CLSI eNews - 1 November 2006 (Plain Text Version)

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News
Executive Vice President's Message
Applying a Quality System to Respiratory Services
Flow Cytometry: New Guidelines to Support its Clinical Application
Press Releases
Standards Status
Vote and Deadlines
Recently Approved Documents
Events and Exhibits
Upcoming Events
CLSI Meetings Calendar
Participate in CLSI
Volunteer
New and Sustaining Members
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Press Releases

Autoverification of Clinical Laboratory Test Results (AUTO10-A); IT Security of In Vitro Diagnostic Instruments and Software Systems (AUTO11-A); Principles and Procedures for Blood Cultures (M47-P)

CLSI Publishes New Guideline for Autoverification of Clinical Laboratory Test Results
Wayne, Pennsylvania, USA—November 2006—With increasing pressure to maintain adequate turnaround time and to enhance the quality of results, clinical laboratories must develop new methods for increasing productivity with limited resources. Automated verification, or autoverification, has emerged as a tool for laboratories whose goal is to streamline their laboratory processes while maintaining the highest quality standards.

Autoverification of Clinical Laboratory Test Results; Approved Guideline (AUTO10-A), recently published by Clinical and Laboratory Standards Institute (CLSI, formerly NCCLS), provides a general framework that will allow each laboratory to easily design, implement, validate, and customize rules for autoverification based on the needs of its own patient population. In addition, important supporting sections are provided that deal with the different aspects of regulatory compliance and validation of algorithms that are essential to establishing and maintaining a modern autoverification system.
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CLSI Publishes New Standard for IT Security
Wayne, Pennsylvania, USA—November 2006—With new international regulations applicable to healthcare organizations; an increase in the degree of integration of the IVD systems in the IT environment of healthcare institutions; and attacks observed in healthcare organizations from a multitude of sources, IT security requirements are growing.

In response to these real and potential IT threats, Clinical and Laboratory Standards Institute (CLSI, formerly NCCLS) has recently published a new standard, IT Security of In Vitro Diagnostic Instruments and Software Systems; Approved Standard (AUTO11-A). This standard provides a framework for communication of IT security issues between the IVD system vendor and the healthcare organization.
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CLSI Publishes New Guideline for Blood Cultures
Wayne, Pennsylvania, USA—November 2006—The prompt and accurate detection of bacteremia and fungemia is one of the most important functions of clinical microbiology laboratories. Guidelines for the collection, processing, and interpretation of blood cultures are needed so that laboratories and providers use optimal laboratory methods for recovering specific pathogens, interpret the results correctly, and help control healthcare costs.

In response to this need, Clinical and Laboratory Standards Institute (CLSI, formerly NCCLS) has recently published a new document, Principles and Procedures for Blood Cultures; Proposed Guideline (M47-P). "The blood culture is among the most important tests performed by laboratories. These CLSI guidelines will help providers and laboratorians develop standardized practices for blood cultures that are based on the most current scientific and medical information," says Michael L. Wilson, MD, Denver Health Medical Center.
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