Root Cause Analysis

Young Boy Killed by Projectile During MRI

By Kim Smiley

It has been over ten years since six year old Michael Colombini died as a result of injuries that occurred during a routine MRI.  He was undergoing a post-surgery MRI after removal of a benign brain tumor when he was hit by a magnetic oxygen tank that was pulled toward the MRI machine at high speed.  His skull was fractured and he died two days later.

How did this horrible accident happen?

A Cause Map, or visual root cause analysis, can be built to help explain the causes that contributed to this death.  In this example, the patient needed an MRI because he had a brain tumor removed and he was hit by a magnetized oxygen tank while in the MRI machine.  This occurred because the oxygen tank was attracted by the huge magnet in the MRI and flew towards the machine at high speed.

MRI magnets will always attract magnetic things, even when the machine is off.  Bringing a magnetic oxygen tank into a MRI examination room is a dangerous situation.  In this example, there are several reasons why the tank was brought into the MRI area.  The tank was bought into the room by a well-meaning nurse who heard the anesthesiologist calling for oxygen.

The nurse had returned to the MRI area in order to retrieve something she had left there earlier in the day when she had accompanied a patient to the space.  She heard the anesthesiologist calling for oxygen and saw the tanks nearby so she handed one to the doctor.  Contributing to this accident is the fact that the oxygen tanks were stored near the door to the MRI exam room.

The anesthesiologist was calling for oxygen because the patient had low oxygen saturation levels and needed additional oxygen.  The patient was a six year old boy so he had been sedated for the MRI procedure.  A piped in system normally supplied oxygen for use during MRIs, but the system had malfunctioned.  Both MRI techs on duty had gone to investigate the piped in oxygen system failure so nobody trained on MRI safety was around when the nurse bought in the oxygen tank.

Some simple solutions that might have helped prevent this accident, even with the oxygen system failure include storing oxygen tanks far away from the MRI exam room and not allowing unescorted non-MRI staff into the space.  It’s also always a good idea to have an acceptable back up for important systems planned in advance.  If a second safe oxygen supply was already provided, this accident could have been prevented.

The magnets in MRI machines are 200 times stronger than a refrigerator magnet and, as this example illustrates, the potential for injuries from projectiles is very real. Like most accidents, this death was caused by a number of failures that occurred at the same time.  All of the staff involved was trying to do the right thing, but the end result was the unnecessary death of a young boy.

Root Cause Analysis

Unbalanced Antidepressant Use

By Kim Smiley

A recent Centers for Disease Control and Prevention report provided results of a study of Americans taking antidepressants from 2005 to 2008.  The study came to two interesting conclusions that have a potential impact on patient safety.  We can outline the potential impacts of the results of this study in a problem outline, then provide a graphic analysis of the causes within a Cause Map, or visual root cause analysis.

First, the study determined that antidepressant use has increased 400% since 1988.  Eleven percent of Americans over the age of 12 are now taking antidepressants.  Any drug has risks, and more people taking a drug means that the total risk for side effects is higher.  Additionally, traces of certain kinds of antidepressants have been found in  the water supply, likely caused partially by improper disposal of these drugs.  (Don’t flush them down the toilet!)  The cost of anti-depressants is an additional issue raised with the high usage of these drugs.

Even though talk therapy is a very useful tool for treating depression, less than 1/3 of patients who are taking antidepressants have met with a mental health professional in the last year.  Patients reportedly prefer drugs to talk therapy, potentially because reimbursement for prescriptions is generally much simpler and cheaper than reimbursement for mental health therapy, which can be capped or may not be covered at all.

Because most antidepressants are obtained with a prescription, the higher usage of antidepressants indicates a higher rate of diagnosis of depression.  While the faltering economy can take some of the blame, hormonal changes (as middle aged women are the most frequent users of antidepressants), a decreased stigma against depression, and increased awareness of the drugs, thanks to pharmaceutical marketing, have also been listed as potential causes for the increase.

Many agree that the decreased stigma towards depression is a positive step; however, the other side of the study found that only one third of people with severe depression symptoms are taking antidepressants.  While many with mild depression symptoms may find relief with talk therapy or other options, American Psychiatric Association guidelines recommend medication for moderate to severe depression symptoms.  This indicates that patients with severe depression may be under medicated and increases the risk for mental health problems and/or suicide.  There are many possibilities for why individuals with severe depression are not getting – or seeking – the help they need.  The high out of pocket cost for anti-depressants may be a barrier to some, as is the ability to receive screening for depression.  Although there are certainly other roadblocks along the way, making screening easier to receive may increase the treatment rate for sufferers.  The Centers for Medicare and Medicaid Services recently announced it would be covering annual screening for depression.  Hopefully this first step will result in more people getting the help they need.

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

Root Cause Analysis

A Stealth Contact Lens Recall?

By Kim Smiley

Avaira Toric contact lenses, manufactured by CooperVision Inc, were voluntary recalled on August 19, 2011.  The recall occurred after dozens of consumers complained about eye problems including impaired vision, eye pain and torn corneas.  According to a company statement, a manufacturing error resulted in a silicone oil residue on some contacts.  More than 8 million lenses were affected worldwide by the recall, but only about 780,000 of these contact lenses were distributed in the USA.

The company has received a large amount of negative media attention following the recall.  News articles and blogs  have claimed that CooperVision was purposely downplaying the recall, resulting in many consumers being unaware that their lenses had been recalled. Unaware of the potential danger, consumers continued to wear their lenses and continued to have eye problems as a result. The FDA publicly threatened to independently inform consumers of the risk associated with these contact lenses if the manufacturer didn’t better publicize the recall.

Following the media attention , the company has increased efforts to notify consumers about the recall.  The FDA has also posted a notice on their website of this recall, identifying it as a Class I recall, the most serious class of recall. The FDA has said that the company’s actions are now consistent with what would be expected with a Class I recall.

This example is a good illustration that the execution of a recall is a very important thing.  If consumers view a recall as slow to happen or badly executed, they will probably be less likely to trust a company in the future.  Ideally, a recall should be executed so that consumers are left with the feeling that a company did the right thing as quickly as possible.

If you are concerned that you might have recalled lenses, you can visit this website  to check.  If your lenses are recall, you are asked to remove them immediately and return them to the point of purchase.

Click on “Download PDF” above to view an outline and initial Cause Map of this example.

Root Cause Analysis

Increased Risk of HIV Transmission with Injectable Contraceptives

By Kim Smiley

A recent study has brought to light some disturbing news for women using injectable contraceptives.  The study, published October 4, 2011, has discovered that the transmission rate of HIV is nearly doubled for both women who use injectable hormones for contraception and their partners.  Specifically, the rate of HIV transmission for women is 6.61 per 100 people per year when using injectable contraceptives, compared to 3.78 for those who do not.  For men whose partners use injectable contraceptives, the rate is 2.61, compared to 1.51 whose partners do not use injectable contraception.

This study may have profound implications.  More than 12 million women in eastern and southern Africa use injectable contraceptives.  Their popularity is likely due to the cost and convenience of the once-quarterly shots, used to prevent unintended pregnancies, long an issue for maternal health in the developing world.  Although the injectable contraception is not meant to prevent transmission of HIV and other sexually transmitted diseases, the hormones (namely progestin) in the injectables appear to cause a biological change that actually increases the rate of HIV infection ABOVE that of using no contraception at all.  Previous studies have also suggested this is the case, and have found that pregnancy also increases the rate of HIV.  Birth control pills (taken once daily) may also increase the risk, though so far the increase is statistically insignificant, possibly because daily pills involve   much smaller amounts of hormone.  (Although the increased transmission risk is true for all who use injectable contraception, the focus is on sub-Saharan Africa because of the high rate of HIV.)

The World Health Organization (WHO) will be reconsidering its contraception recommendations as a result of this study.  Woman using contraceptives are unlikely to use additional means of preventing HIV infection so wide spread use of a birth control method that doubles the risk of HIV infection creates a very real, global health risk.  However, the risk of death or serious health issues from unintended pregnancy have still not decreased, leading health officials unsure what the best path forward will be.  Removing an effective pregnancy control without other equally attractive options could leave more women at risk.  Officials at WHO will be working through this issue to see if both health risks from unintended pregnancy and HIV transmission can be minimized together.  It will be a tough job, but the lives of millions are at stake.

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

Root Cause Analysis

Contaminated Cantaloupes Cause Deaths

By Kim Smiley

The number of food recalls in the news lately is enough to make you lose your appetite.

Let’s start by focusing on just one of the recent recalls.  Listeria from contaminated cantaloupe has caused at least 15 deaths and has sickened more than 80 across the USA.  Tests have traced the listeria back to a single farm in Colorado, but the source has not yet been identified.

Listeria is a common, but potentially deadly bacteria that can be found in soil, water, decaying plant matter and manure so the potential sources are numerous.  Another important piece of information is that Listeria can be difficult to eliminate once it has spread to distribution and processing facilities because it grows well at low temperatures, unlike most bacteria.  Listeria can continue to grow in refrigerated areas where fruit maybe stored or processed.

Finding the source of a listeria outbreak can also be difficult because it can take up to two months for an individual to become sick.  Adding to the complexity of identifying what food is causing an outbreak of listeria is the wide variety of foods that can become contaminated.  Listeria can be found in meat, dairy, fruits and vegetables.

Even once the source of contamination has been identified, it can be difficult to effectively remove the item from the food supply.  In this example, the sheer number of cantaloupes involved as well as a long supply chain made it difficult to remove all contaminated melons.  The farm recalled their entire 2011 cantaloupe crop which was more than 300,000 cases distributed from the end of July to mid-September.  The cantaloupes were shipped to 25 states and sold through many different retailers.

A recent article by CBS stated that the average cantaloupe makes four or five stops on the way to the super market shelves.  Typical cantaloupes will go to a packing house for cleaning and packing, a distributors, a retail distribution center and finally a grocery store before they make it to the consumer.   This makes it very difficult to identify where a food might have been contaminated.

Click on “Download PDF’ above to view a high level Cause Map of this issue.  A Cause Map is an intuitive form of root cause analysis that visually lays out the causes that contribute to an issue.

Root Cause Analysis

Fixes Don’t Have to be Complicated

By Kim Smiley

The main goal of doing root cause analysis is to get to the solutions at the end.  The actual analysis portion serves to provide a comprehensive, orderly way to get to those solutions.  The best way to get solutions is brainstorming by all the personnel who have a stake in the issue – and maybe some who don’t.  The New York Times recent series on “small fixes” has highlighted some amazing developments that are helping to mitigate a large number of healthcare issues, in extremely easy ways.

For example: Pap smears are frequently used to diagnose cervical cancer in wealthy countries.  But what about countries that don’t have enough doctors or labs to make this a practical solution?  Increasing the number of doctors or labs is an extremely long-term, complicated solution.  Instead, Johns Hopkins developed a new procedure that can be done in one visit by a nurse, without lab work.  You brush vinegar on the cervix, precancerous cells turn white, and they’re frozen off right then with carbon dioxide.

Another organization, Diagnostics for All, has developed paper diagnostic forms  for a whole host of diseases, which are smaller than a stamp, can be run off on a Xerox machine, cost less than a penny and can be read without training.  Although these end results are inexpensive and accessible, the path to get there may be more complicated.  Diagnostics for All is supported by grants and foundations, but that kind of support is getting harder to find as the economy continues to worsen.  Additionally, profit for items designed primary to assist developing countries are limited.

There’s also the general feeling that expensive, complicated fixes must be better.  Some of the most effective fixes for healthcare issues – washing hands, using checklists, losing weight – are still not universally used and are constantly in danger of being replaced with costly, cumbersome alternatives.  Sometimes it’s just that people don’t believe something simple can be effective.  Sometimes it’s that the people who have been seeing these problems for years believe that if a solution were that easy, it would have already worked, and something more invasive and expensive is needed.  And, sadly, a lot of it comes down to profit.  Expensive machines, diagnostics and procedures simply make everyone involved more money than using vinegar, paper, and soap.  It’s possible, and hopeful, that the changes in the economy will start turning things in a different direction.

How can you start implementing small fixes in your organization?  First, get everyone involved in the root cause analysis and solution brainstorming.  Bring in a few people who don’t appear to have anything to do with the issue.  Explain the issue to them and let them come up with a few solutions.  Their fresh voice may result in a fresh idea.  Examine all potential solutions for ease of implementation and projected effectiveness.  If you’ve got an idea that’s easy to implement, go ahead and implement it.  If it doesn’t work, or more help is still needed, go on to the more difficult-to-implement solutions.  Start an idea box.  It’s free, it’s easy, and you may be surprised what people come up with.  The New York Times has its own “Small Fixes Challenge” It posts a healthcare problem, explains the details of the issue, and invites reader ideas.  The ideas are reviewed by a healthcare professional well-versed in the topic.

Try a small fix in your organization today.  Ask someone what they see as an issue in the organization.  And then ask them what they’d do to fix it.  A great way to get a variety of responses is ask for the “money is no object” fix, a “free” fix, and then a fix somewhere in the middle.  The answers may surprise you.  And they might have a great idea with their “free” fix.  So, what are you waiting for?  Like all small fixes, it’s worth a try.

Root Cause Analysis

The Number of Accidental Child Poisoning from Medication is Increasing

By Kim Smiley

A recent study in The Journal of Pediatrics revealed that the number of accidental drug overdoses by children is increasing in the United States.  An investigation of hundreds of thousands of patient records showed that the number of accidental drug poisonings among children under 5 years of age increased 22% from 2001 to 2008.

In 95% of the cases, the overdose occurred because the child self-ingested the drugs, as opposed to a labeling or dosing error.

Why?  How are so many young children finding and consuming medication? And more importantly, what could be done to prevent these accidental overdoses?

This incident can be built into a Cause Map, an intuitive visual method for root cause analyses.  Better understanding the causes that contribute to a problem can lead to finding better solutions.

According to the study, one of the causes contributing to the increase in accidental overdoses is that there is simply more medication in homes with small children.  As lifestyles change, the population is facing more health problems.  Obesity and metabolic syndromes are more common at younger ages than in the past and more homes of small children now contain medication associated with these illnesses as well as a variety of other medications.

Changes in drug technology have also affected the severity of overdoses, if not the number of occurrences.  More sustained-release medications are being prescribed and they can result in more severe poisoning.

The study also suggests that there is a possibility that people are being less strict about storing drugs safely, but it’s difficult to prove.  There is also the issue that people may not be aware of how dangerous their prescription and OTC medications are.

One thing we know is that the current safety precautions are ineffective.  Children are findings ways to open child proof caps and warning labels aren’t sufficiently motivating adults to safely store medications in locked or inaccessible locations.

Changing medication packaging is one of the potential solutions being considered for this problem.  New packaging that would be more difficult to open or would only dispense limited amounts of medication.  Bottles can be designed to dispense one pill at a time or restrict the flow of liquid.

Root Cause Analysis

Medical Information from 20,000 Patients Posted Online

By ThinkReliability Staff

Unfortunately, privacy of health records has become an increasingly frustrating issue.  The Department of Health and Human Services revealed that records for 11 million people were potentially made public for over two years.  A recent medical records privacy breach has made the news for the length of time the records were publicly exposed.

A hospital in California recently notified 20,000 patients that their data had been published on a commercial website from September 9, 2010 to August 23, 2011.  The published data was discovered by a patient and had been used to demonstrate the use of turning data into a bar graph.  This particular data had been given to an outside contractor for billing purposes. Although it did not contain information usually used for identity theft – such as social security numbers, it did include names and diagnosis codes, meaning that extremely personal information was included.

We can examine this issue in a Cause Map, or visual root cause analysis.  A Cause Map begins with the impacts to an organization’s goals and uses the principles of cause-and-effect to examine the causes that contributed to these impacts.  Any breach of patient privacy can be considered an impact to the patient services goals.  In fact, health care organizations may choose to add a new goal category of “Patient Privacy”.  (This is shown on the  downloadable PDF.  To view, click “Download PDF” above.)  In addition to the impacted patient services and patient privacy goals, the hospital was fined $250,000 (the maximum) by the California Department of Public Health and provided identity protection services to the affected patients.  Given the astonishingly large numbers of medical records accidentally made public, this is an issue to which all healthcare facilities should be paying attention.

The exact method that the data made it onto a public website (which provided homework assistance) is not known, but the data had been provided to an outside contractor used for billing purposes.  The contractor is no longer being used by the hospital, and some privacy experts say that better confidentiality agreements are needed by hospitals who provide patient information to outside contractors.  What is particularly disturbing about this case is that the data remained online for nearly a year – and was discovered by a patient.  However, there does not seem to be a practical way for individual organizations to monitor the internet for misplaced patient data.  Instead, focus should be on ensuring better protection upfront for medical data, in an attempt to limit breaches of patient privacy.

To view the Outline and Cause Map, please click “Download PDF” above.  Or view the New York Times article to learn more.

Hospital Acquired Condition, Root Cause Analysis

Teenager Paralyzed After Epidural Not Removed

By ThinkReliability Staff

In May 2008, a fourteen-year-old entered an English Children’s Hospital for a routine surgery to remove gallstones.  The recovery, however, was anything but routine.  The patient was given a spinal epidural to reduce pain during the operation; however, the epidural was not removed until two days later. By then, permanent damage of the spinal cord caused the patient to be paralyzed from the waist down.

The hospital has admitted liability, possibly leaving them responsible for some or all of the patient’s specialist care and support.  Because the anesthetic needle was not removed until the patient’s body until far later than it should have been – and more than a day after the patient’s first complaints of leg numbness – it begs the question whether the procedure for administering an epidural included follow-up care, including removal.  Procedures – whether they are written down or not – exist for most complex tasks, especially medical tasks that involve risks to patient safety.  If use of the procedure results in an error, it should be re-examined.  However, many procedures only include the first part of a procedure, or the administration, ignoring follow-up that must be completed to ensure the process is a complete success.  In this case, that follow-up should have included checks to ensure that the patient was recovering from the epidural (which would have noted something amiss when she continued to feel numbness in her legs) and a schedule to remove the epidural.  Because neither of these things happened, a plan for follow-up after administering epidurals must be developed and put into practice.

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

Root Cause

Five Receive HIV Postive Organs

By Kim Smiley

Waiting on a transplant list must be a nerve racking, intensely stressful time.  But what if the problems only get more complicated once the long awaited organ is transplanted?  In a terrible case of miscommunication, two respected hospitals in Taiwan recently performed five transplants using organs from a HIV positive donor.

How did this happen?

A Cause Map, an intuitive form of root cause analysis, can be used to analyze this incident.  As is typically the case, this is an example of multiple errors combining to cause a major issue.  The proper tests were performed.  The lab results showed that the donor was HIV positive, but the test results were never known by the right people.  The initial results were given over the phone and misheard.  One cause of this confusion is that similar words are used for negative and positive tests.  The English word “reactive” is used for a positive HIV test and “non-reactive” is used for a negative test result so a single syllable made all the difference.  But this mistake alone was not the sole cause of the HIV positive organs being transplanted.

Standard procedure requires that surgeons take a time out prior to surgery and verify all information, including important lab test results.  If the final checks were performed as specified, the surgical team would have seen the positive HIV results.  Additionally, the transplants were performed at two separate hospitals so final checks were truncated at two different locations.

The most poignant element of this example may be the fact that the correct information was known prior to the surgeries.  If the test results had been effectively communicated, the HIV positive organs would never have been transplanted.  This example has several lessons learned that can be applied across industries.  This issue highlights the importance of following procedures, even if they seem redundant, and using checklists, even if they seem unnecessary.  The importance of effective communication is also evident.  When using verbal communication, little steps like repeating back information to verify understanding and using words that sound distinctively different from each other can help eliminate errors.

The investigation of this case is still ongoing and the hospitals are working to make necessary changes to ensure an incident of this type never happens again.  The five patients who received the organs are being treated with antiviral HIV medications, but doctors state it is very likely that they will contract HIV as a result of their organ transplants.