eNewsletter 2013 March April

Wayne, Pennsylvania, USA - March 2013 - Clinical and Laboratory Standards Institute (CLSI) has released QMS02-A6-Quality Management System: Development and Management of Laboratory Documents; Approved Guideline-Sixth Edition. This guideline (which replaces GP02-A5) provides direction for document development, control, and management in paper and electronic environments using a process-based approach that supports the laboratory's entire quality management system.

There are four new features in QMS02-A6 that were not offered in the previous version. First, is a process for managing the lifespan of documents from development through retirement. The second feature includes detailed descriptions and more examples of laboratory policies, processes, procedures/job aids, and form documents. The third is the provision of concise instructions for how to prepare process flow charts with several useful, generic examples. Finally, the guideline presents more condensed and effective means for manufacturers and laboratories to prepare documents for examinations performed on automated analyzers.

Using flow charts to depict the sequence of activities in laboratory processes, QMS02-A6 describes what laboratories need to do to meet published regulations, accreditation requirements, and international standards for laboratory documents and procedures manuals. In addition, several examples of common laboratory processes and procedures are provided, and serve as valuable starting points for documenting laboratory information.

"For this guideline we took evidence-based advances in more effective writing that have been successfully used in business and industry, and applied them to all types of laboratory documents," stated QMS02-A6 document Chairholder, Lucia Berte, MA, MT(ASCP)SBB, DLM; CQA(ASQ)CMQ/OE, President of Laboratories Made Better! P.C. in Broomfield, Colorado, USA. "The result is laboratory policies, processes, and procedures that are easy to read, understand, and use."

QMS02-A6 is applicable to documents used by medical laboratories of any size, complexity, or specialty, and is intended for use by administrative and technical personnel who develop laboratory documents, manufacturers, educators, and regulatory and accreditation organizations.

The Clinical and Laboratory Standards Institute (CLSI) is a not-for-profit membership organization that brings together the varied perspectives and expertise of the worldwide laboratory community for the advancement of a common cause: to foster excellence in laboratory medicine by developing and implementing clinical laboratory standards and guidelines that help laboratories fulfil their responsibilities with efficiency, effectiveness, and global applicability.

For additional information, visit the CLSI website at www.clsi.org or call 610.688.0100.
Contact: Megan Scanlon
Marketing Communications Specialist
610.688.0100 ext. 5936; mscanlon@clsi.org

Wayne, Pennsylvania, USA - March 2013 - Clinical and Laboratory Standards Institute (CLSI) recognized outstanding volunteers at the 2013 Leadership Conference in Arlington, Virginia, USA, which took place from Sunday, March 10 to Saturday, March 16.

The Excellence Award winners are volunteers that are dedicated and committed to CLSI's mission, and are recognized for going above and beyond within the CLSI community. The winners were nominated by their peers and then chosen by CLSI's Awards Committee. CLSI's volunteers are essential to the organization's mission to develop best practices in clinical and laboratory testing, and the promotion of their use throughout the world.

CLSI congratulates all of the 2013 Excellence Award winners:

Excellence in Leadership in Global Health Partnerships

• Wilson Mtotela, MLS, MBA, independent laboratory consultant
• Raymond Nyakuwocha, MLS, MSc, mentor in six of the zonal laboratories in Tanzania

Excellence in Global Leadership in Standards Development

• Donald M. Powers, PhD, President of Powers Consulting Services

Excellence in Consensus Management

• James F. Pierson-Perry, Senior Key Expert in the Global Assay Development group of Siemens Healthcare Diagnostics

Excellence in Mentoring in Standards Development

• David G. Grenache, PhD, DABCC, FACB, Associate Professor of Pathology at the University Of Utah School Of Medicine, and a medical director at ARUP Laboratories

Excellence in Standards Development

• Terry Jo Gile, MT(ASCP); MA.Ed, President of Safety Lady LLC®
• James T. Mascarello, PhD, Technical Director at Integrated Genetics
• David B. Sacks, MD, Senior Investigator and Chief of Clinical Chemistry at the National Institutes of Health
• Barbara Zehnbauer, PhD, FACMG, Chief of the Laboratory Research and Evaluation Branch within the Division of Laboratory Science and Standards in the Office of Surveillance, Epidemiology, and Laboratory Services at the Centers for Disease Control and Prevention

John V. Bergen Award

• James H. Nichols, PhD, DABCC, FACB, Professor of Pathology, Microbiology, and Immunology, and Medical Director of Clinical Chemistry at Vanderbilt University School of Medicine

Russell J. Eilers Memorial Award

The highest award presented by CLSI is the Eilers Award, given annually to an individual who has made outstanding contributions to CLSI's success; the recipient of this award is selected by the CLSI President in consultation with the Executive Committee.

• Lucia M. Berte, MA, MT(ASCP)SBB, DLM; CQA(ASQ)CMQ/OE, President of Laboratories Made Better! P.C.

The Clinical and Laboratory Standards Institute (CLSI) is a not-for-profit membership organization that brings together the varied perspectives and expertise of the worldwide laboratory community for the advancement of a common cause: to foster excellence in laboratory medicine by developing and implementing clinical laboratory standards and guidelines that help laboratories fulfil their responsibilities with efficiency, effectiveness, and global applicability. For additional information, visit the CLSI website at www.clsi.org or call 610.688.0100.