COVER STORIES

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.

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

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

AACC ANNUAL MEETING AND EXPO HIGHLIGHTS

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.

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

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 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.

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.

PATIENT SAFETY FOCUS

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.

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.

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.

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

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