Tag Archives: cause mapping

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

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

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.

Root Cause

Anesthesia Without Electricity or Oxygen Tanks

By Kim Smiley

Almost 32 million surgeries are performed globally each year without a proper supply of oxygen and anesthesia, predominantly in developing nations.  Many more surgeries are canceled or delayed because anesthesia isn’t available.  One of the issues that plague hospitals in low income countries is that traditional anesthesia machines need electricity and oxygen tanks to function, both of which can be in short supply. A new design, called the Universal Anesthesia Machine (UAM), can operate without electricity or oxygen if necessary and is proving to be a practical solution to this difficult problem.

The UAM was invented by a doctor, Dr. Paul Fenton, who worked as an anesthesiologist at Queen Elizabeth Central Hospital in Blantyre, Malawi where he saw the problems with providing adequate anesthesia first-hand.  He designed his machine to use electricity when it is available, but to continue to function if power is lost by using a hand-powered pump on top. A digital display of oxygen levels switches to a 10 hour battery when power is lost so that the patient can continue to be monitored.  It also uses a compressor and air from the room so oxygen tanks aren’t required.

In an effort to make the UAM as practical to use as possible, it doesn’t use specialized parts.  Parts needed to maintain the machine should be available through a typical auto supply shop.  It’s also a flexible design that is compatible with all standard adult and pediatric breathing systems.

Honestly, this invention sounds too good to be true, but the UAM seems to be functioning as promised.   The number of UAMs in use is still relatively small (100 have been distributed to 18 countries), but they have already provided oxygen for over 30,000 surgeries.  Inadequate anesthesia is a huge issue, but this new machine may very well prove to be an important step in working towards a solution.

Click on “Download PDF” above to see a Cause Map of the problem of inadequate anesthesia.  You can also learn more about how the Universal Anesthesia Machine works by clicking here.

Root Cause

Deaths and Arrests Leave Many Questioning Mass Sterilizations

By ThinkReliability Staff

The deaths of 13 women after they underwent tubal ligation (female sterilization surgery) at a government- run clinic in India have resulted in outrage and arrests, but few answers. It is known that shortly after one of these mass sterilizations on November 8th at a mobile clinic, the women became ill and died.  The doctor was arrested for performing 83 sterilizations in 6 hours when government regulations permit only 30 in a day.  (The doctor says that pressure and incentives from the government encourage more sterilization surgeries despite guidelines.)  The cleanliness of the tools used for the surgeries as well as of the clinic itself are believed to have caused infections that led to severe septic shock that resulted in these deaths.

However, patients from different clinics who had taken antibiotics from the same batch used at the sterilization clinic also became ill, raising the question of contaminated – or outright counterfeit – drugs.  The owner and son of the manufacturing clinic that provided the antibiotics were also arrested.  It’s now believe that the women exhibited signs of potential poisoning and that trace amounts of a chemical used in rat poison were found in tests of the batch of antibiotics.  The signs of poisoning and septic shock can be similar, so additional testing is needed.

Either way, it’s clear that the care these women received was substandard.  Not only is the condition of the clinics and medication in question, but also the use of these surgeries as a form of family planning, which is common in the area.  In a survey, 34% of households indicated that female sterilization was their main method of family planning. Availability of less permanent birth control and medical care are limited, and population is booming.  The government has encouraged female sterilization, not only by running the mobile clinics but also paying the women who are sterilized.  The women who died from the procedure were given 1,400 rupees, or about $23 US.

Although there is currently limited information on what exactly lead to the death of these women, an analysis of those things that went wrong can still be useful to look for solutions.  (Click “Download PDF” above to view the one-page overview of a Cause Map, or visual root cause analysis, of what is known so far.)  Each possible cause (which indicates that more evidence is needed) can be developed with additional detail when more information is available.

Post-mortem inspection of the women who were killed indicated that their deaths were due to septic shock from severe infections.  The infections were believed to have been obtained during the surgery due to dirty tools or poor conditions.  (It’s not surprising that a clinic with limited resources known for having substandard cleanliness would struggle to ensure clean equipment for 83 surgeries in 6 hours.)  If the antibiotic they were given in order to fight potential infection was adulterated (and not providing the desired active ingredients, or too little of them to be effective), it would decrease the women’s ability to fight off the infection.

The potential poisoning (supported by sickness of others who received medication from the same batch) is believed to be due to counterfeit or adulterated medication.  Preliminary testing showed the presence of a chemical used in rat poison within the medication.  Counterfeit and adulterated drugs are both a problem in India; the World Health Organization (WHO) estimates that as many of 1 in 5 drugs made in India are fake.  The US FDA prevents the importation of the antibiotic used at the clinic from India.  Drug inspectors in the area indicate that about 25% are of substandard quality due to poor manufacturing practices.  Enforcement of drug quality is limited in the area, and issues with medication are seen frequently.

As mentioned above, both the surgeon and the owners of the pharmaceutical manufacturing facility have been arrested.  Both sterilizations and the use of certain drugs have been limited in the area until the causes resulting in the women’s deaths have been determined.  What hasn’t happened (yet) is a serious look at the country’s method of family planning in hopes that these types of tragedies never happen again.

Root Cause

Chronic Obstructive Pulmonary Disease (COPD) is Strangling Nation’s Health

By ThinkReliability Staff

The facts about chronic obstructive pulmonary disease (COPD) aren’t pretty.  COPD is not one but a group of diseases that impact airflow and breathing.  Included in the group are emphysema and chronic bronchitis.  (These diseases are grouped together because they are commonly diagnosed together.) COPD is the third leading cause of death.  In 2010, it was the cause of death of 135,000 Americans.  Every year, COPD results in millions of visits to the doctor’s office or emergency room and hundreds of thousands of hospitalizations, which last an average of almost five days.

All that medical care doesn’t come cheap.  COPD is the fifth most expensive disease in the US, with $32.1 billion in direct medical costs.  (In addition, billions of dollars are attributed to absenteeism and mortality costs as a result of COPD.)  An additional concern is that many COPD sufferers are rehospitalized soon after release.  COPD is the third most common cause of 30-day rehospitalization.  Under the Hospital Readmissions Reduction Program (HRRP), penalties or loss of benefits are applied to hospitals with greater than average rehospitalization.  The penalty for readmission of COPD patients beyond average is $33,000.  Of US hospitals, 44.5% received readmissions penalty in 2013.

Because there is no cure for COPD, limiting rehospitalizations primarily involves ensuring appropriate treatment to limit symptoms, and exacerbations, which account for 50-75% of medical costs.  However, there are actions that can slow the progression of COPD.  By diagramming the cause-and-effect relationships resulting in progression of COPD in a Cause Map, we can visually show how solutions act on these causes.  As discussed above, impacts to goals associated with COPD include patient safety (deaths), environmental (exposure to air pollutants), compliance (potential for penalties/ loss of benefits), patient services (high levels of rehospitalization), operations (absenteeism) and property/labor (direct medical costs).  These impacts are primarily caused by exacerbation of COPD.

Exacerbation of COPD results from the progression of the disease and delayed treatment.  COPD develops due to exposure to air pollutants (primarily tobacco smoke or industrial chemicals), genetic factors (which are just beginning to be understood), and respiratory infections or untreated asthma.  Because there is no cure for COPD, time without treatment is the primary way that symptoms increase.  (82% of COPD sufferers are over age 65.)  Inadequate treatment typically results from the underdiagnosis of COPD (experts predict 10-12 million sufferers have not yet been diagnosed) and insufficient adherence to a medication regime.  Based on self-reported values and pharmacy claims, adherence to prescribed medication regime is 32-50%, meaning less than half of COPD sufferers are following doctor’s orders with regards to their COPD, even though studies have also found that optimized medications can reduce exacerbations of COPD by 20%.

Along with underdiagnosis, a cause of exacerbations is delayed treatment.  Part of this is also caused by insufficient adherence to a prescribed medication regime, but also to delayed reporting.  Symptoms of an exacerbation generally occur about a week prior to a discernible reduction in lung function, but all too often that week is spent without medical care because patients tend to delay reporting symptoms until their lung function is affected.

To reduce the impact of COPD as well as the potential for rehospitalization, the following is recommended:  First, the biggest impact an individual can have on COPD is to stop smoking.  Individuals should also reduce their exposure to air pollutants, including cigarette smoke and industrial chemicals (whether at the work place or in home cleaning products).  Those experiencing an exacerbation of symptoms should report it immediately and should follow all medication guidelines given by their doctor.  For doctors, guidelines for the use of spirometry (a breathing test to measure lung function) can provide a more accurate diagnosis of COPD.  Presenting information to patients about the importance of the above measures can also help reduce COPD exacerbations and potential for rehospitalization.

To view a one-page PDF with an overview of the cause-and-effect relationships, and recommended solutions for minimizing the impact of COPD, please click “Download PDF” above.    Or, visit the COPD Foundation to learn more.  You can also view a Cause Map of America’s Smoking Epidemic, here.

Root Cause

Re-engineered connectors may prevent tubing mix-ups

By ThinkReliability Staff

Patients being treated at healthcare facilities may have multiple tubing connections designed to provide different medical treatment products.  Disaster can occur when tubing is connected incorrectly.  The most well-studied example is when enteral feeding solutions are accidentally directed into intravenous (IV) lines.  The Joint Commission (TJC) found 116 case studies, including 21 that resulted in deaths, due to this type of misconnection, discussed in a recent Sentinel Event Alert.  In 2006, this happened to a pregnant woman, resulting in the death of both her and her fetus.  (See our previous blog on this topic.)

Issues involving tubing misconnections have been reported since the 1970s and are not limited to feeding tube/ IV mix-ups.  Many types of tubing for medical product delivery are susceptible to misconnection due to the use of luer connectors, which allow a high degree of connection compatibility.  Concern is growing over these types of connections, and it’s become clear that training is not adequate to prevent these types of connections.  According to the Joint Commission, “The basic lesson from these cases is that if it can happen, it will happen.  Luer connectors are implicated in or contributed to many of these errors because they enable functionally dissimilar tubes or catheters to be connected.”

Action is being taken that would prevent these misconnections by ensuring that each type of tubing has its own, non-compatible connector.  The Association for the Advancement of Medical Instrumentation (AAMI) is leading an international initiative to develop small-bore connectors standards.  Public review of the standards is now available (along with other helpful information including case studies) on the AAMI website.  The State of California has passed legislation requiring manufacturers of intravenous, epidural or enteral feeding devices to implement the new standards that aim to prevent misconnection, though it does not take effect until January 1, 2016.

Connectors meeting the new, non-compatible standards are becoming available but compatible connectors may still be in use and in inventory systems.  To limit risk of patient death or serious impairment while the new connectors are phased in, TJC recommends that tubing is traced from the patient to its point of origin every time it is connected, disconnected, or during a patient hand-off.  Labeling high-risk tubing and routing tubes and catheters in specific directions (towards the head for IVs; towards the feet for enteric feeding tubes) has also been recommended to reduce the risk of misconnection.

Going forward, only equipment that is incompatible with female luer connections on IVs should be purchased for all non-IV equipment and acceptance testing should be performed on new purchases to ensure it is not compatible with IV tubing connections.

The cause-and-effect relationships leading to the patient safety risks, and the solutions that are being recommended can be visually diagrammed in a Cause Map, or visual root cause analysis.  To view a one-page overview of the issue, please click on “Download PDF” above.