Day 3 of the Westgard Workshops brought us a Risk Management expert with extensive real-world experience. Tina Krenc, the Director of Strategic Quality Assurance for Abbot Diagnostics, and has taught Risk Management for Northwestern's Master of QARA program, and AAMI and ADVAMED.
One of the first lessons Tina taught: Risk Analysis requires a team of multidisciplinary professionals. Since Risk assessment can be subjective (you may think a failure mode is more severe than someone else), you need many perspectives. Typically, you need people with different expertise, so that the team can identify as many all the possible failure modes as possible.
Tina Krenc covered Process Maps, Fault Tree Analysis, and FMEA (failure modes effect analysis). She also included a sample FMEA project. Participants split into groups and attempted to map process steps, determine failure modes, assess severity, probability, and detection - then determine possible remedial actions.
As you can imagine, this was more challenging than many people realized. The principles of Risk Management are fairly simple to explain. The tools are also simple (tables, flowcharts)_and often the only calculation is a simple multiplication of two numbers. However, context is all. Deciding how something might fail, how severe that failure may be, how often that failure may occur, and what might be done about this, requires a lot of thinking. Ultimately, Risk analysis relies on a lot of professional judgment about your laboratory operations. That's another important lesson of the day: What you get out of Risk Analysis will depend on what you bring into it.
Next, Terri Darcy, MD, MMM, explained her experiences with Electronic Medical Records. Terri Darcy is the Medical Director for Clinical Laboratories at the University of Wisconsin and Clinics, and has been leading an implementation project of a system-wide electronic medical records.
One of Terri's key observations picks up directly from the earlier lessons. Terri notes that a lot of the work of electronic medical records is being done by "20-something" computer programmers, straight out of college, with basically no clinical knowledge at all. As a result, a lot of logical decisions from the programming perspective are made - which ultimately are not the right decisions to be made based on the clinical reality of how tests are used. For example, there is a programmer desire to include all tests results on a single chart, regardless of what method was used or where the test was performed. Given the method biases and differences between point-of-care and automated analyzer results, a single chart could easily show changes that do not reflect changes in the clinical state of the patient.
Those were just some of highlights of the Westgard Workshops.
We thank all the speakers and participants for joining us.
Below, some of the "Class of 2010" of the Westgard Workshops:
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