Clinical Pathology Laboratories Have Opportunity to Learn More about ISO 15189
January 13, 2011- Dark Daily Report
ISO 15189 is gaining a foothold among laboratories in the United States. Since the first clinical pathology laboratory in the U.S. earned accreditation to “ISO 15189:2007 Medical Laboratories” in 2008, there has been a steady increase in the number of clinical laboratories that have embarked on their own path to accreditation.
This fall, The Dark Report and Dark Daily invited all three of the organizations in North America that offer accreditation services for ISO 15189 to speak at the fourth annual Lab Quality Confab, which took place in San Antonio, Texas, on November 2-3, 2010. It marked the first time that all three of these ISO-accrediting organizations spoke in public at one time and in one place.
The three North American ISO 15189 accreditation organizations who spoke at Lab Quality Confab were, alphabetical order:
Sessions featuring speakers from these three ISO accreditation organizations proved to be among the best-attended at Lab Quality Confab. There are two reasons for this high level of interest. First, most attendees at Lab Quality Confab are actively using Lean, Six Sigma, and process improvement methods. Thus, their medical laboratory is committed to ongoing improvement in the daily operation and workflow within their laboratory.
ISO 15189 is a QMS Tailored to the Needs of Medical Laboratories
Second, as clinical laboratories and pathology groups become more experienced at implementing ongoing improvements to different areas of workflow within their laboratory, they begin to understand the value of going to the next stage in their lab’s quality journey by implementing a true quality management system (QMS). Because ISO 15189 is a globally-recognized QMS, these laboratory professionals are quick to recognize how accreditation to ISO 15189 can directly benefit their medical laboratory.
Over the past 24 months, The Dark Report and Dark Daily have published stories about how the nation’s first clinical laboratories achieved accreditation to ISO 15189, along with the benefits that adoption of the ISO QMS has brought to these laboratories. One of the very first to earn ISO 15189 accreditation was the central laboratory at Avera Health in Sioux Falls, South Dakota. In the past 12 months, Spectra Laboratories, Inc., of Rockleigh, New Jersey earned its ISO 15189 accreditation. Spectra is one of the nation’s largest laboratory facilities, serving around 30,000 patients each day.