Guest Essay
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.
Dr J.C. Libeer, Ph.D., Ph.D, joins us from Belgium, where he has put together a comprehensive survey of the European quality schemes and programmes, noting their strengths and weaknesses. A must for those who want to learn about and keep current with laboratory quality management in Europe.
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!
Guest authors use QC Design software to customize their QC procedures for their laboratories.