With the long-term potential of next-generation sequencing technologies for use in clinical diagnostic applications, paying attention to the new precisionFDA initiative is one more task that labs need to keep on their to-do list.
Clinical labs should ensure that the components they use in developing and performing laboratory-developed tests are themselves consistent in quality and other attributes necessary to produce an accurate report.
According to US Centers for Disease Control and Prevention, a comprehensive and timely overview of influenza activity is an essential public health activity for a variety of reasons.
Pathology and laboratory medicine organizations wasted little time before responding to the recent publication by the Institute of Medicine on the subject of diagnostic errors.
Without increasingly precise and advanced diagnostic testing, and the laboratories that conduct clinical testing, the advance of personalized medicine would come to a grinding halt.
Readers wanting to enrich their understanding of important clinical laboratory topics will find additional commentary online in this month's features.
It is fundamentally important that the lab portion of the diagnostic community be fully involved in efforts to diagnose and monitor instances of antibiotic resistance.
"The media” are not the only ones contributing to the misunderstanding surrounding a recent study published in the Journal of the American Medical Association.
In addition to determining health and disease status among individual patients, clinical laboratory testing is playing an increasingly important role in improving broader understandings of disease on a population level.
For an increasing number of laboratory directors and managers, coping with shifts in the healthcare marketplace is an everyday reality. But those who are prepared may see the challenges of such change as opportunities as well.
President Obama's announcement of a new precision medicine initiative in his State of the Union address has significant implications for the clinical laboratory community.
In the United States, efforts to combat ebola have focused on refining the standard operating procedures necessary to protect caregivers, including new standards for donning and doffing personal protective equipment.
Regulatory disputes are posing unusual challenges for clinical laboratories trying to plan ahead for 2015.
Public health authorities have begun to martial resources to deal with the crisis over antibiotic-resistant bacteria. In September, President Obama issued an executive order creating a new Task Force for Combating Antibiotic-Resistant Bacteria.
Sometime next month, FDA will publish a framework for the regulation of laboratory-developed tests, bringing an end to the agency's long-held policy of “enforcement discretion."
The word from companies on the exhibit floor at the 2014 meeting of the American Association for Clinical Chemistry turns out to be pretty interesting.
Although enacted primarily as the annual “doc fix” to prevent severe cuts in the Medicare rates for physicians, the Protecting Access to Medicare Act of 2014 could bring about dire consequences for many small clinical labs.
With quick test results come public health benefits and better treatment, but for some rapid diagnostic tests, accuracy remains elusive.
At the beginning of April, President Obama signed into law the Protecting Access to Medicare Act of 2014, which incorporates the first major changes in the Clinical Lab Fee Schedule's policies and procedures since the schedule was implemented in 1984.
For every test that has been accepted for use in clinical laboratories, scores of others have been dropped.