Wayne, Pennsylvania, USA—January 2013—Clinical and Laboratory Standards Institute (CLSI) has just released GP38-A—Quality Management System: Leadership and Management Roles and Responsibilities; Approved Guideline. This guideline is intended to assist laboratories in meeting the leadership-based requirements for a quality management system (QMS), as represented by quality system essential (QSE) Organization.
A previous CLSI document, GP26-A4—Quality Management System: A Model for Laboratory Services; Approved Guideline—Fourth Edition, outlined the 12 QSEs; however, GP38 comprehensively explains one of these QSEs–Organization. This guideline aims to assist laboratories in meeting the leadership-based requirements for their QMS through three organizational dimensions (ie, cultural, structural, and functional) and provides content to demonstrate the importance of handling laboratory quality.
Proper leadership and management are the keys to implementing and maintaining a QMS. The laboratory’s leadership should be setting the expectation that quality management is the laboratory’s “way of doing business” rather than an added activity. Knowing this information, CLSI produced this guideline’s content with the aim of enhancing the effectiveness of leadership at shaping (ie, designing, implementing, and maintaining) the quality-related aspects of each dimension, thereby supporting leaders in the fulfillment of their QMS roles and responsibilities.
“I have frequently heard laboratory colleagues say that QSE Organization is the least understood of the 12 QSEs,” stated GP38 document Chairholder, Christine Flaherty, MHA, CLS, CPHQ, Regional Director of Sutter Health Sacramento Sierra Region Laboratories in Sacramento, California, USA. “A goal of GP38 is to provide clear and understandable information on how to meet the leadership-based requirements for a QMS.”
GP38 contains abundant information on each leadership-based requirement, as well as useful examples and templates. The guideline was organized so that it can be read cover-to-cover or used as a reference tool. Flaherty noted that the document “will be a ‘must have’ for those who want a single reference covering the roles and responsibilities unique to the laboratory managers and leaders who foster and sustain quality.”
This guideline was not written to be prescriptive, but is meant to provide a suggestive approach in implementing the QSE. GP38 is intended to be used by all organizations and individuals involved in the management or operation of preexamination, examination, and postexamination phases of the medical laboratory. This document may be applicable to other types of laboratories, as well as nonlaboratory settings.
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 fulfill their responsibilities with efficiency, effectiveness, and global applicability. For additional information, visit the CLSI website at www.clsi.org or call 610.688.0100.