Category Archives: Root Cause

Root Cause

Duodenoscope Superbug Outbreak: What You Need to Know

By ThinkReliability Staff

The bacteria involved in the outbreak are deadly: The recent outbreak in California involves Carbapenem-resistant Enterobacteriaceae (CRE). According to Centers for Disease Control and Prevention (CDC) Director Tom Frieden, “CRE are nightmare bacteria. Our strongest antibiotics don’t work and patients are left with potentially untreatable infections.” About 50% of patients with a CRE bloodstream infection will die. At least 7 people were infected at the UCLA Medical Center from October 2014 to January 2015, two of whom died.

Duodenoscopes are frequently used: Duodenoscopes are thin flexible scopes with a light and miniature camera attached, used in endoscopic retrograde cholangiopancreatography (ERCP) procedures to diagnose and treat liver, pancreas and bile-duct problems. The FDA hasn’t recalled the scopes because, according to US Food and Drug Administration (FDA) spokeswoman Leslie Wooldridge, “The FDA feels that the lifesaving nature of ERCP, performed on more than 500,000 patients annually in the U.S., makes it important for these devices to remain available.”

Duodenoscopes have been causing problems with infection for a long time: The President of the American Gastroenterological Association, John Allen, M.D. says that duodenoscopes have been causing superbug infections since 1987. He says, “It certainly is disturbing that a fundamental design issue with these scopes would cause problems for this long.” 16 patients developed serious infections after the use of a duodenoscope in France in 2008-2009, as reported in the journal Endoscopy. A 2013 outbreak infected 39 patients in Chicago (after which a duodenscope was destroyed because decontamination efforts were unsuccessful). The FDA received 75 reports involving 135 patients related to duodenoscope contamination from 2013 to 2014. 18 patients in North Carolina have been infected by CRE from duodenoscopes so far this year (2 of those patients have died).

Cleaning duodenoscopes is really difficult: The two duodenoscopes found to have been infected in the California outbreak were “sterilized according to the manufacturer’s specifications”, says the medical center. The FDA issued a warning February 19, 2015, noting that “Recent medical publications and adverse event reports associate multidrug-resistant bacterial infections in patients who have undergone ERCP with reprocessed duodenoscopes, even when manufacturer reprocessing instructions are followed correctly. Meticulously cleaning duodenoscopes prior to high-level disinfection should reduce the risk of transmitting infection, but may not entirely eliminate it.” Effectively, even following the instructions may not fully sterilize the duodenoscope.

The FDA is working on label changes for duodenoscopes: According to Dr. William Maisel, chief scientist for the FDA’s Center for Devices and Radiological Health, “We are working to expedite modifications to the label. We are also talking about updating the risk information.” The FDA recommends that hospitals “consider taking a duodenoscope out of service until it has been verified to be free of pathogens if a patient develops an infection with a multidrug-resistant organism following ERCP, and you suspect that there may be a link between the duodenoscope and the infection.” The FDA has also asked duodenoscope manufacturers to prove that their recommended methods provide adequate disinfection.

Some worry that may not be enough: Says Mary Logan, chief executive of the Association for the Advancement of Medical Instrumentation, “the devices need to be designed better, the instructions need to be more clear, the hospitals need better training, and adequate time needs to be given in hospitals to ensure sterility is top notch.” The CDC is working with duodenoscope manufacturers on a reprocessing (cleaning and sterilizing for reuse) protocol for the instruments. In the meantime, the UCLA Medical Center has turned to gas sterilization and has reported no new infections since the switch. However, the procedure is highly toxic and poses a risk to staff and patients. The FDA says it is “not something that we routinely recommend”.   Hospitals in North Carolina are screening patients for CRE and isolating infected patients, as well as decontaminating their rooms after they’re released. They’ve also enhanced the cleaning and sterilization processes for duodenoscopes.   At least one hospital is quarantining each device for 48 hours to verify by culture that it’s free of CRE and other infections.

It’s all part of a much bigger problem: Some worry that the time and money being spent dealing with the real, though comparatively small, risk of infection from contaminated duodenoscopes takes away from the broader effort of preventing all hospital infections, especially those that are resistant to antibiotics. The CDC has determined that about 1 in 25 patients acquire a hospital-acquired infection during a hospital stay (see our previous blog on this issue). Says David Ropeik, a consultant in risk perception and communication, the concern over this issue is “going to flare up and then it’s going to go away” but “the world will still be at serious peril from a risk we don’t take seriously, which is antibiotic resistance. Germs are figuring out how to resist our antibiotics faster than we can make new ones.”

If you would like to learn more, attend our FREE webinar “Healthcare Case Study – Hospital-Acquired Infections” on Thursday, March 5, 2015 at 11 am EST.  Register here.

Root Cause

65 surgeries required for boy who swallowed button battery

By ThinkReliability Staff

As you can imagine, as someone who regularly analyzes and reports on disasters of every kind, my mind is never far from things that could harm my children. Though the types of events I typically include are well-publicized, the real dangers for children tend to be things closer to home, that one might reasonably consider harmless.

Even after our blog about the dangers of children swallowing batteries (regarding a study that said a child in the US visits an emergency room every 3 hours for issues involving a battery and that 84% of these are button batteries), I didn’t really get it. Sure, swallowing anything is bad, and batteries have nasty chemicals in them. But it wasn’t until I read the story of Emmett Rauch that I really got how bad these issues could be.

When Emmett was one, he swallowed a button battery. His parents could tell that something wasn’t right, and Emmett was diagnosed with a cold, then croup. Luckily at a pediatrician visit 3 days after he swallowed the battery, the pediatrician had second thoughts and sent Emmett to the ER for an x-ray. Once the button battery was discovered lodged in his esophagus, the rush to treat him began. Emmett would receive 65 surgeries over the next four-and-a-half years to rebuild his esophagus and vocal chords.

Amazingly, Emmett is a survivor. He’s one of the lucky ones. There have been 15 deaths associated with small batteries over the last 6 years. Emmett’s mother, Karla Rauch, is now an activist for button battery ingestion awareness. The issues resulting in deaths and injuries to children (primarily under the age of 5) regarding button batteries are as follows:

Chemical reaction caused by batteries in the esophagus: Batteries (even “dead” ones) contain chemicals that create current. The moistness of the esophagus can cause a chemical reaction that can burn holes in the tissue.

Accessibility of button batteries: Kids like shiny things and they like to put things in their mouth. The first line of defense is preventing access to small batteries. Here’s how:

– Keep loose batteries out of reach of children

– Ensure battery compartments on products are secured

– Buy products with battery compartments that require a tool to open if possible

– Use duct tape to secure products with batteries that don’t require a tool

Difficulty of diagnosis – at home: Because the batteries are so small, kids will likely still be able to breathe after swallowing them, limiting parent’s ability to figure out that they’ve swallowed something they shouldn’t. Because of the ubiquity of small batteries, parents may not realize they’re missing.

Difficulty of diagnosis – at the hospital: An x-ray is required to determine that a child has swallowed a battery. An x-ray may not be called for if a doctor thinks (as is common) that the coughing or apparent throat damage is due to another sickness. Even though button batteries have been around for a while, they’re still not a risk that is very apparent to most people. So, if you think there is a possibility your child may have swallowed a battery, act quickly:

– Seek immediate medical attention if you believe a battery has been swallowed

– Do not let the child eat or drink

– Do not induce vomiting

– Tell the medical staff it may be a small battery

– If possible, provide information on the battery

To view an overview of this issue and solutions, please click on “Download PDF” above. Thanks to Karla Rauch for sharing her story. To learn more, see www.emmettsfight.com.

Root Cause

Explosion, Deaths at Maternity Hospital Follow Gas Leak

By ThinkReliability Staff

A gas tanker was providing fuel to a maternity hospital in Mexico City when the gas workers discovered a leak. They contacted the fire department, had the hospital evacuated, and attempted to put out the leak. Unfortunately, the leaked gas exploded, killing at least 2 nurses and 2 babies, and leveling most of the hospital.

Dozens more infants, patients and nursing staff were injured, along with the three gas workers present at the scene. The gas workers have all been arrested, though the charges against them have not been released. While it appears that the workers are being held responsible for the tragedy, providing an objective, factual analysis as to what happened can provide useful information to reduce the risk of the issue happening again.

When performing a root cause analysis of an issue (as we will do here in a Cause Map), it’s important to first capture the impacts to the organizational goals as a result of the incident being investigated. In this case, the patient safety goal is impacted because of the deaths of two infants and the injuries to dozens of patients. The safety of hospital employees was impacted due to the deaths of two nurses and injuries to many more. Additionally, the safety of the gas company employees was impacted because all three of the gas workers were injured.

The environment was impacted due to the gas leak. The compliance goal was impacted because the three workers were arrested. The patient services and operations goals were impacted by the evacuation from the hospital (which is very difficult on patients and staff, although it likely saved many lives in this case). The property goal is impacted because of the severe damage to the hospital and the labor goal is impacted by the rescue efforts. (Hospital neighbors are reported to have provided considerable assistance to the rescue efforts at no small risk to themselves.)

Any time deaths or injuries result from an explosion, it is important not only to determine what caused the explosion, but whether the response could have been improved. In this case, the explosion occurred while the hospital was being evacuated, though a specific timeline of the leak, evacuation and explosion has not been released. Further analysis into the evacuation will help determine whether improvements could have saved lives.

In the case of the explosion, the fuel was provided by the leaked gas. Adequate oxygen was present in the air, and the ignition source (heat) could have been provided by hospital operations (the gas was being delivered near the hospital kitchen) or potentially by work being done to repair the leak (such as static or a spark). The gas leaked due to a faulty gas delivery hose. When a faulty part contributes to a tragedy such as this one, it’s important to determine not only how the damage occurred (if possible), but whether inspections or maintenance could have reduced the risk of an incident. Clearly if the hose had been discovered to be faulty and replaced before the delivery took place, the risk of an explosion would have been greatly decreased.

A broader issue for the entire country is the question of why gas leaks and explosions are fairly common. Part of this is because there is no infrastructure to pipe gas underground and it instead has to be delivered by truck. A similar incident involving a hose issue on a gas truck killed three in Queretaro in July last year. The company that provided the gas to the hospital in this case says that it has 1,000 trucks that deliver gas to over 80% of the country. With such a large distribution network, accidents are bound to happen. However, clearly more effort needs to go into making sure that the impact on human lives is reduced.

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

Root Cause

Program Reduces Use of Antipsychotics & Improves Resident’s Quality of Life

By ThinkReliability Staff

Although the use of antipsychotic drugs for nursing home residents suffering from dementia can increase their risk of death and falls, they are still prescribed for nearly 300,000 nursing home residents across the U.S. The “Nursing Home Patients Bill of Rights” allows their use only under specific conditions: “psychoactive drugs (including antipsychotics as well as drugs for depression and anxiety) may be administered only on the orders of a physician and only as part of a written plan designed to eliminate or modify the symptoms for which the drugs are prescribed. Such drugs may be given only if, at least annually, an independent, external consultant reviews the appropriateness of the drug plan of each resident receiving such drugs.”

Despite the risk of these drugs, and the requirement that their use be continually reviewed, some nursing home residents are given antipsychotic prescriptions and are never taken off them. In 2009, the staff of a small nursing home decided to embark on a program to reduce the use of antipsychotics. It was so successful that they extended the program to all the nursing homes owned by the nonprofit Ecumen. After the first year, antipsychotic use was reduced 97%. At the original facility, 5-7% of residents receive antipsychotics, compared to the national average of 19%.

The change in the residents’ quality of life was dramatic after the program was instituted. Because the residents “came alive and awakened”, they called the program Awakenings. To understand how the program works, it’s helpful to imagine the program being the solution to the problem of overuse of antipsychotics in nursing homes.

First, viewing the problem with respect to the organization’s goals can help determine what the real issue to be addressed is. In this case, resident safety and resident quality of life are two important goals of a nursing home. Resident safety is impacted by the use of antipsychotics because it increases the risk of death and the risk of falls. Resident quality of life is impacted because the use of antipsychotics was not being effectively re-evaluated as required.

The risk of increased death and falls are both related to the use of antipsychotics, which have been found to increase death in those with dementia and also increase the risk of falls. Generally the residents at the nursing home were found to have been prescribed antipsychotics as an intervention to some type of behavior resulting from the dementia (wandering, aggression, resisting care) and the resident’s need for antipsychotics was not effectively re-evaluated, so residents remained on the drugs.

A program to reduce their use had to address both of these causes. The nursing home team consulted with experts to begin weaning patients off the antipsychotics. The Awakenings process then addressed the behaviors being treated with the medication. For each resident, both the medical and personal history is taken into account while developing a care strategy. The care strategy is distributed to the entire care team, including housekeepers and cooks. The care strategy uses as many non-medication-based interventions as possible – and addresses all of the resident’s five senses. Some of the strategies include balloon volleyball, massage, aromatherapy and white noise. For those familiar with the Plan-Do-Check(Study)-Act, this is the “Plan” step.

The care plan is implemented by all staff (Do) and all staff participate in observation and assessment to monitor problem behaviors or other issues (Check/ Study). When issues do arise, the care plan is adjusted – whenever possible, without use of additional medication (Act). The process is described by the Awakenings program like this: “Long-term antipsychotic use masks behavioral symptoms rather than addressing them.   Awakenings discovers unmet needs that often trigger behavioral symptoms and addresses the triggers with non-pharmacological care techniques.  This is done in collaboration with a physician to reach the optimum balance and benefit of non-pharmacological and biomedical approaches.” Although the initial setup is expensive; as Dr. Mark Lachs, chief of geriatrics at Weill Cornell Medical College says, “Behavioral interventions are far more time-consuming than giving a pill”, the staff is pleased with the results and optimistic for the future. Laurel Baxter, the Awakenings project manager says, “I believe we may learn that spending a little time now with a resident, preventing the use of psychiatric medications and their side effects, you’ll save time and money in the long run. I’m optimistic.”

To see the root cause analysis of antipsychotic overuse in a Cause Map (or visual diagram of cause-and-effect relationships) and the Awakenings process, please click on “Download PDF”.

Root Cause

Hospital Admits Fault, Implements Improvements after Death due to Medication Error

By ThinkReliability Staff

A hospital in Oregon administered the wrong medication to a patient who stopped breathing. Because of a fire alarm that happened shortly afterwards, the patient was not monitored for about twenty minutes. After that time the patient had experienced irreversible brain damage and was taken off life support on December 3, 2014.

In a surprising move, the hospital has taken responsibility for the error. Dr. Michel Boileau, the chief clinical officer, has stated, “We do know there was a medication error. We acknowledge that. It’s our mistake.” While an Oregon law, which took place in July, encourages transparency with patients and loved ones and reporting in the case of medical errors, the hospital says communication in the case of errors has been its practice for years and that it’s the right thing to do.

Supporting the transparency, the victim’s son says, “We want the community to know what happened. Precautions need to be taken. The only message we really have is that life is short and you never know when something like this could happen.”

Detailed information regarding the case has been released in the media. Using that information, it is possible to put together a Cause Map showing the cause-and-effect relationships that led to the death, and show how the hospital’s planned improvements address the causes.

In this case, administration of the paralyzing agent Rocuronium instead of the prescribed anti-seizure medication fosphenytoin caused the patient to stop breathing, leading to cardiac arrest and irreversible brain damage. Monitoring of the patient may have caught the lack of oxygen prior to irreversible damage, but in this case the patient was not monitored. Shortly after the administration of the IV, the hospital experienced a fire alarm (“code red”), at which point staff left the patient’s room and closed her door. Staff estimates she was unmonitored for about twenty minutes.

Medication errors that happen within hospital facilities almost always involve an error in the medication process. As part of the investigation, Dr. Boileau states, “We’re looking for any gaps or weaknesses in the process, or to see if there has been any human error involved.” So far the hospital has determined that the IV bag given to the patient was filled with the wrong medication at the in-patient pharmacy but then coded for the correct drug. It’s unclear exactly what happened at the pharmacy, but there was either no check of the medication filling or the check was ineffective, as it allowed the wrong drug to be delivered to the patient for administration.

According to the hospital’s chief nursing officer, Karen Reed, “We are all committed to honoring Ms. Macpherson’s name by learning everything there is to learn here and making sure no other patient has to go through this again.” While the investigation into the details continues, the hospital has already planned some improvements to work towards that goal.

To reduce the risk of medication errors, the hospital is designating a safe zone to be used for medication verification. (Distraction has been shown to be a primary driver of medication mix-ups.) They’re also reviewing and updating their medication protocols and ensuring that a detailed checking process is implemented. Because of the particular danger associated with mistakes involving paralyzing agents (like Rocuronium), alert stickers have been added to these types of drugs. Because of the issues with patient monitoring, procedures that ensure patient monitoring after IV administration (presumably even in the case of an unusual event or emergency) will be implemented.

What does this mean for you? Medication errors are considered rare, but even one is one too many. Medication administration processes at healthcare facilities must be designed to minimize the risk of error by reducing interruptions and ensure double checks. Other guides, such as alert stickers, can be used to emphasize particular risks (not limited to medication errors). In healthcare facilities (or any other facilities where operations can’t safely be put “on hold”), there needs to be a plan for ensuring that necessary tasks are performed, even with emergency or unusual situations.

Read more about this incident.

Learn more about medication errors.

Root Cause

Causes for Medication Errors Identified in Cumulative Cause Map

By ThinkReliability Staff

Despite continuing efforts to reduce patient safety impacts from medical errors, more work is needed to make patients safer. One of the areas which has been identified as a key safety issue is that of medication errors within healthcare facilities. A Cumulative Cause Map is a tool that can identify causes proactively (before incidents occur) based on industry experience, including past errors. As a Cause Map is a visual form of root cause analysis, a Cumulative Cause Map can be considered a visual form of Failure Modes and Effects Analysis (FMEA). It captures potential causes (causes that COULD result in an impact to patient safety) in order to develop and implement solutions that will reduce the risk of the impacts.

In this case, the term “medication error” is used to refer collectively to errors that result in patients receiving the wrong medication, patients receiving medication prescribed for another patient, patients receiving the wrong dose of the correct medication or having the correct medication delivered by the wrong route, and patients receiving medication to which they have a known allergy or has a negative interaction with another medication the patient is known to be taking. An adverse drug event (or ADE) results when the medication error causes patient harm. Our analysis will focus on preventable issues. (Patients may experience an ADE even when a medication is administered correctly.) About half of ADEs are considered preventable, i.e. they result from a medication error.

In this case, our Cumulative Cause Map will identify errors that occur at all steps of the medication delivery process. This process begins when a need for medication is identified and ends when the medication has been administered to the patient. At a very high level, there are four steps to this process: prescribing, transcribing, dispensing, and administration. The process typically begins with a physician, who prescribes the medication, moves to a clerk who transcribes the prescription (if necessary), then to a pharmacist who dispenses the medication, and then typically to a nurse, who administers the medication.

Based on information from studies, industry guides, and case studies of actual medication errors, common issues can be identified at each step of the process. In the prescribing stage, a medication can be prescribed for the wrong patient if there has been insufficient verification of the patient’s identity (and a matching of the patient to their medical records). Additionally, an inappropriate medication, dose or route may be prescribed if the physician is unaware of a patient’s allergies or other medications which could interact with those being prescribed. Miscalculating a dose is another potential error at the prescribing stage. Distraction and/or similar-sounding drug names are other causes for prescription errors.

In the transcribing stage, errors typically result from legibility issues on handwritten prescriptions. However, distraction and/or similar sounding drug names can result in the wrong medication/ dose and/or route of administration being transcribed. Distraction and/or similar sounding drug names is an issue during the prescribing step, as is miscalculating a dose. When medications have to be substituted (for availability or cost concerns), there’s also the potential to choose an inappropriate medication if a patient’s allergies or current medications are unknown.

At the administration step, medication can be administered to the wrong patient due to insufficient identity verification. Or, the wrong medication, dose or route can be administered due to similar sounding names and/or distraction. According to the Institute for Safe Medication Practices, every interruption increases the risk of medication error 12.7%, and medical staff can be interrupted as often as every two minutes while working on the medication delivery process. For this reason many hospitals are trying to reduce interruptions of medical staff during this process by various means.

By looking at the causes that come up again and again in the proactive analysis, steps for improvement at each level of the process can be identified. Ensuring that the right patient is matched to the medical record/ care instructions at every step of the process can reduce medication being administered to the wrong patient. The use of non-handwritten prescriptions and including both the drug’s brand name, generic name and purpose can also reduce the risk of the wrong drug being administered. Ensuring that drug allergies are clearly captured within a patient’s records (and potentially on the patients themselves, in the form of a wristband) and that a current medication list is up to date can reduce the risk of drug reactions. An organization’s experience with these different types of errors will allow it to determine what level of control over each cause is necessary to reduce the risk to an acceptable level.

To view the one-page PDF with a proactive analysis of medication errors in healthcare facilities, please click “Download PDF” above. To learn more about Medication Errors, please join our FREE Webinar on December 18th.