Proficiency testing from a total quality management perspective.

Public concern over increasing health-care costs plus dramatized testing errors, has resulted in CLIA '88 with its more stringent rules governing laboratory performance. The purpose of the 1990 U.S. Health Care Financing Administration Final Rules for Proficiency Tests is to separate the quality laboratory from the poorly performing one. From the perspective of total quality management, the customer (patient) defines quality as virtually error-free test results. The current proficiency testing format defeats this. Its effective purpose is not to identify quality laboratories but to shut down the most prolific laboratories--regardless of their quality. There are two reasons for this. First, the proficiency testing format is incomplete: it is missing a minimum frequency criterion. Second, the data for determining the quality of a laboratory's performance (the degree of error-free results) are not being used. I propose a solution based on continuous improvement that promotes voluntarism, favors the quality laboratory, and reduces federal regulation.