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

Bed Rail Death

By ThinkReliability Staff

A patient’s death in 2006 at an assisted living facility in Vancouver, Washington has helped spurred a review of the safety of bed rails.  The patient’s death was due to strangulation when her neck got caught in side rails on her bed.  The side rails had been provided by her family at the suggestion of the assisted living facility.

A recent Consumer Product Safety Commission (CPSC) review of bed rail fatalities indicates that there have been 155 deaths due to the use of bed rails between 2003 and May 2012 but until now, regulation of the use and design of bed rails has been somewhat haphazard.  We can examine the issues that led to the 2006 death – and have likely contributed in many of the other bed rail-related deaths, in a Cause Map, or visual root cause analysis.

We begin by considering the impacts to the goals.  The patient safety goal is impacted due to the patient strangulation and death.  The patient services goal is impacted because of the patient getting stuck in the bed rail.  Indeed, injuries resulting from bed rails are far more common than deaths, with about 36,000 injuries requiring emergency room treatment reported since 2003.  There is a concern about potentially inappropriate use of bed rails, which can be considered a property goal and the ensuing review of bed rail deaths can be considered a labor impact.

We begin with the patient safety goal and ask “Why” questions to determine the cause-and-effect relationships that resulted in the impacted goals.  The patient death was due to being trapped in bed rails.  This occurred due to her illness – about half of patients who die in bed rail incidents have medical problems, a gap between the bed rail and mattress, and the use of bed rails.  The gap can be attributed to the design of the bed rail and/or the incompatibility between the mattress and bed rail.  In this case, the bed rail was purchased by the family and the mattress provided by the facility.  ASTM standards for bed rails are voluntary and regulations governing bed rails are insufficient in their current state.

Bed rails are used primarily to keep patients from falling out of bed and to assist patients in getting in and out of bed.  However, hospitals and nursing home use has decreased since dangers have become more well known.    Most deaths (61%) attributed to bed rails occur at home.  It is suggested that a decrease in availability of caregivers may increase the use of bed rails.

When the FDA issued a safety alert regarding bed rails in 1995, it adopted voluntary guidelines and did not require safety labels or recall of any types of bed rails.  At the time, there was political support for less regulation, industry was concerned about legal issues and resistant to any tougher regulation and there was – and still is – confusion over which regulatory agency is actually responsible for bed rails.  The CPSC maintains that bed rails are medical devices and not under their authority.  However, the FDA claims that if no medical claims are made associated with the bed rails, they are not within their regulatory authority either.  Additionally, because deaths and injuries related to bed rails are not necessarily reported, and problems not highlighted to consumers, the issues are not well known.  Some are hoping to change that.

Representative Edward J. Markey has called for the formation of a task force to address the issue.  The CPSC completed a report on deaths, which has been provided to the FDA.  And, manufacturers say that newer designs and safety straps will reduce the risk of patient death.

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

Root Cause

Baby Breastfed by Wrong Mom

By ThinkReliability Staff

After a newborn baby at a Minneapolis hospital was placed in the wrong bassinette, he was delivered to the wrong mother and breastfed.  Because breastfeeding can carry risks of transmission of communicable diseases the CDC recommends HIV and hepatitis testing after such events.

We can examine this incident – and what went wrong – in a visual root cause analysis, or Cause Map.  The Cause Mapping procedure begins by determining the impact to the organization’s goals.  In this case, the patient safety goal is impacted due to the risk of transmissible disease.  The hospital involved has stated there will be consequences to staff for not following hospital procedure.  This is an impact to the hospital’s employee impact goal.  The patient services goal is impacted because babies were switched (and apparently misplaced for some period of time) and because of the testing that the baby who was breastfed by the wrong mother will require.  The hospital will pay for the testing, which can be considered an organizational goal impact.

The analysis step of the Cause Mapping process begins with the impacted goals.  To continue the analysis, we ask “why” questions.  The patient safety goal is impacted because of the risk of disease.  The risk of disease is caused by being breastfed by the wrong mother.  This occurred because the wrong baby was brought to the mother,  the mother was breastfeeding, and the infant’s bands were not matched to the mother’s bands, although this was hospital procedure.  According to the hospital’s statement, “While hospital procedures require staff to match codes on the infant’s and mother’s identification bands in   order to prevent incidents like this, it appears these procedures were not followed in this case.”

The wrong baby was brought to the mother because multiple babies were kept in bassinettes in the nursery, and the baby had been placed in the wrong bassinette.  It is unclear what procedure was used to determine which bassinette the baby should be placed in, but the procedure was obviously ineffective.

The hospital has stated that its procedures will be reviewed.  Certainly the procedure to verify a baby’s wristband to a mother’s will be emphasized and retrained.  Additionally, matching of the baby’s wristband with a tag on the bassinette would reduce these types of issues.  Some hospitals have gone so far as to stop using nurseries where multiple babies are placed and instead keep the newborn in the mother’s room.  This also would reduce the risk of baby switching incidents.

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

Root Cause

A Tongue Tie Release Wrongly Performed in Case of Tongue Lesion Resection

By ThinkReliability Staff

A California hospital has been fined $50,000 – its fifth administrative penalty from the State since 2009 – for performing the wrong procedure on a 6-year-old boy.  The boy was supposed to receive a tongue lesion resection, but instead a tongue tie release was performed.

We can examine the issues that resulted in this incident within a Cause Map, or visual root cause analysis.  The first step in any analysis is to define what you are analyzing.  We begin with impacts to the organization’s goals.  In this case, we look at the impacted goals from the respect of the hospital.  First, the patient safety goal  was impacted due to an increased risk of bleeding, infection, and complications from anesthesia.  The compliance goal is impacted because performing the wrong surgical procedure on a patient is a “Never Event” (events that should never happen).  The organizational goal is impacted because of the $50,000 fine levied by the State of California.  The patient services goal is impacted because the wrong procedure was performed and the labor goal was impacted due to the additional procedure that was required to be performed.

The second step of our analysis is to develop the cause-and-effect relationships that describe how the incident occurred.  We can develop these relationships by beginning with the Impacted Goals and asking “why” questions.  For example, the patient safety goal was impacted because of the additional risk to the patient. The patient received additional risk because of the performance of an additional procedure.  An additional procedure was necessary because the wrong procedure was initially performed.

There are many causes that contributed to the wrong surgery being performed.  These causes are outlined in the  report provided by the California Department of Public Health.  In this case, there were several causes that likely resulted in the wrong procedure.  The Operative Report had the incorrect diagnosis – tongue tie – which would suggest that a release would be the appropriate procedure.  Additionally, the Anesthesia Record contained the wrong procedure (tongue tie release), possibly because the Pre-Anesthesia Evaluation originally noted that a tongue tie release was to be performed and was later corrected (by crossing out the incorrect procedure and writing in the actual procedure).

The type and site of surgery was not verified.  The surgeon who performed the surgery could not remember if a time-out had been performed, although there was a record of a time-out performed immediately prior to the surgical procedure.  Since the time-out was performed immediately prior to the procedure and the surgeon was unable to remember the proper procedure, the time-out was obviously ineffective.

The surgeon stated after the surgery that he believed that the tongue tie release surgery which was performed was indicated based on scar tissue that was found under the tongue.  The surgeon did not notice the lesion on the tongue during the surgery and no pre-surgical exam was performed by the surgeon.  Additionally, the surgical site was not marked (as the site of the correct, as well as the incorrect, surgeries were both within the patient’s mouth).

During the procedure, none of the other staff stopped the surgery as it was occurring.  However, given the proximity of the “correct” site to the “incorrect” site, it may have been difficult for the other staff to see what was going on.  The surgeon did note that the lesion removal should have created a sample, the lack of which was not noted by staff.

The surgeon involved in this case has indicated that he will be examining his patients prior to surgery in the future. Hopefully this incident will also serve as a reminder to all medical staff that in the case of a site that cannot be marked as per procedure, extra care should be taken to ensure the correct site is operated on and the correct procedure is performed.

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

Root Cause

Fighting Polio in India

By ThinkReliability Staff

On February 25, 2012, the World Health Organization removed India from the list of countries with active transmission of endemic polio.  This leaves three countries – Nigeria, Pakistan and Afghanistan – that are still struggling to eradicate polio from their population.  (See our previous blog for a discussion of the difficulties these countries are facing.)   India is an example of a remarkable success story made possible by hard work and meticulous planning.  In 2009, India reported the most polio cases of any country in the world – 741.  By the next year, the country reported on 42.  The last case of polio in India was reported on January 13, 2011.

We can use root cause analysis to determine causes of problems, and to learn from the issues of others.  We can also use it to learn from the successes of others.  Here we can use “success mapping” to create a Cause Map, or visual root cause analysis, of a successful outcome – in this case, the eradication of polio from India.  The steps of success mapping are the same as for incident mapping.  In this case, the public health goal was impacted – positively – by the absence of polio cases since 2011 in India.

We begin with the impacted goal, and ask “Why” questions.  The absence of polio cases in India is due to a successful vaccination campaign – covering more than 99% of children.  The successful program is due to a comprehensive, detailed vaccination plan, which we can lay out in a process map.  (To read more about India’s polio vaccination campaign, please see the Global Polio Eradication Initiative’s Website.)

The process for successful vaccination addresses some of the common problems with vaccination programs, which are still seen in the remaining endemic countries.  Notably, access to children is a major difficulty with vaccination programs.  In India, local volunteers canvass neighborhoods and determine the number of children in each home to provide vaccination workers with a number of children to look for and vaccinate.   Vaccination teams are also provided special tracking booklets for newborns, to ensure that any children that were not previously accounted for are added to the total.

There are many reasons that children are unable to be vaccinated.  Aid workers track the specific reason for each child that is not vaccinated and, depending on the reason, an appropriate follow-up team is sent to the house later on the same day and, if still unsuccessful, later in the week.  Follow-up teams include a community influencer if a parent refuses to vaccinate the child and a medical officer if a vaccination is not given because a child is ill.

Because some children are not found at home, transit teams were formed.  These teams vaccinate children at major intersections and transit points, such as train and bus stations.  To ensure full coverage (and that each child is vaccinated only once), children’s fingers are marked after they have received vaccinations.

It is hoped that some of these ideas can also be used by the vaccination teams in the remaining countries that have endemic polio and to ensure that polio does not return to countries that have already been removed from the list.  When ideas are successful at one site, other sites may be able to benefit from them as well.

However, a great process means nothing if you don’t have a team of dedicated workers.   As stated by India’s Prime Minister, “The real credit goes to the 2.3 million volunteers who repeatedly vaccinated children even in the most remote areas, often in very bad weather conditions. I commend each one of them for their dedication, commitment and selfless service.”  We second that commendation, and thank you for helping reduce the risk of this horrible disease.

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