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Clsi 2015-catalog

This document provides information about joining CLSI (Clinical and Laboratory Standards Institute) membership. Membership offers benefits like discounts on CLSI standards and programs, opportunities to collaborate on standards development, and continuing education credits. There are different levels of membership for laboratories, health systems, industries, government agencies, and individuals. Membership helps laboratories improve quality through implementing CLSI standards.

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Set the Standard for Quality in Your Laboratory With CLSI 2015 2016 CATALOG
ORDER TODAY: Toll Free (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.orgA3 ORDER TODAY: Toll Free (US): 877.447.1888 | www.clsi.org | customerservice@clsi.orgA3 Contact our Membership Department at +1.610.688.0100 or membership@clsi.org, or visit www.clsi.org/membership to learn more. There Has Never Been a Better Time to Join CLSI. MEMBERSHIP We know today’s labs face many complex challenges. CLSI is an organization committed to helping you raise the standards for quality in your lab environment and uncover the value that greater testing accuracy, efficiency, and safety provides your health care organization. The Benefits* Access CLSI’s complete library of standards at discounts of up to 70% off! Facilitate accreditation preparedness and speed development of standard operating procedures. Earn convenient and cost-effective continuing education credits through our education programs. Collaborate with colleagues to create and influence the standards that impact the work you do each day. Raise your lab’s visibility and gain recognition among our member organizations. *Industry members receive additional benefits in each category to meet their more robust business needs.Visit www.clsi.org/membership for more information. 1,600+ Organizations Network With in the Global Laboratory Community Actively Collaborate on CLSI Standards Development Receive Up to 70% Savings on CLSI Products and Programs
ORDER TODAY: Toll Free (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org A4ORDER TODAY: Toll Free (US): 877.447.1888 | www.clsi.org | customerservice@clsi.org A4 Find All the Latest CLSI Offerings Online! See our complete library of standards online at the CLSI Shop at shop.clsi.org. Visit www.clsi.org today to: Access all resources from the catalog, as well as new documents and products offered by CLSI. You will also find valuable education programs, and more. Purchase From the CLSI Shop Explore the CLSI U Education Center Find Easy Access to Our Online Products Learn More About Our Membership Benefits
I IIIII Set higher standards as a CLSI Member! Join CLSI and unlock new levels of lab testing quality. Join CLSI today! E-mail membership@clsi.org or visit www.clsi.org/membership. Organizational Membership* Discover how our three comprehensive levels of membership can meet the needs of your facility and budget. New Health System Membership This new level will allow multiple facilities to join under one membership under the health system. Benefits will include global access to the CLSI electronic library of documents for each location. Visit www.clsi.org/membership for further details. I II III Level I Membership Level II Membership Level III Membership For the lab that is committed to implementing the highest standards of lab testing. You will receive: CLSI’s complete library of standards, online and on CD-ROM • eCLIPSE™ Ultimate Access, CLSI’s Web-based searchable library of standards • Infobase™, a CD-ROM library of standards A70%discountonotherCLSI standards,products,andprograms Free shipping within the USA Free Education programs to help your staff stay up-to-date with the latest standards A flexible membership option for labs that want to select the standards, subscription products, and education programs that are most important to them. You will receive: A 50% discount on CLSI standards, products, and programs For the lab that already has a library of CLSI standards and wants to stay up-to-date when new and revised documents are published. You will receive: A subscription to all newly published and revised standards delivered straight to your inbox as soon as they are published A 60% discount on CLSI standards, products, and programs Free shipping within the USA *Industrymembersreceiveadditionalbenefitsineachcategorytomeettheirmorerobustbusinessneeds.Visitwww.clsi.org/membershipformoreinformation. Full Member A 25% discount on CLSI standards, products, and programs Opportunity to participate on committees and the Board of Directors Associate Member A 15% discount on CLSI standards, products, and programs Opportunity to participate on committees Student Member Full-time students enrolled in an academic program A 10% discount on CLSI standards, products, and programs Individual Membership AnaffordableoptionforanyonewhoisinterestedinsupportingorvolunteeringforCLSI,regardlessofemployeraffiliation
Industry and Large Commercial Laboratories Health Care Professions Government and Public Health Agencies Individual I ($25,000) II ($10,000) III ($2,500) I ($5,000) II ($1,500) III ($400) I ($5,000) II ($1,500) III ($400) I ($250) II ($75) III ($25) Full Associate Student Become an integral part of improving global clinical lab testing and advancing the quality of patient care. Join in Our Mission to Improve Health Care Outcomes Membership Application Delegate Name Delegate E-mail Alternate Name Alternate E-mail Organization Address City State/Province Zip/Postal Code Country Phone Number Website Membership Category: Desired Level: We accept checks drawn on US banks; American Express, Discover, MasterCard, and Visa credit cards; and wire transfers. Please select your method of payment: Check Wire Transfer (Wire Date ) American Express Discover MasterCard Visa Credit Card Number Exp. Date / CSV Name on Card Signature For wire transfer instructions, please contact membership@clsi.org. MEMBERSHIPAPPLICATION Mail to: Fax to: E-mail to: Clinical and Laboratory Standards Institute 950 West Valley Road, Suite 2500 Wayne, PA 19087 USA +1.610.688.0700 membership@clsi.org Questions? If you have any questions regarding CLSI membership options and which level will best fit your organization’s needs, please contact our Membership Department directly at +1.610.688.0100.
ORDER TODAY: Toll Free (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org 1 Quality System Regulation for Laboratory-Developed Tests A Practical Guide for the Laboratory January 2015 M100-S25 Performance Standards for Antimicrobial Susceptibility Testing; Twenty-Fifth Informational Supplement January 2015 M07-A10 Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard —Tenth Edition January 2015 M02-A12 Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard—Twelfth Edition Recently Published From CLSI New and revised standards on timely clinical laboratory topics. M100-S25* Performance Standards for Antimicrobial Susceptibility Testing; Twenty-Fifth Informational Supplement M07-A10* Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard— Tenth Edition M02-A12* Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard—Twelfth Edition This document provides updated tables for the Clinical and Laboratory Standards Institute antimicrobial susceptibility testing standards M02-A11, M07-A9, and M11-A8. A standard for global application developed through the Clinical and Laboratory Standards Institute consensus process. EP15-A3 User Verification of Precision and Estimation of Bias; Approved Guideline— Third Edition September 2014 This document provides updated tables for the Clinical and Laboratory Standards Institute antimicrobial susceptibility testing standards M02-A11, M07-A9, and M11-A8. A standard for global application developed through the Clinical and Laboratory Standards Institute consensus process. GP23-A2 Nongynecological Cytology Specimens: Preexamination, Examination, and Postexamination Processes; Approved Guideline—Second Edition November 2014 This document provides updated tables for the Clinical and Laboratory Standards Institute antimicrobial susceptibility testing standards M02-A11, M07-A9, and M11-A8. A standard for global application developed through the Clinical and Laboratory Standards Institute consensus process. GP36-A Planning for Laboratory Operations During a Disaster; Approved Guideline December 2014 EP15-A3 User Verification of Precision and Estimation of Bias; Approved Guideline— Third Edition GP23-A2 Nongynecological Cytology Specimens: Preexamination, Examination, and Postexamination Processes; Approved Guideline—Second Edition GP36-A Planning for Laboratory Operations During a Disaster; Approved Guideline This document provides updated tables for the Clinical and Laboratory Standards Institute antimicrobial susceptibility testing standards M02-A11, M07-A9, and M11-A8. A standard for global application developed through the Clinical and Laboratory Standards Institute consensus process. POCT06 Effects of Different Sample Types on Glucose Measurements 1st Edition This document provides updated tables for the Clinical and Laboratory Standards Institute antimicrobial susceptibility testing standards M02-A11, M07-A9, and M11-A8. A standard for global application developed through the Clinical and Laboratory Standards Institute consensus process. C57 Mass Spectrometry for Androgen and Estrogen Measurements in Serum 1st Edition This document provides updated tables for the Clinical and Laboratory Standards Institute antimicrobial susceptibility testing standards M02-A11, M07-A9, and M11-A8. A standard for global application developed through the Clinical and Laboratory Standards Institute consensus process. POCT13 Glucose Monitoring in Settings Without Laboratory Support 3rd Edition POCT06-Ed1 Effects of Different Sample Types on Glucose Measurements, 1st Edition C57-Ed1 Mass Spectrometry for Androgen and Estrogen Measurements in Serum, 1st Edition POCT13-Ed3 Glucose Monitoring in Settings Without Laboratory Support, 3rd Edition 3rd Edition This document provides updated tables for the Clinical and Laboratory Standards Institute antimicrobial susceptibility testing standards M02-A11, M07-A9, and M11-A8. A standard for global application developed through the Clinical and Laboratory Standards Institute consensus process. MM03 Molecular Diagnostic Methods for Infectious Diseases 1st Edition This document provides updated tables for the Clinical and Laboratory Standards Institute antimicrobial susceptibility testing standards M02-A11, M07-A9, and M11-A8. A standard for global application developed through the Clinical and Laboratory Standards Institute consensus process. QMS18 Process Management MM03-Ed3 Molecular Diagnostic Methods for Infectious Diseases, 3rd Edition QMS18-Ed1 Process Management, 1st Edition QSR LDT Quality System Regulation for Laboratory-Developed Tests: A Practical Guide for the Laboratory *These documents are sold only in packages of M02 and M100; M07 and M100; and M02, M07, and M100. April 2015 MM23 Molecular Diagnostic Methods for Solid Tumors (Nonhematological Neoplasms) MM23-Ed1 Molecular Diagnostic Methods for Solid Tumors (Nonhematological Neoplasms), 1st Edition This document provides updated tables for the Clinical and Laboratory Standards Institute antimicrobial susceptibility testing standards M02-A11, M07-A9, and M11-A8. A standard for global application developed through the Clinical and Laboratory Standards Institute consensus process. EP05-A3 Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline—Third Edition October 2014 EP05-A3 Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline—Third Edition
2015/2016 Table of Contents Document Categories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Index of CLSI Standards and Companion Products. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Catalog Key. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 Document and Product Listings by Category Accreditation Preparedness – Essentials for Verifying Test Performance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 Accreditation Preparedness – Laboratory Practices. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 Automation and Informatics. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 Clinical Chemistry and Toxicology. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 Hematology and Coagulation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 Immunology and Ligand Assay. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28 Microbiology Methodologies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29 Molecular Methods. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32 Newborn Screening. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34 Phlebotomy. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36 Point-of-Care Testing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38 Quality Management Systems. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40 Reducing Risk.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44 Safety. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46 Specimen Handling and Processing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48 Susceptibility Testing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50 Veterinary Medicine.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54 Coming Soon.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57 Featured Products Quality System Regulation for Laboratory-Developed Tests. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 eM100.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29 CLSI Communities.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37 The Key to Quality™. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40 Online Learning Programs.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43 eCLIPSE™ Ultimate Access. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53 Infobase™. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55 CLSI Course Offerings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56 Order Form. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
ORDER TODAY: Toll Free (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org 3ORDER TODAY: Toll Free (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org 3 Former Document Code New Document Code Automation and Informatics GP19-A2 AUTO13-A2 Clinical Chemistry and Toxicology H17-A C61-A General Laboratory H01-A6 GP39-A6 C03-A4-AMD GP40-A4-AMD H03-A6 GP41-A6 H04-A6 GP42-A6 H11-A4 GP43-A4 H18-A4 GP44-A4 HS06-A GP45-A Method Evaluation C28-A3c EP28-A3c C51-A EP29-A C53-A EP30-A C54-A-IR EP31-A-IR X05-R EP32-R Former Document Code New Document Code Microbiology X07-R M55-R Newborn Screening LA04-A5 NBS01-A6* I/LA27-A NBS02-A2* I/LA31-A NBS03-A I/LA32-A NBS04-A I/LA35-A NBS05-A Point-of-Care Testing AST04-A2 POCT13-A2 H49-A POCT14-A Quality Management Systems GP26-A4 QMS01-A4 GP02-A5 QMS02-A6* GP21-A3 QMS03-A3 GP18-A2 QMS04-A2 GP09-A2 QMS05-A2 GP22-A3 QMS06-A3 Former Document Code New Document Code Quality Management Systems (continued) HS04-A2 QMS07-A2 HS11-A QMS10-A GP32-A QMS11-A GP35-A QMS12-A GP37-A QMS13-A GP38-A QMS14-A GP38-AES QMS14-AES Veterinary Medicine M31-A3 VET01-A4 M37-A3 VET02-A3 M42/M49-S1 VET03/VET04-S2 M42-A VET03-A M49-A VET04-A2 X08-R VET05-R In order to better classify our library of documents, CLSI expanded and color coded its document categories. The assigned colors are prominently displayed on each CLSI document cover. The document categories are: As part of this initiative, some CLSI documents were assigned new codes to reflect their categories. See below for the complete list of affected documents, or visit www.clsi.org. * These documents replaced the respective standards noted in the “Former Document Code” column. Automation and Informatics Clinical Chemistry and Toxicology General Laboratory Hematology Immunology and Ligand Assay Method Evaluation Microbiology Molecular Methods Newborn Screening Point-of-Care Testing Quality Management Systems Veterinary Medicine There are more products online at the CLSI Shop. Visit shop.clsi.org to find our full library of resources.Shop Online! DOCUMENTCATEGORIES
ORDER TODAY: Toll Free (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org4 Be Prepared to Comply Using CLSI. Let CLSI Guide You Through the FDA Proposed Requirements for LDTs! Labs that perform LDTs will be held accountable to the same standards as IVD manufacturers. CLSI has the resources you need to prepare for the FDA’s proposed guidance! You can find essential information in our practical guide, Quality System Regulation for Laboratory-Developed Tests (QSR LDT). HOW WHERE THEY AFFECT YOUR ORGANIZATION YOU CAN FIND INFORMATION Order the QSR LDT Practical Guide Today! Visit www.clsi.org/LDTs. Through FDA’s proposed phased-in implementation, after 12 months, enforcement of premarket review requirements for the highest-risk LDTs begins. WHEN THEY WILL GO INTO EFFECT EP19—A Framework for Using CLSI Documents to Evaluate Clinical Laboratory Measurement Procedures QSR LDT—Quality System Regulation for Laboratory- DevelopedTests: A Practical Guide for the Laboratory Learn how to validate LDTs to establish product performance claims as part of your submission packets to the FDA. Learn how the proposed changes for the FDA QSReg for LDTs differs from current CLIA requirements, and what your lab should do to prepare. Members LI: $90 LII: $120 LIII: $150 Nonmembers: $300FREE! Quality System Regulation for Laboratory-Developed Tests A Practical Guide for the Laboratory JUNE 2015 January 2015 This report uses the “measurement procedure lifecycle” framework to aid users of CLSI evaluation protocols documents during establishment and implementation of measurement procedures developed by both commercial manufacturers and clinical laboratories, ie, for laboratory- developed tests. A CLSI report for global application EP19 A Framework for Using CLSI Documents to Evaluate Clinical Laboratory Measurement Procedures 2nd Edition 1 2 3
ORDER TODAY: Toll Free (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org 5 Automation and Informatics Document Code Document Title Location Format AUTO01-A Laboratory Automation: Specimen Container/Specimen Carrier; Approved Standard Online PDF AUTO02-A2 Laboratory Automation: Bar Codes for Specimen Container Identification; Approved Standard—Second Edition Online PDF AUTO03-A2 Laboratory Automation: Communications With Automated Clinical Laboratory Systems, Instruments, Devices, and Information Systems; Approved Standard—Second Edition Online PDF AUTO04-A Laboratory Automation: Systems Operational Requirements, Characteristics, and Information Elements; Approved Standard Online PDF AUTO05-A Laboratory Automation: Electromechanical Interfaces; Approved Standard Online PDF AUTO07-A Laboratory Automation: Data Content for Specimen Identification; Approved Standard Online PDF AUTO08-A Managing and Validating Laboratory Information Systems; Approved Guideline Online PDF and Print AUTO09-A Remote Access to Clinical Laboratory Diagnostic Devices via the Internet; Approved Standard Online PDF AUTO10-A Autoverification of Clinical Laboratory Test Results; Approved Guideline Online PDF AUTO11-A2 Information Technology Security of In Vitro Diagnostic Instruments and Software Systems; Approved Standard—Second Edition Pg. 22 PDF and Print AUTO12-A Specimen Labels: Content and Location, Fonts, and Label Orientation; Approved Standard Pg. 22 PDF and Print AUTO13-A2 Laboratory Instruments and Data Management Systems: Design of Software User Interfaces and End-User Software Systems Validation, Operation, and Monitoring; Approved Guideline—Second Edition Online PDF I/LA33-A Validation of Automated Systems for Immunohematological Testing Before Implementation; Approved Guideline Pg. 28 PDF I/LA33-A TK Validation of Automated Systems for Immunohematological Testing Before Implementation—Sample Templates and Test Cases Toolkit Pg. 28 CD LIS01-A2 Specification for Low-Level Protocol to Transfer Messages Between Clinical Laboratory Instruments and Computer Systems; Approved Standard—Second Edition Online PDF LIS02-A2 Specification for Transferring Information Between Clinical Laboratory Instruments and Information Systems; Approved Standard—Second Edition Online PDF LIS03-A Standard Guide for Selection of a Clinical Laboratory Information Management System Online PDF LIS04-A Standard Guide for Documentation of Clinical Laboratory Computer Systems Online PDF LIS05-A Standard Specification for Transferring Clinical Observations Between Independent Computer Systems Online PDF LIS06-A Standard Practice for Reporting Reliability of Clinical Laboratory Information Systems Online PDF LIS07-A Standard Specification for Use of Bar Codes on Specimen Tubes in the Clinical Laboratory Online PDF LIS08-A Standard Guide for Functional Requirements of Clinical Laboratory Information Management Systems Online PDF LIS09-A Standard Guide for Coordination of Clinical Laboratory Services within the Electronic Health Record Environment and Networked Architectures Online PDF All CLSI standards, guidelines, and companion products are listed in the index below. Various documents are located in the catalog, and a corresponding page number is indicated in the “Location” column. All other documents are available on the CLSI website at www.clsi.org, and are indicated with “Online” in the “Location” column below. Index of CLSI Standards and Companion Products
ORDER TODAY: Toll Free (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org6 INDEX Clinical Chemistry and Toxicology Document Code Document Title Location Format C24-A3 Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions; Approved Guideline—Third Edition Pg. 18, 24 PDF and Print C29-A2 Standardization of Sodium and Potassium Ion-Selective Electrode Systems to the Flame Photometric Reference Method; Approved Standard—Second Edition Online PDF C31-A2 Ionized Calcium Determinations: Precollection Variables, Specimen Choice, Collection, and Handling; Approved Guideline—Second Edition Online PDF C34-A3 Sweat Testing: Sample Collection and Quantitative Chloride Analysis; Approved Guideline—Third Edition Pg. 24 PDF C37-A Preparation and Validation of Commutable Frozen Human Serum Pools as Secondary Reference Materials for Cholesterol Measurement Procedures; Approved Guideline Online PDF C38-A Control of Preanalytical Variation in Trace Element Determinations; Approved Guideline Online PDF and Print C39-A A Designated Comparison Method for the Measurement of Ionized Calcium in Serum; Approved Standard Online PDF C40-A2 Measurement Procedures for the Determination of Lead Concentrations in Blood and Urine; Approved Guideline—Second Edition Pg. 24 PDF and Print C42-A Erythrocyte Protoporphyrin Testing; Approved Guideline Online PDF C43-A2 Gas Chromatography/Mass Spectrometry Confirmation of Drugs; Approved Guideline— Second Edition Online PDF C45-A Measurement of Free Thyroid Hormones; Approved Guideline Online PDF C46-A2 Blood Gas and pH Analysis and Related Measurements; Approved Guideline—Second Edition Pg. 24 PDF and Print C48-A Application of Biochemical Markers of Bone Turnover in the Assessment and Monitoring of Bone Diseases; Approved Guideline Online PDF C49-A Analysis of Body Fluids in Clinical Chemistry; Approved Guideline Pg. 24 PDF and Print C49-A/H56-A QG Collection, Handling, Transport, and Storage for Body Fluids Quick Guide Pg. 24 Print C50-A Mass Spectrometry in the Clinical Laboratory: General Principles and Guidance; Approved Guideline Online PDF C52-A2 Toxicology and Drug Testing in the Clinical Laboratory; Approved Guideline—Second Edition Online PDF and Print C56-A Hemolysis, Icterus, and Lipemia/Turbidity Indices as Indicators of Interference in Clinical Laboratory Analysis; Approved Guideline Pg. 25 PDF and Print C56-A QG Examples of Hemolyzed, Icteric, and Lipemic/Turbid Samples Quick Guide Pg. 25 PDF and Print C57-Ed1 Mass Spectrometry for Androgen and Estrogen Measurements in Serum, 1st Edition Pg. 25 PDF and Print C58-A Assessment of Fetal Lung Maturity by the Lamellar Body Count; Approved Guideline Online PDF C61-A Determination of Serum Iron, Total Iron-Binding Capacity and Percent Transferrin Saturation; Approved Standard Online PDF C62-A Liquid Chromatography-Mass Spectrometry Methods; Approved Guideline Pg. 25 PDF and Print EP05-A3 Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline— Third Edition Online PDF and Print EP06-A Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline Pg. 18 PDF and Print EP07-A2 Interference Testing in Clinical Chemistry; Approved Guideline—Second Edition Pg. 18 PDF and Print EP09-A3 Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Approved Guideline—Third Edition Pg. 18 PDF and Print EP10-A3-AMD Preliminary Evaluation of Quantitative Clinical Laboratory Measurement Procedures; Approved Guideline—Third Edition Online PDF and Print EP12-A2 User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline— Second Edition Online PDF EP14-A3 Evaluation of Commutability of Processed Samples; Approved Guideline—Third Edition Online PDF and Print
ORDER TODAY: Toll Free (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org 7 INDEX Clinical Chemistry and Toxicology Document Code Document Title Location Format EP15-A3 User Verification of Precision and Estimation of Bias; Approved Guideline—Third Edition Pg. 18 PDF and Print EP17-A2 Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline—Second Edition Pg. 19 PDF and Print EP18-A2 Risk Management Techniques to Identify and Control Laboratory Error Sources; Approved Guideline—Second Edition Pg. 44 PDF and Print EP19-Ed2 A Framework for Using CLSI Documents to Evaluate Clinical Laboratory Measurement Procedures, 2nd Edition Pg. 4, 57 PDF EP21-A Estimation of Total Analytical Error for Clinical Laboratory Methods; Approved Guideline Pg. 19 PDF and Print EP24-A2 Assessment of the Diagnostic Accuracy of Laboratory Tests Using Receiver Operating Characteristic Curves; Approved Guideline—Second Edition Online PDF and Print EP25-A Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline Online PDF EP28-A3c Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline—Third Edition Pg. 19 PDF and Print EP30-A Characterization and Qualification of Commutable Reference Materials for Laboratory Medicine; Approved Guideline Online PDF EP31-A-IR Verification of Comparability of Patient Results Within One Health Care System; Approved Guideline (Interim Revision) Pg. 19 PDF and Print EP32-R Metrological Traceability and Its Implementation; A Report Online PDF GP40-A4-AMD Preparation and Testing of Reagent Water in the Clinical Laboratory; Approved Guideline— Fourth Edition Online PDF and Print (continued) General Laboratory EP26-A User Evaluation of Between-Reagent Lot Variation; Approved Guideline Online PDF and Print GP05-A3 Clinical Laboratory Waste Management; Approved Guideline—Third Edition Pg. 46 PDF and Print GP05-A3 CL Waste Management Program—Audit Checklist Pg. 46 PDF and Print GP15-A3 Cervicovaginal Cytology Based on the Papanicolaou Technique; Approved Guideline— Third Edition Online PDF GP16-A3 Urinalysis; Approved Guideline—Third Edition Pg. 48 PDF and Print GP17-A3 Clinical Laboratory Safety; Approved Guideline—Third Edition Pg. 46 PDF and Print GP20-A2 Fine Needle Aspiration Biopsy (FNAB) Techniques; Approved Guideline—Second Edition Online PDF GP23-A2 Nongynecological Cytology Specimens: Preexamination, Examination, and Postexamination Processes; Approved Guideline—Second Edition Online PDF and Print GP27-A2 Using Proficiency Testing to Improve the Clinical Laboratory; Approved Guideline—Second Edition Pg. 20 PDF and Print GP28-A Microwave Device Use in the Histology Laboratory; Approved Guideline Online PDF GP29-A2 Assessment of Laboratory Tests When Proficiency Testing Is Not Available; Approved Guideline—Second Edition Pg. 20 PDF and Print GP31-A Laboratory Instrument Implementation, Verification, and Maintenance; Approved Guideline Pg. 19 PDF and Print GP33-A Accuracy in Patient and Sample Identification; Approved Guideline Pg. 46 PDF and Print GP34-A Validation and Verification of Tubes for Venous and Capillary Blood Specimen Collection; Approved Guideline Online PDF and Print GP36-A Planning for Laboratory Operations During a Disaster; Approved Guideline Pg. 47 PDF and Print GP39-A6 Tubes and Additives for Venous and Capillary Blood Specimen Collection; Approved Standard—Sixth Edition Online PDF and Print GP40-A4-AMD Preparation and Testing of Reagent Water in the Clinical Laboratory; Approved Guideline— Fourth Edition Online PDF and Print GP41-A6 Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture; Approved Standard—Sixth Edition Pg. 36 PDF and Print
ORDER TODAY: Toll Free (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org8 General Laboratory Document Code Document Title Location Format GP41-A6 QG Quality Venipuncture Quick Guide Pg. 36 PDF and Print GP42-A6 Procedures and Devices for the Collection of Diagnostic Capillary Blood Specimens; Approved Standard—Sixth Edition Online PDF GP42-A6 QG Technique for Skin Puncture in Adults and Older Children Quick Guide Online PDF and Print GP43-A4 Procedures for the Collection of Arterial Blood Specimens; Approved Standard—Fourth Edition Online PDF GP44-A4 Procedures for the Handling and Processing of Blood Specimens for Common Laboratory Tests; Approved Guideline—Fourth Edition Pg. 48 PDF and Print GP44-A4 QG Handling, Transport, and Storage of Specimens Quick Guide Pg. 48 Print GP45-A Studies to Evaluate Patient Outcomes; Approved Guideline Online PDF H02-A5 Procedures for the Erythrocyte Sedimentation Rate Test; Approved Standard—Fifth Edition Pg. 26 PDF and Print I08-P Determining Performance of Volumetric Equipment; Proposed Guideline Online PDF I16-T Temperature Monitoring and Recording in Blood Banks; Tentative Guideline Online PDF M29-A4 Protection of Laboratory Workers From Occupationally Acquired Infections; Approved Guideline—Fourth Edition Pg. 47 PDF and Print MM13-A Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods; Approved Guideline Pg. 32, 49 PDF and Print MM13-A QG Handling, Transport, and Storage of Specimens for Molecular Methods Quick Guide Pg. 32 Print POCT10/GP16 WC Microscopic Components in Urine Sediment and Vaginal Fluid Wall Charts Pg. 39, 48 PDF and Print QG 10 Specimen Collection Quick Guides Online Print QMS02-A6 Quality Management System: Development and Management of Laboratory Documents; Approved Guideline—Sixth Edition Pg. 20, 40 PDF and Print (continued) Hematology H02-A5 Procedures for the Erythrocyte Sedimentation Rate Test; Approved Standard—Fifth Edition Pg. 26 PDF and Print H07-A3 Procedure for Determining Packed Cell Volume by the Microhematocrit Method; Approved Standard—Third Edition Online PDF H15-A3 Reference and Selected Procedures for the Quantitative Determination of Hemoglobin in Blood; Approved Standard—Third Edition Online PDF H20-A2 Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental Methods; Approved Standard—Second Edition Online PDF and Print H21-A5 Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays and Molecular Hemostasis Assays; Approved Guideline—Fifth Edition Pg. 26, 49 PDF and Print H21-A5 QG Collection, Handling, Transport, and Storage for Hemostasis Quick Guide Pg. 26, 49 Print H26-A2 Validation, Verification, and Quality Assurance of Automated Hematology Analyzers; Approved Standard—Second Edition Pg. 26 PDF and Print H30-A2 Procedure for the Determination of Fibrinogen in Plasma; Approved Guideline—Second Edition Online PDF H42-A2 Enumeration of Immunologically Defined Cell Populations by Flow Cytometry; Approved Guideline—Second Edition Online PDF H43-A2 Clinical Flow Cytometric Analysis of Neoplastic Hematolymphoid Cells; Approved Guideline—Second Edition Online PDF H47-A2 One-Stage Prothrombin Time (PT) Test and Activated Partial Thromboplastin Time (APTT) Test; Approved Guideline—Second Edition Online PDF H48-A Determination of Factor Coagulant Activities; Approved Guideline Online PDF H51-A Assays of von Willebrand Factor Antigen and Ristocetin Cofactor Activity; Approved Guideline Online PDF
ORDER TODAY: Toll Free (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org 9 INDEX Immunology and Ligand Assay I/LA02-A2 Quality Assurance of Laboratory Tests for Autoantibodies to Nuclear Antigens: (1) Indirect Fluorescence Assay for Microscopy and (2) Microtiter Enzyme Immunoassay Methods; Approved Guideline—Second Edition Online PDF I/LA20-A2 Analytical Performance Characteristics and Clinical Utility of Immunological Assays for Human Immunoglobulin E (IgE) Antibodies and Defined Allergen Specificities; Approved Guideline—Second Edition Pg. 28 PDF I/LA21-A2 Clinical Evaluation of Immunoassays; Approved Guideline—Second Edition Online PDF I/LA23-A Assessing the Quality of Immunoassay Systems: Radioimmunoassays and Enzyme, Fluorescence, and Luminescence Immunoassays; Approved Guideline Online PDF I/LA25-A2 Maternal Serum Screening; Approved Standard—Second Edition Online PDF I/LA26-A2 Performance of Single Cell Immune Response Assays; Approved Guideline—Second Edition Pg. 28 PDF and Print I/LA28-A2 Quality Assurance for Design Control and Implementation of Immunohistochemistry Assays; Approved Guideline—Second Edition Pg. 28 PDF and Print I/LA28-A2 QG Comparison of the Characteristics of Immunoassays Such as Enzyme-Linked Immunosorbent Assay and Immunohistochemistry Quick Guide Pg. 28 Print I/LA30-A Immunoassay Interference by Endogenous Antibodies; Approved Guideline Online PDF I/LA33-A Validation of Automated Systems for Immunohematological Testing Before Implementation; Approved Guideline Pg. 28 PDF I/LA33-A TK Validation of Automated Systems for Immunohematological Testing Before Implementation—Sample Templates and Test Cases Toolkit Pg. 28 CD I/LA34-A Design and Validation of Immunoassays for Assessment of Human Allergenicity of New Biotherapeutic Drugs; Approved Guideline Online Print NBS06-A Newborn Blood Spot Screening for Severe Combined Immunodeficiency by Measurement of T-cell Receptor Excision Circles; Approved Guideline Pg. 35 PDF and Print NBS06-A QG1 Generic Flow Chart for Assays to Measure T-cell Receptor Excision Circles in Newborn Dried Blood Spot Specimens Quick Guide Pg. 35 Print NBS06-A QG2 Schematic for Preparing Dried Blood Spot Reference Materials Quick Guide Pg. 35 Print NBS06-A WC Immunodeficiency Disorders and T-cell Receptor Excision Circle Values in the Newborn Screening Period Pg. 35 Print Hematology Document Code Document Title Location Format H52-A2 Red Blood Cell Diagnostic Testing Using Flow Cytometry; Approved Guideline—Second Edition Pg. 26 PDF and Print H54-A Procedures for Validation of INR and Local Calibration of PT/INR Systems; Approved Guideline Online PDF and Print H56-A Body Fluid Analysis for Cellular Composition; Approved Guideline Online PDF and Print H57-A Protocol for the Evaluation, Validation, and Implementation of Coagulometers; Approved Guideline Online PDF H58-A Platelet Function Testing by Aggregometry; Approved Guideline Online PDF and Print H59-A Quantitative D-dimer for the Exclusion of Venous Thromboembolic Disease; Approved Guideline Pg. 27 PDF and Print H60-A Laboratory Testing for the Lupus Anticoagulant; Approved Guideline Pg. 27 PDF and Print H60-A QG1 Algorithmic Approach to Lupus Anticoagulant Testing Pg. 27 PDF and Print H60-A QG2 Criteria for the Laboratory Diagnosis of the Lupus Anticoagulant Pg. 27 PDF and Print MM05-A2 Nucleic Acid Amplification Assays for Molecular Hematopathology; Approved Guideline— Second Edition Online PDF POCT14-A Point-of-Care Monitoring of Anticoagulation Therapy; Approved Guideline Online PDF and Print (continued)
ORDER TODAY: Toll Free (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org10 Method Evaluation Document Code Document Title Location Format C24-A3 Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions; Approved Guideline—Third Edition Pg. 18, 24 PDF and Print C29-A2 Standardization of Sodium and Potassium Ion-Selective Electrode Systems to the Flame Photometric Reference Method; Approved Standard—Second Edition Online PDF C37-A Preparation and Validation of Commutable Frozen Human Serum Pools as Secondary Reference Materials for Cholesterol Measurement Procedures; Approved Guideline Online PDF C39-A A Designated Comparison Method for the Measurement of Ionized Calcium in Serum; Approved Standard Online PDF C42-A Erythrocyte Protoporphyrin Testing; Approved Guideline Online PDF C43-A2 Gas Chromatography/Mass Spectrometry Confirmation of Drugs; Approved Guideline— Second Edition Online PDF C45-A Measurement of Free Thyroid Hormones; Approved Guideline Online PDF C46-A2 Blood Gas and pH Analysis and Related Measurements; Approved Guideline—Second Edition Pg. 24 PDF and Print C50-A Mass Spectrometry in the Clinical Laboratory: General Principles and Guidance; Approved Guideline Online PDF EP05-A3 Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline— Third Edition Online PDF and Print EP06-A Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline Pg. 18 PDF and Print EP07-A2 Interference Testing in Clinical Chemistry; Approved Guideline—Second Edition Pg. 18 PDF and Print EP09-A3 Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Approved Guideline—Third Edition Pg. 18 PDF and Print EP10-A3-AMD Preliminary Evaluation of Quantitative Clinical Laboratory Measurement Procedures; Approved Guideline—Third Edition Online PDF and Print EP12-A2 User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline— Second Edition Online PDF EP14-A3 Evaluation of Commutability of Processed Samples; Approved Guideline—Third Edition Online PDF and Print EP15-A3 User Verification of Precision and Estimation of Bias; Approved Guideline—Third Edition Pg. 18 PDF and Print EP17-A2 Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline—Second Edition Pg. 19 PDF and Print EP18-A2 Risk Management Techniques to Identify and Control Laboratory Error Sources; Approved Guideline—Second Edition Pg. 44 PDF and Print EP18-A2/EP23-A WS EP18/EP23 Sources of Failure Template Pg. 44 Word EP19-Ed2 A Framework for Using CLSI Documents to Evaluate Clinical Laboratory Measurement Procedures, 2nd Edition Pg. 4, 57 PDF EP21-A Estimation of Total Analytical Error for Clinical Laboratory Methods; Approved Guideline Pg. 19 PDF and Print EP23-A™ Laboratory Quality Control Based on Risk Management; Approved Guideline Pg. 45 PDF and Print EP23-A QG EP23 Quick Reference Guide Pg. 45 PDF and Print EP23-A WB A Practical Guide for Laboratory Quality Control Based on Risk Management; Workbook Pg. 45 PDF and Print EP23-AWS A Sample Form for Laboratory Quality Control Based on Risk Management; Worksheet Pg. 45 Word EP24-A2 Assessment of the Diagnostic Accuracy of Laboratory Tests Using Receiver Operating Characteristic Curves; Approved Guideline—Second Edition Online PDF and Print EP25-A Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline Online PDF EP26-A User Evaluation of Between-Reagent Lot Variation; Approved Guideline Online PDF and Print EP27-A How to Construct and Interpret an Error Grid for Quantitative Diagnostic Assays; Approved Guideline Online PDF
ORDER TODAY: Toll Free (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org 11 Method Evaluation Document Code Document Title Location Format EP28-A3c Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline—Third Edition Pg. 19 PDF and Print EP29-A Expression of Measurement Uncertainty in Laboratory Medicine; Approved Guideline Online PDF and Print EP30-A Characterization and Qualification of Commutable Reference Materials for Laboratory Medicine; Approved Guideline Online PDF EP31-A-IR Verification of Comparability of Patient Results Within One Health Care System; Approved Guideline (Interim Revision) Pg. 19 PDF and Print EP32-R Metrological Traceability and Its Implementation; A Report Online PDF EP36-Ed1 Harmonization of Symbology and Equations, 1st Edition Pg. 57 PDF H26-A2 Validation, Verification, and Quality Assurance of Automated Hematology Analyzers; Approved Standard—Second Edition Pg. 26 PDF and Print MM17-A Verification and Validation of Multiplex Nucleic Acid Assays; Approved Guideline Pg. 33 PDF and Print (continued) Microbiology AST QC QG AST QC Flow Chart Quick Guides Pg. 29, 50 PDF and Print M02-A12 Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard— Twelfth Edition Pg. 29, 50 PDF and Print M06-A2 Protocols for Evaluating Dehydrated Mueller-Hinton Agar; Approved Standard—Second Edition Online PDF M07-A10 Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard—Tenth Edition Pg. 29, 50 PDF and Print M11-A8 Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria; Approved Standard—Eighth Edition Pg. 51 PDF and Print M15-A Laboratory Diagnosis of Blood-borne Parasitic Diseases; Approved Guideline Online PDF M21-A Methodology for the Serum Bactericidal Test; Approved Guideline Online PDF M22-A3 Quality Control for Commercially Prepared Microbiological Culture Media; Approved Standard—Third Edition Pg. 30 PDF and Print M23-A3 Development of In Vitro Susceptibility Testing Criteria and Quality Control Parameters; Approved Guideline—Third Edition Online PDF and Print M24-A2 Susceptibility Testing of Mycobacteria, Nocardiae, and Other Aerobic Actinomycetes; Approved Standard—Second Edition Pg. 51 PDF and Print M26-A Methods for Determining Bactericidal Activity of Antimicrobial Agents; Approved Guideline Online PDF M27-A3 Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts; Approved Standard—Third Edition Pg. 51 PDF and Print M27-S4 Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts; Fourth Informational Supplement Pg. 51 PDF and Print M28-A2 Procedures for the Recovery and Identification of Parasites From the Intestinal Tract; Approved Guideline—Second Edition Pg. 30 PDF and Print M29-A4 Protection of Laboratory Workers From Occupationally Acquired Infections; Approved Guideline—Fourth Edition Pg. 47 PDF and Print M32-P Evaluation of Lots of Dehydrated Mueller-Hinton Broth for Antimicrobial Susceptibility Testing; Proposed Guideline Online PDF M33-A Antiviral Susceptibility Testing: Herpes Simplex Virus by Plaque Reduction Assay; Approved Standard Online PDF and Print M34-A Western Blot Assay for Antibodies to Borrelia burgdorferi; Approved Guideline Online PDF M35-A2 Abbreviated Identification of Bacteria and Yeast; Approved Guideline—Second Edition Pg. 30 PDF and Print M36-A Clinical Use and Interpretation of Serologic Tests for Toxoplasma gondii; Approved Guideline Online PDF
ORDER TODAY: Toll Free (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org12 Microbiology Document Code Document Title Location Format M38-A2 Reference Method for Broth Dilution Antifungal Susceptibility Testing of Filamentous Fungi; Approved Standard—Second Edition Pg. 51 PDF and Print M39-A4 Analysis and Presentation of Cumulative Antimicrobial Susceptibility Test Data; Approved Guideline—Fourth Edition Pg. 51 PDF and Print M39-A4 QG Antibiograms: Developing Cumulative Reports for Your Clinicians Quick Guide Pg. 52 Print M40-A2 Quality Control of Microbiological Transport Systems; Approved Standard—Second Edition Pg. 30 PDF and Print M41-A Viral Culture; Approved Guideline Online PDF M43-A Methods for Antimicrobial Susceptibility Testing for Human Mycoplasmas; Approved Guideline Online PDF M44-A2 Method for Antifungal Disk Diffusion Susceptibility Testing of Yeasts; Approved Guideline—Second Edition Pg. 52 PDF and Print M44-S3 Zone Diameter Interpretive Standards, Corresponding Minimal Inhibitory Concentration (MIC) Interpretive Breakpoints, and Quality Control Limits for Antifungal Disk Diffusion Susceptibility Testing of Yeasts; Third Informational Supplement Pg. 52 PDF and Print M45-A2 Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria; Approved Guideline—Second Edition Pg. 52 PDF and Print M47-A Principles and Procedures for Blood Cultures; Approved Guideline Pg. 31, 36 PDF and Print M47-A QG Collection, Handling, and Transport for Blood Cultures Quick Guide Pg. 31, 36 Print M48-A Laboratory Detection and Identification of Mycobacteria; Approved Guideline Online PDF M50-A Quality Control for Commercial Microbial Identification Systems; Approved Guideline Online PDF and Print M51-A Method for Antifungal Disk Diffusion Susceptibility Testing of Nondermatophyte Filamentous Fungi; Approved Guideline Online PDF M51-S1 Performance Standards for Antifungal Disk Diffusion Susceptibility Testing of Nondermatophyte Filamentous Fungi; Informational Supplement Online PDF M52-Ed1 Verification of Commercial Microbial Identification and Antimicrobial Susceptibility Testing Systems, 1st Edition Pg. 57 PDF and Print M53-A Criteria for Laboratory Testing and Diagnosis of Human Immunodeficiency Virus Infection; Approved Guideline Online PDF M54-A Principles and Procedures for Detection of Fungi in Clinical Specimens—Direct Examination and Culture; Approved Guideline Pg. 31 PDF and Print M55-R Surveillance for Methicillin-Resistant Staphylococcus aureus: Principles, Practices, and Challenges; A Report Online PDF and Print M56-A Principles and Procedures for Detection of Anaerobes in Clinical Specimens; Approved Guideline Pg. 31 PDF and Print M100-S25 Performance Standards for Antimicrobial Susceptibility Testing; Twenty-Fifth Informational Supplement Pg. 29, 50 PDF and Print M100-S25 QG M100-S25 Tables 1A–1C Quick Guide Pg. 29, 50 PDF and Print M100-S25 WC Glossary of Antimicrobial Terms and Abbreviations Wall Chart: Twenty-Fifth Informational Supplement Online Print MM03-Ed3 Molecular Diagnostic Methods for Infectious Diseases, 3rd Edition Pg. 32 PDF and Print MM06-A2 Quantitative Molecular Methods for Infectious Diseases; Approved Guideline—Second Edition Pg. 32 PDF and Print MM11-A Molecular Methods for Bacterial Strain Typing; Approved Guideline Online PDF MM18-A Interpretive Criteria for Identification of Bacteria and Fungi by DNA Target Sequencing; Approved Guideline Online PDF and Print MM22-A Microarrays for Diagnosis and Monitoring of Infectious Diseases; Approved Guideline Pg. 33 PDF and Print (continued)
ORDER TODAY: Toll Free (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org 13 Molecular Methods Document Code Document Title Location Format I/LA28-A2 Quality Assurance for Design Control and Implementation of Immunohistochemistry Assays; Approved Guideline—Second Edition Pg. 28 PDF and Print M53-A Criteria for Laboratory Testing and Diagnosis of Human Immunodeficiency Virus Infection; Approved Guideline Online PDF MM01-A3 Molecular Methods for Clinical Genetics and Oncology Testing; Approved Guideline— Third Edition Online PDF MM03-Ed3 Molecular Diagnostic Methods for Infectious Diseases, 3rd Edition Pg. 32 PDF and Print MM05-A2 Nucleic Acid Amplification Assays for Molecular Hematopathology; Approved Guideline— Second Edition Online PDF MM06-A2 Quantitative Molecular Methods for Infectious Diseases; Approved Guideline—Second Edition Pg. 32 PDF and Print MM07-A2 Fluorescence In Situ Hybridization Methods for Clinical Laboratories; Approved Guideline— Second Edition Pg. 32 PDF and Print MM09-A2 Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine; Approved Guideline—Second Edition Pg. 32 PDF and Print MM10-A Genotyping for Infectious Diseases: Identification and Characterization; Approved Guideline Online PDF MM11-A Molecular Methods for Bacterial Strain Typing; Approved Guideline Online PDF MM12-A Diagnostic Nucleic Acid Microarrays; Approved Guideline Online PDF MM13-A Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods; Approved Guideline Pg. 32, 49 PDF and Print MM13-A QG Handling, Transport, and Storage of Specimens for Molecular Methods Quick Guide Pg. 32 Print MM14-A2 Design of Molecular Proficiency Testing/External Quality Assessment; Approved Guideline—Second Edition Pg. 33 PDF and Print MM16-A Use of External RNA Controls in Gene Expression Assays; Approved Guideline Online PDF MM17-A Verification and Validation of Multiplex Nucleic Acid Assays; Approved Guideline Pg. 33 PDF and Print MM18-A Interpretive Criteria for Identification of Bacteria and Fungi by DNA Target Sequencing; Approved Guideline Online PDF and Print MM19-A Establishing Molecular Testing in Clinical Laboratory Environments; Approved Guideline Pg. 33 PDF and Print MM20-A Quality Management for Molecular Genetic Testing; Approved Guideline Pg. 33 PDF and Print MM22-A Microarrays for Diagnosis and Monitoring of Infectious Diseases; Approved Guideline Pg. 33 PDF and Print MM23-Ed1 Molecular Diagnostic Methods for Solid Tumors (Nonhematological Neoplasms), 1st Edition Online PDF and Print NBS06-A Newborn Blood Spot Screening for Severe Combined Immunodeficiency by Measurement of T-cell Receptor Excision Circles; Approved Guideline Pg. 35 PDF and Print NBS06-A QG1 Generic Flow Chart for Assays to Measure T-cell Receptor Excision Circles in Newborn Dried Blood Spot Specimens Quick Guide Pg. 35 Print NBS06-A QG2 Schematic for Preparing Dried Blood Spot Reference Materials Quick Guide Pg. 35 Print NBS06-A WC Immunodeficiency Disorders and T-cell Receptor Excision Circle Values in the Newborn Screening Period Pg. 35 Print Newborn Screening NBS01-A6 Blood Collection on Filter Paper for Newborn Screening Programs; Approved Standard— Sixth Edition Pg. 34, 36 PDF and Print NBS01-A6 DVD Making a Difference Through Newborn Screening: Blood Collection on Filter Paper Pg. 34, 36 DVD NBS01-A6 QG Specimen Collection and Sample Quality for Newborn Screening Quick Guide Pg. 34, 36 PDF and Print NBS02-A2 Newborn Screening Follow-up; Approved Guideline—Second Edition Pg. 34 PDF and Print NBS02-A2 QG Newborn Screening Follow-up Process Quick Guide Pg. 34 Print
ORDER TODAY: Toll Free (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org14 Newborn Screening Document Code Document Title Location Format NBS03-A Newborn Screening for Preterm, Low Birth Weight, and Sick Newborns; Approved Guideline Pg. 34 PDF and Print NBS03-A QG Algorithm for Newborn Screening of Preterm, Low Birth Weight, and Sick Newborns Quick Guide Pg. 34 Print NBS04-A Newborn Screening by Tandem Mass Spectrometry; Approved Guideline Pg. 35 PDF and Print NBS05-A Newborn Screening for Cystic Fibrosis; Approved Guideline Pg. 35 PDF and Print NBS06-A Newborn Blood Spot Screening for Severe Combined Immunodeficiency by Measurement of T-cell Receptor Excision Circles; Approved Guideline Pg. 35 PDF and Print NBS06-A QG1 Generic Flow Chart for Assays to Measure T-cell Receptor Excision Circles in Newborn Dried Blood Spot Specimens Quick Guide Pg. 35 Print NBS06-A QG2 Schematic for Preparing Dried Blood Spot Reference Materials Quick Guide Pg. 35 Print NBS06-A WC Immunodeficiency Disorders and T-cell Receptor Excision Circle Values in the Newborn Screening Period Wall Chart Pg. 35 Print (continued) Point-of-Care Testing POCT01-A2 Point-of-Care Connectivity; Approved Standard—Second Edition Online PDF POCT02-A Implementation Guide of POCT01 for Health Care Providers; Approved Guideline Online PDF POCT04-A2 Point-of-Care In Vitro Diagnostic (IVD) Testing; Approved Guideline—Second Edition Pg. 38 PDF POCT05-A Performance Metrics for Continuous Interstitial Glucose Monitoring; Approved Guideline Online PDF POCT06-Ed1 Effects of Different Sample Types on Glucose Measurements, 1st Edition Pg. 38 PDF and Print POCT07-A Quality Management: Approaches to Reducing Errors at the Point of Care; Approved Guideline Pg. 38, 44 PDF and Print POCT07-A RG Addressing Errors in Point-of-Care Testing Reference Guide Pg. 38, 44 Print POCT08-A Quality Practices in Noninstrumented Point-of-Care Testing: An Instructional Manual and Resources for Health Care Workers; Approved Guideline Pg. 38 PDF and Print POCT08-A QG1 Corrective Action Report Quick Guide Pg. 38 PDF and Print POCT08-A QG2 Quality Control Troubleshooting Flow Chart Pg. 39 Print POCT08-A QG3 Quality Control Log Sheet Quick Guide Pg. 39 PDF and Print POCT09-A Selection Criteria for Point-of-Care Testing Devices; Approved Guideline Pg. 39 PDF POCT09-A WS Instrument Selection Worksheet Pg. 39 PDF POCT10-A2 Physician and Nonphysician Provider-Performed Microscopy Testing; Approved Guideline— Second Edition Online PDF and Print POCT10-A2 CL1 Provider-Performed Microscopy Training Checklist: Competence/Validation Cumulative Record Online PDF and Print POCT10-A2 CL2 Provider-Performed Microscopy Training Checklist: Initial or Renewal Competence/ Validation Employee Training Checklist Online PDF and Print POCT10-A2 LG Microscope Maintenance Log Online PDF and Print POCT10-A2 QG1 Fecal Leukocyte Examinations (Also Known as Stool White Blood Cells) Quick Guide Online PDF and Print POCT10-A2 QG2 Nasal Smears for Inflammatory Cells (Also Known as “Nasal Smear for Eosinophils,” “Nasal WBCs,” and “Nasal Smear for Granulocytes”) Quick Guide Online PDF and Print POCT10-A2 QG3 Proficiency Testing Exception Response Form (for Use for Microscopic PT Only) Quick Guide Online PDF and Print POCT10-A2 QG4 Urine Sediment Examinations Quick Guide Online PDF and Print POCT10-A2 QG5 Wet Mount Preparations and KOH Preparations Quick Guide Online PDF and Print
ORDER TODAY: Toll Free (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org 15 Quality Management Systems EP18-A2/EP23-A WS Sources of Failure Template Pg. 44 Word EP23-A™ Laboratory Quality Control Based on Risk Management; Approved Guideline Pg. 45 PDF and Print EP23-A QG EP23 Quick Reference Guide Pg. 45 PDF and Print EP23-A WB A Practical Guide for Laboratory Quality Control Based on Risk Management; Workbook Pg. 45 PDF and Print EP23-A WS A Sample Form for Laboratory Quality Control Based on Risk Management; Worksheet Pg. 45 Word GP17-A3 Clinical Laboratory Safety; Approved Guideline—Third Edition Pg. 46 PDF and Print GP27-A2 Using Proficiency Testing to Improve the Clinical Laboratory; Approved Guideline—Second Edition Pg. 20 PDF and Print GP29-A2 Assessment of Laboratory Tests When Proficiency Testing Is Not Available; Approved Guideline—Second Edition Pg. 20 PDF and Print GP31-A Laboratory Instrument Implementation, Verification, and Maintenance; Approved Guideline Pg. 19 PDF and Print GP33-A Accuracy in Patient and Sample Identification; Approved Guideline Pg. 46 PDF and Print K2Q The Key to Quality Pg. 40 PDF and Print POCT07-A Quality Management: Approaches to Reducing Errors at the Point of Care; Approved Guideline Pg. 38, 44 PDF and Print POCT07-A RG Addressing Errors in Point-of-Care Testing Reference Guide Pg. 38, 44 Print POCT08-A Quality Practices in Noninstrumented Point-of-Care Testing: An Instructional Manual and Resources for Health Care Workers; Approved Guideline Pg. 38 PDF and Print POCT08-A QG1 Corrective Action Report Quick Guide Pg. 38 PDF and Print POCT08-A QG2 Quality Control Troubleshooting Flow Chart Pg. 39 Print POCT08-A QG3 Quality Control Log Sheet Quick Guide Pg. 39 PDF and Print QMS01-A4 Quality Management System: A Model for Laboratory Services; Approved Guideline— Fourth Edition Pg. 20, 40 PDF and Print QMS02-A6 Quality Management System: Development and Management of Laboratory Documents; Approved Guideline—Sixth Edition Pg. 20, 40 PDF and Print QMS03-A3 Training and Competence Assessment; Approved Guideline—Third Edition Pg. 21, 40 PDF and Print QMS04-A2 Laboratory Design; Approved Guideline—Second Edition Online PDF and Print QMS05-A2 Quality Management System: Qualifying, Selecting, and Evaluating a Referral Laboratory; Approved Guideline—Second Edition Online PDF and Print QMS06-A3 Quality Management System: Continual Improvement; Approved Guideline—Third Edition Pg. 21, 40 PDF and Print QMS07-A2 Application of a Quality Management System Model for Respiratory Services; Approved Guideline—Second Edition Online PDF QMS10-A A Model for Managing Medical Device Alerts (Hazards and Recalls) for Healthcare Organizations; Approved Guideline Online PDF Point-of-Care Testing Document Code Document Title Location Format POCT10-A2 WC3 Ectoparasites Wall Chart Online PDF and Print POCT10/GP16 WC Microscopic Components in Urine Sediment and Vaginal Fluid Wall Charts Pg. 39, 48 PDF and Print POCT11-A2 Pulse Oximetry; Approved Guideline—Second Edition Online PDF POCT12-A3 Point-of-Care Blood Glucose Testing in Acute and Chronic Care Facilities; Approved Guideline—Third Edition Pg. 39 PDF and Print POCT13-Ed3 Glucose Monitoring in Settings Without Laboratory Support, 3rd Edition Pg. 57 PDF and Print POCT14-A Point-of-Care Monitoring of Anticoagulation Therapy; Approved Guideline Online PDF and Print (continued)
ORDER TODAY: Toll Free (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org16 Quality Management Systems Document Code Document Title Location Format QMS11-A Management of Nonconforming Laboratory Events; Approved Guideline Pg. 21, 47 PDF and Print QMS11-Ed2 Nonconforming Event Management, 2nd Edition Pg. 57 PDF and Print QMS12-A Development and Use of Quality Indicators for Process Improvement and Monitoring of Laboratory Quality; Approved Guideline Pg. 41 PDF and Print QMS13-A Quality Management System: Equipment; Approved Guideline Online PDF and Print QMS14-A Quality Management System: Leadership and Management Roles and Responsibilities; Approved Guideline Pg. 41 PDF and Print QMS14-AES Executive Summary: Quality Management System: Leadership and Management Roles and Responsibilities Pg. 41 PDF and Print QMS15-A Assessments: Laboratory Internal Audit Program; Approved Guideline Pg. 41 PDF and Print QMS16-Ed1 Laboratory Personnel Management, 1st Edition Pg. 57 PDF and Print QMS18-Ed1 Process Management, 1st Edition Pg. 41 PDF and Print QMS20-R Understanding the Cost of Quality in the Laboratory; A Report Pg. 41 PDF and Print (continued) Veterinary Medicine VET01-A4 Performance Standards for Antimicrobial Disk and Dilution Susceptibility Tests for Bacteria Isolated From Animals; Approved Standard—Fourth Edition Pg. 54 PDF and Print VET01S-Ed3 Performance Standards for Antimicrobial Disk and Dilution Susceptibility Tests for Bacteria Isolated From Animals; Third Informational Supplement Pg. 54, 57 PDF and Print VET02-A3 Development of In Vitro Susceptibility Testing Criteria and Quality Control Parameters for Veterinary Antimicrobial Agents; Approved Guideline—Third Edition Pg. 54 PDF and Print VET03-A Methods for Antimicrobial Disk Susceptibility Testing of Bacteria Isolated From Aquatic Animals; Approved Guideline Pg. 54 PDF and Print VET03/VET04-S2 Performance Standards for Antimicrobial Susceptibility Testing of Bacteria Isolated From Aquatic Animals; Second Informational Supplement Pg. 54 PDF and Print VET04-A2 Methods for Broth Dilution Susceptibility Testing of Bacteria Isolated From Aquatic Animals; Approved Guideline—Second Edition Pg. 55 PDF and Print VET05-R Generation, Presentation, and Application of Antimicrobial Susceptibility Test Data for Bacteria of Animal Origin; A Report Pg. 55 PDF and Print
ORDER TODAY: Toll Free (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org 17 CLSI references in the College of American Pathologists (CAP) Accreditation Program Checklists Approved-level consensus standards recognized by the US Food and Drug Administration (FDA) for use in satisfying a regulatory requirement CLSI documents referenced in The Joint Commission Laboratory Accreditation Standards chapters Level I Organization: 70% Level II Organization: 60% Level III Organization: 50% Individual Full: 25% Individual Associate: 15% Individual Student: 10% Standard or Guideline: Document has achieved consensus within the health care community.* Report: Document that has not been subjected to consensus review and is released by the appropriate consensus committee. * American National Standards have been approved by the American National Standards Institute (ANSI). CLSI submits selected standards as candidate American National Standards when such status will enhance their national or international usefulness. NOTE: All CLSI documents can be found online at shop.clsi.org. KEY: CLSI Membership Discounts: DEFINITIONS: CATALOG KEY CAP FDA JC
ORDER TODAY: Toll Free (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org18 EP06 | Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach This guideline provides information for characterizing the linearity of a method during a method evaluation; for checking linearity as part of routine quality assurance; and for determining and stating a manufacturer’s claim for linear range. Item Order Code: EP06-A Nonmember Price: $180 EP07 | Interference Testing in Clinical Chemistry This guideline provides background information, guidance, and experimental procedures for investigating, identifying, and characterizing the effects of interfering substances on clinical chemistry test results. Item Order Code: EP07-A2 Nonmember Price: $180 EP09 | Measurement Procedure Comparison and Bias Estimation Using Patient Samples This guideline addresses the design of measurement procedure comparison experiments using patient samples and subsequent data analysis techniques used to determine the bias between two in vitro diagnostic measurement procedures. Item Order Code: EP09-A3 Nonmember Price: $180 EP15 | User Verification of Precision and Estimation of Bias This guideline describes the estimation of imprecision and of bias for clinical laboratory quantitative measurement procedures using a protocol that can be completed within as few as five days. Item Order Code: EP15-A3 Nonmember Price: $180 Formatted in an enhanced, full-color layout! C24 | Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions This guideline provides definitions of analytical intervals, planning of quality control procedures, and guidance for quality control applications. Item Order Code: C24-A3 Nonmember Price: $140 Members save up to 70% on CLSI products! See page 17 for discount pricing structure. Accreditation Preparedness – Essentials for Verifying Test Performance JUNE 2006 FDA | JC CAP | FDA | JC CAP | FDA | JC CAP | FDA CAP | FDA | JC APRIL 2003 NOVEMBER 2005 AUGUST 2013 SEPTEMBER 2014
ORDER TODAY: Toll Free (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org 19 EP17 | Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures This guideline provides information for evaluation and documentation of the detection capability of clinical laboratory measurement procedures (ie, limits of blank, detection, and quantitation), for verification of manufacturers’ detection capability claims, and for the proper use and interpretation of different detection capability estimates. Item Order Code: EP17-A2 Nonmember Price: $180 EP21 | Estimation of Total Analytical Error for Clinical Laboratory Methods This guideline provides manufacturers and end users with a means to estimate total analytical error for an assay. A data collection protocol and an analysis method, which can be used to judge the clinical acceptability of new methods using patient specimens, are included. These tools can also monitor an assay’s total analytical error by using quality control samples. Item Order Code: EP21-A Nonmember Price: $180 EP28 | Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory This guideline contains information for determining reference values and reference intervals for quantitative clinical laboratory tests. A CLSI-IFCC joint project. Item Order Code: EP28-A3c Nonmember Price: $180 GP31 | Laboratory Instrument Implementation, Verification, and Maintenance This guideline provides information about assessing instrument performance and function from the time of instrument purchase to the routine performance of clinical testing. Item Order Code: GP31-A Nonmember Price: $140 EP31 | Verification of Comparability of Patient Results Within One Health Care System This guideline provides information on how to verify comparability of quantitative laboratory results for individual patients within a health care system. Item Order Code: EP31-A-IR Nonmember Price: $180 Members save up to 70% on CLSI products! See page 17 for discount pricing structure. Accreditation Preparedness – Essentials for Verifying Test Performance CAP | FDA | JC FDA | JC CAP | FDA | JC CAP | JC CAP | JC JUNE 2012 APRIL 2003 OCTOBER 2010 AUGUST 2012 APRIL 2009
ORDER TODAY: Toll Free (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org20 GENERALLABORATORY QMS01 | Quality Management System: A Model for Laboratory Services This guideline provides a model for medical laboratories that will assist with implementation and maintenance of an effective quality management system. Item Order Code: QMS01-A4 Nonmember Price: $180 New enhanced, full-color version! QMS02 | Quality Management System: Development and Management of Laboratory Documents This guideline provides information on the processes needed for document management, including creating, controlling, changing, and retiring a laboratory’s policy, process, procedure, and form documents in both paper and electronic environments. Item Order Code: QMS02-A6 Nonmember Price: $180 Related ISO Quality Document Accreditation Preparedness – Laboratory Practices CAP | FDA | JC CAP | JC GP27 | Using Proficiency Testing to Improve the Clinical Laboratory This guideline provides assistance to laboratories in using proficiency testing as a quality improvement tool. Item Order Code: GP27-A2 Nonmember Price: $140 ISO 15189:2012 Medical laboratories – Requirements for quality and competence This International Standard specifies requirements for quality and competence in medical laboratories. Item Order Code: ISO 15189:2012 Price: $180* *CLSI membership rates do not apply for ISO documents. Want to learn more about ISO quality documents? Visit www.clsi.org/accreditation to view our crosswalk that shows how CLSI quality system essentials (QSEs) correspond with clauses in ISO quality documents. The ISO quality documents are listed along with the related CLSI documents under each QSE. CAP | FDA | JC FEBRUARY 2007 GP29 | Assessment of Laboratory Tests When Proficiency Testing Is Not Available This guideline offers methods to assess test performance when proficiency testing is not available; these methods include examples with statistical analyses. This document is intended for use by laboratory managers and testing personnel in traditional clinical laboratories as well as in point-of-care and bedside testing environments. Item Order Code: GP29-A2 Nonmember Price: $140 CAP | JC AUGUST 2008 JUNE 2011 FEBRUARY 2013 Members save up to 70% on CLSI products! See page 17 for discount pricing structure.
ORDER TODAY: Toll Free (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org 21 @CLSI_LabNews Clinical and Laboratory Standards Institute (Company Page and Group) QMS03 | Training and Competence Assessment This guideline provides background information and recommended processes for the development of training and competence assessment programs that meet quality and regulatory objectives. Item Order Code: QMS03-A3 Nonmember Price: $180 New enhanced, full-color version! QMS06 | Quality Management System: Continual Improvement This guideline considers continual improvement as an ongoing, systematic effort that is an essential component of a quality management system. A continual improvement program may consist of fundamental processes and common supporting elements described in this guideline. Item Order Code: QMS06-A3 Nonmember Price: $180 QMS11 | Management of Nonconforming Laboratory Events This guideline provides an outline and the content for developing a program to manage a health care service’s nonconforming events that is based on the principles of quality management and patient safety. Item Order Code: QMS11-A Nonmember Price: $180 New enhanced, full-color version coming July 2015! Accreditation Preparedness – Laboratory Practices CAP | JC CAP | FDA | JC CAP | JC FEBRUARY 2009 JUNE 2011 NOVEMBER 2007 Search for “CLSI To Go” in the Follow CLSI on Social Media! or Members save up to 70% on CLSI products! See page 17 for discount pricing structure.
ORDER TODAY: Toll Free (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org22 OCTOBER 2014 APRIL 2011 Automation and Informatics AUTO11 | Information Technology Security of In Vitro Diagnostic Instruments and Software Systems This standard provides a framework for communication of information technology security issues between the in vitro diagnostic system vendor and the health care organization. Item Order Code: AUTO11-A2 Nonmember Price: $140 FDA AUTO12 | Specimen Labels: Content and Location, Fonts, and Label Orientation The purpose of this standard is to reduce human errors currently associated with the lack of standardization of labels on clinical laboratory specimens. The standard identifies the required human-readable elements to appear on specimen labels and specifies the exact locations, fonts, and font sizes of these elements. Item Order Code: AUTO12-A Nonmember Price: $140 CAP | FDA | JC Members save up to 70% on CLSI products! See page 17 for discount pricing structure. Free On-Demand Webinar | Introduction to CLSI Document AUTO11—Information Technology Security of In Vitro Diagnostic Instruments and Software Systems This informative webinar introduces CLSI document AUTO11. It addresses items such as the document’s scope, an outline of the document, why the document was created, and how the document is beneficial to the laboratory. Item Order Code: AUTO11-A2 WR Nonmember Price: FREE Visit www.clsi.org/webinars to learn more. Speaker: Ed Heierman III, PhD Software Architect, Abbott, Irving, Texas, USA
ORDER TODAY: Toll Free (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org 23 Don’t Get Cited for Common Deficiencies! CLSI crosswalks help you ensure your lab is prepared for accreditation and inspections. Numerous CLSI documents are referenced in these crosswalks. They serve as key resources in satisfying regulatory requirements and avoiding compliance issues. Be ready for inspection at any time! Download these free CLSI crosswalks at www.clsi.org/accreditation. The Joint Commission
ORDER TODAY: Toll Free (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org24 Clinical Chemistry and Toxicology C24 | Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions This guideline provides definitions of analytical intervals, planning of quality control procedures, and guidance for quality control applications. Item Order Code: C24-A3 Nonmember Price: $140 C40 | Measurement Procedures for the Determination of Lead Concentrations in Blood and Urine This guideline provides information for the measurement of lead concentrations in blood and urine, including specimen collection, measurement by graphite furnace atomic absorption spectrometry, anodic stripping voltammetry, and inductively coupled plasma mass spectrometry. It also includes guidelines for quality assurance and quality control, and information on proficiency testing programs and laboratory certification. Item Order Code: C40-A2 Nonmember Price: $140 C49 | Analysis of Body Fluids in Clinical Chemistry This guideline provides information for the application of widely available measurement procedures for testing body fluids and for reporting and interpreting those results. It emphasizes defining the common clinical situations for this use; acceptable practice for measuring analytes without extended method verification for abnormal body fluid; influence of biologic and analytic variation on interpretation of results; and variability in comparing results between different instrument manufacturers. This document does not consider serum, plasma, whole blood, or fluids for which assays typically have performance claims in the measurement procedure documentation. A CLSI-IFCC joint project. Item Order Code: C49-A Nonmember Price: $140 CAP | FDA | JC JC CAP | JC C34 | Sweat Testing: Sample Collection and Quantitative Chloride Analysis This guideline addresses appropriate methods of collection and analysis, quality control, and the evaluation and reporting of test results. Item Order Code: C34-A3 Nonmember Price: $140 C46 | Blood Gas and pH Analysis and Related Measurements This guideline provides clear definitions of the quantities in current use, and provides a single source of information on appropriate specimen collection, preanalytical variables, calibration, and quality control for blood pH and gas analysis and related measurements. Item Order Code: C46-A2 Nonmember Price: $140 Related Companion Product (Bench Aid) C49/H56 QG | Collection, Handling, Transport, and Storage for Body Fluids Quick Guide Describes recommended methods for the collection, handling, transport, and storage of various types of body fluids. Formatted as durable, waterproof sheets for quick reference. Item Order Code: C49-A/H56-A QG Nonmember Price: $20 CAP | FDA | JC CAP | JC DECEMBER 2009JUNE 2006 FEBRUARY 2009OCTOBER 2013 APRIL 2007 JANUARY 2015 Members save up to 70% on CLSI products! See page 17 for discount pricing structure.
ORDER TODAY: Toll Free (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org 25 C56 | Hemolysis, Icterus, and Lipemia/ Turbidity Indices as Indicators of Interference in Clinical Laboratory Analysis This guideline provides background information on mechanisms of hemolysis, icterus, lipemia/turbidity (HIL) interference; intended usefulness of HIL indices; establishment of HIL alert indices; availability of automated HIL detection systems; and interpretation, strengths, limitations, and verification of HIL indices in the clinical laboratory. Item Order Code: C56-A Nonmember Price: $140 Related Companion Product (Bench Aid) C56 QG | Examples of Hemolyzed, Icteric, and Lipemic/Turbid Samples Quick Guide Shows examples of hemolyzed, icteric, and lipemic/turbid samples. Formatted as a durable, waterproof sheet for quick reference. Item Order Code: C56-A QG Nonmember Price: $20 C57 | Mass Spectrometry for Androgen and Estrogen Measurements in Serum This guideline is intended to aid the laboratorian in developing appropriate procedures for the use of mass spectrometry in the measurement of androgens and estrogens. Item Order Code: C57-Ed1 Nonmember Price: $140 C62 | Liquid Chromatography-Mass Spectrometry Methods This guideline provides information to the clinical laboratorian for the reduction of interlaboratory variance and the evaluation of interferences, assay performance, and other pertinent characteristics of clinical assays. This guideline emphasizes particular areas related to assay development and presents a standardized approach for method verification that is specific to mass spectrometry technology. Item Order Code: C62-A Nonmember Price: $140 Clinical Chemistry and Toxicology FDA | JC JC JULY 2012 OCTOBER 2014 FEBRUARY 2015 OCTOBER 2014 Members save up to 70% on CLSI products! See page 17 for discount pricing structure. Free On-Demand Webinar | Introduction to CLSI Document C62—Liquid Chromatography- Mass Spectrometry Methods This informative webinar introduces CLSI document C62. It addresses items such as the document’s scope, an outline of the document, why the document was created, and how the document is beneficial to the laboratory. Item Order Code: C62-A WR Nonmember Price: FREE Visit www.clsi.org/webinars to learn more. Speaker: William Clarke, PhD, MBA, DABCC Associate Professor of Pathology, Johns Hopkins Medical Institutions, Baltimore, Maryland, USA
ORDER TODAY: Toll Free (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org26 Hematology and Coagulation H02 | Procedures for the Erythrocyte Sedimentation Rate Test This standard provides a description of the principle, materials, and procedure for a standardized erythrocyte sedimentation rate (ESR) method; a selected routine method, as well as a procedure to evaluate routine methods; and an outline of quality control programs for the ESR test. Item Order Code: H02-A5 Nonmember Price: $140 H52 | Red Blood Cell Diagnostic Testing Using Flow Cytometry This guideline addresses the diagnostic red blood cell (RBC) assays performed as fluorescence-based assays on a flow cytometry platform; including testing procedures for fetomaternal hemorrhage detection, paroxysmal nocturnal hematuria screening, membrane defect anemia testing for hereditary spherocytosis, and nucleated RBC counting. Points of validation and quality control, and caveats of interpretation are also discussed. Item Order Code: H52-A2 Nonmember Price: $140 JC CAP | JC H21 | Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays and Molecular Hemostasis Assays This guideline provides procedures for collecting, transporting, and storing blood; processing blood specimens; storing plasma for coagulation testing; and general recommendations for performing the tests. Item Order Code: H21-A5 Nonmember Price: $140 H26 | Validation, Verification, and Quality Assurance of Automated Hematology Analyzers This standard provides guidance for the validation, verification, calibration, quality assurance (QA), and quality control (QC) of automated multichannel hematology analyzers for manufacturers, end-user clinical laboratories, accrediting organizations, and regulatory bodies. In addition, end-user clinical laboratories will find guidance for establishment of clinically reportable intervals and for QA for preexamination and examination aspects of their systems. Item Order Code: H26-A2 Nonmember Price: $140 CAP | FDA | JC CAP | FDA | JC JANUARY 2008MAY 2011 JUNE 2010 MARCH 2014 Related Companion Product (Bench Aid) H21 QG | Collection, Handling, Transport, and Storage for Hemostasis Quick Guide Outlines best practice procedures for the proper collection, transportation, and processing of blood specimens as well as storage of plasma for coagulation testing. Formatted as durable, waterproof sheets for quick reference. Item Order Code: H21-A5 QG Nonmember Price: $20 JANUARY 2008 Members save up to 70% on CLSI products! See page 17 for discount pricing structure.
ORDER TODAY: Toll Free (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org 27 Related Companion Product (Bench Aid) H60 QG1 | Algorithmic Approach to Lupus Anticoagulant Testing Quick Guide Describes the algorithmic approach to lupus anticoagulant testing for independent, paired, and integrated test systems. Formatted as durable, waterproof sheets for quick reference. Item Order Code: H60-A QG1 Nonmember Price: $20 Related Companion Product (Bench Aid) H60 QG2 | Criteria for the Laboratory Diagnosis of the Lupus Anticoagulant Quick Guide Includes sample identification criteria and recommendations specific to each criterion for the laboratory diagnosis of the lupus anticoagulant. Formatted as durable, waterproof sheets for quick reference. Item Order Code: H60-A QG2 Nonmember Price: $20 Hematology and Coagulation JC DECEMBER 2014 DECEMBER 2014 H59 | Quantitative D-dimer for the Exclusion of Venous Thromboembolic Disease This guideline provides information regarding the use of D-dimer in exclusion of venous thromboembolism (VTE) including a description of the value of clinical determination of the pretest probability of VTE; the proper collection and handling of the specimen; assays used for D-dimer analysis; determination of the threshold for exclusion of VTE; interpretation of test results; and aspects of regulatory and accreditation requirements. Item Order Code: H59-A Nonmember Price: $140 CAP | FDA | JC MARCH 2011 H60 | Laboratory Testing for the Lupus Anticoagulant This guideline provides information and recommendations regarding the proper collection and handling of the specimen; descriptions and limitations of screening and confirmatory assays, and mixing tests used to identify lupus anticoagulant (LA); determination of cutoff values and calculations associated with the various assays; and interpretation of test results in an LA panel. Item Order Code: H60-A Nonmember Price: $140 JC APRIL 2014 Members save up to 70% on CLSI products! See page 17 for discount pricing structure.
ORDER TODAY: Toll Free (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org28 Immunology and Ligand Assay I/LA20 | Analytical Performance Characteristics and Clinical Utility of Immunological Assays for Human Immunoglobulin E (IgE) Antibodies and Defined Allergen Specificities This guideline provides information for the design, analytical performance, standardization, quality assurance, and clinical application of laboratory assays used in the measurement of human IgE antibodies of defined allergen specificity. Item Order Code: I/LA20-A2 Nonmember Price: $140 I/LA28 | Quality Assurance for Design Control and Implementation of Immunohistochemistry Assays This guideline provides information for the development of validated diagnostic, prognostic, and predictive immunohistochemical assays. Item Order Code: I/LA28-A2 Nonmember Price: $140 I/LA33 | Validation of Automated Systems for Immunohematological Testing Before Implementation This guideline provides information to the end user and laboratory for validation of automated systems used in immunohematological testing before implementation. Item Order Code: I/LA33-A Nonmember Price: $140 FDA | JC CAP | FDA | JC JC I/LA26 | Performance of Single Cell Immune Response Assays This guideline contains methods of intracellular cytokine evaluation, major histocompatibility complex multimer quantitation, enzyme-linked immunospot technology, and carboxyfluorescein succinimidyl ester tracking dye staining for the assessment of cellular proliferation. It also provides basic aspects of specimen collection, transport, and preparation; results interpretation; and quality assurance and test validation approaches. Item Order Code: I/LA26-A2 Nonmember Price: $140 JC NOVEMBER 2013MARCH 2009 JANUARY 2011 DECEMBER 2009 Related Companion Product (Toolkit) I/LA33 TK | Validation of Automated Systems for Immunohematological Testing Before Implementation—Sample Templates and Test Cases Toolkit Provides 24 customizable templates from the appendixes of I/LA33. Each simplified template, test case, checklist, worksheet, and schedule can be used by the laboratory for development of test cases related to different aspects of installation qualification, operational qualification, and performance qualification. Item Order Code: I/LA33-A TK Nonmember Price: $100 Related Companion Product (Bench Aid) I/LA28 QG | Comparison of the Characteristics of Immunoassays Such as Enzyme-Linked Immunosorbent Assay and Immunohistochemistry Quick Guide Shows a comparison of the characteristics of immunoassays. Formatted as four durable, waterproof sheets on a convenient detachable ring for quick reference. Item Order Code: I/LA28-A2 QG Nonmember Price: $40 DECEMBER 2009 SEPTEMBER 2014 Members save up to 70% on CLSI products! See page 17 for discount pricing structure.
ORDER TODAY: Toll Free (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org 29 Microbiology Methodologies M02* | Performance Standards for Antimicrobial Disk Susceptibility Tests This standard contains the current CLSI-recommended methods for disk susceptibility testing, criteria for quality control testing, and updated tables for interpretive zone diameters. An Interactive Searchable Database for Drug Selection, Interpretation, and Quality Control Procedures! eM100 is built to work the way you do—efficiently and in the laboratory. This online implementation of CLSI’s most widely recognized antimicrobial susceptibility testing document provides information for drug selection, interpretation, and quality control as well as the latest recommendations for detecting resistance mechanisms, all arranged in an easy-to-use, interactive, and searchable format. M07* | Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically This standard addresses reference methods for the determination of minimal inhibitory concentrations of aerobic bacteria by broth macrodilution, broth microdilution, and agar dilution. M100* | Performance Standards for Antimicrobial Susceptibility Testing This supplement provides updated tables for the CLSI antimicrobial susceptibility testing standards M02-A12, M07-A10, and M11-A8. The tabular information presented in M100 represents the most current information for drug selection, interpretation, and quality control using the procedures standardized in the most current editions of M02, M07, and M11. M100 is updated every January, so please check shop.clsi.org for the 2016 version. JANUARY 2015 JANUARY 2015 JANUARY 2015 Related Companion Product (Bench Aid) AST QC QG | AST QC Flow Chart Quick Guide The ultimate “cheat sheet” to quality control (QC) for antimicrobial susceptibility testing. Based on M02, M07, and M100, these easy-to-use flow charts guide you through daily QC testing for both disk diffusion and aerobic dilution. Once required daily QC has been documented, users can convert to weekly QC with a flip of a page. Formatted as durable, waterproof sheets on a convenient detachable ring for convenient, shared use in the laboratory. Item Order Code: AST QC QG Nonmember Price: $120 Related Companion Product (Bench Aid) M100 QG | M100-S25 Tables 1A–1C Quick Guide Provides suggested groupings of antimicrobial agents that should be considered for routine disk and broth dilution testing and reporting by clinical laboratories. Formatted as durable, waterproof sheets on a convenient detachable ring for convenient, shared use in the laboratory. Item Order Code: M100-S25 QG Nonmember Price: $100 *Note that in 2015, M100 must be purchased with one of the following M02 or M07 packages. Item Order Code: M02-A12/M07-A10 PK15 (includes M02-A12, M07-A10, and M100-S25) | Nonmember Price: $500 Item Order Code: M02-A12 PK15 (includes M02-A12 and M100-S25) | Nonmember Price: $340 Item Order Code: M07-A10 PK15 (includes M07-A10 and M100-S25) | Nonmember Price: $340 JANUARY 2015 JANUARY 2015 Members save up to 70% on CLSI products! See page 17 for discount pricing structure. Visit www.clsi.org/eM100 to learn more.
ORDER TODAY: Toll Free (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org30 Microbiology Methodologies M22 | Quality Control for Commercially Prepared Microbiological Culture Media This standard contains quality assurance procedures for manufacturers and users of prepared, ready-to-use microbiological culture media. Item Order Code: M22-A3 Nonmember Price: $180 M35 | Abbreviated Identification of Bacteria and Yeast This guideline provides the minimum identification criteria that can be used to rapidly identify organisms commonly isolated from clinical specimens. Item Order Code: M35-A2 Nonmember Price: $180 M28 | Procedures for the Recovery and Identification of Parasites From the Intestinal Tract This guideline addresses the collection, processing, and examination of intestinal tract specimens for the identification of parasites. Item Order Code: M28-A2 Nonmember Price: $180 JUNE 2005JUNE 2004 NOVEMBER 2008 M40 | Quality Control of Microbiological Transport Systems This standard provides criteria to assist manufacturers and end users of transport devices in providing and selecting dependable products for the transport of microbiological clinical specimens. Item Order Code: M40-A2 Nonmember Price: $180 JUNE 2014 Members save up to 70% on CLSI products! See page 17 for discount pricing structure.
ORDER TODAY: Toll Free (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org 31 Microbiology Methodologies M47 | Principles and Procedures for Blood Cultures This guideline provides recommendations for the collection, transport, and processing of blood cultures as well as guidance for the recovery of pathogens from blood specimens taken from patients who are suspected of having bacteremia or fungemia. Item Order Code: M47-A Nonmember Price: $180 M54 | Principles and Procedures for Detection of Fungi in Clinical Specimens— Direct Examination and Culture This guideline provides protocols, quality control parameters, and interpretive criteria for performing fungal cultures and for the detection and identification of fungi in direct examinations. Item Order Code: M54-A Nonmember Price: $180 CAP | FDA | JC M56 | Principles and Procedures for Detection of Anaerobes in Clinical Specimens This guideline presents standardized, cost-effective, and efficient best practice processes for anaerobe bacteriology to assist clinical laboratories in selecting those methods that lead to improved patient care. Item Order Code: M56-A Nonmember Price: $180 JULY 2014 MAY 2007 OCTOBER 2012 Related Companion Product (Bench Aid) M47 QG | Collection, Handling, and Transport for Blood Cultures Quick Guide Provides a quick reference for nursing, emergency room staff, phlebotomists, and laboratorians on the timing and collection, transport and set-up, as well as procedures for processing blood cultures. Item Order Code: M47-A QG Nonmember Price: $20 MARCH 2015 Members save up to 70% on CLSI products! See page 17 for discount pricing structure.
ORDER TODAY: Toll Free (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org32 Molecular Methods MM03 | Molecular Diagnostic Methods for Infectious Diseases, 3rd Edition This report addresses topics relating to clinical applications, amplified and nonamplified nucleic acid methods, selection and qualification of nucleic acid sequences, establishment and evaluation of test performance characteristics, inhibitors, and interfering substances, controlling false-positive reactions, reporting and interpretation of results, quality assurance, regulatory issues, and recommendations for manufacturers and clinical laboratories. Item Order Code: MM03-Ed3 Nonmember Price: $140 MM07 | Fluorescence In Situ Hybridization Methods for Clinical Laboratories This guideline addresses fluorescence in situ hybridization methods for medical genetic determinations, identification of chromosomal abnormalities, and gene amplification. Recommendations for probe and assay development, manufacture, qualification, verification, and validation; instrument requirements; quality assurance; and evaluation of results are also included. Item Order Code: MM07-A2 Nonmember Price: $140 MM13 | Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods This guideline provides information related to proper and safe biological specimen collection and nucleic acid isolation and purification. These topics include methods of collection, recommended storage and transport conditions, and available nucleic acid purification technologies for each specimen/nucleic acid type. A CLSI-IFCC joint project. Item Order Code: MM13-A Nonmember Price: $140 FDA | JC CAP | JC CAP | FDA | JC MM06 | Quantitative Molecular Methods for Infectious Diseases This guideline provides information for the development and use of quantitative molecular methods, such as nucleic acid probes and nucleic acid amplification techniques of the target sequences specific to particular microorganisms. It also presents recommendations for quality assurance, proficiency testing, and interpretation of results. Item Order Code: MM06-A2 Nonmember Price: $140 FDA | JC NOVEMBER 2010FEBRUARY 2015 AUGUST 2013 DECEMBER 2005 MM09 | Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine This guideline addresses diagnostic sequencing using both automated capillary-based sequencers and massively parallel sequencing instruments. Topics include specimen collection and handling; isolation and extraction of nucleic acid; template preparation; sequence generation, alignment, and assembly; validation and verification; ongoing quality assurance; and reporting results. Item Order Code: MM09-A2 Nonmember Price: $140 CAP | FDA | JC FEBRUARY 2014 Related Companion Product (Bench Aid) MM13 QG | Handling, Transport, and Storage of Specimens for Molecular Methods Quick Guide Describes the recommended methods for the collection of molecular method samples, proper shipping conditions, and storage addressing issues including temperature, preservatives, and duration. Item Order Code: MM13-A QG Nonmember Price: $20 MARCH 2015 Members save up to 70% on CLSI products! See page 17 for discount pricing structure.
ORDER TODAY: Toll Free (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org 33 Molecular Methods MM14 | Design of Molecular Proficiency Testing/External Quality Assessment This guideline provides information for a quality proficiency testing/external quality assessment program, including reliable databases; design control in the choice of materials and measurands; good manufacturing processes; documentation procedures; complaint handling; corrective and preventive action plans; and responsive timing of reports. Item Order Code: MM14-A2 Nonmember Price: $140 MM19 | Establishing Molecular Testing in Clinical Laboratory Environments This guideline provides comprehensive information for planning and implementation of molecular diagnostic testing, including strategic planning, regulatory requirements, implementation, quality management, and special considerations for the subspecialties of molecular genetics, infectious diseases, oncology, and pharmacogenetics. Item Order Code: MM19-A Nonmember Price: $140 MM22 | Microarrays for Diagnosis and Monitoring of Infectious Diseases This guideline provides information for the laboratory development and use of qualitative nucleic acid microarray methods for the diagnosis and monitoring of infectious diseases. It also presents recommendations for validation and verification, quality control, and interpretation of results. Item Order Code: MM22-A Nonmember Price: $140 JC CAP | JC JC MM20 | Quality Management for Molecular Genetic Testing This guideline provides information for implementing international quality management system standards in laboratories that perform human molecular genetic testing for inherited or acquired conditions. Item Order Code: MM20-A Nonmember Price: $140 JC NOVEMBER 2012 MAY 2013 NOVEMBER 2011 FEBRUARY 2014 MM17 | Verification and Validation of Multiplex Nucleic Acid Assays This guideline provides recommendations for analytic verification and validation of multiplex assays, as well as a review of different types of biologic and synthetic reference materials. Item Order Code: MM17-A Nonmember Price: $140 JC MARCH 2008 Members save up to 70% on CLSI products! See page 17 for discount pricing structure.
ORDER TODAY: Toll Free (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org34 Newborn Screening NBS01 | Blood Collection on Filter Paper for Newborn Screening Programs This standard highlights specimen collection methods, discusses acceptable techniques for applying blood drops or aliquots to the filter paper segment of the specimen collection device, and provides instructions on proper specimen handling and transport to ensure quality specimens are consistently obtained for newborn screening analysis. Item Order Code: NBS01-A6 Nonmember Price: $140 NBS03 | Newborn Screening for Preterm, Low Birth Weight, and Sick Newborns This guideline outlines the recommended protocols for screening preterm, sick, or low birth weight infants for hearing loss and disorders detectable through dried blood spot testing. Item Order Code: NBS03-A Nonmember Price: $140 CAP | FDA | JC JC JULY 2013 OCTOBER 2009 NBS02 | Newborn Screening Follow-up This guideline describes the basic principles, scope, and range of follow-up activities within the newborn screening system. Item Order Code: NBS02-A2 Nonmember Price: $140CAP | JC MAY 2013 Related Video NBS01 DVD | Making a Difference Through Newborn Screening: Blood Collection on Filter Paper DVD This video shows how to prepare for specimen collection; collect blood specimens using the recommended heelstick technique; handle specimens properly; maintain appropriate records; and prevent testing problems that can delay the newborn’s diagnosis and treatment. Item Order Code: NBS01-A6 DVD Nonmember Price: $300 Related Companion Product (Bench Aid) NBS01 QG | Specimen Collection and Sample Quality for Newborn Screening Quick Guide How to Collect an Acceptable Blood Spot Specimen Simple Spot Check Item Order Code: NBS01-A6 QG Nonmember Price: $20 Related Companion Product (Bench Aid) NBS02 QG | Newborn Screening Follow-up Process Quick Guide Describes the newborn screening follow-up process. Item Order Code: NBS02-A2 QG Nonmember Price: $20 Related Companion Product (Bench Aid) NBS03 QG | Algorithm for Newborn Screening of Preterm, Low Birth Weight, and Sick Newborns Quick Guide Provides information on when to collect first, second, and third specimens for newborn screening and includes special care baby unit screening algorithm for preterm, low birth weight, and sick newborns. Item Order Code: NBS03-A QG Nonmember Price: $20 JUNE 2014 JULY 2013 JULY 2013 JULY 2013 Members save up to 70% on CLSI products! See page 17 for discount pricing structure.
ORDER TODAY: Toll Free (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org 35 Newborn Screening NBS04 | Newborn Screening by Tandem Mass Spectrometry This guideline serves as a reference source for the numerous activities related to operating a tandem mass spectrometry laboratory as part of public and private newborn screening programs with the goal of creating greater test accuracy, performance, and consistency among laboratories, thereby ensuring data quality that will ultimately benefit all newborns worldwide. Item Order Code: NBS04-A Nonmember Price: $140 NBS06 | Newborn Blood Spot Screening for Severe Combined Immunodeficiency by Measurement of T-cell Receptor Excision Circles This guideline addresses the detection of severe combined immunodeficiency (SCID) by population-based newborn screening using dried blood spot specimens to measure T-cell receptor excision circles. SCID is a lethal disorder of infancy that is not evident at birth, and effective treatment requires presymptomatic detection. Item Order Code: NBS06-A Nonmember Price: $140 Newborn Screening Specialty Collection Collection includes all 6 Newborn Screening documents, the NBS01 DVD, and 6 companion products (bench aids). Item Order Code: NBSSC Nonmember Price: $800 JC JC JULY 2010 APRIL 2013 NBS05 | Newborn Screening for Cystic Fibrosis This guideline describes the use of newborn screening laboratory tests for detecting risk for cystic fibrosis from newborn dried blood spots (DBS) and addresses both the primary screening tests and the reflex tests performed on DBS. Item Order Code: NBS05-A Nonmember Price: $140 JC NOVEMBER 2011 Related Companion Product (Bench Aid) NBS06 QG1 | Generic Flow Chart for Assays to Measure T-cell Receptor Excision Circles in Newborn Dried Blood Spot Specimens Quick Guide Flow chart for assays to measure T-cell receptor excision circles in newborn dried blood spot specimens. Formatted as a durable, waterproof sheet for quick reference. Item Order Code: NBS06-A QG1 Nonmember Price: $20 Related Companion Product (Bench Aid) NBS06 QG2 | Schematic for Preparing Dried Blood Spot Reference Materials Quick Guide Provides a schematic for preparing dried blood spot reference materials. Formatted as a durable, waterproof sheet for quick reference. Item Order Code: NBS06-A QG2 Nonmember Price: $20 Related Companion Product (Wall Chart) NBS06 WC | Immunodeficiency Disorders and T-cell Receptor Excision Circle Values in the Newborn Screening Period Wall Chart Shows immunodeficiency disorders and T-cell receptor excision circle values in the newborn screening period. Item Order Code: NBS06-A WC Nonmember Price: $20 JULY 2013 JULY 2013 JULY 2013 bundle and save! Members save up to 70% on CLSI products! See page 17 for discount pricing structure.
ORDER TODAY: Toll Free (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org36 Phlebotomy Related Companion Product (Bench Aid) GP41 QG | Quality Venipuncture Quick Guide Lists all of the steps of the venipuncture procedure, as well as special considerations, and the order of the tube draw. It also includes a color photo of vein distribution on the right arm for guidance in the venipuncture procedure. Formatted as an 11x17-inch chart. Item Order Code: GP41-A6 QG Nonmember Price: $20 JANUARY 2008 GP41 | Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture This standard provides procedures for the collection of diagnostic specimens by venipuncture, including line draws, blood culture collection, and venipuncture in children. Item Order Code: GP41-A6 Nonmember Price: $140 CAP | FDA | JC OCTOBER 2007 M47 | Principles and Procedures for Blood Cultures This guideline provides recommendations for the collection, transport, and processing of blood cultures as well as guidance for the recovery of pathogens from blood specimens taken from patients who are suspected of having bacteremia or fungemia. Item Order Code: M47-A Nonmember Price: $180 CAP | FDA | JC MAY 2007 Related Companion Product (Bench Aid) M47 QG | Collection, Handling, and Transport for Blood Cultures Quick Guide Provides a quick reference for nursing, emergency room staff, phlebotomists, and laboratorians on the timing and collection, transport and set-up, as well as procedures for processing blood cultures. Item Order Code: M47-A QG Nonmember Price: $20 MARCH 2015 NBS01 | Blood Collection on Filter Paper for Newborn Screening Programs This standard highlights specimen collection methods, discusses acceptable techniques for applying blood drops or aliquots to the filter paper segment of the specimen collection device, and provides instructions on proper specimen handling and transport to ensure quality specimens are consistently obtained for newborn screening analysis. Item Order Code: NBS01-A6 Nonmember Price: $140 CAP | FDA | JC JULY 2013 Related Video NBS01 DVD | Making a Difference Through Newborn Screening: Blood Collection on Filter Paper DVD This video shows how to prepare for specimen collection; collect blood specimens using the recommended heelstick technique; handle specimens properly; maintain appropriate records; and prevent testing problems that can delay the newborn’s diagnosis and treatment. Item Order Code: NBS01-A6 DVD Nonmember Price: $300 Related Companion Product (Bench Aid) NBS01 QG | Specimen Collection and Sample Quality for Newborn Screening Quick Guide How to Collect an Acceptable Blood Spot Specimen Simple Spot Check Item Order Code: NBS01-A6 QG Nonmember Price: $20 JUNE 2014 JULY 2013 Members save up to 70% on CLSI products! See page 17 for discount pricing structure.
ORDER TODAY: Toll Free (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org 37 Share your knowledge and disseminate information. Explore ideas and participate in group or private discussions. Access experience-based solutions from professional colleagues. Find resources to do your job better,shorten decision times,and decrease risk. Network to find individuals who share similar goals and interests. Participate in CLSI’s online Communities to collaborate with fellow professionals! Join today at community.clsi.org. Membership Community – Coming Soon!
ORDER TODAY: Toll Free (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org38 Point-of-Care Testing POCT04 | Point-of-Care In Vitro Diagnostic (IVD) Testing This guideline provides information to users of in vitro diagnostic devices outside the clinical laboratory, to ensure reliable results comparable to those obtained within the clinical laboratory. Item Order Code: POCT04-A2 Nonmember Price: $140 Related Companion Product (Bench Aid) POCT07 RG | Addressing Errors in Point-of-Care Testing Reference Guide Includes preexamination considerations (patient preparation for the test and sample collection and handling); examination considerations (operator related, reagent related, sample related, and device related); and postexamination considerations (communication related and data management related). Formatted as a spiral-bound reference guide for convenient use in the laboratory. Item Order Code: POCT07-A RG Nonmember Price: $50 POCT08 | Quality Practices in Noninstrumented Point-of-Care Testing: An Instructional Manual and Resources for Health Care Workers This instructional guideline delivers laboratory science concepts and activities with the goal of increasing knowledge and quality of laboratory testing for testing personnel with no laboratory background. Item Order Code: POCT08-A Nonmember Price: $140 JC JC POCT07 | Quality Management: Approaches to Reducing Errors at the Point of Care This guideline presents the core infrastructure for a standardized error tracking system with the primary goals of reducing risk and increasing quality of point-of-care testing, while accumulating standardized data for benchmarking use. Item Order Code: POCT07-A Nonmember Price: $140 A Document Competency Quiz is available for this document! Visit www.clsi.org/edu for more information. JC OCTOBER 2010 AUGUST 2006 JANUARY 2015 DECEMBER 2010 Related Companion Product (Bench Aid) POCT08 QG1 | Corrective Action Report Quick Guide Report completed when any control falls outside the acceptable range. Formatted as a durable, waterproof sheet for convenient use in the laboratory. Item Order Code: POCT08-A QG1 Nonmember Price: $20 SEPTEMBER 2011 POCT Companion Product Package This package includes: POCT07-A RG—Addressing Errors in Point-of-Care Testing Reference Guide POCT08-A QG1—Corrective Action Report Quick Guide (Electronic Download) Item Order Code: POCT PK POCT08-A QG2—Quality Control Troubleshooting Flow Chart POCT09-A WS—Instrument Selection Worksheet (Electronic Download) Nonmember Price: $140 bundle and save! POCT06 | Effects of Different Sample Types on Glucose Measurements This report provides information to assist the clinical and point-of-care staff in result and measurement procedure comparisons of glucose tests. Item Order Code: POCT06-Ed1 Nonmember Price: $140 MAY 2015 Members save up to 70% on CLSI products! See page 17 for discount pricing structure.
ORDER TODAY: Toll Free (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org 39 Point-of-Care Testing POCT09 | Selection Criteria for Point-of-Care Testing Devices This guideline provides information on selection of point-of-care testing devices based on the patient care setting and clinical needs. It is designed as an aid to laboratory and facility management to simplify and facilitate the selection process, but also allows evaluation of devices to identify those that are optimal to the patient care setting and population served. Item Order Code: POCT09-A Nonmember Price: $140 POCT12 | Point-of-Care Blood Glucose Testing in Acute and Chronic Care Facilities This guideline contains information for performance of point-of-care blood glucose meter systems that stress quality control, training, and administrative responsibility. Item Order Code: POCT12-A3 Nonmember Price: $140 JC CAP | JC APRIL 2010 JANUARY 2013 Related Companion Product (Bench Aid) POCT08 QG2 | Quality Control Troubleshooting Flow Chart Flow chart for noninstrumented quality control (QC) decision making for QC out of range. Formatted as a durable, waterproof sheet for convenient use in the laboratory. Item Order Code: POCT08-A QG2 Nonmember Price: $20 Related Companion Product (Bench Aid) POCT08 QG3 | Quality Control Log Sheet Quick Guide Log sheet for noninstrumented point-of-care testing. Formatted as a durable, waterproof sheet for convenient use in the laboratory. Item Order Code: POCT08-A QG3 Nonmember Price: $20 Related Companion Product (Worksheet) POCT09 WS | Instrument Selection Worksheet Clinical needs assessment comparison electronic worksheet, which includes items to consider when comparing point-of-care testing system specifications. Item Order Code: POCT09-A WS Nonmember Price: $40 JULY 2013 SEPTEMBER 2011 SEPTEMBER 2011 Related On-Demand POCT08 Webinar | Managing Manual Tests: Challenges and Solutions Objectives: List the CLIA regulations most frequently cited for manual test deficiencies. Describe the inherent challenges of manual testing that have a negative impact on patient care. Recognize how to use the tools or avenues available to ensure quality in point-of-care manual testing. Item Order Code: POCT08 WR Nonmember Price: $99 Visit www.clsi.org/webinars to learn more. Speakers: Karen W. Dyer, MT(ASCP), DLM Survey and Certification Group, Centers for Medicare & Medicaid Services (CMS), Baltimore, Maryland, USA Patricia L. Kraft, MA, MT(ASCP) Laboratory POCT/Safety/Education Coordinator, Good Samaritan Hospital, Dayton, Ohio, USA Related Companion Product (Wall Chart) POCT10/GP16 WC | Microscopic Components in Urine Sediment and Vaginal Fluid Wall Charts Provides images of microscopic components in urine sediment and vaginal fluid, including bacteria and parasites, casts, cells, crystals, noncellular material, and vaginal fluid and KOH preparations. Formatted as two 17x22-inch wall charts for posting in the laboratory. Item Order Code: POCT10/GP16 WC Nonmember Price: $60 MARCH 2015 Members save up to 70% on CLSI products! See page 17 for discount pricing structure.
ORDER TODAY: Toll Free (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org40 Quality Management Systems The Key to Quality™ This workbook includes fundamental information for implementing and sustaining a quality management system (QMS). You will learn: The 12 quality system essentials (QSEs) for building a QMS The policies, processes, and procedures requirements for each QSE How to apply the 12 QSEs in your unique laboratory environment The Key to Quality includes ready-to-use templates and examples of completed forms and QMS tools to assist users in fulfilling the required elements in each QSE. Item Order Code: K2Q Nonmember Price: $600 QMS03 | Training and Competence Assessment This guideline provides background information and recommended processes for the development of training and competence assessment programs that meet quality and regulatory objectives. Item Order Code: QMS03-A3 Nonmember Price: $180 New enhanced, full-color version! QMS06 | Quality Management System: Continual Improvement This guideline considers continual improvement as an ongoing, systematic effort that is an essential component of a quality management system. A continual improvement program may consist of fundamental processes and common supporting elements described in this guideline. Item Order Code: QMS06-A3 Nonmember Price: $180 QMS01 | Quality Management System: A Model for Laboratory Services This guideline provides a model for medical laboratories that will assist with implementation and maintenance of an effective quality management system. Item Order Code: QMS01-A4 Nonmember Price: $180 New enhanced, full-color version! QMS02 | Quality Management System: Development and Management of Laboratory Documents This guideline provides information on the processes needed for document management, including creating, controlling, changing, and retiring a laboratory’s policy, process, procedure, and form documents in both paper and electronic environments. Item Order Code: QMS02-A6 Nonmember Price: $180 CAP | JC CAP | FDA | JC CAP | FDA | JC CAP | JC SEPTEMBER 2013 FEBRUARY 2009 JUNE 2011 JUNE 2011 FEBRUARY 2013 Members save up to 70% on CLSI products! See page 17 for discount pricing structure.
ORDER TODAY: Toll Free (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org 41 Quality Management Systems QMS15 | Assessments: Laboratory Internal Audit Program This guideline provides information for how a laboratory can establish an internal audit program to enhance the quality of its services through continual improvement. Whereas an audit program defines the “who,” “what,” “when,” “where,” and “how” of meeting requirements for internal auditing, the audit process describes the details of how to conduct individual laboratory internal audits. Item Order Code: QMS15-A Nonmember Price: $180 Formatted in an enhanced, full-color layout! QMS18 | Process Management This guideline describes four requirements for managing laboratory processes and provides suggestions for effectively meeting regulatory and accreditation requirements, optimizing efficient use of resources, and contributing to patient safety and positive outcomes. Item Order Code: QMS18-Ed1 Nonmember Price: $180 Formatted in an enhanced, full-color layout! QMS20 | Understanding the Cost of Quality in the Laboratory This report provides guidance to a laboratory in understanding and managing the different types of quality costs that affect processes, services, and financial well-being. Item Order Code: QMS20-R Nonmember Price: $180 Formatted in an enhanced, full-color layout! QMS12 | Development and Use of Quality Indicators for Process Improvement and Monitoring of Laboratory Quality This guideline provides information on development of quality indicators and their use in the medical laboratory. Item Order Code: QMS12-A Nonmember Price: $180 QMS14 | Quality Management System: Leadership and Management Roles and Responsibilities This guideline presents concepts and information intended to assist a laboratory in meeting leadership requirements for its quality management system. Guidance is provided for leaders to effectively design, implement, and maintain the cultural, structural, and functional aspects of their laboratory’s organization that are critical to managing and sustaining quality. Executive Summary also included. This companion product provides an executive summary of QMS14-A. Item Order Code: QMS14-A Nonmember Price: $180 JC JC DECEMBER 2013 MARCH 2015 MAY 2014 DECEMBER 2010 DECEMBER 2012 Related On-Demand Webinar QMS20 Webinar | Impact of Quality Costs on Your Laboratory’s Operating Budget Objectives: List, describe, and provide laboratory examples of the types of quality costs. Distinguish between costs that support good quality and those that result from poor quality. Use basic tools to quantify laboratory failure quality costs. Item Order Code: QMS20-R NOVWR Nonmember Price: $99 Speakers: Lucia M. Berte, MT(ASCP)SBB, DLM, CQA(ASQ)CMQ/OE President, Laboratories Made Better! P.C., Broomfield, Colorado, USA Anne T. Daley, MS, MT(ASCP)DLM, CMQOE(ASQ)CSSBB Senior Consultant, Chi Solutions, Inc., Ann Arbor, Michigan, USA Members save up to 70% on CLSI products! See page 17 for discount pricing structure.
ORDER TODAY: Toll Free (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org42 On-Demand QMS03 Webinar | Providing POCT Training and Competency for Health Care Professionals Objectives: Define the key elements of developing a sound competency and training program. Articulate the principles and the systematic approach required to assess and maintain competency standards for POCT device operators. Item Order Code: QMS03 WR Nonmember Price: $99 On-Demand QMS04 Webinar | Abandon the Past and Prepare for the Future: Laboratory Design Updates Objectives: Understand the overall design process. Incorporate Lean and flexibility into laboratory design. Recognize the utilities, safety issues, codes, and other aspects affecting the layout of the laboratory. Item Order Code: QMS04-A3 WR Nonmember Price: $99 On-Demand QMS11 Webinar | Nonconforming Event Management: Is Your Program Comprehensive? Objectives: Describe the four key processes and associated activities for an effective nonconforming event (NCE) management program. Identify gaps in your organization’s NCE management program. Understand potential resources available within QMS11 to assist in improving your program. Item Order Code: QMS11-A2 WR Nonmember Price: $99 Speakers: Marcia L. Zucker, PhD President, ZIVD LLC, Metuchen, New Jersey, USA Mark D. S. Shephard, PhD, MAACB, OAM Professor, Flinders University International Centre for Point-of-Care Testing, Adelaide, Australia Speaker: Karen K. Mortland, RA, MT(ASCP) Mortland Planning & Design, Inc., Chicora, Pennsylvania, USA Speaker: Anne T. Daley, MS, MT(ASCP)DLM, CMQOE(ASQ) CSSBB President, Daley Consulting, LLC, Mesa, Arizona, USA Quality Management Systems On-Demand QMS18 Webinar | How to Meet Requirements for Managing Any Laboratory Process Objectives: Describe the four regulatory and accreditation requirements for laboratory process management. Use two types of process flow charts for meeting the requirements for every new or changed laboratory process. Explain how the CLSI quality system essentials form a valuable tool for laboratory process management. Item Order Code: QMS18-A WR Nonmember Price: $99 Speaker: Lucia M. Berte, MT(ASCP)SBB, DLM, CQA(ASQ) CMQ/OE President, Laboratories Made Better! P.C., Broomfield, Colorado, USA Members save up to 70% on CLSI products! See page 17 for discount pricing structure. Visit www.clsi.org/webinars to learn more.
ORDER TODAY: Toll Free (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org 43 Do you know how much your lab spends on: Supporting good quality? Resolving problems and errors? Preventing poor quality from occurring? Find out by enrolling in the only program that truly implements the steps needed to determine the existing cost of quality in your lab! Implementing the Cost of Quality in the Laboratory Certificate Program Earn 4.0 P.A.C.E. CE credits through this online self-paced program. Enroll today at www.clsi.org/COQ. EP23™ Online Workshop: Risk-Based Tools to Meet IQCP Requirements Learn how to implement a successful IQCP program! Gain knowledge and skills to implement CLSI document EP23-A™. Simplify QC based on risk management. Create an IQCP for an analyte and learn from a CLSI instructor about how to enhance your IQCP. Enroll today! Visit www.clsi.org/EP23Workshop for more information. Laboratory Quality Management System (LQMS) Certificate Program Do you know how to ensure that your lab: Meets accreditation quality requirements? Runs with the highest efficiency and productivity? Provides the highest quality test results for your patient population? Learn the skills needed for successful implementation with the Laboratory Quality Management System (LQMS) Certificate Program. This program focuses on providing an approach to meeting quality objectives, and delivering consistent, high-quality, cost-effective lab services through implementation of a QMS. Enroll today! Visit www.clsi.org/lqms for more information.
ORDER TODAY: Toll Free (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org44 Reducing Risk POCT07 | Quality Management: Approaches to Reducing Errors at the Point of Care This guideline presents the core infrastructure for a standardized error tracking system with the primary goals of reducing risk and increasing quality of point-of-care testing, while accumulating standardized data for benchmarking use. Item Order Code: POCT07-A Nonmember Price: $140 EP18 | Risk Management Techniques to Identify and Control Laboratory Error Sources This guideline describes risk management techniques that will aid in identifying, understanding, and managing sources of failure (potential failure modes) and help to ensure correct results. Although intended primarily for in vitro diagnostics, this document will also serve as a reference for clinical laboratory managers and supervisors who wish to learn about risk management techniques and processes. Item Order Code: EP18-A2 Nonmember Price: $180 JC CAP | FDA | JC OCTOBER 2010 NOVEMBER 2009 Related Companion Product (Worksheet) EP18/EP23 WS | Sources of Failure Template Worksheet A failure modes and effects analysis table may be used as a checklist or as a tool to help identify potential failures in a testing system. These potential failures are then addressed by an appropriate quality assurance program. Use this electronic template to easily identify these possible failures. Item Order Code: EP18-A2/EP23-A WS Nonmember Price: FREE Related Companion Product (Bench Aid) POCT07 RG | Addressing Errors in Point-of-Care Testing Reference Guide Includes preexamination considerations (patient preparation for the test and sample collection and handling); examination considerations (operator related, reagent related, sample related, and device related); and postexamination considerations (communication related and data management related). Formatted as a spiral-bound reference guide for convenient use in the laboratory. Item Order Code: POCT07-A RG Nonmember Price: $50 Related Educational Product Quiz for Document Competency: POCT07-A—Quality Management: Approaches to Reducing Errors at the Point of Care Document competency quiz designed to test your comprehension of the concepts in CLSI guideline POCT07. Read the document that you have previously purchased and take a quiz to validate reading comprehension. Earn a score of 75% or higher (three attempts allowed) on the 12-question quiz, and print out a certificate for 2.0 P.A.C.E.® continuing education credits! Item Order Code: Quiz POCT07-A Nonmember Price: $50 NOVEMBER 2013 JANUARY 2015 JULY 2013 Members save up to 70% on CLSI products! See page 17 for discount pricing structure.
ORDER TODAY: Toll Free (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org 45 Reducing Risk EP23 | Laboratory Quality Control Based on Risk Management This guideline provides information based on risk management for laboratories to develop quality control plans tailored to the particular combination of measuring system, laboratory setting, and clinical application of the test. Item Order Code: EP23-A Nonmember Price: $180 Formatted in an enhanced, full-color layout! JC OCTOBER 2011 Related Companion Product (Bench Aid) EP23 QG | EP23 Quick Reference Guide Includes the steps needed to create a laboratory’s individualized quality control plan (IQCP) as well as a process flow chart that lists the steps for creating an IQCP. Formatted as an 11x17-inch chart for posting in the laboratory. Item Order Code: EP23-A QG Nonmember Price: $50 Related Companion Product (Worksheet) EP23-A WS | A Sample Form for Laboratory Quality Control Based on Risk Management; Worksheet This EP23 worksheet contains a template and example that help users identify potential failure modes at each stage of the test system’s process and consider what monitors are in place or could be used to detect the problem. The worksheet does not represent a complete or comprehensive evaluation of risk and laboratories are encouraged to use other available resources to meet each institution’s risk management requirements. Item Order Code: EP23-A WS Nonmember Price: $100 Related Companion Product (Workbook) EP23 WB | A Practical Guide for Laboratory Quality Control Based on Risk Management; Workbook This workbook provides an overview of each step necessary to create a comprehensive quality control plan. It is tailored around a specific example that helps readers understand what information to gather to help detect and assess risks. Item Order Code: EP23-A WB Nonmember Price: $100 AUGUST 2013 SEPTEMBER 2013AUGUST 2013 This package includes: EP23—Laboratory Quality Control Based on Risk Management EP23 Implementation Workbook—A Practical Guide for Laboratory Quality Control Based on Risk Management Item Order Code: EP23-A PK EP23 Worksheet—A Sample Form for Laboratory Quality Control Based on Risk Management Nonmember Price: $340 bundle and save! EP23 Package | Laboratory Quality Control Based on Risk Management; Approved Guideline, Workbook, and Worksheet Package Members save up to 70% on CLSI products! See page 17 for discount pricing structure.
ORDER TODAY: Toll Free (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org46 Related On-Demand Webinar GP17 Webinar | The Latest in Laboratory Safety: What You Need to Know to Maintain Compliance Objectives: Understand the major changes in CLSI document GP17— Clinical Laboratory Safety. Discuss the effects of Globally Harmonized System of Classification and Labelling of Chemicals on the guideline and what role it plays in 2015. Explain how to use the document to maintain safety regulation compliance and improve the laboratory safety culture. Item Order Code: GP17-A3 WR Nonmember Price: $99 Speaker: Daniel J. Scungio, MT(ASCP), SLS Sentara Healthcare, Norfolk, Virginia, USA Safety GP17 | Clinical Laboratory Safety This guideline contains general recommendations for implementing a high-quality laboratory safety program, which are provided in a framework that is adaptable within any laboratory. Item Order Code: GP17-A3 Nonmember Price: $140 GP05 | Clinical Laboratory Waste Management Based on US regulations, this guideline provides information on the safe handling and disposal of chemical, infectious, radioactive, and multihazardous wastes generated in the clinical laboratory. Although this document is a valuable resource for a wider audience, it is intended for use primarily in the United States. Item Order Code: GP05-A3 Nonmember Price: $140 GP33 | Accuracy in Patient and Sample Identification This guideline describes the essential elements of systems and processes required to ensure accurate patient identification. The principles in this document may be applied to manual or electronic systems. Design considerations covered include criteria for accuracy, differences in inpatient vs outpatient settings that impact patient identification, language and cultural considerations, and standardization of processes across the health care enterprise. Item Order Code: GP33-A Nonmember Price: $140 CAP | JC CAP | JC CAP | JC JUNE 2012 JANUARY 2011 MARCH 2010 Related Companion Product (Bench Aid) GP05 CL | Waste Management Program– Audit Checklist Checklist that includes the elements of a waste management program. Formatted on a durable, waterproof sheet for quick reference in the laboratory. Item Order Code: GP05-A3 CL Nonmember Price: $20 MARCH 2015 Members save up to 70% on CLSI products! See page 17 for discount pricing structure. Visit www.clsi.org/webinars to learn more.
ORDER TODAY: Toll Free (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org 47 Related On-Demand Webinar QMS11 Webinar | Nonconforming Event Management: Is Your Program Comprehensive? Objectives: Describe the four key processes and associated activities for an effective nonconforming event (NCE) management program. Identify gaps in your organization’s NCE management program. Understand potential resources available within QMS11 to assist in improving your program. Item Order Code: QMS11-A2 WR Nonmember Price: $99 Speaker: Anne T. Daley, MS, MT(ASCP)DLM, CMQOE(ASQ) CSSBB President, Daley Consulting, LLC, Mesa, Arizona, USA Safety GP36 | Planning for Laboratory Operations During a Disaster This guideline provides information for laboratory and health care leadership for development, implementation, and sustainment of effective emergency preparedness plans (all hazards) supporting nonanalytical components of clinical and public health laboratory services that may pertain to various natural and manmade disasters. Item Order Code: GP36-A Nonmember Price: $140 M29 | Protection of Laboratory Workers From Occupationally Acquired Infections Based on US regulations, this guideline provides information on the risk of transmission of infectious agents by aerosols, droplets, blood, and body substances in a laboratory setting; specific precautions for preventing the laboratory transmission of microbial infection from laboratory instruments and materials; and recommendations for the management of exposure to infectious agents. Item Order Code: M29-A4 Nonmember Price: $180 CAP | JC CAP | JC DECEMBER 2014 NOVEMBER 2007 MAY 2014 QMS11 | Management of Nonconforming Laboratory Events This guideline provides an outline and the content for developing a program to manage a health care service’s nonconforming events that is based on the principles of quality management and patient safety. Item Order Code: QMS11-A Nonmember Price: $180 New enhanced, full-color version coming July 2015! Members save up to 70% on CLSI products! See page 17 for discount pricing structure. Visit www.clsi.org/webinars to learn more.
ORDER TODAY: Toll Free (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org48 Specimen Handling and Processing GP44 | Procedures for the Handling and Processing of Blood Specimens for Common Laboratory Tests This guideline includes criteria for preparing an optimal serum or plasma sample and for the devices used to process blood specimens. Item Order Code: GP44-A4 Nonmember Price: $140 GP16 | Urinalysis This guideline addresses procedures for testing urine, including materials and equipment; macroscopic/physical evaluation; chemical analysis; and microscopic analysis. Item Order Code: GP16-A3 Nonmember Price: $140 FDA | JC CAP | FDA | JC MAY 2010 FEBRUARY 2009 Related Companion Product (Wall Charts) POCT10/GP16 WC | Microscopic Components in Urine Sediment and Vaginal Fluid Wall Charts Provides images of microscopic components in urine sediment and vaginal fluid, including bacteria and parasites, casts, cells, crystals, noncellular material, and vaginal fluid and potassium hydroxide preparations. Formatted as two 17x22-inch wall charts for posting in the laboratory. Item Order Code: POCT10/GP16 WC Nonmember Price: $60 Related Companion Product (Bench Aid) GP44 QG | Handling, Transport, and Storage of Specimens Quick Guide Provides recommended conditions for proper handling, transport, and storage of specimens for general chemistry and hematology analysis. Formatted as durable, waterproof sheets for quick reference in the laboratory. Item Order Code: GP44-A4 QG Nonmember Price: $40 Related Educational Product Quiz for Document Competency: GP44—Procedures for the Handling and Processing of Blood Specimens for Common Laboratory Tests Document competency quiz designed to test your comprehension of the concepts in CLSI guideline GP44. Read the document that you have previously purchased and take a quiz to validate reading comprehension. Earn a score of 75% or higher (three attempts allowed) on the 12-question quiz, and print out a certificate for 2.0 P.A.C.E.® continuing education credits! Item Order Code: Quiz GP44-A4 Nonmember Price: $50 MARCH 2015 AUGUST 2014 JULY 2013 Members save up to 70% on CLSI products! See page 17 for discount pricing structure.
ORDER TODAY: Toll Free (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org 49 Specimen Handling and Processing MM13 | Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods This guideline provides information related to proper and safe biological specimen collection and nucleic acid isolation and purification. These topics include methods of collection, recommended storage and transport conditions, and available nucleic acid purification technologies for each specimen/nucleic acid type. A CLSI-IFCC joint project. Item Order Code: MM13-A Nonmember Price: $140 H21 | Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays and Molecular Hemostasis Assays This guideline provides procedures for collecting, transporting, and storing blood; processing blood specimens; storing plasma for coagulation testing; and general recommendations for performing the tests. Item Order Code: H21-A5 Nonmember Price: $140 CAP | FDA | JC CAP | FDA | JC DECEMBER 2005 JANUARY 2008 Related Companion Product (Bench Aid) H21 QG | Collection, Handling, Transport, and Storage for Hemostasis Quick Guide Outlines best practice procedures for the proper collection, transportation, and processing of blood specimens as well as storage of plasma for coagulation testing. Formatted as durable, waterproof sheets for quick reference in the laboratory. Item Order Code: H21-A5 QG Nonmember Price: $20 Related Educational Product Quiz for Document Competency: H21—Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays and Molecular Hemostasis Assays Document competency quiz designed to test your comprehension of the concepts in CLSI guideline H21. Read the document that you have previously purchased and take a quiz to validate reading comprehension. Earn a score of 75% or higher (three attempts allowed) on the 12-question quiz, and print out a certificate for 2.0 P.A.C.E.® continuing education credits! Item Order Code: Quiz H21-A5 Nonmember Price: $50 JULY 2008 JULY 2013 This collection provides information on: Handling and processing of blood and urine specimens Collecting samples for coagulation testing Collecting, transporting, and storing specimens for molecular methods It contains the following documents: GP16 – Urinalysis GP44 – Procedures for the Handling and Processing of Blood Specimens GP44 QG – Handling, Transport, and Storage of Specimens Quick Guide H21 – Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays and Molecular Hemostasis Assays H21-A5 QG – Collection, Handling, Transport, and Storage for Hemostasis Quick Guide MM13 – Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods Item Order Code: SCH03 Nonmember Price: $420 bundle and save! Specimen Handling and Processing Package Members save up to 70% on CLSI products! See page 17 for discount pricing structure.
ORDER TODAY: Toll Free (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org50 Susceptibility Testing M02* | Performance Standards for Antimicrobial Disk Susceptibility Tests This standard contains the current CLSI-recommended methods for disk susceptibility testing, criteria for quality control testing, and updated tables for interpretive zone diameters. M07* | Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically This standard addresses reference methods for the determination of minimal inhibitory concentrations of aerobic bacteria by broth macrodilution, broth microdilution, and agar dilution. M100* | Performance Standards for Antimicrobial Susceptibility Testing This supplement provides updated tables for the CLSI antimicrobial susceptibility testing standards M02-A12, M07-A10, and M11-A8. The tabular information presented in M100 represents the most current information for drug selection, interpretation, and quality control using the procedures standardized in the most current editions of M02, M07, and M11. M100 is updated every January, so please check shop.clsi.org for the 2016 version. JANUARY 2015 JANUARY 2015 JANUARY 2015 *Note that in 2015, M100 must be purchased with one of the following M02 or M07 packages. Item Order Code: M02-A12/M07-A10 PK15 (includes M02-A12, M07-A10, and M100-S25) | Nonmember Price: $500 Item Order Code: M02-A12 PK15 (includes M02-A12 and M100-S25) | Nonmember Price: $340 Item Order Code: M07-A10 PK15 (includes M07-A10 and M100-S25) | Nonmember Price: $340 Related Companion Product (Bench Aid) AST QC QG | AST QC Flow Chart Quick Guide The ultimate “cheat sheet” to quality control (QC) for antimicrobial susceptibility testing. Based on M02, M07, and M100, these easy-to-use flow charts guide you through daily QC testing for both disk diffusion and aerobic dilution. Once required daily QC has been documented, users can convert to weekly QC with a flip of a page. Formatted as durable, waterproof sheets on a convenient detachable ring for convenient, shared use in the laboratory. Item Order Code: AST QC QG Nonmember Price: $120 Related Companion Product (Bench Aid) M100 QG | M100-S25 Tables 1A–1C Quick Guide Provides suggested groupings of antimicrobial agents that should be considered for routine disk and broth dilution testing and reporting by clinical laboratories. Serves as a useful reference for laboratories seeking to meet requirements for proficiency testing and accreditation. Formatted as durable, waterproof sheets on a convenient detachable ring for convenient, shared use in the laboratory. Item Order Code: M100-S25 QG Nonmember Price: $100 JANUARY 2015 JANUARY 2015 Members save up to 70% on CLSI products! See page 17 for discount pricing structure. An Interactive Searchable Database for Drug Selection, Interpretation, and Quality Control Procedures! eM100 is built to work the way you do—efficiently and in the laboratory. This online implementation of CLSI’s most widely recognized antimicrobial susceptibility testing document provides information for drug selection, interpretation, and quality control as well as the latest recommendations for detecting resistance mechanisms, all arranged in an easy-to-use, interactive, and searchable format. Visit www.clsi.org/eM100 to learn more.
ORDER TODAY: Toll Free (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org 51 Susceptibility Testing Related On-Demand Webinar CLSI 2015 Antimicrobial Susceptibility Testing Update Objectives: Identify the major changes found in M100-S25. Design a strategy for implementing the new practice guidelines into your laboratory practices. Develop a communication strategy for informing clinical staff of significant antimicrobial susceptibility testing and reporting changes. Speaker: Janet A. Hindler, MCLS, MT(ASCP) Sr. Specialist, Clinical Microbiology, UCLA Health System, Los Angeles, California, USA Item Order Code: CLSI 2015 Antimicrobial Susceptibility Testing Update Nonmember Price: $125 M11 | Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria This standard provides reference methods for the determination of minimal inhibitory concentrations of anaerobic bacteria by agar dilution and broth microdilution. Item Order Code: M11-A8 Nonmember Price: $180 M27 | Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts This standard addresses the selection and preparation of antifungal agents; implementation and interpretation of test procedures; and quality control requirements for susceptibility testing of yeasts that cause invasive fungal infections. Item Order Code: M27-A3 Nonmember Price: $180 M24 | Susceptibility Testing of Mycobacteria, Nocardiae, and Other Aerobic Actinomycetes This standard provides protocols and related quality control parameters and interpretive criteria for the susceptibility testing of mycobacteria, Nocardia spp., and other aerobic actinomycetes. Item Order Code: M24-A2 Nonmember Price: $180 MARCH 2011FEBRUARY 2012 APRIL 2008 M27 Supplement | Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts This supplement provides updated tables for the CLSI antimicrobial susceptibility testing standard M27-A3. Item Order Code: M27-S4 Nonmember Price: $35 DECEMBER 2012 M38 | Reference Method for Broth Dilution Antifungal Susceptibility Testing of Filamentous Fungi This standard addresses the selection of antifungal agents, preparation of antifungal stock solutions and dilutions for testing implementation and interpretation of test procedures, and quality control requirements for susceptibility testing of filamentous fungi (moulds) that cause invasive and cutaneous fungal infections. Item Order Code: M38-A2 Nonmember Price: $180 M39 | Analysis and Presentation of Cumulative Antimicrobial Susceptibility Test Data This guideline describes methods for recording and analysis of antimicrobial susceptibility test data, consisting of cumulative and ongoing summaries of susceptibility patterns of clinically significant microorganisms. Item Order Code: M39-A4 Nonmember Price: $180 JANUARY 2014APRIL 2008 Members save up to 70% on CLSI products! See page 17 for discount pricing structure.
ORDER TODAY: Toll Free (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org52 Susceptibility Testing M45 | Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria This guideline provides information to clinical microbiology laboratories for standardized susceptibility testing of infrequently isolated or fastidious bacteria that are not presently included in CLSI documents M02 or M07. The tabular information in this document presents the most current information for drug selection, interpretation, and quality control for the infrequently isolated or fastidious bacterial pathogens included in this guideline. Item Order Code: M45-A2 Nonmember Price: $180 AUGUST 2010 M44 and Third Informational Supplement | Method for Antifungal Disk Diffusion Susceptibility Testing of Yeasts This guideline provides newly established methodology for disk diffusion testing of Candida spp., criteria for quality control testing, and interpretive criteria. Zone Diameter Interpretive Standards, Corresponding Minimal Inhibitory Concentration (MIC) Interpretive Breakpoints, and Quality Control Limits for Antifungal Disk Diffusion Susceptibility Testing of Yeasts; Third Informational Supplement These supplemental tables provide new quality control limits for CLSI document M44. It is available as a laminated chart for easy posting. Item Order Code: M44-A2 and M44-S3 Nonmember Price: $180 AUGUST 2009 Related Companion Product (Bench Aid) M39 QG | Antibiograms: Developing Cumulative Reports for Your Clinicians Quick Guide Serves as a handy reference for laboratory personnel. It provides recommendations for preparation of a cumulative antibiogram, examples of selection criteria, and supplemental analyses. It also shows how to prepare tables, includes a description of limitations of data, and provides examples of reports and graphs. Formatted as seven durable, waterproof sheets on a convenient detachable ring. Item Order Code: M39-A4 QG Nonmember Price: $60 JANUARY 2015 This collection provides guidance for microbiologists performing routine susceptibility testing. Information covered includes: Disk and dilution testing procedures Interpretive tables for antimicrobial susceptibility tests Safety precautions It contains the following documents: M02 – Performance Standards for Antimicrobial Disk Susceptibility Tests M07 – Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically M39 – Analysis and Presentation of Cumulative Antimicrobial Susceptibility Test Data M45 – Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria M100 – Performance Standards for Antimicrobial Susceptibility Testing AST QC QG – AST Quality Control Quick Guide M100 QG – M100 Tables 1A–1C Quick Guide M100 WC – Glossary of Antimicrobial Terms and Abbreviations Wall Chart Item Order Code: SCM03 Nonmember Price: $950 bundle and save! General Susceptibility Testing Package Members save up to 70% on CLSI products! See page 17 for discount pricing structure.
ORDER TODAY: Toll Free (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org 53 Now, CLSI Standards Are a Click Away… With eCLIPSETM Ultimate Access, we have made it easy for your lab to access and use our invaluable resources for quality improvement— anytime, anywhere. Subscribe Today! Call +1.610.688.0100 to Unlock Your Ultimate Access. Please contact customerservice@clsi.org to inquire about pricing. CLIPSEUltimate Access e TM Access CLSI Standards Anytime—All You Need Is a Web Connection! Gain instant access to CLSI’s complete library through the eCLIPSE online portal. Ensure your organization has access to the most up-to-date CLSI standards. Empower Your Entire Organization to Use CLSI’s Invaluable Tools. Know You Are Working From the Most Current Standards Information. No hardware needed— with eCLIPSE’s cloud-based technology, documents are always a click away.
ORDER TODAY: Toll Free (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org54 Related On-Demand Webinar VET01 Webinar | Updates to the CLSI Veterinary AST Supplement Objectives: Discuss CLSI document VET01-A4 and its supplement, VET01S, and how they impact veterinary antimicrobial susceptibility testing (AST). Identify the procedures and applications of the various methods recommended by CLSI for AST. Describe the changes made to the supplement and the importance of interpreting results, based on drug selection, for better animal care. Item Order Code: VET01-A4 WR Nonmember Price: $99 Speaker: Michael T. Sweeney, MT Principal Scientist, Zoetis, Kalamazoo, Michigan, USA Veterinary Medicine VET01 and Third Informational Supplement | Performance Standards for Antimicrobial Disk and Dilution Susceptibility Tests for Bacteria Isolated From Animals This standard provides the currently recommended techniques for antimicrobial agent disk and dilution susceptibility testing, criteria for quality control testing, and interpretive criteria for veterinary use. Performance Standards for Antimicrobial Disk and Dilution Susceptibility Tests for Bacteria Isolated From Animals; Third Informational Supplement This supplement provides updated tables for the CLSI antimicrobial susceptibility testing standard VET01. Item Order Code: VET01-A4 Nonmember Price: $230 VET02 | Development of In Vitro Susceptibility Testing Criteria and Quality Control Parameters for Veterinary Antimicrobial Agents This guideline addresses the required and recommended data needed for selection of appropriate interpretive standards and quality control guidance for new veterinary antimicrobial agents. Item Order Code: VET02-A3 Nonmember Price: $140 VET03/VET04 Supplement Performance Standards for Antimicrobial Susceptibility Testing of Bacteria Isolated From Aquatic Animals; Second Informational Supplement This supplement provides updated tables for the CLSI antimicrobial susceptibility testing guidelines VET03-A and VET04-A2. Item Order Code: VET03/VET04-S2 Nonmember Price: $100 VET03 | Methods for Antimicrobial Disk Susceptibility Testing of Bacteria Isolated From Aquatic Animals This guideline provides the most up-to-date techniques for disk diffusion susceptibility testing of aquatic species isolates, and criteria for quality control testing. Item Order Code: VET03-A Nonmember Price: $140 JULY 2013 FEBRUARY 2008 SEPTEMBER 2014JUNE 2006 Members save up to 70% on CLSI products! See page 17 for discount pricing structure. Visit www.clsi.org/webinars to learn more.
ORDER TODAY: Toll Free (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org 55 Veterinary Medicine VET04 and Second Informational Supplement* | Methods for Broth Dilution Susceptibility Testing of Bacteria Isolated From Aquatic Animals This guideline provides the most up-to-date techniques for the determination of minimal inhibitory concentrations of aquatic bacteria by broth micro- and macrodilution, and criteria for data interpretation and quality control testing. The VET04 supplement provides updated tables for VET03-A and VET04-A2. VET05 | Generation, Presentation, and Application of Antimicrobial Susceptibility Test Data for Bacteria of Animal Origin This report offers guidance on areas in which harmonization can be achieved in veterinary antimicrobial surveillance programs with the intent of facilitating comparison of data among surveillance programs. Item Order Code: VET05-R Nonmember Price: $140 SEPTEMBER 2014 SEPTEMBER 2011 *Note that VET04 must be purchased in a package with the VET03/VET04 Supplement. Item Order Code: VET04-A2 PK | Nonmember Price: $180 Infobase 2015 is a user-friendly, searchable CD-ROM of over 200 CLSI standards for best practices in medical testing. Infobase 2015 includes: All standards in the CLSI document library published through December 31, 2014 A feature that allows searching across and within all standards to locate relevant information The ability to access documents without a Web connection Please contact customerservice@clsi.org to learn more. Members save up to 70% on CLSI products! See page 17 for discount pricing structure.
ORDER TODAY: Toll Free (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org56 CLSI Course Offerings CLSI offers numerous educational and training programs and services, including seminars, workshops, on-site assessments, in-lab mentoring, webinars, and online education programs. Offerings include: On-site assessment to evaluate existing lab operations against the accreditation model health officials have selected, identifying and analyzing gaps between existing practices and best practices Assistance with the development of national strategic plans for labs Customized and interactive training and educational programs for lab staff, management, and quality officers, focusing on the development and strengthening of quality management systems Assistance with the development of continuous quality improvement strategies Measurable and scalable programs for all labs seeking international accreditation Visit www.clsi.org/training for more information.
ORDER TODAY: Toll Free (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org 57 JUNE 2015 Be on the lookout for these new and revised standards, which are scheduled to be published through August 2015 to address the timely issues most relevant to our members and customers. The projected publication dates are listed below. CLSI Documents Scheduled for Publication EP36 | Harmonization of Symbology and Equations This report provides a standardized symbology for use throughout CLSI documents. Use of these standardized symbols is expected to be of great benefit to the CLSI readership, volunteers participating in CLSI committees, and the scientific community in general. Item Order Code: EP36-Ed1 FREE! M52 | Verification of Commercial Microbial Identification and Antimicrobial Susceptibility Testing Systems This guideline includes recommendations for verification of commercial US Food and Drug Administration–cleared microbial identification and antimicrobial susceptibility testing systems by clinical laboratory professionals to fulfill regulatory or quality assurance requirements for the use of these systems for diagnostic testing. Item Order Code: M52-Ed1 Nonmember Price: $180 VET01 Supplement Performance Standards for Antimicrobial Disk and Dilution Susceptibility Tests for Bacteria Isolated From Animals This supplement provides updated tables for the CLSI antimicrobial susceptibility testing standard VET01. Item Order Code: VET01S-Ed3 Nonmember Price: $100 EP19 | A Framework for Using CLSI Documents to Evaluate Clinical Laboratory Measurement Procedures This report uses the “measurement procedure lifecycle” framework to aid users of CLSI evaluation protocols documents during establishment and implementation of measurement procedures developed by both commercial manufacturers and clinical laboratories, ie, for laboratory-developed tests. Item Order Code: EP19-Ed2 FREE! POCT13 | Glucose Monitoring in Settings Without Laboratory Support This guideline focuses on performance of point-of-care glucose monitoring systems, with an emphasis on safety practices, quality control, training, and administrative responsibility. Item Order Code: POCT13-Ed3 Nonmember Price: $140 Formatted in an enhanced, full-color layout! QMS11 | Nonconforming Event Management Grounded in the principles of quality management, risk management, and patient safety, this guideline provides an outline and content for developing a program to manage a laboratory’s nonconforming events. Item Order Code: QMS11-Ed2 Nonmember Price: $180 New enhanced, full-color version! QMS16 | Laboratory Personnel Management This guideline provides a roadmap for meeting the regulatory and accreditation requirements of personnel management in the laboratory environment. This guideline offers suggestions and examples on managing the processes required for laboratory personnel to fully achieve laboratory management’s operational and quality goals. Item Order Code: QMS16-Ed1 Nonmember Price: $180 Formatted in an enhanced, full-color layout! JULY 2015 AUGUST 2015 JUNE 2015 JUNE 2015 JULY 2015 AUGUST 2015
Qty Item Code Title Promo Code Price Total Subtotal Shipping/Handling (See info below) Express Shipping Sales Tax (PA Shipments add 6%) Total Discount for multiple copies of the same title offered # of Copies Price per Copy 1–3 Full Price 3–9 5% Discount 10–24 10% Discount 25–99 15% Discount 100–499 20% Discount 500+ Contact CLSI for pricing. Shipping and Handling Within the USA Add 10% (min $10) All other locations International Express 1–3 day delivery Add 35% (min $40) Express Shipping (North America Only)* 2-Day Overnight Early Morning 1–3 Documents $11 $16 $23 4–6 Documents $14 $19 $26 7–10 Documents $16 $21 $28 Specialty Collections $16 $21 $28 *Express charges are in addition to the regular shipping and handling charges. Thank you for your order. Please photocopy this form for multiple orders. Membership Account # (if nonmember, put N/A): Method of Payment Payment enclosed in full MasterCard Visa American Express Discover Card Number Expiration Date (MM/YY): Name (as it appears on credit card) Purchase order MUST be faxed or mailed. Payment due in full upon receipt of invoice. Federal Tax ID #23-7089361 Mail to: Clinical and Laboratory Standards Institute 950 West Valley Road, Suite 2500 Wayne, PA 19087 USA Wire Transfer Contact customerservice@clsi.org. Bill to: (Please print.) Name: Organization: Address: City: State/Province: Zip/Postal Code: Country: Telephone: E-mail: Fax: Ship to (if different than billing address): (Please print.) Name: Organization: Address: City: State/Province: Zip/Postal Code: Country: Telephone: E-mail: Fax: CSV: ORDER TODAY: P: +1.610.688.0100 | Toll Free (US): 877.447.1888 | F: +1.610.688.0700 | www.clsi.org | customerservice@clsi.org

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Clsi 2015-catalog

  • 1.
    Set the Standardfor Quality in Your Laboratory With CLSI 2015 2016 CATALOG
  • 2.
    ORDER TODAY: TollFree (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.orgA3 ORDER TODAY: Toll Free (US): 877.447.1888 | www.clsi.org | customerservice@clsi.orgA3 Contact our Membership Department at +1.610.688.0100 or membership@clsi.org, or visit www.clsi.org/membership to learn more. There Has Never Been a Better Time to Join CLSI. MEMBERSHIP We know today’s labs face many complex challenges. CLSI is an organization committed to helping you raise the standards for quality in your lab environment and uncover the value that greater testing accuracy, efficiency, and safety provides your health care organization. The Benefits* Access CLSI’s complete library of standards at discounts of up to 70% off! Facilitate accreditation preparedness and speed development of standard operating procedures. Earn convenient and cost-effective continuing education credits through our education programs. Collaborate with colleagues to create and influence the standards that impact the work you do each day. Raise your lab’s visibility and gain recognition among our member organizations. *Industry members receive additional benefits in each category to meet their more robust business needs.Visit www.clsi.org/membership for more information. 1,600+ Organizations Network With in the Global Laboratory Community Actively Collaborate on CLSI Standards Development Receive Up to 70% Savings on CLSI Products and Programs
  • 3.
    ORDER TODAY: TollFree (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org A4ORDER TODAY: Toll Free (US): 877.447.1888 | www.clsi.org | customerservice@clsi.org A4 Find All the Latest CLSI Offerings Online! See our complete library of standards online at the CLSI Shop at shop.clsi.org. Visit www.clsi.org today to: Access all resources from the catalog, as well as new documents and products offered by CLSI. You will also find valuable education programs, and more. Purchase From the CLSI Shop Explore the CLSI U Education Center Find Easy Access to Our Online Products Learn More About Our Membership Benefits
  • 4.
    I IIIII Set higherstandards as a CLSI Member! Join CLSI and unlock new levels of lab testing quality. Join CLSI today! E-mail membership@clsi.org or visit www.clsi.org/membership. Organizational Membership* Discover how our three comprehensive levels of membership can meet the needs of your facility and budget. New Health System Membership This new level will allow multiple facilities to join under one membership under the health system. Benefits will include global access to the CLSI electronic library of documents for each location. Visit www.clsi.org/membership for further details. I II III Level I Membership Level II Membership Level III Membership For the lab that is committed to implementing the highest standards of lab testing. You will receive: CLSI’s complete library of standards, online and on CD-ROM • eCLIPSE™ Ultimate Access, CLSI’s Web-based searchable library of standards • Infobase™, a CD-ROM library of standards A70%discountonotherCLSI standards,products,andprograms Free shipping within the USA Free Education programs to help your staff stay up-to-date with the latest standards A flexible membership option for labs that want to select the standards, subscription products, and education programs that are most important to them. You will receive: A 50% discount on CLSI standards, products, and programs For the lab that already has a library of CLSI standards and wants to stay up-to-date when new and revised documents are published. You will receive: A subscription to all newly published and revised standards delivered straight to your inbox as soon as they are published A 60% discount on CLSI standards, products, and programs Free shipping within the USA *Industrymembersreceiveadditionalbenefitsineachcategorytomeettheirmorerobustbusinessneeds.Visitwww.clsi.org/membershipformoreinformation. Full Member A 25% discount on CLSI standards, products, and programs Opportunity to participate on committees and the Board of Directors Associate Member A 15% discount on CLSI standards, products, and programs Opportunity to participate on committees Student Member Full-time students enrolled in an academic program A 10% discount on CLSI standards, products, and programs Individual Membership AnaffordableoptionforanyonewhoisinterestedinsupportingorvolunteeringforCLSI,regardlessofemployeraffiliation
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    Industry and LargeCommercial Laboratories Health Care Professions Government and Public Health Agencies Individual I ($25,000) II ($10,000) III ($2,500) I ($5,000) II ($1,500) III ($400) I ($5,000) II ($1,500) III ($400) I ($250) II ($75) III ($25) Full Associate Student Become an integral part of improving global clinical lab testing and advancing the quality of patient care. Join in Our Mission to Improve Health Care Outcomes Membership Application Delegate Name Delegate E-mail Alternate Name Alternate E-mail Organization Address City State/Province Zip/Postal Code Country Phone Number Website Membership Category: Desired Level: We accept checks drawn on US banks; American Express, Discover, MasterCard, and Visa credit cards; and wire transfers. Please select your method of payment: Check Wire Transfer (Wire Date ) American Express Discover MasterCard Visa Credit Card Number Exp. Date / CSV Name on Card Signature For wire transfer instructions, please contact membership@clsi.org. MEMBERSHIPAPPLICATION Mail to: Fax to: E-mail to: Clinical and Laboratory Standards Institute 950 West Valley Road, Suite 2500 Wayne, PA 19087 USA +1.610.688.0700 membership@clsi.org Questions? If you have any questions regarding CLSI membership options and which level will best fit your organization’s needs, please contact our Membership Department directly at +1.610.688.0100.
  • 6.
    ORDER TODAY: TollFree (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org 1 Quality System Regulation for Laboratory-Developed Tests A Practical Guide for the Laboratory January 2015 M100-S25 Performance Standards for Antimicrobial Susceptibility Testing; Twenty-Fifth Informational Supplement January 2015 M07-A10 Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard —Tenth Edition January 2015 M02-A12 Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard—Twelfth Edition Recently Published From CLSI New and revised standards on timely clinical laboratory topics. M100-S25* Performance Standards for Antimicrobial Susceptibility Testing; Twenty-Fifth Informational Supplement M07-A10* Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard— Tenth Edition M02-A12* Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard—Twelfth Edition This document provides updated tables for the Clinical and Laboratory Standards Institute antimicrobial susceptibility testing standards M02-A11, M07-A9, and M11-A8. A standard for global application developed through the Clinical and Laboratory Standards Institute consensus process. EP15-A3 User Verification of Precision and Estimation of Bias; Approved Guideline— Third Edition September 2014 This document provides updated tables for the Clinical and Laboratory Standards Institute antimicrobial susceptibility testing standards M02-A11, M07-A9, and M11-A8. A standard for global application developed through the Clinical and Laboratory Standards Institute consensus process. GP23-A2 Nongynecological Cytology Specimens: Preexamination, Examination, and Postexamination Processes; Approved Guideline—Second Edition November 2014 This document provides updated tables for the Clinical and Laboratory Standards Institute antimicrobial susceptibility testing standards M02-A11, M07-A9, and M11-A8. A standard for global application developed through the Clinical and Laboratory Standards Institute consensus process. GP36-A Planning for Laboratory Operations During a Disaster; Approved Guideline December 2014 EP15-A3 User Verification of Precision and Estimation of Bias; Approved Guideline— Third Edition GP23-A2 Nongynecological Cytology Specimens: Preexamination, Examination, and Postexamination Processes; Approved Guideline—Second Edition GP36-A Planning for Laboratory Operations During a Disaster; Approved Guideline This document provides updated tables for the Clinical and Laboratory Standards Institute antimicrobial susceptibility testing standards M02-A11, M07-A9, and M11-A8. A standard for global application developed through the Clinical and Laboratory Standards Institute consensus process. POCT06 Effects of Different Sample Types on Glucose Measurements 1st Edition This document provides updated tables for the Clinical and Laboratory Standards Institute antimicrobial susceptibility testing standards M02-A11, M07-A9, and M11-A8. A standard for global application developed through the Clinical and Laboratory Standards Institute consensus process. C57 Mass Spectrometry for Androgen and Estrogen Measurements in Serum 1st Edition This document provides updated tables for the Clinical and Laboratory Standards Institute antimicrobial susceptibility testing standards M02-A11, M07-A9, and M11-A8. A standard for global application developed through the Clinical and Laboratory Standards Institute consensus process. POCT13 Glucose Monitoring in Settings Without Laboratory Support 3rd Edition POCT06-Ed1 Effects of Different Sample Types on Glucose Measurements, 1st Edition C57-Ed1 Mass Spectrometry for Androgen and Estrogen Measurements in Serum, 1st Edition POCT13-Ed3 Glucose Monitoring in Settings Without Laboratory Support, 3rd Edition 3rd Edition This document provides updated tables for the Clinical and Laboratory Standards Institute antimicrobial susceptibility testing standards M02-A11, M07-A9, and M11-A8. A standard for global application developed through the Clinical and Laboratory Standards Institute consensus process. MM03 Molecular Diagnostic Methods for Infectious Diseases 1st Edition This document provides updated tables for the Clinical and Laboratory Standards Institute antimicrobial susceptibility testing standards M02-A11, M07-A9, and M11-A8. A standard for global application developed through the Clinical and Laboratory Standards Institute consensus process. QMS18 Process Management MM03-Ed3 Molecular Diagnostic Methods for Infectious Diseases, 3rd Edition QMS18-Ed1 Process Management, 1st Edition QSR LDT Quality System Regulation for Laboratory-Developed Tests: A Practical Guide for the Laboratory *These documents are sold only in packages of M02 and M100; M07 and M100; and M02, M07, and M100. April 2015 MM23 Molecular Diagnostic Methods for Solid Tumors (Nonhematological Neoplasms) MM23-Ed1 Molecular Diagnostic Methods for Solid Tumors (Nonhematological Neoplasms), 1st Edition This document provides updated tables for the Clinical and Laboratory Standards Institute antimicrobial susceptibility testing standards M02-A11, M07-A9, and M11-A8. A standard for global application developed through the Clinical and Laboratory Standards Institute consensus process. EP05-A3 Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline—Third Edition October 2014 EP05-A3 Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline—Third Edition
  • 7.
    2015/2016 Table of Contents DocumentCategories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Index of CLSI Standards and Companion Products. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Catalog Key. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 Document and Product Listings by Category Accreditation Preparedness – Essentials for Verifying Test Performance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 Accreditation Preparedness – Laboratory Practices. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 Automation and Informatics. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 Clinical Chemistry and Toxicology. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 Hematology and Coagulation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 Immunology and Ligand Assay. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28 Microbiology Methodologies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29 Molecular Methods. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32 Newborn Screening. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34 Phlebotomy. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36 Point-of-Care Testing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38 Quality Management Systems. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40 Reducing Risk.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44 Safety. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46 Specimen Handling and Processing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48 Susceptibility Testing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50 Veterinary Medicine.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54 Coming Soon.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57 Featured Products Quality System Regulation for Laboratory-Developed Tests. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 eM100.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29 CLSI Communities.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37 The Key to Quality™. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40 Online Learning Programs.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43 eCLIPSE™ Ultimate Access. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53 Infobase™. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55 CLSI Course Offerings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56 Order Form. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
  • 8.
    ORDER TODAY: TollFree (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org 3ORDER TODAY: Toll Free (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org 3 Former Document Code New Document Code Automation and Informatics GP19-A2 AUTO13-A2 Clinical Chemistry and Toxicology H17-A C61-A General Laboratory H01-A6 GP39-A6 C03-A4-AMD GP40-A4-AMD H03-A6 GP41-A6 H04-A6 GP42-A6 H11-A4 GP43-A4 H18-A4 GP44-A4 HS06-A GP45-A Method Evaluation C28-A3c EP28-A3c C51-A EP29-A C53-A EP30-A C54-A-IR EP31-A-IR X05-R EP32-R Former Document Code New Document Code Microbiology X07-R M55-R Newborn Screening LA04-A5 NBS01-A6* I/LA27-A NBS02-A2* I/LA31-A NBS03-A I/LA32-A NBS04-A I/LA35-A NBS05-A Point-of-Care Testing AST04-A2 POCT13-A2 H49-A POCT14-A Quality Management Systems GP26-A4 QMS01-A4 GP02-A5 QMS02-A6* GP21-A3 QMS03-A3 GP18-A2 QMS04-A2 GP09-A2 QMS05-A2 GP22-A3 QMS06-A3 Former Document Code New Document Code Quality Management Systems (continued) HS04-A2 QMS07-A2 HS11-A QMS10-A GP32-A QMS11-A GP35-A QMS12-A GP37-A QMS13-A GP38-A QMS14-A GP38-AES QMS14-AES Veterinary Medicine M31-A3 VET01-A4 M37-A3 VET02-A3 M42/M49-S1 VET03/VET04-S2 M42-A VET03-A M49-A VET04-A2 X08-R VET05-R In order to better classify our library of documents, CLSI expanded and color coded its document categories. The assigned colors are prominently displayed on each CLSI document cover. The document categories are: As part of this initiative, some CLSI documents were assigned new codes to reflect their categories. See below for the complete list of affected documents, or visit www.clsi.org. * These documents replaced the respective standards noted in the “Former Document Code” column. Automation and Informatics Clinical Chemistry and Toxicology General Laboratory Hematology Immunology and Ligand Assay Method Evaluation Microbiology Molecular Methods Newborn Screening Point-of-Care Testing Quality Management Systems Veterinary Medicine There are more products online at the CLSI Shop. Visit shop.clsi.org to find our full library of resources.Shop Online! DOCUMENTCATEGORIES
  • 9.
    ORDER TODAY: TollFree (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org4 Be Prepared to Comply Using CLSI. Let CLSI Guide You Through the FDA Proposed Requirements for LDTs! Labs that perform LDTs will be held accountable to the same standards as IVD manufacturers. CLSI has the resources you need to prepare for the FDA’s proposed guidance! You can find essential information in our practical guide, Quality System Regulation for Laboratory-Developed Tests (QSR LDT). HOW WHERE THEY AFFECT YOUR ORGANIZATION YOU CAN FIND INFORMATION Order the QSR LDT Practical Guide Today! Visit www.clsi.org/LDTs. Through FDA’s proposed phased-in implementation, after 12 months, enforcement of premarket review requirements for the highest-risk LDTs begins. WHEN THEY WILL GO INTO EFFECT EP19—A Framework for Using CLSI Documents to Evaluate Clinical Laboratory Measurement Procedures QSR LDT—Quality System Regulation for Laboratory- DevelopedTests: A Practical Guide for the Laboratory Learn how to validate LDTs to establish product performance claims as part of your submission packets to the FDA. Learn how the proposed changes for the FDA QSReg for LDTs differs from current CLIA requirements, and what your lab should do to prepare. Members LI: $90 LII: $120 LIII: $150 Nonmembers: $300FREE! Quality System Regulation for Laboratory-Developed Tests A Practical Guide for the Laboratory JUNE 2015 January 2015 This report uses the “measurement procedure lifecycle” framework to aid users of CLSI evaluation protocols documents during establishment and implementation of measurement procedures developed by both commercial manufacturers and clinical laboratories, ie, for laboratory- developed tests. A CLSI report for global application EP19 A Framework for Using CLSI Documents to Evaluate Clinical Laboratory Measurement Procedures 2nd Edition 1 2 3
  • 10.
    ORDER TODAY: TollFree (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org 5 Automation and Informatics Document Code Document Title Location Format AUTO01-A Laboratory Automation: Specimen Container/Specimen Carrier; Approved Standard Online PDF AUTO02-A2 Laboratory Automation: Bar Codes for Specimen Container Identification; Approved Standard—Second Edition Online PDF AUTO03-A2 Laboratory Automation: Communications With Automated Clinical Laboratory Systems, Instruments, Devices, and Information Systems; Approved Standard—Second Edition Online PDF AUTO04-A Laboratory Automation: Systems Operational Requirements, Characteristics, and Information Elements; Approved Standard Online PDF AUTO05-A Laboratory Automation: Electromechanical Interfaces; Approved Standard Online PDF AUTO07-A Laboratory Automation: Data Content for Specimen Identification; Approved Standard Online PDF AUTO08-A Managing and Validating Laboratory Information Systems; Approved Guideline Online PDF and Print AUTO09-A Remote Access to Clinical Laboratory Diagnostic Devices via the Internet; Approved Standard Online PDF AUTO10-A Autoverification of Clinical Laboratory Test Results; Approved Guideline Online PDF AUTO11-A2 Information Technology Security of In Vitro Diagnostic Instruments and Software Systems; Approved Standard—Second Edition Pg. 22 PDF and Print AUTO12-A Specimen Labels: Content and Location, Fonts, and Label Orientation; Approved Standard Pg. 22 PDF and Print AUTO13-A2 Laboratory Instruments and Data Management Systems: Design of Software User Interfaces and End-User Software Systems Validation, Operation, and Monitoring; Approved Guideline—Second Edition Online PDF I/LA33-A Validation of Automated Systems for Immunohematological Testing Before Implementation; Approved Guideline Pg. 28 PDF I/LA33-A TK Validation of Automated Systems for Immunohematological Testing Before Implementation—Sample Templates and Test Cases Toolkit Pg. 28 CD LIS01-A2 Specification for Low-Level Protocol to Transfer Messages Between Clinical Laboratory Instruments and Computer Systems; Approved Standard—Second Edition Online PDF LIS02-A2 Specification for Transferring Information Between Clinical Laboratory Instruments and Information Systems; Approved Standard—Second Edition Online PDF LIS03-A Standard Guide for Selection of a Clinical Laboratory Information Management System Online PDF LIS04-A Standard Guide for Documentation of Clinical Laboratory Computer Systems Online PDF LIS05-A Standard Specification for Transferring Clinical Observations Between Independent Computer Systems Online PDF LIS06-A Standard Practice for Reporting Reliability of Clinical Laboratory Information Systems Online PDF LIS07-A Standard Specification for Use of Bar Codes on Specimen Tubes in the Clinical Laboratory Online PDF LIS08-A Standard Guide for Functional Requirements of Clinical Laboratory Information Management Systems Online PDF LIS09-A Standard Guide for Coordination of Clinical Laboratory Services within the Electronic Health Record Environment and Networked Architectures Online PDF All CLSI standards, guidelines, and companion products are listed in the index below. Various documents are located in the catalog, and a corresponding page number is indicated in the “Location” column. All other documents are available on the CLSI website at www.clsi.org, and are indicated with “Online” in the “Location” column below. Index of CLSI Standards and Companion Products
  • 11.
    ORDER TODAY: TollFree (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org6 INDEX Clinical Chemistry and Toxicology Document Code Document Title Location Format C24-A3 Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions; Approved Guideline—Third Edition Pg. 18, 24 PDF and Print C29-A2 Standardization of Sodium and Potassium Ion-Selective Electrode Systems to the Flame Photometric Reference Method; Approved Standard—Second Edition Online PDF C31-A2 Ionized Calcium Determinations: Precollection Variables, Specimen Choice, Collection, and Handling; Approved Guideline—Second Edition Online PDF C34-A3 Sweat Testing: Sample Collection and Quantitative Chloride Analysis; Approved Guideline—Third Edition Pg. 24 PDF C37-A Preparation and Validation of Commutable Frozen Human Serum Pools as Secondary Reference Materials for Cholesterol Measurement Procedures; Approved Guideline Online PDF C38-A Control of Preanalytical Variation in Trace Element Determinations; Approved Guideline Online PDF and Print C39-A A Designated Comparison Method for the Measurement of Ionized Calcium in Serum; Approved Standard Online PDF C40-A2 Measurement Procedures for the Determination of Lead Concentrations in Blood and Urine; Approved Guideline—Second Edition Pg. 24 PDF and Print C42-A Erythrocyte Protoporphyrin Testing; Approved Guideline Online PDF C43-A2 Gas Chromatography/Mass Spectrometry Confirmation of Drugs; Approved Guideline— Second Edition Online PDF C45-A Measurement of Free Thyroid Hormones; Approved Guideline Online PDF C46-A2 Blood Gas and pH Analysis and Related Measurements; Approved Guideline—Second Edition Pg. 24 PDF and Print C48-A Application of Biochemical Markers of Bone Turnover in the Assessment and Monitoring of Bone Diseases; Approved Guideline Online PDF C49-A Analysis of Body Fluids in Clinical Chemistry; Approved Guideline Pg. 24 PDF and Print C49-A/H56-A QG Collection, Handling, Transport, and Storage for Body Fluids Quick Guide Pg. 24 Print C50-A Mass Spectrometry in the Clinical Laboratory: General Principles and Guidance; Approved Guideline Online PDF C52-A2 Toxicology and Drug Testing in the Clinical Laboratory; Approved Guideline—Second Edition Online PDF and Print C56-A Hemolysis, Icterus, and Lipemia/Turbidity Indices as Indicators of Interference in Clinical Laboratory Analysis; Approved Guideline Pg. 25 PDF and Print C56-A QG Examples of Hemolyzed, Icteric, and Lipemic/Turbid Samples Quick Guide Pg. 25 PDF and Print C57-Ed1 Mass Spectrometry for Androgen and Estrogen Measurements in Serum, 1st Edition Pg. 25 PDF and Print C58-A Assessment of Fetal Lung Maturity by the Lamellar Body Count; Approved Guideline Online PDF C61-A Determination of Serum Iron, Total Iron-Binding Capacity and Percent Transferrin Saturation; Approved Standard Online PDF C62-A Liquid Chromatography-Mass Spectrometry Methods; Approved Guideline Pg. 25 PDF and Print EP05-A3 Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline— Third Edition Online PDF and Print EP06-A Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline Pg. 18 PDF and Print EP07-A2 Interference Testing in Clinical Chemistry; Approved Guideline—Second Edition Pg. 18 PDF and Print EP09-A3 Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Approved Guideline—Third Edition Pg. 18 PDF and Print EP10-A3-AMD Preliminary Evaluation of Quantitative Clinical Laboratory Measurement Procedures; Approved Guideline—Third Edition Online PDF and Print EP12-A2 User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline— Second Edition Online PDF EP14-A3 Evaluation of Commutability of Processed Samples; Approved Guideline—Third Edition Online PDF and Print
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    ORDER TODAY: TollFree (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org 7 INDEX Clinical Chemistry and Toxicology Document Code Document Title Location Format EP15-A3 User Verification of Precision and Estimation of Bias; Approved Guideline—Third Edition Pg. 18 PDF and Print EP17-A2 Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline—Second Edition Pg. 19 PDF and Print EP18-A2 Risk Management Techniques to Identify and Control Laboratory Error Sources; Approved Guideline—Second Edition Pg. 44 PDF and Print EP19-Ed2 A Framework for Using CLSI Documents to Evaluate Clinical Laboratory Measurement Procedures, 2nd Edition Pg. 4, 57 PDF EP21-A Estimation of Total Analytical Error for Clinical Laboratory Methods; Approved Guideline Pg. 19 PDF and Print EP24-A2 Assessment of the Diagnostic Accuracy of Laboratory Tests Using Receiver Operating Characteristic Curves; Approved Guideline—Second Edition Online PDF and Print EP25-A Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline Online PDF EP28-A3c Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline—Third Edition Pg. 19 PDF and Print EP30-A Characterization and Qualification of Commutable Reference Materials for Laboratory Medicine; Approved Guideline Online PDF EP31-A-IR Verification of Comparability of Patient Results Within One Health Care System; Approved Guideline (Interim Revision) Pg. 19 PDF and Print EP32-R Metrological Traceability and Its Implementation; A Report Online PDF GP40-A4-AMD Preparation and Testing of Reagent Water in the Clinical Laboratory; Approved Guideline— Fourth Edition Online PDF and Print (continued) General Laboratory EP26-A User Evaluation of Between-Reagent Lot Variation; Approved Guideline Online PDF and Print GP05-A3 Clinical Laboratory Waste Management; Approved Guideline—Third Edition Pg. 46 PDF and Print GP05-A3 CL Waste Management Program—Audit Checklist Pg. 46 PDF and Print GP15-A3 Cervicovaginal Cytology Based on the Papanicolaou Technique; Approved Guideline— Third Edition Online PDF GP16-A3 Urinalysis; Approved Guideline—Third Edition Pg. 48 PDF and Print GP17-A3 Clinical Laboratory Safety; Approved Guideline—Third Edition Pg. 46 PDF and Print GP20-A2 Fine Needle Aspiration Biopsy (FNAB) Techniques; Approved Guideline—Second Edition Online PDF GP23-A2 Nongynecological Cytology Specimens: Preexamination, Examination, and Postexamination Processes; Approved Guideline—Second Edition Online PDF and Print GP27-A2 Using Proficiency Testing to Improve the Clinical Laboratory; Approved Guideline—Second Edition Pg. 20 PDF and Print GP28-A Microwave Device Use in the Histology Laboratory; Approved Guideline Online PDF GP29-A2 Assessment of Laboratory Tests When Proficiency Testing Is Not Available; Approved Guideline—Second Edition Pg. 20 PDF and Print GP31-A Laboratory Instrument Implementation, Verification, and Maintenance; Approved Guideline Pg. 19 PDF and Print GP33-A Accuracy in Patient and Sample Identification; Approved Guideline Pg. 46 PDF and Print GP34-A Validation and Verification of Tubes for Venous and Capillary Blood Specimen Collection; Approved Guideline Online PDF and Print GP36-A Planning for Laboratory Operations During a Disaster; Approved Guideline Pg. 47 PDF and Print GP39-A6 Tubes and Additives for Venous and Capillary Blood Specimen Collection; Approved Standard—Sixth Edition Online PDF and Print GP40-A4-AMD Preparation and Testing of Reagent Water in the Clinical Laboratory; Approved Guideline— Fourth Edition Online PDF and Print GP41-A6 Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture; Approved Standard—Sixth Edition Pg. 36 PDF and Print
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    ORDER TODAY: TollFree (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org8 General Laboratory Document Code Document Title Location Format GP41-A6 QG Quality Venipuncture Quick Guide Pg. 36 PDF and Print GP42-A6 Procedures and Devices for the Collection of Diagnostic Capillary Blood Specimens; Approved Standard—Sixth Edition Online PDF GP42-A6 QG Technique for Skin Puncture in Adults and Older Children Quick Guide Online PDF and Print GP43-A4 Procedures for the Collection of Arterial Blood Specimens; Approved Standard—Fourth Edition Online PDF GP44-A4 Procedures for the Handling and Processing of Blood Specimens for Common Laboratory Tests; Approved Guideline—Fourth Edition Pg. 48 PDF and Print GP44-A4 QG Handling, Transport, and Storage of Specimens Quick Guide Pg. 48 Print GP45-A Studies to Evaluate Patient Outcomes; Approved Guideline Online PDF H02-A5 Procedures for the Erythrocyte Sedimentation Rate Test; Approved Standard—Fifth Edition Pg. 26 PDF and Print I08-P Determining Performance of Volumetric Equipment; Proposed Guideline Online PDF I16-T Temperature Monitoring and Recording in Blood Banks; Tentative Guideline Online PDF M29-A4 Protection of Laboratory Workers From Occupationally Acquired Infections; Approved Guideline—Fourth Edition Pg. 47 PDF and Print MM13-A Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods; Approved Guideline Pg. 32, 49 PDF and Print MM13-A QG Handling, Transport, and Storage of Specimens for Molecular Methods Quick Guide Pg. 32 Print POCT10/GP16 WC Microscopic Components in Urine Sediment and Vaginal Fluid Wall Charts Pg. 39, 48 PDF and Print QG 10 Specimen Collection Quick Guides Online Print QMS02-A6 Quality Management System: Development and Management of Laboratory Documents; Approved Guideline—Sixth Edition Pg. 20, 40 PDF and Print (continued) Hematology H02-A5 Procedures for the Erythrocyte Sedimentation Rate Test; Approved Standard—Fifth Edition Pg. 26 PDF and Print H07-A3 Procedure for Determining Packed Cell Volume by the Microhematocrit Method; Approved Standard—Third Edition Online PDF H15-A3 Reference and Selected Procedures for the Quantitative Determination of Hemoglobin in Blood; Approved Standard—Third Edition Online PDF H20-A2 Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental Methods; Approved Standard—Second Edition Online PDF and Print H21-A5 Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays and Molecular Hemostasis Assays; Approved Guideline—Fifth Edition Pg. 26, 49 PDF and Print H21-A5 QG Collection, Handling, Transport, and Storage for Hemostasis Quick Guide Pg. 26, 49 Print H26-A2 Validation, Verification, and Quality Assurance of Automated Hematology Analyzers; Approved Standard—Second Edition Pg. 26 PDF and Print H30-A2 Procedure for the Determination of Fibrinogen in Plasma; Approved Guideline—Second Edition Online PDF H42-A2 Enumeration of Immunologically Defined Cell Populations by Flow Cytometry; Approved Guideline—Second Edition Online PDF H43-A2 Clinical Flow Cytometric Analysis of Neoplastic Hematolymphoid Cells; Approved Guideline—Second Edition Online PDF H47-A2 One-Stage Prothrombin Time (PT) Test and Activated Partial Thromboplastin Time (APTT) Test; Approved Guideline—Second Edition Online PDF H48-A Determination of Factor Coagulant Activities; Approved Guideline Online PDF H51-A Assays of von Willebrand Factor Antigen and Ristocetin Cofactor Activity; Approved Guideline Online PDF
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    ORDER TODAY: TollFree (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org 9 INDEX Immunology and Ligand Assay I/LA02-A2 Quality Assurance of Laboratory Tests for Autoantibodies to Nuclear Antigens: (1) Indirect Fluorescence Assay for Microscopy and (2) Microtiter Enzyme Immunoassay Methods; Approved Guideline—Second Edition Online PDF I/LA20-A2 Analytical Performance Characteristics and Clinical Utility of Immunological Assays for Human Immunoglobulin E (IgE) Antibodies and Defined Allergen Specificities; Approved Guideline—Second Edition Pg. 28 PDF I/LA21-A2 Clinical Evaluation of Immunoassays; Approved Guideline—Second Edition Online PDF I/LA23-A Assessing the Quality of Immunoassay Systems: Radioimmunoassays and Enzyme, Fluorescence, and Luminescence Immunoassays; Approved Guideline Online PDF I/LA25-A2 Maternal Serum Screening; Approved Standard—Second Edition Online PDF I/LA26-A2 Performance of Single Cell Immune Response Assays; Approved Guideline—Second Edition Pg. 28 PDF and Print I/LA28-A2 Quality Assurance for Design Control and Implementation of Immunohistochemistry Assays; Approved Guideline—Second Edition Pg. 28 PDF and Print I/LA28-A2 QG Comparison of the Characteristics of Immunoassays Such as Enzyme-Linked Immunosorbent Assay and Immunohistochemistry Quick Guide Pg. 28 Print I/LA30-A Immunoassay Interference by Endogenous Antibodies; Approved Guideline Online PDF I/LA33-A Validation of Automated Systems for Immunohematological Testing Before Implementation; Approved Guideline Pg. 28 PDF I/LA33-A TK Validation of Automated Systems for Immunohematological Testing Before Implementation—Sample Templates and Test Cases Toolkit Pg. 28 CD I/LA34-A Design and Validation of Immunoassays for Assessment of Human Allergenicity of New Biotherapeutic Drugs; Approved Guideline Online Print NBS06-A Newborn Blood Spot Screening for Severe Combined Immunodeficiency by Measurement of T-cell Receptor Excision Circles; Approved Guideline Pg. 35 PDF and Print NBS06-A QG1 Generic Flow Chart for Assays to Measure T-cell Receptor Excision Circles in Newborn Dried Blood Spot Specimens Quick Guide Pg. 35 Print NBS06-A QG2 Schematic for Preparing Dried Blood Spot Reference Materials Quick Guide Pg. 35 Print NBS06-A WC Immunodeficiency Disorders and T-cell Receptor Excision Circle Values in the Newborn Screening Period Pg. 35 Print Hematology Document Code Document Title Location Format H52-A2 Red Blood Cell Diagnostic Testing Using Flow Cytometry; Approved Guideline—Second Edition Pg. 26 PDF and Print H54-A Procedures for Validation of INR and Local Calibration of PT/INR Systems; Approved Guideline Online PDF and Print H56-A Body Fluid Analysis for Cellular Composition; Approved Guideline Online PDF and Print H57-A Protocol for the Evaluation, Validation, and Implementation of Coagulometers; Approved Guideline Online PDF H58-A Platelet Function Testing by Aggregometry; Approved Guideline Online PDF and Print H59-A Quantitative D-dimer for the Exclusion of Venous Thromboembolic Disease; Approved Guideline Pg. 27 PDF and Print H60-A Laboratory Testing for the Lupus Anticoagulant; Approved Guideline Pg. 27 PDF and Print H60-A QG1 Algorithmic Approach to Lupus Anticoagulant Testing Pg. 27 PDF and Print H60-A QG2 Criteria for the Laboratory Diagnosis of the Lupus Anticoagulant Pg. 27 PDF and Print MM05-A2 Nucleic Acid Amplification Assays for Molecular Hematopathology; Approved Guideline— Second Edition Online PDF POCT14-A Point-of-Care Monitoring of Anticoagulation Therapy; Approved Guideline Online PDF and Print (continued)
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    ORDER TODAY: TollFree (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org10 Method Evaluation Document Code Document Title Location Format C24-A3 Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions; Approved Guideline—Third Edition Pg. 18, 24 PDF and Print C29-A2 Standardization of Sodium and Potassium Ion-Selective Electrode Systems to the Flame Photometric Reference Method; Approved Standard—Second Edition Online PDF C37-A Preparation and Validation of Commutable Frozen Human Serum Pools as Secondary Reference Materials for Cholesterol Measurement Procedures; Approved Guideline Online PDF C39-A A Designated Comparison Method for the Measurement of Ionized Calcium in Serum; Approved Standard Online PDF C42-A Erythrocyte Protoporphyrin Testing; Approved Guideline Online PDF C43-A2 Gas Chromatography/Mass Spectrometry Confirmation of Drugs; Approved Guideline— Second Edition Online PDF C45-A Measurement of Free Thyroid Hormones; Approved Guideline Online PDF C46-A2 Blood Gas and pH Analysis and Related Measurements; Approved Guideline—Second Edition Pg. 24 PDF and Print C50-A Mass Spectrometry in the Clinical Laboratory: General Principles and Guidance; Approved Guideline Online PDF EP05-A3 Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline— Third Edition Online PDF and Print EP06-A Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline Pg. 18 PDF and Print EP07-A2 Interference Testing in Clinical Chemistry; Approved Guideline—Second Edition Pg. 18 PDF and Print EP09-A3 Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Approved Guideline—Third Edition Pg. 18 PDF and Print EP10-A3-AMD Preliminary Evaluation of Quantitative Clinical Laboratory Measurement Procedures; Approved Guideline—Third Edition Online PDF and Print EP12-A2 User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline— Second Edition Online PDF EP14-A3 Evaluation of Commutability of Processed Samples; Approved Guideline—Third Edition Online PDF and Print EP15-A3 User Verification of Precision and Estimation of Bias; Approved Guideline—Third Edition Pg. 18 PDF and Print EP17-A2 Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline—Second Edition Pg. 19 PDF and Print EP18-A2 Risk Management Techniques to Identify and Control Laboratory Error Sources; Approved Guideline—Second Edition Pg. 44 PDF and Print EP18-A2/EP23-A WS EP18/EP23 Sources of Failure Template Pg. 44 Word EP19-Ed2 A Framework for Using CLSI Documents to Evaluate Clinical Laboratory Measurement Procedures, 2nd Edition Pg. 4, 57 PDF EP21-A Estimation of Total Analytical Error for Clinical Laboratory Methods; Approved Guideline Pg. 19 PDF and Print EP23-A™ Laboratory Quality Control Based on Risk Management; Approved Guideline Pg. 45 PDF and Print EP23-A QG EP23 Quick Reference Guide Pg. 45 PDF and Print EP23-A WB A Practical Guide for Laboratory Quality Control Based on Risk Management; Workbook Pg. 45 PDF and Print EP23-AWS A Sample Form for Laboratory Quality Control Based on Risk Management; Worksheet Pg. 45 Word EP24-A2 Assessment of the Diagnostic Accuracy of Laboratory Tests Using Receiver Operating Characteristic Curves; Approved Guideline—Second Edition Online PDF and Print EP25-A Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline Online PDF EP26-A User Evaluation of Between-Reagent Lot Variation; Approved Guideline Online PDF and Print EP27-A How to Construct and Interpret an Error Grid for Quantitative Diagnostic Assays; Approved Guideline Online PDF
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    ORDER TODAY: TollFree (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org 11 Method Evaluation Document Code Document Title Location Format EP28-A3c Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline—Third Edition Pg. 19 PDF and Print EP29-A Expression of Measurement Uncertainty in Laboratory Medicine; Approved Guideline Online PDF and Print EP30-A Characterization and Qualification of Commutable Reference Materials for Laboratory Medicine; Approved Guideline Online PDF EP31-A-IR Verification of Comparability of Patient Results Within One Health Care System; Approved Guideline (Interim Revision) Pg. 19 PDF and Print EP32-R Metrological Traceability and Its Implementation; A Report Online PDF EP36-Ed1 Harmonization of Symbology and Equations, 1st Edition Pg. 57 PDF H26-A2 Validation, Verification, and Quality Assurance of Automated Hematology Analyzers; Approved Standard—Second Edition Pg. 26 PDF and Print MM17-A Verification and Validation of Multiplex Nucleic Acid Assays; Approved Guideline Pg. 33 PDF and Print (continued) Microbiology AST QC QG AST QC Flow Chart Quick Guides Pg. 29, 50 PDF and Print M02-A12 Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard— Twelfth Edition Pg. 29, 50 PDF and Print M06-A2 Protocols for Evaluating Dehydrated Mueller-Hinton Agar; Approved Standard—Second Edition Online PDF M07-A10 Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard—Tenth Edition Pg. 29, 50 PDF and Print M11-A8 Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria; Approved Standard—Eighth Edition Pg. 51 PDF and Print M15-A Laboratory Diagnosis of Blood-borne Parasitic Diseases; Approved Guideline Online PDF M21-A Methodology for the Serum Bactericidal Test; Approved Guideline Online PDF M22-A3 Quality Control for Commercially Prepared Microbiological Culture Media; Approved Standard—Third Edition Pg. 30 PDF and Print M23-A3 Development of In Vitro Susceptibility Testing Criteria and Quality Control Parameters; Approved Guideline—Third Edition Online PDF and Print M24-A2 Susceptibility Testing of Mycobacteria, Nocardiae, and Other Aerobic Actinomycetes; Approved Standard—Second Edition Pg. 51 PDF and Print M26-A Methods for Determining Bactericidal Activity of Antimicrobial Agents; Approved Guideline Online PDF M27-A3 Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts; Approved Standard—Third Edition Pg. 51 PDF and Print M27-S4 Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts; Fourth Informational Supplement Pg. 51 PDF and Print M28-A2 Procedures for the Recovery and Identification of Parasites From the Intestinal Tract; Approved Guideline—Second Edition Pg. 30 PDF and Print M29-A4 Protection of Laboratory Workers From Occupationally Acquired Infections; Approved Guideline—Fourth Edition Pg. 47 PDF and Print M32-P Evaluation of Lots of Dehydrated Mueller-Hinton Broth for Antimicrobial Susceptibility Testing; Proposed Guideline Online PDF M33-A Antiviral Susceptibility Testing: Herpes Simplex Virus by Plaque Reduction Assay; Approved Standard Online PDF and Print M34-A Western Blot Assay for Antibodies to Borrelia burgdorferi; Approved Guideline Online PDF M35-A2 Abbreviated Identification of Bacteria and Yeast; Approved Guideline—Second Edition Pg. 30 PDF and Print M36-A Clinical Use and Interpretation of Serologic Tests for Toxoplasma gondii; Approved Guideline Online PDF
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    ORDER TODAY: TollFree (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org12 Microbiology Document Code Document Title Location Format M38-A2 Reference Method for Broth Dilution Antifungal Susceptibility Testing of Filamentous Fungi; Approved Standard—Second Edition Pg. 51 PDF and Print M39-A4 Analysis and Presentation of Cumulative Antimicrobial Susceptibility Test Data; Approved Guideline—Fourth Edition Pg. 51 PDF and Print M39-A4 QG Antibiograms: Developing Cumulative Reports for Your Clinicians Quick Guide Pg. 52 Print M40-A2 Quality Control of Microbiological Transport Systems; Approved Standard—Second Edition Pg. 30 PDF and Print M41-A Viral Culture; Approved Guideline Online PDF M43-A Methods for Antimicrobial Susceptibility Testing for Human Mycoplasmas; Approved Guideline Online PDF M44-A2 Method for Antifungal Disk Diffusion Susceptibility Testing of Yeasts; Approved Guideline—Second Edition Pg. 52 PDF and Print M44-S3 Zone Diameter Interpretive Standards, Corresponding Minimal Inhibitory Concentration (MIC) Interpretive Breakpoints, and Quality Control Limits for Antifungal Disk Diffusion Susceptibility Testing of Yeasts; Third Informational Supplement Pg. 52 PDF and Print M45-A2 Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria; Approved Guideline—Second Edition Pg. 52 PDF and Print M47-A Principles and Procedures for Blood Cultures; Approved Guideline Pg. 31, 36 PDF and Print M47-A QG Collection, Handling, and Transport for Blood Cultures Quick Guide Pg. 31, 36 Print M48-A Laboratory Detection and Identification of Mycobacteria; Approved Guideline Online PDF M50-A Quality Control for Commercial Microbial Identification Systems; Approved Guideline Online PDF and Print M51-A Method for Antifungal Disk Diffusion Susceptibility Testing of Nondermatophyte Filamentous Fungi; Approved Guideline Online PDF M51-S1 Performance Standards for Antifungal Disk Diffusion Susceptibility Testing of Nondermatophyte Filamentous Fungi; Informational Supplement Online PDF M52-Ed1 Verification of Commercial Microbial Identification and Antimicrobial Susceptibility Testing Systems, 1st Edition Pg. 57 PDF and Print M53-A Criteria for Laboratory Testing and Diagnosis of Human Immunodeficiency Virus Infection; Approved Guideline Online PDF M54-A Principles and Procedures for Detection of Fungi in Clinical Specimens—Direct Examination and Culture; Approved Guideline Pg. 31 PDF and Print M55-R Surveillance for Methicillin-Resistant Staphylococcus aureus: Principles, Practices, and Challenges; A Report Online PDF and Print M56-A Principles and Procedures for Detection of Anaerobes in Clinical Specimens; Approved Guideline Pg. 31 PDF and Print M100-S25 Performance Standards for Antimicrobial Susceptibility Testing; Twenty-Fifth Informational Supplement Pg. 29, 50 PDF and Print M100-S25 QG M100-S25 Tables 1A–1C Quick Guide Pg. 29, 50 PDF and Print M100-S25 WC Glossary of Antimicrobial Terms and Abbreviations Wall Chart: Twenty-Fifth Informational Supplement Online Print MM03-Ed3 Molecular Diagnostic Methods for Infectious Diseases, 3rd Edition Pg. 32 PDF and Print MM06-A2 Quantitative Molecular Methods for Infectious Diseases; Approved Guideline—Second Edition Pg. 32 PDF and Print MM11-A Molecular Methods for Bacterial Strain Typing; Approved Guideline Online PDF MM18-A Interpretive Criteria for Identification of Bacteria and Fungi by DNA Target Sequencing; Approved Guideline Online PDF and Print MM22-A Microarrays for Diagnosis and Monitoring of Infectious Diseases; Approved Guideline Pg. 33 PDF and Print (continued)
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    ORDER TODAY: TollFree (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org 13 Molecular Methods Document Code Document Title Location Format I/LA28-A2 Quality Assurance for Design Control and Implementation of Immunohistochemistry Assays; Approved Guideline—Second Edition Pg. 28 PDF and Print M53-A Criteria for Laboratory Testing and Diagnosis of Human Immunodeficiency Virus Infection; Approved Guideline Online PDF MM01-A3 Molecular Methods for Clinical Genetics and Oncology Testing; Approved Guideline— Third Edition Online PDF MM03-Ed3 Molecular Diagnostic Methods for Infectious Diseases, 3rd Edition Pg. 32 PDF and Print MM05-A2 Nucleic Acid Amplification Assays for Molecular Hematopathology; Approved Guideline— Second Edition Online PDF MM06-A2 Quantitative Molecular Methods for Infectious Diseases; Approved Guideline—Second Edition Pg. 32 PDF and Print MM07-A2 Fluorescence In Situ Hybridization Methods for Clinical Laboratories; Approved Guideline— Second Edition Pg. 32 PDF and Print MM09-A2 Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine; Approved Guideline—Second Edition Pg. 32 PDF and Print MM10-A Genotyping for Infectious Diseases: Identification and Characterization; Approved Guideline Online PDF MM11-A Molecular Methods for Bacterial Strain Typing; Approved Guideline Online PDF MM12-A Diagnostic Nucleic Acid Microarrays; Approved Guideline Online PDF MM13-A Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods; Approved Guideline Pg. 32, 49 PDF and Print MM13-A QG Handling, Transport, and Storage of Specimens for Molecular Methods Quick Guide Pg. 32 Print MM14-A2 Design of Molecular Proficiency Testing/External Quality Assessment; Approved Guideline—Second Edition Pg. 33 PDF and Print MM16-A Use of External RNA Controls in Gene Expression Assays; Approved Guideline Online PDF MM17-A Verification and Validation of Multiplex Nucleic Acid Assays; Approved Guideline Pg. 33 PDF and Print MM18-A Interpretive Criteria for Identification of Bacteria and Fungi by DNA Target Sequencing; Approved Guideline Online PDF and Print MM19-A Establishing Molecular Testing in Clinical Laboratory Environments; Approved Guideline Pg. 33 PDF and Print MM20-A Quality Management for Molecular Genetic Testing; Approved Guideline Pg. 33 PDF and Print MM22-A Microarrays for Diagnosis and Monitoring of Infectious Diseases; Approved Guideline Pg. 33 PDF and Print MM23-Ed1 Molecular Diagnostic Methods for Solid Tumors (Nonhematological Neoplasms), 1st Edition Online PDF and Print NBS06-A Newborn Blood Spot Screening for Severe Combined Immunodeficiency by Measurement of T-cell Receptor Excision Circles; Approved Guideline Pg. 35 PDF and Print NBS06-A QG1 Generic Flow Chart for Assays to Measure T-cell Receptor Excision Circles in Newborn Dried Blood Spot Specimens Quick Guide Pg. 35 Print NBS06-A QG2 Schematic for Preparing Dried Blood Spot Reference Materials Quick Guide Pg. 35 Print NBS06-A WC Immunodeficiency Disorders and T-cell Receptor Excision Circle Values in the Newborn Screening Period Pg. 35 Print Newborn Screening NBS01-A6 Blood Collection on Filter Paper for Newborn Screening Programs; Approved Standard— Sixth Edition Pg. 34, 36 PDF and Print NBS01-A6 DVD Making a Difference Through Newborn Screening: Blood Collection on Filter Paper Pg. 34, 36 DVD NBS01-A6 QG Specimen Collection and Sample Quality for Newborn Screening Quick Guide Pg. 34, 36 PDF and Print NBS02-A2 Newborn Screening Follow-up; Approved Guideline—Second Edition Pg. 34 PDF and Print NBS02-A2 QG Newborn Screening Follow-up Process Quick Guide Pg. 34 Print
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    ORDER TODAY: TollFree (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org14 Newborn Screening Document Code Document Title Location Format NBS03-A Newborn Screening for Preterm, Low Birth Weight, and Sick Newborns; Approved Guideline Pg. 34 PDF and Print NBS03-A QG Algorithm for Newborn Screening of Preterm, Low Birth Weight, and Sick Newborns Quick Guide Pg. 34 Print NBS04-A Newborn Screening by Tandem Mass Spectrometry; Approved Guideline Pg. 35 PDF and Print NBS05-A Newborn Screening for Cystic Fibrosis; Approved Guideline Pg. 35 PDF and Print NBS06-A Newborn Blood Spot Screening for Severe Combined Immunodeficiency by Measurement of T-cell Receptor Excision Circles; Approved Guideline Pg. 35 PDF and Print NBS06-A QG1 Generic Flow Chart for Assays to Measure T-cell Receptor Excision Circles in Newborn Dried Blood Spot Specimens Quick Guide Pg. 35 Print NBS06-A QG2 Schematic for Preparing Dried Blood Spot Reference Materials Quick Guide Pg. 35 Print NBS06-A WC Immunodeficiency Disorders and T-cell Receptor Excision Circle Values in the Newborn Screening Period Wall Chart Pg. 35 Print (continued) Point-of-Care Testing POCT01-A2 Point-of-Care Connectivity; Approved Standard—Second Edition Online PDF POCT02-A Implementation Guide of POCT01 for Health Care Providers; Approved Guideline Online PDF POCT04-A2 Point-of-Care In Vitro Diagnostic (IVD) Testing; Approved Guideline—Second Edition Pg. 38 PDF POCT05-A Performance Metrics for Continuous Interstitial Glucose Monitoring; Approved Guideline Online PDF POCT06-Ed1 Effects of Different Sample Types on Glucose Measurements, 1st Edition Pg. 38 PDF and Print POCT07-A Quality Management: Approaches to Reducing Errors at the Point of Care; Approved Guideline Pg. 38, 44 PDF and Print POCT07-A RG Addressing Errors in Point-of-Care Testing Reference Guide Pg. 38, 44 Print POCT08-A Quality Practices in Noninstrumented Point-of-Care Testing: An Instructional Manual and Resources for Health Care Workers; Approved Guideline Pg. 38 PDF and Print POCT08-A QG1 Corrective Action Report Quick Guide Pg. 38 PDF and Print POCT08-A QG2 Quality Control Troubleshooting Flow Chart Pg. 39 Print POCT08-A QG3 Quality Control Log Sheet Quick Guide Pg. 39 PDF and Print POCT09-A Selection Criteria for Point-of-Care Testing Devices; Approved Guideline Pg. 39 PDF POCT09-A WS Instrument Selection Worksheet Pg. 39 PDF POCT10-A2 Physician and Nonphysician Provider-Performed Microscopy Testing; Approved Guideline— Second Edition Online PDF and Print POCT10-A2 CL1 Provider-Performed Microscopy Training Checklist: Competence/Validation Cumulative Record Online PDF and Print POCT10-A2 CL2 Provider-Performed Microscopy Training Checklist: Initial or Renewal Competence/ Validation Employee Training Checklist Online PDF and Print POCT10-A2 LG Microscope Maintenance Log Online PDF and Print POCT10-A2 QG1 Fecal Leukocyte Examinations (Also Known as Stool White Blood Cells) Quick Guide Online PDF and Print POCT10-A2 QG2 Nasal Smears for Inflammatory Cells (Also Known as “Nasal Smear for Eosinophils,” “Nasal WBCs,” and “Nasal Smear for Granulocytes”) Quick Guide Online PDF and Print POCT10-A2 QG3 Proficiency Testing Exception Response Form (for Use for Microscopic PT Only) Quick Guide Online PDF and Print POCT10-A2 QG4 Urine Sediment Examinations Quick Guide Online PDF and Print POCT10-A2 QG5 Wet Mount Preparations and KOH Preparations Quick Guide Online PDF and Print
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    ORDER TODAY: TollFree (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org 15 Quality Management Systems EP18-A2/EP23-A WS Sources of Failure Template Pg. 44 Word EP23-A™ Laboratory Quality Control Based on Risk Management; Approved Guideline Pg. 45 PDF and Print EP23-A QG EP23 Quick Reference Guide Pg. 45 PDF and Print EP23-A WB A Practical Guide for Laboratory Quality Control Based on Risk Management; Workbook Pg. 45 PDF and Print EP23-A WS A Sample Form for Laboratory Quality Control Based on Risk Management; Worksheet Pg. 45 Word GP17-A3 Clinical Laboratory Safety; Approved Guideline—Third Edition Pg. 46 PDF and Print GP27-A2 Using Proficiency Testing to Improve the Clinical Laboratory; Approved Guideline—Second Edition Pg. 20 PDF and Print GP29-A2 Assessment of Laboratory Tests When Proficiency Testing Is Not Available; Approved Guideline—Second Edition Pg. 20 PDF and Print GP31-A Laboratory Instrument Implementation, Verification, and Maintenance; Approved Guideline Pg. 19 PDF and Print GP33-A Accuracy in Patient and Sample Identification; Approved Guideline Pg. 46 PDF and Print K2Q The Key to Quality Pg. 40 PDF and Print POCT07-A Quality Management: Approaches to Reducing Errors at the Point of Care; Approved Guideline Pg. 38, 44 PDF and Print POCT07-A RG Addressing Errors in Point-of-Care Testing Reference Guide Pg. 38, 44 Print POCT08-A Quality Practices in Noninstrumented Point-of-Care Testing: An Instructional Manual and Resources for Health Care Workers; Approved Guideline Pg. 38 PDF and Print POCT08-A QG1 Corrective Action Report Quick Guide Pg. 38 PDF and Print POCT08-A QG2 Quality Control Troubleshooting Flow Chart Pg. 39 Print POCT08-A QG3 Quality Control Log Sheet Quick Guide Pg. 39 PDF and Print QMS01-A4 Quality Management System: A Model for Laboratory Services; Approved Guideline— Fourth Edition Pg. 20, 40 PDF and Print QMS02-A6 Quality Management System: Development and Management of Laboratory Documents; Approved Guideline—Sixth Edition Pg. 20, 40 PDF and Print QMS03-A3 Training and Competence Assessment; Approved Guideline—Third Edition Pg. 21, 40 PDF and Print QMS04-A2 Laboratory Design; Approved Guideline—Second Edition Online PDF and Print QMS05-A2 Quality Management System: Qualifying, Selecting, and Evaluating a Referral Laboratory; Approved Guideline—Second Edition Online PDF and Print QMS06-A3 Quality Management System: Continual Improvement; Approved Guideline—Third Edition Pg. 21, 40 PDF and Print QMS07-A2 Application of a Quality Management System Model for Respiratory Services; Approved Guideline—Second Edition Online PDF QMS10-A A Model for Managing Medical Device Alerts (Hazards and Recalls) for Healthcare Organizations; Approved Guideline Online PDF Point-of-Care Testing Document Code Document Title Location Format POCT10-A2 WC3 Ectoparasites Wall Chart Online PDF and Print POCT10/GP16 WC Microscopic Components in Urine Sediment and Vaginal Fluid Wall Charts Pg. 39, 48 PDF and Print POCT11-A2 Pulse Oximetry; Approved Guideline—Second Edition Online PDF POCT12-A3 Point-of-Care Blood Glucose Testing in Acute and Chronic Care Facilities; Approved Guideline—Third Edition Pg. 39 PDF and Print POCT13-Ed3 Glucose Monitoring in Settings Without Laboratory Support, 3rd Edition Pg. 57 PDF and Print POCT14-A Point-of-Care Monitoring of Anticoagulation Therapy; Approved Guideline Online PDF and Print (continued)
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    ORDER TODAY: TollFree (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org16 Quality Management Systems Document Code Document Title Location Format QMS11-A Management of Nonconforming Laboratory Events; Approved Guideline Pg. 21, 47 PDF and Print QMS11-Ed2 Nonconforming Event Management, 2nd Edition Pg. 57 PDF and Print QMS12-A Development and Use of Quality Indicators for Process Improvement and Monitoring of Laboratory Quality; Approved Guideline Pg. 41 PDF and Print QMS13-A Quality Management System: Equipment; Approved Guideline Online PDF and Print QMS14-A Quality Management System: Leadership and Management Roles and Responsibilities; Approved Guideline Pg. 41 PDF and Print QMS14-AES Executive Summary: Quality Management System: Leadership and Management Roles and Responsibilities Pg. 41 PDF and Print QMS15-A Assessments: Laboratory Internal Audit Program; Approved Guideline Pg. 41 PDF and Print QMS16-Ed1 Laboratory Personnel Management, 1st Edition Pg. 57 PDF and Print QMS18-Ed1 Process Management, 1st Edition Pg. 41 PDF and Print QMS20-R Understanding the Cost of Quality in the Laboratory; A Report Pg. 41 PDF and Print (continued) Veterinary Medicine VET01-A4 Performance Standards for Antimicrobial Disk and Dilution Susceptibility Tests for Bacteria Isolated From Animals; Approved Standard—Fourth Edition Pg. 54 PDF and Print VET01S-Ed3 Performance Standards for Antimicrobial Disk and Dilution Susceptibility Tests for Bacteria Isolated From Animals; Third Informational Supplement Pg. 54, 57 PDF and Print VET02-A3 Development of In Vitro Susceptibility Testing Criteria and Quality Control Parameters for Veterinary Antimicrobial Agents; Approved Guideline—Third Edition Pg. 54 PDF and Print VET03-A Methods for Antimicrobial Disk Susceptibility Testing of Bacteria Isolated From Aquatic Animals; Approved Guideline Pg. 54 PDF and Print VET03/VET04-S2 Performance Standards for Antimicrobial Susceptibility Testing of Bacteria Isolated From Aquatic Animals; Second Informational Supplement Pg. 54 PDF and Print VET04-A2 Methods for Broth Dilution Susceptibility Testing of Bacteria Isolated From Aquatic Animals; Approved Guideline—Second Edition Pg. 55 PDF and Print VET05-R Generation, Presentation, and Application of Antimicrobial Susceptibility Test Data for Bacteria of Animal Origin; A Report Pg. 55 PDF and Print
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    ORDER TODAY: TollFree (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org 17 CLSI references in the College of American Pathologists (CAP) Accreditation Program Checklists Approved-level consensus standards recognized by the US Food and Drug Administration (FDA) for use in satisfying a regulatory requirement CLSI documents referenced in The Joint Commission Laboratory Accreditation Standards chapters Level I Organization: 70% Level II Organization: 60% Level III Organization: 50% Individual Full: 25% Individual Associate: 15% Individual Student: 10% Standard or Guideline: Document has achieved consensus within the health care community.* Report: Document that has not been subjected to consensus review and is released by the appropriate consensus committee. * American National Standards have been approved by the American National Standards Institute (ANSI). CLSI submits selected standards as candidate American National Standards when such status will enhance their national or international usefulness. NOTE: All CLSI documents can be found online at shop.clsi.org. KEY: CLSI Membership Discounts: DEFINITIONS: CATALOG KEY CAP FDA JC
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    ORDER TODAY: TollFree (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org18 EP06 | Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach This guideline provides information for characterizing the linearity of a method during a method evaluation; for checking linearity as part of routine quality assurance; and for determining and stating a manufacturer’s claim for linear range. Item Order Code: EP06-A Nonmember Price: $180 EP07 | Interference Testing in Clinical Chemistry This guideline provides background information, guidance, and experimental procedures for investigating, identifying, and characterizing the effects of interfering substances on clinical chemistry test results. Item Order Code: EP07-A2 Nonmember Price: $180 EP09 | Measurement Procedure Comparison and Bias Estimation Using Patient Samples This guideline addresses the design of measurement procedure comparison experiments using patient samples and subsequent data analysis techniques used to determine the bias between two in vitro diagnostic measurement procedures. Item Order Code: EP09-A3 Nonmember Price: $180 EP15 | User Verification of Precision and Estimation of Bias This guideline describes the estimation of imprecision and of bias for clinical laboratory quantitative measurement procedures using a protocol that can be completed within as few as five days. Item Order Code: EP15-A3 Nonmember Price: $180 Formatted in an enhanced, full-color layout! C24 | Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions This guideline provides definitions of analytical intervals, planning of quality control procedures, and guidance for quality control applications. Item Order Code: C24-A3 Nonmember Price: $140 Members save up to 70% on CLSI products! See page 17 for discount pricing structure. Accreditation Preparedness – Essentials for Verifying Test Performance JUNE 2006 FDA | JC CAP | FDA | JC CAP | FDA | JC CAP | FDA CAP | FDA | JC APRIL 2003 NOVEMBER 2005 AUGUST 2013 SEPTEMBER 2014
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    ORDER TODAY: TollFree (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org 19 EP17 | Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures This guideline provides information for evaluation and documentation of the detection capability of clinical laboratory measurement procedures (ie, limits of blank, detection, and quantitation), for verification of manufacturers’ detection capability claims, and for the proper use and interpretation of different detection capability estimates. Item Order Code: EP17-A2 Nonmember Price: $180 EP21 | Estimation of Total Analytical Error for Clinical Laboratory Methods This guideline provides manufacturers and end users with a means to estimate total analytical error for an assay. A data collection protocol and an analysis method, which can be used to judge the clinical acceptability of new methods using patient specimens, are included. These tools can also monitor an assay’s total analytical error by using quality control samples. Item Order Code: EP21-A Nonmember Price: $180 EP28 | Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory This guideline contains information for determining reference values and reference intervals for quantitative clinical laboratory tests. A CLSI-IFCC joint project. Item Order Code: EP28-A3c Nonmember Price: $180 GP31 | Laboratory Instrument Implementation, Verification, and Maintenance This guideline provides information about assessing instrument performance and function from the time of instrument purchase to the routine performance of clinical testing. Item Order Code: GP31-A Nonmember Price: $140 EP31 | Verification of Comparability of Patient Results Within One Health Care System This guideline provides information on how to verify comparability of quantitative laboratory results for individual patients within a health care system. Item Order Code: EP31-A-IR Nonmember Price: $180 Members save up to 70% on CLSI products! See page 17 for discount pricing structure. Accreditation Preparedness – Essentials for Verifying Test Performance CAP | FDA | JC FDA | JC CAP | FDA | JC CAP | JC CAP | JC JUNE 2012 APRIL 2003 OCTOBER 2010 AUGUST 2012 APRIL 2009
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    ORDER TODAY: TollFree (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org20 GENERALLABORATORY QMS01 | Quality Management System: A Model for Laboratory Services This guideline provides a model for medical laboratories that will assist with implementation and maintenance of an effective quality management system. Item Order Code: QMS01-A4 Nonmember Price: $180 New enhanced, full-color version! QMS02 | Quality Management System: Development and Management of Laboratory Documents This guideline provides information on the processes needed for document management, including creating, controlling, changing, and retiring a laboratory’s policy, process, procedure, and form documents in both paper and electronic environments. Item Order Code: QMS02-A6 Nonmember Price: $180 Related ISO Quality Document Accreditation Preparedness – Laboratory Practices CAP | FDA | JC CAP | JC GP27 | Using Proficiency Testing to Improve the Clinical Laboratory This guideline provides assistance to laboratories in using proficiency testing as a quality improvement tool. Item Order Code: GP27-A2 Nonmember Price: $140 ISO 15189:2012 Medical laboratories – Requirements for quality and competence This International Standard specifies requirements for quality and competence in medical laboratories. Item Order Code: ISO 15189:2012 Price: $180* *CLSI membership rates do not apply for ISO documents. Want to learn more about ISO quality documents? Visit www.clsi.org/accreditation to view our crosswalk that shows how CLSI quality system essentials (QSEs) correspond with clauses in ISO quality documents. The ISO quality documents are listed along with the related CLSI documents under each QSE. CAP | FDA | JC FEBRUARY 2007 GP29 | Assessment of Laboratory Tests When Proficiency Testing Is Not Available This guideline offers methods to assess test performance when proficiency testing is not available; these methods include examples with statistical analyses. This document is intended for use by laboratory managers and testing personnel in traditional clinical laboratories as well as in point-of-care and bedside testing environments. Item Order Code: GP29-A2 Nonmember Price: $140 CAP | JC AUGUST 2008 JUNE 2011 FEBRUARY 2013 Members save up to 70% on CLSI products! See page 17 for discount pricing structure.
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    ORDER TODAY: TollFree (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org 21 @CLSI_LabNews Clinical and Laboratory Standards Institute (Company Page and Group) QMS03 | Training and Competence Assessment This guideline provides background information and recommended processes for the development of training and competence assessment programs that meet quality and regulatory objectives. Item Order Code: QMS03-A3 Nonmember Price: $180 New enhanced, full-color version! QMS06 | Quality Management System: Continual Improvement This guideline considers continual improvement as an ongoing, systematic effort that is an essential component of a quality management system. A continual improvement program may consist of fundamental processes and common supporting elements described in this guideline. Item Order Code: QMS06-A3 Nonmember Price: $180 QMS11 | Management of Nonconforming Laboratory Events This guideline provides an outline and the content for developing a program to manage a health care service’s nonconforming events that is based on the principles of quality management and patient safety. Item Order Code: QMS11-A Nonmember Price: $180 New enhanced, full-color version coming July 2015! Accreditation Preparedness – Laboratory Practices CAP | JC CAP | FDA | JC CAP | JC FEBRUARY 2009 JUNE 2011 NOVEMBER 2007 Search for “CLSI To Go” in the Follow CLSI on Social Media! or Members save up to 70% on CLSI products! See page 17 for discount pricing structure.
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    ORDER TODAY: TollFree (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org22 OCTOBER 2014 APRIL 2011 Automation and Informatics AUTO11 | Information Technology Security of In Vitro Diagnostic Instruments and Software Systems This standard provides a framework for communication of information technology security issues between the in vitro diagnostic system vendor and the health care organization. Item Order Code: AUTO11-A2 Nonmember Price: $140 FDA AUTO12 | Specimen Labels: Content and Location, Fonts, and Label Orientation The purpose of this standard is to reduce human errors currently associated with the lack of standardization of labels on clinical laboratory specimens. The standard identifies the required human-readable elements to appear on specimen labels and specifies the exact locations, fonts, and font sizes of these elements. Item Order Code: AUTO12-A Nonmember Price: $140 CAP | FDA | JC Members save up to 70% on CLSI products! See page 17 for discount pricing structure. Free On-Demand Webinar | Introduction to CLSI Document AUTO11—Information Technology Security of In Vitro Diagnostic Instruments and Software Systems This informative webinar introduces CLSI document AUTO11. It addresses items such as the document’s scope, an outline of the document, why the document was created, and how the document is beneficial to the laboratory. Item Order Code: AUTO11-A2 WR Nonmember Price: FREE Visit www.clsi.org/webinars to learn more. Speaker: Ed Heierman III, PhD Software Architect, Abbott, Irving, Texas, USA
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    ORDER TODAY: TollFree (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org 23 Don’t Get Cited for Common Deficiencies! CLSI crosswalks help you ensure your lab is prepared for accreditation and inspections. Numerous CLSI documents are referenced in these crosswalks. They serve as key resources in satisfying regulatory requirements and avoiding compliance issues. Be ready for inspection at any time! Download these free CLSI crosswalks at www.clsi.org/accreditation. The Joint Commission
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    ORDER TODAY: TollFree (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org24 Clinical Chemistry and Toxicology C24 | Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions This guideline provides definitions of analytical intervals, planning of quality control procedures, and guidance for quality control applications. Item Order Code: C24-A3 Nonmember Price: $140 C40 | Measurement Procedures for the Determination of Lead Concentrations in Blood and Urine This guideline provides information for the measurement of lead concentrations in blood and urine, including specimen collection, measurement by graphite furnace atomic absorption spectrometry, anodic stripping voltammetry, and inductively coupled plasma mass spectrometry. It also includes guidelines for quality assurance and quality control, and information on proficiency testing programs and laboratory certification. Item Order Code: C40-A2 Nonmember Price: $140 C49 | Analysis of Body Fluids in Clinical Chemistry This guideline provides information for the application of widely available measurement procedures for testing body fluids and for reporting and interpreting those results. It emphasizes defining the common clinical situations for this use; acceptable practice for measuring analytes without extended method verification for abnormal body fluid; influence of biologic and analytic variation on interpretation of results; and variability in comparing results between different instrument manufacturers. This document does not consider serum, plasma, whole blood, or fluids for which assays typically have performance claims in the measurement procedure documentation. A CLSI-IFCC joint project. Item Order Code: C49-A Nonmember Price: $140 CAP | FDA | JC JC CAP | JC C34 | Sweat Testing: Sample Collection and Quantitative Chloride Analysis This guideline addresses appropriate methods of collection and analysis, quality control, and the evaluation and reporting of test results. Item Order Code: C34-A3 Nonmember Price: $140 C46 | Blood Gas and pH Analysis and Related Measurements This guideline provides clear definitions of the quantities in current use, and provides a single source of information on appropriate specimen collection, preanalytical variables, calibration, and quality control for blood pH and gas analysis and related measurements. Item Order Code: C46-A2 Nonmember Price: $140 Related Companion Product (Bench Aid) C49/H56 QG | Collection, Handling, Transport, and Storage for Body Fluids Quick Guide Describes recommended methods for the collection, handling, transport, and storage of various types of body fluids. Formatted as durable, waterproof sheets for quick reference. Item Order Code: C49-A/H56-A QG Nonmember Price: $20 CAP | FDA | JC CAP | JC DECEMBER 2009JUNE 2006 FEBRUARY 2009OCTOBER 2013 APRIL 2007 JANUARY 2015 Members save up to 70% on CLSI products! See page 17 for discount pricing structure.
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    ORDER TODAY: TollFree (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org 25 C56 | Hemolysis, Icterus, and Lipemia/ Turbidity Indices as Indicators of Interference in Clinical Laboratory Analysis This guideline provides background information on mechanisms of hemolysis, icterus, lipemia/turbidity (HIL) interference; intended usefulness of HIL indices; establishment of HIL alert indices; availability of automated HIL detection systems; and interpretation, strengths, limitations, and verification of HIL indices in the clinical laboratory. Item Order Code: C56-A Nonmember Price: $140 Related Companion Product (Bench Aid) C56 QG | Examples of Hemolyzed, Icteric, and Lipemic/Turbid Samples Quick Guide Shows examples of hemolyzed, icteric, and lipemic/turbid samples. Formatted as a durable, waterproof sheet for quick reference. Item Order Code: C56-A QG Nonmember Price: $20 C57 | Mass Spectrometry for Androgen and Estrogen Measurements in Serum This guideline is intended to aid the laboratorian in developing appropriate procedures for the use of mass spectrometry in the measurement of androgens and estrogens. Item Order Code: C57-Ed1 Nonmember Price: $140 C62 | Liquid Chromatography-Mass Spectrometry Methods This guideline provides information to the clinical laboratorian for the reduction of interlaboratory variance and the evaluation of interferences, assay performance, and other pertinent characteristics of clinical assays. This guideline emphasizes particular areas related to assay development and presents a standardized approach for method verification that is specific to mass spectrometry technology. Item Order Code: C62-A Nonmember Price: $140 Clinical Chemistry and Toxicology FDA | JC JC JULY 2012 OCTOBER 2014 FEBRUARY 2015 OCTOBER 2014 Members save up to 70% on CLSI products! See page 17 for discount pricing structure. Free On-Demand Webinar | Introduction to CLSI Document C62—Liquid Chromatography- Mass Spectrometry Methods This informative webinar introduces CLSI document C62. It addresses items such as the document’s scope, an outline of the document, why the document was created, and how the document is beneficial to the laboratory. Item Order Code: C62-A WR Nonmember Price: FREE Visit www.clsi.org/webinars to learn more. Speaker: William Clarke, PhD, MBA, DABCC Associate Professor of Pathology, Johns Hopkins Medical Institutions, Baltimore, Maryland, USA
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    ORDER TODAY: TollFree (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org26 Hematology and Coagulation H02 | Procedures for the Erythrocyte Sedimentation Rate Test This standard provides a description of the principle, materials, and procedure for a standardized erythrocyte sedimentation rate (ESR) method; a selected routine method, as well as a procedure to evaluate routine methods; and an outline of quality control programs for the ESR test. Item Order Code: H02-A5 Nonmember Price: $140 H52 | Red Blood Cell Diagnostic Testing Using Flow Cytometry This guideline addresses the diagnostic red blood cell (RBC) assays performed as fluorescence-based assays on a flow cytometry platform; including testing procedures for fetomaternal hemorrhage detection, paroxysmal nocturnal hematuria screening, membrane defect anemia testing for hereditary spherocytosis, and nucleated RBC counting. Points of validation and quality control, and caveats of interpretation are also discussed. Item Order Code: H52-A2 Nonmember Price: $140 JC CAP | JC H21 | Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays and Molecular Hemostasis Assays This guideline provides procedures for collecting, transporting, and storing blood; processing blood specimens; storing plasma for coagulation testing; and general recommendations for performing the tests. Item Order Code: H21-A5 Nonmember Price: $140 H26 | Validation, Verification, and Quality Assurance of Automated Hematology Analyzers This standard provides guidance for the validation, verification, calibration, quality assurance (QA), and quality control (QC) of automated multichannel hematology analyzers for manufacturers, end-user clinical laboratories, accrediting organizations, and regulatory bodies. In addition, end-user clinical laboratories will find guidance for establishment of clinically reportable intervals and for QA for preexamination and examination aspects of their systems. Item Order Code: H26-A2 Nonmember Price: $140 CAP | FDA | JC CAP | FDA | JC JANUARY 2008MAY 2011 JUNE 2010 MARCH 2014 Related Companion Product (Bench Aid) H21 QG | Collection, Handling, Transport, and Storage for Hemostasis Quick Guide Outlines best practice procedures for the proper collection, transportation, and processing of blood specimens as well as storage of plasma for coagulation testing. Formatted as durable, waterproof sheets for quick reference. Item Order Code: H21-A5 QG Nonmember Price: $20 JANUARY 2008 Members save up to 70% on CLSI products! See page 17 for discount pricing structure.
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    ORDER TODAY: TollFree (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org 27 Related Companion Product (Bench Aid) H60 QG1 | Algorithmic Approach to Lupus Anticoagulant Testing Quick Guide Describes the algorithmic approach to lupus anticoagulant testing for independent, paired, and integrated test systems. Formatted as durable, waterproof sheets for quick reference. Item Order Code: H60-A QG1 Nonmember Price: $20 Related Companion Product (Bench Aid) H60 QG2 | Criteria for the Laboratory Diagnosis of the Lupus Anticoagulant Quick Guide Includes sample identification criteria and recommendations specific to each criterion for the laboratory diagnosis of the lupus anticoagulant. Formatted as durable, waterproof sheets for quick reference. Item Order Code: H60-A QG2 Nonmember Price: $20 Hematology and Coagulation JC DECEMBER 2014 DECEMBER 2014 H59 | Quantitative D-dimer for the Exclusion of Venous Thromboembolic Disease This guideline provides information regarding the use of D-dimer in exclusion of venous thromboembolism (VTE) including a description of the value of clinical determination of the pretest probability of VTE; the proper collection and handling of the specimen; assays used for D-dimer analysis; determination of the threshold for exclusion of VTE; interpretation of test results; and aspects of regulatory and accreditation requirements. Item Order Code: H59-A Nonmember Price: $140 CAP | FDA | JC MARCH 2011 H60 | Laboratory Testing for the Lupus Anticoagulant This guideline provides information and recommendations regarding the proper collection and handling of the specimen; descriptions and limitations of screening and confirmatory assays, and mixing tests used to identify lupus anticoagulant (LA); determination of cutoff values and calculations associated with the various assays; and interpretation of test results in an LA panel. Item Order Code: H60-A Nonmember Price: $140 JC APRIL 2014 Members save up to 70% on CLSI products! See page 17 for discount pricing structure.
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    ORDER TODAY: TollFree (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org28 Immunology and Ligand Assay I/LA20 | Analytical Performance Characteristics and Clinical Utility of Immunological Assays for Human Immunoglobulin E (IgE) Antibodies and Defined Allergen Specificities This guideline provides information for the design, analytical performance, standardization, quality assurance, and clinical application of laboratory assays used in the measurement of human IgE antibodies of defined allergen specificity. Item Order Code: I/LA20-A2 Nonmember Price: $140 I/LA28 | Quality Assurance for Design Control and Implementation of Immunohistochemistry Assays This guideline provides information for the development of validated diagnostic, prognostic, and predictive immunohistochemical assays. Item Order Code: I/LA28-A2 Nonmember Price: $140 I/LA33 | Validation of Automated Systems for Immunohematological Testing Before Implementation This guideline provides information to the end user and laboratory for validation of automated systems used in immunohematological testing before implementation. Item Order Code: I/LA33-A Nonmember Price: $140 FDA | JC CAP | FDA | JC JC I/LA26 | Performance of Single Cell Immune Response Assays This guideline contains methods of intracellular cytokine evaluation, major histocompatibility complex multimer quantitation, enzyme-linked immunospot technology, and carboxyfluorescein succinimidyl ester tracking dye staining for the assessment of cellular proliferation. It also provides basic aspects of specimen collection, transport, and preparation; results interpretation; and quality assurance and test validation approaches. Item Order Code: I/LA26-A2 Nonmember Price: $140 JC NOVEMBER 2013MARCH 2009 JANUARY 2011 DECEMBER 2009 Related Companion Product (Toolkit) I/LA33 TK | Validation of Automated Systems for Immunohematological Testing Before Implementation—Sample Templates and Test Cases Toolkit Provides 24 customizable templates from the appendixes of I/LA33. Each simplified template, test case, checklist, worksheet, and schedule can be used by the laboratory for development of test cases related to different aspects of installation qualification, operational qualification, and performance qualification. Item Order Code: I/LA33-A TK Nonmember Price: $100 Related Companion Product (Bench Aid) I/LA28 QG | Comparison of the Characteristics of Immunoassays Such as Enzyme-Linked Immunosorbent Assay and Immunohistochemistry Quick Guide Shows a comparison of the characteristics of immunoassays. Formatted as four durable, waterproof sheets on a convenient detachable ring for quick reference. Item Order Code: I/LA28-A2 QG Nonmember Price: $40 DECEMBER 2009 SEPTEMBER 2014 Members save up to 70% on CLSI products! See page 17 for discount pricing structure.
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    ORDER TODAY: TollFree (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org 29 Microbiology Methodologies M02* | Performance Standards for Antimicrobial Disk Susceptibility Tests This standard contains the current CLSI-recommended methods for disk susceptibility testing, criteria for quality control testing, and updated tables for interpretive zone diameters. An Interactive Searchable Database for Drug Selection, Interpretation, and Quality Control Procedures! eM100 is built to work the way you do—efficiently and in the laboratory. This online implementation of CLSI’s most widely recognized antimicrobial susceptibility testing document provides information for drug selection, interpretation, and quality control as well as the latest recommendations for detecting resistance mechanisms, all arranged in an easy-to-use, interactive, and searchable format. M07* | Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically This standard addresses reference methods for the determination of minimal inhibitory concentrations of aerobic bacteria by broth macrodilution, broth microdilution, and agar dilution. M100* | Performance Standards for Antimicrobial Susceptibility Testing This supplement provides updated tables for the CLSI antimicrobial susceptibility testing standards M02-A12, M07-A10, and M11-A8. The tabular information presented in M100 represents the most current information for drug selection, interpretation, and quality control using the procedures standardized in the most current editions of M02, M07, and M11. M100 is updated every January, so please check shop.clsi.org for the 2016 version. JANUARY 2015 JANUARY 2015 JANUARY 2015 Related Companion Product (Bench Aid) AST QC QG | AST QC Flow Chart Quick Guide The ultimate “cheat sheet” to quality control (QC) for antimicrobial susceptibility testing. Based on M02, M07, and M100, these easy-to-use flow charts guide you through daily QC testing for both disk diffusion and aerobic dilution. Once required daily QC has been documented, users can convert to weekly QC with a flip of a page. Formatted as durable, waterproof sheets on a convenient detachable ring for convenient, shared use in the laboratory. Item Order Code: AST QC QG Nonmember Price: $120 Related Companion Product (Bench Aid) M100 QG | M100-S25 Tables 1A–1C Quick Guide Provides suggested groupings of antimicrobial agents that should be considered for routine disk and broth dilution testing and reporting by clinical laboratories. Formatted as durable, waterproof sheets on a convenient detachable ring for convenient, shared use in the laboratory. Item Order Code: M100-S25 QG Nonmember Price: $100 *Note that in 2015, M100 must be purchased with one of the following M02 or M07 packages. Item Order Code: M02-A12/M07-A10 PK15 (includes M02-A12, M07-A10, and M100-S25) | Nonmember Price: $500 Item Order Code: M02-A12 PK15 (includes M02-A12 and M100-S25) | Nonmember Price: $340 Item Order Code: M07-A10 PK15 (includes M07-A10 and M100-S25) | Nonmember Price: $340 JANUARY 2015 JANUARY 2015 Members save up to 70% on CLSI products! See page 17 for discount pricing structure. Visit www.clsi.org/eM100 to learn more.
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    ORDER TODAY: TollFree (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org30 Microbiology Methodologies M22 | Quality Control for Commercially Prepared Microbiological Culture Media This standard contains quality assurance procedures for manufacturers and users of prepared, ready-to-use microbiological culture media. Item Order Code: M22-A3 Nonmember Price: $180 M35 | Abbreviated Identification of Bacteria and Yeast This guideline provides the minimum identification criteria that can be used to rapidly identify organisms commonly isolated from clinical specimens. Item Order Code: M35-A2 Nonmember Price: $180 M28 | Procedures for the Recovery and Identification of Parasites From the Intestinal Tract This guideline addresses the collection, processing, and examination of intestinal tract specimens for the identification of parasites. Item Order Code: M28-A2 Nonmember Price: $180 JUNE 2005JUNE 2004 NOVEMBER 2008 M40 | Quality Control of Microbiological Transport Systems This standard provides criteria to assist manufacturers and end users of transport devices in providing and selecting dependable products for the transport of microbiological clinical specimens. Item Order Code: M40-A2 Nonmember Price: $180 JUNE 2014 Members save up to 70% on CLSI products! See page 17 for discount pricing structure.
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    ORDER TODAY: TollFree (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org 31 Microbiology Methodologies M47 | Principles and Procedures for Blood Cultures This guideline provides recommendations for the collection, transport, and processing of blood cultures as well as guidance for the recovery of pathogens from blood specimens taken from patients who are suspected of having bacteremia or fungemia. Item Order Code: M47-A Nonmember Price: $180 M54 | Principles and Procedures for Detection of Fungi in Clinical Specimens— Direct Examination and Culture This guideline provides protocols, quality control parameters, and interpretive criteria for performing fungal cultures and for the detection and identification of fungi in direct examinations. Item Order Code: M54-A Nonmember Price: $180 CAP | FDA | JC M56 | Principles and Procedures for Detection of Anaerobes in Clinical Specimens This guideline presents standardized, cost-effective, and efficient best practice processes for anaerobe bacteriology to assist clinical laboratories in selecting those methods that lead to improved patient care. Item Order Code: M56-A Nonmember Price: $180 JULY 2014 MAY 2007 OCTOBER 2012 Related Companion Product (Bench Aid) M47 QG | Collection, Handling, and Transport for Blood Cultures Quick Guide Provides a quick reference for nursing, emergency room staff, phlebotomists, and laboratorians on the timing and collection, transport and set-up, as well as procedures for processing blood cultures. Item Order Code: M47-A QG Nonmember Price: $20 MARCH 2015 Members save up to 70% on CLSI products! See page 17 for discount pricing structure.
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    ORDER TODAY: TollFree (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org32 Molecular Methods MM03 | Molecular Diagnostic Methods for Infectious Diseases, 3rd Edition This report addresses topics relating to clinical applications, amplified and nonamplified nucleic acid methods, selection and qualification of nucleic acid sequences, establishment and evaluation of test performance characteristics, inhibitors, and interfering substances, controlling false-positive reactions, reporting and interpretation of results, quality assurance, regulatory issues, and recommendations for manufacturers and clinical laboratories. Item Order Code: MM03-Ed3 Nonmember Price: $140 MM07 | Fluorescence In Situ Hybridization Methods for Clinical Laboratories This guideline addresses fluorescence in situ hybridization methods for medical genetic determinations, identification of chromosomal abnormalities, and gene amplification. Recommendations for probe and assay development, manufacture, qualification, verification, and validation; instrument requirements; quality assurance; and evaluation of results are also included. Item Order Code: MM07-A2 Nonmember Price: $140 MM13 | Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods This guideline provides information related to proper and safe biological specimen collection and nucleic acid isolation and purification. These topics include methods of collection, recommended storage and transport conditions, and available nucleic acid purification technologies for each specimen/nucleic acid type. A CLSI-IFCC joint project. Item Order Code: MM13-A Nonmember Price: $140 FDA | JC CAP | JC CAP | FDA | JC MM06 | Quantitative Molecular Methods for Infectious Diseases This guideline provides information for the development and use of quantitative molecular methods, such as nucleic acid probes and nucleic acid amplification techniques of the target sequences specific to particular microorganisms. It also presents recommendations for quality assurance, proficiency testing, and interpretation of results. Item Order Code: MM06-A2 Nonmember Price: $140 FDA | JC NOVEMBER 2010FEBRUARY 2015 AUGUST 2013 DECEMBER 2005 MM09 | Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine This guideline addresses diagnostic sequencing using both automated capillary-based sequencers and massively parallel sequencing instruments. Topics include specimen collection and handling; isolation and extraction of nucleic acid; template preparation; sequence generation, alignment, and assembly; validation and verification; ongoing quality assurance; and reporting results. Item Order Code: MM09-A2 Nonmember Price: $140 CAP | FDA | JC FEBRUARY 2014 Related Companion Product (Bench Aid) MM13 QG | Handling, Transport, and Storage of Specimens for Molecular Methods Quick Guide Describes the recommended methods for the collection of molecular method samples, proper shipping conditions, and storage addressing issues including temperature, preservatives, and duration. Item Order Code: MM13-A QG Nonmember Price: $20 MARCH 2015 Members save up to 70% on CLSI products! See page 17 for discount pricing structure.
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    ORDER TODAY: TollFree (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org 33 Molecular Methods MM14 | Design of Molecular Proficiency Testing/External Quality Assessment This guideline provides information for a quality proficiency testing/external quality assessment program, including reliable databases; design control in the choice of materials and measurands; good manufacturing processes; documentation procedures; complaint handling; corrective and preventive action plans; and responsive timing of reports. Item Order Code: MM14-A2 Nonmember Price: $140 MM19 | Establishing Molecular Testing in Clinical Laboratory Environments This guideline provides comprehensive information for planning and implementation of molecular diagnostic testing, including strategic planning, regulatory requirements, implementation, quality management, and special considerations for the subspecialties of molecular genetics, infectious diseases, oncology, and pharmacogenetics. Item Order Code: MM19-A Nonmember Price: $140 MM22 | Microarrays for Diagnosis and Monitoring of Infectious Diseases This guideline provides information for the laboratory development and use of qualitative nucleic acid microarray methods for the diagnosis and monitoring of infectious diseases. It also presents recommendations for validation and verification, quality control, and interpretation of results. Item Order Code: MM22-A Nonmember Price: $140 JC CAP | JC JC MM20 | Quality Management for Molecular Genetic Testing This guideline provides information for implementing international quality management system standards in laboratories that perform human molecular genetic testing for inherited or acquired conditions. Item Order Code: MM20-A Nonmember Price: $140 JC NOVEMBER 2012 MAY 2013 NOVEMBER 2011 FEBRUARY 2014 MM17 | Verification and Validation of Multiplex Nucleic Acid Assays This guideline provides recommendations for analytic verification and validation of multiplex assays, as well as a review of different types of biologic and synthetic reference materials. Item Order Code: MM17-A Nonmember Price: $140 JC MARCH 2008 Members save up to 70% on CLSI products! See page 17 for discount pricing structure.
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    ORDER TODAY: TollFree (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org34 Newborn Screening NBS01 | Blood Collection on Filter Paper for Newborn Screening Programs This standard highlights specimen collection methods, discusses acceptable techniques for applying blood drops or aliquots to the filter paper segment of the specimen collection device, and provides instructions on proper specimen handling and transport to ensure quality specimens are consistently obtained for newborn screening analysis. Item Order Code: NBS01-A6 Nonmember Price: $140 NBS03 | Newborn Screening for Preterm, Low Birth Weight, and Sick Newborns This guideline outlines the recommended protocols for screening preterm, sick, or low birth weight infants for hearing loss and disorders detectable through dried blood spot testing. Item Order Code: NBS03-A Nonmember Price: $140 CAP | FDA | JC JC JULY 2013 OCTOBER 2009 NBS02 | Newborn Screening Follow-up This guideline describes the basic principles, scope, and range of follow-up activities within the newborn screening system. Item Order Code: NBS02-A2 Nonmember Price: $140CAP | JC MAY 2013 Related Video NBS01 DVD | Making a Difference Through Newborn Screening: Blood Collection on Filter Paper DVD This video shows how to prepare for specimen collection; collect blood specimens using the recommended heelstick technique; handle specimens properly; maintain appropriate records; and prevent testing problems that can delay the newborn’s diagnosis and treatment. Item Order Code: NBS01-A6 DVD Nonmember Price: $300 Related Companion Product (Bench Aid) NBS01 QG | Specimen Collection and Sample Quality for Newborn Screening Quick Guide How to Collect an Acceptable Blood Spot Specimen Simple Spot Check Item Order Code: NBS01-A6 QG Nonmember Price: $20 Related Companion Product (Bench Aid) NBS02 QG | Newborn Screening Follow-up Process Quick Guide Describes the newborn screening follow-up process. Item Order Code: NBS02-A2 QG Nonmember Price: $20 Related Companion Product (Bench Aid) NBS03 QG | Algorithm for Newborn Screening of Preterm, Low Birth Weight, and Sick Newborns Quick Guide Provides information on when to collect first, second, and third specimens for newborn screening and includes special care baby unit screening algorithm for preterm, low birth weight, and sick newborns. Item Order Code: NBS03-A QG Nonmember Price: $20 JUNE 2014 JULY 2013 JULY 2013 JULY 2013 Members save up to 70% on CLSI products! See page 17 for discount pricing structure.
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    ORDER TODAY: TollFree (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org 35 Newborn Screening NBS04 | Newborn Screening by Tandem Mass Spectrometry This guideline serves as a reference source for the numerous activities related to operating a tandem mass spectrometry laboratory as part of public and private newborn screening programs with the goal of creating greater test accuracy, performance, and consistency among laboratories, thereby ensuring data quality that will ultimately benefit all newborns worldwide. Item Order Code: NBS04-A Nonmember Price: $140 NBS06 | Newborn Blood Spot Screening for Severe Combined Immunodeficiency by Measurement of T-cell Receptor Excision Circles This guideline addresses the detection of severe combined immunodeficiency (SCID) by population-based newborn screening using dried blood spot specimens to measure T-cell receptor excision circles. SCID is a lethal disorder of infancy that is not evident at birth, and effective treatment requires presymptomatic detection. Item Order Code: NBS06-A Nonmember Price: $140 Newborn Screening Specialty Collection Collection includes all 6 Newborn Screening documents, the NBS01 DVD, and 6 companion products (bench aids). Item Order Code: NBSSC Nonmember Price: $800 JC JC JULY 2010 APRIL 2013 NBS05 | Newborn Screening for Cystic Fibrosis This guideline describes the use of newborn screening laboratory tests for detecting risk for cystic fibrosis from newborn dried blood spots (DBS) and addresses both the primary screening tests and the reflex tests performed on DBS. Item Order Code: NBS05-A Nonmember Price: $140 JC NOVEMBER 2011 Related Companion Product (Bench Aid) NBS06 QG1 | Generic Flow Chart for Assays to Measure T-cell Receptor Excision Circles in Newborn Dried Blood Spot Specimens Quick Guide Flow chart for assays to measure T-cell receptor excision circles in newborn dried blood spot specimens. Formatted as a durable, waterproof sheet for quick reference. Item Order Code: NBS06-A QG1 Nonmember Price: $20 Related Companion Product (Bench Aid) NBS06 QG2 | Schematic for Preparing Dried Blood Spot Reference Materials Quick Guide Provides a schematic for preparing dried blood spot reference materials. Formatted as a durable, waterproof sheet for quick reference. Item Order Code: NBS06-A QG2 Nonmember Price: $20 Related Companion Product (Wall Chart) NBS06 WC | Immunodeficiency Disorders and T-cell Receptor Excision Circle Values in the Newborn Screening Period Wall Chart Shows immunodeficiency disorders and T-cell receptor excision circle values in the newborn screening period. Item Order Code: NBS06-A WC Nonmember Price: $20 JULY 2013 JULY 2013 JULY 2013 bundle and save! Members save up to 70% on CLSI products! See page 17 for discount pricing structure.
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    ORDER TODAY: TollFree (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org36 Phlebotomy Related Companion Product (Bench Aid) GP41 QG | Quality Venipuncture Quick Guide Lists all of the steps of the venipuncture procedure, as well as special considerations, and the order of the tube draw. It also includes a color photo of vein distribution on the right arm for guidance in the venipuncture procedure. Formatted as an 11x17-inch chart. Item Order Code: GP41-A6 QG Nonmember Price: $20 JANUARY 2008 GP41 | Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture This standard provides procedures for the collection of diagnostic specimens by venipuncture, including line draws, blood culture collection, and venipuncture in children. Item Order Code: GP41-A6 Nonmember Price: $140 CAP | FDA | JC OCTOBER 2007 M47 | Principles and Procedures for Blood Cultures This guideline provides recommendations for the collection, transport, and processing of blood cultures as well as guidance for the recovery of pathogens from blood specimens taken from patients who are suspected of having bacteremia or fungemia. Item Order Code: M47-A Nonmember Price: $180 CAP | FDA | JC MAY 2007 Related Companion Product (Bench Aid) M47 QG | Collection, Handling, and Transport for Blood Cultures Quick Guide Provides a quick reference for nursing, emergency room staff, phlebotomists, and laboratorians on the timing and collection, transport and set-up, as well as procedures for processing blood cultures. Item Order Code: M47-A QG Nonmember Price: $20 MARCH 2015 NBS01 | Blood Collection on Filter Paper for Newborn Screening Programs This standard highlights specimen collection methods, discusses acceptable techniques for applying blood drops or aliquots to the filter paper segment of the specimen collection device, and provides instructions on proper specimen handling and transport to ensure quality specimens are consistently obtained for newborn screening analysis. Item Order Code: NBS01-A6 Nonmember Price: $140 CAP | FDA | JC JULY 2013 Related Video NBS01 DVD | Making a Difference Through Newborn Screening: Blood Collection on Filter Paper DVD This video shows how to prepare for specimen collection; collect blood specimens using the recommended heelstick technique; handle specimens properly; maintain appropriate records; and prevent testing problems that can delay the newborn’s diagnosis and treatment. Item Order Code: NBS01-A6 DVD Nonmember Price: $300 Related Companion Product (Bench Aid) NBS01 QG | Specimen Collection and Sample Quality for Newborn Screening Quick Guide How to Collect an Acceptable Blood Spot Specimen Simple Spot Check Item Order Code: NBS01-A6 QG Nonmember Price: $20 JUNE 2014 JULY 2013 Members save up to 70% on CLSI products! See page 17 for discount pricing structure.
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    ORDER TODAY: TollFree (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org 37 Share your knowledge and disseminate information. Explore ideas and participate in group or private discussions. Access experience-based solutions from professional colleagues. Find resources to do your job better,shorten decision times,and decrease risk. Network to find individuals who share similar goals and interests. Participate in CLSI’s online Communities to collaborate with fellow professionals! Join today at community.clsi.org. Membership Community – Coming Soon!
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    ORDER TODAY: TollFree (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org38 Point-of-Care Testing POCT04 | Point-of-Care In Vitro Diagnostic (IVD) Testing This guideline provides information to users of in vitro diagnostic devices outside the clinical laboratory, to ensure reliable results comparable to those obtained within the clinical laboratory. Item Order Code: POCT04-A2 Nonmember Price: $140 Related Companion Product (Bench Aid) POCT07 RG | Addressing Errors in Point-of-Care Testing Reference Guide Includes preexamination considerations (patient preparation for the test and sample collection and handling); examination considerations (operator related, reagent related, sample related, and device related); and postexamination considerations (communication related and data management related). Formatted as a spiral-bound reference guide for convenient use in the laboratory. Item Order Code: POCT07-A RG Nonmember Price: $50 POCT08 | Quality Practices in Noninstrumented Point-of-Care Testing: An Instructional Manual and Resources for Health Care Workers This instructional guideline delivers laboratory science concepts and activities with the goal of increasing knowledge and quality of laboratory testing for testing personnel with no laboratory background. Item Order Code: POCT08-A Nonmember Price: $140 JC JC POCT07 | Quality Management: Approaches to Reducing Errors at the Point of Care This guideline presents the core infrastructure for a standardized error tracking system with the primary goals of reducing risk and increasing quality of point-of-care testing, while accumulating standardized data for benchmarking use. Item Order Code: POCT07-A Nonmember Price: $140 A Document Competency Quiz is available for this document! Visit www.clsi.org/edu for more information. JC OCTOBER 2010 AUGUST 2006 JANUARY 2015 DECEMBER 2010 Related Companion Product (Bench Aid) POCT08 QG1 | Corrective Action Report Quick Guide Report completed when any control falls outside the acceptable range. Formatted as a durable, waterproof sheet for convenient use in the laboratory. Item Order Code: POCT08-A QG1 Nonmember Price: $20 SEPTEMBER 2011 POCT Companion Product Package This package includes: POCT07-A RG—Addressing Errors in Point-of-Care Testing Reference Guide POCT08-A QG1—Corrective Action Report Quick Guide (Electronic Download) Item Order Code: POCT PK POCT08-A QG2—Quality Control Troubleshooting Flow Chart POCT09-A WS—Instrument Selection Worksheet (Electronic Download) Nonmember Price: $140 bundle and save! POCT06 | Effects of Different Sample Types on Glucose Measurements This report provides information to assist the clinical and point-of-care staff in result and measurement procedure comparisons of glucose tests. Item Order Code: POCT06-Ed1 Nonmember Price: $140 MAY 2015 Members save up to 70% on CLSI products! See page 17 for discount pricing structure.
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    ORDER TODAY: TollFree (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org 39 Point-of-Care Testing POCT09 | Selection Criteria for Point-of-Care Testing Devices This guideline provides information on selection of point-of-care testing devices based on the patient care setting and clinical needs. It is designed as an aid to laboratory and facility management to simplify and facilitate the selection process, but also allows evaluation of devices to identify those that are optimal to the patient care setting and population served. Item Order Code: POCT09-A Nonmember Price: $140 POCT12 | Point-of-Care Blood Glucose Testing in Acute and Chronic Care Facilities This guideline contains information for performance of point-of-care blood glucose meter systems that stress quality control, training, and administrative responsibility. Item Order Code: POCT12-A3 Nonmember Price: $140 JC CAP | JC APRIL 2010 JANUARY 2013 Related Companion Product (Bench Aid) POCT08 QG2 | Quality Control Troubleshooting Flow Chart Flow chart for noninstrumented quality control (QC) decision making for QC out of range. Formatted as a durable, waterproof sheet for convenient use in the laboratory. Item Order Code: POCT08-A QG2 Nonmember Price: $20 Related Companion Product (Bench Aid) POCT08 QG3 | Quality Control Log Sheet Quick Guide Log sheet for noninstrumented point-of-care testing. Formatted as a durable, waterproof sheet for convenient use in the laboratory. Item Order Code: POCT08-A QG3 Nonmember Price: $20 Related Companion Product (Worksheet) POCT09 WS | Instrument Selection Worksheet Clinical needs assessment comparison electronic worksheet, which includes items to consider when comparing point-of-care testing system specifications. Item Order Code: POCT09-A WS Nonmember Price: $40 JULY 2013 SEPTEMBER 2011 SEPTEMBER 2011 Related On-Demand POCT08 Webinar | Managing Manual Tests: Challenges and Solutions Objectives: List the CLIA regulations most frequently cited for manual test deficiencies. Describe the inherent challenges of manual testing that have a negative impact on patient care. Recognize how to use the tools or avenues available to ensure quality in point-of-care manual testing. Item Order Code: POCT08 WR Nonmember Price: $99 Visit www.clsi.org/webinars to learn more. Speakers: Karen W. Dyer, MT(ASCP), DLM Survey and Certification Group, Centers for Medicare & Medicaid Services (CMS), Baltimore, Maryland, USA Patricia L. Kraft, MA, MT(ASCP) Laboratory POCT/Safety/Education Coordinator, Good Samaritan Hospital, Dayton, Ohio, USA Related Companion Product (Wall Chart) POCT10/GP16 WC | Microscopic Components in Urine Sediment and Vaginal Fluid Wall Charts Provides images of microscopic components in urine sediment and vaginal fluid, including bacteria and parasites, casts, cells, crystals, noncellular material, and vaginal fluid and KOH preparations. Formatted as two 17x22-inch wall charts for posting in the laboratory. Item Order Code: POCT10/GP16 WC Nonmember Price: $60 MARCH 2015 Members save up to 70% on CLSI products! See page 17 for discount pricing structure.
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    ORDER TODAY: TollFree (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org40 Quality Management Systems The Key to Quality™ This workbook includes fundamental information for implementing and sustaining a quality management system (QMS). You will learn: The 12 quality system essentials (QSEs) for building a QMS The policies, processes, and procedures requirements for each QSE How to apply the 12 QSEs in your unique laboratory environment The Key to Quality includes ready-to-use templates and examples of completed forms and QMS tools to assist users in fulfilling the required elements in each QSE. Item Order Code: K2Q Nonmember Price: $600 QMS03 | Training and Competence Assessment This guideline provides background information and recommended processes for the development of training and competence assessment programs that meet quality and regulatory objectives. Item Order Code: QMS03-A3 Nonmember Price: $180 New enhanced, full-color version! QMS06 | Quality Management System: Continual Improvement This guideline considers continual improvement as an ongoing, systematic effort that is an essential component of a quality management system. A continual improvement program may consist of fundamental processes and common supporting elements described in this guideline. Item Order Code: QMS06-A3 Nonmember Price: $180 QMS01 | Quality Management System: A Model for Laboratory Services This guideline provides a model for medical laboratories that will assist with implementation and maintenance of an effective quality management system. Item Order Code: QMS01-A4 Nonmember Price: $180 New enhanced, full-color version! QMS02 | Quality Management System: Development and Management of Laboratory Documents This guideline provides information on the processes needed for document management, including creating, controlling, changing, and retiring a laboratory’s policy, process, procedure, and form documents in both paper and electronic environments. Item Order Code: QMS02-A6 Nonmember Price: $180 CAP | JC CAP | FDA | JC CAP | FDA | JC CAP | JC SEPTEMBER 2013 FEBRUARY 2009 JUNE 2011 JUNE 2011 FEBRUARY 2013 Members save up to 70% on CLSI products! See page 17 for discount pricing structure.
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    ORDER TODAY: TollFree (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org 41 Quality Management Systems QMS15 | Assessments: Laboratory Internal Audit Program This guideline provides information for how a laboratory can establish an internal audit program to enhance the quality of its services through continual improvement. Whereas an audit program defines the “who,” “what,” “when,” “where,” and “how” of meeting requirements for internal auditing, the audit process describes the details of how to conduct individual laboratory internal audits. Item Order Code: QMS15-A Nonmember Price: $180 Formatted in an enhanced, full-color layout! QMS18 | Process Management This guideline describes four requirements for managing laboratory processes and provides suggestions for effectively meeting regulatory and accreditation requirements, optimizing efficient use of resources, and contributing to patient safety and positive outcomes. Item Order Code: QMS18-Ed1 Nonmember Price: $180 Formatted in an enhanced, full-color layout! QMS20 | Understanding the Cost of Quality in the Laboratory This report provides guidance to a laboratory in understanding and managing the different types of quality costs that affect processes, services, and financial well-being. Item Order Code: QMS20-R Nonmember Price: $180 Formatted in an enhanced, full-color layout! QMS12 | Development and Use of Quality Indicators for Process Improvement and Monitoring of Laboratory Quality This guideline provides information on development of quality indicators and their use in the medical laboratory. Item Order Code: QMS12-A Nonmember Price: $180 QMS14 | Quality Management System: Leadership and Management Roles and Responsibilities This guideline presents concepts and information intended to assist a laboratory in meeting leadership requirements for its quality management system. Guidance is provided for leaders to effectively design, implement, and maintain the cultural, structural, and functional aspects of their laboratory’s organization that are critical to managing and sustaining quality. Executive Summary also included. This companion product provides an executive summary of QMS14-A. Item Order Code: QMS14-A Nonmember Price: $180 JC JC DECEMBER 2013 MARCH 2015 MAY 2014 DECEMBER 2010 DECEMBER 2012 Related On-Demand Webinar QMS20 Webinar | Impact of Quality Costs on Your Laboratory’s Operating Budget Objectives: List, describe, and provide laboratory examples of the types of quality costs. Distinguish between costs that support good quality and those that result from poor quality. Use basic tools to quantify laboratory failure quality costs. Item Order Code: QMS20-R NOVWR Nonmember Price: $99 Speakers: Lucia M. Berte, MT(ASCP)SBB, DLM, CQA(ASQ)CMQ/OE President, Laboratories Made Better! P.C., Broomfield, Colorado, USA Anne T. Daley, MS, MT(ASCP)DLM, CMQOE(ASQ)CSSBB Senior Consultant, Chi Solutions, Inc., Ann Arbor, Michigan, USA Members save up to 70% on CLSI products! See page 17 for discount pricing structure.
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    ORDER TODAY: TollFree (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org42 On-Demand QMS03 Webinar | Providing POCT Training and Competency for Health Care Professionals Objectives: Define the key elements of developing a sound competency and training program. Articulate the principles and the systematic approach required to assess and maintain competency standards for POCT device operators. Item Order Code: QMS03 WR Nonmember Price: $99 On-Demand QMS04 Webinar | Abandon the Past and Prepare for the Future: Laboratory Design Updates Objectives: Understand the overall design process. Incorporate Lean and flexibility into laboratory design. Recognize the utilities, safety issues, codes, and other aspects affecting the layout of the laboratory. Item Order Code: QMS04-A3 WR Nonmember Price: $99 On-Demand QMS11 Webinar | Nonconforming Event Management: Is Your Program Comprehensive? Objectives: Describe the four key processes and associated activities for an effective nonconforming event (NCE) management program. Identify gaps in your organization’s NCE management program. Understand potential resources available within QMS11 to assist in improving your program. Item Order Code: QMS11-A2 WR Nonmember Price: $99 Speakers: Marcia L. Zucker, PhD President, ZIVD LLC, Metuchen, New Jersey, USA Mark D. S. Shephard, PhD, MAACB, OAM Professor, Flinders University International Centre for Point-of-Care Testing, Adelaide, Australia Speaker: Karen K. Mortland, RA, MT(ASCP) Mortland Planning & Design, Inc., Chicora, Pennsylvania, USA Speaker: Anne T. Daley, MS, MT(ASCP)DLM, CMQOE(ASQ) CSSBB President, Daley Consulting, LLC, Mesa, Arizona, USA Quality Management Systems On-Demand QMS18 Webinar | How to Meet Requirements for Managing Any Laboratory Process Objectives: Describe the four regulatory and accreditation requirements for laboratory process management. Use two types of process flow charts for meeting the requirements for every new or changed laboratory process. Explain how the CLSI quality system essentials form a valuable tool for laboratory process management. Item Order Code: QMS18-A WR Nonmember Price: $99 Speaker: Lucia M. Berte, MT(ASCP)SBB, DLM, CQA(ASQ) CMQ/OE President, Laboratories Made Better! P.C., Broomfield, Colorado, USA Members save up to 70% on CLSI products! See page 17 for discount pricing structure. Visit www.clsi.org/webinars to learn more.
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    ORDER TODAY: TollFree (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org 43 Do you know how much your lab spends on: Supporting good quality? Resolving problems and errors? Preventing poor quality from occurring? Find out by enrolling in the only program that truly implements the steps needed to determine the existing cost of quality in your lab! Implementing the Cost of Quality in the Laboratory Certificate Program Earn 4.0 P.A.C.E. CE credits through this online self-paced program. Enroll today at www.clsi.org/COQ. EP23™ Online Workshop: Risk-Based Tools to Meet IQCP Requirements Learn how to implement a successful IQCP program! Gain knowledge and skills to implement CLSI document EP23-A™. Simplify QC based on risk management. Create an IQCP for an analyte and learn from a CLSI instructor about how to enhance your IQCP. Enroll today! Visit www.clsi.org/EP23Workshop for more information. Laboratory Quality Management System (LQMS) Certificate Program Do you know how to ensure that your lab: Meets accreditation quality requirements? Runs with the highest efficiency and productivity? Provides the highest quality test results for your patient population? Learn the skills needed for successful implementation with the Laboratory Quality Management System (LQMS) Certificate Program. This program focuses on providing an approach to meeting quality objectives, and delivering consistent, high-quality, cost-effective lab services through implementation of a QMS. Enroll today! Visit www.clsi.org/lqms for more information.
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    ORDER TODAY: TollFree (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org44 Reducing Risk POCT07 | Quality Management: Approaches to Reducing Errors at the Point of Care This guideline presents the core infrastructure for a standardized error tracking system with the primary goals of reducing risk and increasing quality of point-of-care testing, while accumulating standardized data for benchmarking use. Item Order Code: POCT07-A Nonmember Price: $140 EP18 | Risk Management Techniques to Identify and Control Laboratory Error Sources This guideline describes risk management techniques that will aid in identifying, understanding, and managing sources of failure (potential failure modes) and help to ensure correct results. Although intended primarily for in vitro diagnostics, this document will also serve as a reference for clinical laboratory managers and supervisors who wish to learn about risk management techniques and processes. Item Order Code: EP18-A2 Nonmember Price: $180 JC CAP | FDA | JC OCTOBER 2010 NOVEMBER 2009 Related Companion Product (Worksheet) EP18/EP23 WS | Sources of Failure Template Worksheet A failure modes and effects analysis table may be used as a checklist or as a tool to help identify potential failures in a testing system. These potential failures are then addressed by an appropriate quality assurance program. Use this electronic template to easily identify these possible failures. Item Order Code: EP18-A2/EP23-A WS Nonmember Price: FREE Related Companion Product (Bench Aid) POCT07 RG | Addressing Errors in Point-of-Care Testing Reference Guide Includes preexamination considerations (patient preparation for the test and sample collection and handling); examination considerations (operator related, reagent related, sample related, and device related); and postexamination considerations (communication related and data management related). Formatted as a spiral-bound reference guide for convenient use in the laboratory. Item Order Code: POCT07-A RG Nonmember Price: $50 Related Educational Product Quiz for Document Competency: POCT07-A—Quality Management: Approaches to Reducing Errors at the Point of Care Document competency quiz designed to test your comprehension of the concepts in CLSI guideline POCT07. Read the document that you have previously purchased and take a quiz to validate reading comprehension. Earn a score of 75% or higher (three attempts allowed) on the 12-question quiz, and print out a certificate for 2.0 P.A.C.E.® continuing education credits! Item Order Code: Quiz POCT07-A Nonmember Price: $50 NOVEMBER 2013 JANUARY 2015 JULY 2013 Members save up to 70% on CLSI products! See page 17 for discount pricing structure.
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    ORDER TODAY: TollFree (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org 45 Reducing Risk EP23 | Laboratory Quality Control Based on Risk Management This guideline provides information based on risk management for laboratories to develop quality control plans tailored to the particular combination of measuring system, laboratory setting, and clinical application of the test. Item Order Code: EP23-A Nonmember Price: $180 Formatted in an enhanced, full-color layout! JC OCTOBER 2011 Related Companion Product (Bench Aid) EP23 QG | EP23 Quick Reference Guide Includes the steps needed to create a laboratory’s individualized quality control plan (IQCP) as well as a process flow chart that lists the steps for creating an IQCP. Formatted as an 11x17-inch chart for posting in the laboratory. Item Order Code: EP23-A QG Nonmember Price: $50 Related Companion Product (Worksheet) EP23-A WS | A Sample Form for Laboratory Quality Control Based on Risk Management; Worksheet This EP23 worksheet contains a template and example that help users identify potential failure modes at each stage of the test system’s process and consider what monitors are in place or could be used to detect the problem. The worksheet does not represent a complete or comprehensive evaluation of risk and laboratories are encouraged to use other available resources to meet each institution’s risk management requirements. Item Order Code: EP23-A WS Nonmember Price: $100 Related Companion Product (Workbook) EP23 WB | A Practical Guide for Laboratory Quality Control Based on Risk Management; Workbook This workbook provides an overview of each step necessary to create a comprehensive quality control plan. It is tailored around a specific example that helps readers understand what information to gather to help detect and assess risks. Item Order Code: EP23-A WB Nonmember Price: $100 AUGUST 2013 SEPTEMBER 2013AUGUST 2013 This package includes: EP23—Laboratory Quality Control Based on Risk Management EP23 Implementation Workbook—A Practical Guide for Laboratory Quality Control Based on Risk Management Item Order Code: EP23-A PK EP23 Worksheet—A Sample Form for Laboratory Quality Control Based on Risk Management Nonmember Price: $340 bundle and save! EP23 Package | Laboratory Quality Control Based on Risk Management; Approved Guideline, Workbook, and Worksheet Package Members save up to 70% on CLSI products! See page 17 for discount pricing structure.
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    ORDER TODAY: TollFree (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org46 Related On-Demand Webinar GP17 Webinar | The Latest in Laboratory Safety: What You Need to Know to Maintain Compliance Objectives: Understand the major changes in CLSI document GP17— Clinical Laboratory Safety. Discuss the effects of Globally Harmonized System of Classification and Labelling of Chemicals on the guideline and what role it plays in 2015. Explain how to use the document to maintain safety regulation compliance and improve the laboratory safety culture. Item Order Code: GP17-A3 WR Nonmember Price: $99 Speaker: Daniel J. Scungio, MT(ASCP), SLS Sentara Healthcare, Norfolk, Virginia, USA Safety GP17 | Clinical Laboratory Safety This guideline contains general recommendations for implementing a high-quality laboratory safety program, which are provided in a framework that is adaptable within any laboratory. Item Order Code: GP17-A3 Nonmember Price: $140 GP05 | Clinical Laboratory Waste Management Based on US regulations, this guideline provides information on the safe handling and disposal of chemical, infectious, radioactive, and multihazardous wastes generated in the clinical laboratory. Although this document is a valuable resource for a wider audience, it is intended for use primarily in the United States. Item Order Code: GP05-A3 Nonmember Price: $140 GP33 | Accuracy in Patient and Sample Identification This guideline describes the essential elements of systems and processes required to ensure accurate patient identification. The principles in this document may be applied to manual or electronic systems. Design considerations covered include criteria for accuracy, differences in inpatient vs outpatient settings that impact patient identification, language and cultural considerations, and standardization of processes across the health care enterprise. Item Order Code: GP33-A Nonmember Price: $140 CAP | JC CAP | JC CAP | JC JUNE 2012 JANUARY 2011 MARCH 2010 Related Companion Product (Bench Aid) GP05 CL | Waste Management Program– Audit Checklist Checklist that includes the elements of a waste management program. Formatted on a durable, waterproof sheet for quick reference in the laboratory. Item Order Code: GP05-A3 CL Nonmember Price: $20 MARCH 2015 Members save up to 70% on CLSI products! See page 17 for discount pricing structure. Visit www.clsi.org/webinars to learn more.
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    ORDER TODAY: TollFree (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org 47 Related On-Demand Webinar QMS11 Webinar | Nonconforming Event Management: Is Your Program Comprehensive? Objectives: Describe the four key processes and associated activities for an effective nonconforming event (NCE) management program. Identify gaps in your organization’s NCE management program. Understand potential resources available within QMS11 to assist in improving your program. Item Order Code: QMS11-A2 WR Nonmember Price: $99 Speaker: Anne T. Daley, MS, MT(ASCP)DLM, CMQOE(ASQ) CSSBB President, Daley Consulting, LLC, Mesa, Arizona, USA Safety GP36 | Planning for Laboratory Operations During a Disaster This guideline provides information for laboratory and health care leadership for development, implementation, and sustainment of effective emergency preparedness plans (all hazards) supporting nonanalytical components of clinical and public health laboratory services that may pertain to various natural and manmade disasters. Item Order Code: GP36-A Nonmember Price: $140 M29 | Protection of Laboratory Workers From Occupationally Acquired Infections Based on US regulations, this guideline provides information on the risk of transmission of infectious agents by aerosols, droplets, blood, and body substances in a laboratory setting; specific precautions for preventing the laboratory transmission of microbial infection from laboratory instruments and materials; and recommendations for the management of exposure to infectious agents. Item Order Code: M29-A4 Nonmember Price: $180 CAP | JC CAP | JC DECEMBER 2014 NOVEMBER 2007 MAY 2014 QMS11 | Management of Nonconforming Laboratory Events This guideline provides an outline and the content for developing a program to manage a health care service’s nonconforming events that is based on the principles of quality management and patient safety. Item Order Code: QMS11-A Nonmember Price: $180 New enhanced, full-color version coming July 2015! Members save up to 70% on CLSI products! See page 17 for discount pricing structure. Visit www.clsi.org/webinars to learn more.
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    ORDER TODAY: TollFree (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org48 Specimen Handling and Processing GP44 | Procedures for the Handling and Processing of Blood Specimens for Common Laboratory Tests This guideline includes criteria for preparing an optimal serum or plasma sample and for the devices used to process blood specimens. Item Order Code: GP44-A4 Nonmember Price: $140 GP16 | Urinalysis This guideline addresses procedures for testing urine, including materials and equipment; macroscopic/physical evaluation; chemical analysis; and microscopic analysis. Item Order Code: GP16-A3 Nonmember Price: $140 FDA | JC CAP | FDA | JC MAY 2010 FEBRUARY 2009 Related Companion Product (Wall Charts) POCT10/GP16 WC | Microscopic Components in Urine Sediment and Vaginal Fluid Wall Charts Provides images of microscopic components in urine sediment and vaginal fluid, including bacteria and parasites, casts, cells, crystals, noncellular material, and vaginal fluid and potassium hydroxide preparations. Formatted as two 17x22-inch wall charts for posting in the laboratory. Item Order Code: POCT10/GP16 WC Nonmember Price: $60 Related Companion Product (Bench Aid) GP44 QG | Handling, Transport, and Storage of Specimens Quick Guide Provides recommended conditions for proper handling, transport, and storage of specimens for general chemistry and hematology analysis. Formatted as durable, waterproof sheets for quick reference in the laboratory. Item Order Code: GP44-A4 QG Nonmember Price: $40 Related Educational Product Quiz for Document Competency: GP44—Procedures for the Handling and Processing of Blood Specimens for Common Laboratory Tests Document competency quiz designed to test your comprehension of the concepts in CLSI guideline GP44. Read the document that you have previously purchased and take a quiz to validate reading comprehension. Earn a score of 75% or higher (three attempts allowed) on the 12-question quiz, and print out a certificate for 2.0 P.A.C.E.® continuing education credits! Item Order Code: Quiz GP44-A4 Nonmember Price: $50 MARCH 2015 AUGUST 2014 JULY 2013 Members save up to 70% on CLSI products! See page 17 for discount pricing structure.
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    ORDER TODAY: TollFree (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org 49 Specimen Handling and Processing MM13 | Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods This guideline provides information related to proper and safe biological specimen collection and nucleic acid isolation and purification. These topics include methods of collection, recommended storage and transport conditions, and available nucleic acid purification technologies for each specimen/nucleic acid type. A CLSI-IFCC joint project. Item Order Code: MM13-A Nonmember Price: $140 H21 | Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays and Molecular Hemostasis Assays This guideline provides procedures for collecting, transporting, and storing blood; processing blood specimens; storing plasma for coagulation testing; and general recommendations for performing the tests. Item Order Code: H21-A5 Nonmember Price: $140 CAP | FDA | JC CAP | FDA | JC DECEMBER 2005 JANUARY 2008 Related Companion Product (Bench Aid) H21 QG | Collection, Handling, Transport, and Storage for Hemostasis Quick Guide Outlines best practice procedures for the proper collection, transportation, and processing of blood specimens as well as storage of plasma for coagulation testing. Formatted as durable, waterproof sheets for quick reference in the laboratory. Item Order Code: H21-A5 QG Nonmember Price: $20 Related Educational Product Quiz for Document Competency: H21—Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays and Molecular Hemostasis Assays Document competency quiz designed to test your comprehension of the concepts in CLSI guideline H21. Read the document that you have previously purchased and take a quiz to validate reading comprehension. Earn a score of 75% or higher (three attempts allowed) on the 12-question quiz, and print out a certificate for 2.0 P.A.C.E.® continuing education credits! Item Order Code: Quiz H21-A5 Nonmember Price: $50 JULY 2008 JULY 2013 This collection provides information on: Handling and processing of blood and urine specimens Collecting samples for coagulation testing Collecting, transporting, and storing specimens for molecular methods It contains the following documents: GP16 – Urinalysis GP44 – Procedures for the Handling and Processing of Blood Specimens GP44 QG – Handling, Transport, and Storage of Specimens Quick Guide H21 – Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays and Molecular Hemostasis Assays H21-A5 QG – Collection, Handling, Transport, and Storage for Hemostasis Quick Guide MM13 – Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods Item Order Code: SCH03 Nonmember Price: $420 bundle and save! Specimen Handling and Processing Package Members save up to 70% on CLSI products! See page 17 for discount pricing structure.
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    ORDER TODAY: TollFree (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org50 Susceptibility Testing M02* | Performance Standards for Antimicrobial Disk Susceptibility Tests This standard contains the current CLSI-recommended methods for disk susceptibility testing, criteria for quality control testing, and updated tables for interpretive zone diameters. M07* | Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically This standard addresses reference methods for the determination of minimal inhibitory concentrations of aerobic bacteria by broth macrodilution, broth microdilution, and agar dilution. M100* | Performance Standards for Antimicrobial Susceptibility Testing This supplement provides updated tables for the CLSI antimicrobial susceptibility testing standards M02-A12, M07-A10, and M11-A8. The tabular information presented in M100 represents the most current information for drug selection, interpretation, and quality control using the procedures standardized in the most current editions of M02, M07, and M11. M100 is updated every January, so please check shop.clsi.org for the 2016 version. JANUARY 2015 JANUARY 2015 JANUARY 2015 *Note that in 2015, M100 must be purchased with one of the following M02 or M07 packages. Item Order Code: M02-A12/M07-A10 PK15 (includes M02-A12, M07-A10, and M100-S25) | Nonmember Price: $500 Item Order Code: M02-A12 PK15 (includes M02-A12 and M100-S25) | Nonmember Price: $340 Item Order Code: M07-A10 PK15 (includes M07-A10 and M100-S25) | Nonmember Price: $340 Related Companion Product (Bench Aid) AST QC QG | AST QC Flow Chart Quick Guide The ultimate “cheat sheet” to quality control (QC) for antimicrobial susceptibility testing. Based on M02, M07, and M100, these easy-to-use flow charts guide you through daily QC testing for both disk diffusion and aerobic dilution. Once required daily QC has been documented, users can convert to weekly QC with a flip of a page. Formatted as durable, waterproof sheets on a convenient detachable ring for convenient, shared use in the laboratory. Item Order Code: AST QC QG Nonmember Price: $120 Related Companion Product (Bench Aid) M100 QG | M100-S25 Tables 1A–1C Quick Guide Provides suggested groupings of antimicrobial agents that should be considered for routine disk and broth dilution testing and reporting by clinical laboratories. Serves as a useful reference for laboratories seeking to meet requirements for proficiency testing and accreditation. Formatted as durable, waterproof sheets on a convenient detachable ring for convenient, shared use in the laboratory. Item Order Code: M100-S25 QG Nonmember Price: $100 JANUARY 2015 JANUARY 2015 Members save up to 70% on CLSI products! See page 17 for discount pricing structure. An Interactive Searchable Database for Drug Selection, Interpretation, and Quality Control Procedures! eM100 is built to work the way you do—efficiently and in the laboratory. This online implementation of CLSI’s most widely recognized antimicrobial susceptibility testing document provides information for drug selection, interpretation, and quality control as well as the latest recommendations for detecting resistance mechanisms, all arranged in an easy-to-use, interactive, and searchable format. Visit www.clsi.org/eM100 to learn more.
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    ORDER TODAY: TollFree (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org 51 Susceptibility Testing Related On-Demand Webinar CLSI 2015 Antimicrobial Susceptibility Testing Update Objectives: Identify the major changes found in M100-S25. Design a strategy for implementing the new practice guidelines into your laboratory practices. Develop a communication strategy for informing clinical staff of significant antimicrobial susceptibility testing and reporting changes. Speaker: Janet A. Hindler, MCLS, MT(ASCP) Sr. Specialist, Clinical Microbiology, UCLA Health System, Los Angeles, California, USA Item Order Code: CLSI 2015 Antimicrobial Susceptibility Testing Update Nonmember Price: $125 M11 | Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria This standard provides reference methods for the determination of minimal inhibitory concentrations of anaerobic bacteria by agar dilution and broth microdilution. Item Order Code: M11-A8 Nonmember Price: $180 M27 | Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts This standard addresses the selection and preparation of antifungal agents; implementation and interpretation of test procedures; and quality control requirements for susceptibility testing of yeasts that cause invasive fungal infections. Item Order Code: M27-A3 Nonmember Price: $180 M24 | Susceptibility Testing of Mycobacteria, Nocardiae, and Other Aerobic Actinomycetes This standard provides protocols and related quality control parameters and interpretive criteria for the susceptibility testing of mycobacteria, Nocardia spp., and other aerobic actinomycetes. Item Order Code: M24-A2 Nonmember Price: $180 MARCH 2011FEBRUARY 2012 APRIL 2008 M27 Supplement | Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts This supplement provides updated tables for the CLSI antimicrobial susceptibility testing standard M27-A3. Item Order Code: M27-S4 Nonmember Price: $35 DECEMBER 2012 M38 | Reference Method for Broth Dilution Antifungal Susceptibility Testing of Filamentous Fungi This standard addresses the selection of antifungal agents, preparation of antifungal stock solutions and dilutions for testing implementation and interpretation of test procedures, and quality control requirements for susceptibility testing of filamentous fungi (moulds) that cause invasive and cutaneous fungal infections. Item Order Code: M38-A2 Nonmember Price: $180 M39 | Analysis and Presentation of Cumulative Antimicrobial Susceptibility Test Data This guideline describes methods for recording and analysis of antimicrobial susceptibility test data, consisting of cumulative and ongoing summaries of susceptibility patterns of clinically significant microorganisms. Item Order Code: M39-A4 Nonmember Price: $180 JANUARY 2014APRIL 2008 Members save up to 70% on CLSI products! See page 17 for discount pricing structure.
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    ORDER TODAY: TollFree (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org52 Susceptibility Testing M45 | Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria This guideline provides information to clinical microbiology laboratories for standardized susceptibility testing of infrequently isolated or fastidious bacteria that are not presently included in CLSI documents M02 or M07. The tabular information in this document presents the most current information for drug selection, interpretation, and quality control for the infrequently isolated or fastidious bacterial pathogens included in this guideline. Item Order Code: M45-A2 Nonmember Price: $180 AUGUST 2010 M44 and Third Informational Supplement | Method for Antifungal Disk Diffusion Susceptibility Testing of Yeasts This guideline provides newly established methodology for disk diffusion testing of Candida spp., criteria for quality control testing, and interpretive criteria. Zone Diameter Interpretive Standards, Corresponding Minimal Inhibitory Concentration (MIC) Interpretive Breakpoints, and Quality Control Limits for Antifungal Disk Diffusion Susceptibility Testing of Yeasts; Third Informational Supplement These supplemental tables provide new quality control limits for CLSI document M44. It is available as a laminated chart for easy posting. Item Order Code: M44-A2 and M44-S3 Nonmember Price: $180 AUGUST 2009 Related Companion Product (Bench Aid) M39 QG | Antibiograms: Developing Cumulative Reports for Your Clinicians Quick Guide Serves as a handy reference for laboratory personnel. It provides recommendations for preparation of a cumulative antibiogram, examples of selection criteria, and supplemental analyses. It also shows how to prepare tables, includes a description of limitations of data, and provides examples of reports and graphs. Formatted as seven durable, waterproof sheets on a convenient detachable ring. Item Order Code: M39-A4 QG Nonmember Price: $60 JANUARY 2015 This collection provides guidance for microbiologists performing routine susceptibility testing. Information covered includes: Disk and dilution testing procedures Interpretive tables for antimicrobial susceptibility tests Safety precautions It contains the following documents: M02 – Performance Standards for Antimicrobial Disk Susceptibility Tests M07 – Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically M39 – Analysis and Presentation of Cumulative Antimicrobial Susceptibility Test Data M45 – Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria M100 – Performance Standards for Antimicrobial Susceptibility Testing AST QC QG – AST Quality Control Quick Guide M100 QG – M100 Tables 1A–1C Quick Guide M100 WC – Glossary of Antimicrobial Terms and Abbreviations Wall Chart Item Order Code: SCM03 Nonmember Price: $950 bundle and save! General Susceptibility Testing Package Members save up to 70% on CLSI products! See page 17 for discount pricing structure.
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    ORDER TODAY: TollFree (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org 53 Now, CLSI Standards Are a Click Away… With eCLIPSETM Ultimate Access, we have made it easy for your lab to access and use our invaluable resources for quality improvement— anytime, anywhere. Subscribe Today! Call +1.610.688.0100 to Unlock Your Ultimate Access. Please contact customerservice@clsi.org to inquire about pricing. CLIPSEUltimate Access e TM Access CLSI Standards Anytime—All You Need Is a Web Connection! Gain instant access to CLSI’s complete library through the eCLIPSE online portal. Ensure your organization has access to the most up-to-date CLSI standards. Empower Your Entire Organization to Use CLSI’s Invaluable Tools. Know You Are Working From the Most Current Standards Information. No hardware needed— with eCLIPSE’s cloud-based technology, documents are always a click away.
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    ORDER TODAY: TollFree (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org54 Related On-Demand Webinar VET01 Webinar | Updates to the CLSI Veterinary AST Supplement Objectives: Discuss CLSI document VET01-A4 and its supplement, VET01S, and how they impact veterinary antimicrobial susceptibility testing (AST). Identify the procedures and applications of the various methods recommended by CLSI for AST. Describe the changes made to the supplement and the importance of interpreting results, based on drug selection, for better animal care. Item Order Code: VET01-A4 WR Nonmember Price: $99 Speaker: Michael T. Sweeney, MT Principal Scientist, Zoetis, Kalamazoo, Michigan, USA Veterinary Medicine VET01 and Third Informational Supplement | Performance Standards for Antimicrobial Disk and Dilution Susceptibility Tests for Bacteria Isolated From Animals This standard provides the currently recommended techniques for antimicrobial agent disk and dilution susceptibility testing, criteria for quality control testing, and interpretive criteria for veterinary use. Performance Standards for Antimicrobial Disk and Dilution Susceptibility Tests for Bacteria Isolated From Animals; Third Informational Supplement This supplement provides updated tables for the CLSI antimicrobial susceptibility testing standard VET01. Item Order Code: VET01-A4 Nonmember Price: $230 VET02 | Development of In Vitro Susceptibility Testing Criteria and Quality Control Parameters for Veterinary Antimicrobial Agents This guideline addresses the required and recommended data needed for selection of appropriate interpretive standards and quality control guidance for new veterinary antimicrobial agents. Item Order Code: VET02-A3 Nonmember Price: $140 VET03/VET04 Supplement Performance Standards for Antimicrobial Susceptibility Testing of Bacteria Isolated From Aquatic Animals; Second Informational Supplement This supplement provides updated tables for the CLSI antimicrobial susceptibility testing guidelines VET03-A and VET04-A2. Item Order Code: VET03/VET04-S2 Nonmember Price: $100 VET03 | Methods for Antimicrobial Disk Susceptibility Testing of Bacteria Isolated From Aquatic Animals This guideline provides the most up-to-date techniques for disk diffusion susceptibility testing of aquatic species isolates, and criteria for quality control testing. Item Order Code: VET03-A Nonmember Price: $140 JULY 2013 FEBRUARY 2008 SEPTEMBER 2014JUNE 2006 Members save up to 70% on CLSI products! See page 17 for discount pricing structure. Visit www.clsi.org/webinars to learn more.
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    ORDER TODAY: TollFree (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org 55 Veterinary Medicine VET04 and Second Informational Supplement* | Methods for Broth Dilution Susceptibility Testing of Bacteria Isolated From Aquatic Animals This guideline provides the most up-to-date techniques for the determination of minimal inhibitory concentrations of aquatic bacteria by broth micro- and macrodilution, and criteria for data interpretation and quality control testing. The VET04 supplement provides updated tables for VET03-A and VET04-A2. VET05 | Generation, Presentation, and Application of Antimicrobial Susceptibility Test Data for Bacteria of Animal Origin This report offers guidance on areas in which harmonization can be achieved in veterinary antimicrobial surveillance programs with the intent of facilitating comparison of data among surveillance programs. Item Order Code: VET05-R Nonmember Price: $140 SEPTEMBER 2014 SEPTEMBER 2011 *Note that VET04 must be purchased in a package with the VET03/VET04 Supplement. Item Order Code: VET04-A2 PK | Nonmember Price: $180 Infobase 2015 is a user-friendly, searchable CD-ROM of over 200 CLSI standards for best practices in medical testing. Infobase 2015 includes: All standards in the CLSI document library published through December 31, 2014 A feature that allows searching across and within all standards to locate relevant information The ability to access documents without a Web connection Please contact customerservice@clsi.org to learn more. Members save up to 70% on CLSI products! See page 17 for discount pricing structure.
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    ORDER TODAY: TollFree (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org56 CLSI Course Offerings CLSI offers numerous educational and training programs and services, including seminars, workshops, on-site assessments, in-lab mentoring, webinars, and online education programs. Offerings include: On-site assessment to evaluate existing lab operations against the accreditation model health officials have selected, identifying and analyzing gaps between existing practices and best practices Assistance with the development of national strategic plans for labs Customized and interactive training and educational programs for lab staff, management, and quality officers, focusing on the development and strengthening of quality management systems Assistance with the development of continuous quality improvement strategies Measurable and scalable programs for all labs seeking international accreditation Visit www.clsi.org/training for more information.
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    ORDER TODAY: TollFree (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org 57 JUNE 2015 Be on the lookout for these new and revised standards, which are scheduled to be published through August 2015 to address the timely issues most relevant to our members and customers. The projected publication dates are listed below. CLSI Documents Scheduled for Publication EP36 | Harmonization of Symbology and Equations This report provides a standardized symbology for use throughout CLSI documents. Use of these standardized symbols is expected to be of great benefit to the CLSI readership, volunteers participating in CLSI committees, and the scientific community in general. Item Order Code: EP36-Ed1 FREE! M52 | Verification of Commercial Microbial Identification and Antimicrobial Susceptibility Testing Systems This guideline includes recommendations for verification of commercial US Food and Drug Administration–cleared microbial identification and antimicrobial susceptibility testing systems by clinical laboratory professionals to fulfill regulatory or quality assurance requirements for the use of these systems for diagnostic testing. Item Order Code: M52-Ed1 Nonmember Price: $180 VET01 Supplement Performance Standards for Antimicrobial Disk and Dilution Susceptibility Tests for Bacteria Isolated From Animals This supplement provides updated tables for the CLSI antimicrobial susceptibility testing standard VET01. Item Order Code: VET01S-Ed3 Nonmember Price: $100 EP19 | A Framework for Using CLSI Documents to Evaluate Clinical Laboratory Measurement Procedures This report uses the “measurement procedure lifecycle” framework to aid users of CLSI evaluation protocols documents during establishment and implementation of measurement procedures developed by both commercial manufacturers and clinical laboratories, ie, for laboratory-developed tests. Item Order Code: EP19-Ed2 FREE! POCT13 | Glucose Monitoring in Settings Without Laboratory Support This guideline focuses on performance of point-of-care glucose monitoring systems, with an emphasis on safety practices, quality control, training, and administrative responsibility. Item Order Code: POCT13-Ed3 Nonmember Price: $140 Formatted in an enhanced, full-color layout! QMS11 | Nonconforming Event Management Grounded in the principles of quality management, risk management, and patient safety, this guideline provides an outline and content for developing a program to manage a laboratory’s nonconforming events. Item Order Code: QMS11-Ed2 Nonmember Price: $180 New enhanced, full-color version! QMS16 | Laboratory Personnel Management This guideline provides a roadmap for meeting the regulatory and accreditation requirements of personnel management in the laboratory environment. This guideline offers suggestions and examples on managing the processes required for laboratory personnel to fully achieve laboratory management’s operational and quality goals. Item Order Code: QMS16-Ed1 Nonmember Price: $180 Formatted in an enhanced, full-color layout! JULY 2015 AUGUST 2015 JUNE 2015 JUNE 2015 JULY 2015 AUGUST 2015
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