Tag: international laboratory accreditation cooperation

March 30, 2015 Intelligence: Late Breaking Lab News

By Robert Michel, from the Volume XXII NO. 5 - March 30, 2015 issue

Last Friday, at Geisinger Medical Center in Danville, Pennsylvania, members of the health systems’s authority board were given tours of the new $63.4 million clinical laboratory facility. It is scheduled to open on May 4 and will feature the latest state-of-the art analyzers and lab automation systems. Located in a new building of 162,378 square feet, it will be home to more than 350 lab employees.

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Achieving CLIA, ISO 15189 at Same Time with A2LA

By Joseph Burns, from the Volume XXII NO. 3 - February 17, 2015 issue

CEO SUMMARY: An interesting milestone for the clinical lab industry is on the horizon. Physicians Choice Laboratory Services in South Carolina will soon become one of the first lab organizations in the United States to earn joint CLIA and ISO 15189 accreditations with the American Association of Laboratory Accreditation (A2LA). While it was undergoing ISO 15189 accreditation, the organization began to prepare for CLIA accreditation through A2LA, both for a single price.

See additional Dark Daily coverge on CLIA and A2LA certification

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ISO 15189 Accreditation Earned by Spectra Labs

By Robert Michel, from the Volume XVII No. 9 - June 21, 2010 issue

CEO SUMMARY: Spectra Laboratories Inc., recently announced that it had earned accreditation to the ISO 15189:2007 standard, following an assessment by a team from the Association for Laboratory Accreditation (A2LA). Spectra is a high-volume laboratory that serves renal patients. It also provides clinical trial testing for pharmaceutical companies. Spectra officials stated that the laboratory wanted

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ISO 15189 Accreditation Requires Specific Steps For Global Recognition

By Robert Michel, from the Volume XVII No. 6 - April 19, 2010 issue

CEO SUMMARY: This intelligence briefing is the third in an ongoing series about quality management systems (QMS) and their role in advancing the performance of clinical laboratories and improving the quality of the testing services they provide. ISO 15189 is a set of standards for medical laboratories based on the ISO 9001 quality management system.

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Explaining Certification Versus Accreditation

By Robert Michel, from the Volume XVI No. 16 - November 23, 2009 issue

CEO SUMMARY: Early signs are that the quality management systems (QMS) most likely to find favor with hospitals and clinical laboratories in the United States will be those that meet standards developed by the International Organization for Standardization (ISO). Many hospitals and clinical labs are considering adopting ISO 9001 or ISO 15189, respectively. As they

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Volume XXV No. 17 – December 3, 2018

DID CONGRESS JUST PASS A LAW that makes innocent labs guilty of criminal acts? At the last minute, Congress added all clinical laboratories to a far-reaching anti-kickback provision in the newly-enacted Support for Patients and Communities Act -- a provision that makes common practices such as paying commissions to sales staff or placing phlebotomists in labs could be illegal. Worse: The experts are baffled by the language of the new law. Notes one of these experts in this issue, "Someone in the clinical lab industry may have to get prosecuted before we get some clarity, unless the Secretary of HHS issues clarifying regulations."

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Tag: international laboratory accreditation cooperation

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