[Establishment of outcome-related analytic performance goals]

Accrediting organizations require laboratories to establish analytic performance criteria that ensure their tests provide results of the high quality required for patient care. However, the procedures for instituting performance criteria that are directly linked to the needs of medical practice are not well established, and therefore alternative strategies often are used to create and implement surrogate performance standards. We reviewed six approaches for establishing outcome-related analytic performance goals: (a) limits defined by regulations and external assessment programs, (b) limits based on biologic variation, (c) limits based on surveys of clinicians about their needs, (d) limits based on effects on guideline driven medical decisions, (e) limits based on analysis of patterns for ordering follow-up clinical tests, and (f) limits based on formal medical decision models. Performance criteria were tabulated for 12 common chemistry analytes and four routine hematology tests. There is no consensus currently about the preferred methods for establishing medically necessary analytic performance limits. The various methods reviewed give considerably different performance limits. The analytic performance limits claimed by a laboratory should correspond to those limits that can be reliably maintained based on validated QC monitoring systems. These limits generally are larger than the observed CVs and bias parameters collected for assay validation. There is a major need for increased communication among laboratorians and clinicians on this topic, especially when the analytic performance limits that can be consistently maintained by a laboratory are inconsistent with the expectations of health care providers.