As we enter the fall of 2012, we're well into the "roll-out" phase of the new CLSI EP23 guideline. There have been articles, "advertorials", webinars, workshops and more - all about the new Risk Analysis Approach. But what's interesting is that while Risk Analysis is somewhat "new" to US healthcare, it's been done for years in other countries. US laboratories should take serious note of recent articles on the effectiveness of these Risk Analysis techniques in healthcare.
CLSI presented an education symposium on "Reducing Risk in Healthcare: Present and Future Trends in the Laboratory" during its annual Leadership Conference, March 21st, 2012. Dr. Westgard presented, participated and offers his perspective on where Risk QC is taking the laboratory.
The CLIA Final Rules of 2003 put into place a set of scientifically unsound practices known as Equivalent QC. For years since that time, CMS has been seeking a solution. Now that CLSI has published the EP23 guideline for Risk Analysis, is the successor to EQC at hand?
An essential part of Risk Analysis is the identification of what might go wrong - in others words, the failure modes of a process. After diagramming a process, each step of the process must be examined to determine the failure modes. Typically this is done by team brainstorming to identify the potential failure modes, then a summary of those modes through a cause-and-effect diagram, sometimes called a "fishbone" or Ishikawa diagram. (Preview)
At the Westgard Workshops 2011, a hot topic of discussion was the issue of Detectability. Whether or not to include it in the Risk Analysis methodology being promoted to the medical laboratory community. There are several arguments for eliminating detection from Risk Analysis. But should we really do away with Detectability?