Tag Archives: Root Cause Analysis

Root Cause

Hiding in Plain Sight

By ThinkReliability Staff

Before you read the rest of this blog, click here and take a look at the radiograph. Did you notice anything  . . . odd?  If not, you’re in good company.  The image shown was used in a study with trained radiologists.  A vast majority – 83% – did not notice the gorilla in the upper right hand corner of the lung.

Yep, that’s right.  There’s a gorilla in that scan.  Did you miss it too?

This study was based off a study performed in 1999 that drew attention to the “inattentional blindness” effect.  Essentially, it means if you’re busy doing something that requires a lot of concentration, there’s a lot you can miss.  This new study attempted to determine whether people who were “trained for looking” – i.e. radiologists – would be better at noticing something “off”.  Actually, they were worse, based on the percent of people who missed the gorilla in the original study – 50% – being far less than the percent of radiologists – 83% – that missed the gorilla in the radiograph.  What’s particularly disturbing is that what the radiologists were looking at was a radiograph, something they’ve been specifically trained to evaluate.  To be fair, they were specifically asked to look for cancerous nodules . . . not large, hairy animals.

What are the broader implications of this study?  Well, the first is acknowledgement of the possibility of missing the seemingly obvious.  This is not, of course, limited to radiologists.  Examples of this happening are seen all over healthcare – when alarms are assumed to be malfunctioning, rather than actually indicating an issue that needs to be dealt with.  Or when sponges are left inside a patient.  It’s certainly not because the surgical staff isn’t concentrating.  Or when you have a patient seemingly ready for surgery . . . only it’s not for him.  When you have a patient who’s ready to go, and a staff who’s ready to go, it is only to easy to assume that – because everything LOOKS right, it is.

The next question, of course, is what can be done to deal with “inattentional blindness”, now that we know it exists for anyone, regardless of specialized training?  Strategies that have been developed to deal with all kinds of medical errors can also help with inattentional blindness.  Taking time to catch your breath, then going back to look again – such as occurs when using a time-out prior to surgery – can give you a fresh look that is more likely to catch those gorillas.  It can also help to use more sets of eyes, by bringing in different staff members from different areas of expertise.  Checklists can also help to focus on the obvious – forcing a check on a patient’s identity, for example.

Much like in the gorilla studies – where people overestimated their ability to notice outlying events – medical personnel who have effectively incorporated time-outs and/or checklists have been surprised at the number of potential events that have been caught by these aids.  Obviously, they’re not a panacea, or a replacement for a well-trained, caring staff.  So, the next time something seems “off”, take another look.  Maybe it’s a gorilla.

Root Cause

Is the NFL Getting More Dangerous?

By Kim Smiley

Player injuries in the National Football League (NFL) have been making headlines for years now.  One of the questions that have been asked is whether increases in players’ weight and speed have been making the game more dangerous.

A Cause Map, an intuitive method for performing a root cause analysis, can be used to analyze this issue.  The first step when building a Cause Map is to determine how the overall goals are impacted.  In this example, the main focus will be player safety, but there are factors worth considering such as the negative publicity this issue has generated for the NFL.  There is also a whole lot of money in play with a lawsuit that more than 4000 players have filed against the NFL for allegedly covering up life-altering brain injuries.

The Cause Map is built by taking one of the impacted goals and asking “why” questions.  Why is there a safety concern?  There is the potential for severe neurological trauma because players are suffering brain injuries on the field.  The obvious reason this happens is because it’s football.  Players are hit and hit hard as part of perfectly legal and allowed tackles.  It’s how the game is played.    Players may also be hurt during illegal plays, such as a helmet-to-helmet contact, which are more likely to cause brain damage.  One extremely hard hit can end a career, but more and more evidence is showing that milder, repeated hits may also cause life-altering brain injuries.  Another potential cause that might be worth exploring is the protection that players wear.  They are still getting hurt despite wearing helmets and pads.  Maybe different equipment could help prevent some of these injuries.

The protective gear has improved and the tackling rules have been modified, but the basic game has remained the same since 1920 when the NFL began with one notable expectation.  The players themselves have changed radically over the decades.  In the 1920, the average lineman was 190 pounds.  The average lineman these days weighs 300 pounds.  Despite the extra 100 plus pounds, the average lineman has also gotten faster.  A faster, heavier player hits with more force and slamming into another body with more force probably isn’t healthier for anybody involved.

Continuing the Cause Map, it makes sense to ask why today’s players are so much bigger and quicker.  Specialization of training and nutrition programs surely play a role in the evolution of the player’s body.  There is also speculation that performance enhancing drugs are being used and complaints about the lack of the effective testing for substances such as human growth hormone.

This is an issue that still needs research.  A better understanding of how impacts are affecting brains is needed so that the full scope of the issue is known.  If the problem is as large as it is suspected, better ways of protecting these players need to be found.

Root Cause

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.

Root Cause

ER Visits Due to Consumption of Energy Drinks More Than Doubled

By ThinkReliability Staff

Consuming high levels of caffeine can lead to various health concerns that may require emergency medical attention.  According to the Substance Abuse & Mental Health Services Administration: “Consumption of energy drinks is a rising public health problem because medical and behavioral consequences can result from excessive caffeine intake.”  Energy drinks can contain extremely high levels of caffeine, which are not required to be listed on the  label.  Emergency room visits due to consumption of high-caffeine level energy drinks more than doubled from 2007 to 2011.

The issues associated with consumption of energy drinks can be documented in a Cause Map, or visual root cause analysis.  We begin with the impacts to the goals; the safety goal is impacted due to the health risks.  Additionally, increased ER visits and media attention to the issue can be considered impacts to various organizations’ goals.

Beginning with the impacts to the goals, asking “Why” questions allows us to uncover the cause-and-effect relationships that lead to these concerns.  Consuming high levels of caffeine can lead to health concerns, including dehydration, headaches, and even seizures.  Most energy drinks contain high levels of caffeine – equivalent to the caffeine in several cups of coffee – but are not required to list the amount of caffeine on the label.  Because some of these beverages are marketed extolling positive health effects, consumers may be unaware of potential risks.  Because some energy drinks are sometimes considered beverages  and sometimes are considered dietary supplements, regulation is limited.

More attention is being called to this issue, along with calls for more regulation and requiring disclosure of the amounts of  caffeine in energy drinks in the hopes that with more information, both to consumers and healthcare professionals, will result in fewer emergency health concerns.

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

Root Cause

FDA Recommends Lower Doses of Sleep Aids

By Kim Smiley

On January 10, 2013, the Federal Drug Administration (FDA) announced a new requirement to dramatically decrease the normally prescribed doses of sleep aids containing zolpidem, which includes Ambien, Edluar and Zolpimist.    Products containing zolpidem are the most commonly prescribed sleep aids with about 40 million dispensed in 2011.

A Cause Map, or visual root cause analysis, can be used to help understand this issue.  The first step in the Cause Mapping process is to fill in an outline with the background information for a problem, such as the date and location.  The bottom half of an outline is filled in with the impacts to an organization’s goals.  In this example, the safety goal is impacted because there is a risk of car accidents after patients used prescriptions containing zolpidem and drove a car.  There have been about 700 reports of car accidents after people used products contain zolpidem. The customer service goal is also impacted because this issue has generated some bad publicity for the companies that manufacture these drugs.

After the outline is completed, the next step is to use the impacts to the goals to ask “why” questions and add the answers to the Cause Map to show the cause-and-effect relationships.  Why is there a risk of car accidents? People may be driving while impaired because zolpidem makes you drowsy and they may have zolpidem in their systems.  Zolpidem is a sedative; it’s the active ingredient in a number of sleep aids.  People may still have zolpidem in their systems because millions of people take prescription sleep aids containing it and it stays in the body longer than was known.    Originally it was believed that it was safe to drive 8 hours after taking zolpidem, but the FDA determined that enough of the drug may be present to impair driving after 8 hours.  Women are especially at risk of impaired driving because they metabolize the drug slower.

The final step in the Cause Mapping process is to determine possible solutions that would prevent a problem from reoccurring.  In this example, the FDA determined that taking a lower dose of sleeping aids containing zolpidem would help reduce the risk of impaired driving and the potential for car accidents.  The new FDA requirements would lower the dose for women from 10 milligrams to 5 milligrams for immediate-release products and from 12.5 milligrams to 6.25 milligrams for the extended-release product. The safest option is always to take the lowest dose of any sleep aid that is effective.

If you use a sleep aid containing 10 mg or 12.5 mg dose zolpidem, the FDA recommends that you continue taking your medication as prescribed until you can contact your healthcare professional.

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

 

 

Root Cause

Transplant Recipient Dies of Lung Cancer After Receiving Smoker’s Lungs

By ThinkReliability Staff

After 18 months on the transplant list, a patient in England finally received a new set of badly needed lungs.  However, though required by NHS Blood and Transplant since March 2011, the medical history of the donor – specifically that the donor was a heavy smoker – was not disclosed to the recipient, who died shortly after of lung cancer.

The issues causing this death can be examined in a Cause Map, or visual root cause analysis.  We begin an investigation by determining which goals were impacted by the event.  In this case, the patient safety goal was impacted due to the death of the transplant recipient.  Additionally, patient services were impacted because the patient was given “higher risk” organs.  Lastly, the worldwide shortage of organs can be considered an impact to the property goal.  Once we have determined these impacts to the goals, we can ask “Why” questions to develop the cause-and-effect relationship leading to the issue.

The patient death was due to lung cancer.  The patient suffered from lung cancer because she received a lung transplant using lungs from a smoker.  The patient was unaware of the donor history though disclosure of the medical history of a donor is required.  Additionally, more patients are being given what are known as “higher risk” organs.  This includes organs from smokers, the elderly, and even drug users.  39% of lung transplants are from smokers.  Doctors believe that patients are better off with these organs than waiting on the transplant list.  Only a handful of transplant recipients have died from diseases related to their donors’ health, but every year about1,000 people in the UK die waiting for a transplant.  The quality of available organs is decreasing due to longer lifespan and obesity.  Additionally, the number of organs has always been less than needed.  The number of potential organ donors is small, due to a combination of factors, including personal reasons for not donating and families not donating a loved one’s organs when their wishes are not made clear.

Disclosure of a donor’s medical history is already required.  Increasing the number of donors is desperately needed to ensure adequate availability of organs.  You can contribute by becoming an organ donor and making your wishes clear to your family.  The medical profession is attempting to increase the usability of organs, using methods such as the one discussed in a previous blog.

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

Root Cause

Maternity Death from Blood Loss after Normal Delivery

By ThinkReliability Staff

In 2010 a woman arrived at a California Medical Center at 2 AM for a full term delivery.  The woman was in good health.  Her membranes were artificially ruptured at 11:26 AM and her baby was delivered vaginally at 3:18 PM.  Unfortunately, after the delivery the patient continued to bleed.  After an hour, the patient was moved to the operating room.  The bleeding source could not be located and the bleeding continued for another 41 minutes until a senior obstetrician was called.  Although the doctor indicated that the Rapid Response Team (RRT) was not needed, it arrived shortly after but was refused entry to the operating room until after a breathing tube had been inserted.  Although Code Blue resuscitative procedures were continued for 72 minutes, the patient died due to excessive blood loss.

This tragic incident can be examined in a visual root cause analysis, or Cause Map, using the information released by the California Department of Public Health.  The first step to performing a root cause analysis is to determine which goals were impacted.  In this case, the patient safety goal was impacted due to the death of a patient.  In cases involving death or injury to a patient, employees can also be impacted in what is known as a second victim.  The death of a healthy patient associated with a normal delivery is considered an “adverse event” per the California Department of Public Health and a “never event” as defined by the National Quality Forum, which can be considered an impact to the compliance goal. The center was fined $50,000, an impact to the organizational goal.  Additionally, the delay in life saving measures to the patient is an impact to the patient safety goal.

Beginning with an impacted goal, asking “Why” questions allows the development of the cause-and-effect relationships that led to the incident.  In this case, the patient died from excessive blood loss and a delay in life saving measures.  The blood loss started as damage from delivery, but was unable to be stopped and treatment of the bleeding was delayed.  All three of these causes contributed to the total amount of blood loss experienced by the patient.  There was a delay moving the patient to the operating room (OR) and a delay calling for assistance from a senior obstetrician (OB).  Additionally, there was delay in treatment by the RRT, which was initially not allowed to enter the OR.

As a result of this incident, the medical center has reviewed and revised its policies regarding post-delivery hemorrhage and response.  Specifically, when a patient suffers more than 750 cc’s of blood loss after vaginal delivery (this patient lost more than 1500 cc’s), she is transferred to the main OR.  An OB Hemorrhage Toolkit, including checklist, has been adopted in Labor & Delivery, and the hospital has joined  a maternal care collaborative.  According to the CEO of the Medical Center, “We have reviewed these situations with everyone involved . . . to learn from them, improve patient care, update our policies and make sure nothing like these incidents can happen again.”

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

Root Cause

Only 3 Countries Remain with Endemic Polio

By ThinkReliability Staff

Polio is a horrible, crippling disease.  According to the World Health Organization (WHO), of the children who contract polio, 1 of 200 will be irreversibly paralyzed.  Of the children who are paralyzed, 5 to 10% will die because their breathing muscles are paralyzed.  The Global Polio Eradication Initiative was formed in 1988.  That year, more than 350,000 people were paralyzed.  So far in 2012 only 181 cases have been reported.  Obviously this is a huge success, but unfortunately, it’s not quite enough.  As Centers for Disease Control & Prevention (CDC) Director Dr. Frieden states “If we fail to get over the finish line, we will need to continue expensive control measures for the indefinite future…More importantly, without eradication, a resurgence of polio could paralyze more than 200,000 children worldwide every year within a decade.”

Because polio cannot live outside the body for long periods of time (unlike most diseases) it can be eradicated.  The only human disease that has been completely eradicated is smallpox.

On February 25, 2012, India was removed from the list of endemic countries, leaving only three countries where polio is endemic: Afghanistan, Nigeria and Pakistan.  Eradication in these countries continues to be difficult for various reasons.  We can look at some of the causes of why eradication has been difficult in these countries and ongoing solutions to these difficulties by analyzing the issue in a Cause Map, a visual form of Root Cause Analysis.

We begin with the impacts to the goals.  Public safety is impacted because of the risk of death and paralysis.  Public services are impacted due to the risk of contracting polio.  Additionally, the compliance goal is impacted because children are not receiving full vaccinations against polio.

There are myriad reasons for children not receiving full immune protection from vaccination against polio.  First is the difficulty finding and accessing children.  Many children in endemic areas are nomadic or homeless.  The use of “transit teams” – vaccination teams stationed at transportation stations and large crossings – aims to increase vaccination of these children.  Children are marked after they receive vaccines, to ensure the vaccines are not repeated and to allow tracking of the success of the program.  In many of the endemic areas, children are inaccessible to vaccination teams due to conflict or violence in these areas.  In some areas vaccination teams are blocked by local governments or even subject to violence.  Some religious and local government leaders do not support the vaccination program, or the makeup of the vaccination teams.  Outreach campaigns aim to reach the public, community and religious leaders.  The GPEI, WHO and CDC are trying to work with governments and religious organizations to increase acceptance of the vaccines.  The creation of small scale immediate immunization response strategies aims to allow fast response when a previously inaccessible area becomes accessible, to maximize immunization during that time.

Some parents will not allow their children to be vaccinated.  In many cultures, women will not open the door to men.  Vaccination teams will generally include at least one woman to help increase acceptance from parents.  Parents are also reluctant to vaccinate newborns, or children who are sick or sleeping.  The importance of vaccinating these children is being added to outreach information and polio hotlines are being created to attempt to provide information to reluctant parents.  Because at least four doses of the polio vaccine are required to fully protect against the disease, these issues are magnified.  Permanent polio teams in the endemic areas aim to maximize the immunization coverage and attempt to eradicate this disease once and for all.

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

Root Cause

NYC Hospital Unexpectedly Evacuated During Sandy

By Kim Smiley

On October 30, 2012, power outages forced evacuation of a New York City hospital amidst the onslaught of Hurricane Sandy.   All 217 patients in the hospital to had moved, including 20 infants staying in the neonatal intensive care unit.

This incident can be analyzed by building a Cause Map, an intuitive format for performing a root cause analysis.  The first step in the process is to fill in an Outline that lays out the basic background information and also identifies the impact to the goals.  In this example, the safety goal is clearly impacted because it is risky to evacuate patients during a hurricane.  Although the potential for injury was very real, no one was hurt during the evacuation and the hospital staff did an amazing job of carrying patients down darkened stairwells and ensuring basic life support remained stable.  The customer service goal is also worth considering since the unexpected evacuation received a large amount of negative publicity.

After the Outline is completed, the next step is to ask “why” questions to add Causes to the Cause Map.  Why were patients at risk?  This occurred because the hospital had to be evacuated because it lost power and the backup power generators failed.  Why the generators failed hasn’t been identified yet, but there is speculation that the age of the equipment may have played a role. It’s also possible that the location of the generators might be factor since a number of hospital building were flooded by ten feet of water.  Electrical service was lost because New York City was hit hard by Hurricane Sandy and saw unprecedented flooding and strong winds.  This wasn’t an unexpected impact of the storm, but the hospital did not expect the generators to fail, especially so quickly.  The patients were also at risk because the hospital had many patients in critical care units that required life support systems and the patients were evacuated under dangerous conditions, both inside and outside the hospital.  At the time of the evacuation the hospital had lost power and patients were being carried down stairs lit by flashlights.  Some patients were bought down 16 flights of stairs.  The evacuation also occurred during the hurricane so the conditions during the drive to a new faculty were potentially dangerous.  The evacuation occurred during the hurricane, as opposed to before the storm hit, because the hospital assured the city that it was prepared and could ride out the hurricane.

This issue is still being investigated, but once all the facts are known solutions can be developed and implemented to help ensure that patients aren’t forced to evacuate under similar adverse conditions.

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

Root Cause

Update: Contaminated Injections Have Now Killed 29

By ThinkReliability Staff

In a previous blog, we discussed deaths related to fungal meningitis believed to have resulted from fungal contamination of a compounded drug used as an injection for back pain.  Sadly, since our last post, the numbers of deaths and injuries has risen.  So far, 29 patients have been killed and more than 360 have been sickened by the infected injections.  Because drugs from the three affected lots were injected for pain relief to approximately 14,000 patients, investigators expect to see many more cases in the coming months.  Some of these patients received injections in other joints, so they are suffering from peripheral joint infection, which is less severe and less likely to lead to death than fungal meningitis.

We can update the Cause Map, or visual root cause analysis, which was started in our previous blog.  Specifically, as investigators are able to provide more detail about the case, we can update causes and validate them with evidence.  We are also able to update the outline as more patient deaths and sickness are discovered.

Investigators have verified that the source of the fungal contamination was the compounding company.  They noted in investigations that the clean room was contaminated due to lack of control of the humidity and temperature.  It appears that the air conditioning was shut down at night, resulting in environmental issues. Additionally, sterilization at the company was found to be inadequate.  Sterilization procedures were not followed, and sterilization equipment was found to be contaminated, possibly because it was not properly tested.  Once the contamination made it into the drug, the drug was shipped without the company knowing of the contamination, because shipping on some lots took place before the results of sterility testing were received.

The Massachusetts Department of Health has announced increased oversight of compounding companies, including annual inspections.  A bill has been introduced in Congress for FDA regulation of compounding companies that produce larger quantities of drugs for mass distribution, as appears to be the case in this instance.  It also recommends requiring compounded drugs to contain a label stating they have not been FDA-approved.  Although the compounding company responsible for the contamination has been closed down, it is hoped that a higher level of regulation will reduce the possibility of similar deaths in the future.

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