Tag Archives: Never Event

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

After Patient Death, CMS Surveyor Declares “Immediate Jeopardy” To Patient Safety

By ThinkReliability Staff

From the moment a patient arrived at an endoscopy clinic in New York on August 28, 2014, things didn’t follow the usual procedure.  The patient brought her own ear, nose and throat physician (ENT) to accompany her into surgery for an esophagogastroduoudenoscopy (EGD), though the ENT did not have privileges at the facility.  The patient signed a consent form for anesthesia, and the EGD and her vital signs were taken, though it appears her weight was either not taken or not recorded.

After a time out that was initiated by the endoscopy technician (as opposed to the anesthesiologist, as required by policy) for the EGD, the patient was administered Propofol for sedation.  After the patient was sedated, the ENT attempted to perform a nasolaryngoscopy, despite not having facility privileges or a record of patient consent, but the initial attempt appears to have been unsuccessful.  After the EGD was completed, the ENT performed another nasolaryngoscopy beginning at 8:28 AM and ending (per interview records) at 8:30 AM.

By that time, the patient’s condition was quickly deteriorating.  Her blood pressure had dropped from its pre-procedure level of 118/80 to 84/40, her pulse from 62 to 47, and oxygen saturation from 100% to 92%.  Both the Cardiac Arrest Record and the Endoscopy Code Blue Record indicate that at 8:28 AM (the same time the second nasolaryngoscopy was beginning) the patient went into cardiac arrest/ ventricular tachycardia and measures were taken for resuscitation (including assisted ventilation, chest compressions, and administration of epinephrine and atropine).

The record of the surgery note that the laryngoscope was withdrawn at 8:30 AM, at which time cardiopulmonary resuscitation (CPR) was undertaken.  The patient was resuscitated and transferred to a hospital, where she died on September 4, 2014.  The cause of death from the autopsy report was anoxic encephalopathy (brain damage) caused by hypoxic cardiac arrest (oxygen deprivation).

The day prior to the patient’s death, a surveyor from the Centers for Medicare and Medicaid Services (CMS) declared “Immediate Jeopardy” due to “significant findings . . . which compromised patient safety”.  Specifically, the surveyor noted that the facility had risked patient safety by allowing a doctor without privileges to be allowed in the operating room and perform a procedure, and not obtaining consent or performing a time out for a procedure that was performed.

The facility quickly submitted a corrective action plan that revised procedures allowing visitors to the facility, ensuring informed consent and time out procedures are used before every procedure, and providing training on these updated procedures to staff.  Immediate jeopardy was removed on 9/5/14, although the facility was still considered out of compliance with CMS requirements, and was given until March 2 to maintain its certification.  (CMS has not released whether the facility has been successful.)

A lawsuit is underway that may provide more detail as to how the CMS findings caused (or didn’t cause) the patient’s death.  At this point, what is known can be captured in a timeline (for a chronology of events) and a Cause Map (to capture the cause-and-effect relationships that led to the impact to the goals) to start organizing and presenting information logically.  As more information is available, the Cause Map can be updated.

To see the timeline and initial Cause Map, click on “Download PDF” above.

 

Root Cause

Causes for Medication Errors Identified in Cumulative Cause Map

By ThinkReliability Staff

Despite continuing efforts to reduce patient safety impacts from medical errors, more work is needed to make patients safer. One of the areas which has been identified as a key safety issue is that of medication errors within healthcare facilities. A Cumulative Cause Map is a tool that can identify causes proactively (before incidents occur) based on industry experience, including past errors. As a Cause Map is a visual form of root cause analysis, a Cumulative Cause Map can be considered a visual form of Failure Modes and Effects Analysis (FMEA). It captures potential causes (causes that COULD result in an impact to patient safety) in order to develop and implement solutions that will reduce the risk of the impacts.

In this case, the term “medication error” is used to refer collectively to errors that result in patients receiving the wrong medication, patients receiving medication prescribed for another patient, patients receiving the wrong dose of the correct medication or having the correct medication delivered by the wrong route, and patients receiving medication to which they have a known allergy or has a negative interaction with another medication the patient is known to be taking. An adverse drug event (or ADE) results when the medication error causes patient harm. Our analysis will focus on preventable issues. (Patients may experience an ADE even when a medication is administered correctly.) About half of ADEs are considered preventable, i.e. they result from a medication error.

In this case, our Cumulative Cause Map will identify errors that occur at all steps of the medication delivery process. This process begins when a need for medication is identified and ends when the medication has been administered to the patient. At a very high level, there are four steps to this process: prescribing, transcribing, dispensing, and administration. The process typically begins with a physician, who prescribes the medication, moves to a clerk who transcribes the prescription (if necessary), then to a pharmacist who dispenses the medication, and then typically to a nurse, who administers the medication.

Based on information from studies, industry guides, and case studies of actual medication errors, common issues can be identified at each step of the process. In the prescribing stage, a medication can be prescribed for the wrong patient if there has been insufficient verification of the patient’s identity (and a matching of the patient to their medical records). Additionally, an inappropriate medication, dose or route may be prescribed if the physician is unaware of a patient’s allergies or other medications which could interact with those being prescribed. Miscalculating a dose is another potential error at the prescribing stage. Distraction and/or similar-sounding drug names are other causes for prescription errors.

In the transcribing stage, errors typically result from legibility issues on handwritten prescriptions. However, distraction and/or similar sounding drug names can result in the wrong medication/ dose and/or route of administration being transcribed. Distraction and/or similar sounding drug names is an issue during the prescribing step, as is miscalculating a dose. When medications have to be substituted (for availability or cost concerns), there’s also the potential to choose an inappropriate medication if a patient’s allergies or current medications are unknown.

At the administration step, medication can be administered to the wrong patient due to insufficient identity verification. Or, the wrong medication, dose or route can be administered due to similar sounding names and/or distraction. According to the Institute for Safe Medication Practices, every interruption increases the risk of medication error 12.7%, and medical staff can be interrupted as often as every two minutes while working on the medication delivery process. For this reason many hospitals are trying to reduce interruptions of medical staff during this process by various means.

By looking at the causes that come up again and again in the proactive analysis, steps for improvement at each level of the process can be identified. Ensuring that the right patient is matched to the medical record/ care instructions at every step of the process can reduce medication being administered to the wrong patient. The use of non-handwritten prescriptions and including both the drug’s brand name, generic name and purpose can also reduce the risk of the wrong drug being administered. Ensuring that drug allergies are clearly captured within a patient’s records (and potentially on the patients themselves, in the form of a wristband) and that a current medication list is up to date can reduce the risk of drug reactions. An organization’s experience with these different types of errors will allow it to determine what level of control over each cause is necessary to reduce the risk to an acceptable level.

To view the one-page PDF with a proactive analysis of medication errors in healthcare facilities, please click “Download PDF” above. To learn more about Medication Errors, please join our FREE Webinar on December 18th.

Root Cause

Re-engineered connectors may prevent tubing mix-ups

By ThinkReliability Staff

Patients being treated at healthcare facilities may have multiple tubing connections designed to provide different medical treatment products.  Disaster can occur when tubing is connected incorrectly.  The most well-studied example is when enteral feeding solutions are accidentally directed into intravenous (IV) lines.  The Joint Commission (TJC) found 116 case studies, including 21 that resulted in deaths, due to this type of misconnection, discussed in a recent Sentinel Event Alert.  In 2006, this happened to a pregnant woman, resulting in the death of both her and her fetus.  (See our previous blog on this topic.)

Issues involving tubing misconnections have been reported since the 1970s and are not limited to feeding tube/ IV mix-ups.  Many types of tubing for medical product delivery are susceptible to misconnection due to the use of luer connectors, which allow a high degree of connection compatibility.  Concern is growing over these types of connections, and it’s become clear that training is not adequate to prevent these types of connections.  According to the Joint Commission, “The basic lesson from these cases is that if it can happen, it will happen.  Luer connectors are implicated in or contributed to many of these errors because they enable functionally dissimilar tubes or catheters to be connected.”

Action is being taken that would prevent these misconnections by ensuring that each type of tubing has its own, non-compatible connector.  The Association for the Advancement of Medical Instrumentation (AAMI) is leading an international initiative to develop small-bore connectors standards.  Public review of the standards is now available (along with other helpful information including case studies) on the AAMI website.  The State of California has passed legislation requiring manufacturers of intravenous, epidural or enteral feeding devices to implement the new standards that aim to prevent misconnection, though it does not take effect until January 1, 2016.

Connectors meeting the new, non-compatible standards are becoming available but compatible connectors may still be in use and in inventory systems.  To limit risk of patient death or serious impairment while the new connectors are phased in, TJC recommends that tubing is traced from the patient to its point of origin every time it is connected, disconnected, or during a patient hand-off.  Labeling high-risk tubing and routing tubes and catheters in specific directions (towards the head for IVs; towards the feet for enteric feeding tubes) has also been recommended to reduce the risk of misconnection.

Going forward, only equipment that is incompatible with female luer connections on IVs should be purchased for all non-IV equipment and acceptance testing should be performed on new purchases to ensure it is not compatible with IV tubing connections.

The cause-and-effect relationships leading to the patient safety risks, and the solutions that are being recommended can be visually diagrammed in a Cause Map, or visual root cause analysis.  To view a one-page overview of the issue, please click on “Download PDF” above.

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

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.

Root Cause

13-Inch Surgical Tool Left In Patient for Months

By Kim Smiley

For about two months after surgery to remove a large malignant tumor Donald Church complained of severe pain.  Initially, he was told that it was normal pain associated with recovery from a major surgery, but an x-ray was ordered after his physician felt a lump in his abdomen.  The x-ray revealed that a malleable retractor similar in size to a ruler had been left inside his body after surgery.  A second surgery was done to remove the tool.  Mr. Church is not expected to suffer long-term health consequences and received a $97,000 settlement.

A Cause Map, a visual format for performing a root cause analysis, can be built to help understand how this issue happened.  Once all the causes that contributed to an issue are found, potential solutions can be found and the most promising can be implemented to help reduce the risk of a similar issue reccurring.

So how did this happen?  How does a large surgical tool get left inside a patient?  This occurred because the patient needed surgery to remove a tumor, the malleable retractor was used during the surgery and the surgeons were unaware that the tool remained inside the patient. (These causes are vertical on the Cause Map with “and” between them because all 3 were necessary for the issue to happen.)  A malleable retractor was used while the wound was being closed to help protect the organs under the wound from possible puncture from the suturing needle.

The surgeon was unaware that the tool was inside the patient because he couldn’t see it and there wasn’t an adequate system in place to manage surgical tools.  Malleable retractors are normally held partly out of the wound, but it had slipped entirely inside the wound during the surgery.  Once the tool was out of sight, it was forgotten.  While many hospitals have requirements to formally count surgical tools as they enter and leave the operating room to ensure that all are accounted for, there wasn’t a policy in place in the facility that performed the surgery at the time.  With no formal system to track tools, there weren’t any easy indications to the operating team that there was a problem.

While this is a particularly egregious example, there are an estimated 4,000 cases of retained surgical items each year in the United States. Better solutions need to be found to reduce the risk of this preventable and potentially deadly problem from happening.  A simple solution to reduce the risk for retained surgical items is to institute a formal procedure for counting surgical supplies and tools before and after surgery.  Simple manual counts are a first step, but errors still occur, especially in the often hectic and stressful environment in an operating room.  Some hospitals use a visual inventory system where tools are brought in a special storage bag with an individual compartment for each item.  As items are done being used they are put back into their specific spot.  If all compartments are full, everything is accounted for so it’s easy to tell if something is missing.

Another solution that is gaining in popularity is use of an electronic tracking system.  The most common use of electronic systems is to track sponges, which are by far the most common object left inside patients.  Each sponge has an electronic tag and the patient is scanned after surgery to verify that none were left behind.  Sponge tracking systems add about $8 to $12 to the cost of each surgery and have dramatically reduced the number of retained sponges when used.

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

Root Cause

Adult Dose of Heparin Delivered to Premature Infants

By ThinkReliability Staff

On September 16, 2006 6 premature newborns in Indianapolis were given adult doses of the blood thinner heparin, used to prevent blood clots that could clog intravenous (IV) tubes.  Adult doses are 1000x more concentrated than infant doses.  Three of the babies died and the other three were in critical condition.  In 2007, in Los Angeles, an overdose was given to three more babies due to the same error.  Luckily none of those babies died.  (Up to 17 babies in Texas also received heparin overdoses in 2008, but these were caused by a mixing error at the hospital pharmacy.)

We can examine this issue in a visual root cause analysis, or Cause Map.  Fully investigating the errors that occurred for these overdoses to happen can lead us to solutions to increase healthcare reliability by decreasing the risk of the same situation recurring.

We begin with the outline, where we capture the what, when and where of the incident, as well as the impact to the organization’s goals.  These medication overdoses impacted the patient safety goal because they resulted in fatalities and serious injury to the babies who received the medications.  Additionally, employees involved in the issue can be affected as a second victim.  Death or serious disability due to a medication error is a “Never Event“, which is an impact to the organization’s compliance goals.  Patient services are impacted due to the incorrect drug dose delivery.

Once we’ve determined the impacts to the goals, we can ask “Why” questions to determine the cause-and-effect relationships that led to the incident.  In this case, 5 opportunities for double-checking the dosage were missed.  The wrong dosage was missed as 1) the bottle was removed from the pharmacy, 2) the bottle was placed in the cabinet, 3) the bottle remained in the cabinet, 4) the bottle was taken from the cabinet, and 5) the drug was administered to the babies.  Some of the reasons that it was missed: there was no effective double check by another staff member, there was no check by a computer and of course due to human error, which was aided by the issue that the adult dosage bottle and the infant dosage bottle looked practically identical (this has since been remedied).

An article in The Journal of Pediatric Pharmacology and Therapeutics states, “As frequently occurs, all of these heparin-associated medication errors happened when a number of system failures occurred simultaneously. System failures included: 1) failure to carefully and accurately read the label on the medication vial prior to administering the drug to the patient; 2) inaccurate filling of automated drug-dispensing cabinets; 3) non-distinct “look-alike” labels on the heparin vials; 4) similar size of the heparin vials as both were 1-mL vials; and 5) “factor of ten” dosing errors.”

Many solutions to this type of error (such as requiring double checks by staff members and using a computerized prescription dispensation system) were suggested as a result of this and other heparin overdoses over the past several years and are already being implemented at hospitals across the nation.

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

Root Cause

Patient Wakes While Being Prepped for Organ Harvesting

By ThinkReliability Staff

An extremely rare but tragic case has been recently brought to light.  On October 16, 2009, a patient was brought to a hospital center in Syracuse, New York after suffering a drug overdose.  Over the next several days, the patient was in a deep coma, though she did not meet the requirements for brain death based on scans performed at the hospital.   The family was notified and agreed to donate her organs.  The patient, after being sedated, was prepped for donation after cardiac death (DCD).  The organ harvesting stopped prior to any organs being removed when the patient opened her eyes on the operating table.

The hospital was cited not only for the error, but for the inadequate response and investigation after the error was made by the state Department of Health and the Centers for Medicare & Medicaid Services (CMS).  Specifically, the CMS report states “The hospital’s Quality Assurance Performance Improvement program did not conduct thorough reviews of an adverse occurrence involving a patient who was being considered for withdrawal of life-sustaining treatment when she regained consciousness.”

We can examine the error using a Cause Map, or visual root cause analysis, to determine the issues related to the incident.  This provides a starting point for developing solutions to reduce the risk of such an incident recurring, and improving healthcare reliability at this site.

It’s important to frame the issue with respect to an organization’s goals.  In this case, the patient safety goal was impacted due to the risk of patient death from having organs removed.  The accidental removal of organs can also be considered an impact to the patient services goal.  The compliance goal is impacted because of the sanction and fine (though a minimal $6,000) from the Health Department.  Negative press and public opinion as a result of this incident – which was uncovered and reported to the Health Department by the press – is an impact to the Organizational goal.

Beginning with an impacted goal – in this case the Patient Safety goal – asking “Why” questions allows us to develop the cause-and-effect relationships that led to the issue.  In this case, the risk for patient death was due to risk of removing her organs.  The risk for removing organs is because the organ harvesting process had begun.  (The investigation did find that there were no concerns with the organ donation process itself, indicating that errors were prior to the donation prep process.)  The process began because the family agreed to donate organs after the patient was (incorrectly) determined to have suffered cardiac death.

There were a combination of errors that resulted in the patient being incorrectly declared “dead”.  Because all of these factors acted together to result in the impact to the goals, it is important to capture and fully investigate all of them to be able to improve processes at the organization.  In this case, the patient was injected with a sedative, which was not recorded in the doctor’s notes.  It is unclear who ordered the sedative and why.  (It’s also unclear why you would sedate a dead patient, as another doctor stated “If you have to sedate them . . .they’re not brain dead.”)  The patient had previously been in a deep coma due to the drug overdose.  It is possible the coma went on longer than usual because the patient was not given activated charcoal to inhibit absorption of the drugs by the body after the staff was unable to  unable to place a tube.  There appears to have been no additional effort – another area that should be investigated to ensure that protocol is sufficient for patient safety.

The hospital’s evaluation of the patient’s condition before a diagnosis of cardiac death was insufficient.  Specifically, it has been noted that the staff performed an inadequate number of brain scans, inadequate testing to determine the drug levels remaining in the body, and ignored signs that the patient was regaining consciousness prior to preparing her for organ donation.  Because details of these issues were not thoroughly investigated, it’s impossible to know whether the protocols in place at the organization were inadequate for determining cardiac death or whether the protocols were adequate and weren’t followed by staff.

Determining if changes need to be made to protocols as a result of this tragic (though I do want to emphasize rare – the state was unable to find any similar cases in its records) incident is of utmost importance to reduce the risk of an incident like this happening again.  Hopefully the additional scrutiny from the state and CMS will ensure improved patient safety in the future.

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

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.