Impure Injections Used

By Kim Smiley

Research is been suspended at a prominent brain-imaging center associated with Columbia University. Food and Drug Administration investigations found that the Kreitchman PET (positron emission tomography) Center has injected mental patients with drugs that contained potentially harmful impurities repeatedly over the past four years.

Investigations by the lab determined that no patients were harmed from the impurities, but this is still a significant issue in a nationally renown laboratory.

How did this happen?

This issue can be investigated by building a root cause analysis as a Cause Map. To start a Cause Map, the impact to the organization goals is determined. In this example, this issue is obviously an impact to safety because there was potential to harm patients. It is also an impact to the production-schedule goal because research has been suspended. Additionally, this problem is an impact to the customer service goal because this issue raises questions about the validity of research results.

To build a Cause Map, select one goal and start asking “why” questions to add causes. In this case, the first goal considered will be the safety goal. There was a potential for injury. Why? Because impure injections were given to patients. Why? Because the injections are necessary for research, because the labs typically prepare the compounds themselves and because the lab prepared the compounds incorrectly. When there is more than one causes that contributed, the causes are added vertically with an “and” between them.

Each impacted goal needs to eventually connect to the same Cause Map. If they do not, the impacted goal may not be caused by the same problem and the goals should be revisited.

To continue building the Cause Map, keep asking “why” questions for each added cause until the level of detail is sufficient.

A Cause Map can be as high level or as detailed as needed. The more significant the impact to the goals, the more likely a detailed Cause Map will be warranted. Once the Cause Map is completed, it can be used to develop solutions to help prevent the problem from reoccurring.

In this example, the lab is currently changing management and reorganizing procedures to help prevent the similar problems in the future.

To view an initial Cause Map for this issue, please click the “Download PDF” button above.

The Downside of Preparedness?

By Kim Smiley

The U.S. Government has announced that 40 million doses of swine flu vaccine have expired and must be disposed of.   In addition, 30 million more doses are about to expire and will also be disposed of (unless there is a sudden need for swine flu vaccine).  The vaccine doses are worth $260-$450 million.  We can capture this information in a problem definition outline.

Then the question is: is this a bad thing (a problem) or a good thing (a success)?  Like a lot of things, it doesn’t necessarily have to be one or the other.  There’s an aspect of success – swine flu did NOT turn out to be a deadly global epidemic, as was predicted – and an aspect of failure – up to $450 million of vaccines were tossed out.

The question that remains for the analysis is: how do we maximize the successes (preventing epidemics) and minimize the not-so-good stuff (wasting vaccines and money)?  A detailed root cause analysis can draw out the successes and problems associated with any event, including this one.  We can use it to look at the planning process used for an epidemic to look for places where the estimation of the need for vaccines can be improved.  We can even look at the use of and expiration dates of the vaccine to determine if, in the future, a backup plan might allow us to get some secondary use out of the vaccines.  Opportunities for improvement are limited only by the brainstorming capability of your organization!