Risk Management Essays
With the expiration date on EQC drawing ever closer, US labs still await the details about its replacement. While CLSI EP23 has been public for more than a year, and CMS has made press releases about the new IQCP (Individualized Quality Control Plans) and has announced the benefits of this new forthcoming policy, the actual regulatory language has yet to be released or described.
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.
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?
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.
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)