"WE HAVE THE TECHNOLOGY"

	Feb. 5, 1997 Carol A. Carriere, SCT(ASCP) Program Director School of Cytotechnology Los Angeles County University of Southern California Medical Center Los Angeles, CA Dear Ms. Carriere, I have read your "In My Opinion" article in the December 1996 Laboratory Medicine magazine several times and finally decided to offer my perspective for your consideration. I am not a cytotechnologist but I have considerable insight into the problem of production screening of a product. My experience comes from 25 years of laboratory work and management in the inspection of semiconductor wafers where the penalty for poor quality inspection is rapid and severe. Improvements in the inspection process occur because of economic pressure to determine the source of every defect so its cause can be eliminated. No electronic production business can survive very long without an effective and efficient inspection process and managing the environment of the people who perform the process is fundamental to any process optimization. I have found a striking difference between the attitude of health care laboratory management and semiconductor quality assurance management. The people who manage in the electronics sector will spare no expense to establish state-of-the-art inspection systems and aggressively pursue process improvements over time. In the health care field, managers seem ignorant of the requirement to purchase technology to improve a process that is essentially unchanged from the early 1900's: a human being perched on a stool peering through oculars into a bright field of light. The people in the process seem to be as expendable as the glass slides they use to mount specimens! Also, since there is rarely a penalty at the corporate level for poor quality work, unscrupulous PAP Mills can enrich themselves at the expense of their customers while professionals like yourself bear the stigma of the resulting bad press. The piece Diane Sawyer did on Prime Time in 1995 indicated that the problem of poor inspection quality is far from resolved even though numerous Federal and State legislators have tried to fix it. Their efforts may be very conscientious but the process can only be fixed from within. Consider what is possible today with technology that we developed and market to the semiconductor industry. A person sits at a Personal Computer, puts the microscope stage transport in a computer-controlled serpentine scan pattern and watches the screen for any anomalies. When one is observed, the person depresses the left mouse button interrupting the scan. The anomaly is scrutinized and a digital picture is taken, complete with an accurate coordinate of its location, and the scan is then reinitiated. The computer reads a bar code identification of each sample, counts the field-of-views reviewed, counts the number of times the scan was interrupted and compiles the statistics for each operator. No headaches, no neckaches, no backaches, no conspicuity concerns, and no cheating. The microscopy system for semiconductor inspections cost around $52,000 and is considered by the marketplace to be very low priced. A system set up for doing production PAP smears would cost about $45,000, which is considered to be very high for health care laboratories. These systems are getting very favorable reviews and, even though the technology is brand new, we have sold two and have several orders pending for electronics inspections. But marketing to the health care industry has been a very different experience. We actually had a potential customer invite us in for a demonstration to assess whether our technology would resolve a problem with inspector's sore backs and necks. After a very successful demonstration, where his inspection staff was outspokenly supportive of our product, he had his financial manager perform a cost/benefit study. He determined that two of our microscopes would pay for themselves in 6 to 12 months by improving throughput. The manager/owner purchased a massage table instead. If that type of attitude is typical for your industry, it is no wonder the turn-over in personnel is so high. And high turn-over usually indicates dissatisfied people which means mediocre work at best, incomplete work at worst. I believe the throughput targets you referenced are the symptom of the problem rather than the problem itself. Simplistic production targets are the result of one dimensional thinking by business planners. Those type of planners need to be educated on laboratory process management or find a different field with fewer degrees of freedom to the problem. I recommend they model how the business process is being managed in the electronic sector where inspection quality drives the process. Poor quality at the inspection operations translate into higher production costs (lost sales) and are addressed through technology advancements to optimize the process as well as improve the workplace of the people who implement it. The business process will never be optimized as long as the people responsible for executing the daily activities perform their jobs in uncomfortable or painful situations as described in the attachment I have included with this memo. I have included a précis of our product to provide some clarification of my points. If you would like to see more detail, check out our home page at http://www.tritekcorp.com or give me a call at (540) 439-3690. Sincerely, Rex A. Hoover (unpublished by recipient)