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CLSI QMS04 A2 : 2ED 2007

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by

LABORATORY DESIGN

Superseded date

06-29-2016

Superseded by

CLSI QMS04 : 2016

Published date

01-12-2013

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Abstract
Committee Membership
Foreword
1 Scope
2 Introduction
3 Definitions
   3.1 Acronyms
   3.2 Abbreviation
   3.3 Conversion Factors
4 Design Process
   4.1 The Project Team
   4.2 Planning and Programming
   4.3 Schematic Design
   4.4 Design Development
   4.5 Construction Documents
   4.6 Bidding and Negotiation
   4.7 Construction
   4.8 Moving In
   4.9 Phasing
   4.10 Lean Design Concepts
5 Laboratory Equipment
   5.1 Equipment Documentation
   5.2 Automated Sample Handling Technology/Systems
   5.3 Planning for Future Equipment
   5.4 Summary Points
6 Biohazards
   6.1 Determining Biosafety Levels
   6.2 Designing for Biosafety Levels
   6.3 Bioterrorism
   6.4 Security
   6.5 Summary Points
7 Health and Safety
   7.1 Laboratory Classification
   7.2 Flammable Storage
   7.3 Wall Construction
   7.4 Fire Egress
   7.5 Fire Alarms
   7.6 Fire Extinguishers
   7.7 Hazardous Equipment
   7.8 Handwashing
   7.9 Emergency Eyewash Stations and Flood Showers
   7.10 Acoustics
   7.11 Ergonomics
   7.12 Summary Points
8 Space Determination
   8.1 Working Laboratory Space
   8.2 Specialized Laboratory Areas
   8.3 Laboratory Support Spaces
   8.4 Laboratory Employee Spaces
   8.5 Patient Support Spaces
   8.6 Utility Space
   8.7 Net vs. Gross Square Feet
   8.8 Relationships
   8.9 Laboratory Casework
   8.10 Summary Points
9 Finishes
   9.1 Casework
   9.2 Flooring
   9.3 Walls
   9.4 Ceilings
10 Ventilation in Laboratory Design
   10.1 Temperature and Humidity
   10.2 Criteria for Supply and Exhaust
   10.3 Air Changes
   10.4 Pressurization
   10.5 Hood Types
   10.6 Redundancy in HVAC Systems
   10.7 Control
   10.8 Code and Safety Issues
   10.9 Summary Points
11 Electrical and Communications
   11.1 Electrical
   11.2 Communication
   11.3 Summary Points
12 Lighting
   12.1 Lighting Levels
   12.2 Location of Lights
   12.3 Light Fixtures
   12.4 Expandability
   12.5 Codes, Regulations, and Safety
   12.6 Summary Points
13 Plumbing
   13.1 Tap Water
   13.2 Deionized (DI) Water
   13.3 Sinks
   13.4 Emergency Eye Wash.
   13.5 Emergency Flood Shower
   13.6 Gases
   13.7 Waste Water
   13.8 Sprinkler Systems
   13.9 Flexibility
   13.10 Summary Points
14 Conclusion
Appendix. Code/Design Resources
References
Additional Resources
Summary of Comments and Subcommittee Responses
Summary of Delegate Comments and Working Group Responses
The Quality System Approach
Related CLSI/NCCLS Publications

Provides a foundation of information about laboratory design elements and guidance to help define the issues to be considered when designing a clinical laboratory.

DevelopmentNote
Supersedes NCCLS GP18 A. (03/2007) Formerly CLSI GP18 A2. (07/2013)
DocumentType
Miscellaneous Product
PublisherName
Clinical Laboratory Standards Institute
Status
Superseded
SupersededBy
Supersedes

BIS IS/ISO 15189 : 2012 MEDICAL LABORATORIES - REQUIREMENTS FOR QUALITY AND COMPETENCE
I.S. EN ISO 15189:2012 MEDICAL LABORATORIES - REQUIREMENTS FOR QUALITY AND COMPETENCE (ISO 15189:2012, CORRECTED VERSION 2014-08-15)
CLSI POCT8 A : 1ED 2010 QUALITY PRACTICES IN NONINSTRUMENTED POINT-OF-CARE TESTING: AN INSTRUCTIONAL MANUAL AND RESOURCES FOR HEALTH CARE WORKERS
PREN ISO 15189 : DRAFT 2011 MEDICAL LABORATORIES - PARTICULAR REQUIREMENTS FOR QUALITY AND COMPETENCE
UNE-EN ISO 15189:2013 Medical laboratories - Requirements for quality and competence (ISO 15189:2012, Corrected version 2014-08-15)
11/30173018 DC : 0 BS EN ISO 15189 - MEDICAL LABORATORIES - PARTICULAR REQUIREMENTS FOR QUALITY AND COMPETENCE
DIN EN ISO 15189:2014-11 Medical laboratories - Requirements for quality and competence (ISO 15189:2012, Corrected version 2014-08-15)
UNI EN ISO 15189 : 2013 MEDICAL LABORATORIES - REQUIREMENTS FOR QUALITY AND COMPETENCE
CLSI QMS01 A4 : 4ED 2011 QUALITY MANAGEMENT SYSTEM: A MODEL FOR LABORATORY SERVICES
CLSI M29 A4 : 4ED 2014 Protection of Laboratory Workers From Occupationally Acquired Infections<br>
ISO 15189:2012 Medical laboratories — Requirements for quality and competence
BS EN ISO 15189:2012 Medical laboratories. Requirements for quality and competence
CLSI GP31 A : 1ED 2009 LABORATORY INSTRUMENT IMPLEMENTATION, VERIFICATION, AND MAINTENANCE

CLSI GP17 A2 : 2ED 2004 CLINICAL LABORATORY SAFETY
CLSI M29 A3 : 3ED 2005 ACQUIRED INFECTIONS; APPROVED GUIDELINE
CLSI GP40 A4 : 4ED 2006 PREPARATION AND TESTING OF REAGENT WATER IN THE CLINICAL LABORATORY

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