Abstract
Standardization issues have become increasingly important over the last several years. Market success for many companies hinges on the successful implementation of standards. Standards can reduce costs at the point of use of diagnostic and analytical instrumentation and can also reduce the costs of manufacturing.
The use of standards can also reduce redundancy in laboratory testing because it reduces waste, allows positive specimen handling and tracking throughout the automation process and helps to speed up the entire process. The principals of just-in-time manufacturing and palletizing can be applied to the laboratory, but only after standards are in place. Installation and service costs are reduced because standards facilitate a customer-oriented plug-and-play simplicity. Furthermore, training costs are reduced since principles of operation and maintenance will be common across different platforms.
In the clinical laboratory there are many standardization groups already working on all aspects of laboratory standardization. In fact, a special committee has been set up to oversee the many standards activities that currently exist.
The Clinical Testing Automation Standards Steering Committee is a group that was recently formed to coordinate the activities of some well-respected standards organizations (e.g., National Committee on Clinical Laboratory Standards, International Federation for Clinical Chemistry Standards Committee, Japanese Commission on Clinical laboratory Standards). Their mission is to develop and organize a worldwide standards process by performing the following tasks:
facilitating the optimization, interfacing, and integration of analytical equipment,
encouraging cooperation between industry and users,
monitoring the standards creation process so that it reduces costs and increases quality and
assisting with implementation of standards so they are actually used
The CTASSC will initially focus on the specimen carrier and its container/transporter, communications specifications, error and exception handling, mechanical interface and system/status performance information. The process they will use to proceed with standards development involves first formalizing the activity through written objectives, getting a group consensus after assembling knowledgeable participants, organizing a working group which will be responsible for actually working out the details, and finally arranging for a clinical test site to determine if the standard works in a functioning laboratory. The members of the current committee include:
R. Markin, M.D., Ph.D., University of Nebraska, Chairman
K. Bennet, Mayo Foundation
G. Hoffmann, M.D., Trillium, GmbH, Grafrath, Germany
S. Howlett, Coulter Corporation, Miami, FL
G. Kramer, Ph.D., NIST, Gaithersburg, MD
P. Mountain, Autolab Systems, Etobicoke, Ontario, Canada
D. O'Bryan, Ph.D., Smith Kline Beecham Laboratories
S. Savitz, Becton Dickinson, Franklin Lakes, NJ
Pipetting robots are beginning to use standardized communications and interfaces.
