Monthly Archives: January 2010

Root Cause Analysis

Positive cancer screenings: the needle in the haystack?

By ThinkReliability Staff

Recent research from the journal Current Biology has determined that workers in all industries, including healthcare, are less likely to find rare items.  Says lead author Jeremy Wolfe of Harvard Medical School, “If you don’t find it often, you often don’t find it.”   The research may help explain some of the difficulty in finding rare cancers.  Simply put, if a medical professional hasn’t seen very many examples of what cancer looks like in screening tests, it’s more difficult for that professional to find it.

This gives an argument towards greater specialization – based on this research, a medical professional who spends all day looking for breast cancer in mammograms would be more effective at finding it than a general practitioner who may only see a few cases of breast cancer throughout his or her career.

However, another recommended solution is to make sure that the people doing the screening see many examples of what they’re looking for.  Not only could this be done during medical training, but some facilities have found success in “booster exercises”.  Essentially, before a worker spends time screening for rare occurrences, such as indications of cancer, look at results that include a number of positive (i.e. cancerous) screenings.  This helps focus the worker’s attention, leading to quicker and more accurate screening results.

Root Cause

Nobody wants bacteria colonizing their chest!

By ThinkReliability Staff

Mediastinitis (deep sternal wound infection) acquired as a surgical complication of coronary artery bypass graft (CABG) surgery is now considered by Medicare as a hospital-acquired condition for which reimbursement will not be given. It is a serious complication that results in an increased risk of death and, from Medicare data, adds almost $300,000 to the cost of a hospital stay.

For these reasons, it is important to work on reducing the occurrence of mediastinitis in medical facilities. A tool we can use to help reduce the occurence is a visual root cause analysis, presented as 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 develop a Cause Map in three steps.

First, define the problem. Here, the problem is mediastinitis, which occurs in the mediastinum, as a result of the process of CABG surgery. After we capture this relevant information regarding the problem, we look at the impact to the organization’s goals. An increased risk of patient death is an impact to the patient safety and patient services goals. The compliance and organizational goals are impacted by the contraction of a hospital-acquired infection. Additionally, the non-reimbursable cost to the hospital is an impact to the materials and labor goal.

Now that the problem has been defined related to the organization’s goals, we perform our root cause analysis, or make our Cause Map. First we put down the impacts to the goals, then by asking “Why” questions we add causes to the map. Here, the impacts to the goals are caused by a patient contracting mediastinitis. The causes of a patient contracting mediastinitis are bacterial colonization of the mediastinum and the bacteria not being destroyed (possibly due to inadequate levels of antibiotics in tissue because of perioperative antibiotics not being administered). The bacterial colonization is caused by bacterial contamination, and/or an environment susceptible to colonization, possibly due to impaired wound healing, such as caused by elevated blood glucose levels. Bacterial contamination is caused by bacteria in the area of an open chest (which is open for the purposes of performing a CABG). The bacteria in the area can be caused by a number of things, including a non-sterile atmosphere, bacterial infection of the skin, insufficient sanitization of the skin, and bacteria on the operative staff hands or gloves.

The root cause analysis can be viewed by clicking “Download PDF” above. The root cause analysis we show here is highly simplified. Even more detail can be added to this Cause Map as the analysis continues. 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.

Once the Cause Map is completed, we look for solutions. The solutions are attached to the cause they control. For example, a solution to elevated blood glucose levels is to use a continuous IV infusion of insulin for diabetic patients during surgery. Other solutions are shown on the Cause Map. Individual medical facilities can evaluate these solutions based on the impact to the organization’s goals to determine which solution(s) will be most effective in reducing their risk.

Click on “Download PDF” above to download a PDF showing the Cause Map.

Root Cause Analysis

The Causes and Effects of Hepatitis B & C

By ThinkReliability Staff

As well as medical errors and industrial accidents, the Cause Mapping method of root cause analysis can be used to research the causes and solutions to disease epidemics.  Take the case of hepatitis B and C.  A report recently released by the Insitute of Medicine states that the infection rates of chronic hepatitis B and C viruses (HBV and HCV) is 3-5 times that of HIV (human immunodeficiency virus).  The report also outlines some of the problem associated with lowering the infection rates of hepatitis B and C.

Using the information presented in this report, it’s possible to make a Cause Map outlining the causes of hepatitis B and C infections.  First we begin with the impact to the goals.  First, the report estimates that there are approximately 15,000 deaths per year associated with chronic HBV and HCV.  Additionally, 3-5 million people are estimated to be living with chronic HBV and HCV.  These are both impacts to the patient safety goal.  In many cases, these infections are not treated.  This is an impact to the patient services goal.

Once we’ve defined the incident in respect to the goals, we can begin our Cause Map.  We begin with an impact to the goals and ask “why” questions until all the causes are on the Cause Map.  In this case, the deaths are caused by chronic HBV and HCV, which are caused when a person is infected and not treated.  Infections can result from being born to an infected mother, infected blood transfusions (before blood was tested for HCV), sexual contact with an infected partner, sharing needles with an infected person, or needlesticks with an infected needle.

Most typically, people who are infected with HBV or HCV do not seek treatment because they are unaware they are infected due to the asymptomatic nature of hepatitis.  Persons may not be screened even in high risk situations because either they or their healthcare providers do not realize the risk, or they do not have adequate access to healthcare.

The infection rate of HBV is decreasing thanks to a vaccine for hepatitis B.  However, a vaccine is not yet available for hepatitis C. This is certainly a priority in the national fight against hepatitis infections, as well as increased education and awareness programs.

This 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 one-page downloadable PDF, please click on “Download PDF” above.

Never Event, Root Cause Analysis

What’s in YOUR heparin?

By ThinkReliability Staff

In 2008, contamination of the U.S. supply of heparin was brought to light. A significant portion of the U.S. supply of heparin was recalled, and the death toll potentially associated with the contamination has now climbed to 81, with hundreds of adverse events also reported. Additionally, prior to the recall there was concern for deaths and injuries associated with the contaminated drug not fulfilling its expected purpose – preventing blood clots during surgeries and kidney dialysis – because the contaminant has no blood thinning properties. So far, the contaminated drug has been found in 10 countries thus far, increasing concern about the drug supply chain.

Researchers have verified that the contaminant in the recalled heparin is oversulfated chondroitin sulfate (OSCS) and that they have discovered a mechanism by which the contaminant can cause the adverse effects (falling blood pressure and severe allergic reactions). Additionally, the researchers have provided a test for regulators to screen heparin for this contaminant.

They have determined that the OSCS was present at the active ingredient supplier plant in China. Because OSCS does not occur in nature and mimics the chemical structure of heparin so closely, it is believed that the (mostly unregulated) crude heparin suppliers in China added OSCS to increase their profit, as OSCS is many times less expensive than heparin. The OSCS was not detected by standard impurity tests, due to its similarity with heparin. In Congressional hearings since the event, the Food and Drug Adminstration (FDA) has said that the inspections of the Chinese plant (as well as those of most foreign plants) were inadequate due to lack of funding for the FDA mission.

The Cause Map shows that the heparin got into the drug supply after being placed in the raw ingredients. It was not discovered by regulators, due to the lack of a commonly used, effective test. 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. As more information is released about the failings of the supply chain in this instance, we can add more details to the Cause Map.

Click on “Download PDF” above to download a PDF showing the Cause Map.

See a more detailed root cause analysis of the heparin contamination.