Westgard says.įor laboratories tasked with performing quality control, he says, “You have option A, you have option B, and now you have option C. Westgard was the first chairman of the Evaluation Protocols Area Committee in CLSI (then known as NCCLS).Īlthough he would prefer to see more rigorous regulation of QC, “Technically, if you look at the CMS regulations, the requirements haven’t been reduced with IQCP,” Dr. A cofounder of Westgard QC in Madison, Wis., Dr. IQCP and its related method, the EP23 standard offered by the Clinical and Laboratory Standards Institute since 2011, may save laboratories some work, but do not necessarily represent a lowering of QC requirements, says quality control expert James Westgard, PhD. But laboratories will need to have sufficient data to support their decisions, and all IQCP activities must meet documentation requirements. What does IQCP mean for laboratories in specific terms? No process maps, fishbone diagrams, or formal risk-assessment charts and protocols will be required for laboratories to develop an IQCP, the CMS promises. 1, 2016, the old EQC, or Equivalent Quality Control, procedures will no longer meet CLIA standards. 1, labs were given two years to make the transition to IQCP and to test laboratory operations under that option.
Abbott istat iqcp update#
The CMS announced IQCP last fall as an exercise of its enforcement discretion under CLIA CLIA regulations of QC remain unchanged from the last update in 2003.įollowing IQCP’s official launch on Jan. IQCP is available for all CLIA-regulated nonwaived tests except pathology and its subspecialties, which the CMS says will be considered later. They can use a one-size-fits-all approach of running two levels of external QC material once a day, the bare minimum under CLIA requirements, or they can do a risk-assessment evaluation to better determine how their assays are performing and how much QC they should run.” “But when we do more in-depth risk analyses, they may not be okay.” “Many assays appear to be okay when we run our QC,” says Alison Woodworth, PhD, director of esoteric chemistry, associate director of clinical chemistry, and assistant professor in the Department of Pathology, Microbiology, and Immunology at Vanderbilt University Medical Center. Employing electronic/integrated controls, IQCP intends to adapt to future technological advances and strengthen manufacturer-laboratory partnerships. For i-STAT test cartridge information and intended use, refer to individual product pages or the cartridge information (CTI/IFU) in the i-STAT Support area.Ībbott - A Leader in Rapid Point-of-Care Diagnostics.A voluntary QC option under CLIA, IQCP aims to give labs greater flexibility in achieving QC compliance by customizing lab QC plans to each unique testing environment via the use of risk-management strategies. Check with your local representative for availability in specific markets. Not all products are available in all regions. GDPR Statement (last updated: May 2018) | California Transparency in Supply Chains Act | Declaration for California Compliance Law.
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Abbott istat iqcp registration#
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