Category Archives: Root Cause Analysis

Never Event, Root Cause Analysis

What’s in YOUR heparin?

By ThinkReliability Staff

In 2008, contamination of the U.S. supply of heparin was brought to light. A significant portion of the U.S. supply of heparin was recalled, and the death toll potentially associated with the contamination has now climbed to 81, with hundreds of adverse events also reported. Additionally, prior to the recall there was concern for deaths and injuries associated with the contaminated drug not fulfilling its expected purpose – preventing blood clots during surgeries and kidney dialysis – because the contaminant has no blood thinning properties. So far, the contaminated drug has been found in 10 countries thus far, increasing concern about the drug supply chain.

Researchers have verified that the contaminant in the recalled heparin is oversulfated chondroitin sulfate (OSCS) and that they have discovered a mechanism by which the contaminant can cause the adverse effects (falling blood pressure and severe allergic reactions). Additionally, the researchers have provided a test for regulators to screen heparin for this contaminant.

They have determined that the OSCS was present at the active ingredient supplier plant in China. Because OSCS does not occur in nature and mimics the chemical structure of heparin so closely, it is believed that the (mostly unregulated) crude heparin suppliers in China added OSCS to increase their profit, as OSCS is many times less expensive than heparin. The OSCS was not detected by standard impurity tests, due to its similarity with heparin. In Congressional hearings since the event, the Food and Drug Adminstration (FDA) has said that the inspections of the Chinese plant (as well as those of most foreign plants) were inadequate due to lack of funding for the FDA mission.

The Cause Map shows that the heparin got into the drug supply after being placed in the raw ingredients. It was not discovered by regulators, due to the lack of a commonly used, effective test. 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. As more information is released about the failings of the supply chain in this instance, we can add more details to the Cause Map.

Click on “Download PDF” above to download a PDF showing the Cause Map.

See a more detailed root cause analysis of the heparin contamination.

Hospital Acquired Condition, Root Cause Analysis

Reduced central line infections? Check.

By ThinkReliability Staff

Sinai-Grace Hospital in Detroit has achieved remarkable reductions in bloodstream infections associated with central lines. They’ve reduced the rate of infections significantly by implementing a simple procedure and checklist. We will perform a root cause analysis that shows how these gains were achieved.

First, the hospital needed to determine what was at stake. Over 18 months, it was estimated that more than 1500 patients would die from infections. This is an impact to the patient safety goal. There was non-compliance with procedures, which is an impact to the compliance and organization goals. Infections result in a longer intensive care unit (ICU) stay, which is an impact to the patient services goal. Lastly, the hospital estimated that, over the 18 months, it would spend $175 million in additional costs from these infections.

Next, the stakeholders in the central line insertion process (doctors and nurses) were asked to help determine why these infections were occurring. Bloodstream infections resulting from intravenous catheters result when a catheter is inserted (for vascular access) with bacteria on it. Generally, the bacteria is on the catheter from a missed step in the catheter process which prevents contamination. The steps that were not always being followed were: doctors washing their hands and donning protective wear, patients not being washed with antiseptic or fully draped, and insertion sites not being covered with sterile dressing after the catheter is inserted.

As a solution, a checklist was created that outlined the six steps of catheter insertion. (The outline, Cause Map, process map, solutions, and checklist are shown on the downloadable PDF. To view it, click on “Download PDF” above.) The six steps included the cleanliness steps discussed above. Additionally, the medical professionals noticed that sometimes the procedures weren’t being followed because the necessary equipment was not available in the ICUs. Senior executives from the hospital were assigned to each unit, and were able to properly stock the ICUs. Additionally, the executives got Arrow International to manufacture central line kits that contained the necessary antiseptic and patient drapes.

The progress at Sinai-Grace has been remarkable, by joining all the necessary parties to an effective root cause analysis. Click on “Download PDF” to see what they did. (Read more in The New Yorker Annals of Medicine.)

Never Event, Root Cause Analysis

That’s not my baby!

By ThinkReliability Staff

New mothers and maternity centers alike live in fear that babies will be discharged to the wrong family. The Joint Commission considers discharge of an infant to the wrong person a never event, and it’s no surprise. Even if the mix-up is quickly rectified, huge problems can ensue.

Luckily, we don’t have to wait until an incident happens to us. We can instead perform a proactive root cause analysis, where we consider what COULD go wrong to result in an infant being discharged to the wrong person. 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.

For our very basic Cause Map, we can consider that two things have to happen in order for a infant to go home with the wrong family. First, the wrong baby has to be given to a family, and second, the matching system has to be ineffective. We’ll break each of these causes down into more detail.

The matching system may be ineffective because it isn’t being used. If a facility doesn’t have a matching system, it obviously won’t be effective. Additionally, if a computerized system is in use there is always the possibility that it won’t be working. Or the staff may not know how to use the system, possibly due to lack of training or insufficient staffing.

If the system is being used but not being checked, it won’t be effective. Again, this could be because the staff doesn’t know how to use the system, or it could just be that the discharge personnel forget.

The wrong baby could be given to a family if the matching system is on the wrong infant. (This is only likely to happen if the matching system is put on outside the delivery room.) Or, the wrong baby could be in a bassinet. This could happen if the baby is kept in an nursery and a nurse is transporting more than one baby..

It’s possible to add even more detail to this Cause Map as the analysis continues. 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. Once the Cause Map is complete, solutions can be brainstormed that match up with causes. The solutions are shown on the downloadable PDF.

Click on “Download PDF” above to download a PDF showing the Cause Map and Solutions.

Root Cause Analysis

How to prevent error? Cut your process in half

By ThinkReliability Staff

Congratulations to Lancaster General Hospital, who received the Best Practices Award In Health-System Pharmacy yesterday (December 7, 2009).  The award was to recognize the hospital’s success in auto-programming of infusion pumps.  As Lancaster’s Medication Safety Pharmacist Amanda Prusch has stated:

Auto-programming provides an additional layer of safety than the stand-alone technologies and by streamlining the IV medication administration process, the potential for error would be reduced.

Lancaster identified a problem – in this case the problem is medication errors, of which 56% are estimated to be from improperly inserted intravenously (I.V.) medications.  Because of the potential for serious adverse patient health outcomes due to medication errors, Lancaster knew something had to be done.  Lancaster looked at the infusion pump programming process, and discovered it had 17 steps, many of them manually performed.  At each manually-controlled step in a process is an opportunity for human error, no matter how careful people are.

By reducing the number of steps in a process, and by reducing the amount of human input required, the opportunity for human error is reduced.  In order to reduce this risk, Lancaster has implemented “fully auto-programmed smart infusion systems” .  The implementation of these systems has reduced the number of steps in the infusion pump programming process to 7 (from 17).  As a result, they have seen a greater than 90% reduction in reprogramming (or errors that were noticed and fixed).  This has surely led to a great reduction in I.V. medication administration errors.  In addition to the patient safety improvements, it has the added bonus of reducing the amount of time spent programming the pumps by 24.8%.  This also contributes to patient safety because it frees up nurses’ valuable time.

Read more about the new infusion pump system.   Lancaster’s solution is just one way to solve the problem of medication errors.  However, by removing steps from a process, not only does it require less time of your most valuable asset (employees), it can reduce the possibility for error.

Never Event, Root Cause Analysis

The surgery went well . . . except it wasn’t supposed to be done on you.

By ThinkReliability Staff

A “never event” that should come as no surprise considering its profound implications on patient safety is performing a procedure on the wrong patient. Ordinarily there are many checks to ensure that a patient’s identity matches that on the procedure order.

However, sometimes a combination of oversights can result in these checks being ineffective. This is especially true when there are patients of similar names, as happened in this particular case.

A patient (patient 1) was scheduled for a procedure in the EP lab. The EP lab called up to Patient 1’s floor, and were directed (incorrectly) to another floor by a person on the telephone. Although Patient 1 was on that floor, another patient with a similar name (patient 2) had been moved to another floor. The EP lab then directed Patient 2’s nurse to bring Patient 2 to the lab. The nurse brought Patient 2 to the lab, over her objections, despite the lack of information in Patient 2’s chart, or a signed consent form.

The various staff members at the EP lab did not verify the identity of the patient, either. However, they did notice the lack of consent form, and convinced Patient 2 to sign a consent form, for a procedure she did not need, was not scheduled for, and had opposed throughout the process.

Although the procedure was stopped partway through, when the true identity was realized, and there was no lasting injury to Patient 2, any procedure performed on the wrong patient has huge risk for patient safety.

On the downloadable PDF page, a simplified version of the process for taking patients to procedures is shown. The individual causes of the incident are identified in the Cause Map, and, where applicable, the process map. This example shows how a process map can be used to identify the various causes that led to an event.

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. Even more detail can be added to this Cause Map as the analysis continues. 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.

Click on “Download PDF” above to download a PDF showing the Cause Map and Process Map.

Root Cause Analysis

How to Determine Your Organization’s Goals

By ThinkReliability Staff

The first step of the Cause Mapping strategy of root cause analysis is to define the problem with respect to the organization’s goals.  In order to do this, you need to know what an organization’s goals are.  While we provide Cause Mapping root cause analysis templates that will give you an idea of where to start, your organization may wish to personalize their investigations so that they correspond to your particular goals.

To define your organization’s goals, try to imagine a perfect day for your organization.  For the healthcare industry, that perfect day doesn’t include anyone getting hurt or killed due to the actions (or lack of action) of the organization’s employees.  This is the patient safety goal.  Additionally, a perfect day would not include any injuries or deaths of employees.  This is the employee safety goal.

Additionally, most industries have a goal of not impacting the environment.  However, a healthcare industry may have a base level of environmental impact, such as a standard amount of hazardous waste disposal or an appropriate number of x-rays.  In this case, your goal might be to not surpass that level rather than having no impact.  This is the environmental goal.  Environmental impacts usually result from leaks or spills of any material other than water, but may also result from improper storage or disposal of hazardous material.  Misuse of diagnostic equipment such as radiographs may result in an environmental impact.

The medical and insurance industries have defined some events that should not happen on a perfect day.  The Joint Commission has its list of “never events” which are events that should never happen, and Medicare has a list of “hospital acquired conditions” which are conditions caused or worsened by medical provider actions for which Medicare will no longer reimburse.  This is the regulatory or compliance goal.

A healthcare organization exists to provide services to its patients.  If patients are not receiving appropriate services in a reasonable amount of time, this impacts the patient services goal.

Another area of concern for almost all organizations is cost.  An incident that results in additional costs to the organization impacts the material and labor goal.  If an incident results in many costs, it’s possible to itemize them within the problem outline.  Quantifying all the costs associated with an incident can help prioritize which incidents require the most immediate attention.  It also provides a bound for the cost of solutions – installing a $100,000 machine to solve an infrequent $20,000 problem doesn’t make sense.  (Of course, for incidents that involve impacts that can’t be easily quantified – human safety, regulatory requirements, patient services, etc.  – these impacts must be considered above and beyond the “cost” of the incident.)

Once you’ve determined all of the goals that are meaningful to your organization, you’re ready to make an outline for the first step of the Cause Mapping method of root cause analysis – define the problem.  But what order do you put the goals in?  Generally, the goals go in order from most to least important.  The safety goal is almost always at the top.  Your organization’s mission statement is an excellent resource to determine the order of the goals.  Ideally, they’ll follow along with your mission statement, with any goals not specifically called out (such as the “material and labor” goal) listed below.  It’s also possible to use a different order so that the biggest impacts from an incident are listed at the top.  However, your organization may prefer to always use the same order for consistency.

If an incident resulted in no impact to one of your organization’s goals, don’t delete the goal from the problem outline.  Instead, write “N/A” next to the goal.  That way, it’s clear that the goal was considered but it was determined that there was no impact.  Deleting the goal may lead others to believe that it’s no longer a goal of the organization!  Shown below is a standard outline for a healthcare organization.

ThinkReliability has specialists who can solve all types of problems. We investigate errors, defects, failures, losses, outages and incidents in a wide variety of industries.  Visit our website to find out more about our investigation services and root cause analysis training.

Never Event, Root Cause Analysis

Fifth Wrong-Site Surgery in Two Years Results in Fine for Hospital

By ThinkReliability Staff

Last month a patient at Rhode Island Hospital received surgery on his fingers. The surgery was supposed to be on two separate fingers (one on the right hand, one on the left), but due to a medical error, both surgeries were performed on the same finger. The family was then notified and the surgery was re-performed on the correct finger.

Although there was no risk of patient death due to this medical error, it is the fifth wrong site surgery to happen at this teaching hospital in two years. Rhode Island Hospital was previously fined $50,000 for three prior wrong-site surgeries. The Rhode Island Health Department fined the hospital $150,000 for the latest incident and is requiring the hospital to install cameras in its operating room.

Although some of the details of the surgical error are unknown, it is known that rather than marking the individual fingers that were supposed to be operated on, the patient’s wrists were marked. Additionally, it was not the operating surgeon who did the markings. The operating team also did not hold a “timeout”, which is used to make sure the operating team has the right patient, right location and right surgery, before performing the second surgery. (In particularly disturbing news, after the error was noticed and the family consented to performing the operation on the correct finger, there was again no “timeout”.)

The downloadable PDF shows the outline of the problem and a very basic Cause Map. (Click on “Download PDF” above.) As more details emerge during the investigation, they can be added to the Cause Map. Once the Cause Map is completed to a level of detail commensurate with the impact to the organization’s goals, solutions can be found to mitigate the future risk.

Want to learn more?

See how else wrong-site surgeries could occur in our proactive Cause Map.

Read the news article.

Root Cause Analysis

Childhood Obesity – A Community Problem

By Kim Smiley

It takes a village to raise a child . . .and to keep one from becoming obese. Childhood obesity is now being recognized as, at least partially, a community problem with community-based solutions. At the peak of the “obesity epidemic”, 32% of children in the U.S. were classified as overweight and 16% were classified as obese.

Obesity can result in a greater risk of disease (more than 90% of overweight children have at least one avoidable factor for heart disease.) This is an impact to the health goal of a community, and the nation. Obesity is the result of sustained weight gain. Weight gain is a simple balance problem. If calories consumed are greater than calories expended, as a result of too many calories consumed, too few expended, or both, weight gain will result. Usually obesity is caused by both.

First we’ll look at the causes of consuming too many calories. Too many calories are consumed when children eat high-calorie, low-satisfaction foods. In many cases, this is because a child has access to these types of foods and because healthy choices are not available. This is true with family, and at school, which generally contribute equally to caloric intake. A high proportion of foods consumed at school may be unhealthy; schools must offer healthier choices. Some schools have done away with soda and candy, but more healthy choices must also be offered. Students bringing their own lunches may suffer doubly from healthy food not being available at home, due to a lack of access or affordability. The all-too-many areas in the country that do not have access to healthy food at supermarkets or farmer’s markets are known as “nutritional deserts”, most frequently found in low-income and/or rural areas. Communities must improve access to healthy food, at school and at home.

The other part of the equation is calories consumed, otherwise known as exercise. However, children don’t need time on the treadmill; they need safe places to play outdoors or a safe route to walk or bike to school in order to get exercise. They also need physical education (PE) at school, and they need to see the importance of physical activity (something their parents may not be modeling at home, based on adult obesity rates, which are extremely high as well). Low-income and/or rural areas are less likely to have safe places to play outdoors, or a safe way for children to bike/walk to school, so these children are disproportionately affected by obesity. Communities must provide an outlet for physical activity for children.

On the downloadable PDF (download by clicking “Download PDF” above), we show the causes and solutions in a Cause Map, a simple intuitive format that fits on one page. The causes are solutions shown here are from the perspective of the community – causes and solutions that can be controlled by a community. If communities began implementing these solutions, the childhood obesity epidemic would be a thing of the past.

Want to learn more? See the Institute of Medicine report, issued in 2007.

Root Cause Analysis

Emergency Generators: A Loss of Power Doesn’t Mean a Loss of Life

By ThinkReliability Staff

If you are working at a healthcare facility, you most likely have an emergency generator. However, that emergency generator probably powers only certain critical sections of the facility, and it probably doesn’t include the administration part of the building. Why is that so?

We can look at impacts to the goals to determine why a solution that’s successfully implemented to solve a problem at one location or organization may not be the right solution for another organization. In a hospital, a loss of power could impact the goals pretty severely – the risk of death to the patients impacts the safety goal, the loss of life-saving equipment impacts the customer service goal. Additionally, the production goal may be impacted because the facility is unable to enter new patients. Last but not least, an additional cost (impact to the materials/labor goal) may be incurred transferring patients to a new facility. Obviously the risk of death means a HUGE impact to the organization’s goals, demanding comprehensive reliability solutions.

Compare this to an office building, such as where our administrative offices would be. If a loss of power occurred, the goals would be impacted – employees could get injured leaving the building if the lights went out. This is an impact to the safety goal. We may lose our business function during the outage, which would be an impact to the customer service and production goals. Additionally, we may have to pay our employees for a non-work day. The goals are impacted, but the severity of the impacts pales compared to the impacts of a hospital or medical facility losing power.

If we create a Cause Map based on these impacts to the goals, it shows that all the impacts to the goals tie back to a loss of electrical power, caused by both a power outage AND a lack of back-up electricity source. (The Outline and Cause Map are shown on the downloadable PDF.)

When determining solutions, there are a few that come to mind, including transferring patients to another healthcare facility (which becomes an impact to the goals) and installing battery backups in equipment. However, because of the severe impacts to the goals, a hospital will likely decide that the whole problem can be solved by installing an emergency generator. Problem solved; we have been able to find the best solution.

The administrative offices may feel differently. The cost of installing an emergency generator is large, and if we compare that cost to the costs that would be incurred due to a loss of power without backup, it’s probably not worth it. Instead, the office building may implement solutions further to the left on the Cause Map, such as installing emergency lighting, or using battery backups, that would mitigate (but not prevent) the impacts to the goals. So, just because a solution was the “right” solution in one case, it may not be in every case.

View the Outlines and Cause Maps for both the hospital and office building by clicking “Download PDF” above.

View the Joint Commission’s article on Power System Failures.

Never Event, Root Cause Analysis

We Regret to Inform You We’ve Removed the Wrong Leg . . .

By ThinkReliability Staff

Performing surgery on the wrong body part or wrong-site surgery is a “never event” as defined by the National Qualify Forum (NQF), and can have serious health consequences for a patient.

We can use a Cause Map to determine some ways to prevent wrong-site surgery. Some of the common errors leading to wrong site surgeries are presented in the Cause Map found on the downloadable PDF. They include: time pressure, lack of paperwork, misreading radiography, not marking or incorrectly marking the surgical site, and marking the wrong site.

Once the root cause analysis is complete, solutions are brainstormed and placed with the cause they control. In this example, we use the solutions to create a basic Process Map for the surgical preparation procedure to prevent wrong site surgeries. The solutions are numbered based on the order they appear on the Process Map. It’s clear that consistent adherence to this Process Map would result in fewer wrong-site surgeries.

Click on “Download PDF” above to download a PDF showing the Cause Map and Process Map.

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