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CLSI Publishes QMS22—Management of Paper-based and Electronic Laboratory Information


Wayne, Pennsylvania, USAThe Clinical and Laboratory Standards Institute announces the upcoming publication of QMS22—Management of Paper-based and Electronic Laboratory InformationThis guideline is intended to help laboratories meet quality management system requirements for quality system essential (QSE) Information Management. In addition to discussing the requirements for how data and information are generated and entered into paper-based or electronic recordkeeping systems, this guideline also offers suggestions and examples for meeting the intent of the requirements.

Suzanne Butch, MA, MLS(ASCP)SBB, DLM, Vice-Chairholder of QMS22 said, “Most facilities have some documents and records on paper and other records in one or more computerized systems.  QMS22 provides guidance in maintaining control of these systems as well as archiving and transitioning from one system to another.”

QMS22 provides information on:

  • Integrity of data and information transfers and transmission
  • Information availability during computer downtime
  • Routine system maintenance
  • Notification and communication during downtime

For more information about QMS22 visit clsi.org/standards/products/quality-management-systems/documents/qms22-preorder or contact Patrick McGinn at pmcginn@clsi.org or +1.484.588.5933.

CLSI sets the standard for quality in medical laboratory testing. A not-for-profit membership organization, CLSI brings together the global laboratory community for the advancement of a common cause: 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 medical laboratory testing standards. Through our unified efforts, we will continue to set and uphold the standards that drive quality test results, enhance patient care delivery, and improve health care around the world.

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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