Delay in Standard Sepsis Protocol May Have Cost Patient Her Life

By ThinkReliability Staff

Information found in this blog is based on an article from Health Affairs, where an emergency physician describes his mother’s fight against neutropenic sepsis contracted after her second bout against cancer.

In this case, the sepsis killed the patient, impacting the patient safety goal.  Additionally, the delay in treatment – even if it did not result in the patient’s death – is an impact to the patient services goal.   With delayed patient services, there is the potential for a lawsuit, or other potential action against the hospital.  We’ll consider this an impact to both the compliance and organizational goal.  We can visually diagram the causes that led to these impacted goals in a Cause Map, or visual root cause analysis.

Here, the patient death was due to her inability to fight neutropenic sepsis, which resulted from a systemic infection that the body – having depleted infection-fighting cells during recent chemotherapy – was unable to fight off.  Medical intervention can improve the survival rate, especially when life-saving measures are begun quickly and followed completely.  In this case, the patient was hospitalized for 23 hours before sepsis protocol was begun.

The patient’s primary doctor was her oncologist, who did not consult with an intensive care doctor.  Despite recommendations to have care of new ICU patients fall within the responsibility of an intensive-care doctor, this solution was not implemented at this particular hospital due to “political barriers”.  It can thus be surmised that this may have been a cause to the delay in consultation during the case as well.

The sepsis protocol was begun only when care was transferred to the intensive-care doctor as a result of the patient’s son requesting transfer to a different hospital.  Perhaps the staff was unaware of the seriousness of the situation, as the monitoring of the patient appeared inadequate.  The transfer of the patient to the ICU was also only done at the specific request of the patient’s son.  Based on the description of the experience at the hospital, it’s not clear why the patient’s doctor did not order the standard sepsis protocol.

The hospital involved in the case has updated its guidelines in treating sepsis.  Hopefully this will successfully result in the reduction of cases such as this one.

To view the Outline, Cause Map, Timeline, and Solutions, please click “Download PDF” above.  Or click here to read more.

ER Visits Due to Consumption of Energy Drinks More Than Doubled

By ThinkReliability Staff

Consuming high levels of caffeine can lead to various health concerns that may require emergency medical attention.  According to the Substance Abuse & Mental Health Services Administration: “Consumption of energy drinks is a rising public health problem because medical and behavioral consequences can result from excessive caffeine intake.”  Energy drinks can contain extremely high levels of caffeine, which are not required to be listed on the  label.  Emergency room visits due to consumption of high-caffeine level energy drinks more than doubled from 2007 to 2011.

The issues associated with consumption of energy drinks can be documented in a Cause Map, or visual root cause analysis.  We begin with the impacts to the goals; the safety goal is impacted due to the health risks.  Additionally, increased ER visits and media attention to the issue can be considered impacts to various organizations’ goals.

Beginning with the impacts to the goals, asking “Why” questions allows us to uncover the cause-and-effect relationships that lead to these concerns.  Consuming high levels of caffeine can lead to health concerns, including dehydration, headaches, and even seizures.  Most energy drinks contain high levels of caffeine – equivalent to the caffeine in several cups of coffee – but are not required to list the amount of caffeine on the label.  Because some of these beverages are marketed extolling positive health effects, consumers may be unaware of potential risks.  Because some energy drinks are sometimes considered beverages  and sometimes are considered dietary supplements, regulation is limited.

More attention is being called to this issue, along with calls for more regulation and requiring disclosure of the amounts of  caffeine in energy drinks in the hopes that with more information, both to consumers and healthcare professionals, will result in fewer emergency health concerns.

To view the Outline and Cause Map, please click “Download PDF” above.  Or click here to read more.

FDA Recommends Lower Doses of Sleep Aids

By Kim Smiley

On January 10, 2013, the Federal Drug Administration (FDA) announced a new requirement to dramatically decrease the normally prescribed doses of sleep aids containing zolpidem, which includes Ambien, Edluar and Zolpimist.    Products containing zolpidem are the most commonly prescribed sleep aids with about 40 million dispensed in 2011.

A Cause Map, or visual root cause analysis, can be used to help understand this issue.  The first step in the Cause Mapping process is to fill in an outline with the background information for a problem, such as the date and location.  The bottom half of an outline is filled in with the impacts to an organization’s goals.  In this example, the safety goal is impacted because there is a risk of car accidents after patients used prescriptions containing zolpidem and drove a car.  There have been about 700 reports of car accidents after people used products contain zolpidem. The customer service goal is also impacted because this issue has generated some bad publicity for the companies that manufacture these drugs.

After the outline is completed, the next step is to use the impacts to the goals to ask “why” questions and add the answers to the Cause Map to show the cause-and-effect relationships.  Why is there a risk of car accidents? People may be driving while impaired because zolpidem makes you drowsy and they may have zolpidem in their systems.  Zolpidem is a sedative; it’s the active ingredient in a number of sleep aids.  People may still have zolpidem in their systems because millions of people take prescription sleep aids containing it and it stays in the body longer than was known.    Originally it was believed that it was safe to drive 8 hours after taking zolpidem, but the FDA determined that enough of the drug may be present to impair driving after 8 hours.  Women are especially at risk of impaired driving because they metabolize the drug slower.

The final step in the Cause Mapping process is to determine possible solutions that would prevent a problem from reoccurring.  In this example, the FDA determined that taking a lower dose of sleeping aids containing zolpidem would help reduce the risk of impaired driving and the potential for car accidents.  The new FDA requirements would lower the dose for women from 10 milligrams to 5 milligrams for immediate-release products and from 12.5 milligrams to 6.25 milligrams for the extended-release product. The safest option is always to take the lowest dose of any sleep aid that is effective.

If you use a sleep aid containing 10 mg or 12.5 mg dose zolpidem, the FDA recommends that you continue taking your medication as prescribed until you can contact your healthcare professional.

To view a high level Cause Map of this issue, click on “Download PDF” above.



Transplant Recipient Dies of Lung Cancer After Receiving Smoker’s Lungs

By ThinkReliability Staff

After 18 months on the transplant list, a patient in England finally received a new set of badly needed lungs.  However, though required by NHS Blood and Transplant since March 2011, the medical history of the donor – specifically that the donor was a heavy smoker – was not disclosed to the recipient, who died shortly after of lung cancer.

The issues causing this death can be examined in a Cause Map, or visual root cause analysis.  We begin an investigation by determining which goals were impacted by the event.  In this case, the patient safety goal was impacted due to the death of the transplant recipient.  Additionally, patient services were impacted because the patient was given “higher risk” organs.  Lastly, the worldwide shortage of organs can be considered an impact to the property goal.  Once we have determined these impacts to the goals, we can ask “Why” questions to develop the cause-and-effect relationship leading to the issue.

The patient death was due to lung cancer.  The patient suffered from lung cancer because she received a lung transplant using lungs from a smoker.  The patient was unaware of the donor history though disclosure of the medical history of a donor is required.  Additionally, more patients are being given what are known as “higher risk” organs.  This includes organs from smokers, the elderly, and even drug users.  39% of lung transplants are from smokers.  Doctors believe that patients are better off with these organs than waiting on the transplant list.  Only a handful of transplant recipients have died from diseases related to their donors’ health, but every year about1,000 people in the UK die waiting for a transplant.  The quality of available organs is decreasing due to longer lifespan and obesity.  Additionally, the number of organs has always been less than needed.  The number of potential organ donors is small, due to a combination of factors, including personal reasons for not donating and families not donating a loved one’s organs when their wishes are not made clear.

Disclosure of a donor’s medical history is already required.  Increasing the number of donors is desperately needed to ensure adequate availability of organs.  You can contribute by becoming an organ donor and making your wishes clear to your family.  The medical profession is attempting to increase the usability of organs, using methods such as the one discussed in a previous blog.

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

Maternity Death from Blood Loss after Normal Delivery

By ThinkReliability Staff

In 2010 a woman arrived at a California Medical Center at 2 AM for a full term delivery.  The woman was in good health.  Her membranes were artificially ruptured at 11:26 AM and her baby was delivered vaginally at 3:18 PM.  Unfortunately, after the delivery the patient continued to bleed.  After an hour, the patient was moved to the operating room.  The bleeding source could not be located and the bleeding continued for another 41 minutes until a senior obstetrician was called.  Although the doctor indicated that the Rapid Response Team (RRT) was not needed, it arrived shortly after but was refused entry to the operating room until after a breathing tube had been inserted.  Although Code Blue resuscitative procedures were continued for 72 minutes, the patient died due to excessive blood loss.

This tragic incident can be examined in a visual root cause analysis, or Cause Map, using the information released by the California Department of Public Health.  The first step to performing a root cause analysis is to determine which goals were impacted.  In this case, the patient safety goal was impacted due to the death of a patient.  In cases involving death or injury to a patient, employees can also be impacted in what is known as a second victim.  The death of a healthy patient associated with a normal delivery is considered an “adverse event” per the California Department of Public Health and a “never event” as defined by the National Quality Forum, which can be considered an impact to the compliance goal. The center was fined $50,000, an impact to the organizational goal.  Additionally, the delay in life saving measures to the patient is an impact to the patient safety goal.

Beginning with an impacted goal, asking “Why” questions allows the development of the cause-and-effect relationships that led to the incident.  In this case, the patient died from excessive blood loss and a delay in life saving measures.  The blood loss started as damage from delivery, but was unable to be stopped and treatment of the bleeding was delayed.  All three of these causes contributed to the total amount of blood loss experienced by the patient.  There was a delay moving the patient to the operating room (OR) and a delay calling for assistance from a senior obstetrician (OB).  Additionally, there was delay in treatment by the RRT, which was initially not allowed to enter the OR.

As a result of this incident, the medical center has reviewed and revised its policies regarding post-delivery hemorrhage and response.  Specifically, when a patient suffers more than 750 cc’s of blood loss after vaginal delivery (this patient lost more than 1500 cc’s), she is transferred to the main OR.  An OB Hemorrhage Toolkit, including checklist, has been adopted in Labor & Delivery, and the hospital has joined  a maternal care collaborative.  According to the CEO of the Medical Center, “We have reviewed these situations with everyone involved . . . to learn from them, improve patient care, update our policies and make sure nothing like these incidents can happen again.”

To view the Timeline, Outline and Cause Map, please click “Download PDF” above.  Or click here to read more.