Monthly Archives: May 2011

Root Cause Analysis

Protein in Donated Blood Causes Life-Threatening Allergy

By ThinkReliability Staff

Blood transfusions are fairly common, with 25 million blood component transfusions occurring per year.  Blood transfusions are also very safe. The risk of health concerns from blood component transfusions is extremely low.  Until recently, it was believed that all the concerns from transfused blood were being tested for and rooted out.  However, a new case presented in the New England Journal of Medicine has presented a new concern.

A six-year-old boy in the Netherlands was receiving pooled platelets when he suffered from an allergic reaction.  The staff was able to prevent potential death or serious injury with an immediate injection of adrenaline.  As a follow-up, the staff tested the boy and ruled out many other potential causes.  The lab tests and testimony from the boy’s mother confirmed an allergy to a peptide, which is a protein that is left in the blood after ingesting peanuts. The peptide, known as Ara h2, is resistant to digestion, as evidenced by studies that have found levels in the blood 24 hours after ingestion.

Because this case demonstrates a newly discovered phenomenon, evidence to support the causes is particularly important.  Evidence supporting the placement of a cause related to a root cause analysis can be placed in a box directly below the cause box on a Cause Map.  (To see the Cause Map, click on “Download PDF” above.)  The allergy to the peanut peptide causing the allergic reaction and the peptides being present were verified by testing and interviews with the donors and the patient’s family.

The immediate solution, to inject adrenaline to prevent the patient’s death from the allergic reaction, was taken immediately but does not do anything to solve the broader problem of potential allergens in the blood supply.  One of the potential solutions is to screen the blood supply for dietary contributions, but considering the large amount of donors and recipients, this is considered to be prohibitively expensive and difficult.  Because there is not a viable alternative blood transplant source, and blood transfusions are still needed by patients with allergies, it seems that the solution must be to figure out a way to remove the proteins, at least from blood transfusions going to people with allergies.  However, another case, from 2003 resulted in a blood product recipient developing allergies when receiving a blood transfusion from a donor who had peanut allergies, so screening the blood supply prior to transfusing people with allergies may not be sufficient.

Hospital Acquired Condition, Never Event

Preventing Central Line Infections

By ThinkReliability Staff

Central line infections, also called central line-associated bloodstream infections (CLASBI), can occur when a large tube is placed in a large vein in the neck, chest, groin or arms to give fluids, blood, or medications or to do certain medical tests quickly.  While they allow exceptional access to internal systems, Central Venous Catheters (CVC) also can cause thousands of patient deaths a year and add billions of dollars in healthcare costs.  However, these infections are entirely preventable.

In this health care scenario, patient safety is the foremost concern.  So the most basic Cause Map would show that the Patient Safety Goal is impacted by preventable bloodstream infections, and that those infections come from pathogens introduced by a central line.  The next step is to elaborate on how pathogens enter the bloodstream, and then determine what appropriate solutions might be.

Preventable bloodstream infections happen because pathogens access the bloodstream and also because the infections aren’t treated early on.  This suggests that by treating infections early on, and vigilantly watching for signs of infection, more serious infections can be prevented.

Pathogens can access the bloodstream because a central line provides a direct conduit to the bloodstream and because pathogens are present.  Again, while these are obvious statements, they allow the opportunity to develop potential solutions.  First, the CDC recommends not using a CVC unless absolutely necessary.  Additionally, CVCs shouldn’t be placed in the femoral artery in adults because it is associated with greater infection rates and secondary problems such as deep venous thrombosis.

Assuming a central line is necessary; more analysis leads to further solutions that might reduce the presence of pathogens.  Pathogens generally come from two sources – the line was improperly put in or somehow the line became contaminated during use.  Using antimicrobial materials is one potential way of minimizing contamination.

Looking closer at the uppermost branch , how the line was put in, leads to some insightful solutions.  One simple solution recommended by the CDC is to use a checklist and follow their guidance.  Checklists are a simple but highly effective way of reducing errors in repetitive processes.  There are two major causes in this branch, dirty hands/gloves from the nurse or doctor putting the CVC in the patient and the patient having dirty skin at the site of the CVC.  CDC guidance also recommends using maximal barriers such as masks and gloves and washing your hands.  Cleaning the patient’s skin with a chlorhexidine-based solution is another important step that can reduce these infections.

With so many possible solutions, it is important to identify where changes need to occur in your own processes.  This is fairly simplistic Cause Map and there are many other solutions suggested by the CDC and other government health agencies.  For more information on steps to reduce CLASBIs, see the U.S. Department of Health and Human Services Guideline.

Root Cause Analysis

Number of Gout Cases Continues to Increase

By Kim Smiley

Gout was historically known as “the disease of kings” or “rich man’s disease” and has long been associated with rich food and excessive alcohol, but recently gout has become a common problem across all socio-economic classes.  More than six million adults in the US have gout and the number will likely keep rising in the future.

Gout occurs when there are high levels of uric acid in the blood stream.  Excessive uric acid forms crystals that collect in joints and soft tissues, causing acute pain and inflammation.  Uric acid is produced when the body processes purines.  Purines are found naturally within the body and are also found in many types of food, including meat (especially organ meat), anchovies, herring, asparagus and mushrooms.

Why are more people suffering from gout? This issue can be investigated by creating a Cause Map and performing a root cause analysis to determine what causes contribute to the problem. (Click on the “Download PDF” button above to view a high level Cause Map of this issue.)

Digging through some of the data available, it becomes clear that the modern diet is one cause, but there are a number of other causes that contribute to gout including higher life expectancy, higher weights, and modern medications.  Risk of gout is also higher for people who suffer from a number of illnesses, including hypertension, diabetes, high cholesterol and congestive heart failure; all diseases which are more common now than they were in the past thanks to advances in modern medicine and increased life expectancy.  Obesity also makes gout more likely and today’s population is heavier on average.  There are also several medications that have been shown to increase the risk of gout, including medicines commonly used to treat high blood pressure and low-dose aspirin.

Gout has typically been considered a man’s disease, but now more women are suffering from it. Prior to menopause, woman naturally have lower levels of uric acid in their blood, but as women live longer more cases of gout are developing in women.

Looking at the risk factors associated with gout, it’s clear why more and more people are suffering from it.  Some risk factors can’t be changed, such as gender or age, but staying healthy overall can reduce the likelihood of suffering from gout.

Never Event

Surgery Performed on Wrong Eye

By Kim Smiley

There are few medical errors scarier than a wrong site surgery.  The idea that you could go to sleep and wake up having had a procedure performed on the wrong body part is terrifying.  Unfortunately, this is exactly what happened to a family in Washington recently.

On April 13, 2011, a surgeon performing a routine procedure to correct a wandering eye mistakenly operated on the wrong eye of a four year old boy.  In this case, the wandering eye was caused by a muscle that was too strong so the surgery was performed to weaken the muscle.  It’s unclear at this point whether the wrong site surgery will have any lasting impact on the patient’s vision, but the patient’s mother has stated that the previously healthy eye is now wandering.  A specialist who examined the boy post-surgery stated that the eye needs to completely heal (about 5 weeks) until any determination can be made about long term consequences.

How did this happen?  How does a surgeon perform a procedure on the wrong part of the body? And most importantly, how do we prevent these types of errors in the future?

The investigation of this incident is still ongoing, but a Cause Map of the incident can be started and then expanded as more information becomes available.  A Cause Map is a visual root cause analysis that lays out the causes of an incident in an intuitive format.  Once the Cause Map is complete, it can be used to develop solutions to help prevent future problems. Click on “Download PDF” above to see an Outline of this incident and the initial Cause Map.

In this example, it isn’t clear yet how the mistake was made.  Findings from the investigation so far have determined that the correct eye was marked before surgery, but statements by the surgeon indicate that the mark may have been accidentally covered by a nurse. The hospital has protocols in place that require checking and double checking the surgery site, but it’s not clear why they weren’t followed.  Once the investigation is complete, the hospital will determine what solutions need to be implemented to ensure that this doesn’t happen again.