Category Archives: Never Event

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.

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.

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.

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.

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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Hospital Acquired Condition, Never Event, Root Cause Analysis

Don’t Plug That In! (Preventing Electrocution in Healthcare Facilities)

By ThinkReliability Staff

Patient death or disability associated with electric shock is one of the never events as defined by The Joint Commission. In order to reduce the occurrences of these unfortunate events, we can perform a root cause analysis on an event that has already occurred. This will allow us to apply the lessons learned to keep this type of event from happening at other facilities. 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.

The first step to a root cause analysis is to define the problem. On an unknown date, a patient was electrocuted and killed while undergoing heart monitoring at a medical facility. The heart monitor was plugged in to an IV pump inadvertently. We put the incident in the context of the organization’s goals: the patient safety goal was impacted because of the death of a patient; the staff was devastated, resulting in employee impact, and the compliance goal was impacted because this was a never event.

Once the problem has been defined, we use the impacts to the goals to begin the second step, analysis. Thegoals become the first cause boxes in our Cause Map. We ask “why” questions to fill in the remainder of the map. Here, the patient was electrocuted because she was hooked up to a heart monitor, and electricity flowed through the heart monitor. The electricity was present because the heart monitor lines were plugged into an IV pump, and the IV pump was plugged into the wall. The heart monitor lines were plugged into an IV pump because a staff member was attempting to reconnect the heart monitor and confused the monitor and the IV pump, and the heart monitor lines were able to be plugged in to the IV pump.

The last step is to define solutions. Here, we’ve only put two solutions, though more are possible. One is to change the adapters so that it isn’t possible to plug the heart monitor into another piece of equipment. Another is to institute a lock-out procedure, so that other pieces of equipment in the room are de-energized (if possible) or tagged to prevent confusion.

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 Root Cause Analysis Investigation.

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Hospital Acquired Condition, Never Event, Root Cause Analysis

Can a Fire Get You Fired? (Preventing Patient Burns in Healthcare Facilities)

By ThinkReliability Staff

Patient death or disability resulting from a burn received while at a medical facility is a “never” event as defined by the National Quality Forum. Medicare has announced that it will not reimburse medical facilities for treatment required as the result of a burn obtained at that facility. Although there are many different ways a patient burn could occur, we will look at  root causes for some of the more common situations that result in a patient burn.

Serious patient burns can result from exposure to hot equipment (typically an electrosurgical device placed on the patient) or from a surgical fire. A surgical fire, like all fires, requires three things to occur: an oxidizer, fuel, and an ignition source (or heat). In surgery, the oxidizer can be provided by atmospheric air, nitrous oxide, or an oxygen-enriched atmosphere. This leg of the fire triangle is typically controlled by an anesthesiologist.

There are many fuel sources in an operating room. Common operating room material, like drapes, gowns, sterile pads and gauze, is flammable under the right conditions, as are certain volatile prepping solutions and ointments, the patient’s hair, and body gases. Fuel sources are generally under the control of the nursing staff.

The most common ignition (heat) sources in the operating room are lasers and electrosurgical devices. These are generally controlled by the surgeon.

Because the three legs of the triangle are controlled by three different people in the operating room, good communication is essential. There are also some other operating procedures that reduce the risk of a fire. These solutions are shown in green boxes on the downloadable PDF.

Click on “Download PDF” above to download a PDF showing the Root Cause Analysis Investigation.

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Hospital Acquired Condition, Never Event, Root Cause Analysis

Patient Falls: A Cause Mapping Example

By ThinkReliability Staff

Patient death resulting from a fall is one of the National Quality Forum’s “Never events” and death or serious disability resulting from a fall is also on the list of hospital-acquired conditions that Medicare/Medicaid will no longer reimburse for. For these reasons, as well as reasons of patient safety, healthcare facilities must work on reducing the risk of patients falling.

Because there are myriad ways a patient can have a fall, we will show an example of a specific case. In this case, a disoriented patient (who was considered a high fall risk) was left alone in an imaging room, without being strapped on, after radiographs were taken. The patient ruptured an eyeball, resulting in blindness in one eye. The medical facility involved received a fine of $25,000.

During the root cause analysis, the facility determined that the policies regarding high fall risks were not followed in this case. As a result, the facility has instituted safety education for the imaging staff, a monitoring process to ensure policies are being followed, and a program whereby a clinical staff member accompanies high fall risk patients to the imaging room. These are the solutions to the root cause analysis.

Although the analysis we performed is specific to this case, the solutions and thought process are not. To reduce falls, every facility should re-evaluate its fall risk program. Are the criteria still valid and being uniformly applied by all staff? Is there more that can be done to reduce the risk of falls? We can help you take a similar incident from your facility to help you improve safety processes.

Click on “Download PDF” above to download a PDF showing the Root Cause Analysis Investigation.

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Hospital Acquired Condition, Never Event, Root Cause Analysis

Oh, the Pressure! (Reducing Cases of Stage III and IV Pressure Ulcers)

By ThinkReliability Staff

Stage III and IV pressure ulcers have been added to the list of hospital-acquired conditions whose treatment will no longer be reimbursed by Medicare. Pressure ulcers are also on the list of “Never” events, or incidents that should never occur at healthcare facilities, and can lead to serious complications from patients who suffer from them. It is imperative that healthcare facilities reduce the risk of patients contracting pressure ulcers.

To reduce the risk of pressure ulcers, a root cause analysis can be performed. Not only can we use root cause analysis to determine the causes of incidents that HAVE occurred at our facility, we can outline the ways incidents COULD occur, or, in this case, what is required for a patient to contract pressure ulcers. For this, we use a proactive Cause Map (or visual root cause analysis).

We start our analysis by examining the impact to the goals. There are many impacts to the goals, but we will just focus on two: the patient safety goal is impacted by a patient contracting a stage III or IV pressure ulcer, and the compliance goal is impacted because this is a “never” event. To continue the Cause Map, we ask “What caused this?” and put the answer to the right. So when we ask “What caused the pressure ulcer?” we write “Death of tissue.” We then continue through the Cause Map this same way.

Death of tissue is caused by poor skin condition and mechanical damage to the tissue. Poor skin condition can be caused by a number of things, including poor environment, contaminants on the skin, and inadequate nutrition.

There are three types of mechanical damage to skin that causes pressure ulcers. These are shear, friction, and pressure injuries. Shear injuries can be caused by the head of a patient’s bed being elevated (so that the skin pressed against the bed is damaged as the rest of the body tends to be pulled downwards by gravity). Friction injuries can be caused by skin being drug over skin linens (to reposition an immobile patient, for example) or by bony prominences (such as knees and ankles) contacting each other. Pressure injuries are generally caused by a patient remaining in the same position. Causes of this are lack of knowledge about pressure ulcers, and being unaware of a specific patient’s risk.

There is more detail that can be added to this root cause analysis, but for the purposes of this example we will stop here and begin looking at solutions. Any cause box on the map can have a solution, or several solutions, but not every box will have a solution. Some solutions that have been compiled from various resources are shown in green boxes. Both the Cause Map and solutions can be broken out into more detail, depending on the needs of the organization.

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

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Hospital Acquired Condition, Never Event, Root Cause Analysis

Type AB? Negative. (ABO-Blood Incompatibility)

By ThinkReliability Staff

Blood incompatibility is a Sentinel Event as defined by The Joint Commission. If a blood incompatibility incident occurs at a medical facility, a root cause analysis is required for the event. What would the root cause analysis look like? We will look at a proactive Cause Map (visual root cause analysis) and associated Process Map as an example.

A recipient being given incompatible blood product is an impact to the patient safety goals (as well as other goals, but we’ll start simple). This could occur if the ABO blood type is identified incorrectly, probably due to mislabeling. It could also occur if the recipient’s blood type is identified incorrectly, possibly due to the recipient test specimen being mislabeled. Or it could occur if blood product is given to the wrong patient due to misidentification of the recipient. There are many other ways it could occur, but these three errors are the source of many blood incompatibility incidents.

As we enter these causes into our Cause Map, we note that these are all procedural errors. When procedural errors appear in the root cause analysis, making a Process Map can assist in the investigation. To make a Process Map, we start with the very basic process. For example, to perform a blood transfusion, we order a transfusion, take a sample from the recipient, test that sample while prepping the patient for a transfusion, pick up blood product from the blood bank (which was deposited there at some point previously), perform the blood transfusion, and then monitor the recipient for reactions.

Then we go into more step by step detail outlining portions of the transfusion process. Then we can identify the specific steps of the procedure that can lead to blood incompatibility incidents when performed incorrectly. This allows us to come up with procedural solutions (such as having a second medical professional positively identify the recipient) that focus our attention on the steps most likely to be performed incorrectly or most likely to lead to serious errors.

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

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