Tag Archives: Root Cause Analysis

Root Cause Analysis

Increased Cost of Drug May Increase Potential for Pre-Term Labor

By Kim Smiley

In 2003, a study by the National Institutes of Health determined that administering hydroxyprogesterone caproate (also known as17P) could reduce the risk of preterm delivery.  Preterm delivery can cause many health issues for infants.  However, there was no commercial source of 17P, so pharmacies compounded it upon request for $10-$20 an injection.  Injections are generally taken starting at weeks 16-24 of pregnancy for up to 20 weeks.

Concern about availability and quality of this compounded drug helped lead to development and expedited U.S. Food and Drug Administration (FDA) approval of a name brand version.  The name brand version was approved on February 3, 2011 and was granted 7 years of market exclusivity under the “Orphan Drug Act”, an FDA incentive to develop products.  The name brand version of the drug was priced at $1,500 an injection.  Concern over the price increase, which could total nearly $30,000 a pregnancy, led to concerns of increases in preterm labor due to the unaffordable drug.  This on turn led to concerns about patient safety and patient services.  Additionally, there has been general outrage over the increase in cost, leading to a request for a Federal Trade Commission (FTC) investigation into the pricing of the drug and a loss of market share for the manufacturer.

To attempt to alleviate the concerns regarding access to the drug, the manufacturer has lowered the price to $690 an injection and has developed a host of other programs to increase affordability of the drug.  The price drop and other programs were announced on April 1, 2011.  The FDA announced on March 30, 2011, that it will not stop pharmacies from continuing to compound 17P, in a rare move to ensure drug availability.  However, some doctors are concerned that prescribing a pharmacy-compounded drug. when there is a brand name drug available, will leave them open to legal action if safety concerns arise.

The impact of this issue on the future of preterm labor and drug pricing is unclear at this point.  It appears that more action may be required to reduce the risk of preterm labor, either by the manufacturer or the FDA, or both.  View the analysis of this issue, including a timeline, problem outline, Cause Map and solutions, by clicking “Download PDF” above

Root Cause Analysis

Contaminated IV Bags Sicken 19

By Kim Smiley

With the aid of the State Health Department and the Centers for Disease Control and Prevention (CDC), six hospitals have traced back recent patient infections to contamination in total parenteral nutrition (TNP) delivered via intravenous (IV) bags.

Although the first infection occurred in January, 2011, a pattern was not established until March, 2011, after nineteen patients were infected with serratia marcescens bacteria.  Patient infection is an impact to the patient safety goal.

The infections occurred as a result of the patients being given contaminated product – in this case, the IV bags.  The bags were recalled, and are no longer in production.  Ten of the patients died.  Investigators have said they won’t be able to determine whether the infection caused the deaths because the patients were already very ill (TNP is used for patients who are too ill to eat on their own).

The IV bags were compounded at a local pharmacy.  There was a potential for contamination in the raw material used for compounding, during the compounding at the pharmacy, or at the hospital.  Because six different hospitals experienced the same rare bacterial contamination, it is unlikely that the contamination occurred at the hospital.

According to Dr. Alexander J. Kallen, a medical officer with the Centers for Disease Control and Prevention, “Historically, what we’ve seen is a breakdown in the manufacturing process.”  The investigation is underway to determine if the contamination was caused by an issue with the manufacturing process, an issue with the sterility of equipment, or a contamination of the raw material.  As the investigation continues, more detail can be added to the Cause Map.  As with any investigation the level of detail in the analysis is based on the impact of the incident on the organization’s overall goals.

While investigating an issue, it can also be helpful to look at the process for identifying and isolating issues, and implementing improvements.  In this case, after patients receive or use products, they are monitored for certain reactions.  If those reactions occur (such as those that indicate a bacterial infection), they are reported to the State Health Department, then the CDC.  The CDC investigates to determine the source of the infection and then pulls the affected products off the market.  Currently, the CDC has identified the product that is contaminated, though not the source of the contamination.

A thorough root cause analysis built as a Cause Map can capture all of the causes in a simple, intuitive format that fits on one page.  To view the Cause and Process maps, click “Download PDF” above.

Root Cause Analysis

Aging Surgeons

By ThinkReliability Staff

Over 20% of today’s physicians are over the age of 65.  Should this be cause for concern?  After all, we rely on our doctors to take care of us when we are often at our most vulnerable.  While increased age means increased experience, there are also down sides.  Age can bring with it a decrease in physical and mental capabilities, as well as a reluctance to adopt newer technologies.  At least this is what multiple studies have hinted at over the past few years.

The problem is that such a “decrease in capabilities” is highly subjective and difficult to measure.  Surgeons rely on a variety of cognitive and tactile skills in their craft – steady hands, learning new techniques, composure under stress, communication skills, and so on.  As highly trained professionals, it is sometimes difficult to decide when it is time to call it quits.

Furthermore, in the United States, age-based discrimination is outlawed in most industries except where regulated.  For instance, airline pilots and air traffic controllers are both subject to earlier-than-average retirements due to public safety concerns.  Many federal and state public workers, such as corrections officers and firefighters, are similarly limited. It’s difficult to argue that some physicians don’t make similar split-second, life-and-death decisions – especially surgeons.

The associated Cause Map visually lays out the dilemma.  Surgeons who aren’t performing adequately do so for two reasons.  First, they have a medical condition precluding them from performing to standards.  (Note that to keep this Cause Map simple, other issues such as mental health problems, addiction, and failure to maintain their continuing education were not examined.)  Second, they are allowed to continue practicing.

Such physicians continue after their abilities are impacted for a number of reasons.  Some might be unaware of their condition or unwilling to accept it, both stemming from a belief that they are still competent to practice.  Additionally, current processes at most hospital are slow to identify such physicians.  Most hospitals rely on co-workers to identify such doctors, clearly a highly subjective and ethically complex system.  Age-based screening is not common at many hospitals, partly because of resistance from hospital staff.  In fact, only 5-10% of hospitals have directly addressed this issue.  Labeling doctors as “unfit to practice” isn’t necessarily a bad thing.  If such doctors are identified early, patient safety is enhanced.  Additionally, early identification can sometimes allow those doctors to continue practicing in a controlled and safe environment.

Now that the problem has been laid out, the next step is to look for possible solutions.  It’s clear that little can be done about age-related deterioration.  So the focus moves to the other branch of the Cause Map.  Here there are a number of possibilities.  While age-based screening is certainly an option, it’s not the only one.  For instance, including hospital staff in making decisions might also help decrease resistance to identifying deficient physicians.  Additional training on the impacts of age might make co-workers more willing to discuss their concerns.  Or doctors might be more willing to adapt to their limitations if regular screening can identify possible health problems.

While more research is needed to determine how extensive this issue is, it is clear that at most hospitals current procedures to identify deficient physicians are lacking.

Root Cause Analysis

Toddler Dies From Contaminated Wipes

By Kim Smiley

A 2 year old boy died December 1, 2010 following a routine surgery to remove a benign cyst from near his spinal cord and brain.  He appeared to be recovering well when he contracted bacterial meningitis and quickly succumbed to the infection.  Tests revealed the bacteria were a rare strain, Bacillus cerus, which is typically associated with food poisoning and not hospital infections.  How the patient was exposed to the bacteria was initially unknown, but now a potential source has been identified.

On January 5, 2011, The Triad Group, one of the nation’s largest medical product suppliers, announced a massive recall of alcohol wipes, swabs and pads because of contamination from the same rare bacteria, Bacillus cerus.  Products by this manufacturer were used to care for the boy during his hospital stay.  Although, a definitive link between the death of the boy and the recalled pads has yet to be established, there is a lawsuit pending.

Since the time of the recall, other people have come forward with possible cases of infection from Bacillus cerus from using the recalled products.  The FDA has launched an investigation.

Even through the investigation is not completed, this example can be built into a Cause Map based on the information that is available.  A Cause Map is an intuitive, visual method of performing a Root Cause Analysis. Any additional information can be added to the Cause Map as it becomes available and any necessary changes made.

When beginning a Cause Map, the first step is to determine the impact to the organizational goals and document them in an Outline.  In this case, the Safety Goal was impacted because a boy died and there is potential that more people were infected by the same harmful bacteria.  Once the impact to the goals is completed, Causes are added to the map by asking “why” questions. In this case, the boy died from bacterial meningitis because he was exposed to Bacillus cerus.  Next, we would ask “why” he was exposed to the bacteria.

Because the link between the recalled wipes and the death of the patient has not been officially determined, a question mark is included with that information when it’s added.  It’s important that all evidence or lack of evidence is documented on the Cause Map so that it is clear which Causes are agreed upon, known facts and which still need to be proven. Click on the “Download PDF” button above to see a high level Cause Map of this example.

The recall is a short term solution to this problem, but at least all products known to be contaminated should be removed from shelves and hospital storerooms.  It isn’t clear yet what steps are needed at the manufacturer to ensure safety of consumers, but the affected products will not be sold again until they are tested and deemed safe.

Root Cause

Developing a Meningitis Vaccine Program to Prevent Epidemics in Africa

By ThinkReliability Staff

Meningitis epidemics occur on a regular basis in Africa. Last year, there were more than 88,000 reported cases.  In 1996-1997, during the largest reported epidemic, more than 250,000 cases were reported.  Meningitis is highly contagious and approximately one in ten cases are fatal.  Disability occurs in approximately one in five cases.

The vaccine that was previously available in Africa was a polysaccharide vaccine, which did not prevent transmission of the disease. Understanding that the current situation was dire, the Meningitis Vaccine Project was formed.  With funding from various donors including The Gates Foundation and money raised in Africa, a vaccine that protects against the group A meningitis strain – responsible for more than eight out of ten infections in Africa – has been developed at a cost of less than $.50 (US) a dose.  More funding is still needed to meet the goal of vaccinating 300 million people across 25 nations.    However, the steps that have already been made are remarkable and represent a huge step forward in helping fight this dreadful disease.

Click on “Download PDF” to see the outline and Cause Map of the 1996-1997 meningitis epidemic and the timeline of the progress of the Meningitis Vaccine Project.  To learn more, see the Meningitis Vaccine Project.

Root Cause Analysis

Wrong Surgery Performed on Patient (Part 2)

By ThinkReliability Staff

This week, we will continue our discussion of an incident where the wrong surgery was performed on a patient.  Last week, we looked at the timeline of events and a process map of the universal protocol developed to reduce the incidence of surgical errors.  This week, we’ll perform a root cause analysis of the issue.

The specific steps identified that didn’t go well, or weren’t performed, from the process map now become causes on our Cause Map.  Instead of the causes or errors being grouped chronologically or by type (as they are on a fishbone diagram), the causes are grouped by their contribution to the incident.  The Cause Map reads from left to right by asking “Why” questions, beginning with the impacts to the goals.

For example, the patient safety goal was impacted because a patient received the wrong surgery.  Why?  Because the physician performed the wrong type of surgery. Why? Because the surgical site was not clearly marked.  Why? It was marked on the correct arm, though not the correct site (the wrong surgery was performed on the correct hand) and the mark was washed off during patient preparations.  These are both issues identified in the process map that did not follow the universal protocol for surgical preparations.  Both of these issues contributed to the wrong surgery.  In addition, the surgeon was thinking about carpal tunnel surgery, since most of his day, especially just prior to the surgery, had been spent on carpal tunnel surgery, either performing it, or doing pre- or post-surgery briefs with other patients.

Neither the patient nor the operating room staff stopped the surgeon from performing the incorrect surgery.  The patient spoke only Spanish, which may have contributed to her not speaking up.  The operating room staff did not include the nurse that had done the patient assessment, due to a last-minute operating room and staff switch due to other delays.  There was no time-out prior to the procedure, which may have alerted the staff about the wrong  procedure, or may have helped the surgeon switch from thinking about carpal tunnel surgery.

Once the analysis is complete, possible solutions are identified on the Cause Map.  Many of the solutions in this case are to ensure that the universal protocol procedures are being followed.  Had they been followed in this case, the risk of performing the wrong surgery would have been reduced.  Many facilities are already using the universal protocol; however, this case study shouldn’t be ignored by them.  The operating surgeon made this case public and added the following comment: “I hope that none of you ever have to go through what my patient and I went through. I no longer see these protocols as a burden. That is the lesson.”

This surgeon has learned his lesson and will likely be more diligent about following these protocols in the future.  However, there’s no need to wait until you, or your staff members, have their own incidents to learn from.  Use this case study to emphasize the needs for these protocols, in hopes that your facility can reduce its own risk.

(Details of this incident were recently published in the New England Journal of Medicine.)

Root Cause Analysis

Hospital Working Hard to Prevent Recurrence of Medication Errors

By ThinkReliability Staff

Experts believe that most medical errors go unreported, due to a combination of lax reporting laws, strict patient privacy laws, and ambiguous definitions of these medical errors.  However, Seattle Children’s Hospital is making an attempt to be forthright and accountable with not only its mistakes, but its plan for improvements.  Seattle Children’s made the news recently when it published the serious reportable events that had occurred there from 2004-2010, including two deaths resulting from medication errors.

Additionally, a third child died after a medication error in September 2010, but it has not been determined if the medication error contributed to the death and an adult patient was given the wrong medication but recovered at around the same time.

In response to these errors, Seattle Children’s is performing a root cause analysis by independent experts to determine the causes.  In the meantime, Seattle Children’s is making specific process improvements, such as allowing only pharmacists and anesthesiologists to administer calcium chloride (an overdose of which led to one of the deaths), as well as general training and reminders for staff.  The hospital held a patient safety day on Saturday, October 30th, 2010, where over 550 staff members participated in training and simulations designed to improve patient safety, with a focus on medication safety.

Although the root cause analysis of the various medication errors has not been completed, Seattle Children’s has identified some specific causes that may contribute to medication errors and is launching improvements to try and reduce the impact of these causes.  For example, interruptions to nurses when they are in the process of ordering, preparing or administering medications can lead to medication errors.  During the training, the staff discussed the types of interruptions that occur and what can be done to reduce them.

Medication errors are estimated to kill 1.5 million people per year, so Seattle Children’s is not the only medical facility that will find itself reeling after the deaths of several patients.  These other facilities should take Seattle Children’s lead and begin a serious attempt to reduce these errors, and deaths.

Want to learn more?  See our webpage about medication errors in medical facilities or watch the video.

Root Cause Analysis

Cholera Outbreak in Haiti

By ThinkReliability Staff

Although the World Health Organization (WHO) has never seen cholera in Haiti before, it’s not a great surprise that an epidemic has spread through crowded makeshift camps where people have been living since the earthquake in January.  Unsanitary conditions frequently lead to outbreaks of the disease and in situations where there is very limited access to healthcare and clean water, death rates are often high.   The death rate in Haiti was nearly 10% at the beginning of the outbreak. It’s now decreased to 7.7% which is still well above the 1% death rate threshold accepted by the United Nations (UN).

We can do a closer examination of the causes contributing to this issue in a Cause Map, or visual root cause analysis.  The first step to the analysis is to capture information about the issue and define the problem with respect to an organization’s goals.  The problem can be defined as a cholera epidemic with a high death rate.  It was first discovered, or at least reported, in November of 2010 at makeshift camps in Haiti.  We’ll use the goals of the Haitian government to determine impacts.  At least 284 people have died and 3,600 people have been infected with cholera. This is an impact to the population safety goal.   The high death rate indicates a failure of population services from the government.  The environmental goal is impacted by the epidemic spread of the disease, and  the financial goal is impacted by the cost of treatment of those afflicted.

The second step of the analysis is to determine the causes that led to the impacted goals.  The high number of deaths results from the high number of infections and the high death rate.  Infections are caused by ingestion of contaminated food and water.  The bacteria that causes cholera is spreading due to heavy rains and the large number of people living in the unsanitary conditions.  The overcrowding in the camps is due to the earthquake that hit Haiti on January 12, 2010.  As previously mentioned, it’s unclear how the  bacteria got there in the first place, but not surprising that it did.  The high death rate is due to untreated dehydration.  Severe diarrhea is a symptom of a cholera infection, and with inadequate medical care and lack of access to clean water, the dehydration can quickly become severe enough to lead to death.

Support organizations like the WHO are desperately trying to stop the spread of the epidemic and reduce the rate of death.  However, it’s clear they have their work cut out for them, given the current circumstances.

Root Cause Analysis

Brain Damage Resulting from Aggravation of Underlying Mitochondrial Disorder by Childhood Vaccinations

By ThinkReliability Staff

The Federal Court Division of Vaccine Injury Compensation (DVIC) ruled on November 9, 2007 that a child’s parents would receive compensation due to a vaccine injury.  Recently the amount of compensation was named – $1.5 million plus $500,000 a year for treatment.  There has been much discussion about what the award means.  With a charged issue such as this one, wording is very important.  The court’s wording in this case is as follows:

“DVIC has concluded that the facts of this case meet the statutory criteria for demonstrating that the vaccinations CHILD received on July 19, 2000, significantly aggravated an underlying mitochondrial disorder, which predisposed her to deficits in cellular energy metabolism, and manifested as a regressive encephalopathy with features of autism spectrum disorder.”

With a very careful reading of the court’s decision, we can put what the court determined was applicable to the case in a Cause Map, or visual root cause analysis.  (I’ve also recorded the chronological information in a timeline, used to assist with our understanding of the issue.  The information from the timeline is also from the ruling.)

First we can enter the impacts to the goals in the outline.  The patient safety goal was impacted because a child wound up brain-damaged (or with encephalopathy).  The resulting payment of over $1.5M is an impact to the financial goals of the vaccine injury board.  Based on the ruling, the vaccines aggravated an underlying condition, which can be considered an impact to the patient services and environmental goals.   Additionally, in this particular circumstance the child received vaccines not on schedule.  This could be considered an impact to the compliance goal.

Beginning with the most important goal – patient safety – we build the Cause Map.  The patient’s encephalopathy was determined to have been caused by an underlying condition that was aggravated by the receipt of vaccines against 9 diseases all at once.  However, the link between this and the encephalopathy isn’t yet clear.  Rather than just stopping our Cause Map, we can add a “?” in the middle of the cause-and-effect relationship, and highlight this unclear relationship.  This allows us to focus our attention.  Even with this question mark in the middle of the map, we can still do a lot to clarify the cause-and-effect causes.

For example, based on the child’s physicians’ diagnoses, we know that the underlying condition was a  mitochondrial disorder.  We also know that the child received vaccines against 9 diseases at once because she was behind on vaccines, having skipped some doses while she was ill.

Even with the uncertainty surrounding this analysis, the Cause Map can still provide clarity to the issue. It can also help lead to possible solutions (though adding more detail will allow for even more).  For example, doctors may adjust catch-up vaccination schedules based on this incident, resulting in fewer vaccines being given at once.

Never Event

Patient Physically Assaulted

By ThinkReliability Staff

On June 24, 2010, a patient at a Maryland Hospital was physically assaulted by security guards after trying to leave the hospital.  A patient who is injured or killed due to physical assault is one of the ‘Never events’, i.e. medical events/errors that should never happen.

We will look at the causes of this event in a Cause Map, or visual root cause analysis.  The information used to put together this analysis is from the legal filing.

On June 23, 2010, a man (who we’ll call “the patient”) was in a serious car accident and was airlifted to a Maryland Hospital.  He woke up the next day, after receiving treatment for blunt torso trauma and chest pain and asked for something to eat.  After some confusion, the patient realized that his identification bracelet was not his – it identified a female patient 13 years his junior.  At this point, he decided to leave the hospital and was stopped with a verbal and physical exchange with several security guards.  He eventually was able to leave successfully, and was treated at a second hospital for broken ribs, a sprained shoulder, a ruptured spleen, and a concussion.

As mentioned before, physical abuse of a patient is a “Never event”, and is an impact to the compliance goal.   More importantly, there was injury to the patient, resulting in an impact to the safety goal.   Because the patient was wrongly identified as needing surgery to remove a cancerous mass, there was the potential for the patient receiving unnecessary surgery, also an impact to the safety goal.  The patient has taken legal action against the employees involved (Employee Impact goal) and has filed a lawsuit against the hospital for more than $12 million (an impact to the organizational goal).   The misidentification of the patient can be considered an impact to the patient services goal.

We begin our Cause Map with these impacted goals.  The patient was beaten because employees were trying to restrain the patient to keep him from leaving, and restrained him in an inappropriate manner.  The employees were trying to get the patient to stay because they believed he needed surgery because he was misidentified.  At this point, the hospital involved should be asking “Where did our identification procedure go wrong?”  The next step in the investigation should be to look at the identification procedure to determine specifically which steps allowed the misidentification to happen.  Only once this is determined can appropriate corrective actions be taken to prevent future misidentifications.

Another area that requires more analysis is the patient restraint procedure.  The security guards in this instance were attempting to restrain the patient to prevent him from leaving.  However, they did this in an inappropriate manner.  The question is, why?  Were the guards not following the existing restraint procedure? If not, why not?  Or, is there no procedure for restraint?  Were the restraint expectations not clearly provided to the guards?  Again, until the specific breakdowns leading to this incident are uncovered, corrective actions will be generic and may not be effective.  To view a one-page PDF showing the investigation at this point, click on “Download PDF” above.