Clsi Guidelines For Procedures

Clsi Guidelines For Procedures

& 43 Number 1

January 2012 tIFcombined; in previous guidelines (HS01-A2 and GP26-A3) they were addressed separately.This unification t(1t/FFigure 1_The Quality Management System Model for Laboratory January 2012

Volume 43 Number 1

LABMEDICINE 27 Lab Guidelines & Standardsquirements for policies, processes, and procedures is provided.ttttttto Information on validation and verification of

processes was expanded in this edition, as was the

section on change management requirements.o The concept of “measurement of variability or uncertainty on introduced as a best practice.ttmanaging the information generated and entered into tto A section on peer review for blood utilization and

transfusion services has been added.o The use of quality indicators has been enhanced.

Quality indicators are essential because they provide

evidence that quality goals are being met.They are

used to establish baseline information for measuring

improvements, and they can help to understand lab-

oratory performance compared to historical perfor-

mance and internal benchmarking, other labora-

tories, and even other industries.While no single

set of indicators is required or even recommended,

more examples of quality indicators (see Appendix

Q) and references to published laboratory quality

indicators (see Appendix R) have been added.tvide additional information for implementing the guideline.These include: t
clsi guidelines for procedures
.BQQJOHt&YBNQMFTworksheet, and an audit report formt6QEBUFEt(SFBUMZGuidelines for the implementation of a QMS in the a gap analysis, followed by a plan to close the gaps.

A phased What Are the Anticipated Challenges

to Implementation?ti8IJMFhelpful, it is not expected to be necessary, given the clarity and ease of use of the guideline,” said Motschman, Lab Guidelines & Standards28 LABMEDICINE

Volume 43 Number 1

January 2012 labmedicine.comchallenge to implementation may instead come from the need for a shift in thinking and lab culture to a more t3FOVNCFSJOHdocument numbering if based on the previous listing t8IJMFJennifer Rhamy, MBA, MA, MT(ASCP)SBB, HP, is the Executive Director of the Laboratory Accreditation 1.CLSI.Quality Management System: A Model for Laboratory Services; Approved Guideline—Fourth Edition.CLSI document GP26-A4.Wayne, PA: Clinical and Laboratory Standards Institute; 2011.2.

CLSI/NCCLS.A Quality Management System Model for Health Care; Approved Guideline—Second Edition.CLSI/NCCLS document HS01-A2.

Wayne, PA: NCCLS; 2004.3.CLSI/NCCLS.Application of a Quality Management System Model for Laboratory Services; Approved Guideline—Third Edition.CLSI/NCCLS


Medical laboratories—Particular requirements for quality and 40&40 Jane Keathley, is the Director of uality at Medical Automation Systems in Charlottesville, prepared or accomplished by Jane Keathley in her personal tion are the author’s own and do not reflect the view of the Centers for Medicare & Medicaid Services, the Department of.
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