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.
Sometimes it’s hard to estimate the impact of shifting healthcare policies until providers actually begin putting them into practice. That seems to be the case with two significant shifts in federal policy that are now working their way toward implementation in clinical laboratories throughout the United States.
Sometimes called the “sunshine vitamin,” vitamin D is active in tissues and cells throughout the body, and is believed to help prevent or reduce a wide range of diseases. But researchers aren’t exactly sure what roles vitamin D plays, and judging how much vitamin D is enough—and for whom—remains something of a moving target.
So far as the realm of molecular diagnostics is concerned, 2013 may go into the books as a year of some significance. But further developments in the coming year could ultimately turn out to be even more important.
Some take-away from the annual conference from one of the presenters.
Regarding the Centers for Medicare and Medicaid Services' long-awaited gap-fill recommendations for the molecular pathology codes—well, the agency released the national limitation amounts, but for only half of the molecular codes.
We begin a discussion in the pub(lication), to be continued in real time.
Staying purposefully in touch.
Vendors at the Clinical Lab Expo showcased products and services to help labs boost their output and operate in accordance with lean initiatives, with the ultimate goal of improving patient outcomes.