Press Releases
Quality Management System Guidelines for Respiratory Services (HS4-A2); Quality Management System Guidelines for Medical Imaging (HS5-A2); Quality Management of Inpatient Medication (HS10-A2); Newborn Screening Follow-up (I/LA27-A); Susceptibility Testing for Organisms Not Previously Targeted (M45-A); Bacterial Strain Typing (MM11-P); Diagnostic Nucleic Acid Microarrays (MM12-A)

CLSI Releases New Quality Management System Guidelines for Respiratory Services
Wayne, Pennsylvania, USA—May 2006—Clinical and Laboratory Standards Institute (CLSI, formerly NCCLS) recently published an updated documents to enhance its quality systems standards and guidelines for clinical and laboratory testing focusing on respiratory services.

The guideline: Application of a Quality Management System Model for Respiratory Services; Approved Guideline–Second Edition (HS4-A2) describes service path of workflow and provides information that will assist in improving processes, as well as for meeting government and accreditation requirements. Individual service areas, such as respiratory therapeutics, pulmonary diagnostics, or sleep diagnostics, can apply this model to their respective operations.
Read full press release.

CLSI Releases New Quality Management System Guidelines for Medical Imaging
Wayne, Pennsylvania, USA—May 2006—Clinical and Laboratory Standards Institute (CLSI, formerly NCCLS) recently published an updated document to enhance its quality systems standards and guidelines for clinical and laboratory testing involving medical imaging.

The guideline: Application of a Quality Management System Model for Medical Imaging Services; Approved Guideline—Second Edition (HS5-A2) describes service path of workflow and provides information that will assist in improving processes, as well as for meeting government and accreditation requirements.
Read full press release.

CLSI Publishes Updated Guideline for Quality Management of Inpatient Medication
Wayne, Pennsylvania, USA—May 2006—Inpatient medication systems need to be designed and procedures written to ensure quality delivery for the reduction of potential medication errors that waste resources and potentially harm patients.  Clinical and Laboratory Standards Institute (CLSI, formerly NCCLS) has recently updated its document, Application of a Quality Management System Model for Inpatient Medication Use; Approved Guideline—Second Edition (HS10-A2), which describes important activities in the path of workflow for inpatient medication, including clinical and distributive pharmacy functions. This workflow is defined as the sequential processes that transform a physician’s medication order into an administered medication. In addition to assisting the hospital pharmacy with improving its medication-related processes, this document can help healthcare facilities meet government and accreditation guidelines.
Read full press release.

CLSI Publishes Approved Guideline for Newborn Screening Follow-up
Potential to Impact the Health of Newborns Globally
Wayne, Pennsylvania, USA—May 2006—As part of newborn screening for congenital conditions, follow-up activities play an essential role in facilitating early diagnosis and intervention for those affected. Rapid, efficient, and effective follow-up is critical to ensure that newborns needing further testing are evaluated quickly to reduce morbidity and mortality.  However, the quality and quantity of follow-up activities vary drastically among global public health newborn screening programs.

CLSI document Newborn Screening Follow-up; Approved Guideline (I/LA27-A) was recently published to serve as a reference for developing and providing follow-up services within a newborn screening system.
Read full press release.

New CLSI Document Addresses Susceptibility Testing for Organisms Not Previously Targeted
Infrequently Isolated or Fastidious Bacteria Now Included in Guidelines for Microbiology Labs
Wayne, Pennsylvania, USA—May 2006—Clinical and Laboratory Standard Institute (CLSI, formerly NCCLS) recently published a document, titled Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria; Approved Guideline (M45-A), which provides guidance to clinical microbiology laboratories for standardized susceptibility testing of infrequently isolated or fastidious bacteria that are not presently included in CLSI’s benchmark documents:  M2 – Performance Standards for Antimicrobial Disk Susceptibility Tests, M7 – Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically, or M11 – Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria. 
Read full press release.

CLSI Publishes Guidelines for Bacterial Strain Typing
Wayne, Pennsylvania, USA—May 2006—Clinical and Laboratory Standards Institute (CLSI, formerly NCCLS) recently published a new document, titled Molecular Methods for Bacterial Strain Typing; Proposed Guideline (MM11-P), which examines the biology behind molecular strain typing and the process of characterizing and validating typing systems. This document provides a much-needed framework to facilitate consistency in reporting bacterial strain typing and to assist both laboratories performing these studies and professionals applying the results. 
Read full press release.

CLSI Publishes Approved Guideline for Diagnostic Nucleic Acid Microarrays
More Information Available Faster for Improved Patient Care
Wayne, Pennsylvania, USA—May 2006—Diagnostic nucleic acid microarrays are a relatively recent outgrowth of more traditional molecular diagnostic methods. They offer the potential to allow rapid, simultaneous genetic testing for multiple traits or mutations in a single disease gene and diagnostic identification of infectious disease organisms. Other configurations of microarrays enable comparative surveys of gene expression in selected tissues and samples, resulting in diagnostic and response predictions.

As with all diagnostic tests, nucleic acid microarrays must be developed and practiced under the appropriate conditions. In addition, there are unique quality control issues, as well as analytical and validation differences, and novel interpretation algorithms compared to simple unitary tests. To facilitate the optimum operation of nucleic acid microarrays, Clinical and Laboratory Standards Institute (CLSI, formerly NCCLS) has published a guideline titled Diagnostic Nucleic Acid Microarrays: Approved Guideline (MM12-A). 
Read full press release.
[ return to top ]