Monthly Archives: April 2011

Root Cause Analysis

Hungover Surgeons More Likely to Err

By ThinkReliability Staff

The headline probably isn’t shocking to anyone who’s woken up the next morning with a pounding headache and dry mouth.  Clearly one’s performance at work is going to be impacted by a night of unabated drinking.  However a recent Irish study, published this month in the Archives of Surgery, show surprising results regarding the lingering effect of alcohol consumption.  Their findings show that well into the day surgeons are more likely to make mistakes.

Modern surgical techniques, including laparoscopic surgery, require great manual dexterity and control as well as sustained mental focus.  It is common knowledge that both of these skills are impaired while intoxicated.  What is unknown is how these skills are impaired after one is no longer intoxicated, but obviously still affected.  In all but one test subject, their blood alcohol content (BAC) had returned to 0.00%.  Initial testing done in the morning showed no significant difference between test and control subjects, however later in the day there was a perceptible decline.  While the study was only a preliminary one, it indicates that more research is needed in this area.

A Cause Map can be especially helpful in a research environment because it helps define causal relationships.  In this case, the researchers focused on the effects of drinking the night previous.  But perhaps there are other reasons at play, such as fatigue, which contribute to the effect.  When searching for causes it is important not to focus in on one aspect, ignoring others, since all causes are required to produce an effect.

It is expected that surgeons wouldn’t actually drink while at work.  However, there are surprisingly no guidelines about when they should stop drinking beforehand.  Pilots are federally mandated not to drink at least 8 hours prior to flying or fly with a blood alcohol content (BAC) of .04% or greater.  Perhaps this study will generate an overdue discussion on the need for abstention prior to surgery.  Potential solutions, such as training or regulations, can be displayed directly on the Cause Map above the appropriate cause.

Root Cause Analysis

Reducing Stillbirth Rates Worldwide

By ThinkReliability Staff

Stillbirth is the loss of a pregnancy after 22 weeks gestation.  Around 2.6 million stillbirths occur every year around the world, primarily in developing countries.  However, the kind of attention being addressed to other issues in the developing world has not been focused on stillbirth, leading the rates of stillbirth to decrease more slowly than other death rates.  In an attempt to draw more attention to this issue – with its profound impact on the family and community – the Lancet has published a series of articles on stillbirth, addressing some of the impacts, causes, and a plan to reduce the number of stillbirths in half by 2020.

The information provided by this comprehensive series can be summarized visually within a Cause Map.  A thorough root cause analysis built as a Cause Map can capture all of the causes in a simple, intuitive format that   fits on one page.  We begin the Cause Map much as the series begins – with a focus on the impacts of stillbirth, beginning with the 2.6 million deaths per year.  We can consider this an impact to the public safety goal.  A related impact is an impact to the public safety goal – lack of access to quality care.  Starting with these two goals, we can begin an analysis of the problems contributing to stillbirth.

Although the data collection for stillbirth lacks consistency, there are five major causes of stillbirth that we’ll address here: fetal growth restriction, childbirth complications, maternal infection, maternal disorders, and congenital abnormalities.  At a very, very high level, we can discuss some of the causes of these issues, which the Lancet series hopes to address in order to halve the number of stillbirths by 2020.

Fetal growth restriction can be caused by inadequate prenatal care.  Increased fetal growth restriction detection and management is expected to reduce the number of stillbirths by 107,000 per year.  Childbirth complications can be caused by lack of quality obstetric care and/or labor past 41 weeks.  Comprehensive emergency obstetric care is expected to reduce yearly stillbirths by 696,000 and  identification/induction of women who are past 41 weeks gestation is expected to reduce another 52,000.

The main maternal infections of concern are malaria and syphilis.  Additional malaria prevention (such as insecticide treated nets) would reduce annual stillbirths by 35,000 and syphilis detection/treatment another 136,000.  Maternal disorders of concern are mainly diabetes and hypertension. Detection and management of maternal diabetes and hypertension would prevent 24,000 and 57,000 stillbirths per year, respectively.  Congenital abnormalities can be caused by insufficient folic acid intake at and after conception.  Increased access to folic acid supplementation would save 27,000 lives.

If all of these recommendations can be fully implemented, more than 1 million stillbirths could be prevented each year.   Far more detail can be added to this Cause Map, depending of the level of analysis required. As with any investigation the level of detail in the analysis is based on the impact of the incident on the organization’s overall   goals.  To see the outline, Cause Map, and solutions, please click “Download PDF” above.  To learn more about stillbirth, and the goals, please see the Lancet series.

Root Cause Analysis

Increased Cost of Drug May Increase Potential for Pre-Term Labor

By Kim Smiley

In 2003, a study by the National Institutes of Health determined that administering hydroxyprogesterone caproate (also known as17P) could reduce the risk of preterm delivery.  Preterm delivery can cause many health issues for infants.  However, there was no commercial source of 17P, so pharmacies compounded it upon request for $10-$20 an injection.  Injections are generally taken starting at weeks 16-24 of pregnancy for up to 20 weeks.

Concern about availability and quality of this compounded drug helped lead to development and expedited U.S. Food and Drug Administration (FDA) approval of a name brand version.  The name brand version was approved on February 3, 2011 and was granted 7 years of market exclusivity under the “Orphan Drug Act”, an FDA incentive to develop products.  The name brand version of the drug was priced at $1,500 an injection.  Concern over the price increase, which could total nearly $30,000 a pregnancy, led to concerns of increases in preterm labor due to the unaffordable drug.  This on turn led to concerns about patient safety and patient services.  Additionally, there has been general outrage over the increase in cost, leading to a request for a Federal Trade Commission (FTC) investigation into the pricing of the drug and a loss of market share for the manufacturer.

To attempt to alleviate the concerns regarding access to the drug, the manufacturer has lowered the price to $690 an injection and has developed a host of other programs to increase affordability of the drug.  The price drop and other programs were announced on April 1, 2011.  The FDA announced on March 30, 2011, that it will not stop pharmacies from continuing to compound 17P, in a rare move to ensure drug availability.  However, some doctors are concerned that prescribing a pharmacy-compounded drug. when there is a brand name drug available, will leave them open to legal action if safety concerns arise.

The impact of this issue on the future of preterm labor and drug pricing is unclear at this point.  It appears that more action may be required to reduce the risk of preterm labor, either by the manufacturer or the FDA, or both.  View the analysis of this issue, including a timeline, problem outline, Cause Map and solutions, by clicking “Download PDF” above

Hospital Acquired Condition, Root Cause Analysis

Tackling a Seemingly Insurmountable Problem

By ThinkReliability Staff

The goal of any root cause analysis is to uncover causes and, most importantly, solutions that will reduce the risk or mitigate the effects of the problem being studied. However, sometimes a problem seems insurmountable. Take rising health care costs. There are myriad causes that contribute to increasing health care costs. Many of the solutions that have been identified are costly, difficult, or both. Additionally, some solutions place the onus on patients, which can limit the effectiveness. Although patients presumably would love to reduce their health care costs, most don’t have the resources to do so.

Although rising healthcare costs is a national issue, some of the problems you face at an organization may seem just as insurmountable. What can be done when an issue appears too big to fix?

First, ensure that you limit your analysis and potential solutions to your own sphere of influence. Although patients individually reducing obesity and taking their medications properly and on time would certainly reduce healthcare risks, those steps must be taken by the individuals. As a healthcare organization though, it is possible to take steps to increase the probability that individuals will take these steps. Generally patient education, automated reminders, and making it easier to do the right thing – by including clearer instructions on prescriptions or offering more fresh fruit in the hospital cafeteria – are steps that can be taken that are within the realm of an organization’s sphere of influence. Attempting to control solutions outside your sphere of influence is an exercise in frustration!

Next, focus on a single piece of the pie. Not all the causes identified during a root cause analysis have to be tackled at once. A great way to get started: find a solution that is nearly free and can be implemented fairly transparently to staff. For example, ask providers to hand out a healthy eating brochure to patients as they leave their appointment. Is this going to make a big impact? Probably not, but it’s somewhere to start. And even a little impact can help.

Or, take a note from Camden, New Jersey. In Camden, 1% of patients are responsible for 30% of medical costs. Jeffrey Brenner, a local physician, is making a difference reducing costs by focusing on those few patients. This is the big “bang for your buck” solution. And, the solutions that work for this 1% will probably help reduce costs for the other 99% as well. By focusing on a small number of patients – determining the causes specific to them and tailor-making solutions – headway is being made against an extremely difficult problem. (Read more at: http://www.newyorker.com/online/blogs/newsdesk/2011/01/atul-gawande-super-utilizers.html)

If you’re feeling overwhelmed, try taking one step at a time. If healthcare costs can be tackled by looking at a small part of the problem, what can your organization do with a focused look at solutions?

Root Cause Analysis

Contaminated IV Bags Sicken 19

By Kim Smiley

With the aid of the State Health Department and the Centers for Disease Control and Prevention (CDC), six hospitals have traced back recent patient infections to contamination in total parenteral nutrition (TNP) delivered via intravenous (IV) bags.

Although the first infection occurred in January, 2011, a pattern was not established until March, 2011, after nineteen patients were infected with serratia marcescens bacteria.  Patient infection is an impact to the patient safety goal.

The infections occurred as a result of the patients being given contaminated product – in this case, the IV bags.  The bags were recalled, and are no longer in production.  Ten of the patients died.  Investigators have said they won’t be able to determine whether the infection caused the deaths because the patients were already very ill (TNP is used for patients who are too ill to eat on their own).

The IV bags were compounded at a local pharmacy.  There was a potential for contamination in the raw material used for compounding, during the compounding at the pharmacy, or at the hospital.  Because six different hospitals experienced the same rare bacterial contamination, it is unlikely that the contamination occurred at the hospital.

According to Dr. Alexander J. Kallen, a medical officer with the Centers for Disease Control and Prevention, “Historically, what we’ve seen is a breakdown in the manufacturing process.”  The investigation is underway to determine if the contamination was caused by an issue with the manufacturing process, an issue with the sterility of equipment, or a contamination of the raw material.  As the investigation continues, more detail can be added to the Cause Map.  As with any investigation the level of detail in the analysis is based on the impact of the incident on the organization’s overall goals.

While investigating an issue, it can also be helpful to look at the process for identifying and isolating issues, and implementing improvements.  In this case, after patients receive or use products, they are monitored for certain reactions.  If those reactions occur (such as those that indicate a bacterial infection), they are reported to the State Health Department, then the CDC.  The CDC investigates to determine the source of the infection and then pulls the affected products off the market.  Currently, the CDC has identified the product that is contaminated, though not the source of the contamination.

A thorough root cause analysis built as a Cause Map can capture all of the causes in a simple, intuitive format that fits on one page.  To view the Cause and Process maps, click “Download PDF” above.