Tag Archives: Diabetes

Root Cause

Patient death after ambulance delayed due to “extreme demand”

By ThinkReliability Staff

An inquest into the death of a young patient in London after a significant delay in the arrival of an ambulance released some disturbing details into the emergency process. We can perform a root cause analysis of the issues that led to the delay, and death, by capturing cause-and-effect relationships in a visual Cause Map.   As with many complex incidents, it will be helpful to capture the chronology of an event within a timeline. This timeline should not be confused with an analysis, but can be useful in organizing information related to the incident.

In this case, the patient, who had type 1 diabetes and had been feeling sick for more than a day, asked a friend to call an ambulance at about 5:00 pm on September 7, 2015. The friend dialed 111, which is the non-emergency medical helpline from the National Health Service. The initial call handler determined that the situation was not an emergency, but marked it for a 20-minute follow-up with a clinician. A clinical supervisor called back and spoke to the patient at 5:42 pm. She determined that it was an emergency that required an ambulance within 30 minutes. However, because it was known that the ambulance service was delayed, she asked the patient if she could get a friend to drive her to the hospital. The patient said she preferred an ambulance.

At this point it appears there was no contact until 10:15 pm, at which point a call-back was made to check on the patient’s ongoing symptoms. The friend at this time found the patient unconscious, having suffered cardiac arrest, and called 999, the emergency call system, at 10:23 pm. The ambulance arrived at 10:30 pm and took the patient to a hospital, where she died 5 days later.

At the inquest, the coroner testified that if the patient “had received definitive hospital care before she suffered a cardiac arrest in the evening of September 7, the likelihood is she would have survived.” Thus, from the perspective of the National Health Service, the patient safety goal is impacted because a death occurred that was believed to be at least partially due to an ambulance delay. Additional goals impacted are the patient services goal because of the delayed emergency treatment (the stated goal for the patient’s medical condition was 30 minutes, whereas the ambulance arrived nearly 4 hours after that goal). The schedule and operations goal is also impacted due to the insufficient capacity of both ambulances and the call system.

The Cause Mapping begins with an impacted goal and develops cause-and-effect relationships by asking “why” questions. The patient death was due to diabetic ketoacidosis, a severe complication of type 1 diabetes that may have resulted from an additional illness or underlying condition. As stated by the coroner, the delayed emergency treatment also resulted in the patient’s death. The ambulance that would take the patient to the hospital was delayed because the demand exceeded capacity. Demand was “extreme” (there were 200 other patients waiting for ambulances in London at the same time). The lack of capacity resulted from low operational resourcing, though no other information was available about what caused this. (This is a question that should be addressed by the service’s internal investigation.)

The patient was not driven to the hospital, which would potentially have gotten her treated faster and maybe even saved her life. The patient requested an ambulance and the potentially significant delay time was not discussed with the friend who had originally called. At the time of the first call-back, the estimated arrival time of an ambulance was not known. (By the time of the second call-back, it was too late.)

The second call-back was also delayed. Presumably this call was to update the patient’s symptoms as necessary and reclassify the call (to be more or less urgent) as appropriate. However, the demand exceeded supply for the call center as well as for ambulances. The call center received 300 calls during the hour of the initial call regarding this patient, which resulted in the service operations being upgraded to “purple-enhanced”. (This is the third-most serious category, the most serious being “black” or “catastrophic”.)   The change in operations meant that personnel normally assigned to call-backs were instead assigned to take initial emergency calls. Additionally, it’s likely the same “operational resourcing” issues that affected ambulance availability also impacted the call center.

Additional details of the causes related to the insufficient capacity of emergency medical services are required to come up with effective solutions. The ambulance service has completed its own internal investigation, which was presented to the family of the patient. The patient’s brother says, “I hope these lessons will be learnt and this case will not happen again” and the family says they will continue to raise awareness of the dangers of diabetes.

To view the initial analysis of this issue, including the timeline, click on “Download PDF” above. Or click here to read more.

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Root Cause

Manifestation of Poor Glycemic Control Part 3

By ThinkReliability Staff

In previous blogs, we wrote about nonketotic hyperosmolar coma and diabetic ketoacidosis, which are both conditions related to hyperglycemia, or high blood glucose.  In this blog, we consider the last type of manifestation of poor glycemic control that, when it occurs in the hospital, is considered a hospital-acquired condition by Medicare & Medicaid, meaning that hospitals will not receive additional payment for cases when this condition is acquired during hospitalization.  Hypogelycemic coma, along with nonketotic hyperosmolar coma and diabetic ketoacidosis, results from poor glycemic control within the hospital, but is caused by low blood glucose.

As we did with the other two manifestations of poor glycemic control, we can look at the impacted goals for a hospital and the potential causes and solutions for this condition in a visual root cause analysis or Cause Map.  The goals for hypoglycemic coma are the same to the other manifestations of poor glycemic control and include increased risk of patient death, length of patient stay and treatment needs.  The costs associated with hypoglycemic coma (greater than $7 million in the US from the 212 cases reported to CMS in 2007) are no longer reimbursable when the condition is acquired in the hospital.  There is also always the potential that a patient death can result in a second victim – the patient’s provider(s).

Hypoglycemic coma results from uncontrolled hypoglycemia, which can result from overtreatment with insulin, drug-induced hypoglycemia, drug interaction with insulin, decreased glucose production and/or loss of glucose.  Overtreatment with insulin was implicated in 90% of hypoglycemia cases in a recent study and can result from medication errors (see our analysis on medication errors in hospital settings),  or a failure to adjust insulin for diet or other factors.  Drug-induced hypoglycemia can result from administration of fluoroquinolones (the mechanism for this effect is unknown) and/or inadequate nutrition.  Drugs that interact with insulin may be administered to a diabetic patient if providers are lacking in knowledge about glycemic control.  Underlying disease or infection, such as chronic renal insufficiency, which was implicated in approximately 50% of hypoglycemia cases in the study, can result in decreased glucose production or loss of glucose.

As with the other types of manifestations of poor glycemic control, efforts must be made to prevent these types of incidents.  As suggested with hyperglycemic events, insulin plans should be individualized, accounting for all relevant factors related to glycemic control and diet.  Patients treated with insulin in the hospital should have their blood glucose levels monitored frequently, especially as insulin has been identified as a High-alert medication by The Joint Commission.   Any patients found unconscious should also immediately have their blood glucose levels measured.  Patient’s nutritional intake must be carefully monitored, especially for cases involving medications that might cause hypoglycemia.  Last but not least, controls and procedures involving drugs given to diabetic patients should be carefully controlled, due to the high potential and risk for interaction with insulin.

Two other conditions are considered hospital-acquired manifestations of poor glycemic control: nonketotic hyperosmolar coma and diabetic ketoacidosis.   In previous blogs, we discussed the causes of these issues, and suggested solutions to reduce the risk of these types of incidents.

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

Root Cause

Manifestation of Poor Glycemic Control Part 2

By ThinkReliability Staff

In a previous blog, we discussed how poor glycemic control can result in hyperglycemia which could lead to nonketotic hyperosmolar coma.  Diabetic ketoacidosis, if resulting from poor glycemic control within a hospital setting, is another hospital-acquired condition as determined by Medicare & Medicaid, meaning that hospitals will not receive additional payment for cases when this condition is acquired during hospitalization.  Like nonketotic hyperosmolar coma, diabetic ketoacidosis can have a significant impact on patient safety and can be investigated within a Cause Map, or a visual root cause analysis.

The impacted goals for a hospital resulting from hospital-acquired diabetic ketoacidosis are very similar to those for nonketotic hyperosmolar coma.  Patient safety is impacted due to an increased risk of death, which can also result in a provider being a “second victim.  This is a “no-pay” hospital acquired condition, which is estimated to cost $42,974 per case.  According to the Centers for Medicare & Medicaid Services (CMS), in 2007 there were 11,469 cases of hospital-acquired diabetic ketoacidosis, resulting in a total cost to the healthcare system of almost half a billion dollars.

According to a study  published in the International Journal for Quality in Health Care, diabetic emergencies, including nonketotic hyperosmolar coma,  increases the risk of patient death (from 9% to 16%),  length of patient stay (from 7 to 14 days) and treatment requirements.  The costs associated with nonketotic hyperosmolar coma (greater than $114 million in the US in 2007, according to CMS) are no longer reimbursable when the condition is acquired in the hospital.  Additionally, patient death due to hospital-acquired conditions can result in a second   victim – the healthcare provider(s).  Additionally, this diagnosis results in increased stay and treatment requirements.

Beginning with the impacted goals and asking “Why” questions, we quickly determine that diabetic ketoacidosis, like nonketotic hyperosmolar coma, results from uncontrolled hyperglycemia.  Rather than perform the same analysis of causes of hyperglycemia (which, if we’re doing our job right, should result in the same cause-and-effect relationships), we can link to the analysis shown in our previous blog.   However, for diabetic ketoacidosis, we also have a cause of dehydration.  Since this was not a cause previously analyzed, we will add to this portion of the Cause Map.

Patient dehydration can result from a medication that increases fluid loss, an underlying medical condition, or inadequate water intake.  Inadequate water intake can result from a patient’s limited access to water, such as a patient who is bedridden and is not provided adequate water from a caregiver, or the patient feels too ill to drink, or the patient is unable to drink, due to incapacitation, confusion, restraints or sedation.  A combination of these causes may also occur.

Because of the importance of preventing these conditions resulting from hyperglycemia and dehydration, every effort should be made to prevent these outcomes from occurring.

Two other conditions are considered hospital-acquired manifestations of poor glycemic control, diabetic ketoacidosis and hypoglycemic coma.  In future blogs, we will discuss the causes of these issues, and suggested solutions to reduce the risk of these types of incidents.  It is recommended that an individualized insulin plan be used, rather than a sliding scale, to ensure blood glucose levels are kept at or below 110 mg/dL.  A specific glycemic management team, which carefully coordinates medical nutritional therapy with insulin control, can also reduce the risk of glycemic events.  Patients who are found to have an insulin deficiency should be treated with intravenous insulin.

Because 20-30% of diabetic ketoacidosis cases are estimated to be the initial presentation of previously undiagnosed diabetes, some experts recommend testing the glucose levels of all children who have not been diagnosed with diabetes, and all patients who are vomiting or require intravenous hydration.  To reduce the risk of dehydration, patient’s fluid intake should be tracked and any patients who are unable to  drink should have intravenous fluids.

Nonketotic hyperosmolar coma and diabetic ketoacidosis are two hospital-acquired events that result from hyperglycemia.  The remaining hospital-acquired manifestation of poor glycemic control, hypoglycemic coma, will be covered in a future blog.

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

Root Cause

Manifestation of Poor Glycemic Control Part 1

By ThinkReliability Staff

Nonketotic hyperosmolar coma resulting from poor glycemic control within a hospital setting is now considered a hospital-acquired condition by Medicare & Medicaid, meaning that hospitals will not receive additional  payment for cases when this condition is acquired during hospitalization.  Because of the severity of the impact of this condition, its implications and causes should be carefully studied to determine ways to reduce the risk of this condition being acquired during a hospital stay.

We can look at the impacted goals for a hospital and the potential causes for this condition, in a visual root cause analysis or Cause Map.  To perform a Cause Mapping analysis, we will first determine the impacts of a given condition on an organization’s goals, then develop cause-and-effect relationships to diagram the causes that result in the condition.

According to a study published in the International Journal for Quality in Health Care, diabetic emergencies, including nonketotic hyperosmolar coma,  increases the risk of patient death (from 9% to 16%),  length of patient stay (from 7 to 14 days) and treatment requirements.  The costs associated with nonketotic hyperosmolar coma (greater than $114 million in the US in 2007, according to CMS) are no longer reimbursable when the condition is acquired in the hospital.  Additionally, patient death due to hospital-acquired conditions can result in a second victim – the healthcare provider(s).

To analyze this issue, we begin with an impacted goal and ask “Why” questions.  In this case, we are looking at the impact to the patient safety goal becaue of the  increased risk of patient death due to nonketotic hyperosmolar coma, which is caused by uncontrolled hyperglycemia (high blood glucose).   Associated infection, medication that interferes with glucose absorption, and insulin deficiency can all contribute to hyperglycemia.  Insufficient knowledge of providers about glycemic control can result in diabetic patients being given medications that interfere with glucose absorption, or in inadequate control of diabetes with insulin in the hospital setting.

The study referenced above also found that insufficient staffing, which may result in insufficient backups/checks of staff, use of workarounds, and ineffective communication between the team, leading to insufficient tracking of glycemic control.    Providers may also be unaware of a patient’s diabetic status, due to poor record keeping or communication.   Inadequate insulin therapy can also contribute to hyperglycemia.  Specifically, medication errors involving insulin (see our medication error Cause Map), fear of hypoglycemia (which may result in fear of aggressive insulin therapy), and  failure to adjust insulin for diet or other factors, including age, renal failure, liver disease, can result in an all too common “one size fits all” linear sliding insulin scale providing inadequate results.

Two other conditions are considered hospital-acquired manifestations of poor glycemic control, diabetic ketoacidosis and hypoglycemic coma.  In future blogs, we will discuss the causes of these issues, and suggested solutions to reduce the risk of these types of incidents.

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

Root Cause Analysis

Study Finds that Diabetics are at Risk of Medication Errors

By Kim Smiley

A new study found that nearly a third of diabetic hospital patients experienced a medication error in a one week period.  The study examined bedside data for 12,800 patients and 6,600 patient questionnaires for hospitals in England and Wales.  Medication errors when treating diabetics can have severe consequences because many diabetics require medication to maintain healthy blood sugar levels.  Blood sugar levels that are either too high or too low can result in significant illness and even death if untreated.

The two most common errors found by the study were failing to properly adjust medication when a patient’s blood sugar level was high (23.9%) and failing to sign off on the patient’s bedside information chart when insulin was given (11.1%).

This issue can be examined by building a Cause Map, an intuitive, visual root cause analysis format.  The first step to building a Cause Map is to determine the impact to the overall organizational goals.  In this example, the risk to diabetic patients is an impact to the safety goal.  The next step is to ask “why” questions and add the cause boxes to the Cause Map to illustrate the cause and effect relationships between all the factors that contributed to the issue.

In this example, the risk to the diabetic patients occurred because medication errors occurred and the patients required medication to maintain healthy blood sugar levels.  The study did not provide details on why the medication errors were made by hospital staff, but that information could be added to the Cause Map if it becomes known.  A Cause Map can be still be useful when only a high level map can be built because it can help identify an at risk population and a common problem, the diabetic patients and the medication errors, which could help identify where more research is needed or where resources could be directed.  To view a high level Cause Map of this issue, click on “Download PDF” above.

A potential solution that has been suggested for this problem is to improve training for hospital staff on how to properly treat diabetic patients.  A more detailed look at understanding exactly why the staff is making errors could help direct the training plan to the most needed areas.

Root Cause Analysis

Drug Used to Treat Diabetes May Increase Risk of Heart Disease

By ThinkReliability Staff

Since rosiglitazone was approved for use in controlling blood sugar in Type 2 diabetics who did not have success with front line treatments in 1999, studies have shown that this drug (included in trade name drugs Avandia, Avandamet and Avaglim) increases the risk of heart disease in users.  This is of particular concern because most Type 2 diabetics die from heart disease.  It is estimated that 60,000 to 200,000 people have suffered from heart disease due to these drugs.

A black box warning was placed on these drugs, but not until November 2007.  The European Medicines Agency recommended that the drug be suspended from European markets in 2010, and the drug was withdrawn from New Zealand markets in 2011.  What took so long?

We can attempt to add some clarity to this issue by viewing it in a Cause Map, or visual root cause analysis.  To begin this analysis, we look at the impact to the goals from the point of view of the manufacturer.  The patient safety goal is impacted because of the increased occurrence of stroke, heart attack, and death. The compliance goal is  impacted because – according the Senate Finance Committee – trial results that would have indicated the increased risk for cardiovascular disease were not publicly released in a timely manner.  Reduced sales as a result of the risk are estimated to be more than $2 billion (an impact to the organizational goal) and lawsuits (an impact to the patient services goal) are projected to cost more than $1 billion.

Although the actual mechanism that is causing the increased risk of cardiovascular disease is unknown, the cause of the increased occurrence of heart attack, stroke and death is due to use of the drug rosiglitazone.  Although rosiglitazone has been found to be an effective second-line treatment for Type 2 diabetes, it is unlikely that doctors would have prescribed it as readily had they known about the increased risk of heart disease.  Instead, they were likely swayed by a multi-million dollar advertising campaign, while test results that showed increased cardiovascular risk were allegedly covered up.

Unfortunately, it’s not the first (or last) time this has happened.  In early 2012, the British Medical Journal raised concern about research misconduct – including cases where poor results from clinical trials are not released to the public.  In the US, it was found that less than half of studies – including those funded by the government – are publicly released in a timely manner.  Although there are regulations that require publication of studies, they aren’t always (or even usually) followed.  Some consideration of what can be done to ensure that these regulations are effective is ongoing.

Meanwhile, rosiglitazone has been removed from Europe and New Zealand markets.  In the US, new regulations went into effect making the drug extremely difficult to come by.  A different drug – Actos – is said to have similar effects on controlling blood sugar without the increased cardiovascular risk.  However, patients should consult with their doctors.

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