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CLSI - CLSI EP19 - A FRAMEWORK FOR USING CLSI DOCUMENTS TO EVALUATE CLINICAL LABORATORY MEASUREMENT PROCEDURES - SECOND EDITION; VOL 35; NO 10 Organization: CLSI
Date: 2015-06-01
Description: Some measurement procedures, eg, those that produce an index result (ie, discreet categories, eg, positive, negative, specific mutation result) will involve special evaluations for which, currently, there are no CLSI documents. EP19 is intended for use by clinical laboratory professionals, manufacturers, and governmental agencies.
CLSI - CLSI QMS16 - LABORATORY PERSONNEL MANAGEMENT - FIRST EDITION; VOL 35; NO 16 Organization: CLSI
Date: 2015-09-01
Description: Clinical and Laboratory Standards Institute (CLSI). Laboratory Personnel Management. 1st ed. CLSI guideline QMS16 (ISBN 1-56238-913-0 [Print]; ISBN 1-56238-914-9 [Electronic]).
CLSI - CLSI POCT13 - GLUCOSE MONITORING IN SETTINGS WITHOUT LABORATORY SUPPORT - THIRD EDITION; VOL 35; NO 09 Organization: CLSI
Date: 2015-06-01
Description: Operators monitoring glucose levels in these types of settings should refer to CLSI document POCT12.1 This guideline may be used in a variety of locations, which include but are not limited to: Physicians' offices Camps attended by people with diabetes Mobile emergency medical facilities Free-standing dialysis facilities Home health care settings (not applicable to individuals with diabetes who do their own testing) Visiting nursing programs or home care agencies Public health facilities Mobile or free-standing clinics (eg, migrant worker clinics, other clinics in remote locations) Occupational health facilities Pharmacies Prisons Residential care communities Schools and student health facilities Urgent care centers Day care centers Long-term care and skilled nursing facilities Group homes What Is Included in This Guideline?
CLSI - CLSI AUTO3 - LABORATORY AUTOMATION: COMMUNICATIONS WITH AUTOMATED CLINICAL LABORATORY SYSTEMS, INSTRUMENTS, DEVICES, AND INFORMATION SYSTEMS; APPROVED STANDARD - SECOND EDITION; VOL 29; NO 21 Organization: CLSI
Date: 2009-09-01
Description: This standard fits into the series of interrelated CLSI automation standards (AUTO01, AUTO0,AUTO04, and AUTO05)
CLSI - CLSI GP28 - MICROWAVE DEVICE USE IN THE HISTOLOGY LABORATORY; APPROVED GUIDELINE - FIRST EDITION; VOL. 25 NO. 7 Organization: CLSI
Date: 2005-02-01
Description: This CLSI guideline is written for multiple audiences, including; laboratory technicians, microwave device manufacturers, microwave device resellers, compliance and safety officials, and administrators.
CLSI - CLSI AUTO2 - LABORATORY AUTOMATION: BAR CODES FOR SPECIMEN CONTAINER IDENTIFICATION; APPROVED STANDARD - SECOND EDITION; VOL 25; NO 29 Organization: CLSI
Date: 2005-12-01
Description: The bar code used for specimen container identification which is referred to in this document may be any one of three SAC attribute fields defined in CLSI/NCCLS document AUTO3-Laboratory Automation: Communications With Automated Clinical Laboratory Systems, Instruments, Devices, and Information Systems, Section 6.3.3.
CLSI - CLSI GP27 - USING PROFICIENCY TESTING TO IMPROVE THE CLINICAL LABORATORY; APPROVED GUIDELINE - SECOND EDITION; VOL. 27 NO. 8 Organization: CLSI
Date: 2007-02-01
Description: Please refer to the most current editions of CLSI document C24-Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions for additional guidance for quality control applications, and CLSI/NCCLS document GP29-Assessment of Laboratory Test When Proficiency Testing Is Not Available.
CLSI - CLSI AST4 - GLUCOSE MONITORING IN SETTINGS WITHOUT LABORATORY SUPPORT; APPROVED GUIDELINE - SECOND EDITION; VOL 25; NO 12 Organization: CLSI
Date: 2005-05-01
Description: Foreword This revision of CLSI/NCCLS document AST4—Glucose Monitoring in Settings Without Laboratory Support includes several modifications of the earlier version, which was last published in June 1999: Newer technologies have been addressed.
CLSI - CLSI M48 - LABORATORY DETECTION AND IDENTIFICATION OF MYCOBACTERIA; APPROVED GUIDELINE - VOL 28; NO 17 Organization: CLSI
Date: 2008-05-01
Description: Procedures for the direct detection of mycobacteria by microscopy and amplification techniques, the optimal recovery of mycobacteria from clinical specimens, and the identification of mycobacterial species by traditional (phenotypic) and alternative (phenotypic and genotypic) laboratory methods are addressed. Mycobacterial susceptibility testing is addressed in CLSI/NCCLS document M24.
CLSI - CLSI AUTO10 - AUTOVERIFICATION OF CLINICAL LABORATORY TEST RESULTS; APPROVED GUIDELINE - FIRST EDITION; VOL 26; NO 32 Organization: CLSI
Date: 2006-10-01
Description: For additional information, refer to the current edition of CLSI document AUTO11—IT Security of In Vitro Diagnostic Instruments and Software Systems.
CLSI - CLSI QMS24 - USING PROFICIENCY TESTING AND ALTERNATIVE ASSESSMENT TO IMPROVE MEDICAL LABORATORY QUALITY - THIRD EDITION Organization: CLSI
Date: 2016-09-01
Description: This guideline does not recommend specific corrective actions for specific root causes (see CLSI document QMS117).
CLSI - CLSI C56 - HEMOLYSIS, ICTERUS, AND LIPEMIA/TURBIDITY INDICES AS INDICATORS OF INTERFERENCE IN CLINICAL LABORATORY ANALYSIS; APPROVED GUIDELINE - VOL. 32 NO. 10 Organization: CLSI
Date: 2012-07-01
Description: Procedures for investigating, identifying, and characterizing the effects of interfering substances on clinical chemistry test results are not discussed in detail in C56, as these are described in CLSI document EP07.
CLSI - CLSI GP44 - PROCEDURES FOR THE HANDLING AND PROCESSING OF BLOOD SPECIMENS FOR COMMON LABORATORY TESTS; APPROVED GUIDELINE - FOURTH EDITION; VOL 30; NO 10 Organization: CLSI
Date: 2010-05-01
Description: Users are referred to the current version of applicable CLSI documents for more detailed discussion as appropriate.
CLSI - CLSI H18 - PROCEDURES FOR THE HANDLING AND PROCESSING OF BLOOD SPECIMENS FOR COMMON LABORATORY TESTS; APPROVED GUIDELINE - FOURTH EDITION; VOL. 30 NO. 10 Organization: CLSI
Date: 2010-05-01
Description: Users are referred to the current version of applicable CLSI documents for more detailed discussion as appropriate.
ISO TS 16782 - CLINICAL LABORATORY TESTING - CRITERIA FOR ACCEPTABLE LOTS OF DEHYDRATED MUELLER-HINTON AGAR AND BROTH FOR ANTIMICROBIAL SUSCEPTIBILITY TESTING - FIRST EDITION Organization: ISO
Date: 2016-10-15
Description: Although dMHA can be used for determination of MICs using the agar dilution method[4][6] or the gradient diffusion method, this Technical Specification only includes performance testing of dMHA using disc diffusion methodology as described by the Clinical and Laboratory Standards Institute (CLSI)[5] and European Committee on Antimicrobial Susceptibility Testing (EUCAST)[3].
CLSI - CLSI EP10 - PRELIMINARY EVALUATION OF QUANTITATIVE CLINICAL LABORATORY MEASUREMENT PROCEDURES; APPROVED GUIDELINE - THIRD EDITION; VOL 26; NO 34; INCORPORATES AMENDMENT 5/2014 Organization: CLSI
Date: 2006-11-01
Description: Accreditation bodies may have requirements for verification or validation that exceed the procedures in this document (see CLSI document EP151). Manufacturers can also benefit by performing this protocol either as assays are developed or when they are validated.
SNV - SN EN ISO 16256 - CLINICAL LABORATORY TESTING AND IN VITRO DIAGNOSTIC TEST SYSTEMS - REFERENCE METHOD FOR TESTING THE IN VITRO ACTIVITY OF ANTIMICROBIAL AGENTS AGAINST YEAST OF FUNGI INVOLVED IN INFECTIOUS DISEASES Organization: SNV
Date: 2013-03-01
Description: Reference methods for broth dilution antifungal susceptibility testing of filamentous fungi have been developed and are now available as CLSI document M38 and EUCAST document E.DEF 9.1[4][5][6][7][8].
CEN - EN ISO 16256 - CLINICAL LABORATORY TESTING AND IN VITRO DIAGNOSTIC TEST SYSTEMS - REFERENCE METHOD FOR TESTING THE IN VITRO ACTIVITY OF ANTIMICROBIAL AGENTS AGAINST YEAST OF FUNGI INVOLVED IN INFECTIOUS DISEASES Organization: CEN
Date: 2012-12-01
Description: Reference methods for broth dilution antifungal susceptibility testing of filamentous fungi have been developed and are now available as CLSI document M38 and EUCAST document E.DEF 9.1[4][5][6][7][8].
ISO 16256 - CLINICAL LABORATORY TESTING AND IN VITRO DIAGNOSTIC TEST SYSTEMS - REFERENCE METHOD FOR TESTING THE IN VITRO ACTIVITY OF ANTIMICROBIAL AGENTS AGAINST YEAST FUNGI INVOLVED IN INFECTIOUS DISEASES - FIRST EDITION Organization: ISO
Date: 2012-12-01
Description: Moreover, testing filamentous fungi (moulds) introduces several additional problems in standardization not addressed by the current procedure. Reference and are now available as CLSI document M38 and EUCAST document E.DEF 9.1 This International Standard describes the broth micro dilution reference method which can be implemented by either of two pathways.
DS/EN ISO 16256 - CLINICAL LABORATORY TESTING AND IN VITRO DIAGNOSTIC TEST SYSTEMS - REFERENCE METHOD FOR TESTING THE IN VITRO ACTIVITY OF ANTIMICROBIAL AGENTS AGAINST YEAST OF FUNGI INVOLVED IN INFECTIOUS DISEASES Organization: DS
Date: 2013-01-07
Description: One pathway involves visual determination of MICs (CLSI method); the second pathway involves spectrophotometric determination of MICs (EUCAST method).

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