Clinical Laboratories Marching Toward Globalization

September 12th 2008

Many of you know about my views on the globalization of healthcare and the steady convergence in laboratory operations across most developed nations. Among the signs of this phenomenon are the widespread use of the same analyzers, tests, and reagents, along with uncannily similar forms of organization and operation. (

Simply said, a walk through any modern clinical laboratory in most countries today reveals few surprises. Quite the opposite is true. Today’s modern laboratories feature similar floor plans and physical layouts. They use the same products from the major global in vitro diagnostics (IVD) manufacturers. Test menu and work flow are fundamentally similar.

This trend is now getting reinforced by a new dynamic in the international laboratory testing marketplace. It is the emerging interest in quality management systems (QMS) by progressive laboratory administrators and pathologists. One primary driver in this development has been ISO 15189 Medical Laboratories. First issued in 2003, ISO 15189 was intentionally designed to be a quality management system. (To keep up with current trends register for our Free Dark Daily Newsletter)

Outside the United States, ISO 15189 has been noticed by independent laboratory owners and government healthcare authorities alike. The value of a QMS like ISO 15189 to owners of independent laboratories is that it can be a recognition of quality standards that is meaningful to the public. That helps them compete for the laboratory testing business of physicians and patients in their community. For government healthcare authorities, ISO 15189 makes a good basis for mandatory laboratory licensure and/or accreditation. This is particularly true in countries which have had no mandatory requirement for licensing or accrediting medical laboratories.

This trend gets little attention by laboratory managers and pathologists here in the United States, not the least because they must comply with the federal and state licensure laws. They are also preoccupied in dealing with the challenges of declining reimbursement, a scarce supply of technical staff, and the incessant demands that their laboratory produce more test results with a shrinking budget. However, laboratory managers should not ignore the domestic implications of this international trend.

For that reason, I have assembled a fascinated series of speeches on ISO 15189 and quality management systems at the upcoming Lab Quality Confab, which will take place on September 24-25, 2008, at the Hilton Hotel in Atlanta, Georgia. Leading off will be the experience in achieving ISO 15189:2007 accreditation of a laboratory network in Ontario, Canada, and Piedmont Medical Laboratory of Winchester, Virginia. Following that will be a presentation by Glen Fine, Executive Vice President, Chief Staff Officer at the Clinical & Laboratory Standards Institute (CLSI) of Wayne, Pennsylvania. Fine will provide an insight look at the global movement toward quality management systems, including ISO 15819. Concluding this session will be a detailed look at FMEA (Fault Mode and Effects Analysis) and FTA (Fault Tree Analysis) by Tina Krenc, Director, Diagnostics R&D Phase System, Abbott Diagnostics, Abbott Park, Illinois. 




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