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

Alarm-Related Ventilator Deaths

By ThinkReliability Staff

Although The Joint Commission dropped alarm safety as a patient safety goal in 2005 (a year after setting it as a goal), recent reviews by the US Food and Drug Administration and the ECRI Institute have noted concerns with alarm-associated ventilator deaths.  We can look at the issue of alarm-related ventilator deaths in a Cause Map, or visual root cause analysis, to see some of the causes related to these deaths, and some plans to reduce them.

Ventilator-related deaths occur when a patient who can not intake sufficient oxygen on their own (due to illness or injury) no longer receives sufficient oxygen from a ventilator.  Only a few minutes of insufficient oxygen intake can  result in brain damage or even death.  The patients do not receive sufficient oxygen from the ventilator because it stops working due to malfunction, becomes blocked with mucus, or becomes dislodged or disconnected, potentially due to patient movement.  In addition to an issue with the ventilator providing sufficient air to the patient, a death can occur when the ventilator issue is not fixed immediately.

Normally the ventilator issue is not fixed immediately because the caregiver is unaware of the issue. (Caregiver in this instance includes not only healthcare professionals but families caring for loved ones at home who are dependent on ventilators.)  In these cases, the caregiver is unaware of an issue with the ventilator because they are dependent on listening for an alarm to indicate a problem, and they don’t notice the alarm.  Caregivers not noticing an alarm were determined to cause 65% of ventilator deaths, according to The Joint Commission.

How do caregivers miss an alarm?  There are many possible reasons.  The ventilator alarm may not sound due to a malfunction.  Although this issue is commonly cited, the ECRI study determined that this was the case in only 2 of 119 cases it examined.  The alarm may not be sufficiently obvious to a busy caregiver.  Namely, the alarm may be set inappropriately by personnel who have insufficient training on ventilator systems.  Relatively few patients are on ventilators, and insufficient funding and time for training may mean that staff (or families) do not adequately understand how the ventilator works.   Another cause may be that some ventilators sound only once.  If you miss it, it’s done.  (As a solution, ventilator manufacturers are considering alarms that continue until reset.)

Another issue related to lack of responding to alarms is an issue known as “alarm fatigue”.  Caregivers can become desensitized to alarms, hearing so many every day, many of which are false alarms.  Ventilators, too, can produce false alarms when a patient coughs, or rolls over.

What can be done to reduce these deaths?  The first line of attack is frequent vacuuming and careful placement of the ventilator to reduce the risk of it becoming clogged or dislodged.  Next, an attempt to make caregivers less dependent on alarms, and more able to see problems using other indications, and more ventilator training may increase the ability of caregivers spotting issues without waiting for alarms.  As far as dealing with alarm fatigue, consideration should be taken into how alarms are presented to nurses.  Too many audible alarms may lead to ignoring even the life-threatening ones.  It may be better to have non-urgent issues presented as “alerts” rather than a one-time beeping.

To view the Outline and Cause Map, please click “Download PDF” above.  Or click here to read more.

Hospital Acquired Condition

Facial Burns from Surgical Fires

By ThinkReliability Staff

At least two patients received burns to the face from surgical fires in early December 2011.  Surgical fires are becoming an increasing risk to patients (and staff) in the operating room.  Although the 550-650 surgical fires a year that are estimated to occur by the ECRI Institute is a small percentage of patients undergoing surgery, this doesn’t make surgical fires seem “rare” to those who are affected.

A surgical fire, like any fire, requires the presence of three elements: a heat (or ignition) source, fuel, and an oxidizing agent.  Oxygen is necessarily present for breathing; however, additional oxygen supplied to the patient increases the risk of a fire.  Additionally, nitrous oxide produces oxygen from thermal decomposition.  An increased level of oxygen increases the risk of a surgical fire.  Like oxygen, fuel will always be present in a surgical room.  Prep agents, drapes, and even a patient’s hair are fuel sources.  Vapors from insufficiently dry prep agents are extremely flammable.  Although some drapes are advertised as flame-resistant, the ECRI has determined that all types of drapes burn in oxygen.

Surgical equipment, such as electro-cautery devices and lasers, are believed to provide the ignition source for many surgical fires.  The increased use of such devices is believed to contribute to the increase in surgical fires.  Although these devices can provide benefits during surgery, a non-ignition source tool should be considered for surgery performed near the oxygen supply of a patient requiring oxygen.

The best way to protect patients from surgical fires is to prevent them by reducing the use of oxygen, decreasing the flammability of potential fuel sources in the operating room (by allowing prep agents to dry and coating hair or other flammable objects with water-based lubricant) and ensuring that heat sources are monitored carefully to reduce the risk of ignition.  In addition, operating teams should be prepared in the case of fire to minimize effects on patient and staff safety by taking steps to extinguish the fire and evacuate if necessary.

The effects and causes of surgical fires, as well as some recommended solutions, can be diagrammed in a Cause Map, a visual form of root cause analysis.  To view the Cause Map for surgical fires, please click “Download PDF” above.  Or click here to read a more detailed write-up about patient burns.

Additional resources on surgical fires:

ECRI Institute

FDA

The Joint Commission

Anesthesia Patient Safety Foundation (APSF)

Root Cause Analysis

Bacterial Contamination of Tampons

By ThinkReliability Staff

On November 9, 2011, the FDA announced a recall of a certain subset of tampons for contamination with the bacteria Enterobacter sakazakii.  The recall is for certain products delivered to certain stores, mainly in the central U.S. Region.  For a full list of the product  recalls, check the FDA recall site.

The specific source of the contaminant has not been identified.  Investigations of previous instances of contamination with the Enterobacter sakazakii have had difficulty determining an exact source, as this bacteria is found within human  and animal guts.  However, even with limited information, we can begin a Cause Map, or visual root cause analysis, which allows us to view the areas where more data collection is needed in order to gather evidence to complete the analysis.

We begin by capturing the basic information about the incident as well as the impacts to the goals.  The safety goal is impacted due to the risk of infection from the contamination tampons.  The environmental and customer service goals are impacted because a product was bacterially contaminated.  Additionally, the product recall impacts the production, property and labor goals.  We begin our Cause Map with the impacts to the goals.

Both the risk for infection and the product recall were caused by the bacterial contamination of a product.  The product was contaminated because contaminated raw material was used for its manufacture.  This occurred both because the raw material was contaminated and because the quality control or testing process for the raw material was insufficient.  Whether there was no testing process for the given bacteria or whether the process did not recognize the bacteria and stop the use of the contaminated raw material is unclear.

At this point, because the source of the raw material contamination is unknown, an open question which requires evidence-gathering is “how did the raw material get contaminated”? This will require cooperation from the raw material manufacturer.   The other necessary information is to do a detailed review of the quality control and/or testing that is used on raw materials prior to manufacturing and determine how the contaminated material was able to be used to make a final product.  Once this process is looked at in detail, specific solutions that would prevent a recurrence of this type of contamination can be implemented.

To view the Outline and Cause Map, please click “Download PDF” above.  Or click here to read more.

Root Cause Analysis

Working to Ensure Safe Assembly of Surgical Tools

By ThinkReliability Staff

A 2-month old was undergoing a cystoscopy to incise a ureterocele in the bladder.  During the endoscopic procedure, a resectoscope was used to remove the unwanted tissue.  However, during the operation part of the resectoscope slipped off, exposing a hook-shaped internal piece of the instrument.  Fortunately the patient was not injured; however the potential for injury was very real.  How did the medical instrument come apart?

The first step in an incident investigation is to determine what the problem is and what the impacts to the organization’s goals are.  In this case, the problem is fairly straightforward – the resectoscope fell apart while inserted into a patient.  Although details are scant in this case, the problem statement is filled out as completely as possible to document what occurred.  The second part is to determine the impact to the organization’s goals.  An obvious impact is the potential harm to the patient, related to the hospital’s patient safety goal.  There was also the possibility of legal action, which would impact property goals.  Finally, there likely was the need to redo the procedure, taking additional time, thus impacting the organization’s labor goal.

The second step is to build a Cause Map by asking why an event occurred.   The Cause Map visually depicts what led to the young patient being exposed to harm.  In this case, the three goal impacts converge on the event where the hook electrode became uncovered.  It should be noted that multiple causes led to the patient being exposed to harm; if the resectoscope had been broken but had not been in use, then it would not have mattered.  It is crucial to include all reasons on the Cause Map because those reasons may be key to developing the optimal solution.

Facts that need to be captured about an investigation can be included in evidence boxes on the Cause Map.  They can provide the reader with important background information.  In this example, information about the hook electrode is included so that the reader knows what it is.

Reviewing the complete Cause Map, it turns out that the resectoscope was incorrectly assembled.  The third step in an incident investigation is to develop a set of solutions.  Remembering that all causes are necessary to produce an effect, the investigation team can brainstorm solutions to eliminate or counteract contributing causes.  In this case, three possible solutions were developed.  It is possible that the resectoscope could be designed differently so that the insulation would not be able to slip.  While this is a reasonable long term solution, it would not immediately remedy the problem.  Another solution would be to verify that the instrument is in working order before using on a patient.  This may have occurred, but it should be included until ruled out as a potential solution.  A final idea is to revise the assembly procedures for the resectoscope.  This is in fact what the FDA recommended.

The FDA recommends that the manufacturer’s assembly procedures always be carefully followed.  A process map is another helpful tool to determine where something went wrong.  The organization can build a process map depicting the ideal sequence of events, then compare that with what actually occurred.  The problem may not be in the instructions; the instructions might be perfect!  However, if someone doesn’t follow those instructions correctly, the process isn’t going to reach the desired outcome.

At this point, the investigation team might go back to the Cause Map to elaborate on the why the resectoscope was incorrectly assembled.  This might generate new solutions and changes to the ideal process map.  Through this iterative process, an optimum solution can be found.

This event was reported as part of the FDA’s MedWatch program.  The FDA encourages health professionals to voluntarily report problems on medical devices.  For more information on the MedWatch program, please visit their website.

Root Cause

Interpretation of Electronic Fetal Heart Rate Monitoring

By ThinkReliability Staff

Electronic fetal heart rate monitoring (EFM) is used to determine fetal distress.  When fetal distress is indicated, intervention and/or early delivery are generally performed.  Because of this, EFM is performed frequently, even in low risk births.  However, EFM has a high rate of false positives, resulting in unnecessary surgical intervention, which can impact both patient safety and an organization’s goals, especially as the rate of cesarean sections continue to increase.  One of the causes for these high rates of false positives is the variable and inconsistent interpretation of EFM data.  This is in itself an impact to the patient services goal.

This produces a highly simplified version of the Cause Map, but leads to a cause that has significant opportunity to provide improved results.  Specifically, the cause of “variable and inconsistent interpretation” suggests that guidance for more consistent interpretation may aid in reducing unnecessary surgical intervention due to false positives from EFM.

With guidance provided from the American Family Physician, we can create a process map to aid in the use of EFM.  A process map shows the steps and decision trees involved in a process, attempting to guide practitioners towards accepted best practices.

EFM is used continuously for high risk patients and intermittently for low risk patients  unless abnormalities occur.  There are three types of patterns produced by EFM: reassuring, non-reassuring, and ominous.  (Definitions for these patterns, as well as high risk patients are also from the American Family Physician).  Reassuring patterns generally are found to correlate with fetal health, and indicate that the delivery can continue.  Ominous patterns should lead to evaluation for immediate delivery.  Non-reassuring patterns are found between the two – and so lead to the most difficulty in interpretation.  Specific steps are outlined to be taken in the case of non-reassuring patterns which attempt to normalize the pattern.  Additionally, specific tests are recommended to attempt to determine the cause.  If the cause can be determined and corrected, continuous monitoring should accompany an attempt to continue the delivery.

If the pattern is not normalized, evaluation for immediate delivery should occur.  There is no decision tree at this stage  because the decision on whether (and how quickly) to perform delivery must be determined based on the patient’s specific state, based on the knowledge of the practitioner.  Although some steps remain subjective, attempting to fit those that are not into a process map can improve the odds for everyone.

Root Cause Analysis

The July Effect

By ThinkReliability Staff

No one ever looks forward to a trip to the hospital, and a new study suggests that you might be particularly wary during the coming weeks.  A new study shows a 10% spike in patient fatalities during the month of July.  Many in the medical profession have been aware of “the July Effect” anecdotally for years, but researchers in the University of California at San Diego study combed through over 62 million death certificates dating back to 1976 to prove its existence.

Why the spike?  Sociologist Dr. David Phillips, who conducted the study, believes it is because new doctors begin their residencies in July each year.  The phenomenon is limited to fatal medical errors, and is not evident in surgical or “general” error rates.  Consistent with the study’s “New Resident Hypothesis”, fatalities are even higher in counties with higher concentrations of teaching hospitals, in which there would be more resident doctors.  It is clear there is a link between higher rates of medication errors and the presence of brand new doctors.

The study is one of the first to demonstrate the linkage though.  Multiple smaller studies have failed to show any correlation between time of year and death rates.  Researchers point out that the new study focused on a much longer time range and broader geographic area than any previous study however.

Although the study raises some interesting questions, it stops short of providing solutions.  Doctors already face a rigorous course of study to prepare for their residencies, which of course are designed to provide the experience needed.  New doctors are also generally well supervised.  And to some extent there will always be risk associated with inexperience when it comes to teaching hospitals.

A Cause Map can illuminate areas that might benefit from further research.  The study narrowed down one of the contributing factors to medication administration.  Why just in that area though?  Are new residents better supervised in the OR?  Do new doctors have the capability of prescribing and administering medication during their first month?  What types of errors do they make when doing this?  Do they prescribe the wrong medication completely?  The wrong dosage?  Or do they overlook adverse interactions with other medications?

More research is needed to accurately determine why the July Effect occurs, but patients can be prepared.  Experts agree that patients should ask plenty of questions and bring along an advocate for support.  For more information, the study, “A July Spike in Fatal Medication Errors: A Possible Effect of New Medical Residents”, is available here.

Root Cause Analysis

Working Towards Solutions for Medication Errors

By ThinkReliability Staff

It’s no surprise that we’ve written frequently about medication errors.  It is estimated that medication errors harm approximately 1.5 million people annually in the U.S.  We’ve outlined some of the many causes that contribute to medical errors at medical facilities, as well as some of the things that the public can do to reduce their risk of medication errors.

Some of the more common issues that lead to medication errors include confusion on the label of the medication.  It is estimated that almost half of Americans don’t understand the dosing instructions on their medication, leading to the potential for medication dosing errors.  It’s no wonder, when “take one pill a day,” can be written in 44 different ways according to Dr. Ruth Parker.   Additionally, many patients receive medication instructions that are either not in their primary language, or contain errors in the translation (see our previous blog about errors in translated medication instructions.)

It’s obvious that if almost half of people receiving medication instructions don’t understand them that something should be changed.  An expert panel appointed by the US Pharmacopeial Convention (USP) has created national labeling standards in order to reduce medication errors caused by patient confusion with medication instructions.  It is hoped that a final version of these rules is published by May 2012 and will then be implemented nationally.  (Additionally, Canada is considering these standards as well.)

The proposed standards attempt to cover some of the most common errors in label decoding that lead to medication errors, including use of unfamiliar terms (such as Latin terms or jargon) and pictures instead of text (such as a picture of a crossed off alcohol bottle rather than “do not take with alcohol”).  Additionally, medication instructions would be provided in the preferred language of the patient (and hopefully national standards will reduce the translation errors currently found on many medication bottles) in clearer font, with the information important to the medication found larger and on top and other information (such as the provider and pharmacy names) below and less emphasized.

Coming up with process improvements, such as these, with an expert panel allows consideration of many issues and points of view.  When you’re looking at improvements in your organization, you already have an expert panel – it’s the people who do the work processes day in and day out.  Additionally, information released by other organizations can be leveraged to provide solutions relevant to your organization.  Take advantage of the expertise found in your organization when you are looking to improve processes – it will save time and money, and may even save lives.

Root Cause

Diagnosing Hearing Loss in Babies

By ThinkReliability Staff

All new parents wait to hear that first wail in the delivery room, followed by a quick counting of fingers and toes.  Satisfied with their healthy new baby and exhausted from delivery, few notice the battery of tests newborns face in their first few days of life.  Thanks to these tests, many serious problems can be detected and treated before they become life-threatening.

Many states now mandate hearing screening at birth.  Even minor hearing loss, if not caught early, can seriously impede language and social development.  Nearly 2% of babies fail their initial screening, prompting more through testing.  Approximately 0.2% of children born in the U.S. will be diagnosed with hearing loss.  While most children with hearing loss have conductive (outer or middle ear) or sensorineural (inner ear) hearing loss, there is another type of hearing loss.  With auditory neuropathy (AN) spectrum disorder, sound enters the ear normally; but because of damage to the inner ear or hearing nerve, the brain isn’t able to understand the signal.  The sound is similar to what you might hear underwater or on radio with a lot of static.

Little is known about AN, including what causes it and how to treat it.  Hearing aids seem to help in about half of AN cases, although sometimes children and adults grow out of it.  And some patients thrive with cochlear implants.  Until recently, most weren’t certain how many even suffered from the condition.  A recent study shows that this condition may affect up to 15% of children with born hearing loss.

With all the confusion surrounding AN, few pediatricians and audiologists are aware of this condition or what treatment options are available.  Often the first course of treatment is a hearing aid.  Unfortunately this treatment, which amplifies sound entering the ear canal, can be exactly the wrong treatment for some types of AN.  For those with damage to the hearing nerve, blasting noise into the ear canal simply damages the external, working portions of the ear.  Infants have very sensitive hearing, and just a week of continuous hearing aid use can be enough to cause permanent damage.  Unwitting parents, worried about their children and eager to follow the doctor’s orders, may not realize their children are capable of “hearing”, albeit distortedly, until it’s too late.

A Cause Map can help sort out the factors contributing to this problem.  The top of the Cause Map shows the desired outcome.  Mandatory or recommended screening in infancy results in earlier diagnoses of hearing loss, which limits developmental delays further down the road.  However the bottom portion of the Cause Map shows how current screening practices can often lead to misdiagnosis and the wrong treatment.  By focusing on this area of the Cause Map, solutions can be identified to eliminate the unintended effect.

Two such potential solutions have been identified.  First, changes to the screening process might identify AN early on.  Considering that up to 15% of hearing loss may be caused by AN, this may be a more feasible solution than previously thought.  Second, an awareness campaign may help doctors and audiologists become more aware of AN and how to properly treat it.

With more research and greater awareness, there is hope that those with auditory neuropathy spectrum disorder will not accidently suffer more.  For more information on AN, please visit the National Institute on Deafness and Other Communications Disorders website.

Root Cause Analysis

Infants Exposed to Unnecessary Radiation

By ThinkReliability Staff

A recent New York Times article, X-Rays and Unshielded Infants, used an example of poor x-ray technique issues to highlight problems with the operation of radiation equipment in the medical industry.

In 2007, a director at a medical center in Brooklyn, New York discovered that premature babies were routinely being over-radiated during x-rays.  Full body x-rays of babies, known as “babygrams” were being done when not medically necessary. When a simple chest x-ray was ordered, as is common for premature babies with lung issues, the entire body was being x-rayed without any shielding.  Additionally, the CT scanners had been set too high for infants in some cases.  There were also issues of poor body positioning that made it difficult for doctors to accurately read the x-rays.

The end result was that many young babies were being habitually exposed to unnecessary radiation at this facility.  This is especially troubling when you consider the fact that children are particularly vulnerable to radiation exposure because their cells divide more quickly because they are still growing.

The causes in this example aren’t well known, but a basic Cause Map can be started and could be expanded if more information becomes available.  Click on “Download PDF” above to view the Cause Map.

What is clear is that this is more than a case where one person made a single error.  The culture and training in the department didn’t recognize the importance of limiting radiation exposure.  The radiation field as a whole is also minimally regulated.  Standards and regulations are decided at the state level and many states choose not to regulate all occupations working with radiation.  In 15 states radiation therapists are unregulated, 11 states don’t regulate imaging technologists and medical physicist are unregulated in 18 states. For the past 12 years, the American Society of Radiologic Technologists has lobbied for a bill to set education and certification requirements for people working in medical imaging and radiation therapy, but as of yet no bill has been passed.

After the improper radiation techniques were discovered, the hospital instituted many changes to their procedures.  No more full body x-rays were performed and shielding was used to minimize radiation exposure for children as well as adult patients. An investigation is also underway by the New York state health department.

Hospital Acquired Condition, Never Event

Preventing Central Line Infections

By ThinkReliability Staff

Central line infections, also called central line-associated bloodstream infections (CLASBI), can occur when a large tube is placed in a large vein in the neck, chest, groin or arms to give fluids, blood, or medications or to do certain medical tests quickly.  While they allow exceptional access to internal systems, Central Venous Catheters (CVC) also can cause thousands of patient deaths a year and add billions of dollars in healthcare costs.  However, these infections are entirely preventable.

In this health care scenario, patient safety is the foremost concern.  So the most basic Cause Map would show that the Patient Safety Goal is impacted by preventable bloodstream infections, and that those infections come from pathogens introduced by a central line.  The next step is to elaborate on how pathogens enter the bloodstream, and then determine what appropriate solutions might be.

Preventable bloodstream infections happen because pathogens access the bloodstream and also because the infections aren’t treated early on.  This suggests that by treating infections early on, and vigilantly watching for signs of infection, more serious infections can be prevented.

Pathogens can access the bloodstream because a central line provides a direct conduit to the bloodstream and because pathogens are present.  Again, while these are obvious statements, they allow the opportunity to develop potential solutions.  First, the CDC recommends not using a CVC unless absolutely necessary.  Additionally, CVCs shouldn’t be placed in the femoral artery in adults because it is associated with greater infection rates and secondary problems such as deep venous thrombosis.

Assuming a central line is necessary; more analysis leads to further solutions that might reduce the presence of pathogens.  Pathogens generally come from two sources – the line was improperly put in or somehow the line became contaminated during use.  Using antimicrobial materials is one potential way of minimizing contamination.

Looking closer at the uppermost branch , how the line was put in, leads to some insightful solutions.  One simple solution recommended by the CDC is to use a checklist and follow their guidance.  Checklists are a simple but highly effective way of reducing errors in repetitive processes.  There are two major causes in this branch, dirty hands/gloves from the nurse or doctor putting the CVC in the patient and the patient having dirty skin at the site of the CVC.  CDC guidance also recommends using maximal barriers such as masks and gloves and washing your hands.  Cleaning the patient’s skin with a chlorhexidine-based solution is another important step that can reduce these infections.

With so many possible solutions, it is important to identify where changes need to occur in your own processes.  This is fairly simplistic Cause Map and there are many other solutions suggested by the CDC and other government health agencies.  For more information on steps to reduce CLASBIs, see the U.S. Department of Health and Human Services Guideline.