Tag Archives: cause mapping

Root Cause

More Known About Why A Donated Kidney Was Trashed

By ThinkReliability Staff

In a previous blog, we wrote about a donated kidney that was accidentally thrown out rather than being transplanted.  We began the root cause analysis investigation with the information that was available, but there were still a lot of open questions.

The Centers for Medicare & Medicaid Services (CMS) has released a report on the incident, which provides additional information we can use to update our Cause Map.  We can update all areas of the investigation, including updating any additional goals that were found to be impacted.  In this case, three employees had been placed on administrative leave.  Since the time of the previous blog, four employees have had their careers impacted – one has resigned, one has been fired, one has had a title removed, and another has since returned from paid administrative leave.  Additionally, there is a risk that the hospital may be removed from the Medicare program, another impact to the compliance goal.

The report provides more specific causes, and evidence, regarding the incident.  We know now that the kidney, which was to be transplanted, was instead thrown in a hopper by the circulating nurse.  We can ask “Why” questions to add more detail.  The kidney was thrown in the hopper because the contents of the slush machine were thrown in the hopper and the kidney was in the slush machine.  It still isn’t clear why the kidney was in the slush machine in the donor’s operating room (rather than being transferred immediately to the recipient’s room), but more information regarding the disposal is now available.

The nurse disposed of the hopper because she was unaware that  the slush machine contained the kidney.  The nurse had been on lunch break when the location of the kidney was announced and was not briefed on the status of the operation upon her return.  There was no documentation on where the kidney was located, and the nurse assumed that it was in the recipient’s room.  For reasons that are unclear (as it is usually the job of the technician who is responsible for the machine), the nurse decided to empty the slush machine while the operation was still ongoing.  This appeared to be against procedure, but the procedure had “exceptions” according to staff, and was ineffective in this case.  The technician that was responsible for the slush machine was exerting inadequate control, as the staff members have stated that no one noticed the nurse empting the slush machine.  This also demonstrates inadequate control of the kidney, since there appeared to be no staff person responsible for the kidney itself.

Since the incident, the hospital has developed a procedure for intra-operative hand-off, which includes a briefing requirement for staff members who enter an operating room mid-procedure.  Additionally, clarification has been provided that nothing will leave an operating room until the patient has left, post-procedure.  Although the transplant program is still shutdown pending investigation, a recommendation that might reduce this type of problem in the future would be to ensure that a staff member is designated as responsible for any donated organs from removal to transplant.

To view the updated Cause Map and potential solutions, please click “Download PDF” above

Root Cause Analysis

Teen Impersonates a Physician’s Assistant

By Kim Smiley

A teen, who was 17 at the time, was arrested on September 2, 2012 for impersonating a physician’s assistant in a Florida hospital.  The young man worked at a hospital, treating patients and performing duties typical of a physician’s assistant, for about a week before anyone became suspicious of his lack of credentials.  Investigation into the case found that he examined patients, removed an IV and even performed CPR without any medical training.

How could this possibly happen?  A Cause Map, or visual root cause analysis, of this situation can be built to help understand the different causes that contributed to a young man successful impersonating a medical professional.  The first step in building a Cause Map is to determine how the issue impacted the overall organization goals.  In this example, the safety goal is clearly impacted since an unlicensed individual treated patients.  The customer service goal was also impacted because of the negative publicity for the hospital involved in the scandal.

Causes are added to the Cause Map by asking “why” questions.  Why did this happen?  How did a teen end up performing the duties of a physician’s assistant?  Statements by the teen indicated that he was interested in learning more about the profession so he decided to work at the hospital.  He was able to pull this off because he was incorrectly given a physician’s assistant identification badge and nobody initially questioned his credentials because he acted the part well.

The teen worked as a clerk in a doctor’s office near the hospital and when he went to the ID office to get a badge, he was somehow given the wrong one.  His credentials were never checked and personnel at the ID office have stated that this was because the office was very busy at the time.  The teen also never told anybody he had the wrong badge and decided to use it.

The masquerade was also successful for a time because the teen played the role of physician’s assistant well.  He wore scrubs and a stethoscope and used the correct terminology.

This case went to trial in August 2012.  The teen was found guilty on two counts of impersonating a physician assistant and two counts of practicing medicine without a license.  His sentencing is scheduled for November 14 and he faces up to 25 years in prisons.

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

Root Cause Analysis

Safe Use of Opioids in Inpatient Hospitals

By ThinkReliability Staff

The use of opioids for pain relief in inpatient hospitals can lead to serious potential adverse effects, including respiratory depression and drug interaction.  On August 8, 2012, The Joint Commission published a Sentinel Event Alert: “Safe use of opioids in hospitals”.  The alert contains information about potential causes of the adverse effects possible with the use of opioids as well as solutions that, if implemented by healthcare facilities, can reduce the risk of patient safety impacts from the use of opioids.

We can present the information provided by The Joint Commission in a Cause Map, or visual root cause analysis.  We begin with the impacts to the goals.  In this case, we look specifically at two potential impacts to the patient safety goal – the risk of drug-drug interactions and respiratory depression involving opioids.

Drug-drug interactions can result when a patient is taking another drug that interacts with opioids. In this case, the provider prescribing the opioid is unaware of the potential interaction between the drugs prescribed or is unaware of the patient’s drug history, because a complete history is unavailable and a patient is either unable or unwilling to provide a compete list. While drug-drug interactions are possible with any level of opioid, the over-use of opioids for pain relief is a particular concern.  Opioids can be effectively used for pain relief, but over-use can occur when a high dose is needed to manage pain, either due to tolerance from chronic conditions or patient abuse, or obesity.  Studies have shown that obese patients may require more opioids for pain relief than would be suggested by their weight alone.  A patient receiving the wrong dose of opioids (besides being an issue in itself) can also contribute.  Issues have been raised regarding the difficulty in calculating doses with drugs of different potency, especially as patients move from one drug to another.  Additionally, prescribing dose based on weight alone can result in a higher or lower dose than needed as the proper dose of opioids is subject to patient weight, age, sex, and tolerance level.

Issues with prescribing the wrong dose or wrong type of medication can occur when a patient or family member is responsible for the administration.  Problems with medication administered by a provider typically occur around changes of the type or delivery method of the pain killer.  Special care should be taken to recalculate the dose  corresponding to any change in the drug dosage, type or delivery method.  Similar-looking bottles and similar-sounding names are always a potential pitfall in proper drug administration and special care should always be taken in these cases.

Opioids reduce respiratory rate, which can result in respiratory depression.  Respiratory depression can be impacted by other factors, such as a patient who is sleeping (most respiratory depression occurs during typical sleeping hours), or who is already pre-disposed to respiratory depression.  This most commonly occurs with post-surgical patients (who may have residual anesthesia), old or young patients (who may be affected more greatly by the respiratory effects), patients who have abnormal respiratory control due to obstructive sleep apnea or morbid obesity, patients with supplemental oxygen and patients who have a self-administered drug delivery system, such as a fentanyl patch.  Special care and monitoring should be taken with patients who have a higher risk level for respiratory depression.

However, monitoring for respiratory depression is difficult.  Visually assessing respiratory depression (especially while a patient is sleeping or on supplemental oxygen) is extremely difficult.  Using pulse oximetry can result in misleading values (including normal values while a patient is suffering from respiratory depression) and high false alarms.  Because respiratory depression occurs gradually, intermittent monitoring may not be sufficient to pick up on a patient’s decline.

There is no one-size-fits-all solution for reducing respiratory depression.  Rather, an individualized plan based on patient pain requirements and risk factors is shown to be the recommended way to reduce the risk of respiratory depression and ensure proper pain control for patients.

To view the Cause Map and recommended solutions, please click “Download PDF” above.  Or learn more from The Joint Commission Sentinel Event Alert.

Root Cause Analysis

Working to Eradicate A Painful Parasite

By Kim Smiley

The lifecycle of the Guinea worm is the stuff of nightmares.  This parasite is ingested by a host as larvae, mate and mature inside the host and then the adult female painfully emerges to lay her eggs. The adult female is between two to three feet long and the thickness of a spaghetti noodle.  The only way to get rid of the parasite is to wrap it around a stick and slowly pull it out, a process that takes several weeks or even months.

Individuals who are infected by this parasite can suffer for months, making it difficult to work and feed their families.  There is no immunity to Guinea worms so it’s possible for people to suffer year after year if they continue to ingest the larvae of the Guinea worms.  There is also no drug to treat Guinea worm disease and there is no vaccine that prevents infections.

But there is hope in the fight against this excruciating disease.  The number of cases of Guinea worm disease has decreased dramatically.  In 1986 there were an estimated 3.5 million cases of Guinea worm disease spread across 21 countries in Asia and Africa.  In 2011, there were only 1,058 reported cases of Guinea worm disease in four African countries.

How was this possible?  The first step in answering that question is to understand more about the disease.  The problem of Guinea worm disease can be illustrated by building a Cause Map, an intuitive root cause analysis format.  By asking “Why” questions, causes can be added to the Cause Map and the problem can be analyzed.    Why are people getting the disease?  People are drinking water that is contaminated with copepods, also called water fleas, which are infested with larvae of Guinea worms.  There is also typically no other supply of safe drinking water and the water wasn’t treated or filtered prior to consumption.

Painful blisters form when the female Guinea worm emerges from the body and people put their sores into the same water used for drinking (because it is usually the only water available) to help relieve the burning sensation.   The female Guinea worm then releases hundreds of thousands of guinea worm larvae once she senses water.  Guinea worm larvae is eaten by the water fleas.  The infected water fleas are small and ingested along with the water, which restarts the whole process.

This process had been going on for thousands of years, affecting millions and millions of people.  Its remains have even been found in Egyptian mummies.  But simple changes have nearly eliminated the disease.  In fact, Guinea worm disease is predicted to be the first human disease ever eradicated without a vaccine and only human disease to be eradicated other than small-pox.

Relatively simple changes have made all the difference in the world.  People were educated about how to prevent the disease.  Millions of straws with filters were handed out to villagers to strain out the infected water fleas and prevent the parasite from entering the body.  Efforts were also made to treat water with larvicide and provide access to uncontaminated drinking water.

Without new hosts, the Guinea worm larvae died.  Once the lifecycle was broken, the disease disappeared from many regions.  There are now only four countries that reported any cases of the disease last year, the vast number being in war torn South Sudan where public health efforts have been difficult to sustain.

Click on “Download PDF” above to view a high level Cause Map of this issue

Root Cause Analysis

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.

Root Cause Analysis

Possible Link Between Antibiotics and Obesity

By Kim Smiley

A study recently published in the International Journal of Obesity found that infants given antibiotics before six months of age were 22 % more likely to be overweight between the ages of 10 months and 3 years.  Researchers believe this may be because the natural balance of bacteria in their digestive tracts is altered by the antibiotics.

Obesity has long been assumed to be a matter of too much food into the body while too few calories are burned, but new studies. including the recent one finding a link between use of antibiotics early in life and body weight later in childhood,  are suggesting that the issue may be more complicated than it appears on the surface.

Scientists are still studying how bacteria in human digestive tracts affect how the body processes food, but many researchers believe that the balance of bacteria plays a role in how the body absorbs calories.  The amount of calories that a body absorbs from the same amount of identical food may not be a constant.  More studies are needed to understand the relationship between bacteria in the gut and body weight, but studies done so far are intriguing.

The link between antibiotics and higher body mass remained even when researchers controlled for factors such as what the baby ate, the weight of a baby’s parents, whether the mother smoked while pregnant, and the family’s socioeconomic status.  Researchers did note that the study found an association and not a cause-effect link and that further studies are needed, but there seems to be a relationship between how antibiotics affect the body and body mass.

More research is needed to fully understand this issue, but this study is an interesting step to better understanding the causes of childhood obesity.  On the downloadable PDF, we have created a Cause Map, or visual root cause analysis, to show the possible cause-and-effect relationships between use of antibotics in early enfancy and childhood obesity.

In this specific study used to build this example, the researchers were quick to point out that infants should be given antibiotics if they are needed, but it’s important to understand how the medication may be affecting bodies, especially very young bodies.

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

Root Cause Analysis

DC Searches for Solutions to Slow the HIV Epidemic

By Kim Smiley

Washington DC is trying some new methods to help fight the AIDS epidemic.  DC has long had one of the highest rates of HIV infection in the United States, but there is hope that these new techniques might change that fact.

This issue can be built into a Cause Map, a visual root cause analysis.  A Cause Map shows the relationship because the causes that contribute to an issue and can also show how potential solutions would impact those causes.  To view a high level Cause Map of this issue, click on “Download PDF” above.

The focus of DC’s fight against HIV is treatment, which seems to be the key to controlling the HIV infection rate.  While researchers are still searching for a cure, simply treating people infected with HIV has the potential to dramatically slow down the epidemic.  HIV positive patients who consistently take their drugs lower their chances of infecting others by 96% because the amount of virus in their bloodstream is significantly lower.

The first step in treating infected people is to identify who is infected.  Testing is also important because the earlier patients can be identified; the more effective treatment is typically.  Washington DC has increased testing efforts in order to identify the estimated 5,000 people who live in the DC area and are unaware that they are infected.  People are now being paid to get tested and HIV tests are being offered in a number of new locations such as grocery stores, high schools, on corners where addicts gather, and at the DMV.  There are also efforts to focus testing on the highest risk populations by paying for referrals and social network tracing.

The next area of difficulty is getting patients consistent treatment.  Only 29% of people diagnosed in DC take their drugs every day, which is about average for an American city.  Washington DC is working to track HIV patients, who are typically more transient than the rest of the population and to help get treatment to as many people as possible.

Another cause of the AIDS epidemic that Washington DC is working to improve is to slow the spread of the virus itself.  Typical transmission routes for HIV are unprotected sex and use of dirty needles.  Last year, five million male and female condoms were given away in the DC area.  There were also more than 300,000 clean needles given away.

These innovative new programs seem to be having a positive impact on the epidemic. New cases have fallen to 835 from 1,103 in 2006.  The number of AIDS test administered has greatly increased.  Only time will tell how effective these solutions have been at slowing down the HIV epidemic in the nation’s capital.

Root Cause Analysis

The Low Survival Rate of Pancreatic Cancer

By Kim Smiley

Sally Ride, the first US woman in space and a national hero, died after a 17-month battle against pancreatic cancer on July 21, 2012.  Pancreatic cancer is a particularly deadly cancer with only a 6% five-year survival rate.  This disease also affects many people.  In 2010 alone, an estimated 43,000 people in the US were diagnosed with pancreatic cancer.

The reasons that pancreatic cancer is so deadly can be explored by building a Cause Map, a visual root cause analysis.  The first step in building a Cause Map is outlining the problem which includes defining how the problem impacts the organizational goals.  In this example, the primary goal considered is the impact to the safely goal since pancreatic cancer has such a low survival rate.

In order to build the Cause Map, “why” questions are asked and the answers are added to the Cause Map.  Why does pancreatic cancer have such a low survival rate?  The survival rate is low because the cancer has usually spread beyond the pancreas by the time it is detected and pancreatic cancer is difficult to treat.  The cancer has typically spread before detection because there are very few symptoms in the early stages of the cancer and any symptoms that do exist are usually vague, like aches and pains that could easily be attributed to other illnesses.  There is also no screening test like there are for breast or prostate cancer to detect pancreatic cancer at this time.

Pancreatic cancers are difficult to treat for several reasons.  First, pancreatic cancers are resistant to chemotherapy.  The best course of treatment is typically removal of the tumor, but many cases are caught too late for the tumor to be removed because the cancer has usually spread by the time it is detected.

Researchers are working on improving the survival rate for pancreatic cancer.  There are some promising studies that show it may be possible to develop a screening test that could detect pancreatic cancer at earlier stages, which could significantly improve the chances for survival.

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

Root Cause Analysis

Delay in Treatment for Sepsis Results in Death of a Child

By ThinkReliability Staff

On April 1, 2012, a patient at a university medical center in New York died from sepsis.  The death was especially heartbreaking as the patient was 12 years old . . . and had been healthy just 4 days prior.  However, he had contracted a bacterial bloodstream infection (sepsis), which has a high mortality rate (nearly 40%, according to the United Hospital Fund) that grows with every passing hour.  (A study cited by the New York Times found that the survival rate decreases by 7.6% every hour before antibiotics are given.)  With response time so crucial to patient outcome, rapid action at every step of the process is required.

We can look at this incident in a visual root cause analysis, or Cause Map.  The purpose of this map is not to assign blame, but rather to discover and document causes in the hope of finding solutions to reduce the occurrence of this type of issue.

We begin with the impacts to the goals.  In this case, the patient safety goal was impacted due to a patient death.  Because of the high potential for emotional impact to providers, employees are also impacted.    The potential for a lawsuit is an impact to the organizational goal, and the initial misdiagnosis of the patient is an impact to the patient services goal.

We begin with the patient safety goal and ask “Why” questions to develop cause-and-effect relationships that will show all the causes of the incident.  The patient died of severe septic shock and insufficient intervention.  (Had intervention come earlier, the patient may have lived.)  The onset of the sepsis appears to have been a cut acquired at school, which was bandaged, but possibly not cleaned, likely due to the lack of severity of the initial injury.  Delay of treatment allowed the sepsis to overwhelm the immune system.  The treatment was delayed due to an initial misdiagnosis of dehydration.     Sepsis is particularly difficult to diagnose because many of its symptoms mirror symptoms of other more common ailments.  Information was not shared between providers – the child’s primary care pediatrician, parents, and the hospital staff, which may have contributed to the difficulty in diagnosis.  Test results taken at the hospital came in after discharge and were not shared by phone with the primary provider or parents.  Additionally, even after lab results from the hospital suggested that the white blood cell count was abnormally high, indicating infection, no action was taken.

From this very basic, high level map, at least four areas of specific improvement can be noted.  Protocol at the school for injuries that involve cuts – even if they seem minor – should include cleaning or disinfection.   The hospital should have – and follow – protocol for that specifies action to be taken upon receipt of lab results.   This protocol should include documenting and sharing test results with other providers and caregivers.  Because of the difficulty in diagnosing sepsis, and the importance of quick action, the United Hospital Fund is current developing a STOP Sepsis Collaborative, which aims to “reduce mortality in patients with severe sepsis and septic shock by implementing a protocol-based approach to case identification and rapid treatment”.  Ideally, implementation of the results of this collaborative will reduce the risk of patient death from a situation like this tragic case.

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

Root Cause Analysis

Accidentally Ingested Wire Bristles

By Kim Smiley

There have been a number of documented cases of people accidentally swallowing wire bristles from the brushes commonly used to clean grills.  If ingested, the bristles can cause significant pain and have the potential to puncture organs, including the intestine which can lead to dangerous infections.  There isn’t a lot of data available to determine how often this occurs, but a recent report discussing six cases of ingested wire bristles at a single hospital in a one year period hint that this may be more common than many realize.

This issue can be analyzed by building a Cause Map or visual root cause analysis.  The first step in creating a Cause Map is to determine how the issue impacts the overall goals of an organization.  In this example, we’ll consider the organization the general public and the main impacted goal is the safety goal since there is a risk of serious health issues.  Causes are now added to the Cause Map by asking “why” questions.  Why is there a risk of serious health issues?  Because there is the potential to swallow a wire bristle and the wire bristle can do a lot of damage within the body.   (To view a high level Cause Map of this issue, click “Download PDF” above.)

Continuing the “why” questions, we would now ask “why” is there a potential to swallow a wire bristle?  This possibilities exists because people may inadvertently swallow the bristles without realizing it, the bristles come from wire brushes that are often used to clean residential grills and the bristles sometimes fall out of the brushes and stick to the grill.  People may inadvertently ingest the bristles because the bristles can stick to meat and the texture can hide the presence of the bristle.  Many people are also unaware of the potential danger of eating a wire bristle so they aren’t looking to find bristles.  Investigation into this issue has not found any defects that are causing bristles to fall out.  No one brand or type of grill brushes has been singled out as the culprit in these causes, but a worn grill brush is more likely to shed bristles than a new brush.

All six patients in the report did make full recoveries after treatment.  In three of the cases, the wire bristles were stuck in the throat and required only laryngoscopic removal; the other three cases required more invasive surgery to remove the object.

The best way to protect yourself from the possibility of this occurring is to inspect the grill after using a wire grill brush or to find another method to clean your grill.  The Consumer Product Safety Commission has asked that medical professions or consumers report any incidents of swallow grill brush bristles to http://www.saferproducts.gov to help monitor this issue.