Quality control of test systems waived by the Clinical Laboratory Improvement Amendments of 1988 - Perceptions and practices

Context.-Recent advances in laboratory testing technology have resulted in a rapidly increasing number of test systems targeted for physician office, point-of-care, and home health care settings. With enhanced error detection mechanisms and unitized reagents, these new systems simplify the testing p rocess and the assessment of analytical test performance. Many also meet th e criteria set by the Clinical Laboratory Improvement Amendments of 1988 (C LIA) to qualify as waived test systems, and laboratories using only waived tests are subject to very limited regulatory oversight. Objective.-To evaluate use patterns and perceptions about quality control r equirements with respect to waived testing. Design,and Setting.-Survey of a network of 431 hospital, independent, and p hysician office laboratories in the US Pacific Northwest. Results.-Responding laboratories (n = 221) were taking advantage of the ava ilability of waived tests and using them to make definitive diagnoses. We f ound considerable differences between quality control practices and the lab oratories' perceptions of quality control requirements. Most respondents we re performing traditional quality control on waived tests, influenced by th eir interpretation of regulations, the intended use of the test, and the te sting personnel employed. Conclusions.-Technology optimized for alternate quality control can represe nt an improvement in ease of use while meeting expectations for accuracy an d providing relief from regulatory burdens. However, laboratory personnel e xhibit confusion in applying new quality control systems.