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DODD 6440.02 - CLINICAL LABORATORY IMPROVEMENT PROGRAM (CLIP) Organization: DODD
Date: 2014-05-29
Description: Establishes the Center for Clinical Laboratory Medicine (CCLM), formerly known as the Clinical Laboratory Improvement Program Office, under the Defense Health Agency (DHA).
CLSI - I06-A - SERVICE OF CLINICAL LABORATORY INSTRUMENTS; APPROVED GUIDELINE - FIRST EDITION; VOL. 4 NO. 4 Organization: CLSI
Date: 1984-03-01
Description: This guideline encompasses operator training, installation, preventive maintenance, and repair for the proper service of clinical laboratory instruments. This guideline includes tow classification schemes: Levels of Training Various levels that may be required depending on the complexity of the clinical laboratory instruments.
CLSI GP05 - CLINICAL LABORATORY WASTE MANAGEMENT; APPROVED GUIDELINE - THIRD EDITION; VOL. 31 NO. 3 Organization: CLSI
Date: 2011-01-01
Description: Despite the many similarities of clinical laboratories to one another, differences do exist; no single laboratory waste management program is appropriate for all facilities.
DODD 6440.02-M - CLINICAL LABORATORY IMPROVEMENT PROGRAM (CLIP) PROCEDURES Organization: DODD
Date: 2014-05-29
Description: b. All medical laboratories as defined in the Glossary. The Center for Clinical Laboratory Medicine (CCLM) issues certificates of accreditation within the DoD in lieu of Department of Health and Human Services (HHS).
ASTM E1712 - STANDARD SPECIFICATION FOR REPRESENTING CLINICAL LABORATORY PROCEDURE AND ANALYTE NAMES Organization: ASTM
Date: 1997-08-10
Description: Scope 1.1 This specification covers the construction of elected laboratory procedure and analyte names, because data concerning clinical laboratory tests must identify these procedures in a common fashion if such data are to be transferable between databases or to be recognized in lookups or searches.
ASTM E1246 - STANDARD PRACTICE FOR REPORTING RELIABILITY OF CLINICAL LABORATORY COMPUTER SYSTEMS Organization: ASTM
Date: 2001-11-10
Description: This practice describes a system for collecting data, maintaining records, and reporting on the reliability of operating clinical laboratory computer systems. The reliability measure will be achieved by documenting the number, severity, cause, impact, and duration of the failures that a system experiences.
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: The purpose of this document is to help clinical laboratories use proficiency testing (PT) as a quality improvement tool. 15-20 This guideline delineates a systematic approach to monitoring PT results, and to investigating and responding to unacceptable PT results, including a classification of the types of problems that cause PT failures.
CLSI MM19 - ESTABLISHING MOLECULAR TESTING IN CLINICAL LABORATORY ENVIRONMENTS; APPROVED GUIDELINE - VOL 31; NO 21 Organization: CLSI
Date: 2011-11-01
Description: This document was written by experienced molecular laboratory professionals to provide an introduction to molecular diagnostics for nonmolecular, routine clinical laboratories, as well as a framework for decision making and implementation of molecular testing.
ASTM E1029 - STANDARD GUIDE FOR DOCUMENTATION OF CLINICAL LABORATORY COMPUTER SYSTEMS Organization: ASTM
Date: 2001-11-10
Description: This guide covers documentation for a computer system operating in a clinical laboratory. Documentation is defined as the information needed to install, use, maintain, or modify the system.
CRC - CLINICAL LABORATORY INVES - CLINICAL LABORATORY INVESTIGATION AND PSYCHIATRY: A PRACTICAL HANDBOOK Organization: CRC
Date: 2008-10-15
Description: While there is at present no single, specific laboratory test for any psychiatric disorder, the laboratory nevertheless helps clinicians to exclude important, treatable causes of psychiatric morbidity and assists with appropriate treatment strategies.
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:   The primary audience for this standard is health care providers in the clinical laboratory implementing laboratory automation, vendors of laboratory automation, instrumentation, and LISs.
CLSI EP17 - EVALUATION OF DETECTION CAPABILITY FOR CLINICAL LABORATORY MEASUREMENT PROCEDURES; APPROVED GUIDELINE - SECOND EDITION; VOL 32; NO 8 Organization: CLSI
Date: 2012-06-01
Description: This document provides guidelines for the evaluation and verification of detection capability claims of clinical laboratory measurement procedures (ie, limit of blank [LoB], limit of detection [LoD], and limit of quantitation [LoQ]), as well as for their proper use, documentation, and interpretation.
ASTM E1466 - STANDARD SPECIFICATION FOR USE OF BAR CODES ON SPECIMEN TUBES IN THE CLINICAL LABORATORY Organization: ASTM
Date: 1992-03-15
Description: It documents the form, placement, and content of bar code labels on specimen tubes that are used on clinical laboratory analyzers. It enables Laboratory Information System vendors to produce reliable bar coded symbols that are readable by any complying clinical laboratory analyzer vendor.
CLSI LIS07 - STANDARD SPECIFICATION FOR USE OF BAR CODES ON SPECIMEN TUBES IN THE CLINICAL LABORATORY - FIRST EDITION; VOL. 23 NO. 13 Organization: CLSI
Date: 2003-04-01
Description: It documents the form, placement, and content of bar code labels on specimen tubes that are used on clinical laboratory analyzers. It enables Laboratory Information System vendors to produce reliable bar coded symbols that are readable by any complying clinical laboratory analyzer vendor.
TSE - TS ENV 1614 - HEALTCARE INFORMATICS- STRUCTURE FOR NOMENCLATURE, CLASSIFICATION, AND CODING OF PROPERTIES IN CLINICAL LABORATORY SCIENCES Organization: TSE
Date: 1999-04-08
Description: This European Prestandard provides system of concepts for the nomenclature, classification and coding of properties, including quantities in clinical laboratory sciences. Bu standard, klinik laboratuvar bilimlerinde, niceliklerinde dahil olduğu terminoloji, sınıflandırma ve özelliklerin kodlanmasındaki kavramlar sistemini kapsar.
DS/ENV 1614 - HEALTHCARE INFORMATICS - STRUCTURE FOR NOMENCLATURE, CLASSIFICATION, AND CODING OF PROPERTIES IN CLINICAL LABORATORY SCIENCES Organization: DS
Date: 1995-11-28
Description: The Prestandard provides a coherent concept system underlying systematic names, classifications and coding for properties, including quantities, in clinical laboratory sciences. The system is intended to facilitate the communication of messages about such properties through computing and telecommunications equipment.
ASTM E1381 - STANDARD SPECIFICATION FOR LOW-LEVEL PROTOCOL TO TRANSFER MESSAGES BETWEEN CLINICAL LABORATORY INSTRUMENTS AND COMPUTER SYSTEMS Organization: ASTM
Date: 2002-08-10
Description: This specification describes the electronic transmission of digital information between clinical laboratory instruments and computer systems. The clinical laboratory instruments under consideration are those that measure one or more parameters from one or more patient samples.
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: This guideline is intended for use by: • Manufacturers responsible for establishing HIL indices and alert indices (cutoff values) for use in the automated HIL detection systems in their clinical laboratory instruments • Laboratory directors, managers, supervisors and medical technologists for establishing or evaluating HIL indices and making judgments about the acceptability of specimens and test results C56 provides recommendations for: • Establishing HIL indices to assess sample quality • Estimating interference effects of hemoglobin, bilirubin, and turbidity to generate alert indices and gray zones • Reporting (by manufacturers) interference effects of HIL in the reagent instructions for use (IFU) • Establishing error flags for HIL interference • Verifying HIL indices in the clinical laboratory • Managing potential process outcomes of HIL measurements (reporting or rejecting specimens/results due to HIL interference) This document provides a comprehensive review of the currently available automated HIL detection systems in clinical analyzers.
ASTM E1639 - STANDARD GUIDE FOR FUNCTIONAL REQUIREMENTS OF CLINICAL LABORATORY INFORMATION MANAGEMENT SYSTEMS Organization: ASTM
Date: 2001-05-10
Description: Scope 1.1 This guide covers the capabilities needed for a logical structure of a Clinical Laboratory Information Management System (CLIMS). It was written so that both the vendors or developers of CLIMS and laboratory managers would have a common understanding of the requirements and logical structure of a laboratory data system.
CLSI EP28 - DEFINING, ESTABLISHING, AND VERIFYING REFERENCE INTERVALS IN THE CLINICAL LABORATORY; APPROVED GUIDELINE - THIRD EDITION; VOL 28; NO 30 Organization: CLSI
Date: 2010-10-01
Description: It includes specific recommendations regarding procedures that can be used to establish and verify reliable reference intervals for use in clinical laboratory medicine. By following these recommendations, laboratories can provide reference intervals that are adequate and useful for clinical interpretation.

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