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.

Drug Shortages in the US

By Kim Smiley

The FDA has reported a record number of drug shortages in 2010 that is continuing to increase into 2011.  Some of the drugs included in this shortage are chemotherapy drugs.  Providers across the U.S. are reporting that the shortages may endanger patients if they are unable to receive the necessary drugs.  In some cases, drugs that are more expensive, less effective, or both are being used.  Or, patients are turning to the “grey market”, buying drugs of questionable safety that have, in most cases, been significantly marked up.  Additionally, because already approved drugs are needed for clinical trials, some clinical trials have been delayed, limiting the addition of new medications.

We can look at this issue in a Cause Map, a visual root cause analysis.  A Cause Map connects the impacts to the goals of an organization, or in this case, the U.S. healthcare system.  The patient safety goal is impacted because of the risk to patient health.  The organization goal is impacted because of delayed clinical trials.  The patient services goal is impacted because of the lack of needed medication.  Also, the property goal is impacted because of the replacement with more expensive medications.  We use these goals as the basis for our Cause Map, then ask “Why” questions to complete the analysis.

Insufficient supply is caused by demand greater than supply.  Both of these factors can contribute to the overall effect.  Although there are several reasons for increased demand, the most pertinent to this issue appears to be hoarding – where physicians hear of shortages and are attempting to create a stockpile for their patients.   However, increased insurance coverage and general increased need for medication for diseases such as cancer are also likely contributing.

Reduced supply is also contributing to the shortage.  Shortage of raw ingredients is considered to account for about 10% of the issue, with quality issues and insufficient production accounting for the rest.  In some cases, manufacturers are believed to be limiting their production – or ending it all together – because the drugs do not provide much profit.  Many of the limited drugs are generics, which do not provide as much profit as name brand drugs, especially as drug profits were limited by the Medicare Prescription Drug, Improvement and Modernization Act of 2003, which limited price increases in an attempt to limit Medicare spending.  The resulting drug shortage – which is sometimes resulting in paying for much more expensive drugs – is certainly an unintended consequence of this act.

Despite best intentions, changes made to fix an identified problem may in fact cause another one – sometimes one that is far greater.  This is why follow-up to implemented solutions must occur at regular intervals, and must include a comprehensive assessment of whether the solutions are effective.

Some of the solutions recommended to prevent the issues caused by these drug shortages are to create a national stockpile of certain kinds of drugs and requiring notification to the FDA of  supply shortages.  In the meantime, the FDA is providing guidance to patients and providers to attempt to ease the ongoing issues.

Promising New Leukemia Treatment

By Kim Smiley

One of the best things about the Cause Mapping method of root cause analysis is its flexibility.  For instance, root cause analysis is often associated with fixing problems, but Cause Mapping is also well suited for use when something positive happens.  Why would you bother to analyze something that isn’t a “problem”? Understanding why positive outcomes occurred might help you reproduce the success in other situations.

To better understand how this might work, check out this example that analyses a new treatment for leukemia that is showing excellent promise after the initial trials.  Researchers at the University of Pennsylvania recently published a study  outlining their success treating three leukemia patients with a novel treatment.  A year after treatment, two of the patients appear cancer free and the third patient’s cancer was reduced by 70%.  How did they accomplish this feat?

They drew blood from the patients and genetically modified their T cells (cells that normally serve as part of the immune system) to seek and destroy cancer cells.  Similar concepts have been tried in the past, but the previously modified T cells died out before they were able to destroy the cancer.  A different carrier, a harmless version of the HIV virus, was used to insert genes that told the T cells to multiple rapidly and target cancer cells.  A large batch of the modified T cells were grown and then injected back into the patients.  The patients endured intense flu-like symptoms while the cancers cells died out, but the other side effects have been minimal so far.

So how could a Cause Map help in this example?  It could be used in a number of ways to help others learn and apply lessons.  For somebody interested in the details of the specific cancer research performed, a detailed Cause Map could be created to better understand the intricate details of the technique so that it could be applied more efficiently to treatment for other cancers.  A person interested in how medical research is funded could create a Cause Map that details how this project was funded to learn how to fund their own work. On a larger scale, a Cause Map could be created to understand why certain areas of medical research are better funded than others and to ensure that we’re getting the biggest bang for our research bucks.

For this specific case, a Cause Map could be used to track information and record all relevant details in a simple, intuitive format.  This treatment method will require more intensive testing before it could hope to become standard treatment and having an easily understand method to record and organize all relevant data would be very useful.  Cause Maps can be created in as much detail as needed and they can be built to focus on whatever aspect of the problem is of interest.

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

Heatstroke Deaths of Football Players

By Kim Smiley

A study released in 2010 shed some light on what seems like a high number of football players dying of heat-related deaths.  The study determined that the number of heat-related deaths have actually increased in recent years from less than two per year in the early 90s to nearly 3 currently.  The study outlined some of the causes for the increase.  We can look at these causes in a thorough root cause analysis built as a Cause Map.

We begin with the outline, which captures the impact to the goals as well as the general information about the issue we are investigating.  In this case, we are looking at deaths of football players in the U.S.  The study determined that most deaths occur during football practice in August, in the morning, to linemen.  The impact to the goal of concern is risk of player death.

Beginning with the impacted goal, we can ask why questions to analyze the issue.  The player deaths occur from heatstroke that is not treated immediately, whether from players and/or coaches not recognizing the signs of heatstroke, or treatment being delayed while waiting for an ambulance or other medical professional.  Heatstroke occurs when a person’s heat generation is greater than their cooling ability.  This means there are two parts to the analysis: the heat generation, and the cooling ability.  In this case, increased heat generation occurs from high ambient heat and high levels of body heat being produced, caused by practicing outside in hot weather.

Insufficient cooling ability can occur when a player’s sweating isn’t doing enough to cool him – such as when a player isn’t producing sweat due to dehydration or when the sweat isn’t evaporating, such as in high humidity.  Additionally, players who are large (have a high BMI) tend to be more susceptible to heatstroke as their bodies tend to store more heat.  This is presumably why most deaths occur in linemen, who tend to be larger (79% of the players who died had a BMI above 30.)  Most deaths occur in August, which, in addition to being hot, tends to be the start of the season, meaning players are not accustomed to practicing in the heat.

What can players, coaches, school districts, and parents do to limit the risk of death from heatstroke?  First, ensure that everyone involved in a sporting program recognizes the signs of heat-related illness.  There is a CDC toolkit that provides important information.  Next, make sure that a player who has signs of heat-related illness is treated immediately – while waiting for the ambulance to arrive, take the player out of the sun and spray him with water.  To try and avoid heat-related illnesses, ease into practices at the beginning of the season, limit practice time in extremely high heat and/or humidity, and provide plenty of hydration.

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

Working to Ensure Safe Assembly of Surgical Tools

By ThinkReliability Staff

A 2-month old was undergoing a cystoscopy to incise a ureterocele in the bladder.  During the endoscopic procedure, a resectoscope was used to remove the unwanted tissue.  However, during the operation part of the resectoscope slipped off, exposing a hook-shaped internal piece of the instrument.  Fortunately the patient was not injured; however the potential for injury was very real.  How did the medical instrument come apart?

The first step in an incident investigation is to determine what the problem is and what the impacts to the organization’s goals are.  In this case, the problem is fairly straightforward – the resectoscope fell apart while inserted into a patient.  Although details are scant in this case, the problem statement is filled out as completely as possible to document what occurred.  The second part is to determine the impact to the organization’s goals.  An obvious impact is the potential harm to the patient, related to the hospital’s patient safety goal.  There was also the possibility of legal action, which would impact property goals.  Finally, there likely was the need to redo the procedure, taking additional time, thus impacting the organization’s labor goal.

The second step is to build a Cause Map by asking why an event occurred.   The Cause Map visually depicts what led to the young patient being exposed to harm.  In this case, the three goal impacts converge on the event where the hook electrode became uncovered.  It should be noted that multiple causes led to the patient being exposed to harm; if the resectoscope had been broken but had not been in use, then it would not have mattered.  It is crucial to include all reasons on the Cause Map because those reasons may be key to developing the optimal solution.

Facts that need to be captured about an investigation can be included in evidence boxes on the Cause Map.  They can provide the reader with important background information.  In this example, information about the hook electrode is included so that the reader knows what it is.

Reviewing the complete Cause Map, it turns out that the resectoscope was incorrectly assembled.  The third step in an incident investigation is to develop a set of solutions.  Remembering that all causes are necessary to produce an effect, the investigation team can brainstorm solutions to eliminate or counteract contributing causes.  In this case, three possible solutions were developed.  It is possible that the resectoscope could be designed differently so that the insulation would not be able to slip.  While this is a reasonable long term solution, it would not immediately remedy the problem.  Another solution would be to verify that the instrument is in working order before using on a patient.  This may have occurred, but it should be included until ruled out as a potential solution.  A final idea is to revise the assembly procedures for the resectoscope.  This is in fact what the FDA recommended.

The FDA recommends that the manufacturer’s assembly procedures always be carefully followed.  A process map is another helpful tool to determine where something went wrong.  The organization can build a process map depicting the ideal sequence of events, then compare that with what actually occurred.  The problem may not be in the instructions; the instructions might be perfect!  However, if someone doesn’t follow those instructions correctly, the process isn’t going to reach the desired outcome.

At this point, the investigation team might go back to the Cause Map to elaborate on the why the resectoscope was incorrectly assembled.  This might generate new solutions and changes to the ideal process map.  Through this iterative process, an optimum solution can be found.

This event was reported as part of the FDA’s MedWatch program.  The FDA encourages health professionals to voluntarily report problems on medical devices.  For more information on the MedWatch program, please visit their website.