All posts by ThinkReliability Staff

ThinkReliability are specialists in applying root cause analysis to solve all types of problems. We investigate errors, defects, failures, losses, outages and incidents in a wide variety of industries. Our Cause Mapping analysis method of root causes, captures the complete investigation with the best solutions all in an easy to understand format. ThinkReliability provides investigation services and root cause analysis training to clients around the world and is considered the trusted authority on the subject.
Root Cause Analysis

FDA’s Wish List: Regulatory Authority for Lab-Developed Tests

By ThinkReliability Staff

Laboratory testing is incredibly important to health care – it is thought to be an influence in about 70% of health decisions. Results of testing will often be used to diagnose a patient, or select a treatment plan. Thus, inaccurate testing results can lead to inappropriate, sometimes even dangerous, treatments. However, diagnostic tests manufactured and used within a single laboratory, known as laboratory developed tests, or LDTs, are not subject to regulation by the FDA.

This has led to significant concern by the FDA, outlined in a report making the case for FDA oversight for these tests. Their concerns can be diagrammed in a Cause Map, or visual root cause analysis, allowing us to see how the specific concerns are related and impact patient safety and other regulatory goals.

The first step in any problem solving method is to determine the problem that is to be solved. Using the Cause Mapping method, the “problem” is defined as an impact to an organization’s goals. In this case, patient safety is impacted because of the possibility for insufficient treatment of life-threatening disease and the potential for patients to undergo unnecessary dangerous procedures. Additionally, patient services are impacted because of the threat to the scientific integrity of clinical trials using these tests.

The second step in the Cause Mapping method is the analysis. Beginning with one of the impacted goals and asking ‘why’ questions develops the cause-and-effect relationships involved in the issue. In this case, we begin with the patient safety goal that is impacted due to insufficient treatment for life-threatening disease. This is due to either a failure to detect the disease and/or to patients choosing to undergo unproven therapies. We address each cause in turn.

The failure to detect a disease is caused by inaccurate test results and/or insufficient interpretation of test results. Inaccurate test results can be caused by tests not being clinically valid (one of the FDA’s prime concerns) because the test is not regulated by the FDA. The test is not required to be regulated by the FDA, which is the addressed in the FDA’s report. The argument against requiring FDA regulation for tests is that the laboratories that create and use the tests are regulated under the Clinical Laboratory Improvement Amendments (CLIA). However, according to the FDA, CLIA is intended to regulate the operators of laboratories, not diagnostic devices. The report provides multiple case studies of problematic LDTs, which were offered from laboratories “following the minimum requirements of CLIA.”

Inaccurate test results are also caused by not identifying adverse events, which are not systematically reported for these tests (another of the FDA’s prime concerns). An additional prime concern of the FDA is that performance data is not required to be reviewed prior to marketing these devices. Not only is FDA approval not required, but there is an incentive for companies not to seek FDA approval of LDTs, leading to an uneven playing field (another of the FDA’s prime concerns) for companies who do seek FDA approval of laboratory tests. Insufficient interpretation of test results occurs because testing labels do not provide adequate information on interpretation (another of the FDA’s prime concerns).   Again, these causes are due to not requiring regulation by the FDA.

The FDA is concerned that results from unapproved testing may result in patients choosing to undergo unproven therapies. Misleading manufacturer’s claims and/or lack of transparency can mean patients are unaware that the tests have not been cleared or approved by the FDA. These causes are both listed as prime concerns of the FDA. Patients are unable to assess tests available because there is no comprehensive listing of tests currently being used (the last prime concern of the FDA).

Because of these reasons (causes), the FDA is requesting oversight of LDTs. The oversight provided by the FDA would ideally provide solutions to these issues by addressing each of the concerns (causes) listed in the report. To learn more, click here to read the report. Or, click on “Download PDF” above to view the cause-and-effect relationships including the FDA’s concerns about LDTs.

Root Cause

Disabled resident dies when caregiver falls asleep

By ThinkReliability Staff

A physically disabled resident in a New York state-run care home required checks every two hours to ensure he was receiving adequate oxygen.  On the night of September 10, 2013, his nurse fell asleep, and he went more than 8 hours without the checks.  During this time, his oxygen level dropped to 40% (anything below 90% is considered dangerous), and he later died of hypoxic brain injury.

Says Patricia Gunning, prosecutor for the New York State (NYS) Justice Center for the Protection of People with Special Needs, “This case serves as a tragic reminder of the serious risk posed by an all too common workforce problem of caregiver fatigue or workers sleeping on shifts.”

Sadly, “all too common” turned out to be all too true.  The NYS Justice Center for the Protection of People with Special Needs was formed in mid-2013, and oversees agencies responsible for more than a million people in state care or state-funded nonprofits.  During its first year, it found 458 reports alleging abuse or neglect that cited a caregiver sleeping on the job.  This included caregivers who slept through a resident’s grand-mal seizure and a resident’s elopement, residents with unattended access to medications and food, and residents who were in a car driven by a caregiver who fell asleep at the wheel.

Even with a seemingly overwhelming problem such as this, progress can be made by looking at the specifics of one case, identifying causes that led to the problem, and developing solutions.  These solutions can then be considered for individual or widespread application.  We will examine the specifics of this case in a Cause Map, or visual root cause analysis, which lays out the cause-and-effect relationships leading to a problem.

The problem being examined is determined by the impact to an organization’s goals.  In this case, the resident safety goal was impacted because of the death of the resident.  The resident services goal was impacted because the resident did not receive adequate oxygen.  The compliance goal is impacted because of the felony charges against the nurse, who was sentenced to 90 days in prison.

Beginning with the most prominent impacted goal – in this case the resident safety goal – and asking “why” questions develop the cause-and-effect relationships that led to that impact.  In this case, the resident died from hypoxic brain injury (per diagnosis), from a lack of oxygen.  Due to the resident’s physical disability, his oxygen delivery equipment was required to be checked every 2 hours around the clock.  On the night of September 10 to September 11, more than 8 hours passed between checks, at which point the patient was found unresponsive.  (He died two weeks later.)

The resident’s oxygen delivery was not checked for more than 8 hours (as opposed to the required two) because the caregiver on duty had fallen asleep.  Testimony from the nurse in question as well as others from the facility describing sleeping on overnight shifts as a common occurrence.  Later research from the NYS Justice Center for the Protection of People with Special Needs found that many incidents involving caregiver sleeping on duty involved staff working extended or otherwise non-traditional work shifts.  The nurse who fell asleep on duty worked 12-hour night shifts at a site where many signed up for overtime and just barely passed duty hour requirements.

In response to the numerous caregiver sleeping events it discovered, the NYS Justice Center for the Protection of People with Special Needs has provided a toolkit aimed to protect people with special needs from caregiver fatigue.  The Center recommends that care provider agencies implement & regularly review policies meant to deter and detect sleeping on the job, establish contingency plans to relieve staff found unfit for duty, and provide assistance to residents in calling for help if caregiver is unresponsive.  Due to the myriad issues associated with caregiver fatigue, the American Nurses Association (ANA) continues to fight to reduce nurse fatigue, and possible harm to patients.

To see a one-page PDF with an overview of the investigation related to the resident lack of oxygen due to caregiver sleeping, click on “Download PDF” above.  Or, click here to learn more.

Root Cause

After Patient Death, CMS Surveyor Declares “Immediate Jeopardy” To Patient Safety

By ThinkReliability Staff

From the moment a patient arrived at an endoscopy clinic in New York on August 28, 2014, things didn’t follow the usual procedure.  The patient brought her own ear, nose and throat physician (ENT) to accompany her into surgery for an esophagogastroduoudenoscopy (EGD), though the ENT did not have privileges at the facility.  The patient signed a consent form for anesthesia, and the EGD and her vital signs were taken, though it appears her weight was either not taken or not recorded.

After a time out that was initiated by the endoscopy technician (as opposed to the anesthesiologist, as required by policy) for the EGD, the patient was administered Propofol for sedation.  After the patient was sedated, the ENT attempted to perform a nasolaryngoscopy, despite not having facility privileges or a record of patient consent, but the initial attempt appears to have been unsuccessful.  After the EGD was completed, the ENT performed another nasolaryngoscopy beginning at 8:28 AM and ending (per interview records) at 8:30 AM.

By that time, the patient’s condition was quickly deteriorating.  Her blood pressure had dropped from its pre-procedure level of 118/80 to 84/40, her pulse from 62 to 47, and oxygen saturation from 100% to 92%.  Both the Cardiac Arrest Record and the Endoscopy Code Blue Record indicate that at 8:28 AM (the same time the second nasolaryngoscopy was beginning) the patient went into cardiac arrest/ ventricular tachycardia and measures were taken for resuscitation (including assisted ventilation, chest compressions, and administration of epinephrine and atropine).

The record of the surgery note that the laryngoscope was withdrawn at 8:30 AM, at which time cardiopulmonary resuscitation (CPR) was undertaken.  The patient was resuscitated and transferred to a hospital, where she died on September 4, 2014.  The cause of death from the autopsy report was anoxic encephalopathy (brain damage) caused by hypoxic cardiac arrest (oxygen deprivation).

The day prior to the patient’s death, a surveyor from the Centers for Medicare and Medicaid Services (CMS) declared “Immediate Jeopardy” due to “significant findings . . . which compromised patient safety”.  Specifically, the surveyor noted that the facility had risked patient safety by allowing a doctor without privileges to be allowed in the operating room and perform a procedure, and not obtaining consent or performing a time out for a procedure that was performed.

The facility quickly submitted a corrective action plan that revised procedures allowing visitors to the facility, ensuring informed consent and time out procedures are used before every procedure, and providing training on these updated procedures to staff.  Immediate jeopardy was removed on 9/5/14, although the facility was still considered out of compliance with CMS requirements, and was given until March 2 to maintain its certification.  (CMS has not released whether the facility has been successful.)

A lawsuit is underway that may provide more detail as to how the CMS findings caused (or didn’t cause) the patient’s death.  At this point, what is known can be captured in a timeline (for a chronology of events) and a Cause Map (to capture the cause-and-effect relationships that led to the impact to the goals) to start organizing and presenting information logically.  As more information is available, the Cause Map can be updated.

To see the timeline and initial Cause Map, click on “Download PDF” above.

 

Root Cause

VA works to save nurses’ backs

By ThinkReliability Staff

More than 35,000 nursing employees suffer back and other injuries every year that impact their ability to perform their jobs.   Their rate of musculoskeletal injuries is about three times that of construction workers.

The commonly taught “proper” lifting techniques and sharing the lift with other employees doesn’t help.  Says William Marras, director of The Ohio State University’s Spine Research Institute, “The bottom line is, there’s no safe way to lift a patient manually.  The magnitude of these forces that are on your spine are so large that the best body mechanics in the world are not going to keep you from getting a back problem.”

Armed with these findings, and some studies of their own, the Department of Veterans Affairs (VA) is leading the way in preventing these types of injuries.  The VA discovered that at least $22M (believed to be underestimated) was spent treating employees’ injuries every year.  There are other indirect costs – patient care suffers when nurses are unable to perform their jobs.  At least 2,400 nursing employees at the 153 hospitals operated by the VA suffer injuries every  year that interfere with their ability to work.

Says the VA, “In recent years, a patient body weight of 35 pounds was established as the maximum weight that providers can safely lift when lifting and moving patients without the risk of injury.  This limit requires a new approach to lifting and moving patients.”

To determine what that new approach should be, the VA looked at what was causing the injuries, and why.  (To see the cause-and-effect relationships leading to the nurse injuries at the VA in the Cause Mapping format, click on “Download PDF” above.)  As part of their routine tasks, nurses regularly lift more than 35 pounds.  (The weight of a 200-pound patient’s leg is about 40 pounds.)  Not only moving patients, but repositioning them was a problem.

The availability of equipment that provides lifting (or repositioning) assistance to nurses was a big issue.  Many hospitals purchase just a few pieces, which are frequently unavailable (or incredibly inconvenient) when needed.  The VA is working to install ceiling lifts in all patient rooms and everywhere else patients need to go (clinics, imaging departments, etc.).  They’re also using “floating” mattresses, which use an air stream to “float” patient mattresses from bed to gurney.

Even having readily available equipment didn’t completely solve the problem.  The VA is working to ensure that staff, who were accustomed to manually handling patients, would actually use the equipment.  Rather than minimal and occasional training, the VA trains on lifting constantly.  At least one employee on duty at all times is responsible for ensuring safe lifting technology is used.  Injuries that can be sustained from manual lifting are emphasized.  Additionally, each hospital has a “safety champion”.  This is a full-time position that ensures that other employees have what they need to ensure safe lifting and that the hospital as a whole puts in the time and money to protect worker’s backs.

These programs come at a cost, but appear to be very successful in reducing injury rates (and associated costs) at these hospitals.  The VA as a whole has spent more than $200 million since 2008 on its “safe patient handling program” and has reduced nursing injuries from moving patients 40%.  One California VA hospital has spent $2 million to install lifts across the hospital.  Before the program, it spent $1 million over four years hiring replacements for injured employees.  Last year, nobody got hurt badly enough to miss work.  Says Tony Hilton, the hospital’s safe patient handling and mobility coordinator (“safety champion”), “Remember, I’m your guardian angel.  You know I’ve got your back.”

Click on “Download PDF” to see an overview of the cause-and-effect relationships for which the VA is implementing solutions to reduce nursing injuries.  Or, click here to learn more about the VA’s program.

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