January 2009 Clinical Laboratory News: Volume 35, Number 1

CLN Banner Logo


ISO Accreditation Comes to America
Are Labs Ready to Embrace an International Quality Management System?
By Bill Malone


Lab accreditation programs based on the ISO 15189 standard for medical labs are now being offered in the U.S., causing speculation that more clinical labs will start looking at accreditation as a way to embrace quality management systems.

C. difficile Infections on the Rise
Is it Time to Return to Culturing?
By Gina Rollins


Recent studies have shown that the prevalence of C. difficile among hospitalized patients is much higher than originally thought, adding stress and costs to U.S. healthcare facilities. Unfortunately, detecting C. difficile infections remains a challenge.


Fatigue and Error


Matthew B. Weinger, MD discusses the relationship between fatigue and lab error, as well as steps managers can take to reduce the effects of fatigue in the lab.

Engineers in the Clinical Laboratory


Lean and Six Sigma are problem solving methods commonly utilized by engineers to reduce waste and improve efficiency in industrial processes, though many of these process improvement initiatives are transferable to healthcare and lab settings. Brian Nass and Patrick Fasse, two engineers who specialize in process improvement, discuss how using engineering methods can improve efficiency and performance in the clinical lab.


HIV Screening
A Look at the CDC Guidelines and HIV Rapid Tests
By Patricia Slev, PhD


It has been 2 years since CDC released revised guidelines for HIV screening, yet implementation is still spotty. But as rapid HIV tests have become more widely available, more information on their performance in different contexts may lead to new testing algorithms.


Recommendations Revised for Chronic HBV Infection Testing


CDC Program Aims to Develop Genetic Testing Reference Materials


For the majority of genetic tests currently available, no reference or quality control materials exist, making it difficult for labs to develop and validate the quality of these tests. In order to combat this, CDC is initiating efforts to develop appropriate testing materials that can be used in labs performing genetic tests.


Diagnostic Profiles

Industry Profiles

News from the FDA

Page Access:

Next Month

Labs Respond to Recession

JUPITER Makes CRP a Star