Tools, Technologies and Training for Healthcare Laboratories

Tips on Managing the Quality of Immunoassays

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.

Defect Rates, Quality and Productivity

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.

What's New With CLIA'88, JCAHO & CAP

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.

European Approaches to Analytical Goal-Setting

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.

QC - The Regulations

Dr. Sharon Ehrmeyer returns with an section for our Basic QC Practices series. If you're operating a laboratory in the U.S., there's a government agency out there that wants to regulate you - do you know which one? In this article, Dr. Ehrmeyer details all the various bureaucracies and their regulations. See which rules apply to you!