Monthly Archives: July 2014

Root Cause

Solving the Problem of Organ Donation

By ThinkReliability Staff

6,570 Americans die every year waiting for a donor organ.  Says Johns Hopkins surgeon Dr. Andrew Cameron, “There just aren’t enough organ donors to go around.  That’s not a medical problem.  That’s a social problem.”  Though 95% of people support organ donation, only 40% are registered organ donors.  For the over 123,000 people on the waiting list, there just aren’t enough donor organs to go around.

This issue can be addressed within a Cause Map, a visual root cause analysis.  The first step is to capture the “what”, “when”, and “where of the incident, as well as the impact to the goals.  In this case, the problem is lack of donor organs available, causing patient deaths.  Though the problem exists everywhere, the focus of this blog will be on ongoing organ shortage in the United States.  Important differences in the United States related to organ donation are that only 40% of Americans are registered organ donors (despite widespread public support), and that there is no central registry of organ donors within the United States.  (Organ registries are typically state-run.)

The large number of deaths resulting from inadequate donor organs is an impact to the patient safety goal.  The delay in receipt of organs can be considered both an impact to the patient services and schedule/operations goal.  The lack of available organs can be considered an impact to the property goal.

To develop the cause-and-effect relationships that led to the impacted goals, we ask “why” questions.  In this case, the patient deaths result from the need for donor organs due to disease or injury, and the delay in receipt of organs.  The delay in receipt of organs is due to a lack of available organs.  Millions of Americans die every year, and while not all organs are acceptable for transplant, more than one organ can often be used from donors, resulting in multiple lives saved from each donor.

In an interesting cause-and-effect result, increased traffic safety has resulted in fewer fatal traffic accidents of young, healthy people, which has led to a decrease in available donor organs.  Of course there is no effort to try and increase organ donation by stopping the decrease of deaths of young people.

The shortage of donors from people who are eligible (upon death or brain death) result from not signing up for the organ donation registry and/or from a family not choosing to donate organs.  There are multiple reasons suggested for people not choosing to register or donate organs.  To solve the problem, companies are working on increasing the number of donors.  Dr. Cameron coordinated with Facebook to allow users to register as organ donors and saw the number of organ donors go up “22 fold”.  Says Dr. Cameron, “That’s proof that we can move the needle.”  The startup Organize is “building a portfolio of technology that makes it easier for people to demonstrate their desire to be an organ donor.”  The company hopes that it will improve organ donation to the point that it puts itself out of business in five years.

To view the overview of the organ donation problem and solutions, click on “Download PDF” above.  As discussed in a previous blog, work is also being done to increase the number of organs that are acceptable for donation (in this case with kidneys).

Root Cause

Scientists Moving a Lab Find Forgotten Smallpox

By Kim Smiley

On July 1, 2014, vials marked “variola”, the virus that causes smallpox, were found when a fridge was being cleaned out as part of the effort to move a National Institutes of Health campus to a new location. The vials were immediately secured and a CDC team was dispatched to retrieve the vials. No exposure to smallpox is suspected, but the discovery is still alarming. There are only two heavily secured locations where smallpox is supposed to exist in the world so the fact that vials of a dangerous virus were just sitting forgotten in a fridge has raised many issues that that should be investigated.

This issue can be analyzed by building a Cause Map, a visual root cause analysis method.  To build a Cause Map, the problem is first defined by identifying impacts to the overall goals and then “why” questions are asked to lay out all the causes that contributed to an issue to show the cause-and-effect relationships.  For this example, the safety goal was impacted because there was potential for a smallpox outbreak.  This would be the first box on the Cause Map and more boxes would be added by asking “why”.

So “why” was there potential for a smallpox outbreak?  This occurred because there was a potential for people to be exposed to the smallpox virus and the population has little to no immunity to smallpox.  There was potential for exposure to smallpox because “lost” vials of smallpox were in a fridge in an unsecured lab.  The vials, which were created in 1954, appear to have been in the fridge a long time and somewhere along the way, their presence was forgotten.  Smallpox can survive in refrigeration for a long time and testing has shown that the virus was still viable.  The general population has little immunity to smallpox.  The last smallpox case in the United States was in 1949 and the US stopped vaccinating for smallpox in 1972.

The final step of the Cause Mapping process is to use the Cause Map to develop and implement solutions to  reduce the risk of a similar problem occurring in the future.  In this example, the immediate problem was addressed by moving the vials to a secured lab.  Once scientists are done studying the vials, the contents and all traces of the virus will be destroyed.  Longer-term solutions will likely include ensuring that all  government laboratory storerooms are inventoried to ensure that no other potentially dangerous vials have been “lost”.  Inventory procedures should also be reviewed to ensure they are adequate.

To me, the most worrisome part of this issue is that the vials were only discovered because workers were moving the lab to a new location. It naturally raises questions about what else might be out there and how frequently inventory is happening, or not happening as the case may be.   Investigation into this incident has already uncovered a number of other vials filled with potentially dangerous specimens in the same storage facility.   If any other potentially dangerous vials are “lost” in other locations, I hope we find them before 60 years have passed.

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

Root Cause

Fire Door Falls on Dementia Patient

By ThinkReliability Staff

On November 7, 2013, during renovation taking place at a care home in Moston, Great Britain, staff responded to a cry for help, finding a resident underneath a fire door that had been removed and leaned against a wardrobe during the remodeling work.  The resident suffered a broken hip and died on December 2nd.  The management trust that operated the care home and the renovating firm were both fined under the Health and Safety at Work Act after a Health and Safety Executive (HSE) investigation found that the renovation area, which contained multiple hazards, had been left unlocked the night before.

According to HSE Inspector Laura Moran, “Both firms clearly knew there were vulnerable residents living at the care home but they still allowed the door to what was essentially a building site to be left unlocked on numerous occasions.”  Clearly multiple failures led to the resident’s death.  Diagramming the cause-and-effect relationships related to this issue can help clarify what happened, and offer areas for improvement.

We can perform an analysis of this incident in a Cause Map, or visual root cause analysis.  We begin with the impacted goals.  The patient safety goal was impacted due to the death of the patient.  In addition, the employee safety goal was impacted due to the potential for employee injury.  The fines can be considered an impact to the compliance goal and the patient services goal is impacted due to the insufficient protection provided for residents.

Beginning with an impacted goal and asking “why” questions develops the cause-and-effect relationships.  In this case, the patient death resulted from a broken hip.  The broken hip resulted from the patient being crushed under a fire door.  (It took 3 people to lift the fire door off the patient.)  The patient was crushed under the fire door because the fire door fell and the patient was in the renovation area where the fire door was located.  Both of these causes are required – had the fire door not fallen, the patient would not have been crushed, even if she was in the renovation area.  If the fire door fell but the patient was not present, the patient also would not have been crushed.  When both causes are required to produce an effect, the causes are joined by and “and” on the Cause Map.

The fire door fell as it was leaning against a wardrobe due to the renovation.  The patient, who suffered from dementia, was prone to wandering and was able to access the area under renovation because it had not been locked.  Neither the renovation firm nor the care home staff locked the area, or checked to verify that it was locked.

Other goals can be added as effects in the appropriate locations of the analysis.  For example, the patient services goal was impacted due to the insufficient protection of patients.  This occurred because the renovation area was unlocked and because the hazards in the renovation area.  (Beyond the fire door, the care home staff found exposed wiring, loose boards, and other potential safety hazards.)  The insufficient protection of patients resulted in the fine.  The impact to the employee safety goal was impacted due to the renovation area hazards as well.

Some amount of hazard always exists in construction sites – this is why hard hats are generally required.  It’s also why access to these sites is controlled.  In this case, limiting access to only those that need it was determined to be the best way to protect patients.  Because the previous process for ensuring the area was locked had failed, according to Inspector Moran, “Following the incident, the companies introduced a new procedure which meant workers had to collect and return a key at the start and end of each day, and lock the door when there was no one inside.”

The lessons learned from this tragedy are applicable not only to the specific situation of care homes undergoing renovation but to all those who have a need to protect a vulnerable population or limit access to a hazardous site to ensure safety.  Simple things like making sure doors are locked at the end of the day may save a life.

 

Root Cause

Heavy Metal Toxicity Professor Killed by Mercury Exposure

By ThinkReliability Staff

Professor Karen Wetterhahn knew firsthand how dangerous heavy metals could be.  Her research involved determining the biologic toxicity of heavy metals.  The chemical she was working with on August 14, 1996, was particularly dangerous.  Dimethylmercury, used as a reference standard, is lethal at about 400 mg, a few drops.  This classifies it as “supertoxic”.  When she spilled a few drops on her gloved hand, she assumed the precautions she had taken (the use of disposable latex gloves and a ventilated hood) were adequate.  She was incorrect, but would not know it for quite a while.

It took 149 days before Professor Wetterhahn began to exhibit neurological symptoms, 154 days before she sought care, and 168 days before chelation therapy began.  Chelation therapy involves the use of agents that form chemical bonds with metal ions to form a water-soluble complex, allowing the heavy metal to be excreted from the body.  However, according to a report on Professor Wetterhahn’s death in the New England Journal of Medicine (NEJM), chelation treatment delayed after exposure “is of little or no clinical benefit”.

Professor Wetterhahn became unresponsive on February 12, 1997 and died on June 8.  As a result of her poisoning, more research has been done to better determine the causes that led to her death, as well as determining actions that can reduce the risk of more deaths from mercury poisoning.  We can look at these causes in a Cause Map, or visual root cause analysis.

The death of Professor Wetterhahn was due to accidental dimethylmercury poisoning, which is lethal in just a few drops, and ineffective chelation therapy (which may have been able to reduce the impact had it been administered immediately after exposure).  Due to the latency of neurological symptoms and the belief that protections taken while working with dimethylmercury were adequate, this did not occur.

Based on later research and testing, it was determined that Professor Wetterhahn was exposed through her skin when she dropped a few drops of dimethylmercury on her glove.  The disposable latex gloves she was wearing were later found to result in permeation to the skin in a matter of seconds.    The Material Safety Data Sheet (MSDS), which defines necessary personal protection for working with various chemicals, specified only “wear appropriate chemical-resistant gloves”.  The use of a plastic-laminate chemically-resistant glove was found to result in no permeation after four hours and should be used rather than disposable latex while working with this chemical.

It is also possible that mercury exposure occurred via inhalation. Although Professor Wetterhahn was using a ventilated hood, dimethylmercury is extremely volatile and could have created an inhalation hazard when it was spilled.

Many organizations would be tempted to identify the spill of the dimethylmercury as the root cause and end the investigation there.   However, basing personnel safety solely on attempting to prevent spills does not provide adequate protection.  In this case, the risks of using dimethylmercury were found to be so high that an alternative is recommended unless absolutely necessary.  If the use of the supertoxic compound is found to be essential, very specific personal protection equipment is called for as well as seeking treatment immediately after possible exposure.

In the NEJM report, the authors state “Before she lapsed into a vegetative state, the patient requested that her case be presented to the general medical community, to scientists working with mercury, and to toxicologists, in the hope of improving the recognition, treatment, and prevention of future cases of mercury poisoning.”   By examining all the causes and possible solutions, it is hoped that all chemical work can be made safer, in honor of Professor Wetterhahn.

To view the Outline, Cause Map and timeline of this issue, please click on “Download PDF” above.