All posts by ThinkReliability Staff

ThinkReliability are specialists in applying root cause analysis to solve all types of problems. We investigate errors, defects, failures, losses, outages and incidents in a wide variety of industries. Our Cause Mapping analysis method of root causes, captures the complete investigation with the best solutions all in an easy to understand format. ThinkReliability provides investigation services and root cause analysis training to clients around the world and is considered the trusted authority on the subject.
Root Cause

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

Hospital Admits Fault, Implements Improvements after Death due to Medication Error

By ThinkReliability Staff

A hospital in Oregon administered the wrong medication to a patient who stopped breathing. Because of a fire alarm that happened shortly afterwards, the patient was not monitored for about twenty minutes. After that time the patient had experienced irreversible brain damage and was taken off life support on December 3, 2014.

In a surprising move, the hospital has taken responsibility for the error. Dr. Michel Boileau, the chief clinical officer, has stated, “We do know there was a medication error. We acknowledge that. It’s our mistake.” While an Oregon law, which took place in July, encourages transparency with patients and loved ones and reporting in the case of medical errors, the hospital says communication in the case of errors has been its practice for years and that it’s the right thing to do.

Supporting the transparency, the victim’s son says, “We want the community to know what happened. Precautions need to be taken. The only message we really have is that life is short and you never know when something like this could happen.”

Detailed information regarding the case has been released in the media. Using that information, it is possible to put together a Cause Map showing the cause-and-effect relationships that led to the death, and show how the hospital’s planned improvements address the causes.

In this case, administration of the paralyzing agent Rocuronium instead of the prescribed anti-seizure medication fosphenytoin caused the patient to stop breathing, leading to cardiac arrest and irreversible brain damage. Monitoring of the patient may have caught the lack of oxygen prior to irreversible damage, but in this case the patient was not monitored. Shortly after the administration of the IV, the hospital experienced a fire alarm (“code red”), at which point staff left the patient’s room and closed her door. Staff estimates she was unmonitored for about twenty minutes.

Medication errors that happen within hospital facilities almost always involve an error in the medication process. As part of the investigation, Dr. Boileau states, “We’re looking for any gaps or weaknesses in the process, or to see if there has been any human error involved.” So far the hospital has determined that the IV bag given to the patient was filled with the wrong medication at the in-patient pharmacy but then coded for the correct drug. It’s unclear exactly what happened at the pharmacy, but there was either no check of the medication filling or the check was ineffective, as it allowed the wrong drug to be delivered to the patient for administration.

According to the hospital’s chief nursing officer, Karen Reed, “We are all committed to honoring Ms. Macpherson’s name by learning everything there is to learn here and making sure no other patient has to go through this again.” While the investigation into the details continues, the hospital has already planned some improvements to work towards that goal.

To reduce the risk of medication errors, the hospital is designating a safe zone to be used for medication verification. (Distraction has been shown to be a primary driver of medication mix-ups.) They’re also reviewing and updating their medication protocols and ensuring that a detailed checking process is implemented. Because of the particular danger associated with mistakes involving paralyzing agents (like Rocuronium), alert stickers have been added to these types of drugs. Because of the issues with patient monitoring, procedures that ensure patient monitoring after IV administration (presumably even in the case of an unusual event or emergency) will be implemented.

What does this mean for you? Medication errors are considered rare, but even one is one too many. Medication administration processes at healthcare facilities must be designed to minimize the risk of error by reducing interruptions and ensure double checks. Other guides, such as alert stickers, can be used to emphasize particular risks (not limited to medication errors). In healthcare facilities (or any other facilities where operations can’t safely be put “on hold”), there needs to be a plan for ensuring that necessary tasks are performed, even with emergency or unusual situations.

Read more about this incident.

Learn more about medication errors.

Root Cause

Causes for Medication Errors Identified in Cumulative Cause Map

By ThinkReliability Staff

Despite continuing efforts to reduce patient safety impacts from medical errors, more work is needed to make patients safer. One of the areas which has been identified as a key safety issue is that of medication errors within healthcare facilities. A Cumulative Cause Map is a tool that can identify causes proactively (before incidents occur) based on industry experience, including past errors. As a Cause Map is a visual form of root cause analysis, a Cumulative Cause Map can be considered a visual form of Failure Modes and Effects Analysis (FMEA). It captures potential causes (causes that COULD result in an impact to patient safety) in order to develop and implement solutions that will reduce the risk of the impacts.

In this case, the term “medication error” is used to refer collectively to errors that result in patients receiving the wrong medication, patients receiving medication prescribed for another patient, patients receiving the wrong dose of the correct medication or having the correct medication delivered by the wrong route, and patients receiving medication to which they have a known allergy or has a negative interaction with another medication the patient is known to be taking. An adverse drug event (or ADE) results when the medication error causes patient harm. Our analysis will focus on preventable issues. (Patients may experience an ADE even when a medication is administered correctly.) About half of ADEs are considered preventable, i.e. they result from a medication error.

In this case, our Cumulative Cause Map will identify errors that occur at all steps of the medication delivery process. This process begins when a need for medication is identified and ends when the medication has been administered to the patient. At a very high level, there are four steps to this process: prescribing, transcribing, dispensing, and administration. The process typically begins with a physician, who prescribes the medication, moves to a clerk who transcribes the prescription (if necessary), then to a pharmacist who dispenses the medication, and then typically to a nurse, who administers the medication.

Based on information from studies, industry guides, and case studies of actual medication errors, common issues can be identified at each step of the process. In the prescribing stage, a medication can be prescribed for the wrong patient if there has been insufficient verification of the patient’s identity (and a matching of the patient to their medical records). Additionally, an inappropriate medication, dose or route may be prescribed if the physician is unaware of a patient’s allergies or other medications which could interact with those being prescribed. Miscalculating a dose is another potential error at the prescribing stage. Distraction and/or similar-sounding drug names are other causes for prescription errors.

In the transcribing stage, errors typically result from legibility issues on handwritten prescriptions. However, distraction and/or similar sounding drug names can result in the wrong medication/ dose and/or route of administration being transcribed. Distraction and/or similar sounding drug names is an issue during the prescribing step, as is miscalculating a dose. When medications have to be substituted (for availability or cost concerns), there’s also the potential to choose an inappropriate medication if a patient’s allergies or current medications are unknown.

At the administration step, medication can be administered to the wrong patient due to insufficient identity verification. Or, the wrong medication, dose or route can be administered due to similar sounding names and/or distraction. According to the Institute for Safe Medication Practices, every interruption increases the risk of medication error 12.7%, and medical staff can be interrupted as often as every two minutes while working on the medication delivery process. For this reason many hospitals are trying to reduce interruptions of medical staff during this process by various means.

By looking at the causes that come up again and again in the proactive analysis, steps for improvement at each level of the process can be identified. Ensuring that the right patient is matched to the medical record/ care instructions at every step of the process can reduce medication being administered to the wrong patient. The use of non-handwritten prescriptions and including both the drug’s brand name, generic name and purpose can also reduce the risk of the wrong drug being administered. Ensuring that drug allergies are clearly captured within a patient’s records (and potentially on the patients themselves, in the form of a wristband) and that a current medication list is up to date can reduce the risk of drug reactions. An organization’s experience with these different types of errors will allow it to determine what level of control over each cause is necessary to reduce the risk to an acceptable level.

To view the one-page PDF with a proactive analysis of medication errors in healthcare facilities, please click “Download PDF” above. To learn more about Medication Errors, please join our FREE Webinar on December 18th.

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.

Root Cause

Humidity May Cause Loss of Hospital Accreditation

By ThinkReliability Staff

A hospital in California has received a preliminary denial of accreditation from The Joint Commission, which may lead to a loss of Medicare and Medicaid funding.  This move is rare – less than 1% of hospitals are denied accreditation.  The ruling was made during an onsite survey after reports that four patients had developed surgical-site infections after hip replacement surgery within a month.  (The patients all recovered after administration of antibiotics.)

Says the hospital’s Associate Director of Emergency Services, “Surgical infections are extremely rare. When we saw the cluster we stood up and took notice. We stabbed every corner and every crevice.”

However, that may not be entirely true.  First of all, surgical infections are probably not what’s considered “extremely rare”.  In a recent study, the Centers for Disease Control and Prevention (CDC) found that 1 in 25 patients acquires an infection while in the hospital  and infections are among the leading cause of death worldwide.  (See our previous blog for more details.)  Only slightly more than 20% of those infections were found to be surgical site infections from inpatient surgery, but that still results in about 157,500 surgical site infections a year.

There’s also a question about how quickly action was taken to address the issues identified by The Joint Commission, specifically high humidity.  After the four patients were infected with enterobacter (a bacteria that is harmless in the gut but can cause illness in a wound), the hospital cultured equipment and instruments and found no contamination.  However, three of the surgeries which resulted in the surgical site infections took place in an operating room that had been identified in February or March to have high humidity due to issues with the heating and ventilation system.  Although a new system would not be installed for several months, surgeries continued to take place in that operating room until The Joint Commission identified problems with heat and humidity.

The germs that caused these infections can also be introduced to a surgical site by medical staff – usually due to improper hand washing or surgical prep procedures.  It’s unclear if this may have been the case here – there has been no discussion of this possibility – but handwashing issues are a constant source of infections at healthcare facilities.  According to studies, more than 50% of infections are largely preventable with good hygiene and technique.

The hospital has 23 days from the October 8th preliminary denial of accreditation to meet federal standards.  The hospital is installing new heating and air conditioning equipment and is reviewing its procedures for “hospital documentation and staff communication”.   Hopefully other processes will be reviewed as well.  The hospital expects to reopen its operating rooms soon.

To view an overview of the investigation of this issue, please click “Download PDF” above. The downloadable PDF shows the goals impacted by this issue, a visual layout of the cause-and-effect relationships that led to the impacted goals, and the solutions being discussed by the hospital to improve patient safety regain their accreditation.

Root Cause

FDA To Device Maker: Complaints Not Properly Investigated

By ThinkReliability Staff

The Food and Drug Administration (FDA) issued a warning letter – a possible precursor to regulatory action – to a manufacturer of pulse oximeters challenging its response to violations identified during a facility inspection in 2013.  Specifically it found that:

1) Complaints of device failures were not adequately investigated,

2) Investigation records did not include required information,

3) Procedures did not identify all potentially affected product, and

4) Causes of failures were not investigated.

The company’s response to the initial violations found during the FDA inspection was found to be unacceptable.  Some of the comments to the FDA regarding the violations were: “The reported event poses no risk to user or patient safety, therefore, no Corrective and Preventive Action required”, “The cable and sensor that were returned with the instrument were also investigated and no problem was found”, “Through the investigation process, it was determined that Masimo’s product did not malfunction”. To each of the violations, the company claimed that either no problem was found, or that the problem did not involve any failures of the pulse oximeters identified in the complaints.

This doesn’t ring true to Diana Zuckerman, the president of the National Center for Health Research.  She says, “It may well be that it’s a user error. But you have to investigate that and show that it’s a user error and not a device error… When a company refuses to respond in any way to the FDA other than to say that the FDA is wrong on every issue, that’s not very credible.  Especially when users made complaints that the company’s product put patients at risk.”

Included in the complaints are that the manufacturer’s pulse oximeters failed to alarm in a patient that died and that they resulted in burns on both an 11-month old and 33-year-old and a skin tear on another patient.  Complaints also indicated issues with consistency of readings and exposed wires at the connection points.  The failures are getting attention not only because FDA warning letters are fairly rare – this is the first such letter to the company in its 25-year history – but also because of the company head’s views on medical errors and funding of the nonprofit Patient Safety Movement Foundation.

Pulse oximeters are used to monitor a patient’s pulse and blood oxygen.  Abnormal readings can indicate a change in a patient’s condition which may require medical intervention.  If the device fails to function, it can lead to patient injury or even death.  Because the devices are intended for use in diagnosis, they are regulated by the FDA and have to conform with FDA practices.  If the violations identified by the FDA in the warning letter are not corrected, the company may face regulatory action.

For now, the company has not released its plans to ensure compliance with the FDA requirements.  The FDA is clearly looking at updates to the investigation process used to respond to customer complaints and ensuring that causes identified as part of those reviews result in changes to other processes, such as manufacturing and quality control.

To view an outline and analysis (in the form of a Cause Map, a visual form of root cause analysis) of the FDA’s findings, click on “Download PDF” above.

Root Cause

Healthcare Worker with Active TB May Have Infected Infants

By ThinkReliability Staff

A healthcare worker may have exposed more than 751 infants and 55 coworkers to tuberculosis (TB), a potentially deadly disease, during the 11.5 months she worked with newborns in the nursery and post-partum unit.  The employee was found to have symptoms of active TB (the only kind that is contagious) in July 2014 and was tested on August 21, 2014.  Infants and coworkers who were in those units between September 1, 2013 and August 16, 2014 are potentially affected.

The impacts of the potential exposure are significant.  The goal of ensuring patient safety has been impacted because of the potential exposure of 751 infants (so far identified).  Additionally, the goal of ensuring employee safety has also been impacted as 55 coworkers are also potentially impacted (those already screened have not shown any signs of infectious tuberculosis).  Because of the close contact required to spread TB, the issue has not been identified as a public health threat.  Regulatory agencies are still interested – the hospital has been cited by the Department of State Health Services for issues relating at least in part to infection control that are “an immediate jeopardy to patient safety”.  (It wasn’t clear how or if these issues are directly related to the TB exposure but were found in an inspection that occurred as a result of it.) All the patients who have been exposed may potentially require a course of antibiotics, typically six to nine months.  Infants under six months are being given the course as a preventive measure.  This impacts the patient services goal.  All the screening and treatment is being provided by the hospital free of charge, which is an impact to the hospital’s labor and time goal.

Developing the cause-and-effect relationships that led to the goals that were impacted can provide clarity to the investigation and potential solutions.  Exposure to TB occurred when an employee with an active infection came to work and was potentially aided by the hospital’s infection control policies or procedures, which may not have been effective in preventing the spread of the disease.  It’s unclear how the employee contracted tuberculosis, but she was likely not vaccinated. Although a vaccine against tuberculosis exists, it’s rarely used in US.

A question raised by this issue is why the long period of time during which there was a potential exposure?  Tuberculosis can remain latent in the body for months or even years before turning into an active case.  (It is only contagious when active.)  The employee appears to have passed a routine annual health screening in July 2013 and started showing symptoms at or near her next annual health screening in July 2014.  However, she was not tested for the disease until August 21st and appears to have continued work until August 16th.  It’s unclear why the delay occurred, and the hospital will surely be looking to ways to minimize patient exposure to workers who may be sick.

The hospital is working with the Texas Department of State Health Services and the Centers for Disease Control and Prevention to screen and treat patients and other healthcare workers that came into contact with the infected worker based on employment and medical records in an extensive outreach campaign.  The employee has been placed on leave and is being treated.  The hospital is required to submit a corrective action plan to the Texas Department of State Health Services, which should identify corrective actions to issues raised as a result of the state’s inspection and by the Centers for Medicare & Medicaid Services.

To view the impacted goals, cause-and-effect relationships and potential solutions in a Cause Map, or visual root cause analysis, please click “Download PDF” above.  Or, click here to learn more.