News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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Innovative Clinical Pathology Laboratories Are Adding Value to Pharmacogenomic Test Reports to Help Physicians Better Interpret and Act upon the Results

There’s even a company called Translational Software providing a service to incorporate enriched information about such tests into the reports that labs deliver to doctors

Personalized medicine is the good news story in healthcare and clinical laboratory medicine today. Armed with new understanding about the human genome, physicians are able to customize therapies for patients that will produce the best outcomes while avoiding or minimizing the negative side effects associated with many common prescription drugs.

This is why pharmacogenomics testing is a booming segment of the clinical laboratory industry. On its website, the Duke Center for Personalized and Precision Medicine describes this emerging lab medicine specialty as follows: “Pharmacogenomic tests are used to inform dosing and predict efficacy and adverse events for therapeutic agents. Most tests involve genetic testing, and in the case of cancer, both the DNA of the host and the tumor can be used to inform the choices for treatment.” (more…)

CLMA’s Inaugural ICE Award Recognizes the Initiative at Seattle Children’s Hospital Laboratories that Decreased Unnecessary Genetic Tests while Contributing to Better Patient Outcomes

The Clinical Laboratory Management Association is encouraging medical laboratories to submit abstracts about their programs to deliver more value to patients and physicians through the use of clinical pathology laboratory tests

Now, more than ever, the house of laboratory medicine needs to be publishing clinic studies and evidence that the money spent on appropriate medical laboratory testing is returned tenfold from improved patient outcomes and substantial reductions in the cost per episode of care that can be associated with the use of those lab tests.

It is this credible evidence that can help shape healthcare policy in positive ways, while encouraging government and private payers to recognize the true value of clinical laboratory tests and thus establish adequate reimbursement to insure the continuation of high-quality lab testing services in the United States. (more…)

Because of Sizeable Deductibles, More Patients Owe More Money to Clinical Pathology Laboratories, Spurring Labs to Get Smarter about Collecting from Patients

One Arizona medical laboratory focused on collecting from patients who were overdue on amounts averaging just $40 and, in 18 months, collected $3.2 million!

In today’s clinical laboratory marketplace, competency in revenue management is becoming just as important as clinical excellence. Blame it on these multi-year trends: shrinking lab budgets, Medicare price cuts, and payers excluding labs from narrow networks.

At the dawn of this decade—just five years ago—few pathologists and clinical lab executives would have predicted that the financial survival of their lab organizations would depend upon becoming more proficient and more sophisticated with billing and collections. Yet this is now a necessary response to the year-over-year decline in lab prices and revenue experienced since 2010. (more…)

Theranos Selects Phoenix Metro to Plant Its Flag and Enter the Competitive Market for Clinical Pathology Laboratory Testing

As predicted by Fortune Magazine in its coverage of Theranos, with its expansion into Phoenix, the lab company is getting its closest scrutiny from pathologists and medical technologists

Recent developments in Phoenix, Arizona, make it clear that Theranos has chosen this desert metropolis to be the launching pad for its much-publicized proprietary clinical laboratory testing business.

The highly-secretive company, which claims to have more market value than either Quest Diagnostics Incorporated (NYSE: DGX) or Laboratory Corporation of America (NYSE: LH), is now building the infrastructure needed to operate as a local medical laboratory company in Phoenix.

Theranos Has CLIA Laboratory in Scottsdale

The April 20 issue of The Dark Report presented two exclusive intelligence briefings about Theranos and its business plans. The company now has its “wellness centers” operating in about 41 Walgreens pharmacies throughout the Phoenix metropolitan area. It has opened a clinical laboratory facility in Scottsdale and is currently working to acquire its CLIA certification. When certified, this lab facility will allow Theranos to perform testing locally, eliminating the need to transport all specimens to its CLIA lab in Fremont, California. (more…)

Are CLIA Inspections of Clinical Pathology Laboratories Getting Tougher? Why It Pays to Achieve “Inspection Readiness”

Experts say that CLIA inspections are becoming more rigorous, with inspectors taking more interest in how medical labs comply in the areas of personnel, PT, and quality control

Recent reports indicate that regulatory inspections of clinical laboratories are getting tougher. Some pathologists and medical lab managers acknowledge that they’ve had to scramble in response to the unexpected deficiencies identified by Clinical Laboratory Improvement Amendments (CLIA) inspectors following inspections of their labs.

These developments make it more important than ever that clinical laboratories work to become “inspection ready.” At the same time, it is essential that every laboratory compliance officer stay up to date with changes in how CLIA and other regulatory inspections are conducted.

Unwelcome Publicity When Medical Lab Regulators Find Deficiencies

There’s another factor at play in this unfolding story. News headlines immediately follow when federal and state lab regulators discover a problem with a laboratory and the quality of the test results that it is reporting. This raises the stakes for every lab director, because even highly respected medical laboratory organizations can find themselves at the center of unwelcome attention when the public becomes aware of inspection deficiencies. (more…)

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