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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JAMA Report Highlights Inaccuracies in Pathologists’ Breast Cancer Diagnoses

Study done by researchers at the University of Washington determined that diagnostic concordance with consensus expert panel missing in nearly 25% of breast cancer cases studied

Standards of quality in clinical care are increasing at a steady pace and anatomic pathology is no exception. The most recent example is the publication of a study in a respected national medical journal that revealed how pathologists participating in the study produced an unexpectedly high rate of diagnostic inaccuracy for certain types of breast cancers.

This situation did not go unnoticed by the national media. On March 17, no less than The New York Times headlined their story on the findings of this story with the title: “Breast Biopsies Leave Room for Doubt, Study Finds.”

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Obama’s $215 Million Precision Medicine Initiative: Will Congress Fund It and Can It Advance Genetic Testing and the Value of Clinical Laboratory Services?

As proposed, the President’s Precision Medicine Initiative would incorporate a large, volunteer study cohort in innovative ways

Even as a new presidential initiative to boost precision medicine makes headlines, there is uncertainty as to how the program can be funded. The Precision Medicine Initiative was announced by President Obama on January 30, 2015.

Many pathologists, clinical chemists, and medical laboratory scientists recognize that such a program would pump additional funds into the research and development of new diagnostic tests that are designed to aid physicians in their practice of precision medicine.

The big question is how to pay for this initiative. President Obama proposed budgeting $215 million to fund this effort. But such funding must be approved by a Congress that is at odds with the President on nearly every issue. Additionally, The American Clinical Laboratory Association (ACLA) warns that the Food and Drug administration’s (FDA) 2014 announcement to regulate laboratory developed testing services (LDTs) is in conflict with the President’s initiative. (more…)

California Regulators Find Many Problems with the Provider Directories That Health Insurers Make Available to Consumers

In California, a survey found significant inaccuracies in provider directories posted online—may trigger action by regulators to have insurers address this problem

Transparency in healthcare is an important trend. In recent years, much attention has been given to increasing the transparency of the prices charged to patients by hospitals, physicians, and medical laboratories. But now the transparency trend is about to drive change in the provider directories that health insurance plans make available to their beneficiaries and consumers.

When choosing a health plan, many people look for insurance that includes their own physician, or at least a doctor close to home. That is why an accurate and up-to-date provider list is essential to consumer choice and access.

But many health insurers fall short in this regard. California recently released chastising reports on two of its major health plans, Anthem Blue Cross and Blue Shield (ABCBS) (NYSE:WLP) and Blue Shield of California, (BSCA) for publishing inaccurate provider lists on the state’s California Covered insurance exchange. (more…)

Most Clinical Laboratories and Pathology Groups Unprepared to Help Client Physicians Meet Meaningful Use Stage 2 Criteria

Because of the failure of many EHR products to obtain MU Stage 2 certification, physicians using those EHRs are being forced to buy and implement a different EHR

Like the jaws of a vise squeezing together, the nation’s clinical laboratories and pathology groups now find themselves caught in the jaws of the federal government’s complex program to encourage providers to adopt and use electronic health record (EHR) systems.

One jaw is the failure of many EHR systems to certify to Meaningful Use Stage Two requirements, thus exposing physicians using those EHRs to substantial Medicare penalties as early as this year.

The other jaw of this proverbial vise is the need—for the second time—for many medical laboratories to spend substantial amounts of money to create a new LIS-to-EHR interface to those client physicians who are replacing their first EHR system, because it is not certified to Meaningful Use Stage 2 and they want to avoid Medicare penalties for use of a non-certified EHR. (more…)

Implantable Wireless Heart Failure Management System Significantly Reduces Hospital Readmissions and May Inspire Implantable Diagnostic Test Devices

Implantable devices with this technology could be designed to perform some of the same kinds of assays currently handled in medical labs

Implantable diagnostic devices that report results wirelessly to patients’ physicians could be both a threat and an opportunity for clinical laboratories and pathology groups. News of clearance by the Food and Drug Administration (FDA) of an implantable monitoring device for home use by heart patients demonstrates that such technology is improving with rapid speed.

Could Implantable Monitoring Devices Replace Some Medical Lab Tests?

Patients use CardioMEMS from the comfort of their homes. The implantable monitoring device measures pulmonary artery pressures and heart rates and transmits that data wirelessly to physicians. It was last summer when the FDA cleared the CardioMEMS Heart Failure Management System, manufactured by St. Jude Medical of St. Paul, MN. Such implantable technology could eventually perform certain assays currently handled in medical laboratories. (more…)

Does Your Clinical Laboratory or Pathology Group Have the Effective Leaders It Needs During These Challenging Times?

On May 5-6 in New Orleans, leadership will be a major theme when “the U.S. Army War College meets the Executive War College on Lab and Pathology Management” in a special workshop for executive leaders of labs and pathology groups

Some would argue that leadership in medical laboratories today has something in common with the opening line of a famous 19th century novel.

“It was the best of times, it was the worst of times,” is the first sentence in “A Tale of Two Cities,” Charles Dickens’ famous novel. Many pathologists and clinical laboratory managers would agree that this sentence accurately describes today’s marketplace for medical laboratory testing. (more…)

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