Tag Archives: patient safety

Root Cause

Common Birth Control Pills Have Increased Risk of Blood Clots

By Kim Smiley

Deaths of 24 Canadian women associated with the use of Yaz and Yasmin birth control pills have been making headlines in recent weeks.  South of the border in the US, more than $1 billion has already been paid out to settle thousands of lawsuits over alleged side effects.  Yaz and Yasmin are drospirenone-based birth control pills that are the most widely prescribed birth control pills worldwide so any concerns with the safety of the medication are alarming.

This issue can be analyzed by building a Cause Map, or visual root cause analysis.  A Cause Map lays out the many causes that contribute to an issue in an intuitive way that illustrates the cause-and-effect relationships.  The first step in the Cause Mapping process is to fill in an Outline with basic background information and to determine how the problem is affecting the overall goals of the organization.  In this example, side effects from the pills have been reported to have caused deaths and injuries.    Lawsuits associated with the side effects, specifically blood clots, have cost the drug manufacturer huge amounts of money as well as generated significant negative publicity, neither of which are outcomes a company is hoping for.

The complaints about severe and potentially deadly side effects have been focused on blood clots.  Blood clots are a known potential side effect of using any birth control pills.  It is believed that the estrogen used in birth control pills increases the clotting factors in blood making blood clots more likely.  The reason these specific pills are making headlines is that researchers have found that drospirenone-based birth control pills have a higher risk of blood clots than other birth control pills.  Researchers have estimated that the risk of blood cloths is 1.5 to 3 times higher with drospirenone-containing pills than with some other birth control pills.

For perspective, the FDA has stated that if 10,000 women who are not pregnant and do not use birth control pills are followed for one year, between 1 and 5 of these women will develop a blood clot and for women using birth control pills the range is 3 to 9.  But, and in my opinion this is a pretty big but, it’s worth knowing that the risk of blood clots during pregnancy is estimated to be 5 to 20 out of 10,000 and it’s even higher during first 12 weeks postpartum; estimated to be 40 to 65.

Please talk to your doctor if you have any concerns about blood clots or questions about whether a particular birth control pill is safe for you, especially if you think you may have other risk factors for blood clots.  If you’re curious about the symptoms of a blood clot or about other risk factors you can get more information here.

Please click on “Download PDF” above to see a high level Cause Map of this issue.

Root Cause

Lack of Care After Overdose Led to Patient Death

by ThinkReliability Staff


An inquest into the death of a patient in a Milton Keynes hospital was completed on May 17, 2013 by the local coroner.  The coroner found that the staff failed to take and report appropriate observations and render effective treatment.  Diagramming the cause-and-effect relationships identified in the inquest in a visual root cause analysis, or Cause Map, allows identification of lessons learned and possible solutions to reduce the risk of this type of incident happening again.

We begin with the impacts to the goals.  In this case, the patient safety goal is impacted due to the patient death.   It was suggested that nursing shortages may have been related to the issues that occurred.  If this is the case, the shortages would impact employees.  The inquest that resulted due to the patient death can be considered an impact to the compliance and organization goals.  Last but not least, the insufficient patient treatment is an impact to the patient services goal.

Beginning with these impacted goals, we can ask Why questions to determine the cause-and-effect relationships that resulted in the patient death.  In this case, the patient death was due to respiratory arrest caused by an obstructed airway.  The patient being placed on her back while unconscious (though sources differ on whether the patient was placed on her back or her side) due to a drug overdose.   The patient overdose was due to a self-administered overdose and not being administered the antidote for the drugs on which she had overdosed.

The patient was not given an antidote for the drugs on which she overdosed.  The family of the patient, who had a history of mental illness and frequented the hospital, believes that the staff believed she was faking her symptoms.

Through the patient’s eleven hours within the hospital’s Accident & Emergency (A&E) Department, only 2 formal observations were recorded.  One set of observations was recorded on a glove, which was later lost.  Abnormal results from these observations were not passed along from the healthcare aid who was responsible for the patient, likely due to nursing shortages.

Once all of the causes related to the incident have been recorded within the Cause Map, solutions can be brainstormed and recommended for implementation.  The coroner involved in the case has requested the Secretary of State for Health implement changes that would require seriously ill patients to be observed by nurses rather than healthcare assistants. The hospital has stated that they “have conducted an investigation to ensure lessons are learned” and “will be continuing to improve our service in regard to emergency patients”.  The hospital has commissioned training for their healthcare assistances to improve their skills.

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

Root Cause

Reuse of Insulin Pens May Have Spread Hepatitis

By ThinkReliability Staff

After a similar incident at a Veterans hospital, a hospital in New York reviewed its insulin injection procedures and discovered that insulin pens may have been used for more than one patient.  Re-use of insulin pens for more than a single patient carries a small risk of cross-contamination, which can result in a patient being infected with a communicable disease, such as hepatitis B, hepatitis C, or HIV.

The hospital notified 1,915 patients who had received injections between November  2009 and January 2013 of the possibility for contamination and recommended testing.  Twelve patients have tested positive for Hepatitis C, and one has tested positive for Hepatitis B, though an investigation is ongoing to determine if this is related to the injections.

The use of insulin pens resulted in 30 outbreaks from syringe or needle reuse over ten years, from 2001-2010. So, although the possibility for cross-contamination is considered low, the risk for the spreading of communicable diseases is unacceptably high.

The potential for spreading communicable diseases is an important impact to the patient safety and environmental goals.  We can examine these impacted goals and the cause-and-effect relationships that led to these impacts, in a Cause Map, or visual root cause analysis.

We begin by defining the impacts to the goals.  In addition to the patient safety goal, the compliance goal is impacted because re-using insulin pens is against recommendations by the FDA and CDC.  The organizational goal is  impacted due to a lawsuit from the patients who have tested positive for Hepatitis B and Hepatitis C.  Patient services are impacted due to the improper reuse of the insulin pens, and the labor and property goals are impacted by the additional follow-up, testing and potential treatment for the almost 2,000 patients affected.  Once we have determined the impacts to an organization’s goals, we can ask “Why” questions, which helps develop cause-and-effect relationships that resulted in these impacts.

Insulin pens are designed for multiple injections, meaning that there is stored insulin within the cartridge after a single injection is given.  Backflow of blood into the pen can result in the remaining insulin being contaminated.  This can result in the spread of communicable disease if the pen is then used on a different patient for subsequent injections.

Because it is known that insulin pens should not be used on multiple patients, it is evident that there was an issue with the procedure or policy regarding use of insulin pens.  It is unclear what the specific issues were relating to this incident, but the hospital involved has reviewed and reinforced policies and procedures related to insulin injection.

Many facilities, including the hospital discussed here, which discovered the potential for re-use during a review after a similar incident at a Veteran’s hospital, have discontinued the use of insulin pens due to the potential for cross-contamination.

To view the Outline and Cause Map, please click “Download PDF” above.  Or click here to read the hospital’s press release.

Click here to visit our previous blog about about hepatitis B and C.

Click here to visit our previous blog about a different contamination issue involving hepatitis C.

 

Root Cause

Rabies From Donated Kidney Kills Recipient

By ThinkReliability Staff

A kidney donation recipient died in February, 2013.  It was determined that his death was due to rabies – specifically rabies that had been transferred with the donated kidney during the transplant in September 2011.  Although infectious disease transmission through transplant – especially rabies – is rare, there is benefit in visually diagramming a root cause analysis of this event in a Cause Map.   A Cause Map begins with the specific impacts to an organization’s goals resulting from an incident, and shows the cause-and-effect relationships that led to those impacts.

In this case, the patient safety goal was impacted due to the recipient death.  The receipt of organs infected with a disease such as rabies is an impact to the patient services goal.  Three other recipients also received organs from the same donor but have not shown symptoms of rabies.    Their treatment is an impact to the property and labor goals, due to the cost, time and inconvenience of those treatments.

The impacted goals form the first cause-and-effect relationship in our Cause Map.  We ask “Why” questions to determine other cause-and-effect relationships.  In this case, the donor death was due to rabies.  The donor was infected with rabies from an infected transplanted organ, and was not treated for rabies.  The recipient was not treated for rabies as the symptoms did not emerge until a year after the transplant (rabies can have a long incubation period).  The donor organs were infected with rabies from an unknown cause, though rabies usually results from contact with wild animals (specifically, this strain of rabies appears to be from a raccoon).   The transplant medical team was unaware that the donor had rabies.

Though the donor had encephalitis, it was thought that it was due to a food-borne illness.  (Detail on how the diagnosis was obtained has not been released.)  While there is testing for certain diseases performed on donor organs, due to the time constraints on the viability of the organ, testing for rabies is not generally performed.  However, new guidance from the Disease Transmission Advisory Committee (put out after this donation occurred) urges caution in use of organs from donors with encephalitis, perhaps including more robust testing for specific illnesses, or using only certain organs.

Due to an acute shortage of viable donated organs, some believe that organs from disease-positive donors should be used, and treatment started immediately.  With many in need of transplants dying on the waiting list, this may be a more practical approach, though there are certainly concerns about transmitting diseased organs to those who are already very ill, and who will be taking immune suppressing drugs to prevent rejection of transplanted organs, making them more susceptible to such diseases.

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

Read our previous blog about a recipient who died of lung cancer after receiving the lungs of a heavy smoker

Root Cause

Are Medical Residents Dangerously Fatigued?

By Kim Smiley

Medical residents work extremely long, tiring schedules on their arduous path to becoming physicians.  Possible consequences of this demanding schedule have long been debated.  Many wonder if it’s safe to have someone who has been on duty for 24 hours straight treating patients.

This issue can be explored by building a Cause Map, or visual root cause analysis.  A Cause Map is built by asking “why” questions and laying out the different causes that contributed to an issue to the cause-and-effect relationships.  In this example, there is potential risk to patients and to the medical residents themselves.  Patients may be at risk because fatigued medical residents are treating patients and fatigued people are more likely to make mistakes, increasing the chance of a medical error that affects patient safety.  Residents are fatigued because they work long hours and the current regulations allow 80 hour work weeks.

Additionally, the health of the residents themselves may be at risk.  A poll by the Mayo clinic found that 11 percent of medical residents had been in an auto accident.  The poll also found that 8 percent of residents reported having at least one blood or body fluid exposure due to fatigue or stress, potentially exposing them to any number of diseases.  Sleep deprivation itself can also have long term health consequences increasing the likelihood of a number of illness including heart disease and gastrointestinal problems.

While there is ongoing debate on whether residents are still working too many hours, there have been changes made to reduce resident fatigue. In 2003, residents were limited to 80 hours per week by the Accreditation Council for Graduate Medical Education.  Prior to this move, there was essentially no limit to the hours a resident could log.  This issue isn’t black and white and there are also many who argue that the limits have had negative unintended consequences.  Fewer hours in the hospital mean that residents see fewer patients and have less experience when they become independent physicians.  Limiting shifts also increases the potential for each patient to be seen by more doctors and for essential information to be lost during turnovers.  This isn’t an issue with a clear answer and any additional restrictions in the hours a resident is allowed to work will need to be mitigated with effective methods of turning over patient care and assurances that residents are getting adequate training.

This is a good example to demonstrate the important of taking an investigation past determining that the problem is caused by “human error”.  Medical errors are caused by human errors, but the most useful part of the investigation usually comes from asking why the error was made.  Was the person overly fatigued?  Was the procedure confusing?  Would the process go smoother with a phase to verify information or a checklist?  An investigation shouldn’t be stopped at “human error”; it should be taken a few steps farther to see what may have contributed to the error and what changes may help prevent a similar error in the future.

Root Cause

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.

Root Cause

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.

 

 

Root Cause

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.

Root Cause

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.

Root Cause

Bed Rail Death

By ThinkReliability Staff

A patient’s death in 2006 at an assisted living facility in Vancouver, Washington has helped spurred a review of the safety of bed rails.  The patient’s death was due to strangulation when her neck got caught in side rails on her bed.  The side rails had been provided by her family at the suggestion of the assisted living facility.

A recent Consumer Product Safety Commission (CPSC) review of bed rail fatalities indicates that there have been 155 deaths due to the use of bed rails between 2003 and May 2012 but until now, regulation of the use and design of bed rails has been somewhat haphazard.  We can examine the issues that led to the 2006 death – and have likely contributed in many of the other bed rail-related deaths, in a Cause Map, or visual root cause analysis.

We begin by considering the impacts to the goals.  The patient safety goal is impacted due to the patient strangulation and death.  The patient services goal is impacted because of the patient getting stuck in the bed rail.  Indeed, injuries resulting from bed rails are far more common than deaths, with about 36,000 injuries requiring emergency room treatment reported since 2003.  There is a concern about potentially inappropriate use of bed rails, which can be considered a property goal and the ensuing review of bed rail deaths can be considered a labor impact.

We begin with the patient safety goal and ask “Why” questions to determine the cause-and-effect relationships that resulted in the impacted goals.  The patient death was due to being trapped in bed rails.  This occurred due to her illness – about half of patients who die in bed rail incidents have medical problems, a gap between the bed rail and mattress, and the use of bed rails.  The gap can be attributed to the design of the bed rail and/or the incompatibility between the mattress and bed rail.  In this case, the bed rail was purchased by the family and the mattress provided by the facility.  ASTM standards for bed rails are voluntary and regulations governing bed rails are insufficient in their current state.

Bed rails are used primarily to keep patients from falling out of bed and to assist patients in getting in and out of bed.  However, hospitals and nursing home use has decreased since dangers have become more well known.    Most deaths (61%) attributed to bed rails occur at home.  It is suggested that a decrease in availability of caregivers may increase the use of bed rails.

When the FDA issued a safety alert regarding bed rails in 1995, it adopted voluntary guidelines and did not require safety labels or recall of any types of bed rails.  At the time, there was political support for less regulation, industry was concerned about legal issues and resistant to any tougher regulation and there was – and still is – confusion over which regulatory agency is actually responsible for bed rails.  The CPSC maintains that bed rails are medical devices and not under their authority.  However, the FDA claims that if no medical claims are made associated with the bed rails, they are not within their regulatory authority either.  Additionally, because deaths and injuries related to bed rails are not necessarily reported, and problems not highlighted to consumers, the issues are not well known.  Some are hoping to change that.

Representative Edward J. Markey has called for the formation of a task force to address the issue.  The CPSC completed a report on deaths, which has been provided to the FDA.  And, manufacturers say that newer designs and safety straps will reduce the risk of patient death.

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