Tag Archives: cause mapping

Root Cause

Patient death after ambulance delayed due to “extreme demand”

By ThinkReliability Staff

An inquest into the death of a young patient in London after a significant delay in the arrival of an ambulance released some disturbing details into the emergency process. We can perform a root cause analysis of the issues that led to the delay, and death, by capturing cause-and-effect relationships in a visual Cause Map.   As with many complex incidents, it will be helpful to capture the chronology of an event within a timeline. This timeline should not be confused with an analysis, but can be useful in organizing information related to the incident.

In this case, the patient, who had type 1 diabetes and had been feeling sick for more than a day, asked a friend to call an ambulance at about 5:00 pm on September 7, 2015. The friend dialed 111, which is the non-emergency medical helpline from the National Health Service. The initial call handler determined that the situation was not an emergency, but marked it for a 20-minute follow-up with a clinician. A clinical supervisor called back and spoke to the patient at 5:42 pm. She determined that it was an emergency that required an ambulance within 30 minutes. However, because it was known that the ambulance service was delayed, she asked the patient if she could get a friend to drive her to the hospital. The patient said she preferred an ambulance.

At this point it appears there was no contact until 10:15 pm, at which point a call-back was made to check on the patient’s ongoing symptoms. The friend at this time found the patient unconscious, having suffered cardiac arrest, and called 999, the emergency call system, at 10:23 pm. The ambulance arrived at 10:30 pm and took the patient to a hospital, where she died 5 days later.

At the inquest, the coroner testified that if the patient “had received definitive hospital care before she suffered a cardiac arrest in the evening of September 7, the likelihood is she would have survived.” Thus, from the perspective of the National Health Service, the patient safety goal is impacted because a death occurred that was believed to be at least partially due to an ambulance delay. Additional goals impacted are the patient services goal because of the delayed emergency treatment (the stated goal for the patient’s medical condition was 30 minutes, whereas the ambulance arrived nearly 4 hours after that goal). The schedule and operations goal is also impacted due to the insufficient capacity of both ambulances and the call system.

The Cause Mapping begins with an impacted goal and develops cause-and-effect relationships by asking “why” questions. The patient death was due to diabetic ketoacidosis, a severe complication of type 1 diabetes that may have resulted from an additional illness or underlying condition. As stated by the coroner, the delayed emergency treatment also resulted in the patient’s death. The ambulance that would take the patient to the hospital was delayed because the demand exceeded capacity. Demand was “extreme” (there were 200 other patients waiting for ambulances in London at the same time). The lack of capacity resulted from low operational resourcing, though no other information was available about what caused this. (This is a question that should be addressed by the service’s internal investigation.)

The patient was not driven to the hospital, which would potentially have gotten her treated faster and maybe even saved her life. The patient requested an ambulance and the potentially significant delay time was not discussed with the friend who had originally called. At the time of the first call-back, the estimated arrival time of an ambulance was not known. (By the time of the second call-back, it was too late.)

The second call-back was also delayed. Presumably this call was to update the patient’s symptoms as necessary and reclassify the call (to be more or less urgent) as appropriate. However, the demand exceeded supply for the call center as well as for ambulances. The call center received 300 calls during the hour of the initial call regarding this patient, which resulted in the service operations being upgraded to “purple-enhanced”. (This is the third-most serious category, the most serious being “black” or “catastrophic”.)   The change in operations meant that personnel normally assigned to call-backs were instead assigned to take initial emergency calls. Additionally, it’s likely the same “operational resourcing” issues that affected ambulance availability also impacted the call center.

Additional details of the causes related to the insufficient capacity of emergency medical services are required to come up with effective solutions. The ambulance service has completed its own internal investigation, which was presented to the family of the patient. The patient’s brother says, “I hope these lessons will be learnt and this case will not happen again” and the family says they will continue to raise awareness of the dangers of diabetes.

To view the initial analysis of this issue, including the timeline, click on “Download PDF” above. Or click here to read more.

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Root Cause Analysis

Study finds many patients don’t understand their discharge instructions

By Kim Smiley 

Keeping patients as comfortable and safe as possible following hospitalization is difficult if they aren’t receiving appropriate follow-up care after returning home.  But a recent study “Readability of discharge summaries: with what level of information are we dismissing our patients?” found that many patients struggle to understand their follow-up care instructions after leaving the hospital.  

Generally, follow-up care instructions are verbally explained to patients prior to discharge, but many find it difficult to remember all the necessary information once they return home.  The stress of the hospitalization, memory-clouding medication, injuries that may affect memory and the sheer number of instructions can make remembering the details of verbal follow-up care instructions difficult. 

In order to help patients understand and remember their recommended discharge instructions, written instructions are provided at the time of discharge.  However, the study found that many patients cannot understand their written follow-up care instructions.  The study determined that a significant percentage of patients are either functionally illiterate or marginally literate and lack the reading skills necessary to understand their written instructions.  One assessment found that follow-up care instructions were written at about a 10th grade level and another assessment determined that the instructions should be understood by 13 to 15-year-old students.  

One of the causes that contributes to this problem is that discharge instructions are written with two audiences in mind – the patient and their family as well as their doctor.  Many patients need simple, clear instructions, but other doctors understand medical jargon and more complicated care instructions.  

It is important to note that the study did have several limitations.  Researchers did not give patients reading tests and instead relied on the highest level of education attained to estimate literacy skills.  Non-English speakers were excluded.  Even with this limitation, the study provided information that should help medical professionals provide clear guidance on follow-up care recommendations. 

The obvious solution is to work towards writing care instructions that are as simple and clear to understand as possible. In order to help patients clearly understand their follow-up care instructions, the American Medical Association already recommends that health information be written at a sixth grade reading level.  Providing clear contact information and encouraging patients to call their nurse or doctor with any questions about discharge instructions could also improve the follow-up care patients are receiving.

Root Cause Analysis

Shoveling snow really can trigger heart attacks

By Kim Smiley

You may have heard that shoveling snow can trigger a heart attack and studies have found that there is truth behind that concern.  Before you pick up a shovel this winter, there are a few things you should know.

Shoveling can be much more strenuous than many people realize – even more strenuous than running at full speed on a treadmill.  Snow shoveling also tends to be a goal-oriented task.  People want to clear the driveway before they stop and they may push their bodies beyond the point where they would if they were exercising for fitness.

Cold temperatures can increase the risk of heart problems occurring.  When a body gets cold, the arteries constrict and blood pressure can increase, which in turn increases the risk of heart issues.  High blood pressure and a sudden increase in physical activity can be a dangerous combination.  Additionally, it may take longer than normal for emergency help to arrive if it is needed because of snow and ice on the roadways which makes the situation potentially even more dangerous.

If you are young and fit, snow shoveling can be a great workout (and maybe you could help out your elderly neighbors if possible…), but if you are at risk of heart problems, you may want to put some thought into how you attack the problem of clearing your driveway and/or sidewalks.  First off, you should know if you are potentially at high risk.  Studies have found that people over 55 are four times more likely to experience heart-related issues while shoveling and men are twice as likely as women. People with known heart problems, diabetes or high blood pressure are also potentially high-risk.  Anybody who is sedentary is also at a higher risk of heart issues than somebody who exercises regularly.

So what should you do if you are concerned about the risk of heart problems and shoveling?  If possible, you may want to avoid shoveling if there is somebody else who can do it.  If you are determined to shovel yourself, make sure you drink lots of water and dress warmly.  Try to push the snow if possible, rather than shoveling it.  It is also generally better to shovel lots of lighter loads rather than fewer, heavy loads.  If possible, you may want to shovel several times throughout the storm to spread the work out over time. Take frequent breaks and stop immediately if you feel tired, lightheaded, short of breath or your chest hurts. Stay safe this winter!

To see a Cause Map, a visual root cause analysis, of this issue, click on “Download PDF” above.  A Cause Map visually lays out all the causes that contribute to an issue so that it can be better understood.  This example Cause Map also includes evidence and potential solutions.

Root Cause Analysis

Chipotle Improves Food Safety Processes After Outbreaks

By ThinkReliability Staff

On February 8, all Chipotle stores will close in order for employees to learn how to better safeguard against food safety issues.  This is just one step of many being taken after a string of outbreaks affected Chipotle restaurants across the United States in 2015.  Three E. coli outbreaks (in Seattle in July, across 9 states in October and November, and in Kansas and Oklahoma in December) sickened more than 50 customers.  There were also 2 (unrelated) norovirus outbreaks (in California in August and Boston in December) and a salmonella outbreak in Minnesota from August through September.

In addition to customers being sickened, the impacts to the company have been severe.  The outbreaks have resulted in significant negative publicity, reducing Chipotle’s share price by at least 40% and same-store sales by 30% in December.  Food from the restaurants impacted by the fall E. coli outbreak was disposed of during voluntary closings, and the company has invested in significant testing and food safety expertise.

E. coli typically sickens restaurant customers who are served food contaminated with E. coli. Food ingredients can enter the supply chain contaminated (such as the 2011 E. coli outbreak due to contaminated sprouts), or be contaminated during preparation, either from contact with a contaminated surface or a person infected with E. coli. While testing hasn’t found any contamination on any surfaces in the affected restaurants or any employees infected with E. coli, it hasn’t been able to find any contaminated food products either. While this is not uncommon (the source for the listeria outbreak that resulted in the recall of ice cream products has not yet been definitively determined), it does require more extensive solutions to ensure that any potential sources of contamination are eliminated.

Performing an investigation with potential, rather than known causes, can still lead to solutions that will reduce the risk of a similar incident recurring.  Potential or known causes can be determined with the use of a Cause Map, a visual form of root cause analysis.  To create a Cause Map, begin with an impacted goal and ask “Why” questions to determine cause-and-effect relationships.  In this case, the safety goal was impacted because people got sick from an E. coli outbreak.  A contaminated ingredient was served to customers.  This means the ingredient either entered the supply chain contaminated or it was contaminated during preparation, as discussed above.  In order for a contaminated ingredient to enter the supply chain, it has to be contaminated with E. coli, and not be tested for E. coli.  Testing all raw ingredients isn’t practical.

Chipotle is instituting solutions that will address all potential causes of the outbreak.  Weekly and quarterly audits, as well as external assessments will increase oversight.  Cilantro will be added to hot rice to decrease the presence of microbes.  The all-employee meeting on February 8 will cover food safety, including new sanitation procedures that will be used going forward.  The supply chain department is working with suppliers to increase sampling and testing of ingredients.  Certain raw ingredients that are difficult to test individually (such as tomatoes) will be washed, diced, and then tested in a centralized prep kitchen and shipped to individual restaurants.  Other fresh produce items delivered to restaurants (like onions) will be blanched (submerged in boiling water for 3-5 seconds) for sanitation prior to being prepared.

Chipotle has released a statement describing their efforts: “In the wake of recent food safety-related incidents at a number of Chipotle restaurants, we have taken aggressive actions to implement pioneering food safety practices. We have carefully examined our operations—from the farms that produce our ingredients, to the partners that deliver them to our restaurants, to the cooking techniques used by our restaurant crews—and determined the steps necessary to make the food served at Chipotle as safe as possible.”  It is hoped that the actions being implemented will result in the delivery of safe food, with no outbreaks, in 2016.

To view the impacts to the goals, timeline of outbreaks, analysis, and solutions, please click on “Download PDF” above.  Or click here to learn more.

Root Cause Analysis

The water crisis in Flint, Michigan

By Kim Smiley

The quality of tap water, or rather lack thereof, in Flint, Michigan has been all over headlines in recent weeks. But prior to a state of emergency being declared and the National Guard being called up, residents of the town reported strangely colored and foul tasting water for months and were largely ignored. In fact, they were repeatedly assured that their water was safe.

Researchers have determined that lead levels in the tap water in Flint, Michigan are 10 times higher than previously measured. Forty-three people have been found to have elevated lead levels in their blood and there are suspected to be more cases that have not been identified. Even at low levels, lead can be extremely damaging, especially to young children under 6. Lead exposure can cause neurological damage, decreased IQ, learning disabilities and behavior problems. The effects of lead exposure are irreversible.

The water woes in Flint, Michigan began when the city switched their water supply to the Flint river in April 2014. Previously, the city’s water came from Lake Huron (through the city of Detroit water system). The driving force behind the change was economics. Using water from the Flint river was cheaper and the struggling city needed to cut costs. Supplying water from the Flint River was meant to be a temporary move to hold the city over while a new connection to the Great Lakes was built within a few years.

The heart of the problem is that the water from the Flint river is more corrosive than the water previously used. The older piping infrastructure in the area used lead pipes in some locations as well as lead solder in some joints. As the more corrosive water flowed through the piping, the lead leached into the water.

A Cause Map, a visual root cause analysis, can be built to document what is known about this issue. A Cause Map intuitively lays out the cause-and-effect relationships that contributed to an issue. Understanding the many causes that contribute to an issue leads to better, more detailed solutions to address the problem and prevent it from reoccurring. The Flint water crisis Cause Map was built using publicly available information and is meant to provide an overview of the issue. At this point, most of the ‘whats’ are known, but some of the ‘whys’ haven’t been answered. It isn’t clear why the Flint river water wasn’t treated to make it less corrosive or why it took so long for officials to do something about the unsafe water. Open questions are noted on the Cause Map by including a box with a question mark in it.

This issue is now getting heavy media coverage and officials are working on implementing short-term solutions to ensure safety of the residents. The National Guard and other authorities are going door-to-door and handing out bottled water, water filters, and testing kits. Michigan Governor Richard Snyder declared a state of emergency in Flint on January 5, 2016 which allows more resources to be used to solve the issue. However, long-term solutions are going to be expensive and difficult.

The city’s water supply was switched back to Lake Huron in October 2015, but it will take more than that to “fix” the problem because there is still a concern about lead leaching from corroded piping. Significant damage to the piping infrastructure was done and the tap water in at least some Flint homes is still not safe. It is estimated that fixing the piping infrastructure could cost up to $1.5 billion. A significant amount of resources will be needed to undo the damage that has been done to the infrastructure of the city, and there is no way to undo the damage lead poisoning has already done to the area’s residents, especially the children.

Root Cause Analysis

More than 2,700 babies are born with microcephaly in 2015 in Brazil

By Kim Smiley

In 2014, fewer than 150 babies were born with microcephaly in Brazil, but the number dramatically increased in 2015 with more than 2,700 cases.  Microcephaly is a neurological disorder where the growth of the head is stunted with reduced brain function in 90 percent of cases.  Infants with microcephaly often have reduced life spans and require significant long-term care.  The spike in microcephaly is so alarming that some doctors and health officials are encouraging women in the regions with a high concentration of microcephaly cases to avoid becoming pregnant at this time.

Health officials are still working to understand exactly what caused the increase in microcephalic babies, but many believe Zika virus is contributing to the problem.  Zika virus is a mosquito-borne virus and the symptoms are similar to many other mosquito-borne viruses such as dengue and chikungunya.  Latin America reported their first Zika virus cases in 2014 and the spread of Zika virus matches the timing of the increase in microcephaly cases.  Additionally, many mothers of babies with microcephaly report having symptoms associated with Zika virus early in their pregnancies.

A Cause Map, a visual root cause analysis, can be built to illustrate what is known about this issue as this time.  As more information becomes available the Cause Map can easily be expanded to incorporate new information.  A Cause Map is built by asking “why” questions and laying out all the causes that contribute to an issue to show the cause-and-effect relationships. Understanding all the causes that contribute to an issue can aid in development of effective solutions.

In this example, more evidence is needed to confirm that Zika virus is responsible for the microcephaly increase in babies.  (A box with a question mark on a Cause Map indicates areas where more information is required.) The timing of the increase in microcephaly cases and the spread of Zika virus is certainly suspect, but additional data will be needed to ensure that other factors aren’t involved as well.  An autopsy on a baby born with microcephaly revealed the presence of Zika virus, which is another data point, but again isn’t enough to conclusively prove the connection between Zika virus and microcephaly.

Tracking cases of Zika virus is difficult for several reasons.  Many people infected with Zika virus have no symptoms so it is difficult to determine exactly how many have been infected, including pregnant woman.  Zika is spread by mosquitos so everyone in the region is potentially exposed.  Only a few labs in Brazil have the capability to test for Zika virus which makes researching the virus more difficult.  Scientists are working on solving this mystery as quickly as they can, but reality is it will likely be some time before the connection between Zika virus and microcephaly is definitively proven or disproven.

Health officials are working to reduce the number of mosquitos in Brazil, even going door-to-door to look for potential breeding locations.  Reducing the number of mosquitos should hopefully reduce the number of cases of microcephaly if the suspicion about the involvement of Zika virus is correct.  Additionally, pregnant women are encouraged to stay indoors and wear plenty of insect repellant to prevent mosquito bites.  And of course, woman may want to avoid pregnancy as recommended until the mystery is solved, but this obviously isn’t always possible or practical.

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

Root Cause Analysis

Nurse with tuberculosis potentially exposed over 1,000 –  including 350 infants

By Kim Smiley

A nurse recently diagnosed with active tuberculosis may have potentially exposed over 1,000 people. The nurse worked in the area near the newborn nursery so the potentially exposed individuals include 350 infants.  No additional tuberculosis cases have been reported at this time, but hospital officials are working to test all potentially exposed individuals and are offering preventative treatment to the exposed infants because they are at higher risk of dangerous complications from the disease.

This issue can be analyzed by building a Cause Map, a visual format for performing a root cause analysis.  Cause Mapping allows the causes that contribute to an issue to be better understood,  which can aid in the development of effective solutions.  The first step in Cause Mapping is to fill in an outline to capture the basic background information (who, what, when and where) for a problem.  Additionally, the outline has space on the bottom to list how the problem impacted the goals.   The second step in the process is to determine how the problem occurred by building the actual Cause Map by starting at one of the impacted goals and asking “why” questions to lay out all the causes that contributed to an issue.  The idea is to identify ALL the causes and not just one single “root cause” so that many different solutions are considered, not just the ones that impact a single cause.

So how did a nurse unintentionally expose 1,000 people to tuberculosis?  The nurse was unaware that she had tuberculosis.  She did not exhibit many of the common symptoms such as coughing and the disease was only identified after a chest x-ray that was done for an unrelated medical concern.  Additionally, she tested negative for tuberculosis in September during an annual checkup so there was no reason to believe that she was at risk of spreading tuberculosis.

No specific information has been released about why the nurse in this particular example tested negative for tuberculosis at the time of her screening, but there are a number of factors that can affect the accuracy of testing.  If the tuberculosis infection is recent (within 8-10 weeks) the test may not catch it; recent live-virus vaccination can affect results as can some viral illnesses.  And of course, incorrect test administration or misinterpretation of the results could also cause a false negative test result.

The final step in the Cause Mapping process is to develop solutions that address the specific problem at hand and hopefully prevent a reoccurrence of the issue.  The nurse has been put on leave until the risk of spreading the illness has passed to prevent more people from being exposed.  The risk of infection from this particular individual is believed to be low because she wasn’t coughing, which can spread the illness, but hospital officials are identifying and testing all potentially exposed individuals.  Additionally, the 350 potentially exposed infants are being offered treatment to prevent tuberculosis because the health risks to them are more severe than older children and adults (tuberculosis can enter the bloodstream and infect other organs).

The good news about this case is that no additional cases of tuberculosis have been found and the overall risk of the infection spreading is believed to be low because of the mild symptoms experienced by the nurse.  The bad news is that it will continue to be difficult to identify a case of tuberculosis if the individual involved has mild or no obvious symptoms and gets a false negative on a tuberculosis test.

A similar case occurred in Texas in 2014, where another healthcare worker who worked around infants was found to have active tuberculosis.  Click here to see that example.

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 Analysis

FDA’s Wish List: Regulatory Authority for Lab-Developed Tests

By ThinkReliability Staff

Laboratory testing is incredibly important to health care – it is thought to be an influence in about 70% of health decisions. Results of testing will often be used to diagnose a patient, or select a treatment plan. Thus, inaccurate testing results can lead to inappropriate, sometimes even dangerous, treatments. However, diagnostic tests manufactured and used within a single laboratory, known as laboratory developed tests, or LDTs, are not subject to regulation by the FDA.

This has led to significant concern by the FDA, outlined in a report making the case for FDA oversight for these tests. Their concerns can be diagrammed in a Cause Map, or visual root cause analysis, allowing us to see how the specific concerns are related and impact patient safety and other regulatory goals.

The first step in any problem solving method is to determine the problem that is to be solved. Using the Cause Mapping method, the “problem” is defined as an impact to an organization’s goals. In this case, patient safety is impacted because of the possibility for insufficient treatment of life-threatening disease and the potential for patients to undergo unnecessary dangerous procedures. Additionally, patient services are impacted because of the threat to the scientific integrity of clinical trials using these tests.

The second step in the Cause Mapping method is the analysis. Beginning with one of the impacted goals and asking ‘why’ questions develops the cause-and-effect relationships involved in the issue. In this case, we begin with the patient safety goal that is impacted due to insufficient treatment for life-threatening disease. This is due to either a failure to detect the disease and/or to patients choosing to undergo unproven therapies. We address each cause in turn.

The failure to detect a disease is caused by inaccurate test results and/or insufficient interpretation of test results. Inaccurate test results can be caused by tests not being clinically valid (one of the FDA’s prime concerns) because the test is not regulated by the FDA. The test is not required to be regulated by the FDA, which is the addressed in the FDA’s report. The argument against requiring FDA regulation for tests is that the laboratories that create and use the tests are regulated under the Clinical Laboratory Improvement Amendments (CLIA). However, according to the FDA, CLIA is intended to regulate the operators of laboratories, not diagnostic devices. The report provides multiple case studies of problematic LDTs, which were offered from laboratories “following the minimum requirements of CLIA.”

Inaccurate test results are also caused by not identifying adverse events, which are not systematically reported for these tests (another of the FDA’s prime concerns). An additional prime concern of the FDA is that performance data is not required to be reviewed prior to marketing these devices. Not only is FDA approval not required, but there is an incentive for companies not to seek FDA approval of LDTs, leading to an uneven playing field (another of the FDA’s prime concerns) for companies who do seek FDA approval of laboratory tests. Insufficient interpretation of test results occurs because testing labels do not provide adequate information on interpretation (another of the FDA’s prime concerns).   Again, these causes are due to not requiring regulation by the FDA.

The FDA is concerned that results from unapproved testing may result in patients choosing to undergo unproven therapies. Misleading manufacturer’s claims and/or lack of transparency can mean patients are unaware that the tests have not been cleared or approved by the FDA. These causes are both listed as prime concerns of the FDA. Patients are unable to assess tests available because there is no comprehensive listing of tests currently being used (the last prime concern of the FDA).

Because of these reasons (causes), the FDA is requesting oversight of LDTs. The oversight provided by the FDA would ideally provide solutions to these issues by addressing each of the concerns (causes) listed in the report. To learn more, click here to read the report. Or, click on “Download PDF” above to view the cause-and-effect relationships including the FDA’s concerns about LDTs.

Root Cause Analysis

Patient Discharged Alone, Without Being Treated

By ThinkReliability Staff

A patient with schizophrenia and dementia was discharged from a New York City emergency room alone and without effective treatment. Less than two hours after her discharge, she was taken via ambulance to another hospital, which performed emergency surgery on a perforation in the digestive tract. However, because of various communication issues, the family was not notified of her whereabouts until three days later.

Multiple factors were involved in this issue. To provide some clarity about what happened, and where the investigation should go next, we can put the information that is known into a Cause Map, or visual root cause analysis. The Cause Map can be expanded as more information is known.

The first step of any problem investigation is to determine what problem needs to be solved. Rather than attempting to define a complex issue as just one “problem”, the problem is defined as the impact to an organization’s goals. In this case, patient safety was impacted due to the risk of injury to the patient. The regulatory goal is impacted due to the risk of a lawsuit or other regulatory action. Patient services were impacted because of the improper discharge. Additionally, the labor/ time goal is impacted because of an investigation, which the “first” hospital (or regulatory agency) should be performing, although the hospital has not released any information, citing privacy concerns.

The second step of a problem investigation is the analysis. We begin the analysis with one of the impacted goals. To develop the cause-and-effect relationships that make up the Cause Map, we ask “why” questions. In this case, the patient safety goal was impacted because of the risk to the patient. The risk was caused by being discharged alone, and also by being discharged without proper treatment. Because both of these causes resulted in the impact, they are joined with an “AND”. The patient was discharged improperly based on a decision to discharge the patient. Because the first hospital has not released any more details, we have to end that line of questioning with a “?”. However, once the causes related to the patient being improperly discharged are determined, solutions that will improve the discharge process to reduce the risk of other patients being improperly discharged can be brainstormed and implemented.

To ensure the analysis is complete, the other impacted goals must also be addressed. In this case, the labor/ time goal is impacted by the investigation. The investigation results from the patient being discharged improperly (also an impact to the patient services goal) and the hospital’s delay in notifying the family of the patient’s whereabouts. The second hospital did not have the family’s contact information because it was unable to receive it from the first hospital. This is another area that will need to be investigated further. Although the second hospital treated the patient after deeming it was an emergency, the second hospital had no way of contacting the patient’s family. This is particularly important in this case as the patient’s son was designated to make medical decisions for her. Additionally, even though the second hospital notified the first hospital it was treating the patient on the day the patient went “missing”, the first hospital, despite frequent contact with the patient’s family, did not pass that information along until three days later. The communication breakdowns at the first hospital must be addressed.

The third step of a problem investigation is to determine solutions to reduce the risk of similar issues recurring. In this case, more detail is needed about the discharge and communication processes. The solutions will ideally improve those processes to ensure that discharges and communication about patients are made following proper protocol.

To view the initial problem investigation, or Cause Map, click on “Download PDF” above. Click here to see our previous blog about intentional improper patient discharge, or “patient dumping”.