Tag Archives: Process Map

Root Cause Analysis

CDC provides guidance for states to respond to Zika cases

By ThinkReliability Staff

The first Zika cases related to the current outbreak were found in Brazil in May 2015, along with a dramatic increase in microcephaly in babies born in that year. (See our previous blog about the possible link – now verified – between Zika and microcephaly.) Microcephaly is a serious birth defect that impacts many children whose mothers contract Zika while pregnant.

Active Zika transmission currently exists in nearly all of South and Central America, the Caribbean, and some Pacific Islands. 934 people in the US have been infected with Zika; 287 of those infected are pregnant women. Most of these people were infected outside the country and then traveled to the US. Zika is primarily spread by mosquitos, but can also be transmitted through blood transfusion, laboratory exposure and sexual contact.

While no cases of transmission by mosquito have yet been reported in the continental US, the Centers for Disease Control and Prevention (CDC) has released a blueprint for states to respond to locally transmitted cases of Zika. A visual diagram outlining the steps to be taken from the blueprint (a Process Map) can be helpful. (To view the Process Map for the CDC’s interim Zika response process, click on “Download PDF”.)

The CDC’s plan involves four stages. The first stage is implemented during mosquito season. This stage involves surveillance for suspected locally transmitted infections (i.e. persons with “symptoms compatible with Zika virus infection who do not have risk factors for acquisition through travel or sexual contact”, with pending test results). Upon a suspected infection, state officials and the CDC should be notified. State or local officials will open an epidemiological investigation (including ongoing surveillance) and begin implementing controls, involving both reducing mosquito populations and continuing public outreach, with CDC assistance as needed.

Stage 2 occurs upon confirmation of a locally transmitted infection. At this point, notification expands to include local blood centers as well as others required by International Health Regulations. The CDC will assist with an expanded investigation, surveillance, and communication, including deployment of an emergency response team (CERT) if desired. Once Stage 2 has been reached, stand down will only occur after 45 days (3 mosquito incubation periods) without additional infections or when environmental conditions no longer permit transmission.

If there is confirmed Zika in two or more persons whose movement during the exposure period overlaps within a one-mile diameter, Stage 3 (widespread local transmission) is entered. First, local officials will attempt to determine the transmission area, the “geographic area in which multiperson local transmission has occurred and may be ongoing”. Communication, surveillance, testing and controls are enhanced and expanded. Interventions for blood safety and vulnerable populations (including pregnant women) are implemented.

Once the infection has spread outside a county, it enters Stage 4 (widespread multijurisdictional transmission). All steps taken in previous stages are expanded and enhanced. The CDC will evaluate whether local capacity is adequate for response, and will assist as needed. Stage 4 actions will be continued until the criteria for stand down is met.

Based on previous experience with two mosquito-transmitted diseases, chikungunya & dengue fever, the CDC does not believe Stage 4 will be reached within the United States. However, as Dr. Tim F. Jones, an epidemiologist for the State of Tennessee, says, “Even though the percentages and the likelihoods are incredibly low, the outcome is awful.” Risk is a function of probability and consequence. Even with a low probability, the high consequence makes the risk from Zika considerable, and worth planning for.

To view the Process Map, click on “Download PDF” above. Or, click here to view the CDC’s interim guidance.

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Root Cause

The end of the Guinea worm?

By Kim Smiley 

Guinea worm disease is poised to become the second human disease to be eradicated (after smallpox). In the 1980s, there were millions of cases of Guinea worm disease each year and the number has plummeted to only two confirmed cases so far in 2016, both believed to have been contained before the disease had a chance to spread. This accomplishment is particularly impressive considering that there is no cure or vaccine for Guinea worm disease. In fact, the most effective “cure” for the disease used today is the same one that has been used for thousands of years – to wrap the worm around a stick and slowly pull it out. (Read our previous blog “Working to Eradicate a Painful Parasite” to learn more about the problems caused by Guinea worm disease.)

So how has this horrible disease been fought so effectively?  We need to understand how the disease spreads to understand how the cycle was broken.  (Click on “Download PDF” to see a Process Map of the Guinea worm lifecycle.) The Guinea worm is a human parasite that spreads from host to host through the water supply.  The (rather disgusting) lifecycle begins with Guinea worm embryos squirming and wiggling in a freshwater pond, hoping to attract the attention of unsuspecting water fleas.  Once consumed by a water flea, the Guinea worm embryos drill out of the water flea’s digestive tract, move around the body cavity and feed on the water flea.  When a human then drinks the water containing the infected water flea, the lifecycle continues.

The water flea is dissolved by digestive juices in the human’s stomach and the Guinea worm embryo drills out of the intestines and crawls into the abdominal blood vessels, remaining in the body for several months until it reaches sexual maturity.  If the human is unlucky enough to be hosting both a male and female Guinea worm, the parasites will mate.  The male then die and millions of embryos grow in the female.  The female worm will usually make her way to the host’s leg or foot, pierce the skin and release an irritant that creates a painful blister.

Human hosts will often put the fiery blister into water to soothe the pain.  The female worm senses the water and releases thousands of embryos from her mouth.  She doesn’t release all her embryos at once, but will continue to release embryos when she senses water over a period of time.  If the embryos happen to land in a pond with water fleas, the whole painful process can start anew.

Once the lifecycle of the Guinea worm was understood, communities and aid organizations were able to use the information to disrupt the lifecycle and prevent the Guinea worm from spreading.  Some aid organizations helped provide access to clean drinking water or straws with filters that removed water fleas and prevented Guinea worm infections. In other places, the Guinea worm larvae were killed by treating the water with larvicide. But the most effective solution has been simply keeping infected people out of the water supply.  Once most people understood the consequence of putting Guinea worm blisters in drinking water they simply (if painfully) avoided the ponds used for drinking water, but some communities also implemented new laws and fines or posted guards at water holds to ensure that no infected individuals went into the water. These methods have proven very effective and the Guinea worm is now one of the most endangered animals on the planet.

The key to fighting the Guinea worm was education. The most effective solutions were simple and low-tech. No modern vaccine or modern medical knowledge was needed to prevent Guinea worm infections, just knowledge about how the disease spread. Guinea worms have been infecting people for millions of years (they have even been seen in Egyptian mummies), and the lifecycle could have been broken long ago if it had been better understood.

Hospital Acquired Condition

“Desensitization” Process Improves Compatibility of Donor Kidneys

By ThinkReliability Staff

Many patients with advanced and permanent kidney failure are recommended for kidney transplants, where a donor kidney is placed into their body. Because most of us have two kidneys, donor kidneys can come from either living or deceased donors. If a compatible living donor is not found, a patient is placed on the waiting list for a deceased donor organ. Unfortunately, there are about 100,000 people on that waiting list. While waiting for a new kidney, patients must undergo dialysis, which is not only time-consuming but also expensive.

Researchers estimate that about 50,000 people on the kidney transplant waiting list have antibodies that impact their ability to find a compatible donor kidney. Of those, 20,000 are so sensitive that finding a donor kidney is “all but impossible” . . . .until now.

A study published March 9, 2016 in the New England Journal of Medicine provides promising results from a procedure that alters patients’ immune systems so they can accept previously “incompatible” donor kidneys. This procedure is called desensitization. First, antibodies are filtered out of a patient’s blood. Then the patient is given an infusion of other antibodies. The immune system then regenerates its own antibodies which are, for reasons as yet unknown, less likely to attack a donated organ. (If there’s still a concern about the remaining antibodies, the patient is treated with drugs to prevent them from making antibodies that may attack the new kidney.)

The study examined 1,025 patients with incompatible living donors at 22 medical centers and compared them to an equal number of patients on waiting lists or who received a compatible deceased donor kidney. After 8 years, 76.5% of the patients who were desensitized and received an “incompatible” living donor kidney were alive compared to only 43.9% of those who remained on the waiting list and did not receive a transplant.

The cost for desensitization is about $30,000 and a transplant costs about $100,000. However, this avoids the yearly life-long cost of $70,000 for dialysis. The procedure also takes about two weeks, so patients must have a living donor. The key is that ANY living donor will work, because the desensitization makes just about any kidney suitable, even for those patients who previously would have had significant trouble finding a compatible organ. Says Dr. Krista L. Lentin, “Desensitization may be the only realistic option for receiving a transplant.”

The study discusses only kidney transplants but there’s hope that the process will work for living-donor transplants of livers and lungs. Although the study has shown great success, the shortage of organ donations – of all kinds – is still a concern.

To view the process map for kidney failure without desensitization, and how the process map can be improved with desensitization, click on “Download PDF” above. To learn more about other methods to increase the availability of kidney donations, see our previous blog on a flushing process that can allow the use of kidneys previously considered too damaged for donation.

 

Root Cause Analysis

Do you know how an MRI works?

By Kim Smiley

About 30 million magnetic resonance imaging (MRI) scans are performed in the United States each year. They are most frequently used to create images of the brain and spinal cord, but can also help diagnose aneurysms, eye and inner ear disorders, strokes, tumors and other medical issues. MRIs are painless and do not expose a patient to potentially harmful radiation, making them one of the safest medical procedures available.

MRIs are fairly common and most people have heard of them, but do you have any idea how they work?  A Process Map is used to document how a work process is performed, which can be useful when explaining how a process works to somebody who is unfamiliar with it.  To view a high level Process Map of how an MRI is used to create an image, click on “Download PDF”.

The high level Process Map is very basic and would not be useful to somebody trying to learn how to perform an MRI, but it might be helpful in explaining to a patient what to expect during the procedure and how an MRI image is produced.  A more detailed Process Map that included information on each step that needs to be done to perform an MRI could be built for use as a training aid or as a way to document best work practices, but sometimes a basic high level Process Map can also be helpful.

So how does an MRI create detailed images of the inside of a human body? An MRI uses a strong magnet to create a large, steady magnetic field around the patient’s body.  Many atoms, such as hydrogen atoms, have strong magnetic moments that cause them to align in the same direction when exposed to a magnetic field.  Once atoms in the patient’s body are aligned along the field lines of the large magnet, the MRI machine produces a pulse of radio frequency current.  During the pulse of energy (which is extremely brief), atoms in the patient’s body absorb this energy and rotate to align with the radio frequency current.  Once the pulse is over, the atoms will rotate back to their original position, emitting energy.  Atoms in different types of body tissue return to their original positions at different rates and release different energy signals. The body is pulsed many times by different frequencies at different locations to target the specific type of issue being looked at by the MRI. All of the energy emitted by the atoms during these pulses is collected by antennas and a computer uses a mathematical formula to convert the data into images.

Obviously this is a very high level explanation that leaves out a lot of detail, but the basic idea is that an MRI uses changing magnetic fields and the body’s natural magnetic properties to produce detailed images of the human body.  The patient’s role during an MRI is simple (if maybe a little claustrophobic), but the process by which the MRI image is produced is fairly complicated to understand.  Having a simple, visible explanation of what is going on may help make a patient feel more comfortable with their experience.

Can you think of a time when it would be useful to explain the big picture of a work process to somebody, whether a manager or a customer? Creating a simple high Level Process Map to help explain a process to people that aren’t directly involved in the work is something that can be useful across many industries.

Root Cause Analysis

Understanding the diagnostic process is the first step towards improving diagnosis in health care

By ThinkReliability Staff

On September 22, 2015, the Institute of Medicine (IOM) released a report entitled “Improving Diagnosis in Health Care“. To achieve that goal, the committee, “developed a conceptual model to articulate the diagnostic process, describe work system factors that influence this process, and identify opportunities to improve the diagnostic process and outcomes.”

With a goal of improving a given process – in this case, the diagnostic process – it’s important to understand how the process should work in theory (which may be very different from how the process actually works in practice). The conceptual model outlined within the report provides an overview of the theoretical diagnostic process at several different levels of detail.

A Process Map is similar to a geographical map in that it can provide different levels of detail while remaining accurate. For example, a map of a country as a whole typically contains only the most major roads, a map of a city will contain far more roads, and an inset providing detail of a section of the city may contain all the roads. All these maps are accurate; but the city map contains more detail than the national map.

Similarly, an overview of the diagnostic process can be summarized in just four steps: patient reporting of a health problem, information gathering and analysis, diagnosis, and treatment. By adding more detail to this process, the responsive nature of the process is revealed – if sufficient information is not gathered to make a working diagnosis, the process returns to the information gathering step. A similar “decision point” is made after treatment – if treatment is found to be ineffective, the process again returns to the information gathering step for another look at the diagnosis.

Even more detail can be provided about the information gathering step. Information gathering typically involves a clinical history/ interview, a physical exam, diagnostic testing and/or imaging, and referral or consultation with other health care professionals. As the information gathering step can be broken down into more detail, so can the diagnostic testing/ imaging step. In more detail, the diagnostic testing/ imaging step involves ordering diagnostic tests and/or imaging, preparation and collection of the specimen/image, examination of the specimen/ image, result interpretation, follow-up, and incorporating the results into the patient’s medical record. (Because of the similarities at a high level between the diagnostic testing and diagnostic imaging processes, they have been combined in the Process Map on the PDF, but a more detailed process would have separate steps for each.)

When analyzing a complex process, such as the diagnosis process, breaking it down into steps allows for an analysis of problems that occur at each step. Next week, our blog will discuss in more detail the impacts from diagnostic error, potential causes of diagnostic error, and the recommendations from the IOM report to improve diagnosis and reduce diagnostic error.

To view the diagnostic process map at several levels of detail, click on “Download PDF” above. Click here to read the Institute of Medicine report “Improving Diagnosis in Health Care.”

 

Root Cause

How One Hospital Improved Heart Attack Care

By ThinkReliability Staff

The heart is responsible for pumping blood through the body, but it also requires blood flow to continue functioning. When the blood supply to the heart is cut off, it’s known as a heart attack and it can be deadly. According to the Centers for Disease Control and Prevention (CDC), about 15% of people who have a heart attack will die from it. Time is of the essence when treating heart attacks. Again according to the CDC, “The more time that passes without treatment to restore blood flow, the greater the damage to the heart.”

Treatment to restore blood flow is generally a balloon (which pushes aside the blockage) and a stent (which holds the artery open). In the United States, this is performed in a hospital. Although hospitals can’t control the amount of time it takes to get a heart attack victim TO the hospital, they can control the time from when a patient enters the hospital until treatment is begun. This is known as the door to balloon (or D2B) time.

A national campaign to improve the speed of heart attack treatment was launched. At that time, the typical heart attack process went like this: a patient suffered a heart attack and (hopefully) 911 was called. An ambulance picked up the patient and delivered them to a hospital. Once the patient arrived at the hospital, an electrocardiogram (EKG) was taken and transmitted to a cardiologist, who determined whether or not the patient was suffering from a heart attack. If it was a heart attack, an interventional cardiologist and other members of the heart attack team were called and made their way to the hospital. The patient was taken through a consent and surgical prep process, and then then balloon and stent were installed. At this time, the national goal was for half of patients to receive a stent and balloon within 90 minutes of arrival at a hospital.

One of the hospitals to take up the challenge was Our Lady of Lourdes Medical Center in New Jersey. In 2007, heart attack treatment was on par or better than other hospitals, with half of patients treated within 93 minutes. (In many locations it took more than 2 hours.) By 2011, treatment time was down to 71 minutes. The head of the cardiovascular disease program challenged the staff to continue to decrease the time and staff members set up a “D2B task force”. This task force looked at each step in the process for potential improvements. Some individual steps were shortened. The forms required for consent were reduced as much as possible. The time spent individually calling in all the members of the cardiac care team was reduced by having a single call ring to all their pagers. Those on the team that were on call were limited to being 30 minutes away from the hospital.

Other steps, instead of being performed one after the other, were performed simultaneously. Instead of waiting for the patient to arrive at the hospital for an EKG, it is taken in the ambulance and transmitted to the emergency room. Each step required for surgical prep is performed as much as possible simultaneously by a team. Additionally, one surgical room is reserved for heart attack patients and is kept stocked with necessary supplies.

Now the median D2B time is 50 minutes. This was demonstrated on March 29, when a patient arrived at the medical center at 1:54 AM and whose D2B time was 55 minutes. This was unusually long for the center. What caused the difference? Because the patient was a 49-year-old woman with ambiguous symptoms, the emergency room doctor waited until the patient arrived at the hospital for another EKG to verify the heart attack before the heart attack team was called.

From 2003 to 2013 the death rate from coronary heart disease has fallen 38%. Some of this drop is attributed to better control of cholesterol and blood pressure, but some is surely due to quicker treatment at most US hospitals.

The “before” and “after” process map that shows the flow of heart attack treatment at Our Lady of Lourdes Medical Center can be diagrammed visually to show how the process flows. To view the process map, the problem outline and timeline of the treatment of the heart attack patient on March 29, 2015, please click on “Download PDF” above. Or click here to read more.

Root Cause

Program Reduces Use of Antipsychotics & Improves Resident’s Quality of Life

By ThinkReliability Staff

Although the use of antipsychotic drugs for nursing home residents suffering from dementia can increase their risk of death and falls, they are still prescribed for nearly 300,000 nursing home residents across the U.S. The “Nursing Home Patients Bill of Rights” allows their use only under specific conditions: “psychoactive drugs (including antipsychotics as well as drugs for depression and anxiety) may be administered only on the orders of a physician and only as part of a written plan designed to eliminate or modify the symptoms for which the drugs are prescribed. Such drugs may be given only if, at least annually, an independent, external consultant reviews the appropriateness of the drug plan of each resident receiving such drugs.”

Despite the risk of these drugs, and the requirement that their use be continually reviewed, some nursing home residents are given antipsychotic prescriptions and are never taken off them. In 2009, the staff of a small nursing home decided to embark on a program to reduce the use of antipsychotics. It was so successful that they extended the program to all the nursing homes owned by the nonprofit Ecumen. After the first year, antipsychotic use was reduced 97%. At the original facility, 5-7% of residents receive antipsychotics, compared to the national average of 19%.

The change in the residents’ quality of life was dramatic after the program was instituted. Because the residents “came alive and awakened”, they called the program Awakenings. To understand how the program works, it’s helpful to imagine the program being the solution to the problem of overuse of antipsychotics in nursing homes.

First, viewing the problem with respect to the organization’s goals can help determine what the real issue to be addressed is. In this case, resident safety and resident quality of life are two important goals of a nursing home. Resident safety is impacted by the use of antipsychotics because it increases the risk of death and the risk of falls. Resident quality of life is impacted because the use of antipsychotics was not being effectively re-evaluated as required.

The risk of increased death and falls are both related to the use of antipsychotics, which have been found to increase death in those with dementia and also increase the risk of falls. Generally the residents at the nursing home were found to have been prescribed antipsychotics as an intervention to some type of behavior resulting from the dementia (wandering, aggression, resisting care) and the resident’s need for antipsychotics was not effectively re-evaluated, so residents remained on the drugs.

A program to reduce their use had to address both of these causes. The nursing home team consulted with experts to begin weaning patients off the antipsychotics. The Awakenings process then addressed the behaviors being treated with the medication. For each resident, both the medical and personal history is taken into account while developing a care strategy. The care strategy is distributed to the entire care team, including housekeepers and cooks. The care strategy uses as many non-medication-based interventions as possible – and addresses all of the resident’s five senses. Some of the strategies include balloon volleyball, massage, aromatherapy and white noise. For those familiar with the Plan-Do-Check(Study)-Act, this is the “Plan” step.

The care plan is implemented by all staff (Do) and all staff participate in observation and assessment to monitor problem behaviors or other issues (Check/ Study). When issues do arise, the care plan is adjusted – whenever possible, without use of additional medication (Act). The process is described by the Awakenings program like this: “Long-term antipsychotic use masks behavioral symptoms rather than addressing them.   Awakenings discovers unmet needs that often trigger behavioral symptoms and addresses the triggers with non-pharmacological care techniques.  This is done in collaboration with a physician to reach the optimum balance and benefit of non-pharmacological and biomedical approaches.” Although the initial setup is expensive; as Dr. Mark Lachs, chief of geriatrics at Weill Cornell Medical College says, “Behavioral interventions are far more time-consuming than giving a pill”, the staff is pleased with the results and optimistic for the future. Laurel Baxter, the Awakenings project manager says, “I believe we may learn that spending a little time now with a resident, preventing the use of psychiatric medications and their side effects, you’ll save time and money in the long run. I’m optimistic.”

To see the root cause analysis of antipsychotic overuse in a Cause Map (or visual diagram of cause-and-effect relationships) and the Awakenings process, please click on “Download PDF”.

Root Cause

27 Patients to be Tested After Ultrasound Probe Sterilization Error

By ThinkReliability Staff

On December 21, 2013, 27 men were notified that, due to improper sterilization of equipment used for their prostate procedures, they should be tested for HIV and hepatitis B and C.   Both the medical center and patients involved are understandably concerned about how they got to this point.

In order to better understand the issues involved, we can put together an investigation file using Cause Mapping, a visual form of root cause analysis.  First, we capture the basic information about the issue.

The procedures were performed from September 19 to December 10 of this year at a Seattle medical center and involved ultrasound probes used for prostate procedures.  Because more than one date is involved, we can use a timeline to add more detail to the investigation.  In this case, patients were found to have been affected beginning September 19 and ending December 10, though it’s not clear if the incorrect sterilization began on that date, or if that was the first date that a probe was used on a patient with a communicable disease.  The improper sterilization was reported to hospital officials December 17 and affected patients were notified beginning December 21st.  As a result of information released by the medical center, we know that one step in the sterilization process for the probes was not completed.  We capture this as an important “difference” that may aid in the analysis.

Next, we determine the goals that were impacted as a result of the issue.

The patient safety and patient services goals were impacted due to the risk of disease transmission for the 27 patients (the probability of which is estimated to be very low).  The compliance goal is impacted because of equipment that was not sterilized as required.  The labor goal is impacted because the medical center is paying for two rounds of HIV and hepatitis testing for the affected patients.  If it is determined over the course of the investigation that other goals were impacted as well, these can be captured in the Problem Outline as well.

Once we have determined the impacted goals, we use these goals as the first “effect” to determine the cause-and-effect relationships that resulted in the issue.  In this case, the patient safety and services goals were impacted due to the risk of disease.  The disease risk resulted from the reuse of prostate probes that had the possibility to spread disease.  The disease risk occurred because the probes may have been used on a patient that had a communicable disease and the probes were not properly sterilized before their reuse.

We can show the steps that should have occurred in the sterilization process of these probes, as well as where the specific issue in the process occurred, in a Process Map.  This map shows the steps involved in a procedure, in this case the ultrasound probe sterilization procedure.  After a probe is used, it goes through a three-step process, involving cleaning, disinfecting or decontaminating with a disinfectant spray, then sterilization by being doused with sterilization fluid.  Then the sterilized equipment is placed in a protective sheath before re-use.  (Because of the use of this protective sheath, the probe, when properly used, does not contact the patient, decreasing the risk of disease transmission.)  In this case, the sterilization step was not performed.

We include the fact that the procedure was not performed properly in the Cause Map.  The Chief Medical Officer reports that their investigation found that the cause was “human error” and no more information has been released.

In order to determine effective solutions to prevent the issue from recurring, more detail needs to be obtained about the expectations for the process being performed, as well as the verification (if any) that took place to ensure that the procedure was being performed correctly.  Once it’s possible to determine what allowed the process to break down, safeguards that will reduce the risk of it happening again can be implemented.

To view the initial investigation file, including the Outline, Cause Map, Timeline and Process Map, please click “Download PDF” above.

Root Cause

Teen Dies From Peanut Reaction Despite Epinephrine Injections

By ThinkReliability Staff

Even with the best medical treatment known provided quickly after an anaphylactic reaction, a teen died after taking a bite of a snack containing peanuts, to which she was severely allergic. It is important to note that the snack was not clearly marked to contain peanuts and it was a style of treat (Rice Krispies) that would not ordinarily contain peanuts.

In a situation requiring emergency response, it is important to ensure that all the prescribed steps were taken.  The required steps can be diagrammed visually within a Process Map.  In this case, all available actions were taken to attempt to reverse the allergic reaction. (View the Process Map of the appropriate food allergy response by clicking “Download PDF” above.)

For reasons as yet unknown, food allergies have been increasing over recent years.  This has resulted in a greater risk for anaphylactic reactions, which can result in serious injury and even death, usually from throat closure from swelling (known as severe laryngeal edema).

According to John Lehr, the Chief Executive Officer of  Food Allergy Research & Education:  “Avoidance is the only way to avoid a reaction, but we know accidents happen.  That’s the insidious nature of food allergies.”

Because avoidance is the only way to avoid an anaphylactic reaction, many schools and other public facilities have stopped offering any food containing peanuts.  Others have designated peanut-free zones to help those with allergies avoid contact with peanuts.  (Although peanut allergies are not the most prevalent, they are the most dangerous, both from reaction severity and likelihood of contact.)  Certainly, snacks containing peanuts must be clearly marked as such.

Because of the high risk of serious injury or even death from food allergies,  please pass the word about food allergies.  If you are an allergy sufferer, ensure that you have multiple epinephrine auto-injectors that have not expired.  It may save your life.  (Although up to 40% of anaphylaxis victims require two or three epinephrine injections, death after receiving injections is extremely rare.)   Also note, from John Lehr:  “We tell people that their last reaction is not an indication of their next reaction.  Don’t think because you have not had a severe reaction that you can’t have one.”  If you provide food to the public or children, consider removing peanuts from your  kitchen and at the very least, clearly mark anything that does contain peanuts.   Remember, the risk from food allergies is very real, and can be very severe.

You can see the cause-and-effect relationships that led to this tragedy, as well as the Process Map discussing anaphylactic response, in visual form, by clicking “Download PDF” above.  Or click here to read more.

Root Cause

Patient Receives Unneeded Mastectomy

By ThinkReliability Staff

Information about a lab mix-up that resulted in a patient receiving an unnecessary mastectomy was recently released by a health authority in Nova Scotia, Canada.  The authority has conducted an investigation into the error and how it occurred.  We can look at some of the information that will need to be considered in order to reduce the risk of a similar issue recurring.

First, we capture the “What”, “When”, and “Where” of the incident.  In this case, a switch of pathology results occurred in late April, 2013 at a cancer center in Nova Scotia.  The error was caught as a result of oversight analysis of tissue samples.

We can capture the goals impacted as the result of the issue.  In this case, the patient safety goal was impacted because a patient (Patient 1) received an unnecessary surgery (mastectomy).  In addition, the patient safety goal was impacted because another patient (Patient 2) did not receive a necessary surgery.  The staff employees are impacted because they are reportedly devastated, as frequently happens in cases like these.  The organization goal is impacted due to the apology given to the public as a result of this issue.  The patient services goal is impacted due to a switch of the tissue samples.  The property goal is impacted because an unnecessary procedure was performed, and the labor goal is impacted due to the extensive investigation that is taking place.

Asking “Why” questions can help determine the cause-and-effect relationships that led to the impacted goals.  In this case, the patient safety impacts are due to the switching of the patient’s sampling.  This occurred due to the results being recorded into the wrong records.

While trying to solve a problem, it can be helpful to examine the related processes.  In this case, we look at the tissue sampling process.  Any process is meant to get from point A to point B. In this case, the process ideally takes us from a tissue sample being taken (point A) to a diagnosis (point B).  We know that we did not get to point B in this case (i.e. the diagnosis was incorrect).  Looking at the steps in more detail can help us determine which specific part of the process did not go as intended, which will allow us to identify process-specific solutions.

A sample is taken from a patient, labeled, and sent to the lab.  The lab tests the sample, obtains the results, then delivers them to the patient’s physician or care center.  At that point, the results are recorded in the patient’s records and then used to make a diagnosis.  The error reportedly occurred at the point where the results were entered into the patients’ records.

Once we’ve identified the specific point where the error occurred, we can identify potential solutions.  In this case, the facility involved is implementing bar-coding and moving towards an automated system.  Although there is still the potential for error, it is reduced with automated systems and bar codes because the data has to be transcribed fewer times. As the Premier of Nova Scotia stated, “Human error is always a possibility. But one of the things we strive for is to ensure there are appropriate controls in place to ensure that the risk of these things is absolutely minimized.”

To view the Cause Map and Process Map, please click “Download PDF”.