Tag Archives: medical error

Patient Gets MRI (and a Diagnosis) Only After 24 Visits to 13 Doctors

By ThinkReliability Staff

In a tragic case of incorrect diagnosis, a 16-year-old patient died January 24, 2013, eleven months after being diagnosed with “migraines”.  In fact, the patient had a rare brain tumor (known as a disseminated oligodendroglioma-like leptomeningeal tumor).  She died eight days after receiving an MRI that finally properly diagnosed the causes of her headaches, numbness, nausea and eyesight problems.

It’s unclear if earlier diagnosis would have saved the life of the patient.  Though the prognosis is poor for a leptomeningeal tumor, a oligodendroglioma that is treated before it is disseminated gives a long-term survival chance to 80-100%.  The tumor had disseminated once it was found on the MRI, eleven months after the patient was diagnosed with migraines.  However, even if her prognosis was poor, the patient could have spent the last eleven months of her short life enjoying time with her family and friends, instead of making 24 trips to 13 different doctors and, in one particularly devastating appointment, being accused of “putting the symptoms on”.

Although the coroner at the inquest said there was no need to make a formal recommendation for changes at the hospital that failed to diagnose the patient, a spokesperson for that hospital said “In the next few weeks, many of the clinicians who looked after Natasha will be meeting to discuss this sad case and ensure that any opportunities for learning are not missed.”

It is hoped that these opportunities for learning can reduce the possibility of another patient suffering as this patient did, due to a misdiagnosis.  Misdiagnosis is a common source of medical error.  According to an article by Michael Astion, MD, PhD, “Available data suggests that misdiagnoses occur in 15% or more of clinical cases, but overall there is very limited data on the frequency of misdiagnosis in medicine.”  Especially in rare clinical cases such as this one, sharing details of the disease and diagnosis may help other clinicians in the same position.

In order to effectively determine lessons learned and improvements that can be made, the details of a case need to be presented clearly and concisely.  I’ve put together the details of the case in a Cause Map, which uses cause-and-effect to demonstrate the linkage of the issues that led to the tragedy discussed here.

In a blog discussing the cases and possible responses, Suzanne Leigh suggests that if an MRI was denied, other cheaper alternatives, such as a CT scan, be considered.  She also suggests a much more thorough review to “ensure that in the future, scans are  not withheld from patients with potentially life-threatening conditions”  and that the hospital involved should “study the flaws in the system and human errors that led to the failure of 13 doctors to order a diagnostic MRI that would have resulted in emergency treatment earlier in the disease’s progression”.  Given the tragedy of this case, the suggestions seem far more appropriate than the treatment of the patient over the last year of her life.

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

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.

Are Medical Residents Dangerously Fatigued?

By Kim Smiley

Medical residents work extremely long, tiring schedules on their arduous path to becoming physicians.  Possible consequences of this demanding schedule have long been debated.  Many wonder if it’s safe to have someone who has been on duty for 24 hours straight treating patients.

This issue can be explored by building a Cause Map, or visual root cause analysis.  A Cause Map is built by asking “why” questions and laying out the different causes that contributed to an issue to the cause-and-effect relationships.  In this example, there is potential risk to patients and to the medical residents themselves.  Patients may be at risk because fatigued medical residents are treating patients and fatigued people are more likely to make mistakes, increasing the chance of a medical error that affects patient safety.  Residents are fatigued because they work long hours and the current regulations allow 80 hour work weeks.

Additionally, the health of the residents themselves may be at risk.  A poll by the Mayo clinic found that 11 percent of medical residents had been in an auto accident.  The poll also found that 8 percent of residents reported having at least one blood or body fluid exposure due to fatigue or stress, potentially exposing them to any number of diseases.  Sleep deprivation itself can also have long term health consequences increasing the likelihood of a number of illness including heart disease and gastrointestinal problems.

While there is ongoing debate on whether residents are still working too many hours, there have been changes made to reduce resident fatigue. In 2003, residents were limited to 80 hours per week by the Accreditation Council for Graduate Medical Education.  Prior to this move, there was essentially no limit to the hours a resident could log.  This issue isn’t black and white and there are also many who argue that the limits have had negative unintended consequences.  Fewer hours in the hospital mean that residents see fewer patients and have less experience when they become independent physicians.  Limiting shifts also increases the potential for each patient to be seen by more doctors and for essential information to be lost during turnovers.  This isn’t an issue with a clear answer and any additional restrictions in the hours a resident is allowed to work will need to be mitigated with effective methods of turning over patient care and assurances that residents are getting adequate training.

This is a good example to demonstrate the important of taking an investigation past determining that the problem is caused by “human error”.  Medical errors are caused by human errors, but the most useful part of the investigation usually comes from asking why the error was made.  Was the person overly fatigued?  Was the procedure confusing?  Would the process go smoother with a phase to verify information or a checklist?  An investigation shouldn’t be stopped at “human error”; it should be taken a few steps farther to see what may have contributed to the error and what changes may help prevent a similar error in the future.

Delay in Standard Sepsis Protocol May Have Cost Patient Her Life

By ThinkReliability Staff

Information found in this blog is based on an article from Health Affairs, where an emergency physician describes his mother’s fight against neutropenic sepsis contracted after her second bout against cancer.

In this case, the sepsis killed the patient, impacting the patient safety goal.  Additionally, the delay in treatment – even if it did not result in the patient’s death – is an impact to the patient services goal.   With delayed patient services, there is the potential for a lawsuit, or other potential action against the hospital.  We’ll consider this an impact to both the compliance and organizational goal.  We can visually diagram the causes that led to these impacted goals in a Cause Map, or visual root cause analysis.

Here, the patient death was due to her inability to fight neutropenic sepsis, which resulted from a systemic infection that the body – having depleted infection-fighting cells during recent chemotherapy – was unable to fight off.  Medical intervention can improve the survival rate, especially when life-saving measures are begun quickly and followed completely.  In this case, the patient was hospitalized for 23 hours before sepsis protocol was begun.

The patient’s primary doctor was her oncologist, who did not consult with an intensive care doctor.  Despite recommendations to have care of new ICU patients fall within the responsibility of an intensive-care doctor, this solution was not implemented at this particular hospital due to “political barriers”.  It can thus be surmised that this may have been a cause to the delay in consultation during the case as well.

The sepsis protocol was begun only when care was transferred to the intensive-care doctor as a result of the patient’s son requesting transfer to a different hospital.  Perhaps the staff was unaware of the seriousness of the situation, as the monitoring of the patient appeared inadequate.  The transfer of the patient to the ICU was also only done at the specific request of the patient’s son.  Based on the description of the experience at the hospital, it’s not clear why the patient’s doctor did not order the standard sepsis protocol.

The hospital involved in the case has updated its guidelines in treating sepsis.  Hopefully this will successfully result in the reduction of cases such as this one.

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

Manifestation of Poor Glycemic Control Part 3

By ThinkReliability Staff

In previous blogs, we wrote about nonketotic hyperosmolar coma and diabetic ketoacidosis, which are both conditions related to hyperglycemia, or high blood glucose.  In this blog, we consider the last type of manifestation of poor glycemic control that, when it occurs in the hospital, is considered a hospital-acquired condition by Medicare & Medicaid, meaning that hospitals will not receive additional payment for cases when this condition is acquired during hospitalization.  Hypogelycemic coma, along with nonketotic hyperosmolar coma and diabetic ketoacidosis, results from poor glycemic control within the hospital, but is caused by low blood glucose.

As we did with the other two manifestations of poor glycemic control, we can look at the impacted goals for a hospital and the potential causes and solutions for this condition in a visual root cause analysis or Cause Map.  The goals for hypoglycemic coma are the same to the other manifestations of poor glycemic control and include increased risk of patient death, length of patient stay and treatment needs.  The costs associated with hypoglycemic coma (greater than $7 million in the US from the 212 cases reported to CMS in 2007) are no longer reimbursable when the condition is acquired in the hospital.  There is also always the potential that a patient death can result in a second victim – the patient’s provider(s).

Hypoglycemic coma results from uncontrolled hypoglycemia, which can result from overtreatment with insulin, drug-induced hypoglycemia, drug interaction with insulin, decreased glucose production and/or loss of glucose.  Overtreatment with insulin was implicated in 90% of hypoglycemia cases in a recent study and can result from medication errors (see our analysis on medication errors in hospital settings),  or a failure to adjust insulin for diet or other factors.  Drug-induced hypoglycemia can result from administration of fluoroquinolones (the mechanism for this effect is unknown) and/or inadequate nutrition.  Drugs that interact with insulin may be administered to a diabetic patient if providers are lacking in knowledge about glycemic control.  Underlying disease or infection, such as chronic renal insufficiency, which was implicated in approximately 50% of hypoglycemia cases in the study, can result in decreased glucose production or loss of glucose.

As with the other types of manifestations of poor glycemic control, efforts must be made to prevent these types of incidents.  As suggested with hyperglycemic events, insulin plans should be individualized, accounting for all relevant factors related to glycemic control and diet.  Patients treated with insulin in the hospital should have their blood glucose levels monitored frequently, especially as insulin has been identified as a High-alert medication by The Joint Commission.   Any patients found unconscious should also immediately have their blood glucose levels measured.  Patient’s nutritional intake must be carefully monitored, especially for cases involving medications that might cause hypoglycemia.  Last but not least, controls and procedures involving drugs given to diabetic patients should be carefully controlled, due to the high potential and risk for interaction with insulin.

Two other conditions are considered hospital-acquired manifestations of poor glycemic control: nonketotic hyperosmolar coma and diabetic ketoacidosis.   In previous blogs, we discussed the causes of these issues, and suggested solutions to reduce the risk of these types of incidents.

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

Donated Kidney Trashed

By ThinkReliability Staff

On August 10, 2012, a living donor’s kidney was thrown out, instead of being transplanted as planned.  The incident was chalked up to “human error”, which is almost certainly part of the problem . . . but definitely not all of it.

This extremely rare, but serious, event is being analyzed by several oversight agencies, as well as a contractor hired by the medical center in Ohio where the event took place, to ensure that needed improvements are identified and put into place so this type of incident doesn’t happen again.  We can examine the currently known information in a visual root cause analysis, or Cause Map.  To do so, we begin with the impacted goals.

There are many goals that were impacted as a result of this error.  Firstly, the patient safety goal was impacted because the patient did not receive the transplanted kidney.  This can also be considered an impact to the patient services goal.  Three personnel from the hospital were placed on administrative leave as a result of the incident.  This results in an impact to employees.  The compliance goal is impacted because this event has resulted in a review by several oversight agencies.  The living kidney donor program is currently shut down for review, which can be considered an impact to the organization goal.  The kidney was disposed of improperly, which is an impact to the environmental goal.  (Medical waste has strict requirements for disposal.)   The loss of the donated kidney can be considered an impact to the property goal.  Personnel time was taken both to attempt to resuscitate the kidney and to participate in an independent review of the donor program.  These can both be considered impacts to the labor/time goal.

Once we have determined the impacts to the goals, we can ask “Why” questions to develop the cause-and-effect relationships that led to these impacts.  In this case, the patient did not receive a kidney transplant because the kidney was thrown out and because of concern about the kidney’s viability.  Part of this concern was the delay in actually finding the kidney, likely due to the fact that it was disposed of improperly.  The reason given by the medical center for the disposal of the kidney is “human error”.  However, there is ordinarily a support system involved in organ transplants that would minimize these types of errors.  Certainly the fact that the program has been stopped and three employees – at least one of whom was not directly involved in the transplant operation – were placed on administrative leave suggest that the organization is looking at more than just a screw-up by one person acting alone.

Specifically, the investigation should look at communication – was the nurse who disposed of the organ told it was destined for transplant?  Was there a surgical time-out immediately prior to the removal with the entire operating team that discussed the plan for the kidney?  Also the training and preparation of the surgical team should be investigated.  Had the team been properly trained and prepped for this type of surgery?  The fact that it was done frequently at this facility doesn’t mean that adequate training was in place.  What about the procedure for treatment and supervision of donated organs?  Donated organs have to be treated in a very particular way to ensure their viability for the transplant patient.  Who, if anyone, was responsible for ensuring that the organ was prepared in a proper way for transplant?  Were they involved in the surgical time-out?  Lastly, because an error was made with the disposal procedure, the procedure, training and communication regarding disposal of medical waste needs to be analyzed to ensure it is adequate. The hope is that by doing a thorough review – and improvement – of policies, procedures, training and communication at the facility, it will not only reduce the risk of this type of error, but provide improvement in many other aspects of the care provided as well.

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

Use of Contraindicated Clip Leads to Death of Kidney Donor

By ThinkReliability Staff

In 2011, a kidney donor in Texas bled to death after her renal artery became open.  Sadly, her death was associated with the use of clips to close the artery – rather than staples – even though the use of clips was contraindicated for this purpose.  The instructions that came with the clips said this, as did several warning letters sent from the manufacturer in previous years.

We can look at this tragic issue in a Cause Map, or visual root cause analysis.  We begin with the impacted goals.  Because of the patient death, the patient safety goal is impacted.  Emotional impacts from employees resulting from a patient death can be considered an effect to the employee impact goal.  The use of a device other than intended is a result to the patient services goal and is considered a “never event” (an event which should never happen), resulting in an impact to the compliance goal.  A lawsuit resulting from the patient death is an impact to   the organization goal.  A total of four kidney donors are known to have died as a result of using these clips.

We begin with the impacted goals and ask “Why” questions to understand the cause-and-effect relationships resulting in this tragedy.  The patient died from a massive, sudden bleed caused by the bleeding of the renal artery which was open.  The renal artery had been opened as part of the kidney donor surgery, and had been closed using clips that slid off the renal artery.  The stump remaining on the renal artery after this kind of surgery is too short to allow the clips adequate purchase, and the clips slid off.  The hospital staff was unaware that these clips were contraindicated for this use.  Although a warning was placed on the instructions for the clips, these instructions were not kept in the operating room.  Additionally, the manufacturer sent out several letters to hospitals warning them not to use these clips for kidney surgery.  However, at that time, this hospital was not using the clips, and had forgotten about the letters when the clips were purchased.

Once the causes related to the issue have been captured, possible solutions can be brainstormed.  In this case, there are solutions for all the stakeholders in the event.  The operating team should use staples instead of these clips to close the renal artery.  The FDA has issued a safety notification to attempt to provide additional warnings against using these clips after kidney donation.  The hospital has implemented a system to track and document warnings and recalls related to medical equipment.  Some personnel in the medical community have requested that the warning not to use the clips after kidney surgery are printed directly on the clips, rather than on the operating instructions.  Dr. Amy Friedman, the Director of Transplant Services at Upstate Medical University in New York, who had raised concerns about using clips in kidney donors starting in 2004, would also like the warnings to include information that donors have died as a result of using these clips.  Although the FDA believes that the warnings up to this point have been sufficient, hopefully the additional actions will prevent another death from the use of these clips.

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

Airman Loses Both Legs After Gallbladder Surgery

By ThinkReliability Staff

A former member of the US Air Force lost both legs after a routine gallbladder surgery and was medically retired.  During the surgery, his aorta was lacerated.  Subsequent delays meant his legs were without blood flow for hours.

After the damage to the aortic laceration was repaired, still more time passed before the patient was transferred to a civilian hospital for treatment.  The Air Force Medical Center did not have a vascular surgeon on-site.  By the time the legs were removed, the patient had lost more than 2/3 of his blood volume.

Multiple issues contributed to the injuries received by the airman.  We can examine these issues in a visual root cause analysis presented as a Cause Map.  First we determine the impacts to the goals.  The patient safety goal was impacted due to the potential for patient death during the surgery and aftermath.  Although there was no disciplinary action taken by the Air Force, a $54.8 million lawsuit has been filed that claims negligence.  Last but certainly not least, the loss of both of the patient’s legs can be considered an impact to the patient services goal.

We begin with the impacted goals and ask “Why” questions to determine the cause-and-effect relationships that led to the impacted goals.  In this case, the patient’s legs had to be removed after they were without blood flow for several hours.  The blood loss was caused by a laceration to the aorta, made during the gallbladder surgery, and the subsequent accidental suturing of the aorta during the repair.  The repair to the aorta was delayed as it was not immediately recognized.  A surgical resident was performing the operation, and it is likely inexperience and lack of supervisor from the supervising surgeon contributed to this delay.  Additionally, although the operating room staff was unable to get a blood pressure reading from the patient, it was assumed that the machine was malfunctioning. After the aorta repair, there was further delay in recognizing and treating the loss of blood flow to the legs.  As there was no vascular surgeon on-site, the patient was eventually transferred to a civilian facility, where both legs were amputated.

The facility has not commented on the case and so it is unclear what actions might be taken to protect patients.  There have been several charges of negligence at the facility in recent years.

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

Patient Brain Damaged Due to Malpractice and Surgeon Inexperience

By ThinkReliability Staff

When complications occur during surgery, an experienced surgeon and surgical team can help ensure a positive outcome for the patient.  Inexperience can lead to problems – in this case, brain damage.  A special concern in this case is that hospital documentation advertised that the surgeon was accredited when he did not meet the requirements.  They were convicted of fraud.

When a patient suffers brain damage, the patient safety goal is impacted.  Any time the patient safety goal is impacted, an investigation  should be performed.  In this case, we can look at the issue in a Cause Map, or visual root cause analysis.

With the Cause Mapping approach, we begin with the impacts to the organization’s goals.  In addition to the brain damage, the patient also suffered from  loss of eyesight, another impact to the patient safety goal.   The  doctor was convicted of malpractice, which is an impact to the employee.   Additionally, the hospital was convicted of fraud, which can be considered an impact to the compliance goal.  The hospital was assigned $178 million in compensatory damage and $10 million in punitive damages.    Last but not least, the patient services goal was impacted due to the uncorrected leakage in the patient’s abdomen.

We can begin with the first patient safety goal and ask “why” questions to add more detail to the map.   In this case, the patient suffered brain damage as a result of a stroke.  The patient suffered a stroke because of uncorrected leakage in the abdomen.  The leakage occurred as a result of bariatric surgery, potentially due to the inexperience of the surgeon.  In addition,  the leakage was not treated for 8 days.  Again, it is believed that the inexperience of the surgeon contributed to insufficient patient care.

The fact that the leakage was untreated for 8 days was considered reason for malpractice.  While the patient was on a respirator due to his stroke, he was not treated with eye drops, resulting in a retinal burn that left him blind.  The hospital was convicted of fraud because it used documentation with the accreditation seal from the American Society Bariatric Surgery’s Center of Excellence referencing the surgeon who performed this surgery.  However, the surgeon did not meet the requirements for accreditation.  He had performed an insufficient number of surgeries and had not taken an adequate number of bariatric education courses to meet accreditation  requirements.  The use of the seal in hospital documentation was determined to be fraud.

This case reinforces the necessity for patients to be active in their own care in selecting their physicians.  Specifically, patients should perform  their own investigation of their surgeon’s qualifications.  However, in this case accurately determining those qualifications would have been difficult due to the associated fraud.  If the patient had asked how many surgeries the surgeon had performed, he may have decided to go elsewhere.

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

Patient Death over the Holidays

By ThinkReliability Staff

On December 31, 2010, a patient entered St. James’s Hospital in Leeds for a urinary tract infection.  Unfortunately for the patient, the hospital was experiencing nursing shortages due to the holiday and the patient died 3 days later.  The death of the patient is an impact to the patient safety goal.  We can look at this incident in more detail, based on the information available, in a root cause analysis presented in a visual Cause Map format.

Besides the impact to the patient safety goal, there was an employee impact due to the staffing shortage.  The patient’s son noted mistakes in the patient notes and charts (an impact to the compliance goal) and received a settlement from the National Health Service (NHS).  Last but certainly not least, the patient services goal was impacted due to the delay in appropriate treatment that the patient experienced.

To add more detail to the Cause Map, we can ask “why” questions.  The patient’s death was due to the combination of a urinary tract infection and the delay in appropriate treatment.  The urinary tract infection was caused by a catheter in place as the patient was bed-bound due to a previous stroke.   The delay in treatment was two-fold: first, the patient was not given another dose of antibiotics for 24 hours after the initial dose administered in the emergency room.  Second, the medication that was eventually given was not effective as the infection was resistant to that particular antibiotic.  The junior doctor who prescribed the medication failed to notice the antibiotic resistance and there was no over check of the prescription, likely due to the staffing shortage.

The patient was not monitored for 15 hours during the first 24 hours she was in the hospital.  Neither the nurses (again, likely due to the shortage) nor the consultant who performed morning rounds monitored her during this time.  This likely also led to mistakes in the patient’s notes and chart (which her son says number 140) and contributed to the patient’s death.  The NHS and hospital involved have developed an action plan to ensure that lessons are learned from this incident.

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