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The Fundamentals for Implementing a Quality Management System (QMS) in the Clinical Laboratory

from the Clinical and LaboratoryStandards Institute (CLSI)

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Working Group on The Key to Quality

Tania Motschman, MS, MT(ASCP)SBB, CQAChairholderLaboratory Corporation of AmericaBurlington, North Carolina, USA

Maureen E. Ahler, MSQA, MT(ASCP)Kaiser Permanente Medical CareNorth Hollywood, California, USA

Lucia M. Berte, MA, MT(ASCP), SBBLaboratories Made Better!Broomfield, Colorado, USA

Joan M. Carlson, MLT(CMLTA), BSc(MLS)Alberta Health Services – Edmonton General HospitalEdmonton, Alberta, Canada

Anne T. Daley, MS, MT(ASCP)DLMChi Solutions, Inc.Mesa, Arizona, USA

Christine D. Flaherty, MHA, CLS, CPHQSutter Health Sacramento Sierra Region LaboratoriesSacramento, California, USA

Karen Heaton, MLT(CMLTA)Calgary Laboratory ServicesCalgary, Alberta, Canada

Jennifer F. Rhamy, MBA, MA, MT(ASCP)The Joint CommissionOakbrook Terrace, Illinois, USA

Harriet R. Walsh, MA, MT(ASCP)Centers for Medicare & Medicaid ServicesBaltimore, Maryland, USA

staff

Clinical and Laboratory Standards InstituteWayne, Pennsylvania, USA

Luann Ochs, MS Senior Vice President – Operations

Jennifer K. Adams, MT(ASCP), MSHAStaff Liaison

Megan L. Tertel, MAEditor

Copyright ©2013 Clinical and Laboratory Standards Institute. Except as stated below, any reproduction of content from a CLSI copyrighted standard, guideline, companion product, or other material requires express written consent from CLSI. All rights reserved. Interested parties may send permission requests to [email protected].

CLSI hereby grants permission to each individual member or purchaser to make a single reproduction of this publication for use in its laboratory procedure manual at a single site. To request permission to use this publication in any other manner, e-mail [email protected].

Suggested CitationCLSI. The Key to QualityTM. CLSI product K2Q. Wayne, PA: Clinical and Laboratory Standards Institute; 2013.

ISBN 1-56238-881-9 (Print)ISBN 1-56238-882-7 (Electronic)ISSN 1558-6502 (Print)ISSN 2162-2914 (Electronic)

The Clinical and Laboratory Standards Institute consensus process, which is the mechanism for moving a document through two or more levels of review by the health care community, is an ongoing process. Users should expect revised editions of any given document. Because rapid changes in technology may affect the procedures, methods, and protocols in a standard or guideline, users should replace outdated editions with the current editions of CLSI documents. Current editions are listed in the CLSI catalog and posted on our website at www.clsi.org.

If your organization is not a member and would like to become one, and to request a copy of the catalog, contact us at:

P: 610.688.0100 F: 610.688.0700 E: [email protected] W: www.clsi.org

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the key to quality | table of contents

Table of Contents

Introduction

The CLSI Quality Management System Model Overview

International Application

Terminology

Organization of The Key to Quality

Implementation Overview

Section 1 – Fundamentals and Instructions

The CLSI QMS Model

The Quality System Essentials

The Laboratory’s Path of Workflow

Making the Case for a QMS

Plan to Make the Case

Prepare a Convincing Case

Present the Case Effectively

Performing the Gap Analysis

Determining Priorities for Implementation

Implementing the QMS

Develop the Implementation Plan

Carry Out the Plan and Evaluate the Effects

Integrate Within the Organization

Sustain the Outcomes and Gains in Performance

Continue the Implementation Cycle

Communicating, Educating, and Training

Communicate Information

Educate About the QMS

Train on QMS Procedures

Communication, Education, and Training Example

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the key to quality | table of contents

Section 2 – Quality System Essentials (QSEs)

QSE Organization (OR)

QSE Customer Focus (CF)

QSE Facilities and Safety (FS)

QSE Personnel (PE)

QSE Purchasing and Inventory (PI)

QSE Equipment (EQ)

QSE Process Management (PM)

QSE Documents and Records (DR)

QSE Information Management (IM)

QSE Nonconforming Event Management (NC)

QSE Assessments (AS)

QSE Continual Improvement (CI)

References

Section 3 – Supplemental Information and Appendixes

Abbreviations and Acronyms

QMS Glossary

QMS Glossary References

QSE Crosswalk to ISO 15189:2012, ISO 17025:2005, and ISO 9001:2008

Related CLSI Reference Materials

Bibliography

Appendixes

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IntroductionThe complexity of today’s health care environment reinforces the need for an infrastructure that supports the highest level of quality and patient safety. Quality cannot be taken for granted, in the laboratory. Yet many laboratories throughout the world operate without well-defined or even documented policies, processes, or procedures.

The Key to Quality

provides guidance

on how to establish

or enhance your

laboratory’s

infrastructure with

a QMS that supports

continual quality

improvement.

A quality management system (QMS) directs and controls an organization with regard to quality and uses a systematic and process-oriented approach essential to meet quality goals and objectives.

The Key to Quality workbook is designed to provide a better understanding of how a laboratory’s QMS can be developed. This edition revises the previous version published in 2007. It updates content, provides additional information on implementation, and offers expanded examples, checklists, and templates. It is based upon other CLSI QMS consensus documents and was itself developed through a consensus process. By using the guidance and tools in The Key to Quality, you can establish or enhance the infrastructure for a QMS or a methodology for continual quality improvement with the following outcomes:

The CLSI QMS model contains 12 fundamental building blocks known as quality system essentials (QSEs). The QSEs are:

• Improved patient care• Reduced risk of medical errors• Streamlined laboratory processes• Increased productivity and efficiency• Reduced costs

• Organization (OR)• Customer Focus (CF)• Facilities and Safety (FS)• Personnel (PE)• Purchasing and Inventory (PI)• Equipment (EQ)

• Enhanced employee abilities• Improved customer satisfaction• Compliance with regulatory and

accreditation requirements

• Process Management (PM)• Documents and Records (DR)• Information Management (IM)• Nonconforming Event Management (NC)• Assessments (AS)• Continual Improvement (CI)

The CLSI Quality Management System Model Overview

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Figure 1. CLSI Quality Management System Model1

Fundamentals and InstructionsThe CLSI QMS Model provides a solid infrastructure for laboratories of varying, size, scope, or specialty anywhere in the world. This simple model provides a management infrastructure that supports any type of laboratory’s technical operations (see Figure 1).

The model was derived by sorting the individual reference requirements from international standards, national regulations, and accreditation requirements for medical laboratories into similar groups—ie, identifying all the requirements for a subject such as laboratory equipment or personnel and arranging them in the sequential order of how they occur in the laboratory. The resulting groups of requirements were recognized as fundamental building blocks of quality and were given the title of quality system essentials (QSEs).

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Part of the Model Examples of Questions That Might Be Asked

QSE Information Management

• Can the paper or electronic information system accommodate the influx of new records?

• Are there any aspects of the information and examination results that have special confidentiality or reporting considerations (eg, sexually transmitted disease/sexually transmitted infection, human immunodeficiency virus)?

QSE Nonconforming Event Management

• Do any changes need to be made to the existing nonconformance report form?

QSE Assessments • What is the expected turnaround time for results and reports?• Are there any other indicators needed to measure how well the new instrument/

examination is functioning?• What proficiency testing will be used to monitor the new examination method?

QSE Continual Improvement • Is there a need to improve any existing processes to accommodate use of the new instrument?

If a laboratory begins examining patient samples with a new instrument before first considering all these (and other) questions, problems are most likely to arise that may dissatisfy internal and external customers, affect the laboratory’s reputation, and have legal and liability issues. In addition, the problems are likely to be costly to resolve, eroding the laboratory’s limited financial resources.

The QMS model enables any laboratory to design and manage its infrastructure and technical processes in a way that meets customer, regulatory, and accreditation requirements while providing the laboratory’s best contribution to patient care and safety. The resources provided in The Key to Quality are designed to help your laboratory achieve those goals.

Abbreviations: QSE, quality system essential.

Table 2 continued

the key to quality | the laboratory’s path of workflow 13

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DETERMINING PRIORITIES FOR IMPLEMENTATION

Because of certain supporting relationships and interdependencies between different aspects of the QMS, it is necessary to implement some parts of the QMS before others.

The information in this section provides guidance for how to sequence QMS or QSE implementation activities.

Prioritizing implementation activities addresses the QMS/QSE interdependencies and greatest risks first and efficiently uses resources for obtaining optimal results.

Use a prioritization rationale to plan the order of QMS or QSE activities.

Wha

tW

hyH

ow

Leaders’ vision for quality1.

2.

3.

Nonconforming events Assessments

Customer complaints QC

Document management

process

Communication of overall intent with respect to quality

Management Review

Continual Improvement

Staff training and competence

Quality Policy

Quality Report

QMS documents

Figure 2. Three Examples of QSE Interdependencies

Three examples of QSE interdependencies are represented in Figure 2 below. The first example illustrates the interdependencies of activities within the QSE Organization. Communication of the overall intent with respect to quality cannot be done until the quality policy is developed. The quality policy cannot be developed until the leaders’ have determined their vision for quality. The second example illustrates interdependencies between activities in the QSE Personnel and the QSE Documents and Records. Staff training and competence cannot be done until the documents from which you will train are developed. It is not a good idea to develop documents until you have a process in place to manage these documents. In the third example, activities among several QSEs (Continual Improvement, Organization, Nonconforming Event Management, Assessments, Customer Focus, and Process Management) are involved. Continual improvement activities are evaluated, prioritized, and endorsed by management during management review. Management review includes review of the quality report. The quality report is comprised of a compilation of data about nonconforming events, internal and external assessments, customer complaints, and quality control.

the key to quality | determining priorities for implementation20

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