Transcript
The Fundamentals for Implementing a Quality Management System (QMS) in the Clinical Laboratory
from the Clinical and LaboratoryStandards Institute (CLSI)
SAMPLE
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 permissions@clsi.org.
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 permissions@clsi.org.
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in technology may affect the procedures, methods, and protocols in a standard or guideline, users should replace outdated editions with the current editions of CLSI documents.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: customerservice@clsi.org W: www.clsi.org
SAMPLE
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
9
10
11
14
14
15
17
18
20
23
24
24
26
28
28
29
30
32
33
34
3
4
4
5
7
1
from the Clinical and LaboratoryStandards Institute (CLSI)
SAMPLE
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
35
43
49
57
63
69
77
87
95
101
109
115
121
123
126
134
136
138
145
147
2
SAMPLE
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
3
from the Clinical and LaboratoryStandards Institute (CLSI)
SAMPLE
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).
9
from the Clinical and LaboratoryStandards Institute (CLSI)
SAMPLE
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
SAMPLE
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
SAMPLE
P: 610.688.0100 F: 610.688.0700 E: customerservice@clsi.org W: www.clsi.org
Copyright ©2013, Clinical and Laboratory Standards Institute. 950 West Valley Road • Suite 2500 • Wayne, PA 19087 USA
SAMPLE
top related