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ASM, CAP and CLSI Collaborate to Prepare Materials to Address New Regulations in the Laboratory

Representatives from American Society for Microbiology (ASM), College of American Pathologists (CAP), and Clinical and Laboratory Standards Institute (CLSI) have jointly prepared materials for laboratories to use as a guide in development of an antimicrobial susceptibility testing (AST) Individualized Quality Control Plan (IQCP) for a commercial automated AST system.

The IQCP is the Clinical Laboratory Improvement Amendments (CLIA) Quality Control (QC) policy that will become effective as an alternative QC option for all laboratory tests on January 1, 2016. For IQCP compliance, laboratories can either develop an IQCP or perform daily QC as described in current CLIA regulations. It will no longer be acceptable for laboratories to follow CLSI AST guidelines alone for converting from daily to weekly testing of QC strains. Laboratories will be required to develop an IQCP (or perform CLIA mandated QC) regardless of
when weekly QC of AST was implemented.

“These new CMS regulations will have major impact on laboratory testing, most notably in clinical microbiology,” said Dr. Susan Sharp, Chair of ASM’s Public and Scientific Affairs Board Committee on Laboratory Practices.

Although there are certain elements that must be included in each IQCP as defined by CMS, CMS is not prescriptive and each laboratory director must customize their own AST
IQCP, according to test method, patient population, environment and personnel competency. The materials developed through the ASM, CAP and CLSI collaboration will assist laboratories in developing AST IQCP’s that align with the specific needs of individual labs.

“Collaboration is so important when new requirements are introduced and laboratories need guidance,” said CAP President Gene N. Herbek, MD, FCAP. “The CAP believes the work with ASM and CLSI is vital to helping laboratories continue to perform at a high level to meet the demands of laboratory quality control and accurate patient testing.”

Specifically, the following materials are available:

• Template (PowerPoint®) that describes the components that should be included in an IQCP for a commercial MIC AST system
• Example of a completed IQCP (tabular format)
• Listing of Q&A’s

“CLSI aims to help simplify quality control based on risk management for laboratorians,” said CLSI CEO, Glen Fine, MS, MBA, CAE. “These invaluable resources will assist laboratorians with implementing successful IQCPs in their microbiology labs.”

The materials can be found on each organizations website. Additional materials will be developed through this collaboration to assist addressing IQCP for other tests in clinical microbiology laboratories.

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The American Society for Microbiology is the largest single life science society, composed of over 39,000 scientists and health professionals. ASM’s mission is to advance the microbiological sciences as a vehicle for understanding life processes and to apply and communicate this knowledge for the improvement of health and environmental and economic well-being worldwide.

As the leading organization with more than 18,000 board-certified pathologists, the College of American Pathologists (CAP) serves patients, pathologists, and the public by fostering and advocating excellence in the practice of pathology and laboratory medicine worldwide. The CAP’s Laboratory Improvement Programs, initiated 65 years ago, currently has customers in more than 100 countries, accrediting 7,700 laboratories and providing proficiency testing to 20,000 laboratories worldwide. Find more information about the CAP at CAP.org. Follow CAP on Twitter at @pathologists.

The Clinical and Laboratory Standards Institute (CLSI) sets the standard for quality in clinical laboratory testing. A not-for-profit membership organization, CLSI brings together the global laboratory community to foster excellence in laboratory medicine. For nearly 50 years, our members, volunteers, and customers have made CLSI a respected, transformative leader in the development and implementation of clinical laboratory testing standards. By using CLSI standards, laboratorians can improve process quality, speed the development of standard operating procedures, and implement safer practices with greater ease and efficiency.

 

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