Guest Essay
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!
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.
Guest authors use QC Design software to customize their QC procedures for their laboratories.
Dr. Sharon Ehrmeyer is back again! You may remember her article on regulations in our Basic QC Practices series. In this article, she explains which regulations and standards and agencies are involved with Method Validation. A must-read reference.
Dr. Callum G. Fraser, one of the leading experts in defining quality goals, has provided us with an article based on his presentation at the 1998 Fourth European Conference Quality [r]evolution in Clinical Laboratories in Antwerp. Dr. Fraser provides a detailed discussion of biologic goals and describes the process as well as the sources of data. Links in the essay are provided to tables on this webiste that contain the data.