The Clinical and Laboratory Standards Institute (CLSI) recently published 'Quality management system: continual improvement; approved guideline - third edition' (GP22-A3).
This document provides guidance on how to approach continual improvement (CI) initiatives in a systematic and organised manner to produce sustainable outcomes.
GP22 is aligned with the most recent international, national and accreditation requirements, and there is extensive expansion from the last version of this guideline on content discussing the fundamental processes and common supporting elements within a continual improvement program.
The guideline's appendixes provide more than 25 examples of documents and forms that can be used or modified to assist in implementing or enhancing any laboratory's program.
The fundamental processes that the guideline discusses include identifying opportunities for improvement, selecting an opportunity, generating solutions, implementing solutions, evaluating the effects of solutions and integrating and sustaining improvements.
These processes are supported by the common elements of management review, teamwork, improvement models and tools, documents and records, change management, risk management and communication.
The document also assists the user in understanding that continual improvement should be an ongoing, methodical effort that is an essential component of a quality-management system.
This document will benefit organisations and individuals involved in the management or execution of pre-examination, examination and post-examination phases of the medical laboratory and may be applicable to other laboratories and non-laboratory settings.