Biological Matter Laboratory Equipment Standards
Biological Matter Laboratory Equipment Standards cover a range of biological matter and the approved guidelines for the equipment and procedures used to obtain, analyze, and store it. Used heavily in the medical field, these standards play an important role in producing reliable data that can be compared against related data gathered at different points in time or by different people.
CLSI C34-Ed4
Sweat Testing: Specimen Collection and Quantitative Chloride Analysis - 4th Edition
This guideline describes methods for all aspects of sweat testing, including collection and analysis, results evaluation and reporting, and quality control.
CLSI C44-A
Harmonization of Glycohemoglobin Measurements; Approved Guideline
This document describes an established program to harmonize glycohemoglobin (GHB) testing results among laboratories to a common, outcomes-based reference system and includes recommendations for the clinical application of harmonized GHB testing results.This document is no longer being reviewed as part of our consensus process. However, because of its usefulness to a limited segment of the healthcare community, we are continuing to make the document available for its informational content
CLSI C46-A2
Blood Gas and pH Analysis and Related Measurements; Approved Guideline-Second Edition
This document 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
CLSI C49
Analysis of Body Fluids in Clinical Chemistry - 2nd Edition
This guideline provides information for the medical laboratory for evaluating measurement procedures, as well as a strategy to characterize assay performance when applied to body fluid matrixes. Key concepts that apply to the entire test cycle, including preexamination, examination, and postexamination phases of body fluid testing, are discussed.
CLSI C52-Ed3 (R2021)
Toxicology and Drug Testing in the Medical Laboratory - 3rd Edition
This guideline provides an overview of drug testing by medical laboratories, including testing for drugs of abuse. It discusses the preexamination, examination, and postexamination considerations for specimen collection, methods of analysis, and the reporting and interpretation of results.
CLSI C57-Ed1 (R2020)
Mass Spectrometry for Androgen and Estrogen Measurements in Serum
This guideline describes principles, requirements, and recommendations of current mass spectrometry (MS) measurement procedures for routine analysis of androgens and estrogens in serum. The main focus of this document is on the analytical validation and clinical application of androgen and estrogen measurement procedures using MS. It includes guidance, references, and QA parameters that will assist with the implementation and operation of MS systems. Information on maintaining appropriate instrument settings and performance parameters, approaches to ensure accurate and precise measurements, measurement procedure validation requirements, QA procedures, and interpretation and reporting of results are included. Recommendations are included for sample preparation, and pre- and postexamination (pre- and postanalytical) considerations.
CLSI C58-A
Assessment of Fetal Lung Maturity by the Lamellar Body Count; Approved Guideline
This document provides guidelines for the use of automated cell counting to enumerate lamellar bodies in amniotic fluid. It describes the different counting technologies used in automated cell counters as well as methods laboratorians can use to verify/validate the lamellar body count test
CLSI C60-A
Blood Alcohol Testing in the Clinical Laboratory Approved Guideline
This guideline provides technical and administrative guidance on laboratory procedures related to blood alcohol testing, including specimen collection, methods of analysis, quality assurance, and reporting of results.The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus guideline for use in satisfying a regulatory requirement.This document is no longer being reviewed as part of our consensus process. However, because of its usefulness to a limited segment of the healthcare community, we are continuing to make the document available for its informational content.This document is included in the CLSI document code change and rebranding that is currently in process. The code will be changed from T/DM06-A to C60-A. Please make sure that the document title corresponds to the publication that you intend order.
CLSI GP16-A3
Urinalysis; Approved Guideline-Third Edition
Clinical and Laboratory Standards Institute document GP16-A3-Urinalysis; Approved Guideline-Third Edition is written for laboratory and nonlaboratory personnel responsible for the collection, transport, and analysis of urine specimens. The guideline addresses macroscopic evaluation, chemical analysis, and microscopic examination of urine
CLSI GP23-A
Nongynecologic Cytologic Specimens: Collection and Cytopreparatory Techniques; Approved Guideline
Developed for use by clinical personnel responsible for the collection and processing of cytologic specimens. This guideline Provides recommendations for the collection and handling of specimens from nongynecologic sources for transport to the cytology laboratory. Also included are procedures for processing the specimens (i.e., smear preparation, fixation, and staining) for cytologic evaluations. This document does not address issues related to the interpretation of the slide preparation.
CLSI GP43-A4
Procedures for the collection of Arterial Blood Specimens; Approved Standard-Fourth Edition
Collection of a blood specimen, as well as its handling and transport, are key factors in the clinical laboratory analysis and ultimately in delivering quality patient care. NCCLS document H11-procedures for the Collection of Arterial Blood Specimens serves a dual purpose: to reduce the potential hazard to the patiend and to maintain the integrity of the arterial blood specimen. Collection arterial blood is not only technically difficult but also imposes a degree of risk for the patient Arterial blood is also one of the specimens most sensitive to preanalytic effects. Arterial blood is also one of the specimens most sensitive to preanalytic effects. This standard will be particularly valuable to those involved in blood specimen collection, such as clinical laboratory directors, respiratory therapists, physicians, physicians in training, nurses, medical technologists, exercise physiologists, phlebotomists, and perfusionists.
CLSI GP44-A4
Procedures for the Handling and Processing of Blood Specimens for Common Laboratory Tests; Approved Guideline - Fourth Edition
Addresses handling and processing of blood specimens for examination procedures using serum, plasma, or whole blood in the clinical laboratory. The variables associated with precentrifugation, centrifugation, and post centrifugation phases of specimen handling and processing are emphasized. Factors that can introduce test result inaccuracy or systematic bias after the specimen is collected but before the test is performed are discussed and performance criteria for in vitro diagnostic blood collection devices used to separate serum or plasma from cellular components are also addressed. This guideline specifies criteria to assist the laboratory and other health care providers in recognizing and reducing or eliminating preexamination errors resulting from improper handling of blood specimens.
CLSI H02-A5
Procedures for the Erythrocyte Sedimentation Rate Test; Approved Standard - Fifth Edition
This document addresses the methodology and devices for the measurement of the erythrocyte sedimentation rate (ESR) phenomenon. It also provides guidance for validation, verification, quality assurance (QA), and quality control (QC) through standardized approaches to ensure good laboratory science and clinical relevance. The intended audience includes manufacturers of such devices, end-user clinical laboratories, accrediting organizations, and regulatory bodies
CLSI H15-A3
Reference and Selected Procedures for the Quantitative Determination of Hemoglobin in Blood; Approved Standard-Third Edition
describes the measurement of blood hemoglobin using the hemiglobincyanide (HiCN) method, including composition of, and criteria for, the reagent and the calibration of photometers. A separate section contains specifications for, and spectral characteristics of, HiCN solutions suitable for use as standards. The document enables users to achieve accurate hemoglobin concentration values for diagnostic or reference purposes. Producers of HiCN calibration standards can use the document as a guideline; users will have the information necessary to check for the content and purity of those materials. FDA
CLSI H20-A2
Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental Methods; Approved Standard-Second Edition
Clinical and Laboratory Standards Institute document H20-A2 - Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental Methods; Approved Standard - Second Edition evaluates automated and semiautomated hematology instruments for their capability to perform an acceptable leukocyte (WBC) differential count. The standard focuses on WBC found in blood films. The standard presents a detailed description of an acceptable manual-visual WBC differential count, which serves as the reference for the instrumental differential counter. The types of abnormalities for inclusion are outlined.
CLSI H21-A5
Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays and Molecular Hemostasis Assays; Approved Guideline-Fifth Edition
NCCLS document H21-A4-Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays; Approved Guideline-Fourth Edition is an update of the previous edition published in 1998. The guideline provides procedures for the collection, transport, and processing of blood specimens for coagulation testing. Tests of the coagulation system are very sensitive to storage (time and temperature), concentration of anticoagulant, and surface of containers; attention to these parameters is important. H21-A4 is primarily directed toward laboratory and/or clinical personnel responsible for obtaining patient specimens and preparing plasma for analysis by coagulation testing.
CLSI H22-P
Histochemical Method for Leukocyte Alkaline Phosphatase; Proposed Standard
describes the semi-quantitative, histochemical method for determining leukocyte alkaline phosphatase (LAP). The method includes procedures for preparing fixative, buffer, and counterstains; for staining blood smears; scoring criteri
CLSI H3-A6
Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture; Approved Standard-Sixth Edition. (Publication Date: 10/31/2007)
Clinical and Laboratory Standards Institute document H3-A6 - Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture; Approved Standard - Sixth Edition provides a descriptive, stepwise procedure for the collection of diagnostic blood specimens by venipuncture. Special considerations for venipuncture in children, line draws, blood culture collection, and venipuncture in isolation situations are included. See GP41-Ed7
CLSI H52-A2
Red Blood Cell Diagnostic Testing Using Flow Cytometry; Approved Guideline - Second Edition
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. (Reaffirmed June 2016)
CLSI H56-A
Body Fluid Analysis for Cellular Composition; Approved Guideline
Clinical and Laboratory Standards Institute document H56-A-Body Fluid Analysis for Cellular Composition; Approved Guideline provides recommendations for standardizing the collection and transport of body fluids, numeration and identification of cellular components, and guidance for qualitative and quantitative assessment of body fluid.
CLSI H58-A
Platelet Function Testing by Aggregometry; Approved Guideline
Provides concrete, standard procedures for using aggregometry to assess platelet function in patient specimens with the intent to achieve greater uniformity of results.
CLSI I/LA25-A2
Maternal Serum Screening; Approved Standard - Second Edition
This document addresses the steps required to provide reliable screening and reporting using examples of serum markers currently in common use (AFP, hCG, uE3, inhibin A, PAPP-A). Emphasized is first-trimester screening, in which serum markers used are PAPP-A and hCG, and the main ultrasound marker is nuchal translucency. Outcome evaluation, information management, and calculation of risk are also emphasized. (Reaffirmed September 2018)
CLSI I/LA29-A
Detection of HLA-Specific Alloantibody by Flow Cytometry and Solid Phase Assays; Approved Guideline
The current and emerging technologies for detecting and characterizing human leukocyte antigen (HLA) alloantibodies provide powerful tools for predicting the risk of immunological response to a transplant. Clinical and Laboratory Standards Institute document I/LA29-A - Detection of HLA-Specific Alloantibody by Flow Cytometry and Solid Phase Assays; Approved Guideline describes criteria for optimizing methods that utilize flow cytometry and other conventional and multiplex platforms. The intended audience includes solid organ and stem cell transplant laboratories, manufacturers of systems for histocompatibility testing, and organizations that manage organ sharing.
CLSI M43-A
Methods for Antimicrobial Susceptibility Testing for Human Mycoplasmas; Approved Guideline
This document provides guidelines for the performance and quality control of agar and broth microdilution antimicrobial susceptibility tests on human mycoplasmas and ureaplasmas.
CLSI M47-A
Principles and Procedures for Blood Cultures; Approved Guideline
The laboratory detection of bacteremia and fungemia remains one of the most important functions of clinical microbiology laboratories. During the past 30 years, a number of studies have defined the critical factors in the recovery of pathogens from blood and the optimal laboratory methods for recovering specific pathogens, and have established the performance characteristics of blood culture systems. Despite this information, there remains a need for guidelines for the collection, processing, and interpretation of blood cultures. Several in vitro blood culture devices are cleared by the United States Food and Drug Administration (FDA) for use in the United States. These devices typically are available for use in other countries. This guideline is intended to provide guidance to clinical microbiologists and other laboratorians (e.g., pathologists, laboratory supervisors, laboratory managers) for the recovery of pathogens from blood specimens taken from patients who are suspected of having bacteremia or fungemia. Specific recommendations will be offered for the collection, transport, and processing of blood cultures. The existing blood culture technology will be reviewed and the relative benefits of these technologies will be compared. Procedures for the identification of pathogens will not be addressed. Antimicrobial susceptibility testing of bacteria is addressed in CLSI/NCCLS documents M2 - Performance Standards for Antimicrobial Disk Susceptibility Tests, M7 - Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically, and M11 - Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria. Antimicrobial susceptibility testing of fungi is covered in CLSI/NCCLS documents M27 - Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts and M38 - Reference Method for Broth Dilution Antifungal Susceptibility Testing of Filamentous Fungi.
