Monthly Archives: January 2015

Root Cause

The Disneyland Measles Outbreak: What you Need to Know

By ThinkReliability Staff

About 100 people, including 5 Disney theme park employees, have been infected with measles after an outbreak centering around the Disney theme parks in California. According to Disney, those 5 employees have returned to work, along with other exposed employees who have proved immunity against the disease. Because the Disney theme parts are so popular with people all over the world, measles has now been found in at least 10 other counties and 5 other states in the U.S. Says Dr. James Cherry, pediatric infectious diseases expert at UCLA, “Disneyland – this is the ideal scenario. This is sort of the perfect storm. People go to Disneyland, and they went from all different counties and all different states.”

Why measles, and why now?

According to Dr. Anthony Fauci, the Director of the National Institute of Allergy and Infectious Diseases, there were an average of 88 cases a year of measles between 2001 and 2013. (Measles was declared eliminated in the US in 2000.) In 2014, there were 644 cases in 23 separate outbreaks.   Although measles is eliminated in the US, “Travelers to areas where measles is endemic can bring measles back to the US, resulting in limited domestic transmission of measles,” according to a California Department of Public Health statement.

Once measles has entered an area, it can spread quickly. Says Matt Zahn, Orange County Health Care Agency medical director, “Measles spreads very easily by air and by direct contact. Simply being in the same room with someone who has measles is sufficient to become infected.” The Centers for Disease Control and Prevention (CDC) says “Measles is so contagious, that if one person has it, 90% of the people close to that person who are not immune will also become infected.” Additionally, the measles virus can remain “active and contagious on infected surfaces for up to 2 hours,” says the CDC. That 90% makes measles “one of the most infectious or transmissible viruses that we’re aware of,” says a Cody Meissner, a professor of pediatrics at Tufts University School of Medicine.

Decreasing vaccination levels in Orange County, where the outbreak is centered, are fueling the spread of the disease. In 2006, 95% of California kindergartners were fully vaccinated for measles. Now, only 92.6% are. Local officials say the outbreak involves a significant number of people who were not immunized, either by choice or because they are too young (measles vaccines are administered starting at 12 months old) or who have other health issues precluding vaccination.

Vaccination rates of the MMR vaccine (which includes immunization against measles) have been dropping, due to increasing concerns about side effects from vaccines and decreasing concerns about the disease itself. (Click here to read our previous blog about this issue.) Says Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, “The development of the measles vaccination and the elimination of measles from this country several years ago, until it bounced back no with these outbreaks, was really a triumph in medical public health endeavor. Good vaccinations, in some respects paradoxically, are victims of their own success. Now that we don’t see a lot of measles, the scare of the difficulty and the seriousness of it is not on people’s radar screen. It gets back on their radar screen when you see what is going on right now throughout the country, which could be completely avoidable if people had vaccinated their children.”

Who is at risk?

According to Orange County Health Agency Spokesperson Deanne Thompson, “It is at large in the community now, and particularly infants too young to be immunized, people with other health conditions and, of course, people who aren’t immunized need to be very concerned. [They] really should rethink that and consider getting vaccinated.”

Anyone who has not been vaccinated for measles is particularly at risk, and California state officials have warned those who have not been vaccinated or are otherwise immune to measles to stay away from the theme parks. It is possible that those who have received the vaccine can also get the disease, though it is far less likely.

What should you do?

“The best way to prevent measles and its spread is to get vaccinated,” says Dr. Ron Chapman, director of California Department of Public Health. If that isn’t possible, at this point, it is recommended to stay away from the Disney theme parks in California until the outbreak is over. If you are taking your baby out of the country, the CDC recommends vaccination at 6 months for measles. If your child does get the measles, keep in mind that’s it not something that doctors today have seen frequently, or possibly at all. The CDC is making an effort to educate physicians. Says Jane Seward, the deputy director of the Division of Viral Diseases for the CDC, “We’ve really tried to hammer home the message that if you see somebody with a febrile rash illness, ask them if they’ve gone overseas, ask them about measles in their community, and ask them about their vaccination status. Think of measles.”

To view a Cause Map, a visual root cause analysis, of this outbreak, click on “Download PDF” above.  To learn more about this issue, click here.

Root Cause

Non-Sterile Product Administered Intravenously to At Least 40 Patients

By ThinkReliability Staff

A non-sterile product that was meant for clinical simulation (training) only was administered intravenously (via IV) to at least 40 patients, one of whom died and at least 17 of whom became seriously ill. Because the death was in a hospice patient, it was not determined definitively that it was caused by the solution. The Food and Drug Administration (FDA) is taking no chances – after the reports of patient injury, the FDA had released an alert warning medical practitioners not to use the product “for clinical simulation” on patients. The company that manufactured the products later implemented a recall.

Whether or not the patient death can be blamed solely on the IV use of a non-sterile product, administering a non-sterile product to a patient is clearly an impact to the patient safety and patient services goals. At least 17 injuries (which typically were discovered very quickly after use of the non-sterile IV product) have been tied to the error. The recall is a product goal to the manufacturer – which does not produce any sterile products. The investigation by the FDA is an impact to the labor goal. How these goals were impacted and what is being done or recommended to prevent these impacts can be captured in a Cause Map, a visual root cause analysis diagram of cause-and-effect relationships. (To view the Cause Map, please click on the image above.)

Patient safety was impacted because of the administration of a non-sterile IV product to patients. These patients were receiving saline product via IV to treat various medical conditions (dehydration, for example) and the product was not sterile. Because the product was for training purposes only, it was not meant to be sterile. Healthcare facilities that administered the solution said they were unaware that it was a non-sterile product.

The non-sterile product was delivered to the facility, whether by the ordering or delivery of the incorrect product. According to Dr. Alexander J. Kallen, the medical officer at the Centers for Disease Control and Prevention (CDC), “It seems like it’s not just one single mistake. There could have been instances where ordering was done by office staff who didn’t know the difference, as well as instances where the right product was ordered but they received the wrong stuff.” It does appear that the facilities in question (which are located in Florida, Georgia, Idaho, Louisiana, North Carolina, New York, and Colorado) all received the product from the same distributor, indicating a likely issue associated with the distributor’s delivery or ordering process. A nationwide shortage of sterile saline solution may have led to the use of additional suppliers, contributing to the confusion.

Even if the wrong product is delivered to a healthcare facility, there are still multiple opportunities to identify the problem before patient harm results. In this case, had anyone at the healthcare facility looked at the product – which was labeled “For clinical simulation”, the products could have been removed from the facility, as did happen at some facilities, which returned the non-sterile product.

The FDA has requested that all healthcare facilities and product distributors individually inspect saline product to be administered to patients to verify that it is sterile and not intended for training purposes. The manufacturer of the training products has asked its distributors to add language to its advertisements specifying that they are for training, and are not sterile for patient use. In the meantime, the FDA is working with manufacturers of sterile saline to increase the supply, and has provided links to available supply on their website.

What should you do? If you are involved in an IV transfusion, either as a patient or a practitioner, check what’s being delivered and ensure it matches your doctor’s order. Go to the FDA’s site to learn more about the recall, investigation or saline shortage.

 

Root Cause

Infant Death Due to Infection from Water Birth

By ThinkReliability Staff

A recently-released study in the CDC’s Emerging Infectious Diseases Journal discusses causes of the death of an infant from legionellosis (commonly known as Legionnaires’ disease) apparently due to a contaminated tub used for a home water birth. While the tub had been disinfected since the birth (and so did not test positive for legionnella), it is believed that the source of the infection was the tub the baby was born in.

The investigation into the baby’s death discusses various issues with the home water births along with solutions. According to the study, “Findings from this investigation revealed a gap in the standardization and implementation of infection control practices for midwives during home water births. . . recommendations included use of standard written procedures for employees and clients before, during, and after the water birth. These procedural documents were suggested to outline proper timing of tub filling to reduce proliferation of microorganisms, documentation of client awareness of possible risks when deviating from written procedures, and laboratory testing procedures to be followed when birthing tubs are suspected of being contaminated with Legionella or other pathogens.” The specific cause-and-effect relationships that led to the contamination and infant’s death can be viewed in a Cause Map, or visual root cause analysis, by clicking “Download PDF” above.

The birthing tub in this particular case was filled with private well water two days prior to the birth. Upon filling, enzyme-based, non-FDA-approved water purifying drops were added to the water and the water was kept warm and circulated in the tub until the delivery. The tub used was a recreational-grade, jetted tub with internal tubing that is not approved for use as medical equipment and is particularly difficult to disinfect.

There were no procedures provided by the midwifery center that discussed required steps before and during the water birth, though this is not uncommon. The study found that, although most certified nursing midwives supported water birth, only 30% had received training.

Shortly after the infant’s death, the American Academy of Pediatrics and the American College of Obstetricians and Gynecologists issued a joint statement saying that water births should be avoided (see our previous blog on this topic). It’s unclear whether or not information regarding the infant’s death in January 2014 was known prior to the statement released in March, 2014, though one of the concerns with water births (along with drowning) was the possibility that the infant could obtain an infection from a water birth.

Over the summer, another infant developed legionellosis from a birthing pool in England, and the National Health Service banned the use of home birthing pools with built-in heaters and recirculation pumps. Internationally, there were no other cases of infants developing legionellosis from water births since the late 1990s.

Though water births or the use of specific types of birthing equipment have not been banned in the US, birthing in a tub is discouraged. The CDC study recommends that procedures and training about cleaning and the disinfection required before and during water births be developed and disseminated through the midwifery community and potential clients. While legionellosis in infants is rare, it is believed that additional cases may be discovered with better surveillance.

Read more: Fritschel E, Sanyal K, Threadgill H, Cervantes D. Fatal legionellosis after water birth, Texas, USA, 2014. Emerg Infect Dis [Internet]. 2015 Jan 7. http://dx.doi.org/10.3201/eid2101.140846 DOI: 10.3201/eid2101.140846

 

 

Root Cause

Patient zero believed to have gotten Ebola from bats

By Kim Smiley

Scientists believe they have identified the origin of the ongoing Ebola outbreak.  The first person believed to have contracted Ebola was a two-year-old boy named Emile Ouamouno from a village called Meliandou in Guinea.  The fact that patient zero was a small child is unusual since he is too young to have been a hunter or travel far from the village alone.  His exposure to bushmeat, which has been identified as a likely culprit for transmission to humans in previous Ebola outbreaks, was also limited.

So how did a young boy contract Ebola?  A Cause Map, a form of visual root cause analysis, can be built to help analyze this issue.  A Cause Map intuitively lays out the causes that contributed to a problem to show the cause-and-effect relationships.  (Click on “Download PDF” above to view a high level Cause Map.)  As the Cause Map shows, researchers believe the boy was exposed to bats that carried Ebola.

Children from the village liked to play in a nearby hollow tree filled with Angolan free-tailed bats. Researchers believe that the boy may have come into contact with either bats infected with Ebola or their feces.   Unfortunately, the tree burned in the time since the Ebola epidemic started and researchers were unable to take samples from it, so it cannot be confirmed conclusively that the bats in the tree spread Ebola.  This information would have been particularly useful because this species of bats has not been previously linked to Ebola and Angolan free-tailed bats commonly live near people.  The scientists were able to rule out larger mammals such as chimpanzees and antelopes as the source of the current outbreak.

Tracking the origins of Ebola has proved difficult, in part because Ebola is a zoonotic disease, meaning that it can be transmitted between species.  Bats have long been suspected of being carriers of Ebola, but scientists have never been able to conclusively prove which animals are responsible for human Ebola outbreaks.  Ebola outbreaks tend to occur in remote areas where it’s difficult to gather data in a timely manner, especially in the midst of an Ebola outbreak.  Cultural differences can also make research difficult because local populations are often suspicious of the researchers, many of who are foreigners.

The current Ebola outbreak has killed nearly 8,000 people and is still spreading.  As populations grow and people are exposed to more animals, outbreaks like this may become more common.  If the species responsible for spreading Ebola could be identified, researchers would be better able to prevent future Ebola cases and possibly prevent outbreaks from occurring.

If you are curious, here are some interesting articles on lessons learned during the Ebola Outbreak –

Malaria killing thousands more than Ebola in West Africa

Ebola’s lessons, painfully learned at great cost in dollars and human lives