October 2011 Clinical Laboratory News: Volume 37, Number 10

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COVER STORIES

The Era of Personalized Medicine in Cancer
Will Companion Diagnostics be the Tipping Point?
By Genna Rollins

The promise of personalized medicine is being fulfilled in the realm of cancer diagnosis and treatment, thanks to rapidly advancing technologies and an ever-improving understanding of cancer biology. This emerging field will place new emphasis on the role of labs as clinical consultants, as well imposing as a new regulatory paradigm for anti-cancer therapies and companion diagnostics.

Under Construction: The Road to FDA Clearance
Should New Tests Be Cleared Based on Old Laws?
By Bill Malone

A new report from the Institute of Medicine recommends that FDA replace its 30-year-old 510(k) review program. Now the agency must decide how to proceed with its existing plans to revamp the program that clears 90% of all new tests and other medical devices.

SERIES ARTICLE

Cystic Fibrosis
How Newborn Screening Algorithms Detect Disease
By Stanley F. Lo, PhD

Screening newborns for cystic fibrosis (CF) has change dramatically over the years due to technological improvements in molecular testing. Catching CF early is essential to improving a quality of life for affected newborns.

NEWS BRIEF

Study Calls for More HIV Testing in EDs

AACC ANNUAL MEETING AND EXPO HIGHLIGHTS

FDA Says Lab-Developed Test Regulation Will Take Time
By Bill Malone

With the lab community still waiting on a definite plan from FDA about how it will regulate all lab-developed tests, agency officials assured laboratorians that it would be a slow, careful process.

TSH Not the Total Picture of Clinical Symptoms
By Genna Rollins

Endocrine, sex, and stress hormones can have major consequences for healthy aging and longevity, but is TSH the only hormone that clinicians should monitor?

Advocates Warn Labs to Prepare for Copays
By Bill Malone

Labs have fought and won battles against a Medicare copay for lab testing before. But with deep budget cuts looming for government programs, there’s less room to negotiate this time around.

Biological Variation Overlooked too Often
By Genna Rollins

Biological variation is an important factor in test result variation, so it should be used to consider the context of patients’ testing, as well as laboratory quality control initiatives.

Lab Tests Key to Definitive Polycystic Ovary Syndrome Diagnosis
By Genna Rollins

Polycystic ovary syndrome is a complex disease that shares symptoms and biochemical trends with other disease, so a definitive diagnosis requires active collaboration between laboratorians and physicians.

MouseOnline Extra
Expo News
Read highlights of the Expo.

PATIENT SAFETY FOCUS

The Checklist Movement
Why Laboratories Should Embrace Memory Aids
By Corinne R. Fantz, PhD

Checklists have enormous potential to improve the safety of processes that often involve repetition and always require precision. Such lists can assist staff in remembering to perform specific tasks that if ignored could cause patient harm.

Performance Inflation
Is There a Hospital that Hasn’t Won an Award?
By Michael Astion, MD, PhD

Hospitals often win awards because of their quality or service. Despite receiving accolades, administrators must balance the need to affirm improved performance with the need to accurately assess and discuss where their hospital stands on ensuring patient safety.

Two New National Quality Forum Serious Reportable Events Focus on Clinical Labs
How Should Your Laboratory Prepare?
By Teresa Darcy MD, MMM

The 2011 updates to the National Quality Forum Serious Reportable Events list provide an important opportunity for the laboratory community to improve the safety of patients. For the first time, two events focus on the laboratory.

Developing an Ethical Code of Conduct
Why Labs Should Seek Solutions from Big Business
By Sarah Watts-Justice, MHA, MPA

Many companies now embrace societal goals and long-term sustainability strategies without hurting the bottom line. Labs could benefit from some of their strategies for developing an ethical code of conduct.

INSIDE

AACC’s EXPERT ACCESS
Managing a Multigenerational Lab Staff

Each month, AACC’s Expert Access Live Online Program features a different hot topic. Read excerpts from a Q&A with Carmen L. Wiley, PhD, DABCC, FACB, about how your lab can bridge the generational gaps between Baby Boomers and younger workers.

PROFILES

Regulatory Profiles
Industry Profiles
Diagnostic Profiles
News from the FDA

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Next Month

Anti-nuclear Antibody Testing in Rheumatology

Quality Control Based on Risk Management