QMS04Laboratory Design

This guideline provides a foundation of information about

laboratory design elements and guidance to help define issues to

consider when designing a medical laboratory.

A guideline for US application developed through the Clinical and Laboratory Standards Institute consensus process.

3rd Edition

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Clinical and Laboratory Standards Institute Setting the standard for quality in medical laboratory testing around the world.

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 medical laboratory standards and guidelines that help laboratories fulfill their responsibilities with efficiency, effectiveness, and global applicability. Consensus Process

Consensus—the substantial agreement by materially affected, competent, and interested parties—is core to the development of all CLSI documents. It does not always connote unanimous agreement, but does mean that the participants in the development of a consensus document have considered and resolved all relevant objections and accept the resulting agreement. Commenting on Documents

CLSI documents undergo periodic evaluation and modification to keep pace with advancements in technologies, procedures, methods, and protocols affecting the laboratory or health care.

CLSI’s consensus process depends on experts who volunteer to serve as contributing authors and/or as participants in the reviewing and commenting process. At the end of each comment period, the committee that developed the document is obligated to review all comments, respond in writing to all substantive comments, and revise the draft document as appropriate.

Comments on published CLSI documents are equally essential, and may be submitted by anyone, at any time, on any document. All comments are managed according to the consensus process by a committee of experts. Appeals Process

When it is believed that an objection has not been adequately considered and responded to, the process for appeals, documented in the CLSI Standards Development Policies and Processes, is followed.

All comments and responses submitted on draft and published documents are retained on file at CLSI and are available upon request.

Get Involved—Volunteer!Do you use CLSI documents in your workplace? Do you see room for improvement? Would you like to get involved in the revision process? Or maybe you see a need to develop a new document for an emerging technology? CLSI wants to hear from you. We are always looking for volunteers. By donating your time and talents to improve the standards that affect your own work, you will play an active role in improving public health across the globe.

For additional information on committee participation or to submit comments, contact CLSI.

Clinical and Laboratory Standards Institute950 West Valley Road, Suite 2500 Wayne, PA 19087 USA P: +1.610.688.0100F: +1.610.688.0700www.clsi.orgstandard@clsi.org

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

P: +1.610.688.0100 F: +1.610.688.0700 E: customerservice@clsi.org W: www.clsi.org.

QMS04, 3rd ed.June 2016

Replaces QMS04-A2

Laboratory DesignKaren K. Mortland, RA, MT(ASCP)Peter GuptaSteven J. LaCroix, MS, CBSPJason MajorowiczPatrick J. Maul, MBA, MT(ASCP)Vassilios I. Nicolaou, AIA, NCARB

Daniel J. Scungio, MT(ASCP), SLSSamya Semaan-Heart, MT, MPH, FACHEAnand K. Seth, PE, CEM, CPEAdam Walter, CSSMBB / CLAKurukula AC Wickramaratne, MBBS, DPath, MDTerry Williams, M.Arch, MS

AbstractClinical and Laboratory Standards Institute guideline QMS04—Laboratory Design is written for laboratory personnel responsible for, or involved in, the design of a laboratory. This guideline covers selected nonstructural elements that affect the planning, layout, and safety of a medical laboratory. The elements discussed include space, casework, equipment, classifications, health and safety, ventilation, lighting, plumbing, electrical systems, and communications.

Clinical and Laboratory Standards Institute (CLSI). Laboratory Design. 3rd ed. CLSI guideline QMS04 (ISBN 1-56238-936-X [Print]; ISBN 1-56238-937-8 [Electronic]). Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087 USA, 2016.

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Copyright ©2016 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 procedures manual at a single site. To request permission to use this publication in any other manner, e-mail permissions@clsi.org.

Suggested CitationCLSI. Laboratory Design. 3rd ed. CLSI guideline QMS04. Wayne, PA: Clinical and Laboratory Standards Institute; 2016.

Previous Editions:

December 1994, April 1998, February 2007

ISBN 1-56238-936-X (Print)

ISBN 1-56238-937-8 (Electronic)

ISSN 1558-6502 (Print)

ISSN 2162-2914 (Electronic) Volume 36, Number 8

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QMS04, 3rd ed.

ContentsAbstract iCommittee Membership iiiForeword viiiChapter 1: Introduction 1

1.1 Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

1.2 Background . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

1.3 Terminology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Chapter 2: Design Process 15

Chapter 3: Project Team Selection 19

3.1 The Project Team . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20

3.2 Commissioning and Certification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23

3.3 Outcome . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23

Chapter 4: Planning and Programming 25

4.1 Team Responsibilities. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

4.2 Develop Goals and Objectives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .29

4.3 Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .39

4.4 Relationships . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59

4.5 Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59

4.6 Area Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .66

4.7 Block Diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .71

4.8 Phasing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .73

4.9 Meetings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .73

4.10 Utilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74

4.11 Preliminary Opinion of Probable Construction Costs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74

4.12 Sign-off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .77

4.13 Outcome. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .77

Chapter 5: Schematic Design 79

5.1 Team Responsibilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .81

5.2 Floor Plan. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .82

5.3 Review Plans . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .86

5.4 Preliminary Opinion of Probable Construction Costs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .87

5.5 Sign-off. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .87

5.6 Outcome . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .87

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Contents (Continued)Chapter 6: Design Development 89

6.1 Team Responsibilities. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .91

6.2 Casework. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .92

6.3 Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .97

6.4 Furniture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .98

6.5 Finishes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .98

6.6 Utilities. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100

6.7 Review Plans . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115

6.8 Preliminary Opinion of Probable Construction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115

6.9 Sign-off. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115

6.10 Outcome. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115

Chapter 7: Construction Documents 117

7.1 Team Responsibilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119

7.2 Construction Criteria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121

7.3 Preliminary Opinion of Probable Construction Costs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 122

7.4 Outcome . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 122

Chapter 8: Bidding and Negotiations 123

8.1 Team Responsibilities. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125

8.2 Addendums . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 126

8.3 Bids Are Prepared. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 126

8.4 Selection Is Made. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .127

8.5 Agreements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .127

8.6 Outcome . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .127

Chapter 9: Construction 129

9.1 Team Responsibilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .131

9.2 Phasing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .133

9.3 Change Orders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134

9.4 Punch List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134

9.5 Construction Costs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134

9.6 Outcome . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .135

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Contents (Continued)Chapter 10: Moving In 137

10.1 Team Responsibilities. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 138

10.2 Phasing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139

10.3 Moving In . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139

10.4 Outcome. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140

Chapter 11: Quality System Essentials 141

11.1 Quality System Essentials as the Management Infrastructure for Laboratory Design . . . . . . . . . . . . . . . . . . . . . .142

11.2 Quality System Essential Considerations for Laboratory Design. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .142

Chapter 12: Conclusion 147

Chapter 13: Supplemental Information 149

References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 150

Additional Resources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 154

Appendix A. Biosafety Level Designations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 156

Appendix B. Laboratory Hoods and Specialty Exhaust . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .159

Appendix C. Example Program or Area Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .162

Appendix D. Example Opinion of Probable Construction Cost. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 164

Appendix E. Sample Budget Worksheet. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .165

The Quality Management System Approach. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 166

Related CLSI Reference Materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 168

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ForewordQuality system essential (QSE) Facilities and Safety is one of the 12 QSEs described in CLSI document QMS011 and the CLSI product The Key to Quality™,2 which provides the necessary background information and guidance to develop and maintain a QMS. The QMS model depicted in Figure 1 demonstrates how each QSE, such as Facilities and Safety, is a building block to quality and is necessary to support any laboratory’s path of workflow from preexamination to examination to postexamination.

DISCIPLINES• Chemistry• Hematology• Microbiology• Transfusion Medicine• Anatomic Pathology• Cytology • Immunology• Genetics• Etc.

LABORATORY PATH OF WORKFLOW

QUALITY SYSTEM ESSENTIALS

PREEXAMINATION EXAMINATION POSTEXAMINATION• Order

Assessments ContinualImprovement

Documentsand Records

InformationManagement

NonconformingEvent Management

Personnel Purchasing and Inventory Equipment Process

Management

Organization Customer Focus Facilities and Safety

International • National • Regional • Local • Organizational Requirements

• Sample Collection

• Sample Transport

• Receive and Process

• Examination • Review and Interpretation

• Report Release

• Sample Management

QSEs are the foundational building blocks that function effectively to support the laboratory’s path of workflow. If a QSE is missing or not well implemented, problems will occur in preexamination, examination, and postexamination laboratory activities. For example, when the laboratory lacks defined processes for establishing and maintaining adequate space, workflow, and environmental conditions, the quality of work may be affected and safety of patients and staff compromised.

Figure 1. The Quality Management System Model for Laboratory Services (see CLSI document QMS011). The 12 QSEs function as building blocks necessary to support any laboratory’s path of workflow and laboratory disciplines. This figure represents how the 12 QSEs support a medical laboratory’s disciplines.

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International guidance related to the QSEs and the laboratory’s path of workflow is available. Topics include:

A process-based model for quality that any business should use to manage its operations, with information relating directly to the QSEs3

Requirements for both quality management and technical operations of testing and calibration laboratories4

Standards for quality management and technical operations in the medical laboratory environment5

Optimal laboratory design requires a careful blend of many design elements, which can be effectively accomplished only if opportunities, possibilities, and potential problems are well understood. A good understanding of the design issues that affect space, workflow, casework, equipment, classifications, ventilation, lighting, plumbing, electrical systems, and communications encourages asking pertinent questions and facilitates wise choices during reviews of existing laboratories and planning of new or remodeled laboratories.

This guideline provides a foundation of information about laboratory design elements and guidance to help define consideration of issues when designing a laboratory.

The content and organization of this guideline are intended to encourage its frequent use throughout the laboratory design process. One aspect of this guideline that distinguishes it from other publications on laboratory design is the inclusion, where possible, of specific minimum and recommended guidelines. The minimum limits are limits at which laboratory safety or functionality begins to be compromised. Recommended guidelines are limits at which more acceptable levels of safety and functionality are attained. It is important for laboratory consultants, architects, and engineers to consult specific codes and local authorities during the design process to ensure that all criteria are met for that particular region or country. This guideline is not intended to be an end to the process, but, instead, a start in the right direction.

Although this guideline draws heavily from the recommended and mandated guidelines and regulations applicable to the United States, the material contained in this guideline may be useful for improving laboratory design throughout the world. Although QMS04 may be a useful resource for a wider audience, it is intended primarily to help the US user navigate through US requirements. Because laboratory design practices are heavily regulated and widely country specific, it has been determined that development of a comparable guideline intended for global application may not be feasible. However, the development of such a guideline may be possible in the future as part of a long-term effort to harmonize regulations and practices.

The unique tagline on the cover and the imprint of the US flag on the Abstract page and throughout the guideline footers call attention to QMS04’s national focus and differentiate it from CLSI’s global consensus documents.

note:Laboratory design includes:

Space Workflow Casework Equipment Classifications Ventilation Lighting Plumbing Electrical systems Communications

note:During the design process, laboratory consultants, architects, and engineers should consult specific codes and local authorities to ensure that all criteria are met for their respective region or country.

note:Although QMS04 is intended primarily for US laboratories, the information may be a useful resource throughout the world.

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Overview of ChangesUpdates from the second edition include:

Changes in codes, testing, equipment, and building systems

Reorganization of information to align with the laboratory design process

NOTE: The content of this guideline is supported by the CLSI consensus process, and does not necessarily reflect the views of any single individual or organization.

key wordsArchitecture

Design

Engineering

Equipment

Lean

Safety

Space

Utilities

Workflow

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ChapterIntroductionThis chapter includes:

Guideline’s scope and applicable exclusions

Background information pertinent to the guideline’s content

“Note on Terminology” that highlights particular use and/or variation in use of terms and/or definitions

Terms and definitions used in the guideline

Abbreviations and acronyms used in the guideline

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Laboratory Design

11 Introduction1.1 Scope

This guideline discusses selected elements of laboratory design that affect the planning, layout, and safety of the medical laboratory. These elements include space, workflow, casework, equipment, classifications, ventilation, lighting, plumbing, electrical systems, and communications. This guideline is intended to provide general guidance in laboratory design for those working in and managing laboratories.

Many important and specific issues that need consideration in a well-designed laboratory are beyond the scope of this guideline and are best worked through with the project’s consultants, architects, and engineers. These issues could include structural issues, modifications to the overall base building, and changes to house utility systems.

1.2 BackgroundLaboratory design includes many activities that, when thoughtfully and carefully applied, culminate in a well-conceived and highly functional laboratory. Medical laboratories often struggle to adapt and adjust to an abundance of changes resulting from technological advances, increased computerization, and a decreased workforce. Laboratorians are confronted with new procedures and equipment that should be incorporated into their facilities to remain relevant and competitive. Many owners have found it necessary to either replace or remodel existing facilities to maintain the functional viability of their laboratories.

At this point, laboratory managers encounter another legacy of change—the proliferation of building codes that need to be managed in the laboratory design process. One consequence of technologies that include chemicals and biohazards is the accompanying code requirements. Strict adherence to these codes affects many facets of the laboratory, from occupancy permits to accreditation.

It is not reasonable to expect laboratory managers to be intimately familiar with evolving regulations, or to master architecture and engineering. These areas are the provinces of consultants, architects, and engineers who specialize in laboratory design, as well as code enforcement officers. However, managers should have a general understanding of space requirements, codes, and regulations that affect their laboratories. Awareness of the various regulatory agencies’ requirements, and the areas they designate as hazardous, allows laboratory managers to be alert to potential dangers and noncompliance in existing and new facilities.

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The Quality Management System ApproachClinical and Laboratory Standards Institute (CLSI) subscribes to a quality management system (QMS) approach in the development of standards and guidelines, which facilitates project management; defines a document structure using a template; and provides a process to identify needed documents. The QMS approach applies a core set of “quality system essentials” (QSEs), basic to any organization, to all operations in any health care service’s path of workflow (ie, operational aspects that define how a particular product or service is provided). The QSEs provide the framework for delivery of any type of product or service, serving as a manager’s guide. The QSEs are as follows:

OrganizationCustomer FocusFacilities and Safety

PersonnelPurchasing and InventoryEquipment

Process ManagementDocuments and RecordsInformation Management

Nonconforming Event ManagementAssessmentsContinual Improvement

QMS04 covers the QSE indicated by an “X.” For a description of the other documents listed in the grid, please refer to the Related CLSI Reference Materials section on page 168.

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XGP40

K2Q K2Q K2Q K2Q K2Q K2Q K2Q K2Q K2Q K2Q K2Q K2QQMS01 QMS01 QMS01 QMS01 QMS01 QMS01 QMS01 QMS01 QMS01 QMS01 QMS01 QMS01

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Related CLSI Reference Materials*GP40 Preparation and Testing of Reagent Water in the Clinical Laboratory. 4th ed., 2012. This

document provides guidelines on water purified for clinical laboratory use; methods for monitoring water quality and testing for specific contaminants; and water system design considerations.

K2Q The Key to Quality™. 2nd ed., 2013. This product provides fundamental information for implementing and sustaining a quality management system (QMS). It also includes information on the 12 quality system essentials (QSEs) for building a QMS; the policies, processes, and procedure requirements for each QSE; and, how to apply the 12 QSEs in the laboratory environment.

QMS01 Quality Management System: A Model for Laboratory Services. 4th ed., 2011. This document

provides a model for medical laboratories that will assist with implementation and maintenance of an effective quality management system.

* CLSI documents are continually reviewed and revised through the CLSI consensus process; therefore, readers should refer to the most current editions.

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For more information, visit www.clsi.org today.

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