January 2011 Clinical Laboratory News: Volume 37, Number 1

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The Three Year Outlook for Diagnostics
Continued Uncertainty, Renewed Focus on Value Predicted
By Genna Rollins

What changes and challenges lay ahead for the IVD industry and clinical labs during the next 3 years? CLN asked experts to reflect on the future of the field and readers to voice their opinion on the most significant issues.

Online Extra - CLN Survey Comments: A Look Ahead - How do Readers Feel about the Future?



Reimbursement and Reform in 2011
Will the Push for Integration Open a New Role for Labs?
By Bill Malone

Accountable care organizations and other healthcare reform provisions that push clinical integration will bring both challenges and opportunities for the lab. Some even see ACOs as another harbinger of the death of fee-for-service reimbursement—a prospect that could upend current presumptions about how value is assigned to lab tests. 

CLN Online Extra

   Online Extra - 2011 Lab Fee Schedule Highlights   


Clinical Utility of Serum and Red Blood Cell Analysis
By Cynthia Balion PhD, FCACB and Bhushan M. Kapur PhD, FRSC, FACB, FCACB

Clinicians routinely order folate tests for evaluation of macrocytic anemia. While this clinical practice is well-entrenched, it may not be necessary today because the prevalence of folate deficiency is very low. Learn how labs can control unnecessary orders for the test.


Hidden Epidemic: Chronic HBV and HCV Infections



Q&A with FDA’s Alberto Gutierrez
By Bill Malone

Alberto Gutierrez, PhD, director of the Food and Drug Administration’s Office for In Vitro Diagnostics, shares his thoughts on the challenges facing the agency’s review of devices and assays, including new technology, shifts in clinical practice, and greater transparency.


Clinical Chemistry  Celebrates the International Year of Chemistry

The International Union of Pure and Applied Chemistry and the United Nations Educational, Scientific, and Cultural Organization have designated 2011 as the International Year of Chemistry to celebrate the achievements of chemistry and its contributions to mankind. AACC’s Clinical Chemistry journal will mark the year with special editorials and other content.



Barcode Scanning Errors, a Threat to Patient Safety
By Nancy Sasavage, PhD

Barcodes play a fundamental role in many facets of healthcare today. This article examines the limitations of linear barcode technology and suggests some helpful strategies that laboratories can use for implementing barcode systems and improving the accuracy of existing barcode systems.


The Competence-Confidence Conundrum
A Look at Self-Assessment
By Michael Astion MD, PhD

How good are you at assessing your knowledge? Here’s a chance to test yourself on the concepts of the competence-confidence conundrum and compare your answers to those of subscribers to a competency assessment exam.


Shift-to-Shift Communication
What Can Labs Learn from NASA and other Highly Reliable Organizations?
By Erin Grimm, MD

Poor communication can negatively affect a lab’s ability to operate efficiency and effectively. Learn how improving communication during shift changes between staff can increase lab efficiency, boost productivity, and improve overall patient safety.


Reference Intervals and Patient Safety
The Ins and Outs of Establishing Reference Intervals
By Frederick Strathmann, PhD

Extensive guidelines exist to help laboratories provide a minimum standard of patient care; however, no consensus exists on how to establish reference intervals. Find out why creating reference intervals are an essential component of patient safety.


Regulatory Profiles

Industry Profiles

Diagnostic Profiles

News from the FDA

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CLN January 2011






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Next Month

Emerging Role of hs-cTn Tests

Lab Leaders Collaborate with Physician Groups