VALIDATION, VERIFICATION, AND QUALITY ASSURANCE OF AUTOMATED HEMATOLOGY ANALYZERS

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

06-25-2010

Publisher

Clinical Laboratory Standards Institute

Defines portions of the life cycle of an automated multi-channel hematolgoy system and provides guidance for validation, verification, calibration, quality assurance (QA), and quality control (QC) through standardized approaches to ensure good laboratory science and clinical relevance.

DevelopmentNote	Supersedes NCCLS H26 P2 and NCCLS H38 P. (07/2010)
DocumentType	Miscellaneous Product
ISBN	1-56238-728-6
Pages	104
PublisherName	Clinical Laboratory Standards Institute
Status	Current
Supersedes	CLSI H38 P : 1ED 99 CLSI H26 A : 1ED 96 CLSI H26 P2 : 2ED 2009

BIS IS/ISO 15189 : 2012	MEDICAL LABORATORIES - REQUIREMENTS FOR QUALITY AND COMPETENCE
I.S. EN ISO 15189:2012	MEDICAL LABORATORIES - REQUIREMENTS FOR QUALITY AND COMPETENCE (ISO 15189:2012, CORRECTED VERSION 2014-08-15)
CLSI NBS06 A : 1ED 2013	NEWBORN BLOOD SPOT SCREENING FOR SEVERE COMBINED IMMUNODEFICIENCY BY MEASUREMENT OF T-CELL RECEPTOR EXCISION CIRCLES
CLSI NBS07 : 1ED 2017	NEWBORN BLOOD SPOT SCREENING FOR POMPE DISEASE BY LYSOSOMAL ACID A-GLUCOSIDASE ACTIVITY ASSAYS
PREN ISO 15189 : DRAFT 2011	MEDICAL LABORATORIES - PARTICULAR REQUIREMENTS FOR QUALITY AND COMPETENCE
UNE-EN ISO 15189:2013	Medical laboratories - Requirements for quality and competence (ISO 15189:2012, Corrected version 2014-08-15)
CLSI I/LA34 P : 1ED 2010	DESIGN AND VALIDATION OF IMMUNOASSAYS FOR ASSESSMENT OF HUMAN ALLERGENICITY OF NEW BIOTHERAPEUTIC DRUGS
11/30173018 DC : 0	BS EN ISO 15189 - MEDICAL LABORATORIES - PARTICULAR REQUIREMENTS FOR QUALITY AND COMPETENCE
DIN EN ISO 15189:2014-11	Medical laboratories - Requirements for quality and competence (ISO 15189:2012, Corrected version 2014-08-15)
UNI EN ISO 15189 : 2013	MEDICAL LABORATORIES - REQUIREMENTS FOR QUALITY AND COMPETENCE
CLSI QMS01 A4 : 4ED 2011	QUALITY MANAGEMENT SYSTEM: A MODEL FOR LABORATORY SERVICES
ISO 15189:2012	Medical laboratories — Requirements for quality and competence
BS EN ISO 15189:2012	Medical laboratories. Requirements for quality and competence
CLSI QMS13 A : 1ED 2011	QUALITY MANAGEMENT SYSTEM: EQUIPMENT

CLSI GP27 A2 : 2ED 2007	USING PROFICIENCY TESTING TO IMPROVE THE CLINICAL LABORATORY
CLSI H44 A2 : 2ED 2004	METHODS FOR RETICULOCYTE COUNTING (FLOW CYTOMETRY AND SUPRAVITAL DYES)
CLSI H52 A : 1ED 2000	FETAL RED CELL DETECTION
CLSI EP21 A : 1ED 2003	ESTIMATION OF TOTAL ANALYTICAL ERROR FOR CLINICAL LABORATORY METHODS
CLSI EP5 A2 : 2ED 2004	EVALUATION OF PRECISION PERFORMANCE OF QUANTITATIVE MEASUREMENT METHODS
CLSI H15 A3 : 3ED 2000	REFERENCE AND SELECTED PROCEDURES FOR THE QUANTITATIVE DETERMINATION OF HEMOGLOBIN IN BLOOD
CLSI EP31 A : 1ED 2008	VERIFICATION OF COMPARABILITY OF PATIENT RESULTS WITHIN ONE HEALTH CARE SYSTEM
CLSI EP6 A : 1ED 2003	EVALUATION OF THE LINEARITY OF QUANTITATIVE MEASUREMENT PROCEDURES - A STATISTICAL APPROACH
CLSI M29 A3 : 3ED 2005	ACQUIRED INFECTIONS; APPROVED GUIDELINE
CLSI H42 A2 : 2ED 2007	ENUMERATION OF IMMUNOLOGICALLY DEFINED CELL POPULATIONS BY FLOW CYTOMETRY
CLSI H20 A2 : 2ED 2007	Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental Methods, 2nd Edition<br>
CLSI EP15 A2 : 2ED 2006	USER VERIFICATION OF PERFORMANCE FOR PRECISION AND TRUENESS
CLSI GP41 A6 : 6ED 2007	PROCEDURES FOR THE COLLECTION OF DIAGNOSTIC BLOOD SPECIMENS BY VENIPUNCTURE
CLSI H7 A3 : 3ED 2000	PROCEDURE FOR DETERMINING PACKED CELL VOLUME BY THE MICROHEMATOCRIT METHOD
CLSI I/LA24 A : 1ED 2004	FLUORESCENCE CALIBRATION AND QUANTITATIVE MEASUREMENT OF FLUORESCENCE INTENSITY
CLSI EP17 A : 1ED 2004	PROTOCOLS FOR DETERMINATION OF LIMITS OF DETECTION AND LIMITS OF QUANTITATION
CLSI GP42 A6 : 6ED 2008	PROCEDURES AND DEVICES FOR THE COLLECTION OF DIAGNOSTIC CAPILLARY BLOOD SPECIMENS
CLSI C24 A3 : 3ED 2006	STATISTICAL QUALITY CONTROL FOR QUANTITATIVE MEASUREMENT PROCEDURES: PRINCIPLES AND DEFINITIONS
CLSI EP9 A2 : 2ED 2002	METHOD COMPARISON AND BIAS ESTIMATION USING PATIENT SAMPLES
CLSI GP2 A5 : 5ED 2006	LABORATORY DOCUMENTS - DEVELOPMENT AND CONTROL