Posted by Sten Westgard, MS
I had the pleasure and honor of participating again in the longest-running workshop offered by the AACC at the annual convention: Concepts and Practices in the Evaluation of Laboratory Methods.
This meeting was first offered at the AACC annual meeting in 1977. The original presenters were Carl Garber, PhD, and R. Neill Carey, PhD. In the last 5 years, these two originals have "retired" from the workshop (but not from the profession, mind you) and have let others step up. Dave Koch, PhD, joined in 1982 and is now guiding the helm of this workshop.
The number 36 in parentheses is included because the first workshop on the topic was presented in 1976 by Dr. James O. Westgard, at the American Society of Medical Technology. The presentation was a summary of papers he had published on method evaluation inthe 1970s.
Here's a picture of the current roster of speakers:
Dan Hoefner, PhD, Dave Koch, PhD, and Sten Westgard, MS
There's no surprise that this workshop has been running for more than three and a half decades. There is a chronic need in the diagnostic field for understanding of statistical evaluation processes. Over the years, the burden has been shifted more onto the diagnostic manufacturer. To make up for a loss in the skils of the laboratory personnel, often the purchase price of a new instrument includes the requirement that the manufacturer will perform the validation studies as the new instrument is brought into the laboratory. Even then, though, the laboratory directors and managers often lack the skills to properly direct and interpret the results of the required method validation studies.
As if to emphasize the need for a good understanding of method validation, the Institute of Medicine's report on the 510(k) process just came out, and the verdict isn't good:
"Conclusion 7-1 The 510(k) clearance process is not intended to evaluate the safety and effectiveness of medical devices with some exceptions. The 510(k) process cannot be transformed into a premarket evaluation of safety and effectiveness as long as the standard for clearance is substantial equivalence to any previously cleared device."
Institute of Medicine Report - Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 years.
While many people assume that an FDA clearance means the device/method/instrument must have good quality, the Institute of Medicine just pierced that bubble. Laboratories can't outsource their responsibility for quality - they have to validate those methods as they are introduced to the laboratory, and make sure that they meet an appropriate standard for quality.
In summary, the FDA 510(k) process is showing its age at 35 years, but the Method Evaluation workshop is still going strong. Indeed, it's more vital than ever.