Monthly Archives: November 2015

Root Cause Analysis

Patient Discharged Alone, Without Being Treated

By ThinkReliability Staff

A patient with schizophrenia and dementia was discharged from a New York City emergency room alone and without effective treatment. Less than two hours after her discharge, she was taken via ambulance to another hospital, which performed emergency surgery on a perforation in the digestive tract. However, because of various communication issues, the family was not notified of her whereabouts until three days later.

Multiple factors were involved in this issue. To provide some clarity about what happened, and where the investigation should go next, we can put the information that is known into a Cause Map, or visual root cause analysis. The Cause Map can be expanded as more information is known.

The first step of any problem investigation is to determine what problem needs to be solved. Rather than attempting to define a complex issue as just one “problem”, the problem is defined as the impact to an organization’s goals. In this case, patient safety was impacted due to the risk of injury to the patient. The regulatory goal is impacted due to the risk of a lawsuit or other regulatory action. Patient services were impacted because of the improper discharge. Additionally, the labor/ time goal is impacted because of an investigation, which the “first” hospital (or regulatory agency) should be performing, although the hospital has not released any information, citing privacy concerns.

The second step of a problem investigation is the analysis. We begin the analysis with one of the impacted goals. To develop the cause-and-effect relationships that make up the Cause Map, we ask “why” questions. In this case, the patient safety goal was impacted because of the risk to the patient. The risk was caused by being discharged alone, and also by being discharged without proper treatment. Because both of these causes resulted in the impact, they are joined with an “AND”. The patient was discharged improperly based on a decision to discharge the patient. Because the first hospital has not released any more details, we have to end that line of questioning with a “?”. However, once the causes related to the patient being improperly discharged are determined, solutions that will improve the discharge process to reduce the risk of other patients being improperly discharged can be brainstormed and implemented.

To ensure the analysis is complete, the other impacted goals must also be addressed. In this case, the labor/ time goal is impacted by the investigation. The investigation results from the patient being discharged improperly (also an impact to the patient services goal) and the hospital’s delay in notifying the family of the patient’s whereabouts. The second hospital did not have the family’s contact information because it was unable to receive it from the first hospital. This is another area that will need to be investigated further. Although the second hospital treated the patient after deeming it was an emergency, the second hospital had no way of contacting the patient’s family. This is particularly important in this case as the patient’s son was designated to make medical decisions for her. Additionally, even though the second hospital notified the first hospital it was treating the patient on the day the patient went “missing”, the first hospital, despite frequent contact with the patient’s family, did not pass that information along until three days later. The communication breakdowns at the first hospital must be addressed.

The third step of a problem investigation is to determine solutions to reduce the risk of similar issues recurring. In this case, more detail is needed about the discharge and communication processes. The solutions will ideally improve those processes to ensure that discharges and communication about patients are made following proper protocol.

To view the initial problem investigation, or Cause Map, click on “Download PDF” above. Click here to see our previous blog about intentional improper patient discharge, or “patient dumping”.

Root Cause Analysis

Equipment, procedural failure lead to resident scalding

By ThinkReliability Staff

While equipment and procedures were both in place to prevent resident scalding from too-hot baths, failures of both resulted in a resident receiving serious burns on August 13, 2013. The Health and Safety Executive (HSE) report was recently released on the incident, which resulted in prosecution for the care home and the employee responsible for the bath.

This incident illustrates the limitation in looking for the “one” root cause. There wasn’t just one thing that resulted in this incident; rather multiple failures were required to result in the tragic scalding. We can show these causes by performing a visual root cause analysis, known as a Cause Map. Note that the term “root cause” refers to a system of causes, much like the root of a plant is a system.

We begin the analysis by looking at the impact to the goals. Resident safety was impacted due to the very serious burning of a resident. The burning was so severe it resulted in the amputation of ten toes and the resident will never walk again. In addition, employee safety is impacted because of the emotional impact to the employee (known as the second victim). The employee safety is also impacted due to a risk of burns. The environmental goal is impacted due to the lack of temperature control and the compliance goal is impacted due to the prosecution of both the employee and the care home. Resident services are impacted from a resident being placed in a scalding bath. The failure of a thermostat is an impact to the property goal and the time required for response and investigation is an impact to the labor and time goal.

Beginning with one of the impacted goals (in this case we’ll begin with the resident safety goal) and asking “why” questions develops the cause-and-effect relationships that caused the incident. In this case, the resident’s injuries resulted from being placed in a scalding bath and being unable to exit due to physical and communication limitations. The resident was placed in the too-hot bath because the water in the bath was too hot, and the caregiver placed the resident in the bath. Both of these things (the water temperature being too high, and the caregiver placing the resident in the bath) had to occur in order for the injury to occur.

The water temperature was too high because of the failure of the immersion heater thermostat. The reason for the failure, as well as how long it was not working, is unknown. The caregiver placed the resident in the bath because she did not check the water temperature and failed to realize it was too hot. The caregiver appears to have been unaware of the thermostat failure, or certainly there would have been other safeguards in check. Additionally, there were inadequate thermometers provided to check the water temperature. (A manual check for comfort was still possible, though in this case could have resulted in a burn to the employee.) Although it was “required” to test the water temperature and record that the check had been done, there were no written instructions to that effect.

The care home has purchased portable thermometers for caregivers’ use, but the HSE also recommends the use of a secondary thermostatic cut-out, which would prevent boiling of the water tank even if the thermostat failed. The HSE has also provided a white paper “Managing the risks from hot water and surfaces in health and social care“, that discusses appropriate risk assessments and control measures to prevent burns of vulnerable care home residents.

To view the Cause Map of this incident, click “Download PDF” above.

Or, click here to read the HSE report of the incident.

Root Cause Analysis

Price of Daraprim jumped ~5,000%

By Kim Smiley

The cost of prescription drugs have been in the news the last several years as the United States struggles to deal with rising health care costs, but few stories have come close to generating as much outrage as the recent massive price increase of Daraprim.  As new specialty drugs hit the market, they are often expensive as drug companies recoup the costs of development and maximize profits while the drug is covered by patents, which may be frustrating but is understandable.  That is not what happened in the case of Daraprim, a lifesaving drug used as an antimalarial drug and to treat toxoplasmosis.  The medication has been around since the 1950s and isn’t covered by any patents.

So why has the price of Daraprim suddenly increased about 5,000 percent?  A Cause Map, or visual root cause analysis, can be used to intuitively show the causes that contributed to the issue.  (To view an outline and a High Level Cause Map, click on “Download PDF” above.) This is one of those issues where it may be tempting to identify the “root cause” or focus on a single cause that contributed to the issue, but there are many factors that need to be considered.  The piece of the puzzle that is probably the easiest to focus on is the fact that a new company bought the only company with regulatory approval to sell the drug in the United States and significantly raised the price.  Basically, there is demand for the drug and the company which has a monopoly on the supply in the US took advantage of it by increasing the price per pill from $13.50 to about $750.

The CEO of the company has been widely villainized for what many consider a predatory price increase, but it is important to remember that the Daraprim price increase was legal.  Many find the price increase distasteful, but there are currently no laws or regulations that prevent huge medication price increases, which is another cause that contributed to the issue.

While a generic version of the drug is available in many other countries for less than a dollar a pill, it cannot be sold in the US without going through a lengthy and expensive approval process. Possible solutions to prevent similar price increases in the future could be to create laws that limit price increases on drugs without patents on them or to increase the supply of medications sold in the US by allowing some sort of reciprocal approvals with countries that have strong regulatory systems in place.  A senate committee is requesting documents and information relating to the pricing of Daraprim and several other medications and there are lawmakers pushing to create legislation that would limit price hikes.

Another enterprising company seems to have found their own solution to the problem of the high cost of Daraprim – creating a cheaper alternative. Imprimis Pharmaceuticals has stated that they will produce a substitute drug that will be priced as low as $99 for a 100 pills.  The alternative drug isn’t a generic version of Daraprim, but rather a compounded drug that combines two FDA approved drugs (pyrimethamine, the only ingredient in Daraprim, and leucovorin) that are often used together.  The compounded drug would not be FDA approved, but doctors can prescribe it specifically for a patient based on the rules governing compounded medications.

It isn’t as elegant as having another FDA-approved supplier of Daraprim, but it seems like a viable work-around for many patients.  It also seems like satisfactory justice for the price of 60-year-old pyrimethamine drugs to end up cheaper in the US after they were hiked up to such high levels.