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EP19 is organized around the measurement procedure lifecycle paradigm (see Tables 1 and 2), which follows the concept that all measurement procedures undergo an initial establishment phase performed by manufacturers, followed by implementation in laboratories. The document follows the...
This guideline describes general technical principles for ensuring optimal specimen collection, transport, storage, and nucleic acid isolation for molecular diagnostic test methods. It is intended for all health care professionals responsible for obtaining and transporting specimens from patients...
This guideline is intended to help laboratories meet QMS requirements for the records portion of quality system essential (QSE) Documents and Records Management. It presents recommendations for developing a records management program, including designing, creating, reviewing, retaining, and...
This document is intended for pharmaceutical manufacturers involved in the development of antimicrobial agents and tests to support evaluation of antimicrobial agent activity. It is also intended for manufacturers of antimicrobial disks and any independent laboratory that supports the...
Clinical and Laboratory Standards Institute document M59-Epidemiological Cutoff Values for Antifungal Susceptibility Testing includes epidemiological cutoff values (ECVs) and quality control tables developed following the guidance in CLSI document M57.1 These ECVs are valid only when...
Clinical and Laboratory Standards Institute document M60-Performance Standards for Antifungal Susceptibility Testing of Yeasts includes minimal inhibitory concentration, zone diameter, and quality control tables developed following the guidance in CLSI documents M271 and M44.2 The...
Abstract The data in the tables are valid only if the methodologies in CLSI documents M02,1 M07,2 and M113 are followed. These standards contain information about disk diffusion (M021) and dilution (M072 and M113) test procedures for aerobic and anaerobic bacteria. Clinicians depend heavily...
Clinical and Laboratory Standards Institute document M61-Performance Standards for Antifungal Susceptibility Testing of Filamentous Fungi includes minimal inhibitory concentration and quality control tables developed following the guidance in CLSI documents M381 and M51.2 The data in...
Clinical and Laboratory Standards Institute guideline M48-Laboratory Detection and Identification of Mycobacteria covers topics related to laboratory diagnosis of mycobacterial infections, including safety and risk assessment, referrals, clinical significance, acceptable...
This guideline is intended for use by referring laboratories seeking a broad spectrum of services, a limited number of esoteric examinations, consultative services, or a backup service provider for examinations performed by the referring laboratory. This guideline provides...
Abstract The data in the tables are valid only if the methodologies in CLSI document VET031 are followed. This guideline contains information about disk and broth dilution susceptibility test procedures for bacteria isolated from aquatic animals. The clinical importance of antimicrobial...
Abstract The data in the tables are valid only if the methodologies in CLSI document VET011 are followed. This standard contains information about disk and dilution susceptibility test procedures for aerobic and facultatively anaerobic bacteria. Clinicians need information from the...
This guideline provides veterinary and aquatic animal disease diagnostic laboratories with currently recommended antimicrobial broth dilution and disk diffusion susceptibility testing methods for nonfastidious bacteria isolated from aquatic animals, including criteria for QC testing with two...
This standard describes reference agar disk diffusion techniques, as well as standard broth (macrodilution and microdilution) and agar dilution methods used to determine in vitro antimicrobial susceptibility of bacteria that grow aerobically. It includes: • Agar plate preparation • Broth and agar...
This standard describes the collection of blood specimens for newborn screening (NBS) programs, including equipment, sources of blood, collection sites, and techniques for blood spot specimen collection.3 This standard is intended to improve and ensure the quality of dried blood spot (DBS)...
Clinical and Laboratory Standards Institute document M62-Performance Standards for Susceptibility Testing of Mycobacteria, Nocardia spp., and Other Aerobic Actinomycetes includes the minimal inhibitory concentrations and quality control ranges developed following the standards described in...
This guideline specifies recommendations for conducting performance qualification (PQ), routine function checks, calibration verification, and preventive maintenance (PM) of 20 types of general laboratory equipment. Installation qualification (IQ) and operational qualification (OQ) are...
This guideline provides recommendations to laboratories on procedures for collecting, processing, and handling fungal specimens and interpreting direct stain examinations and culture results. In addition, methods for direct or indirect detection from patient specimens, such as antigen,...
Clinical and Laboratory Standards Institute guideline EP07-Interference Testing in Clinical Chemistry is intended to promote uniformity in the evaluation of interference characteristics of medical laboratory measurement procedures. EP07 describes procedures to screen potential...
