General Principles and Guidelines on the Use of Mass Spectrometry in the Clinical Laboratory (C50-P); Laboratory Design (GP18-A2); Using Proficiency Testing to Improve the Clinical Laboratory (GP27-A2); Laboratory Detection and Identification of Mycobacteria (M48-P)

CLSI Publishes New Guideline for Use of Mass Spectrometry in the Clinical Laboratory
Wayne, Pennsylvania, USA—March 2007 — The development of more user-friendly, affordable, and versatile mass spectrometers, as well as the availability of stable isotopes that serve as internal standards to facilitate more accurate quantification, has allowed a large increase in the use of mass spectrometry (MS) for clinical applications.

Clinical and Laboratory Standards Institute (CLSI, formerly NCCLS) has recently published General Principles and Guidelines on the Use of Mass Spectrometry in the Clinical Laboratory; Proposed Guideline (C50-P) to provide accurate and state-of-the-art information and guidance for the appropriate use of MS in the clinical laboratory. It includes guidance, references, and quality assurance markers that will assist with the implementation and correct operation of an MS system for its many applications. Information on maintaining optimum performance, approaches to ensuring accurate and precise mass measurement, verification of methods, quality control of assays within and between instruments, instrument troubleshooting, sample preparation, interpretation of results, and limitations of the technology is included.
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CLSI Publishes Updated Guideline for Optimal Laboratory Design
Wayne, Pennsylvania, USA—March 2007— Clinical laboratories are striving to adapt and adjust to a myriad of changes that have come about through technological advances, increased computerization, and a decreased workforce. Laboratorians are confronted with new procedures and equipment that must be incorporated into their facilities to stay on both the clinical and the competitive cutting edge. Many laboratory managers have found it necessary to either replace or remodel existing facilities to maintain the functional viability of their laboratories. In addition, the incorporation of increased building code requirements is vital for accreditation.

Clinical and Laboratory Standards Institute (CLSI, formerly NCCLS) has recently updated its document, Laboratory Design; Approved Guideline—Second Edition (GP18-A2), which addresses selected nonstructural elements that affect the planning, layout, and safety of a clinical laboratory. The elements addressed include space, casework, equipment, classifications, health and safety, ventilation, lighting, plumbing, electrical, and communications. Laboratory design includes many activities that, when thoughtfully and carefully applied, culminate in a well-conceived and highly functional laboratory. 
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New Edition of CLSI’s Guideline for Using Proficiency Testing to Improve the Clinical Laboratory
Wayne, Pennsylvania, USA—March 2007— Proficiency testing (PT) is a valuable tool in the quality improvement process. PT provides objective evidence of competence for customers, accrediting bodies, and regulatory agencies, and it serves as a unique source of information that is not obtainable in any other way. 

The new edition of Clinical and Laboratory Standards Institute’s (CLSI, formerly NCCLS) document, titled Using Proficiency Testing to Improve the Clinical Laboratory; Approved Guideline—Second Edition (GP27-A2), 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. This document also provides guidelines for how to use PT as a tool to prevent problems through analyzing acceptable results, educating laboratory personnel, and monitoring internal processes. 
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CLSI Publishes New Guideline for Diagnosis of Mycobacterial Infections
Wayne, Pennsylvania, USA—March 2007—The enormous global problem of tuberculosis (with roughly one-third of the world’s population infected with Mycobacterium tuberculosis), coupled with an increasing incidence of infections caused by nontuberculous mycobacteria, present unique challenges for the laboratory diagnosis of mycobacterial infections.  Not only must the diagnosis of M. tuberculosis be optimized and expedited for good patient management and institution of appropriate control measures to prevent transmission of tuberculosis, but similar demands for accurate identification of the ever-increasing numbers of species of nontuberculous mycobacteria are also pressing for the laboratory. 

In light of these issues, Clinical and Laboratory Standards Institute (CLSI, formerly NCCLS) has recently published Laboratory Detection and Identification of Mycobacteria; Proposed Guideline (M48-P), which addresses topics related to the laboratory diagnosis of mycobacterial infections, including safety and related issues; levels of service and referrals; clinical significance of mycobacteria; acceptable specimen types and their collection; transport and storage; specimen processing methods; methods for the direct detection of mycobacteria in clinical specimens; culture methods, including contamination issues; reporting and quality control; and phenotypic and genotypic identification procedures.
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