Tag Archives: cause mapping

Root Cause

Reuse of Insulin Pens May Have Spread Hepatitis

By ThinkReliability Staff

After a similar incident at a Veterans hospital, a hospital in New York reviewed its insulin injection procedures and discovered that insulin pens may have been used for more than one patient.  Re-use of insulin pens for more than a single patient carries a small risk of cross-contamination, which can result in a patient being infected with a communicable disease, such as hepatitis B, hepatitis C, or HIV.

The hospital notified 1,915 patients who had received injections between November  2009 and January 2013 of the possibility for contamination and recommended testing.  Twelve patients have tested positive for Hepatitis C, and one has tested positive for Hepatitis B, though an investigation is ongoing to determine if this is related to the injections.

The use of insulin pens resulted in 30 outbreaks from syringe or needle reuse over ten years, from 2001-2010. So, although the possibility for cross-contamination is considered low, the risk for the spreading of communicable diseases is unacceptably high.

The potential for spreading communicable diseases is an important impact to the patient safety and environmental goals.  We can examine these impacted goals and the cause-and-effect relationships that led to these impacts, in a Cause Map, or visual root cause analysis.

We begin by defining the impacts to the goals.  In addition to the patient safety goal, the compliance goal is impacted because re-using insulin pens is against recommendations by the FDA and CDC.  The organizational goal is  impacted due to a lawsuit from the patients who have tested positive for Hepatitis B and Hepatitis C.  Patient services are impacted due to the improper reuse of the insulin pens, and the labor and property goals are impacted by the additional follow-up, testing and potential treatment for the almost 2,000 patients affected.  Once we have determined the impacts to an organization’s goals, we can ask “Why” questions, which helps develop cause-and-effect relationships that resulted in these impacts.

Insulin pens are designed for multiple injections, meaning that there is stored insulin within the cartridge after a single injection is given.  Backflow of blood into the pen can result in the remaining insulin being contaminated.  This can result in the spread of communicable disease if the pen is then used on a different patient for subsequent injections.

Because it is known that insulin pens should not be used on multiple patients, it is evident that there was an issue with the procedure or policy regarding use of insulin pens.  It is unclear what the specific issues were relating to this incident, but the hospital involved has reviewed and reinforced policies and procedures related to insulin injection.

Many facilities, including the hospital discussed here, which discovered the potential for re-use during a review after a similar incident at a Veteran’s hospital, have discontinued the use of insulin pens due to the potential for cross-contamination.

To view the Outline and Cause Map, please click “Download PDF” above.  Or click here to read the hospital’s press release.

Click here to visit our previous blog about about hepatitis B and C.

Click here to visit our previous blog about a different contamination issue involving hepatitis C.

 

Root Cause

Rabies From Donated Kidney Kills Recipient

By ThinkReliability Staff

A kidney donation recipient died in February, 2013.  It was determined that his death was due to rabies – specifically rabies that had been transferred with the donated kidney during the transplant in September 2011.  Although infectious disease transmission through transplant – especially rabies – is rare, there is benefit in visually diagramming a root cause analysis of this event in a Cause Map.   A Cause Map begins with the specific impacts to an organization’s goals resulting from an incident, and shows the cause-and-effect relationships that led to those impacts.

In this case, the patient safety goal was impacted due to the recipient death.  The receipt of organs infected with a disease such as rabies is an impact to the patient services goal.  Three other recipients also received organs from the same donor but have not shown symptoms of rabies.    Their treatment is an impact to the property and labor goals, due to the cost, time and inconvenience of those treatments.

The impacted goals form the first cause-and-effect relationship in our Cause Map.  We ask “Why” questions to determine other cause-and-effect relationships.  In this case, the donor death was due to rabies.  The donor was infected with rabies from an infected transplanted organ, and was not treated for rabies.  The recipient was not treated for rabies as the symptoms did not emerge until a year after the transplant (rabies can have a long incubation period).  The donor organs were infected with rabies from an unknown cause, though rabies usually results from contact with wild animals (specifically, this strain of rabies appears to be from a raccoon).   The transplant medical team was unaware that the donor had rabies.

Though the donor had encephalitis, it was thought that it was due to a food-borne illness.  (Detail on how the diagnosis was obtained has not been released.)  While there is testing for certain diseases performed on donor organs, due to the time constraints on the viability of the organ, testing for rabies is not generally performed.  However, new guidance from the Disease Transmission Advisory Committee (put out after this donation occurred) urges caution in use of organs from donors with encephalitis, perhaps including more robust testing for specific illnesses, or using only certain organs.

Due to an acute shortage of viable donated organs, some believe that organs from disease-positive donors should be used, and treatment started immediately.  With many in need of transplants dying on the waiting list, this may be a more practical approach, though there are certainly concerns about transmitting diseased organs to those who are already very ill, and who will be taking immune suppressing drugs to prevent rejection of transplanted organs, making them more susceptible to such diseases.

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

Read our previous blog about a recipient who died of lung cancer after receiving the lungs of a heavy smoker

Root Cause

US Stockpiles Smallpox Medicine, Fear of Bioterrorism

By Kim Smiley

The last case of smallpox in the United States occurred in 1949, but the government recently made headlines for spending $463 million on enough medicine to treat two million people infected with the disease.  It is feared that the deadly and disfiguring disease could be used by bioterrorists and the government wanted to be prepared in the event of an attack.

The concern that smallpox could be used for bioterrorism can be analyzed by building a Cause Map, a visual root cause analysis.  The first step is to fill in an Outline with the background information for the problem and determine which goals are impacted.  In this example, the safety goal is impacted because there is a chance of many deaths if smallpox is released, the financial goal is impacted because hundreds of millions of dollars were spent on treatment for smallpox and the customer service goal is impacted because people are nervous about the potential for smallpox bioterrorism.  Once the impacts to the goals are determined, the Cause Map is built by asking “why” questions.

Why is there a potential for many deaths?  This is true because there is the potential that a smallpox outbreak could happen, many are unprotected against smallpox, and smallpox is a very deadly, highly contagious disease.  An outbreak could occur if bioterrorists released smallpox because the virus still exists in research labs in the US and Russia.  Advances in the genetic field have also opened the possibility that the smallpox virus could be  re-engineered and essentially created in a lab anywhere in the world.   Many people are unprotected against smallpox because the vaccination program ended in 1980 when it was eradicated.  People vaccinated prior to 1980 likely maintain some level of protection from smallpox, but the effectiveness of the vaccine degrades over time and they are no longer fully protected.  Smallpox is a very dangerous disease because it has fatality rate of about 30% and many survivors are left blind or disfigured.  It’s also very contagious and can be spread without direct contact because it can be transmitted via aerosolized droplets from saliva and other body fluids.

The financial goal is also worth considering.  Hundreds of millions of dollars have been spent to prepare for a potential smallpox attack.  The government has long stockpiled smallpox vaccines in the event they were needed, but the move to buy medicine to treat the disease is fairly recent and substantially more expensive than just buying vaccines.  This option has only recently been a possibility because there was no treatment for smallpox until now.  A private company developed antiviral medicine to treat smallpox in the hope that it would be profitable.

Developing solutions to problems that might occur is always tricky and likely to cause debate.  There are many reasons why a smallpox bioterrorism attack is frightening, but how much money should the US government spend to prepare for an attack?    How much preparation is enough?  There is no simple answer, but it’s important to understand these types of problems to the best of our ability to help make well thought out and reasonable decisions.

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

 

 

 

Root Cause

Cases of Deadly ‘Superbugs’ on the Rise in US

By Kim Smiley

A new antibiotic resistant strain of bacteria is causing deaths and raising flags in US healthcare facilities. The bacteria is called Carbapenem-Resistant Enterobacteriaceae, often shortened to CRE, and is named for its ability to resist carbapenem antibiotics, the last resort treatment for antibiotic resistant bacteria. The fatality rate for those infected may be as high as 50 percent. In 2012, 4 percent of hospitals reported cases of CRE, up from about 1 percent a decade ago. The situation at long-term care hospitals is significantly worse, with 18 percent reporting cases last year.

The issue of CRE can be analyzed by building a Cause Map, a visual method for performing a root cause analysis. The first step is to create an Outline that documents all the background information for an issue. How the problem impacts the overall organization goals is also listed on the bottom of the Outline. In this example, the safety goal is obviously impacted since there have been patient deaths. After the Outline is completed, the second step is to build the Cause Map. The Cause Map is built by asking “why” questions to determine what causes contributed to the issue and then arranging the causes visually to show cause-and-effect relationships. Why have there been patient deaths?  This has occurred because they were infected with CRE and CRE infections are dangerous.

People are being exposed to CRE primarily in healthcare settings. CRE is being passed between patients within the same facility and between healthcare facilities as infected patients are transferred to different healthcare settings. Exposure is occurring between patients because infected patients may not be identified or adequately isolated. Many healthcare facilities do not have the capability to test for CRE and it’s also difficult to identify who should be tested since some patients who carry the bacteria are not symptomatic. CRE also tends to infect individuals who have other health issues and weakened immune systems. Treatment of the other issues may involve invasive medical devices, such as catheters, that can provide a pathway for infection into the body.

CRE infections are dangerous because they have a high rate of fatality, up to 50 percent according to the CDC, and they are difficult to treat. CRE are resistant to virtually all antibiotics. This strain of bacteria is also particularly worrying because they can transfer their resistance to other bacteria within their family, compounding the problem. Antibiotic resistant bacteria have developed over the years because of the wide use of antibiotics. Each time antibiotics are used, bacteria have a chance to evolve and they have over the years.

The final step in the Cause Mapping process is to find solutions that would reduce the risk of the problem in the future. In this example, there isn’t an easy solution. There are no promising new antibiotics in development at this time that would likely be able to treat CRE infections so the best hope is to prevent the bacteria from spreading. The CDC has recommended steps such as identifying and isolating infected patients.

This example also show important it is to track the effectiveness of solutions after they are implemented because there can be unintended consequences that show up later on. Antibiotics have saved thousands of lives, but they are becoming less effective as bacteria develop resistance to them. New solutions will be needed to prevent or fight these types of infections in the future. Cause Mapping is a useful tool to document evolving issues because they can easily be adjusted and added to as new information is available.

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

Root Cause

Are Medical Residents Dangerously Fatigued?

By Kim Smiley

Medical residents work extremely long, tiring schedules on their arduous path to becoming physicians.  Possible consequences of this demanding schedule have long been debated.  Many wonder if it’s safe to have someone who has been on duty for 24 hours straight treating patients.

This issue can be explored by building a Cause Map, or visual root cause analysis.  A Cause Map is built by asking “why” questions and laying out the different causes that contributed to an issue to the cause-and-effect relationships.  In this example, there is potential risk to patients and to the medical residents themselves.  Patients may be at risk because fatigued medical residents are treating patients and fatigued people are more likely to make mistakes, increasing the chance of a medical error that affects patient safety.  Residents are fatigued because they work long hours and the current regulations allow 80 hour work weeks.

Additionally, the health of the residents themselves may be at risk.  A poll by the Mayo clinic found that 11 percent of medical residents had been in an auto accident.  The poll also found that 8 percent of residents reported having at least one blood or body fluid exposure due to fatigue or stress, potentially exposing them to any number of diseases.  Sleep deprivation itself can also have long term health consequences increasing the likelihood of a number of illness including heart disease and gastrointestinal problems.

While there is ongoing debate on whether residents are still working too many hours, there have been changes made to reduce resident fatigue. In 2003, residents were limited to 80 hours per week by the Accreditation Council for Graduate Medical Education.  Prior to this move, there was essentially no limit to the hours a resident could log.  This issue isn’t black and white and there are also many who argue that the limits have had negative unintended consequences.  Fewer hours in the hospital mean that residents see fewer patients and have less experience when they become independent physicians.  Limiting shifts also increases the potential for each patient to be seen by more doctors and for essential information to be lost during turnovers.  This isn’t an issue with a clear answer and any additional restrictions in the hours a resident is allowed to work will need to be mitigated with effective methods of turning over patient care and assurances that residents are getting adequate training.

This is a good example to demonstrate the important of taking an investigation past determining that the problem is caused by “human error”.  Medical errors are caused by human errors, but the most useful part of the investigation usually comes from asking why the error was made.  Was the person overly fatigued?  Was the procedure confusing?  Would the process go smoother with a phase to verify information or a checklist?  An investigation shouldn’t be stopped at “human error”; it should be taken a few steps farther to see what may have contributed to the error and what changes may help prevent a similar error in the future.

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

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

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.