HOW MANY MISTAKES, HOW TO FIND THEM

The topic of quality control often evokes prolific discussion among th ose whose business is its administration. Reliable methods for identif ying mistakes must be developed in both the manufacture and use of tes t devices. Unit test devices are uncomplicated to run and provide quic k results in a world where speed and simplicity are paramount, yet the ir very nature as individual assay units introduces questions about th e relevance of conventional quality control procedures. Hybritech's IC ON(R) QSR(R) CKMB assay is a unit test device that requires daily moni toring according to CLIA'88 regulations. The challenge is to ensure th at quality-control testing is value-added, assuring clinicians valid p atient sample results although controls are run in a separate ''assay. '' We find that conventional quality-control procedures are indeed val id; however, the fundamental difference of unit test devices must be r ecognized and accounted for by understanding the capability of the ass ay in each laboratory.