Oct 14, 2010 | Laboratory Pathology, News From Dark Daily
North America’s three ISO 15189 accreditation bodies will be at Lab Quality Confab, along with most of the nation’s ISO-15189 accredited clinical pathology laboratories
In the United States and Canada, acceptance and use of ISO 15189:2007 Medical Laboratories has been limited to a handful of clinical pathology laboratories—except in the Canadian province of Ontario, where, starting almost eight years ago, ISO 15189 became the basis of the province’s mandatory clinical laboratory accreditation program.
But now more pathologists and clinical laboratory managers south of the U.S.–Canadian border are asking a fundamental question: “Is ISO 15189 accreditation an effective way to move my laboratory organization to higher levels of analytical quality while continuously reducing or eliminating errors that affect patient safety and clinical outcomes? More senior medical lab leaders are answering this question with a “yes.”
Clinical Laboratories Turning to ISO 15189
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Oct 15, 2008 | Laboratory Management and Operations, Laboratory Pathology
When it comes to hospital accreditation, the Centers for Medicare and Medicaid Services (CMS) recently disrupted the status quo in at least three ways. First, last month it approved Norway-based Det Norske Veritas (DNV) as a hospital accreditation program in the United States. Significantly, this is the first new hospital accreditation organization in the U.S. in 40 years.
Second, by taking this action, CMS is bringing the hospital industry closer to the use of ISO 9001 quality management systems. That’s because Det Norske Veritas, which already accredits hospitals in several countries worldwide, bases its accreditation process on use of ISO 9001. It has also created a program that combines the CMS “Conditions of Participation” with the ISO 9001 quality management system. DNV calls this program the “National Integrated Accreditation for Healthcare Organizations (NIAHO).” At least 22 hospitals in the United States have already earned accreditation using NIAHO.
Third, by granting deeming status to DNV, CMS has introduced a new competitor for accreditation business into the U.S. marketplace-one that incorporates its accreditation standards on the ISO 9001 quality management system (QMS). Dark Daily predicts that it won’t take long for the Joint Commission to respond to this new competition by introducing an accreditation program that is also based on a quality management system like ISO 9001.
One U.S. hospital that has worked with Det Norske Veritas since 2005 is Newport Hospital in Newport, Rhode Island. During this time, the 120-bed community hospital has been surveyed four times by teams from DNV under its NIAHO program. Early in 2008, Newport Hospital was also surveyed by the Joint Commission and CMS, giving it a unique perspective on the similarities and differences from each of these survey programs. According to Terry McWilliams, Vice President of Medical Affairs at Newport Hospital, “They [Det Norske Veritas] consistently look for system-related issues and overall process improvement.” He further stated that the DNV survey, as conducted in his hospital was “clearly never inferior to our experience with any other agency-and at times superior! They really objectively look at your processes and how you might be able to improve them to get to that next level.”
For regular subscribers and readers of Dark Daily, these new developments are consistent with the healthcare trend of incorporating quality management systems, such as ISO 9001 and ISO 15189 Medical Laboratories, into the operation of healthcare organizations. It was in September that Dark Daily reported that the first two American laboratories were closing in on their ISO 15189:2007 accreditation. Piedmont Medical Laboratory (PML) of Winchester, Virginia, and Avera Health Laboratories of Sioux Falls, South Dakota, are in the process of completing the final steps required to earn accreditation under ISO 15189:2007. Each laboratory is using the College of American Pathologists (CAP) as its ISO 15189 accrediting body. (See “Two Labs in Friendly Race to Win First ISO 15189 Accreditation in U.S.“)
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