Monthly Archives: November 2014

Root Cause

Patient Rediagnosis Lifts Death Sentence

By ThinkReliability Staff

A patient diagnosed with stage-four lung cancer and given less than a year to live was relieved to have the correct diagnosis – treatable sarcoidosis. However, he was then concerned about how the misdiagnosis occurred in the first place, risking his health had he gone along with a recommendation for chemotherapy.

After nearly a year of coughing, the patient underwent a CT scan and was diagnosed with sarcoidosis, a treatable lung disease. Shortly after that diagnosis, a lung biopsy found the presence of stage-four lung cancer. The patient was referred to an oncologist, who recommended chemotherapy. Luckily for the patient, the diagnosis didn’t seem right and he sought a second opinion. Although the tissue samples from the initial biopsy tested positive for stage-four lung cancer, additional biopsy results showed that he did not have cancer.

In order to reduce the risk of a diagnosis error like this one occurring in the future, it’s important to identify all the causes that contributed to the issue. We can capture these cause-and-effect relationships in a Cause Map, or visual root cause analysis. The first step in the Cause Mapping process is to capture the impacts to the goals. In this case, there was a potential safety impact to the patient receiving unneeded chemotherapy, which could have potentially caused a worsening of the actual disease from which he was suffering. The patient services goal was impacted by the misdiagnosis and the property and labor goals were both impacted by the potential for unneeded treatment, as can occur with any misdiagnosis.

Once the impacts to the goals have been determined, the next step is to determine the cause and effect relationships by beginning with an impacted goal and asking “Why” questions. The misdiagnosis resulted from the contamination of a biopsy sample sent to the lab to determine the pathology of the disease. The patient’s lab sample was contaminated with stage-four lung cancer from another patient. (DNA testing confirmed the presence of both the patient’s biopsy sample and tissue from a sample of the lung cancer sufferer.) The presence of DNA from both samples indicates that they were cross-contaminated, though the method is still unknown. (The patient with lung cancer was properly diagnosed.) Because the two diseases are pathologically similar, it was not immediately clear that there was a problem with the sample used to make the diagnosis.

Once the patient sought another opinion, it was verified that the first biopsy sample did contain cancer cells. However, another biopsy and blood tests showed he did not have cancer. The original hospital confirmed their diagnosis of cancer even after this information until another biopsy was performed at that facility. Five months after the initial cancer diagnosis was the diagnosis updated to sarcoidosis. The patient filed a complaint with that hospital, as well as the hospital where chemotherapy was recommended, on October 23, 2014.

Once all the causes are determined, solutions can be determined that address the various causes. Because it’s still not clear how the cross-contamination at the lab occurred, an investigation specifically addressing that issue should occur, looking in detail at the specimen handling procedures and adding improvements where necessary to reduce the risk of cross-contamination. (The risk is already very low; the lab has said that it generally handles 70,000 specimens a year and this is the first contamination issue known.)

Additionally, the method for reconsidering diagnoses based on additional testing from alternate providers must be examined. Though the initial misdiagnosis in this case, based on a lab sample that clearly showed the presence of cancer cells, is understandable enough, the ensuing delay in updating the diagnosis despite heavy pushback from the patient is not. Ideally the lessons learned from this case will provide safer and more effective healthcare for everyone.

Root Cause

Deaths and Arrests Leave Many Questioning Mass Sterilizations

By ThinkReliability Staff

The deaths of 13 women after they underwent tubal ligation (female sterilization surgery) at a government- run clinic in India have resulted in outrage and arrests, but few answers. It is known that shortly after one of these mass sterilizations on November 8th at a mobile clinic, the women became ill and died.  The doctor was arrested for performing 83 sterilizations in 6 hours when government regulations permit only 30 in a day.  (The doctor says that pressure and incentives from the government encourage more sterilization surgeries despite guidelines.)  The cleanliness of the tools used for the surgeries as well as of the clinic itself are believed to have caused infections that led to severe septic shock that resulted in these deaths.

However, patients from different clinics who had taken antibiotics from the same batch used at the sterilization clinic also became ill, raising the question of contaminated – or outright counterfeit – drugs.  The owner and son of the manufacturing clinic that provided the antibiotics were also arrested.  It’s now believe that the women exhibited signs of potential poisoning and that trace amounts of a chemical used in rat poison were found in tests of the batch of antibiotics.  The signs of poisoning and septic shock can be similar, so additional testing is needed.

Either way, it’s clear that the care these women received was substandard.  Not only is the condition of the clinics and medication in question, but also the use of these surgeries as a form of family planning, which is common in the area.  In a survey, 34% of households indicated that female sterilization was their main method of family planning. Availability of less permanent birth control and medical care are limited, and population is booming.  The government has encouraged female sterilization, not only by running the mobile clinics but also paying the women who are sterilized.  The women who died from the procedure were given 1,400 rupees, or about $23 US.

Although there is currently limited information on what exactly lead to the death of these women, an analysis of those things that went wrong can still be useful to look for solutions.  (Click “Download PDF” above to view the one-page overview of a Cause Map, or visual root cause analysis, of what is known so far.)  Each possible cause (which indicates that more evidence is needed) can be developed with additional detail when more information is available.

Post-mortem inspection of the women who were killed indicated that their deaths were due to septic shock from severe infections.  The infections were believed to have been obtained during the surgery due to dirty tools or poor conditions.  (It’s not surprising that a clinic with limited resources known for having substandard cleanliness would struggle to ensure clean equipment for 83 surgeries in 6 hours.)  If the antibiotic they were given in order to fight potential infection was adulterated (and not providing the desired active ingredients, or too little of them to be effective), it would decrease the women’s ability to fight off the infection.

The potential poisoning (supported by sickness of others who received medication from the same batch) is believed to be due to counterfeit or adulterated medication.  Preliminary testing showed the presence of a chemical used in rat poison within the medication.  Counterfeit and adulterated drugs are both a problem in India; the World Health Organization (WHO) estimates that as many of 1 in 5 drugs made in India are fake.  The US FDA prevents the importation of the antibiotic used at the clinic from India.  Drug inspectors in the area indicate that about 25% are of substandard quality due to poor manufacturing practices.  Enforcement of drug quality is limited in the area, and issues with medication are seen frequently.

As mentioned above, both the surgeon and the owners of the pharmaceutical manufacturing facility have been arrested.  Both sterilizations and the use of certain drugs have been limited in the area until the causes resulting in the women’s deaths have been determined.  What hasn’t happened (yet) is a serious look at the country’s method of family planning in hopes that these types of tragedies never happen again.

Root Cause

Chronic Obstructive Pulmonary Disease (COPD) is Strangling Nation’s Health

By ThinkReliability Staff

The facts about chronic obstructive pulmonary disease (COPD) aren’t pretty.  COPD is not one but a group of diseases that impact airflow and breathing.  Included in the group are emphysema and chronic bronchitis.  (These diseases are grouped together because they are commonly diagnosed together.) COPD is the third leading cause of death.  In 2010, it was the cause of death of 135,000 Americans.  Every year, COPD results in millions of visits to the doctor’s office or emergency room and hundreds of thousands of hospitalizations, which last an average of almost five days.

All that medical care doesn’t come cheap.  COPD is the fifth most expensive disease in the US, with $32.1 billion in direct medical costs.  (In addition, billions of dollars are attributed to absenteeism and mortality costs as a result of COPD.)  An additional concern is that many COPD sufferers are rehospitalized soon after release.  COPD is the third most common cause of 30-day rehospitalization.  Under the Hospital Readmissions Reduction Program (HRRP), penalties or loss of benefits are applied to hospitals with greater than average rehospitalization.  The penalty for readmission of COPD patients beyond average is $33,000.  Of US hospitals, 44.5% received readmissions penalty in 2013.

Because there is no cure for COPD, limiting rehospitalizations primarily involves ensuring appropriate treatment to limit symptoms, and exacerbations, which account for 50-75% of medical costs.  However, there are actions that can slow the progression of COPD.  By diagramming the cause-and-effect relationships resulting in progression of COPD in a Cause Map, we can visually show how solutions act on these causes.  As discussed above, impacts to goals associated with COPD include patient safety (deaths), environmental (exposure to air pollutants), compliance (potential for penalties/ loss of benefits), patient services (high levels of rehospitalization), operations (absenteeism) and property/labor (direct medical costs).  These impacts are primarily caused by exacerbation of COPD.

Exacerbation of COPD results from the progression of the disease and delayed treatment.  COPD develops due to exposure to air pollutants (primarily tobacco smoke or industrial chemicals), genetic factors (which are just beginning to be understood), and respiratory infections or untreated asthma.  Because there is no cure for COPD, time without treatment is the primary way that symptoms increase.  (82% of COPD sufferers are over age 65.)  Inadequate treatment typically results from the underdiagnosis of COPD (experts predict 10-12 million sufferers have not yet been diagnosed) and insufficient adherence to a medication regime.  Based on self-reported values and pharmacy claims, adherence to prescribed medication regime is 32-50%, meaning less than half of COPD sufferers are following doctor’s orders with regards to their COPD, even though studies have also found that optimized medications can reduce exacerbations of COPD by 20%.

Along with underdiagnosis, a cause of exacerbations is delayed treatment.  Part of this is also caused by insufficient adherence to a prescribed medication regime, but also to delayed reporting.  Symptoms of an exacerbation generally occur about a week prior to a discernible reduction in lung function, but all too often that week is spent without medical care because patients tend to delay reporting symptoms until their lung function is affected.

To reduce the impact of COPD as well as the potential for rehospitalization, the following is recommended:  First, the biggest impact an individual can have on COPD is to stop smoking.  Individuals should also reduce their exposure to air pollutants, including cigarette smoke and industrial chemicals (whether at the work place or in home cleaning products).  Those experiencing an exacerbation of symptoms should report it immediately and should follow all medication guidelines given by their doctor.  For doctors, guidelines for the use of spirometry (a breathing test to measure lung function) can provide a more accurate diagnosis of COPD.  Presenting information to patients about the importance of the above measures can also help reduce COPD exacerbations and potential for rehospitalization.

To view a one-page PDF with an overview of the cause-and-effect relationships, and recommended solutions for minimizing the impact of COPD, please click “Download PDF” above.    Or, visit the COPD Foundation to learn more.  You can also view a Cause Map of America’s Smoking Epidemic, here.

Root Cause

Re-engineered connectors may prevent tubing mix-ups

By ThinkReliability Staff

Patients being treated at healthcare facilities may have multiple tubing connections designed to provide different medical treatment products.  Disaster can occur when tubing is connected incorrectly.  The most well-studied example is when enteral feeding solutions are accidentally directed into intravenous (IV) lines.  The Joint Commission (TJC) found 116 case studies, including 21 that resulted in deaths, due to this type of misconnection, discussed in a recent Sentinel Event Alert.  In 2006, this happened to a pregnant woman, resulting in the death of both her and her fetus.  (See our previous blog on this topic.)

Issues involving tubing misconnections have been reported since the 1970s and are not limited to feeding tube/ IV mix-ups.  Many types of tubing for medical product delivery are susceptible to misconnection due to the use of luer connectors, which allow a high degree of connection compatibility.  Concern is growing over these types of connections, and it’s become clear that training is not adequate to prevent these types of connections.  According to the Joint Commission, “The basic lesson from these cases is that if it can happen, it will happen.  Luer connectors are implicated in or contributed to many of these errors because they enable functionally dissimilar tubes or catheters to be connected.”

Action is being taken that would prevent these misconnections by ensuring that each type of tubing has its own, non-compatible connector.  The Association for the Advancement of Medical Instrumentation (AAMI) is leading an international initiative to develop small-bore connectors standards.  Public review of the standards is now available (along with other helpful information including case studies) on the AAMI website.  The State of California has passed legislation requiring manufacturers of intravenous, epidural or enteral feeding devices to implement the new standards that aim to prevent misconnection, though it does not take effect until January 1, 2016.

Connectors meeting the new, non-compatible standards are becoming available but compatible connectors may still be in use and in inventory systems.  To limit risk of patient death or serious impairment while the new connectors are phased in, TJC recommends that tubing is traced from the patient to its point of origin every time it is connected, disconnected, or during a patient hand-off.  Labeling high-risk tubing and routing tubes and catheters in specific directions (towards the head for IVs; towards the feet for enteric feeding tubes) has also been recommended to reduce the risk of misconnection.

Going forward, only equipment that is incompatible with female luer connections on IVs should be purchased for all non-IV equipment and acceptance testing should be performed on new purchases to ensure it is not compatible with IV tubing connections.

The cause-and-effect relationships leading to the patient safety risks, and the solutions that are being recommended can be visually diagrammed in a Cause Map, or visual root cause analysis.  To view a one-page overview of the issue, please click on “Download PDF” above.