Guest Essay
Dr. Art Eggert discusses the evolution of clinical laboratory utilization. Do you remember back when laboratories used to be a profit center instead of a cost center? Dr. Eggert traces the history of laboratory testing and its costs, and discusses how to optimize laboratory testing benefits while minimizing the expense.
Dr. R. Neill Carey shows how to derive quality requirements for immunoassays from the proficiency testing criteria. Theophylline, cortisol, thyroxine, and folate examples are illustrated.
Dr. Robert Burnett describes the need to focus our future thinking on defect rates to better manage the analytical quality of laboratory tests. In the midst of our preoccupation with the profound changes that are taking place in health care delivery in general, and laboratory medicine in particular, it might be of some comfort to realize that there are some fundamental things that have remained the same. Two management objectives that have not changed in organizations, including clinical laboratories, are the need for high quality and the need for high productivity.
Dr. Sharon Ehrmeyer, a frequent speaker on government regulations, graces our website with a timely essay on the newest developments in CLIA, JCAHO, & CAP. This article is an update of CLIA’88, the Joint Commission on Healthcare Organizations (JCAHO), and the College of American Pathologists (CAP) regulatory and accreditation guidelines. CLIA’88 establishes minimum performance standards for all clinical laboratories; JCAHO and CAP are professional organizations which have received deemed status from the Healthcare Financing Administration (HCFA). Both voluntary organizations inspect their members using standards that meet or exceed those of CLIA.
In the US, when it comes to quality requirements, we have CLIA and clinical decision criteria and a whole host of other choices (many of them bad). But, if you can believe it, the situation in Europe is even more complicated! Dr. Per Hyltoft-Petersen discusses external quality assurance schemes, ISO, analytical goal-setting, and finally biological goal-setting.