one on the right hand, one on the left), but due to a medical error, both surgeries were performed on the same finger. The family was then notified and the surgery was re-performed on the correct finger.

Although there was no risk of patient death due to this medical error, it is the fifth wrong site surgery to happen at this teaching hospital in two years. Rhode Island Hospital was previously fined $50,000 for three prior wrong-site surgeries. The Rhode Island Health Department fined the hospital $150,000 for the latest incident and is requiring the hospital to install cameras in its operating room.

Although some of the details of the surgical error are unknown, it is known that rather than marking the individual fingers that were supposed to be operated on, the patient’s wrists were marked. Additionally, it was not the operating surgeon who did the markings. The operating team also did not hold a “timeout”, which is used to make sure the operating team has the right patient, right location and right surgery, before performing the second surgery. (In particularly disturbing news, after the error was noticed and the family consented to performing the operation on the correct finger, there was again no “timeout”.)

The downloadable PDF shows the outline of the problem and a very basic Cause Map. (Click on “Download PDF” above.) As more details emerge during the investigation, they can be added to the Cause Map. Once the Cause Map is completed to a level of detail commensurate with the impact to the organization’s goals, solutions can be found to mitigate the future risk.

Want to learn more?

See how else wrong-site surgeries could occur in our proactive Cause Map.

Read the news article.

Never Event, Root Cause Analysis

We Regret to Inform You We’ve Removed the Wrong Leg . . .

By ThinkReliability Staff

Performing surgery on the wrong body part or wrong-site surgery is a “never event” as defined by the National Qualify Forum (NQF), and can have serious health consequences for a patient.

We can use a Cause Map to determine some ways to prevent wrong-site surgery. Some of the common errors leading to wrong site surgeries are presented in the Cause Map found on the downloadable PDF. They include: time pressure, lack of paperwork, misreading radiography, not marking or incorrectly marking the surgical site, and marking the wrong site.

Once the root cause analysis is complete, solutions are brainstormed and placed with the cause they control. In this example, we use the solutions to create a basic Process Map for the surgical preparation procedure to prevent wrong site surgeries. The solutions are numbered based on the order they appear on the Process Map. It’s clear that consistent adherence to this Process Map would result in fewer wrong-site surgeries.

Click on “Download PDF” above to download a PDF showing the Cause Map and Process Map.

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