Tag: CLSI

CLSI Publishes a Revised Microbiology Document

From the press release:

“The Clinical and Laboratory Standards Institute (CLSI) has published a revised document titled Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria (M45-Ed3).This guideline informs clinical, public health, and research laboratories on susceptibility testing of infrequently isolated or fastidious bacteria that are not included in CLSI documents M02, M07, or M100. Antimicrobial agent selection, test interpretation, and quality control are discussed.
“Susceptibility testing is particularly necessary in situations in which the etiological agent belongs to a bacterial species for which resistance to commonly used antimicrobial agents has been documented, or could arise. The intent of this document revision is to assist labs in determining an approach for testing that is relevant to their individual practice settings.”

To order the document go to shop.clsi.org/m45.

CLSI Releases New Fall 2015 Webinar Schedule

From the press release:

CLSI has released a new fall webinar schedule. Starting this month, the organization will focus on helping laboratory professionals develop their own individualized quality control plans (IQCPs) and provide them with new ways to deal with antimicrobial susceptibility testing (AST) challenges. 

On September 15, 2015, CLSI will host a webinar entitled, Developing Your Laboratory’s IQCP for Antimicrobial Susceptibility Testing. Presented by Susan E. Sharp, PhD, ABMM, FAAM, Director, Regional Microbiology and Molecular Infectious Diseases Laboratories at Kaiser Permanente in Portland, Oregon, USA, and Linda C. Bruno, MA, MT(ASCP), Director, Microbiology and Molecular Pathology Labs at ACL Laboratories in Rosemont, Illinois, USA, this webinar will focus on requirements for IQCP as mandated by the Centers for Medicare & Medicaid Services. It will also focus on the new College of American Pathologists (CAP) requirements for IQCP and how to develop an IQCP for AST.

On October 6, 2015, CLSI will partner with CAP to present Antimicrobial Susceptibility Challenges in regards to the CLSI AST documents and other AST resources that are currently available. Led by Janet A. Hindler, MCLS, MT(ASCP), Sr. Specialist, Clinical Microbiology at UCLA Health System in Los Angeles, California, USA, and Audrey N. Schuetz, MD, MPH, D(ABMM), FCAP, Interim Director, Clinical Microbiology Laboratory; Associate Professor of Pathology and Laboratory Medicine; and Associate Professor of Medicine, Weill Cornell Medical College/NewYork-Presbyterian Hospital from New York, New York, USA, this webinar will cover appropriate agents to report on individual species when isolated from select body sites. There will also be information presented about practical strategies for identifying, confirming, and reporting results for multidrug-resistant bacteria.

Lastly, on November 19, 2015, CLSI will host a webinar called Finding Value in Your AST IQCP: Improving Accuracy and Timeliness of AST Reports. This webinar will focus on what AST results should be confirmed before reporting and will cover processes that can be implemented to identify the most common AST reporting errors. Join A. Beth Prouse, MS, MT(ASCP), Clinical Microbiologist, at Peninsula Regional Medical Center in Salisbury, Maryland, USA, and Janet Hindler as they present on these topics as well as describe ways to improve AST report turnaround time.

Register for these webinars on the CLSI website at www.clsi.org/webinars. Member discounts apply to all CLSI-hosted webinars (September 15 and November 19).

CLSI Publishes New Guide for Laboratory-Developed Tests

From the press release:

“The Clinical and Laboratory Standards Institute (CLSI) has published Quality System Regulation for Laboratory-Developed Tests: A Practical Guide for the Laboratory.This guide converts the requirement complexities of US Food and Drug Administration (FDA) regulations into plain language, offering intuitive assistance on how to conform to the Quality System Regulation (QSReg), 21 CFR 820, when creating laboratory-developed tests (LDTs). This CLSI practical guide can help laboratorians learn how to address the new demands, beyond the Clinical Laboratory Improvement Amendments (CLIA) regulations, within their unique laboratory settings.

“LDTs are in vitro diagnostic devices that are intended for clinical use and are designed, manufactured, and used within a single laboratory. This practical guide is intended to clarify how to implement the QSReg that may be required for some classifications of LDTs. On October 3, 2014, the FDA issued draft guidance for regulating LDTs that includes notification or registration of LDTs with the FDA, reporting adverse events, and other requirements. This document only addresses the QSReg that is currently applicable to manufacturers and is expected to become applicable for some classifications of LDTs when the final guidance is published.”

To purchase this guide for your laboratory, visit the CLSI website.

CLSI Releases New Microbiology Standard for Detection of Anaerobes

Anyone who has worked in Microbiology for any length of time knows that anaerobes are finicky at best and impossible to identify at worst. Having guidelines for their identification would be helpful. Enter CLSI.

From their press release:

“The Clinical and Laboratory Standards Institute (CLSI) released a new microbiology standard, Principles and Procedures for Detection of Anaerobes in Clinical Specimens; Approved Guideline (M56-A). This document presents standardized, cost-effective, and efficient best practice processes for anaerobe bacteriology to assist clinical laboratories in selecting those methods that lead to improved patient care.”